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Philips expands commercial availability of LumiGuide imaging system

By
Bryan Kay
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Philips expands commercial availability of LumiGuide imaging system

LumiGuide in use

Philips has announced the expanded commercial availability of LumiGuide 3D device guidance—the much-heralded first real-time artificial intelligence (AI)-enabled light-based navigation solution for image-guided therapy—across Europe and the USA. 

LumiGuide integrates with Philips’ Azurion platform, which is designed to drive procedural innovation across clinical domains.

“I have done over 160 fenestrated and branched aortic procedures with LumiGuide and have found that the system improves efficiency, reduces the procedure time, and reduces time on the fluoroscopy pedal to near zero,” said Adam W. Beck (University of Alabama at Birmingham, USA).

LumiGuide, powered by Philips Fiber Optic RealShape (FORS) technology, is the first solution to use light to visualize the shape and position of LumiGuide wires and compatible endovascular catheters inside the body in real time and in 3D without X-ray.

Following a limited market release in late 2023, LumiGuide will be commercially available from January 2026 in key European markets and the United States, Philips reported.

NIH-funded WARRIORS trial advances toward launch

By
Marlén Gomez
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NIH-funded WARRIORS trial advances toward launch
Adam Beck

The National Institutes of Health (NIH) has approved funding for the WARRIORS international randomized trial comparing endovascular aneurysm repair (EVAR) with watchful waiting in women with small abdominal aortic aneurysms (AAAs) measuring 4–5.5 centimeters.

In the United States, the trial will leverage the SVS Vascular Quality Initiative (VQI) endovascular aneurysm repair (EVAR) and vascular medicine registries to collect data at treatment and at one- and five-year follow-ups. Patients will provide consent to the data-coordinating center at the University of Alabama at Birmingham to receive their identified data. This center will oversee site selection, contracts and data queries.

Adam Beck, MD, chair of the SVS Vascular Quality Initiative (VQI) and U.S. principal investigator for the WARRIORS trial, emphasized the importance of both the scientific question and the innovative use of registry infrastructure.

“This trial addresses one of the most important unanswered questions in aortic disease—how best to care for women with small AAAs. Integrating VQI registry data directly into a national and international randomized study allows us to streamline site selection and dramatically enhance data collection efficiency. This model has the potential to accelerate enrollment, reduce cost and fundamentally change how large-scale vascular trials are conducted,” said Beck.

The trial is a study outside of the SVS Patient Safety Organization (PSO) but uses the VQI registries for data collection with SVS PSO permission.

The U.S. arm of the WARRIORS trial plans to enroll 350 patients across 35 sites. Fivos, the SVS PSO’s technology partner, will support registry development, create custom variables and provide training for participating centers. Data will be transmitted quarterly for three years during enrollment and annually for five years of long-term follow-up, for a total project duration of eight years.

The NIH-funded trial is expected to clarify whether early intervention with EVAR offers benefits over surveillance in women with small AAAs—a question with significant implications for clinical practice.

SVS smoking cessation initiative aligns with national cancer society effort to help efforts aimed at curbing the habit

By
Marlén Gomez
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SVS smoking cessation initiative aligns with national cancer society effort to help efforts aimed at curbing the habit
Nikolaos Zacharias

Vascular specialists have been intensifying efforts to combat tobacco use through the Society for Vascular Surgery Patient Safety Organization (SVS PSO), which is leading a targeted campaign to help patients quit smoking and reduce their risk of vascular disease. The initiative aligns with the Great American Smokeout, a national event that took place on Nov. 20 encouraging smokers to begin their journey toward a smoke-free life.

Organized annually by the American Cancer Society, the event takes place on the third Thursday of November. The campaign urges smokers to make a plan to quit or start the process that day. It highlights the health benefits of quitting, including a lower risk of cancer, heart disease and stroke, and improved overall well-being.

For vascular surgery patients, smoking cessation is especially critical. Tobacco use is a leading modifiable risk factor for cardiovascular disease and peripheral arterial disease (PAD).

In July 2023, the SVS Vascular Quality Initiative (VQI) launched its third National Quality Initiative (NQI), known as CAN-DO Smoking Cessation, which stands for Choosing Against Nicotine Despite Obstacles. The initiative is designed to reduce smoking among vascular patients by leveraging clinical data, patient education and clinician engagement.

CAN-DO builds on the success of previous SVS VQI efforts, including the discharge medication NQI, which improved five-year survival rates by increasing the use of antiplatelet agents and statins. That initiative achieved nearly 90% compliance across 18 VQI regions, demonstrating the impact of data-driven quality improvement.

The smoking cessation initiative focuses on two key reporting measures: preoperative smoking status, identifying patients who are actively smoking within one month of their vascular procedure; and smoking cessation at follow-up, tracking whether patients have quit smoking between nine and 21 months after their procedure.

SVS VQI data show that about 32% of patients across registries successfully quit smoking between their procedure and long-term follow-up. These results underscore the importance of targeted interventions during what clinicians call the “teachable moment,” when patients are more receptive to health advice due to the urgency of their condition.

The initiative is designed to be easy to implement, requiring minimal additions to clinical workflows. The SVS VQI has developed a wide range of resources to support both clinicians and patients, including smoking cessation toolkits, sample charters and smart phrases for electronic health records, educational webinars, posters such as “Effects of Nicotine on the Body,” and patient handouts like “Smoking Cessation Quick Tips.”

Clinicians are also encouraged to pursue Certified Tobacco Treatment Specialist certification to enhance their ability to counsel patients effectively.

Since its launch, CAN-DO has gained momentum across all 18 VQI regions. Centers have created regional and national charters, developed billable smart phrases for electronic health records and contributed abstracts to the VQI at the SVS Vascular Annual Meeting (VQI@VAM). As of 2025, 30 charters have been established, and the initiative is set to become part of the SVS VQI Participation Awards in 2026.

“This level of engagement reflects the vascular community’s commitment to improving patient outcomes through behavioral change,” said Nikolaos Zacharias, MD, medical director for quality and safety at Massachusetts General Hospital, Brigham Division of Vascular Surgery. “By combining clinical data, education and collaboration, the initiative is transforming how vascular specialists address smoking in their practices.”

The growth of CAN-DO aligns with the Great American Smokeout, as both efforts share a common goal: reducing the burden of tobacco-related disease and improving public health. The Smokeout provides a national platform to amplify the message of smoking cessation, while the SVS VQI offers a clinical framework to make that message actionable.

“Together, they represent a powerful alliance between public health advocacy and clinical quality improvement,” Zacharias said. “Vascular specialists can use this opportunity to reinforce the importance of quitting smoking—not just for patients undergoing vascular procedures, but for all individuals at risk of tobacco-related disease.”

The SVS VQI Smoking Cessation NQI continues to evolve, with new resources and engagement strategies being added regularly. Its success depends on ongoing collaboration among clinicians, patients and regional groups.

For more information, visit vqi.org/Smoking-Cessation and the SVS patient education portal at vascular.org/Quit-Smoking.

Meta-analysis: Drug-coated devices show comparable aggregate outcomes to non-drug-coated devices in CLTI

By
Killian Meara
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Meta-analysis: Drug-coated devices show comparable aggregate outcomes to non-drug-coated devices in CLTI
From left to right: Arshia Javidan, David Szalay and Allen Li

Drug-coated balloon (DCB) angioplasty appears to offer similar benefits as plain old balloon angioplasty (POBA), with or without stenting, for patients with chronic limb-threatening ischemia (CLTI) who are undergoing endovascular femoropopliteal segment lower extremity revascularization, according to new meta-analysis data presented at the annual meeting of the Canadian Society for Vascular Surgery (CSVS) in Ontario, Canada (Sept. 26–27).

Investigators from University of Toronto, led by senior author David Szalay, MD, associate professor in the department of surgery, conducted a meta-analysis that analyzed data from six clinical trials comparing POBA with DCB for the treatment of the femoropopliteal segment in patients with CLTI.

The study looked at four key outcomes: freedom from major amputation, major adverse limb events, the need for additional procedures, and mortality. The goal was to see whether using drug-coated devices, which release the medication paclitaxel, led to better results than using plain balloons. Data was gathered from Embase, MEDLINE, and relevant articles cited in major guidelines on peripheral arterial disease (PAD).

Findings showed there was no statistically significant difference in limb events or mortality between DCB or POBA. After synthesizing evidence using the GRADE tool, all key endpoints except mortality were rated with a moderate to high degree of certainty. “The results show there isn’t a statistically significant difference in terms of the four outcomes we analyzed when comparing a drug-coated device to a plain balloon angioplasty,” said first author Allen Li, MD, a second-year integrated vascular surgery resident at the University of Toronto.

Though the absence of a clear difference might appear to narrow the decision-making process, co-author Arshia Javidan, MD, a fifth year integrated vascular surgery resident at the University of Toronto, said the implications are far more nuanced due to the complexity and heterogeneity of the CLTI population. “It will always depend on the specific patient and their anatomy rather than a large paintbrush that we can sweep across the whole field and say we should or shouldn’t use [paclitaxel] in these scenarios,” said Javidan.

Li and Javidan both emphasized that the study’s overall strengths and limitations should be considered when interpreting the results. “One of the biggest limitations of the study, and with every high-level meta-analysis, is that it is not patient-level data,” said Javidan. “These are outcomes taken in aggregate where you lose so much of the granularity that exists in making these decisions.”

The study contributes to ongoing discussions about using drug-coated devices in clinical practice. Javidan said patients with CLTI are high-risk and prone to restenosis, and paclitaxel effectively targets neointimal hyperplasia. While previous research raised concerns about increased mortality with paclitaxel, he said that this has not been consistently supported by later data. “The messaging around paclitaxel-coated devices is that it really is patient dependent,” said Javidan. “You have to choose the right device for the right patient.”

Earlier this year, new data emerged showing drug-coated balloons and stents were not associated with reduced risk of amputation or improved quality of life compared with uncoated devices in the SWEDEPAD 1 and 2 trials. In addition, higher five-year mortality with drug-coated devices in patients with intermittent claudication was noted, leading researchers to stress that the safety of paclitaxel-coated devices is an “ongoing discussion.” These late-breaking findings were presented at the European Society of Cardiology (ESC) 2025 congress in Madrid, Spain, and simultaneously published in The Lancet.

Javidan noted that this ongoing debate is compounded by foundational issues in how research is conducted. “Our ability to synthesize evidence through meta-analysis is fundamentally limited by the heterogeneity in how major trials define their patient population, their endpoints, and even the anatomy of the lesions they are treating,” he said. “Adopting universal classification and anatomic standards, like WIfI and GLASS, and demanding precise definitions for endpoints are not academic exercises — they are essential for delineating clinical truth and improving patient safety.”

Despite this and other challenges, Li and Javidan said the field has made significant progress over the past decade. “We’ve come together and have come up with what is close to global consensus guidelines on a lot of these definitions,” Javidan said.

Li and Javidan also pointed to future directions in CLTI research, including the use of large-scale databases like the Vascular Quality Initiative (VQI) for patient-level analyses. “What is needed now is really looking specifically in the subgroups of CLTI,” Li said. “PAD exists on a spectrum. We saw from the initial trials looking at DCBs in claudicants there were significant benefits. Similarly, CLTI also has a spectrum — patients can present with rest pain, minor tissue loss, or major tissue loss, and have varying anatomic and patterns of arterial disease. Looking in specific subgroups and seeing whether or not one subgroup might benefit more, that’s the next step in applying the results of this study.”

Changing the game in knee osteoarthritis: A vascular approach

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Changing the game in knee osteoarthritis: A vascular approach
Chinmaya Shelgikar
Chinmaya Shelgikar, MD, discusses the benefits of vascular surgeons performing geniculate artery embolization.

Geniculate artery embolization (GAE) is an intra-arterial, catheter-based procedure used to treat chronic knee pain that is caused by osteoarthritis (OA). It targets the distal branches of the geniculate arteries supplying the synovium and joint capsule of the knee and then occluding the distal vessels.

A salient pathological feature of knee OA is low-grade chronic inflammation, often accompanied by abnormal angiogenesis in the synovium and adjacent structures. It is hypothesized that these new, fragile blood vessels play a role in pain generation by carrying inflammatory mediators and sensitizing nearby nerves.

The technique of GAE is relatively straightforward. It can either be done through an antegrade or retrograde common femoral access using a 5F sheath. Often, the genicular vessels can be selected with a 4F catheter. This is usually followed by a micro catheter into the distal branches and then selective embolization using 100-to-300-micron embospheres. Typically, three-to-four vessels are selected to be embolized. To avoid non-target embolization, it is essential to do a thorough diagnostic angiogram to make sure that the geniculate vessels do not collateralize to the popliteal artery or the recurrent anterior tibial artery.

The procedure typically takes 1 to 2 hours and is performed under conscious sedation in an office-based lab (OBL) or hospital outpatient setting. Most patients can return home the same day and resume normal activities within a few days. GAE does not alter the structural integrity of the knee, making it an appealing option for patients who are not candidates for surgery or wish to delay knee replacement. Long-term clinical studies are still ongoing; however, one-year data appear promising.

Patient selection for GAE is crucial. They should be fully worked up by orthopedic surgery or physical medicine and rehabilitation (PM&R) specialists. Direct patient referrals should be avoided. There are several benefits for vascular surgeons to learn this procedure. From a technical perspective, it is good practice for keeping up with micro catheter skills and embolization techniques. These skills can be then extrapolated to other vascular bodies, including the prostate, liver and for treatment of arteriovenous malformations.

It is also an important way to collaborate with specialties that we don’t normally share patients with and would facilitate a symbiotic relationship with our orthopedic surgery colleagues. Commonly, we only know them when a vascular complication occurs in one of their patients. Additionally, a tighter working relationship with PM&R may help increase peripheral arterial disease (PAD) volumes as well. Finally, in the era of decreasing reimbursement for PAD work, this can be an important way to financially supplement a vascular practice; especially those working in an OBL.

In general, the patients best suited for this procedure are those who have moderate-to-severe osteoarthritis who have failed conservative treatments such as physical therapy, NSAIDs, intra-articular corticosteroids, geniculate nerve ablation or hyaluronic acid injections. It is not recommended for patients with advanced joint destruction, extensive bone-on-bone changes, or those with active infections or coagulopathies. The procedure is fully covered for Medicare recipients under the CPT code 37242.  Private payers often require a prior authorization but denials are less common given the cost of knee replacement surgery.

Potential risks of this procedure—including embolization and access-site injuries—are rare. Most commonly, patients will have post-embolization syndrome, including skin discoloration, knee swelling, and more pronounced knee pain for the first few weeks. This improves significantly and most patients at one-month follow-up do not have any significant symptoms.

Chinmaya Shelgikar is vascular surgeon with Trinity Health IHA Medical Group in Ann Arbor, Michigan.

How important is complex endovascular aortic training in the current landscape?

By
Saranya Sundaram
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How important is complex endovascular aortic training in the current landscape?
Saranya Sundaram

Just a few years ago, it was commonly accepted that training in complex endovascular aortic operations (e.g. physician-modified endografts [PMEGs], use of in-situ laser fenestration, redo-branched aortic interventions etc.) depended heavily on the location and practice of the institution where residents/fellows trained.

If vascular surgeons at a particular institution participated in these procedures, it was often with multiple vascular surgery attendings scrubbed or with interdisciplinary participation from either interventional radiology or cardiothoracic surgery. Trainees at high-volume institutions had the benefit of being able to participate in these procedures, but expertise did not necessarily affect board certification or job availability.

This is not to say either of those outcomes are affected by comfort with complex endovascular aortic procedures today. However, with the landscape of who we treat and what we treat them with constantly shifting, it’s an important aspect of training to re-assess. New data on long-term follow up after acute dissection now suggests early intervention may have benefit to aortic-specific survival and delayed disease progression.1 Publications have suggested a higher incidence of branch involvement in younger patients presenting with acute aortic dissection.2 And survival rates predict over 70% survival of both those fixed and unfixed, suggesting more chronic dissections may present requiring further intervention.

Even in the abdominal aneurysm sphere, an increasing number of commercially available branched devices have been placed in patients that may eventually require repair. And proximal degeneration of prior infrarenal repairs continues to necessitate proximal branched endograft extensions to achieve appropriate seal. Prior branched interventions such as snorkels—even physician-modified endografts—are not immune to endoleak and need for revision of branched interventions.

Not all trainees want to or plan to participate in complex endovascular aortic interventions in their future practice. But that does not negate the increased interest in those who can demonstrate competence in “backtable” endograft modification or comfort with in-situ laser fenestration, endoleak evaluation/repair, or deployment of off-the-shelf branched endografts. From speaking to several graduates who went to practice at mainly community or private settings, even they have been asked to participate or manage patients requiring “complex endovascular aortic techniques” because of their training background/procedural comfort. It’s clear that the patient need is present; with continued shortage in vascular surgeon availability, it makes sense increasingly complex aortic pathology has been identified at non-academic practices. It’s only time before these patients find a practitioner who can offer them an appropriate intervention, which could now be dictated by graduating trainee comfort with these practices.

A few years back, trainees were advised to interrogate program comfort with open intervention to ensure they received a well-rounded surgical training. As the landscape of vascular surgery continues to change, it may now be important for trainees to determine if they will have adequate exposure to complex aortic techniques, especially if they desire to work at a high-volume academic or community practice with general call. Though, at this current moment, comfort with these techniques do only serve to benefit trainees in what they can offer to their future practices.

References

  1. Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407–16.
  2. Wu S, Cao C, Lun Y, Jiang H, Wang S, He Y, Sun J, Li X, He Y, Huang Y, Chen W, Xin S, Zhang J. Age-related differences in acute aortic dissection. J Vasc Surg. 2022 Feb;75(2):473–483.e4.

Saranya Sundaram, MD, is a fourth-year integrated vascular surgery resident at the Medical University of South Carolina (MUSC) in Charleston.

Leadership development program cohort 6 celebrates graduation

By
Marlén Gomez
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Leadership development program cohort 6 celebrates graduation
SVS Leadership Development PRogram cohort 6

The sixth cohort of the Society for Vascular Surgery (SVS) Leadership Development Program (LDP) gathered Oct. 19–20 in Rosemont, Illinois, for a capstone workshop and graduation ceremony, marking the culmination of an intensive, months-long journey in leadership training for vascular surgeons.

The LDP is an immersive, experiential program designed to equip vascular surgeons with the tools and strategies needed to lead effectively within their practices, hospitals and professional societies. The curriculum blends evidence-based instruction with real-world application, fostering a dynamic environment where participants engage in problem-solving, mentorship and peer-to-peer learning.

Gabriela Velazquez, MD chair of the LDP, emphasized the program’s unique ability to build a strong, supportive network among participants.

“In the LDP, you build this community of people who are really invested in a leadership journey—not just to navigate how things work in their institutions, but to seek support as they overcome challenges in their careers and other opportunities that come their way,” Velazquez said. “One of the things I’ve really loved is gaining insight from other leaders with so much experience. It gives us a different perspective on how to manage challenges that once felt daunting.”

Graduates of the LDP report increased confidence in leadership roles, improved negotiation skills and a greater likelihood of taking on leadership positions within professional societies.

For more information about future cohorts of the Leadership Development Program, visit vascular.org/LDP.

‘Vascular surgery is leading the way’: Neurodivergence in care

By
Marlén Gomez
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‘Vascular surgery is leading the way’: Neurodivergence in care
Carlos Pineda

“We are the first major U.S.-based surgical society to present this topic to our membership. Once again, vascular surgery is leading the way,” said Carlos Pineda, MD, a member of the Society for Vascular Surgery (SVS) Cultural Competency Committee (CCC), formerly known as the DEI Committee. Pineda was speaking during his opening remarks at the committee’s fourth annual summit, entitled “Neurodivergence for the Vascular Surgeon.”

The virtual event, held on Oct. 18, placed vascular surgery at the forefront of a growing movement to recognize and support neurodivergent professionals in healthcare. The Summit introduced attendees to the concept of neurodiversity, an umbrella term that includes conditions such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), dyslexia and other cognitive variations.

While industries like technology and finance have made strides in embracing neurodivergent talent, medicine—particularly surgical specialties—has only recently begun to explore this area.

The idea for this Summit’s theme was sparked by a conversation within the CCC last fall. Pineda recalled how William Schutze, MD, an SVS member and volunteer, was moved by the 2024 presidential address at the Southern Association for Vascular Society (SAVS) annual meeting. During the talk, David L. Cull, MD, shared his personal experiences with a learning difference.

“To hear a firsthand, honest account from a respectful vascular surgeon about the challenges and strengths associated with learning differences was both fascinating and eye-opening,” said Pineda. “By understanding this topic better, we’ll be able to help our colleagues, trainees and students who are neurodivergent. Many possess extraordinary abilities that, when recognized and supported, can help advance our specialty and improve care for our neurodivergent patients.”

Scott Humphries, MD, medical director of the Colorado Physician Health Program (CPHP), opened the neurodiversity summit with a primer on neurodivergence, exploring its scientific underpinnings and the stigma that often surrounds this topic.

“When we look at neurodivergency, we’re looking at where someone falls on a spectrum,” said Humphries. “It’s not about drawing hard lines, but understanding how traits can affect daily life, and when individuals may need additional support.”

As a psychiatrist, Humphries emphasized that while neurodivergent conditions are often straightforward to treat, overconfidence in diagnosis can lead to missteps.

James Henderson, MD, FHEA, a consultant on neurodivergence, a surgeon and deputy lead of Autistic Doctors International, offered a personal perspective. Diagnosed with autism in his mid-forties, Henderson shared how his neurodivergence shaped his approach to medicine.

“To me, autism is simply a way of being,” he said. “It’s not something that can or should be cured. We just perceive and interact with the world differently, and that diversity of thought can be a strength.”

Henderson reminded attendees that neurodivergence is deeply individual. “If you’ve met one [autistic person], you’ve met only one [autistic person],” he said.

Omid Jazaeri, MD, vice-chair of the CCC, shifted the focus to patient care, highlighting how neurodivergence affects not only providers but also the patients they serve. With 15–20% of adults estimated to be neurodivergent—many undiagnosed until later in life—Jazaeri emphasized the importance of adapting care strategies in vascular surgery where the patient population skews older.

“Caring for your neurodivergent patient isn’t extra work. It’s essential work. It’s work that you must do to accommodate for them,” he said.

Jazaeri outlined practical strategies for improving communication and care, such as avoiding medical jargon, offering visual aids and written summaries, allowing extra processing time, and validating patient perspectives, even when they seem atypical.

“When you’re discussing high-stakes decisions like carotid surgery, or even low-risk procedures like varicose vein treatments, you have to be very specific and clear,” he said. “Don’t assume patients understand; give them the time and tools they need.”

In the Summit’s closing session, Jazaeri called for a shift in mindset: “We need to move away from framing neurodivergence as a deficit. It’s a difference—one that enriches our profession.”

“We have to stop labeling patients as ‘non-compliant’ or ‘difficult’ without understanding the context they’re coming from. There’s a real opportunity here to change how we train, support and evaluate both patients and professionals,” he said.

Patrick Ryan, MD, a summit participant, was also diagnosed with a learning disorder in adulthood. He questioned the speakers about how well SVS accommodates neurodivergence in leadership evaluations. Rana Afifi, MD, chair of the CCC, acknowledged that the organization has room to grow.

“We have a lack of awareness, lack of knowledge and lack of education about this,” she said. “The choices on the leadership track in the SVS were made in a way where it did not at some point give room for uniqueness and different skills.”

In recent years, the CCC itself has updated its rubrics to focus more on competencies and less on traditional markers such as position or background when selecting nominees.

Jazaeri proposed several initiatives as action items for the SVS to tackle over the next three to five years, including advocating with the American College of Surgeons (ACS) and American Medical Association (AMA) for neurodiversity standards in surgery, launching pilot grants for neurodivergence research, embedding neurodiversity into SVS physician well-being frameworks and establishing mentorship networks for neurodivergent vascular surgeons.

“It affects all of us,” Pineda said.  “Trainees, colleagues, coworkers, family, patients and sometimes ourselves. Brushing it with a framework is definitely going to help raise awareness and support. Approaching things with curiosity and not judgment will help. That’s why we have to be open to different opinions. Making this change in our behavior will definitely impact all those around us.”

Stent maintenance: Sustaining long-term patency in deep venous system

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Stent maintenance: Sustaining long-term patency in deep venous system
Stephen Black

This advertorial is sponsored by Stryker/Inari Medical.

As venous stenting becomes more common, the focus must now shift to what occurs after the procedure, according to consultant vascular surgeon Stephen Black, MD, FRCS. The concept of stent maintenance is key, acknowledging that venous stents—once implanted—will require lifelong monitoring to maintain their function.

“When we stent venous patients, we have to remember that their life expectancy is completely different from patients with arterial disease,” says Black, from Guy’s and St Thomas’ NHS Foundation Trust in London, England, and professor of venous surgery at King’s College London. “These are people who will often live with their stents for 30, 40, even 50 years. It’s unrealistic to think that there will never be a need for ongoing follow-up, or that we can discharge them from care after a year or two.”

Unlike arterial or coronary disease, where long-term mortality remains high, venous patients typically live long, active lives after intervention. “The mortality after venous procedures is extremely low,” Black explains. “That means we have to think about what lifelong care looks like for these patients.”

Why surveillance matters

The first few weeks after stent implantation represent a critical window for detecting early stent failure. “Most stents that fail do so early,” explains Black. To better understand and mitigate this risk, his team at Guy’s and St Thomas’ analyzed a decade of surveillance data from 348 patients with chronic post-thrombotic syndrome (PTS), representing more than 500 treated limbs. The findings were clear: re-intervention occurs early, with nearly 50% taking place within six weeks and two-thirds prompted by ultrasound surveillance rather than symptoms, resulting in an acute presentation. A two-week surveillance scan proved highly predictive of long-term outcome. Patients with >50% in-stent restenosis had significantly poorer patency even after re-intervention (p<0.0001), while 30–50% in-stent stenosis was also associated with higher re-intervention rates (p=0.0019).

“These early scans allow us to identify high-risk patients and act before stent occlusion occurs, improving long-term secondary patency,” says Black. At St Thomas’ Hospital, the standard ultrasound surveillance protocol for venous stents is one day, two weeks, six weeks, three months, six months and one year post-intervention. “Patients with early in-stent restenosis need closer imaging and perhaps earlier intervention,” Black explains. This approach, he says, will make post-stent care more efficient and better targeted.

Black emphasizes that even in patients who initially do well, circumstances can change. “Life happens,” he says. “A patient might do perfectly fine for years on anticoagulation, but if they have children, or undergo another surgery where anticoagulation needs to be interrupted, they can develop in-stent restenosis.”

Understanding and defining in-stent restenosis is becoming increasingly important. “We’re starting to look at what constitutes in-stent restenosis and what tools we can use to tackle it,” Black says. “It’s been encouraging to see innovation in this space. Technologies like the RevCore Thrombectomy Catheter and VenaCore Thrombectomy Catheter are part of an expanding toolkit, but we’re still in the early stages.”

Pairing technologies for the future

“Simply debulking the stent is not enough,” Black continues. “We also have to think about what adjunctive technologies we need, whether that’s improving vessel inflow, addressing wall inflammation, or enhancing the biological environment to keep stents patent over time.

“Debulking technology will need to be paired with other tools. Once a stent occludes, it can be almost impossible to cross. You can have the best device in the world, but if you can’t get through the occlusion, you can’t use it. So we need to think about how we cross more effectively and what adjunctive tools will make that achievable.”

He also raises the possibility that stents themselves may alter venous biology over time. “A vein is a capacitance vessel. It’s designed to expand and contract depending on flow,” he explains. “Once you stent it, that adaptability is gone. That may be one of the reasons we see progressive stenosis develop years later.”

Evolving toward biological solutions

Looking ahead, Black envisions new ways to support stented veins and maintain physiologic flow. “We may have to think about how we modulate flow through intermittent pneumatic compression, muscle stimulators or other existing technologies,” he says. “But more interestingly, bioabsorbable materials might play a role. A stent that restores flow, then dissolves, could return the vessel to normal function without lifelong maintenance. We’re not there yet, but it’s something to watch closely.”

Ultimately, Black emphasizes that stent maintenance is a lifelong commitment. “Once we place a stent, we take on the responsibility to look after that patient for as long as they live,” he says. “We have to understand what lifelong management really looks like and make sure we’re ready to deliver it.”

This article is sponsored by Inari Medical. The HCPs sharing their views and opinions here express their experience with Inari Medical devices. The HCPs’ opinions of these devices were formed independently of Inari Medical and may not represent every experience or outcome with the devices.

Indications For Use: The RevCore thrombectomy catheter is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels and (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The RevCore thrombectomy catheter is intended for use in the peripheral vasculature. The VenaCore Thrombectomy Catheter is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels; and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. The VenaCore Thrombectomy Catheter is intended for use in the peripheral vasculature. Review complete Instructions for Use, Indications for Use, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. For all non-Inari products, please refer to complete manufacturer Instructions for Use/Intended Purpose. All copyrights and trademarks are the property of their respective owners PRO-2444-USA-EN-v1

Froedtert Hospital first in Wisconsin to earn national vascular verification

By
Marlén Gomez
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Froedtert Hospital first in Wisconsin to earn national vascular verification

Froedtert Hospital has become the first hospital in Wisconsin to receive national verification as a Comprehensive Inpatient Vascular Center through the American College of Surgeons (ACS) Vascular Verification Program (VVP), in partnership with the SVS.

The designation also recognizes Froedtert Hospital as an ACS Surgical Quality Partner, a title awarded to institutions that meet rigorous standards in surgical care and demonstrate a commitment to continuous quality improvement.

“Achieving vascular verification from the American College of Surgeons and the Society for Vascular Surgery is a testament to our team’s unwavering commitment to excellence in patient care,” said Peter Rossi, MD, associate director of the Heart and Vascular Service Line for the Froedtert & the Medical College of Wisconsin health network and division chief of vascular and endovascular surgery at the Medical College of Wisconsin. “This recognition reflects the skill, collaboration and dedication of our multidisciplinary team in providing the highest standards of vascular care to our community.”

The Vascular Verification Program is an evidence-based initiative designed to help hospitals build and strengthen quality improvement infrastructure within vascular programs.

Hospitals interested in pursuing verification through the Vascular Verification Program can find more information at vascular.org/VVP.

SVS Foundation funds vascular initiatives to the tune of $360,000 last year

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Marlén Gomez
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SVS Foundation funds vascular initiatives to the tune of $360,000 last year

The Society for Vascular Surgery (SVS) Foundation’s 2025 annual report details a year of significant progress in research, education and advocacy aimed at improving vascular health worldwide.

The foundation awarded more than $359,000 in grants during the 2024–2025 cycle, continuing its legacy of supporting research and training. Since 1987, the SVS has provided nearly $16 million in funding to advance vascular science and prepare future leaders in the field.

The report underscores the foundation’s mission to optimize vascular health through research, education and programs that prevent and treat circulatory disease.

Among the year’s milestones was the creation of the Enrico Ascher Vascular Innovation Institute, which will officially launch at the 2026 Vascular Annual Meeting (VAM). The institute is designed to foster innovation, mentorship and education in vascular surgery, offering seed funding for new ideas and hosting the Roy Greenberg Distinguished Lecture and SVS Medal of Innovation.

The report also highlights the Vascular Health Step Challenge, which marked its fourth year with its first in-person event. More than 100 participants joined a walk at Stanford University, contributing to a global effort that logged 47,806 miles and raised $78,000 to promote awareness of peripheral arterial disease.

Financially, the foundation reported $8.1 million in total liabilities and equity, with 51% of funds spent on programs. Contributions came primarily from industry (60%), followed by individual donors (25%) and foundations or societies (15%). All board members contributed, along with 31% of active members.

For more information or to view the full report, visit vascular.org/SVS-Foundation.

‘Historical’ CREST-2 data show reduced stroke risk with carotid stenting versus medical therapy alone

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‘Historical’ CREST-2 data show reduced stroke risk with carotid stenting versus medical therapy alone
Brajesh K. Lal presents the results of CREST-2 at VEITH 2025

The international CREST-2 study has found that, for people with severe carotid artery narrowing who have not experienced recent stroke symptoms, a minimally invasive carotid artery stenting (CAS) procedure—combined with intensive medical therapy—significantly lowered stroke risk compared with medical therapy alone. The more traditional surgical approach of carotid endarterectomy (CEA) did not show the same benefit, however.

The research was presented today at both the 2025 VEITHsymposium in New York City (Nov. 18–22) by co-principal investigator Brajesh K. Lal, MD, a professor of surgery at the University of Maryland in Baltimore, and at the 2025 Society of Vascular and Interventional Neurology (SVIN) annual meeting in Orlando, Florida (Nov. 19–22) by James Meschia, MD, a vascular neurologist at the Mayo Clinic in Jacksonville, Florida. The trial has also been published in the New England Journal of Medicine.

CREST-2 was funded by the US National Institutes of Health (NIH), and is said to be the largest study to date comparing current treatment approaches for carotid artery disease caused by plaque buildup in the arteries supplying blood to the brain. According to the study researchers, although surgery and stenting have long been used to open these arteries, newer medications and better risk-factor control have raised questions about whether such procedures are still needed for people who do not have symptoms.

“Decades ago, surgery clearly helped prevent strokes in many patients,” said co-principal investigator and study senior author co-principal investigator Thomas Brott, MD, a professor of neurology from the Mayo Clinic in Jacksonville. “But medical therapy has improved so much that we needed to re-examine the balance between benefit and risk for people who have no symptoms.”

The CREST-2 program consisted of two parallel, randomized clinical trials conducted at 155 medical centers in five countries: Australia, Canada, Israel, Spain and the USA. Each of the trials enrolled more than 1,200 adults with severe carotid artery narrowing of 70% or greater who had not had a stroke or transient ischemic attack in the past six months.

In one trial, participants received either stenting plus intensive medical therapy or medical therapy alone, and, in the other, participants received endarterectomy plus medical therapy or medical therapy alone. All participants received comprehensive medical care—including lifestyle coaching and medication as needed—to manage their blood pressure, low-density lipoprotein (LDL) cholesterol and diabetes, and to help them stop smoking.

Researchers analyzed the occurrence of stroke and death within 44 days of stenting or surgery, and the occurrence of stroke over the course of four years on the same side of the body as the narrowed artery.

The trial comparing stenting versus medical therapy found a significant reduction in stroke; over four years, 2.8% of patients treated with stenting and medical therapy had a stroke compared to 6% of those on medical therapy alone—roughly halving the risk of stroke. However, in the endarterectomy trial, the difference in stroke rates—3.7% with surgery plus medical therapy versus 5.3% with medical therapy alone—was not statistically significant. In addition, serious complications were shown to be uncommon with either procedure.

The findings are believed to provide clearer guidance for physicians and patients considering a preventive procedure for carotid artery stenosis, with Brott emphasizing the importance of personalized decision-making as well.

“For some patients—particularly those with more advanced narrowing, or plaque that appears unstable or more likely to cause a blockage—stenting may offer added protection, while, for others, medical therapy alone may be enough,” he stated.

Close follow-up and coordinated care helped all participants in CREST-2 achieve and maintain significant improvements in their blood pressure and cholesterol levels, the researchers further claim.

Brott and colleagues will continue to track participants for long-term results, and they are also currently studying whether imaging tools can help identify which patients benefit most from each treatment.

Atherectomy in PAD: Meta-analysis of ‘extensive’ published literature supports use in ‘appropriately selected’ patients

By
Jocelyn Hudson
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Atherectomy in PAD: Meta-analysis of ‘extensive’ published literature supports use in ‘appropriately selected’ patients
Eric Secemsky at VEITH 2025
Eric Secemsky presents the findings at VEITH 2025

A systematic review and meta-analysis of more than 300 original investigations on atherectomy in peripheral arterial disease (PAD) highlights “overall favorable” clinical outcomes. This and other findings from what researchers say is the first investigation to provide a “comprehensive” overview of the atherectomy literature were recently published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) and presented at the 2025 VEITHsymposium in New York City (Nov. 18–22).

“Although atherectomy for peripheral interventions has been studied for over 35 years, recent criticisms suggest it lacks supportive evidence,” the researchers, led by co-first authors Jeffrey Carr, MD, an interventional cardiologist from Christus Health Heart and Vascular Institute in Tyler, Texas, Ralf Langhoff, MD, an interventional angiologist from Humboldt University Berlin, Berlin, Germany, and Eric Secemsky, MD, an interventional cardiologist from Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, write. As a result, Carr and colleagues set out to provide an “intentionally broad overview” of both the quality of the “extensive” published literature on atherectomy and the procedure’s clinical outcomes.

The research team conducted a systematic review of original research published in MEDLINE, Embase, and PubMed through November 2024, identifying both prospective and retrospective studies on atherectomy for infrainguinal peripheral artery interventions. They note that while case studies and meta-analyses were included in the systematic review, these study types were excluded from the quantitative meta-analysis.

Carr and colleagues specify that study design, device class, patient and lesion characteristics, provisional stenting, distal embolisation, and 12-month outcomes—namely patency, major amputation, target lesion revascularization, and mortality—were captured.

In JSCAI, the authors share that their systematic review included 322 published atherectomy papers comprising 121 directional, 44 laser, 30 orbital, 72 rotational, and 55 mixed atherectomy classes. They note that the designs were meta-analyses in 3.7% (12 papers), randomized controlled trials in 5.9% (19 papers), prospective observational studies in 29.8% (96 papers), retrospective observational studies in 45.7% (147 papers), and case studies in 14.9% (48 papers). Additionally, they state that adjunctive therapies were used in 91.5% and 29.2% were included in a comparator arm.

Carr and colleagues report that, among 190 papers included in their meta-analysis, the 12-month patency, target lesion revascularisation, major amputation, and mortality rates were 75.4% (51 studies), 15.6% (67 studies), 1.7% (71 studies), and 2.8% (63 studies), respectively. Furthermore, they report that the distal embolisation rate was 2.2% (159 studies) and the provisional stenting rate, 9.3% (131 studies). “Considerable heterogeneity was observed,” the authors write.

Acknowledging some limitations of their paper, Carr and colleagues recognize that a lack of data prevented the assessment of longer-term follow-up data beyond the five-year mark. In addition, they accept their review is restricted in its ability to compare classes of atherectomy devices across studies and is “unable to provide firm conclusions” regarding the outcomes of atherectomy as a standard procedure, given that the majority of included studies used adjunctive therapies, among other drawbacks.

Carr and colleagues summarise in their conclusion that the present analysis highlights low rates of amputation, mortality, provisional stenting, and distal embolization with atherectomy and demonstrates an absence of safety signals and efficacy rates that are within accepted standards. They remark that the investigation “supports the use of atherectomy in appropriately selected patients as part of the endovascular treatment algorithm for [PAD]”.

Looking ahead, the authors suggest future trials should address the impact of plaque modification with atherectomy in the context of evolving drug delivery solutions with drug-coated balloons, drug-eluting stents, and bioabsorbable devices.

“As atherectomy devices continue to evolve, it is important to support newer technology with trials, registries, and other evidence-generation means,” the authors suggest, considering future research in this space. They also highlight the importance of evaluating the cost-effectiveness and accretive value of atherectomy outcomes with longer-term studies.

Carr and colleagues note in their JSCAI paper that this work was supported by Medtronic.

Esprit BTK: Drug-eluting resorbable scaffold poised as first-line therapy for below-the-knee CLTI

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Esprit BTK: Drug-eluting resorbable scaffold poised as first-line therapy for below-the-knee CLTI
Esprit BTK

This advertorial is sponsored by Abbott.

Esprit BTK

“We now have something on label and FDA [Food and Drug Administration] approved that we can use as a first-line therapy for tibial vessels,” Richard Pin, MD, chief of vascular surgery at Southcoast Health in New Bedford, Massachusetts, tells Vascular Specialist, designating a primary role for the Esprit BTK everolimus-eluting resorbable scaffold system (Abbott) in the treatment of below-the-knee (BTK) chronic limb-threatening ischemia (CLTI).

In this interview, Pin highlights his extensive clinical experience with Esprit BTK and shares how the device is fundamentally changing clinical practice for a challenging disease state where timely intervention is key.

Tackling tibial vessel disease

According to Pin, one of the most pressing unmet needs in the treatment of CLTI relates to tibial vessel disease. Moreover, “time is critical” in these patients, Pin says—many of whom are referred from wound care centers—to prevent tissue loss and amputation.

Esprit BTK, Pin remarks, has “helped tremendously” in the tibial vessels, offering a “new weapon in the armamentarium” and a more durable treatment option able to keep vessels patent over a longer period of time than angioplasty thanks to its radial strength and sustained everolimus elution, all while leaving nothing behind. “Often, tibial vessels are the culprit in terms of recurrent disease, recurrent wounds, and now we have a durable option to treat that,” he says.

Pin underscores that for patients with CLTI—many of whom are poor surgical candidates due to comorbidities and lack of suitable bypass conduit—balloon angioplasty alone often falls short. Esprit BTK offers a transformative alternative, Pin claims, combining recoil resistance and everolimus elution with the long-term benefits of a bioresorbable scaffold, giving physicians a more effective and durable option to restore perfusion and preserve future treatment options.

Reduced reinterventions

Pin’s views on Esprit BTK rest on vast clinical experience, with his institution being part of the landmark LIFE-BTK randomized controlled trial (RCT)—for which two-year data were presented at VIVA 2024—as well as the LIFE-BTK pharmacokinetics sub-study and the device’s post-approval study (PAS). “Our experience with Esprit BTK has been pretty extensive,” he says, “despite the short time that it’s been on the market.”

Case images demonstrating Pin’s use of the Esprit BTK device

Summarizing some of the headline findings from the available data, Pin details a 31% superiority versus balloon angioplasty in terms of limb salvage and primary patency at one year, with sustained benefits through two years.1,2 Most importantly, he highlights a significantly reduced need for patients to return to clinic for a reintervention following treatment with the Esprit BTK, with 90.3% of Esprit BTK patients not requiring a reintervention through two years in the trial.2,3 “Those were the things that were borne out through the clinical trial, and, from an anecdotal standpoint, those are the things we see first-hand when we’ve been using Esprit BTK,” Pin says.

The main therapy available prior to Esprit BTK has been balloon angioplasty, Pin shares, highlighting several limitations to this approach in a recounting of his treatment algorithm: “We would do our angiogram and try to open up any tibial vessels with angioplasty alone, and if that didn’t give us a satisfactory result, then we were talking about doing something off label, which was putting a coronary stent into a tibial vessel to support a dissection or recoil in the vessel that wasn’t adequately treated with angioplasty alone.” However, Pin continues, a permanent metallic implant has not been rigorously studied in an RCT in the tibials, and can compromise future treatment options, affecting limb salvage and patency.

Pin emphasizes the long-term advantages of Esprit BTK, noting that patients treated with the device are closely monitored both at his center and at wound care facilities. He details that this integrated follow-up approach—combining regular wound assessments with ultrasound and ankle brachial index (ABI) surveillance within the first one to three month—enables early monitoring and supports optimal healing. In addition, Pin remarks that the structured, ongoing follow-up every three to four months until wound resolution reflects the confidence clinicians have in Esprit BTK’s ability to promote durable vessel patency and sustained wound improvement, far beyond what balloon angioplasty alone can offer.

Pin is confident the device will continue to bring about positive long-term results, with three-year data from the LIFE-BTK trial to be released this autumn.

Key features: A first-of-its-kind device

Pin underlines several unique features of the Esprit BTK that he sees as crucial to its success so far. He highlights, for example, the fact that it is the first device of its kind to be approved by the FDA for treatment of the tibial vessels and uniquely can address both the mechanical and biological needs to effectively treat CLTI.

Pin reiterates that the scaffold provides the support to treat recoil or dissection from balloon angioplasty, with radial strength equivalent to a metallic stent within the first six months.4 On this point, Pin states that recoil is a significant issue when treating tibial vessels and is therefore something that must be addressed for optimal treatment: “Once you start working on tibial vessels often, you know that they’re going to recoil. It’s not a question of if, it’s when, and the scaffold really prevents that from occurring.” Pin underlines another key feature in that the sustained three-month period of everolimus elution from Esprit BTK is able to suppress any kind of hyperplasia as well as any longer-term issues with stenosis, therefore maximizing patency.1

Pin highlights one of Esprit BTK’s most transformative features in its bioresorbable scaffold that “leaves nothing behind.”5 Unlike permanent metallic implants, he explains, “Over the course of three years, the scaffold is going to dissolve, and so you don’t really have anything that is going to be a long-term irritant to the vessel. Or, if you want to go back and need to treat something else, there isn’t a piece of metal that may compromise, for instance, a distal bypass sometime down the road.”

Pin notes that the resorbable and novel nature of Esprit BTK resonates strongly with patients—many of whom have previously received permanent metallic stents. “They’re very interested,” he says. “A lot of these patients have had other stents put in before, and they’ve been told that these are for life. And here we are, with something that’s resorbable, it definitely piques peoples’ interest. This is really something patients find cutting edge in terms of technology.”

Reflecting on his experience with Esprit BTK, Pin emphasizes the meaningful difference it has made in the lives of his patients. “Esprit BTK has truly changed outcomes for the patients I treat,” he shares, highlighting the device’s role in improving healing and preserving limbs in a population with limited alternatives. He advocates for its use as a first-line therapy, citing its unique ability to combine effective revascularisation with long-term vessel preservation—something traditional therapies often fail to deliver. For patients facing the devastating consequences of CLTI, Pin summarizes, Esprit BTK offers new hope where few options exist.

References

  1. Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Instructions for Use (IFU). Refer to IFU for additional information
  2. DeRubertis BG et al, Two-Year Outcomes of the LIFE-BTK Randomized Controlled Trial Evaluating the Esprit™ BTK Drugeluting Resorbable Scaffold for Treatment of Infrapopliteal Lesions, VIVA 2024
  3. Reintervention defined as CD-TLR
  4. Data on file. Testing done with XIENCE Sierra™ 3.5×38 mm at nominal
  5. Excluding platinum markers

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Terumo Aortic announces launch of Fenestrated Treo pivotal IDE study in US

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Jocelyn Hudson
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Terumo Aortic announces launch of Fenestrated Treo pivotal IDE study in US
Fenestrated Treo

Terumo Aortic today announced enrollment of the first patient in the Fenestrated Treo pivotal investigational device exemption (IDE) study in the U.S. This study is designed to evaluate the endovascular repair of juxtarenal and suprarenal aortic aneurysms using the Fenestrated Treo abdominal stent-graft system. Getinge’s investigational iCast covered stent system will be used as a bridging stent in the study.

“Achieving the first enrollment in this FDA-approved IDE is a major milestone that brings us one step closer to making a fenestrated endovascular graft system available to patients in the USA, representing a significant advancement in treating complex abdominal aortic aneurysms (AAA),” Terumo Aortic states in a press release.

The study will include up to 45 sites in the U.S. Terumo Aortic anticipates that approximately 210 patients will be enrolled across three study arms, representing juxtarenal aneurysms, suprarenal aneurysms, and patients with chronic kidney disease. Patients will then be followed for five years post procedure.

The first patient was enrolled by J. Westley Ohman, MD, from Washington University School of Medicine in St Louis.

Benjamin Starnes, MD, from Harborview Medical Center in Seattle, the national principal investigator for the study, commented: “The Fenestrated Treo stent-graft system provides a revolutionary technology that is not available with any other endovascular graft in the U.S. today. I believe this product will become the gold standard for treating juxtarenal and suprarenal aneurysms.”

Jeffrey Mifek, global vice president of clinical and medical affairs at Terumo Aortic, said: “The Fenestrated Treo stent-graft system has now been implanted in more than 1,200 patients outside the U.S., and today we are delighted to mark the first implant of this device in our US pivotal study. The US IDE system can be manufactured with up to five fenestrations. This capability expands the options available for tailoring grafts to individual patient anatomies within the U.S. market.”

‘We need to look at the totality of evidence’: VIVA panelists examine SWEDEPAD findings

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Jocelyn Hudson
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‘We need to look at the totality of evidence’: VIVA panelists examine SWEDEPAD findings
Eric Secemsky at VIVA 2025
Eric Secemsky at VIVA 2025

A focused session at the 2025 Vascular Interventional Advances (VIVA) conference (2–5 November, Las Vegas, USA) homed in on the latest findings from the SWEDEPAD registry-based randomized controlled trials (RCTs), with panelists discussing the results with reference to the wider evidence base on drug-coated device use in peripheral arterial disease (PAD). 

Joakim Nordanstig (University of Gothenburg, Gothenburg, Sweden) opened proceedings with a summary of the SWEDEPAD results, which he and co-principal investigator Mårten Falkenberg (Sahlgrenska University Hospital and the University of Gothenburg, Gothenburg, Sweden) first shared at the 2025 European Society of Cardiology (ESC) congress (29 August–1 September, Madrid, Spain). Results were simultaneously published in The Lancet. 

Nordanstig, who joined the session remotely, reiterated that drug-coated balloons and stents were not associated with reduced risk of amputation or improved quality of life compared with uncoated devices in the SWEDEPAD 1 and 2 trials of patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication, respectively. He added that higher five-year mortality with drug-coated devices in patients with intermittent claudication was noted. 

Subsequently, Eric Secemsky (Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA) took to the podium to consider the SWEDEPAD findings in the context of real-world data pointing to the contrary.  

“Obviously, we have to take SWEDEPAD seriously because it’s a prospective trial,” Secemsky remarked, before stressing that clinicians “need to be thoughtful of all the other evidence we have to support the safety of paclitaxel”. Secemsky pointed to his and colleagues’ recently published and US Food and Drug Administration (FDA)-commissioned SAFE-PAD study among several others that demonstrate the safety of paclitaxel-coated devices. 

Secemsky also questioned the relative importance of a mortality signal to the patient population in question. He highlighted data showing that, on average, patients would accept a device offering a reduction in two-year clinically driven target vessel revascularization (CD-TVR) risk from 30% to 10% and a reduction in five-year CD-TVR risk from 40% to 30% if the five-year mortality risk increase was less than or equal to 4.6%.  

On this note, Secemsky warned against a repeat of the reaction to the Katsanos meta-analysis from 2018, which saw a cutback in the use of paclitaxel devices. “It’s really critical for us to not get stuck where we were seven years ago,” he said, opining that “real patient harm” resulted from the Journal of the American Heart Association (JAHA)-published paper. 

“The million-dollar question”

During a panel discussion following the two presentations, session co-moderator Joshua Beckman (UT Southwestern Medical Center, Dallas, USA) asked Nordanstig for his explanation of the mortality finding in SWEDEPAD 2.  

“That is the million-dollar question,” Nordanstig replied, noting he was “very surprised” when he first saw the results.  

Nordanstig recalled that the SWEDEPAD team published an unplanned interim analysis in 2020—in response to the the paclitaxel safety discussion that arose following the publication of the Katsanos paper—which did not identify a mortality signal. He remarked that the signal in SWEDEPAD 2, however, is “hard to ignore” and that it would have been “impossible” not to raise concerns. 

But Nordanstig was clear that discussion around SWEDEPAD should move away from the mortality signal and recenter around the trial’s primary findings. He professed to being “very concerned” that the SWEDEPAD team did not observe effectiveness of drug-coated devices for reducing limb amputations in SWEDEPAD 1. “In our dataset, it looks like we are postponing reinterventions rather than preventing them,” he said. 

Secemsky focused on postponing reinterventions. “I wouldn’t minimise what postponing intervention means to patients,” he said. “In the USA, most of these patients are of low socioeconomic status, they don’t want to take time off work, so part of what we do is postpone. And we do this in the coronaries too. We use drug-eluting stents to postpone reinterventions and decrease them; sometimes we don’t use them to save lives or prevent bypass.” 

“The patient needs to be first, and [postponing reinterventions] is a very patient-centric endpoint,” Secemsky stressed. Nordanstig agreed that “there is value in postponing interventions,” but also concern that this did not translate to better limb salvage rates in SWEDEPAD 1. 

Efficacy versus effectiveness

Later in the discussion, Beckman asked Nordanstig for his reaction to the “total dataset” on the efficacy and safety of paclitaxel. 

“We need to be careful, and we need to look at the totality of evidence,” Nordanstig responded, before noting that the SWEDEPAD team is “planning further scrutiny of the evidence”. 

Referencing a point made earlier in the session by Secemsky, Nordanstig stated that it would be informative to have data on cause-specific mortality available. “We have death causes in all patients from SWEDEPAD 1 and 2, so that is something we will look into,” he said. The presenter reiterated, however, that he is “more concerned about the lack of effectiveness [of drug-coated devices] than the mortality signal in SWEDEPAD 2”. 

On effectiveness, session co-moderator Brian DeRubertis (New York-Presbyterian and Weill Cornell Medical Center, New York, USA) considered the patients with intermittent claudication in SWEDEPAD. “I’m wondering if there are aspects of the patients’ quality of life that are not captured by some of the metrics that we use,” he pondered. “Two patients in the same Rutherford Category can have vastly different experiences in terms of what they’re able to do on a day-to-day basis, so is it possible that some of the lack of effectiveness we see has to do with what we record in these patients’ experience?” 

Nordanstig noted that, due to the pragmatic nature of the SWEDEPAD trial, the investigators had to work with the registry data that were available to them. However, he stressed that the VascuQoL-6 quality-life-life assessment used in SWEDEPAD 2 has been shown to closely correlate to everyday walking capacity, highlighting this as a relevant outcome measure for patients with claudication, while also acknowledging the test “might not show the full picture”. 

Secemsky also commented on the limitations of quality of life as an endpoint. “The quality of life [in SWEDEPAD 2] is at one year, and there was about 42% stenting in this trial, so I’m worried that most people, if they get a stent, they’re probably going to be patent still at one year, which might wash out a little bit of the effect of difference,” he said. 

Session panellist Iris Baumgartner (Bern Center for Vascular Medicine and Intervention, Vasc Alliance AG Angiology, Bern, Switzerland) questioned whether real-world use of drug-coated devices might explain the differing results between SWEDEPAD and the data from randomized controlled trials. 

“This might be what is happening when you bring a technology that has been tested and proved during a very controlled experiment in a pivotal trial into a strategy trial on all patients, and we need to recognize that difference,” Nordanstig commented. “We did not control the research environment to the level that is usually done in a small, device-specific RCT, but I think it’s very important from a healthcare perspective and from a payer perspective to have these kind of trials that show effectiveness rather than efficacy and it might be that there are more and less experienced operators doing these procedures in over 3,500 patients, but I would not expect that this is not controlled for during randomization.” 

RapidAI earns US FDA clearance for AI-driven aortic measurement and surveillance product

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Jocelyn Hudson
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RapidAI earns US FDA clearance for AI-driven aortic measurement and surveillance product

RapidAI today announced the US Food and Drug Administration (FDA) clearance of Aortic Management, part of Rapid Aortic, which the company describes as “a comprehensive deep clinical AI [artificial intelligence] solution designed to transform the acute assessment and longitudinal management of aortic disease”.

RapidAI shares that its Rapid Aortic product not only provides deep clinical information powered by AI to help clinicians “quickly and accurately” identify more aortic aneurysms, dissections, and other anomalies, but also automatically generates critical measurements, produces automated 3D reconstructions of the entire aorta, and tracks anatomical changes over time.

“Rapid Aortic represents a significant advancement for aortic patient management,” said vascular surgeon Trissa Babrowski (University of Chicago, Chicago, USA). “With instant access to every textbook landmark and zonal maximum measurement, advanced visualisations, and robust longitudinal tracking for surveillance, Rapid Aortic empowers physicians to efficiently identify, confidently assess, and diligently monitor every aortic patient within their system.”

RapidAI specifies that Rapid Aortic is fully integrated into the Rapid Edge Cloud, which the company states is the first cloud-based IT platform with on-prem capabilities that ensures continuous service during any disruptions. Additionally, RapidAI notes that all modules are integrated into Rapid Navigator Pro, the company’s next-generation radiology solution, as well as the Rapid mobile and web applications.

enVVeno receives ‘unfavorable’ appeal decision from FDA for VenoValve device

By
Bryan Kay
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enVVeno receives ‘unfavorable’ appeal decision from FDA for VenoValve device
VenoValve
VenoValve

enVVeno Medical has announced that it has received an “unfavorable” decision from the Food & Drug Administration (FDA) in response to its supervisory appeal of the not-approvable letter it received on Aug. 19 in response to its premarket approval (PMA) application for the VenoValve device, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).

The supervisory appeal upheld the review staff decision in the not-approvable letter that the VenoValve did not meet the standard of reasonable assurance of safety and effectiveness, enVVeno reported.

“Although the appeal decision was not the result we are looking for, it did provide valuable insight into the criteria that would be necessary for approval of enVVe, our next generation transcatheter based replacement venous valve,” said Robert Berman, enVVeno Medical’s CEO.

“enVVe should have a different safety profile than an open surgical device and is ready for human testing. Assuming that we can reach alignment with the Agency on achieveble endpoints for enVVe, it makes sense to turn our attention and devote our resources to enVVe. We will continue to interact with the FDA on enVVe and will provide periodic updates on our progress.”

Cracking CLTI: How Shockwave Javelin intravascular lithotripsy is opening up new frontiers in heavily calcified peripheral arterial occlusive disease

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Cracking CLTI: How Shockwave Javelin intravascular lithotripsy is opening up new frontiers in heavily calcified peripheral arterial occlusive disease

This advertorial is sponsored by Shockwave Medical.

Three vascular surgeons discuss how and when they deploy the transformative Shockwave Javelin first-of-its-kind Forward Intravascular Lithotripsy (IVL) Platform in cases of heavily calcified peripheral vascular occlusive disease.

Viewpoints on when and how to use Shockwave Javelin vary, but one insight unites them: prior to its emergence there were limited options available to get through the sorts of severely calcified lesions the device opens up. Or, as Sung Yup Kim, MD, an associate professor of surgery at Mount Sinai Health System in New York, puts it: “In the past we have used balloons, we have used orbital atherectomy, cutting balloons with no major success, nothing would track in these areas, and there were cases where we just had to abort and think about an open option. Shockwave Javelin allows us to deliver endovascular therapy for these patients.”

Paul Foley

“At the outset, how we thought we were initially going to use Shockwave Javelin is not how it has turned out to be.” The words of Paul Foley, MD, director of the vascular lab at Doylestown Hospital in Doylestown, Pennsylvania, as he assesses the evolution in his use of the Shockwave Javelin, from initial study in the FORWARD PAD investigational device exemption (IDE) trial, through limited market release and, earlier this year, the launch of the platform in the U.S. Understanding now what the device can do, Foley sees Shockwave Javelin as a routine IVL delivery device in tibial vessels and below the ankle, which is also able to tackle some of the most challenging disease.

That broader canvas for the Shockwave Javelin platform includes use as a primary IVL modality. In the limited market release phase of Shockwave Javelin, the conventional wisdom went that “if you had a boulder of calcium that you couldn’t get across, this was going to be the savior device,” Foley explains. “And, certainly, that’s one piece of Shockwave Javelin.”

However, after more experience Foley has found Shockwave Javelin’s role to be more nuanced and depends on the vessel bed, he says. In the femoropopliteal space, the Shockwave Javelin works best as facilitator, “modifying calcium to facilitate the next step”. In the tibial vessels, Foley continues, a good outcome is defined as successfully crossing the lesion while delivering pulses. “I don’t see Shockwave Javelin simply as a method of crossing the uncrossable anymore; I see it as way more than that. When I look at a calcified, highly stenotic tibial vessel, Shockwave Javelin is now my knee-jerk device.” Below the ankle, Foley says, the Shockwave Javelin is breaking new ground by effectively crossing through vessels previously unpassable by any other method.

Shockwave Javelin is proving to be a multi-tool for patients with chronic limb-threatening ischemia (CLTI), he adds. While vessel bed may vary, the success of the product lies in modifying plaque while achieving luminal gain and a reduction in diameter stenosis—and doing so safely without a high risk of angiographic complications, perforation or distal embolisation.1

Case example provided by Paul Foley

Kenneth Tran

For Kenneth Tran, MD, a clinical assistant professor of surgery at Stanford Health Care in Stanford, California, Shockwave Javelin first and foremost has proven an important precursor in complex cases.

“It’s not intended to be used as the primary IVL technology—I think of it as enabling me to do my next step in my treatment algorithm, where I can’t deliver the device I’m trying to deliver,” he says. In below-the-knee (BTK) lesions, Tran sees its use as often initial vessel prep, such as to advance an intravascular ultrasound (IVUS) catheter or Shockwave E8 IVL balloon.

However, he recognizes instances in which Shockwave Javelin has a role to play as the go-to IVL catheter. “For isolated lesions that are very small, I have had success using the Shockwave Javelin as the sole lithotripsy device,” says Tran.

Sung Yup Kim

On the other hand, Kim sees Shockwave Javelin make the biggest difference in his practice in cases involving the femoropopliteal vessel bed. These patients will tend to have either a low segmental chronic total occlusion (CTO) or a couple of focal areas where no devices will track, he explains.

“These are cases where we already have a wire through, there is a rock sitting there, and, with Shockwave Javelin on that spot, we crack open the area, apply some forward pressure, and then try to crack the calcium distal to that. We maintain Shockwave Javelin for one or two cycles in one spot that is really, really calcified and heavy. Then, in the next few cycles, we are moving forward with Shockwave Javelin.”

Kim doesn’t see the platform as a crossing device. “It is not a case of when you can’t go through a CTO, and you use Shockwave Javelin and try to tunnel a channel through severe calcium,” he says. “I don’t think that’s the purpose of Shockwave Javelin.” Kim tends to encounter trouble with femoropopliteal lesions most often at the Hunter’s canal, where the artery sometimes bends at the popliteal facia. “If you have a severe calcium there, the bend is a killer with a rock-hard calcium,” Kim says.

Step forward Shockwave Javelin: in this small portion of cases, too, the device has proven successful, he adds.

Access points

Views on optimal access vary. While Kim prefers a contralateral approach for precision to traverse tough lesions, both Foley and Tran err toward an antegrade access.

“If there is no inflow disease, no disease in the common femoral artery, no disease in the femoropopliteal region that I think is significant, so that going in there is going to be a high likelihood I’m doing a below-knee or a tibial or even a pedal artery intervention, I approach all of those cases from an antegrade approach,” says Foley. “And I don’t have any hesitation to do that because I believe that, with an antegrade approach for below the knee, especially for calcified lesions, really stenotic or at least occlusive lesions, you have a much better chance of getting across them. You get much better pushability and tactile feedback than you would if you were going up and over from a contralateral approach. “But in any patient in whom I’m doing an antegrade approach where I know I’m going to be working below the knee, I always have the foot prepped out so that I have a low threshold of approaching from a retrograde pedal access as well.”

Shockwave Javelin provides more flexibility in terms of the level of support available while across a lesion, Tran says. In the BTK space, the antegrade approach allows for more pushability, but some anatomically inappropriate patients enforce the up-and-over access of the contralateral approach, he adds.

The platform is a unique tool that can be used to modify calcium previously beyond what was available in his PAD toolkit, Tran says. “This has enabled treatment of more complex tibial lesions from an up-and-over approach. It has also allowed us to be able to treat more complex lesions more thoroughly with larger profile devices.”

Reference

  1. Corl J et al. FORWARD PAD IDE/feasibility studies: Primary endpoint analysis of a novel non–balloon-based peripheral IVL catheter. J AmColl Cardiol Intv. 2025 Feb, 18 (3) 398–399.

Updated safety information for the Shockwave advertorial: In the US: Rx Only. Prior to use, please reference Instructions For Use for information on indications, contraindications, warnings, precautions, and adverse events. www.shockwavemedical.com/IFU

Dr. Foley, Dr. Kim and Dr. Tran are paid consultants of Shockwave Medical, the views expressed are of their own opinions, reflect their daily medical practice and do not necessarily represent Shockwave Medical. SPL-78322 Rev. A

ViTAA Medical announces FDA 510(k) clearance for aortic planning platform

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Bryan Kay
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ViTAA Medical announces FDA 510(k) clearance for aortic planning platform
Case planning with AiORTA Plan

ViTAA Medical today announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for AiORTA Plan, which the company describes as a “fully automated, hyper-precise aortic surgery planning solution”.

The tool aims to automate key preoperative measurements and streamline aortic case preparation by generating a complete aortic plan in minutes in a web-based system, producing automated aneurysm segmentation, centerline extraction, precise diameter and angulation measurements, and instant volumetric modeling.

The other elements of ViTAA’s broader AiORTA platform—which also includes AiORTA Maps and AiORTA Watch—are currently in multicenter clinical studies. Maps is a diagnostic aid that aims to produce patient-specific vessel strength analysis, while Watch looks to provide longitudinal monitoring for early complication detection.

“Regulatory clearance of AiORTA Plan validates our approach of combining automation with precision medicine,” said Randy Moore (Calgary, Canada), a vascular surgeon and chief medical officer at ViTAA Medical. “As we continue our international clinical studies for AiORTA Maps and AiORTA Watch, we’re focused on delivering solutions that help physicians see beyond outdated size guidelines and gain insights into vessel behavior that can inform decision-making throughout the patient journey.”

“This FDA clearance is a foundational milestone for ViTAA,” said Mitchel Benovoy, ViTAA Medical CEO. “AiORTA Plan brings hyper-precision, efficiency, and extreme speed to the front line of the aortic workflow. It’s the first step in our platform strategy: from pre-operative planning with AiORTA Plan to critical vessel-integrity insights and outcome predictions with AiORTA Maps, and long-term postoperative endoleak surveillance and risk stratification with AiORTA Watch—both currently in clinical studies. Our vision is end-to-end, patient-specific vascular care at every stage of the disease.”

Frank J. Veith (New York, USA), who performed the first endovascular aneurysm repair (EVAR) of an abdominal aortic aneurysm (AAA) in the U.S. three decades ago, hailed the approval as a milestone. “This is an important advance,” he said. “AiORTA Plan can streamline how physicians prepare for complex aortic procedures, and as the broader AiORTA platform matures with Maps and Watch in clinical evaluation, it has the potential to transform individualized care by providing critical insight.”

Elucid launches PlaqueIQ image analysis software for carotid arteries

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Bryan Kay
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Elucid launches PlaqueIQ image analysis software for carotid arteries

Elucid has announced the launch of its PlaqueIQ image analysis software for the quantification and classification of plaque morphology in the carotid arteries. According to the company, as the “first and only” computed tomography (CT)-based plaque analysis software indicated for the carotid vasculature, PlaqueIQ may help physicians diagnose carotid plaques at risk for rupture, and develop patient-specific treatment pathways to monitor and prevent ischemic stroke.

“The ability to characterize plaque composition precisely revolutionizes carotid stroke risk assessment,” said David Deaton, MD, an adjunct associate professor of surgery at the University of Pennsylvania in Philadelphia. “Plaque composition has long been recognized as a critical risk element for stroke but was not available with conventional imaging techniques. Precise determination of plaque composition supersedes the traditional stenosis assessment and allows a more accurate identification of patients at highest risk for carotid stroke, and facilitates procedural choice and planning.”

PlaqueIQ is a Food and Drug Administration (FDA)-cleared tool that provides non-invasive plaque analysis based on objective histology, offering physicians “CT Virtual Histology,” Elucid claims. The software delivers quantification and classification of plaque morphology, and is described in a press release as being “uniquely capable” of identifying and quantifying lipid-rich necrotic core—a plaque type strongly linked with both cardiovascular and cerebrovascular risk.

Elucid notes that PlaqueIQ is designed to help physicians prioritize and personalize treatment based on actual coronary and carotid artery disease as opposed to population-based risk. The technology is intended to support physicians in evaluating the treatment of patients’ symptoms and their risk of future events like heart attack or stroke by enabling the development of personalized care pathways informed by each patient’s individual plaque characteristics.

When used for both the coronary and carotid arteries, PlaqueIQ non-invasively delivers a quantitative and qualitative assessment of systemic atherosclerotic risk, and creates the potential to perform both coronary and carotid plaque analysis in a single scan.

‘Excellent’ one-year outcomes from ROADSTER 3 show TCAR is ‘safe and effective’

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Bryan Kay
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‘Excellent’ one-year outcomes from ROADSTER 3 show TCAR is ‘safe and effective’
Meghan Dermody

One-year outcomes in the ROADSTER 3 post-approval study to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) using the Enroute stent and neuroprotection system (Boston Scientific) in standard-surgical-risk patients revealed a 1.5% intention-to-treat rate of composite major adverse events (1.3% per protocol).

Delivering the results at the 2025 Vascular Interventional Advances (VIVA) conference (2–5 November, Las Vegas, USA), Meghan Dermody (Penn Medicine/Lancaster General Hospital, Lancaster, USA) also reported an intention-to-treat ipsilateral stroke rate between 31–365 days of 0.6% (0.7% per protocol).

The results were drawn from patients enrolled between September 2022 and June 2024—344 intention to treat and 219 per protocol—at 48 U.S. sites. The primary endpoint was the hierarchical composite incidence of major adverse events defined as stroke, death or myocardial infarction within 30 days and ipsilateral stroke from 31 to 365 days post procedure. The rate of stroke/death/MI at 30 days was 0.9% (0.6% per protocol), with a 30-day stroke rate of 0.9% (0.6% PP).

“ROADSTER 3 is the first independently adjudicated, prospective study evaluating TCAR in a standard-surgical-risk population,” said Dermody, who first presented 30-day outcomes from the study at VIVA 2024. “Results demonstrate that TCAR is safe and effective, with excellent clinical outcomes.”

The 30-day outcomes represented the lowest reported in a standard-surgical-risk population, she added.

Online Wound Care Curriculum offers on-demand education for vascular teams

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Marlén Gomez
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Online Wound Care Curriculum offers on-demand education for vascular teams

Stay updated on the latest advancements in wound care with the Society for Vascular Surgery (SVS), Society for Vascular Nursing (SVN), and American Podiatric Medical Association’s Wound Care Curriculum.

This program, now available through SVS VascuLEARN, offers vascular professionals flexible, evidence-based training that is applicable immediately.

The online module includes 27 on-demand videos, allowing participants to earn up to 6.25 continuing education credits, including AMA PRA Category 1 Credits, ABS-accredited CME, APMA CECH and CNE. The course features pre- and post-tests to assess knowledge and is available through Feb. 17, 2028. To register, visit vascular.org/WoundCare.

One-year results from IVC stent clinical trial show positive safety and efficacy data

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Bryan Kay
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One-year results from IVC stent clinical trial show positive safety and efficacy data
Stephen Black presents during The VEINS 2025 in Las Vegas

Twelve-month results from the clinical trial assessing a dedicated venous stent for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without combined iliofemoral obstruction showed the device exceeded its performance goal for freedom from a composite of efficacy and safety events.

The data from 89 patients were presented today at The VEINS 2025 (Nov. 1–2) in Las Vegas, by Stephen Black, MD, from King’s College London in London, England.

The prospective, multicenter, non-randomized, single-arm trial of the Viabahn Fortegra (Gore) venous stent—formerly known as Viafort—represents the first such independently adjudicated study examining the use of venous stent placement for the treatment of symptomatic iliocaval venous obstruction, Black told The VEINS 2025.

The overall rate of freedom from composite primary endpoint events was 74.7%, exceeding the 58% performance goal. The composite is made up of freedom from loss of primary patency stent embolisation through 12 months of follow-up; and freedom from device- or procedure-related death, clinically significant pulmonary embolism confirmed via computed tomography angiography (CTA), device- or procedure-related vascular injury requiring surgical or endovascular intervention, and device- or procedure-related major bleeding events through 30 days.

Additionally, there was “a significant improvement in patient pain levels from baseline to 12 months, as seen by a mean reduction in the rVCSS [revised Venous Clinical Severity Score] pain score of less than or equal to 1,” Black revealed.

Some 94.3% of patients in the trial had lesions spanning three-vessel regions—the IVC and bilateral iliofemoral, he said. US enrollment is now complete.

Gore is seeking an indication for use of the device in the IVC under the US Food and Drug Administration (FDA) Breakthrough Device program. The Viabahn Fortegra is being studied under two investigational device trials, with the other assessing its use for treatment of symptomatic iliofemoral venous obstruction at sites in the USA.

InterVene receives US FDA 510(k) clearance for Recana thrombectomy system

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Jocelyn Hudson
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InterVene receives US FDA 510(k) clearance for Recana thrombectomy system
Recana thrombectomy system
Recana thrombectomy catheter system

InterVene recently announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Recana thrombectomy catheter system, which is designed for the treatment of venous in-stent restenosis and native vessel obstructions.

A press release notes that Recana is a fully integrated system featuring a debulking catheter, introducer and collection sheaths, and nitinol collection baskets designed to simplify challenging venous procedures for physicians and improve clinical outcomes for their patients.

“The long-term consequences of venous obstructions and occlusions can be devastating for patients,” said William Marston (University of North Carolina, Chapel Hill, USA). “Based on my pre-clinical experience, I believe the Recana system represents a promising treatment option that overcomes key limitations of traditional recanalisation methods.”

InterVene shares that it designed Recana’s integrated system of complementary components to enable single-session treatment, reduce the need for additional devices, and improve procedural efficiency. Its stainless-steel helical coring element has a sharpened bevelled edge to clear tough, residual venous obstructions and occlusions, with a spiral nose cone to assist with crossing. Nitinol collection baskets deploy from the lower extremities to capture thrombotic material, streamlining the procedure workflow.

“The Recana system marks an important advancement in the treatment of venous stent obstruction, a common outcome following deep venous stent placement, particularly in patients with thrombotic pathology,” said Kush Desai (Northwestern Medicine, Chicago, USA). “This innovative solution has the potential to transform the standard of care for this challenging condition, ultimately improving patient outcomes and quality of life.”

One-year results from IVC stent clinical trial show positive safety and efficacy data

By
Bryan Kay
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One-year results from IVC stent clinical trial show positive safety and efficacy data
Stephen Black presents during The VEINS 2025 in Las Vegas

Twelve-month results from the clinical trial assessing a dedicated venous stent for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without combined iliofemoral obstruction showed the device exceeded its performance goal for freedom from a composite of efficacy and safety events.

The data from 89 patients were presented today at The VEINS 2025 (1–2 November; Las Vegas, USA) by Stephen Black (King’s College London, London, UK).

The prospective, multicentre, non-randomised, single-arm trial of the Viabahn Fortegra (Gore) venous stent—formerly known as Viafort—represents the first such independently adjudicated study examining the use of venous stent placement for the treatment of symptomatic iliocaval venous obstruction, Black told The VEINS 2025.

The overall rate of freedom from composite primary endpoint events was 74.7%, exceeding the 58% performance goal. The composite is made up of freedom from loss of primary patency stent embolisation through 12 months of follow-up; and freedom from device- or procedure-related death, clinically significant pulmonary embolism confirmed via computed tomography angiography (CTA), device- or procedure-related vascular injury requiring surgical or endovascular intervention, and device- or procedure-related major bleeding events through 30 days.

Additionally, there was “a significant improvement in patient pain levels from baseline to 12 months, as seen by a mean reduction in the rVCSS [revised Venous Clinical Severity Score] pain score of less than or equal to 1,” Black revealed.

Some 94.3% of patients in the trial had lesions spanning three-vessel regions—the IVC and bilateral iliofemoral, he said. US enrolment is now complete.

Gore is seeking an indication for use of the device in the IVC under the US Food and Drug Administration (FDA) Breakthrough Device programme. The Viabahn Fortegra is being studied under two investigational device trials, with the other assessing its use for treatment of symptomatic iliofemoral venous obstruction at sites in the USA.

Anton Sidawy becomes president of American College of Surgeons

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Anton Sidawy becomes president of American College of Surgeons
Anton N. Sidawy

Former Society for Vascular Surgery (SVS) President Anton N. Sidawy, MD, FACS, DFSVS,  became the 106th president of the American College of Surgeons (ACS) at the ACS Clinical Congress 2025 in Chicago earlier this month (Oct. 4–7).

A professor of surgery and the Lewis B. Saltz chair of the Department of Surgery at the George Washington University School of Medicine and Health Sciences in Washington, D.C., Sidawy said his rise to the ACS presidency “fills me with pride and the satisfaction that my peers see me as a passionate servant leader and consensus builder.”

Sidawy served as SVS president from 2009–10. He is the former editor-in-chief of the Journal of Vascular Surgery (JVS) and served as the founding editor-in-chief of both the Journal of Vascular Surgery-Venous and Lymphatic Disorders (JVS-VL) and Journal of Vascular Surgery-Cases, Innovations and Techniques (JVS-CIT).

His has also led as president of the the Society for Clinical Vascular Surgery and the Eastern Vascular Society. Notably, Sidawy led the efforts in the creation of the ACS-SVS Vascular Verification Program (VVP), a national quality improvement program focused on improving vascular surgical and interventional care.

Sidawy is the second former SVS president to serve as ACS president in recent years. Julie A. Freischlag, MD, CEO of Atrium Health Wake Forest Baptist in Winston-Salem, North Carolina, served from 2021–22.

SVS receives slew of VAM 2026 ‘Hot Topics’ session proposals

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Marlén Gomez
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SVS receives slew of VAM 2026 ‘Hot Topics’ session proposals

Proposals for the new “Hot Topics” session at the 2026 Vascular Annual Meeting (VAM) recently drew in a slew of responses for the inaugural iteration of the program feature.

Hot Topics sessions are designed to feature short, high-impact presentations on emerging issues, innovations and practice-changing developments in vascular surgery. Each proposal required an outline of a single lecture topic that can be delivered in 15 minutes or less and focus on clinical relevance and timeliness, organizers said.

Submissions sent by email or other methods were not be considered. Selected presenters will be notified by the end of October and will work with the SVS Postgraduate Education Committee to finalize session content.

VAM 2026 will take place June 10–13 at the Hynes Convention Center in Boston.

For more information on Hot Topics and the VAM program in general, visit vascular.org/Hot-Topics and at vascular.org/VAM.

A story foretold: The AMA, Ed Annis, Medicare and the loss of physician autonomy

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A story foretold: The AMA, Ed Annis, Medicare and the loss of physician autonomy
Arthur E. Palamara

In 1979, after three years of group practice, I opened an office as a solo vascular surgeon. With a wife, three children and a mortgage to support, the move was gutsy. To survive, no referral was too small, no operation too minor to be ignored. Every patient encounter was appreciated. A partner joined and we prospered. Despite hard work and talent, clouds were on the horizon, as we realized that small groups were disadvantaged by omnivorous insurance companies who cared little for good outcomes. Our practice was assimilated by a major hospital. After 12 years and my partner’s death, it became apparent that my employer and I had dissimilar agendas. With little explanation, I am forced to move on.

Since my energy and ability remain vigorous, the need to re-emerge in private solo practice provides the only option. I will again depend solely upon my wit and resources. Having avoided expensive doctor traps like airplanes, boats, cars and divorce, financial security is not an issue. Still, creating a practice after 47 years reveals a completely different mine-laden medical landscape.

Facing so many daunting obstacles, starting a practice from scratch may no longer be possible. Easier for me with money in the bank, it would seem to be essentially impossible for a doctor out of fellowship with $250,000 worth of student debts.

Insurance companies and hospitals have altered the environment to the point where physicians are now considered a “commodity.” The U.S. spends $4.9 trillion on healthcare (2023), with only $1.18 trillion going to doctors and “clinical service.” (Since 80% of doctors are now employed, I’m not sure how ChatGPT arrived at that figure.) Most employed doctors working for hospitals receive salaries supplemented at facility rates, which are quite a bit (!) higher than procedural rates.

Considering the remaining $3.8 trillion, and since other developed countries spend half of what the U.S. spends, one can assume that 50% goes for administration and/or corporate profit. Our outcomes are dismal, somewhat worse than 18% in world rankings. How did this come about? Or rather, how did doctors and our powerful American Medical Association (AMA) allow this to happen?

On May 20, 1962, President John F. Kennedy gave a speech at Madison Square Garden in New York outlining the foundation of Medicare. The King-Anderson bill, as it was known, was to be part of Social Security. As outlined, it would only cover 66% of the hospital bill, the patient having to fork over the rest. Kennedy opined: “The doctors don’t comprehend what we are trying to do. We don’t cover doctors’ bills here. We don’t affect the freedom of choice. You can go to any doctor you want.”

The AMA was vehemently opposed to this bill. Jesuit-trained Dr. Ed Annis of Miami made numerous speeches on the AMA’s behalf in 1961. In fact, he debated Sen. Hubert Humphrey on television, vociferously arguing against its passage. Jesuit graduates are great debaters, and his Marquette training served him well. The AMA gave him the perfect opportunity. They rented Madison Square Garden, and, on television, Dr. Annis spoke to an empty stadium. He argued that the legislation would impose an “unpredictable burden on every working taxpayer and will lower the quality and availability of hospital services throughout our country.” The overture was not lost on the U.S. public and the event enhanced both the reputation and power of the AMA.

President Kennedy was assassinated in 1963 and never enjoyed the fruits of his goal of providing healthcare for all. His successor, President Lydon B. Johnson, passed the Medicare and Medicaid Act in 1965. This legislation remains an essential part of the American fabric. Unarguably, Medicare and Medicaid have saved countless lives.

Ed was a terrific guy with a twinkle in his eye. He loved telling the story of his debates with labor leaders, politicians and, indeed, the Madison Square Garden speech. When he was chosen president of the AMA (out of turn), he insisted that the elected president not be denied his year in office. He was quite proud that he never missed an AMA meeting for some 50 years until his passing in 2009. While he may have been on the wrong side of history, Ed never regretted his stance on Medicare and felt that the loss of physician autonomy and poor patient care were the result. He may not have been wrong.

Although Medicare/Medicaid are firmly entrenched, no one could have anticipated their derivatives: health maintenance organizations (HMOs) and Medicare Advantage plans, called by some “Medicare Dis-advantage.” With justifiable reason. In spite of increased utilization and pricey pharmaceuticals, Medicare Advantage plans enjoyed their highest gross margins of profit in 2023, $1,982 per enrollee. Medicare Advantage total revenue reached $384 billion in 2023.

While I am not sympathetic to their plight, 2024 saw a reduction in profitability because of increased utilization by seniors, leading to reduced benefits and disposing of unprofitable markets. Negative patient reaction caused President Joe Biden to reduce overpayments, adjustment of reimbursement rates and risk adjustment.

That insurance giant UnitedHealthcare is far from a paragon of virtue amid all of this is exemplified by a string of lawsuits: misleading investors; insider trading; NaviHealth algorithm to deny rehabilitation; algorithms for care denials; antitrust acquisition of Amedisys (home healthcare and hospice) and Optum; the No Surprises Act; upcoding fraud. This is but a partial list. Patient frustration is evidenced by the unexpected outpouring of sympathy for a lone assassin who gunned down the CEO of UnitedHealthcare in December. Not that people endorse violence as a solution, but frustration with insurance companies is so great that the CEO’s murder poked a sleeping bear.

And we physicians—who do most of the work—have not seen an increase in reimbursement since 2000. Even more insulting is the fact that physician pay (per the Medicare Physician Fee Schedule) was cut 2.83% while Medicare Advantage plans received an additional 3.2%! President Donald Trump’s One Big Beautiful Bill Act includes a 2.5% Medicare increase for 2026. Without additional legislation, Congress will be obligated to remove this increase in 2027.

Perhaps his frustration after hearing the same complaints verbalized by the membership culminated in a fiery speech by outgoing AMA President Bruce Scott. It was simply titled: “We’re not going to take it anymore!” Regretfully, the only fatigued solution they offer is to give more money to politicians in the forlorn hope that they will eventually see the error of their ways and direct federal funding to those who provide hands-on patient care.

Yet at every turn, health insurers construct new roadblocks. Their requiring physicians to obtain prior authorization has made treating patients more difficult and inserts another impediment to patient care, as well as cost to physicians. UnitedHealthcare bought InterQual to determine medical necessity, which is akin to Health and Human Services Secretary Robert F Kennedy Jr. assessing the value of vaccines.

AMA leadership desperately pleads with Congress to tie Medicare funding to the Medicare Economic Index. Congress, faced with a $35 trillion deficit, and wars in Eastern Europe and the Middle East, is unlikely to reform healthcare anytime soon.

So where is a modern Dr. Ed Annis? Why does the AMA not rent out Madison Square Garden and preach to the multitude who stand ready to support righteous leadership? Why have they abandoned their role of patient advocacy? Why do they remain content to fiddle with corporate mandated impositions.

To the good, the AMA House of Delegates voted to pursue a class action lawsuit against health insurers’ prior authorization by a 80–20 vote with over 700 delegates voting. Maybe that’s a start. Maybe we can go further, using the McCarran-Ferguson exemptions (named the Competitive Health Insurance Reform Act of 2021) that exposes the pernicious conduct of health insurance companies to antitrust laws. That would serve AMA members and our patients better than pleading for legislative relief.

Until then, I will have to be content with earning $475 for a below-knee amputation and $400 for an arteriovenous fistula. But little can compete with the satisfaction of performing a successful amputation or the gratitude of a patient.

Arthur E. Palamara, MD, is a vascular surgeon practicing in Hollywood, Florida. He is active in county, state and national medical organizations

‘Ask not what vascular surgery can do for you… ask what it can do to you’

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Bryan Kay
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‘Ask not what vascular surgery can do for you… ask what it can do to you’
Patrick Muck delivers the 2025 MVSS presidential address

During his own recent presidential address on home turf, Patrick Muck, MD, invoked immortable words from the inaugural address of President John F. Kennedy to make a very serious point about radiation safety in vascular care: “Ask not what vascular surgery can do for you… ask what it can do to you.”

Muck said that with the rise in endovascular intervention over open surgery, and procedures becoming longer and more complex, the foundational principle in radiation protection of ALARA, or As Low As Reasonably Achievable, should be placed firmly into vascular surgery’s focus.

“It is aimed at minimizing exposure to ionizing radiation while considering economic, technical and social factors,” the 2024–25 Midwestern Vascular Surgery Society (MVSS) president and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, Ohio, told those gathered in the Queen City for MVSS 2025 (Sept. 18–20). “It emphasizes optimization: justifying any radiation use and keeping doses as low as practical without a strict zero-exposure goal.” Yet its application, interpretation and associated dose limits have evolved, and “while the core principle hasn’t been overhauled, supporting elements like dose limits and implementation guidance has shifted.”

With little change over the decades, he said, are governing bodies suitably adapting to radiation protection technology now available to mitigate exposure?

“We’re doing more and more minimally invasively, whether it be aneurysm, peripheral arterial, TCAR [transcarotid artery revascularization], IVC [inferior vena cava] filter, venous and dialysis procedures,” he tells Vascular Specialist after the address. “Because of that, we’re getting longer and longer cases and more and more exposure to radiation. We know what radiation can do to us, but do we discuss this topic enough and the mitigation systems that are now out there?”

Muck referred to several emerging barrier protection technologies during his address, among them EggNest radiation protection, the Protego radiation protection shield and the Radiaction shield. Speaking to Vascular Specialist, he focused on one which was recently introduced at his center: the Rampart Guardian system, a ceiling-mounted or mobile radiation shield, aimed at providing barrier protection. “I showed a couple of cases we’ve done, one an endovascular aneurysm repair [EVAR] and the other bilateral iliac stent placement,” he says. “For the EVAR, we used the Rampart Guardian system and I showed how we received only 0.2mrem. The next day, when we did the bilateral iliac stents, we used traditional shields and personal lead protection and had 3mrem, 15 times the radiation, this is the same old personal protection and shielding we have been using for decades.”

The time is now to address radiation mitigation and consider bringing in systems like those from EggNest and Rampart Guardian, Muck added. “I believe we’re just at the infancy with barrier protection.”

Randomized data ‘debunks’ widely used negative pressure wound therapy

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Jocelyn Hudson
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Randomized data ‘debunks’ widely used negative pressure wound therapy
Ian Chetter

“How did an ineffective and costly intervention become routine care in the NHS [UK National Health Service]?” Ian Chetter, MBChB, chair of surgery at Hull York Medical School, University of Hull in Hull, England, posed at the 39th European Society for Vascular Surgery (ESVS) annual meeting in Istanbul, Turkey (Sept. 23–26), following a presentation highlighting the SWHSI-2 trial results.

SWHSI-2—data from which were first shared at the 2024 Vascular Society of Great Britain and Ireland (VSGBI) Annual Scientific Meeting and recently published in The Lancet— suggested that negative pressure wound therapy (NPWT) should not be first-line treatment for open surgical wounds.

“Negative pressure doesn’t seem to have any benefit whatsoever.” This was Chetter’s key conclusion to be drawn from the “long-awaited” results of the SWHSI-2 trial in his initial presentation of the results at the VSGBI 2024 VSASM meeting. For Chetter, the data underscore the severity of the clinical issue at hand, highlight a pressing need for research aimed at accelerating wound healing, and raise questions around how this technology—commonly used in the NHS—was accepted into clinical practice without the robust evidence to back it.

Providing context to the trial at the UK meeting, co-investigator Catherine Arundel, MD, from York Trials Unit at the University of York in York, England, first noted the “common” nature of secondary wounds healing by secondary intention (SWHSI) and the “prolonged and complex” nature of their healing. Arundel also underlined the costly nature of treatment, “particularly considering that the use of complex, expensive treatments such as [NPWT] has been and continues to be increasing.”

Against this backdrop, SWHSI-2 was initiated by Chetter, Arundel and colleagues and funded by National Institute for Health and Care Research funding. This was a pragmatic, multicenter, two-arm, parallel-group randomized controlled trial designed to assess NPWT versus usual care in patients with open surgical wounds. The primary outcome was wound healing and time to wound healing. Across 28 UK sites, 686 patients were enrolled, with 349 allocated to the negative pressure intervention group and 337 to usual care.

Chetter then provided an overview of patient characteristics, noting that 75% of the trial cohort were men, the majority of whom were white and had diabetes. He added that 90% of patients were vascular patients. “Although we tried to recruit across the different surgical specialties,” said Chetter, “this ended up being a vascular surgical, diabetic foot wound trial.” Regarding wound characteristics, Chetter shared that the wounds included in the trial were large—26cm2 on average—with the majority on either the foot or the leg.

Sharing the results of SWHSI-2 for the first time at VSASM 2024, Chetter reported that 42% of patients had unhealed wounds at 12 months, a result which “shocked” him. “Importantly,” he continued,” there was no difference in the number of healed wounds between patients randomised to negative pressure or usual care.”

Chetter added that the median time to wound healing was 187 days (NPWT)/195 (standard dressings), or six months, and that there was no difference between negative pressure and usual care. “There’s no evidence that negative pressure accelerates healing in these patients,” the presenter told the VSASM audience, going on to state that the primary result was consistent throughout various subgroup analyses.

The researchers also looked at secondary outcomes, finding high rates of hospital readmission, reoperation, and wound infection, as well as a high number of patients receiving antibiotics for their surgical wound infections, with no statistically significant difference between the two groups. “Negative pressure doesn’t reduce wound infection, doesn’t reduce your risk of reoperation, and doesn’t reduce your risk of requiring antibiotics,” Chetter said.

Furthermore, on the topic of secondary outcomes, Chetter underlined that 10% of patients ended up with an amputation and 10% of patients died.

Quality of life was also measured. “With both treatments,” Chetter reported, “the scores improved—so wound healing improved, and pain improved with both treatments over time—but there’s no statistically significant difference between the two groups. So, negative pressure doesn’t improve wound pain and doesn’t improve your quality of life related to the wound.”

Finally, Arundel shared the results of a cost-effectiveness analysis. “Within the trial,” she summarized, “we can say that negative pressure was more costly, but not more effective than usual care.”

The researchers also considered the longer-term cost-effectiveness of negative pressure, employing a decision analytic model that allowed the team to use both evidence from the trial and external evidence. “There are very small gains in quality-adjusted life years over a longer-term model,” Arundel shared with VSASM. “There were lower healthcare costs for negative pressure compared to usual care, but higher intervention costs, and the incremental costs are therefore higher for negative pressure, but not significantly.”

“There was no gain in terms of quality of life, and no real gain in terms of cost either,” Arundel concluded at this point during the dedicated SWHSI-2 trial session.

‘A chronic, disabling problem’

Following the presentation of these first-time results, Chetter shared his key take-home messages.

“These wounds are a chronic, disabling problem,” the presenter stressed, citing again the proportion of wounds in the trial that did not heal being “much higher” than he expected and the length of time it took for those wounds that did heal being “much longer” than anticipated.

Chetter continued that the indications for negative pressure are “minimal”. It “doesn’t accelerate healing, doesn’t improve your quality of life, and doesn’t reduce those secondary outcome measures that we looked at,” he listed. In addition, the presenter reiterated that negative pressure does not reduce a patient’s chance of their wound getting an infection, does not reduce their chance of needing another operation or being readmitted to hospital, and does not reduce their chance of needing antibiotics. Chetter also referenced again the “scary” amputation and mortality rates of 10% among the patients included in the trial.

Here, Chetter queried how the SWHSI-2 findings might impact his clinical decision-making moving forward. “If I was faced with a patient […] and I could predict that that patient would be in the 40% that didn’t heal or be in the 10% that ended up with an amputation, anyway, would we together— me and the patient—make a different decision about how we manage that foot problem?” he asked.

Closing his presentation, Chetter restated the severity of the problem at the centre of the SWHSI-2 trial. “These wounds are horrendous,” he stressed. “They severely affect our patients.” As a result, Chetter’s forward-looking message was clear: “We need to continue research to try and find a way to accelerate wound healing. Patients are desperate to get these wounds to heal and the quicker we can help them heal these wounds, the better.”

Chetter also highlighted the fact that the data raise wider questions about evidence-based practice. “I think we need to contemplate how technology gets into the NHS,” he posited, citing that NPWT is “widely used” and “widely advocated for” in the UK.

“It was kind of putting the cart before the horse,” the presenter analogized, detailing that NPWT was accepted into UK practice without “robust” clinical and cost-effectiveness data being available.

Initial reactions

Before opening the floor to questions, session co-chair Matt Brown, MD, from King’s College London, London, commented on the significance of the SWHSI-2 results for vascular practice: “This is incredibly important, to debunk some of these things we do routinely because we think they work.”

Subsequently, one audience member asked for Chetter’s advice to encourage units who might rely on their positive experiences regarding negative pressure to change their practice based on the SWHSI-2 data.

“My answer is: the data’s there,” Chetter replied. “It’s a level-one, high-quality trial—the best evidence you can get. Why would you go against that?”

Manj Gohel, MD, from Cambridge University Hospitals NHS Foundation Trust in Cambridge, England, praised the “incredible achievement” of Chetter, Arundel and colleagues in completing the trial. “This is why we do randomized trials—to challenge those dogmas,” he remarked, adding that the results were “going to take a while to sink in.”

Gohel went on to ask whether there are any subgroups in which there is still a role for negative pressure. Chetter replied in the affirmative, with the caveat that there are far fewer than previously thought. One example he mentioned was as a wound management strategy. “Save the money,” was Chetter’s main piece of advice here. “Spend it on something more useful, like more nurses, more research nurses, to get that research delivery problem sorted out.”

Will SWHSI-2 change practice?

At ESVS 2025, where Chetter presented the SWHSI-2 findings during the Janet Powell session on late-breaking news in clinical trials, a question from Ian Loftus, MD, from St George’s University Hospitals NHS Foundation Trust in London, England, probed whether the results will translate into clinical practice. Loftus cited anecdotal evidence that he has not seen a reduction in the use of NPWT at his center in the months following Chetter and Arundel’s initial presentation of the findings in November 2024.

Chetter noted that the SWHSI-2 team has ongoing plans to disseminate the results of the trial widely, and subsequently to conduct a survey to assess their real-world impact. He also shared that the team plans to look at Hospital Episode Statistics (HES) data to see whether NPWT prescriptions are falling.

Interim RAPID-PE study reveals ‘excellent’ safety data in first 50 patients

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Bryan Kay
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Interim RAPID-PE study reveals ‘excellent’ safety data in first 50 patients
Bashir endovascular catheter

Prespecified interim analysis data from the first 50 patients in RAPID-PE have demonstrated “excellent safety” and “remarkably efficient lab times” in patients receiving on-the-table pharmacomechanical lysis without any post-procedure infusion with the Bashir endovascular catheter (Thrombolex) for the treatment of intermediate-risk acute pulmonary embolism (PE). The findings were presented during the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference (Oct. 25–28) in San Francisco.

RAPID-PE, a single-arm, prospective, multicenter U.S. study, protocol delivers 4mg recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery (8mg total for bilateral PE) by multiple hand-injected pulse sprays using an expanded 8Fr device. The dual mechanism of action is designed to create immediate mechanical fissures to restore blood flow while enabling low-dose lytic to act within and beyond the clot.

Interim data for the primary endpoint showed no mortality or hemodynamic decompensation at seven days. Major bleeding was seen in 2%  and the median total procedure time was 43.5 minutes, with a median catheter dwell time of 17.5 minutes. Eight percent of patients went to  after the procedure and the median length of hospital stay was 2.9 days. These procedures were performed by 17 different operators across various participating sites.

Presenting author Wissam Jaber, MD, an interventional cardiologist at Emory University in Atlanta and RAPID-PE co-national principal investigator, commented: “This interim cohort demonstrates that [the device] can democratize the catheter-based treatment of intermediate-risk PE patients with excellent safety and remarkably efficient lab times, often without the need for an ICU stay.”

‘The patient is there to see me and my face’: Making shared decision-making central to vascular care

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Killian Meara
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‘The patient is there to see me and my face’: Making shared decision-making central to vascular care
Matthew Corriere

Matthew Corriere, MD, believes a major shift is needed in how clinicians communicate and make decisions with their patients. During the 2025 distinguished address given at the New England Society for Vascular Surgery (NESVS) annual meeting in Providence, Rhode Island (Sept. 26–28), Corriere urged colleagues to step away from the computer and back toward the patient, highlighting shared decision-making and why it should become a central part of vascular care.

As director of the division of vascular surgery at Ohio State University’s Wexner Medical Center, Corriere has seen firsthand how time pressures and electronic record systems have made clinic visits less personal. He argued that effective care requires listening to patients.

“The patient is there to see me and my face,” Corriere said. “We need to not get so into the computer and input and billing that we start depersonalizing that individual in front of us. We need to get shared goals with them.”

This is especially true for patients with peripheral arterial disease (PAD), who often arrive at visits expecting immediate procedures, he said. When dealing with claudication, some believe they will face amputation without surgery or stents. “There’s a clear argument that we need to be a little more open and engaging with our patients in treatment selection,” Corriere said.

Corriere emphasized the need to “right-size treatment intensity,” saving procedures for only when they improve quality of life and reduce harm. He warned that both overtreatment and undertreatment can lead to poor outcomes.

“I think the biggest value for shared decision making is when we’re at a point of equipoise,” Corriere said. “That could be because we have exhausted non-invasive strategies enough and it’s time to pull the trigger on something else. Or it can also be in decisions regarding restenosis, where we’re on the merry-go-round and we’re trying to balance the benefit for doing something more invasive or not.”

Corriere and his colleagues conducted a study that surveyed patients on how much they want to be involved in decision-making. Data showed that 93% of respondents wanted to choose a treatment together with their clinician. However, only about half reported ever being offered alternatives to a recommended procedure.

Although shared decision-making has proven to be beneficial, Corriere noted how many clinicians believe it is just rolling over and doing whatever the patient wants. He said that should never be the case.

Corriere encouraged clinicians to ask their patients questions and really listen to their answers. “When you have goals and preferences that seem discordant with your clinical judgment, focus on the conversation and reorienting to get a mutually agreed upon set of goals and a plan,” he said.

Positive data show novel delayed-release diameter reduction technique in construction of PMEGs is viable

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Bryan Kay
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Positive data show novel delayed-release diameter reduction technique in construction of PMEGs is viable
Kirthi Bellamkonda

A novel physician-modified endograft (PMEG) technique for the treatment of thoracoabdominal and complex abdominal aortic aneurysms (TAAA and AAA) involving delayed-release diameter reduction to aortic size and shape—allowing for sequential target vessel cannulation—is safe and effective, according to a new study.

Results from the 203-patient analysis of PMEG fenestrated endovascular aneurysm repairs (FEVARs)—carried out in a physician-sponsored investigational device exemption (PS-IDE) at Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, from 2017–2024—were presented at the 2025 annual meeting of the New England Society for Vascular Surgery (NESVS) in Providence, Rhode Island (Sept. 26–28). Delivering the data, Kirthi Bellamkonda, MD, a vascular surgery resident at Dartmouth Hitchcock, set the scene: despite the emergence of commercial devices into the complex aortic aneurysm repair space, PMEG remains the predominant technology to treat these patients, and the traditional PMEG technique has changed little since its inception.

Bellamkonda reported an average aneurysm diameter of 59.9mm among the cohort, with a distribution of 24% juxtarenal aneurysms, 46% pararenal aneurysms, 10% extent IV TAAAs and 18% extent II or III TAAAs. Technical success was 100%, with 30-day outcomes showing 2.5% mortality, 2% organ failure (of which half was renal failure), about 1% paraplegia and paraparesis, and 5% access site complications.

At one year, there were no cases of open conversion, stent fracture or migration, Bellamkonda added. Paraplegia and paraparesis were found to be similar to the 30-day outcomes. One-year target vessel instability was 6.6%, of which 2% was component stenosis and 4.6% component occlusion.

So why delayed-release diameter reduction, Bellamkonda pondered. “We reduce the number of simultaneous wires from four to one compared to the traditional technique, which reduces the risk of wire loss and re-cannulation, as well as the trauma to bridge vessels,” she said. “This allows us to work with a smaller contralateral sheath and improves intraoperative efficiency.” Given the continued role for PMEG in complex treatment, Bellamkonda said that the study group hopes to see the technique and design disseminate and help inform industry improvements in graft manufacturing.

TAMBE and TBE: Evolving experiences and piecing together channels of inquiry

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Bryan Kay
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TAMBE and TBE: Evolving experiences and piecing together channels of inquiry

New findings chronicling progress with both the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE)— approved by the Food and Drug Administration (FDA) last year—and Gore Tag thoracic branch endoprosthesis (TBE), which recently acquired a new indication for use in aortic zones 0 and 1, dotted the programs of some of the regional vascular society meetings in September.

Data gathered from the Mayo Clinic in Rochester, Minnesota, and the University of Southern California Keck Medical Center in Los Angeles for a comparative analysis between fenestrated and branched endovascular aneurysm repair (F/BEVAR) using physician-modified endografts (PMEGs) and the off-the-shelf TAMBE device for complex abdominal (AAAs) and thoracoabdominal aortic aneurysms (TAAAs) showed “comparable high technical success and optimal perioperative outcomes,” according to the study group.

Armin Tabiei, MD, a vascular surgery resident at the University of California Los Angeles (UCLA), presented findings from the study—covering procedures undertaken between 2015 and 2025— during the 2025 annual meeting of the Western Vascular Society (WVS) in Ojai, California (Sept. 14–17). Focused on a primary endpoint of freedom from target artery instability (TAI), Tabiei reported that among the 668 PMEG and 78 TAMBE patient groups, 77% of the former and 64% of the latter were estimated to be free of TAI at three years. “However, when only evaluating the renal target arteries, the freedom from instability was 89% for PMEG and 73% for TAMBE,” he said.

A majority of the patients were treated for TAAA, with a high rate of extent IV aneurysms. Early mortality occurred in 29 patients, all of whom were treated with a PMEG. Major adverse events occurred in 19% of the PMEG group and 17% of the TAMBE group.

Mean follow-up was 20 months in the PMEG group and 16 months in the TAMBE cohort. Three-year freedom from reintervention was 60% (PMEG) vs. 53% (TAMBE), while freedom from type I or III endoleak was 72% vs. 90%. “Freedom from aortic-related mortality was also similar, with rates of 99% in the TAMBE group and 94% in the PMEG group,” Tabiei added.

Overall survival was significantly lower in the PMEG group, with a three-year rate of 65% compared to 88% in the TAMBE group, which was “likely a reflection of more patients in the TAMBE group being treated under the clinical trial with more stringent inclusion criteria.”

Later in the same session, Zachary Rengel, MD, a vascular surgery resident from the Keck Medical Center, took a look at renal artery outcomes at the vessel level, comparing TAMBE and PMEG repairs, seeking to identify risk factors for TAI that could help guide patient selection. Covering procedures from 2015–2025 carried out at the same two aortic centers, Mayo and USC, Rengel told WVS that 633 patients underwent PMEG and 88 TAMBE. “This encompassed 1,339 renal arteries split almost evenly between the right and left,” he said.

At five years, freedom from TAI was significantly higher in PMEG patients at 89.5% compared to 82.7% in those treated with TAMBE. “Right renal arteries had worse performance with TAMBE—77.9% at two years compared to 91.3%,” Rengel continued. “Left renal arteries were comparable, with a significant difference seen between PMEG and TAMBE.”

In a subgroup analysis by aneurysm extent, “we saw that this difference in target vessel instability was driven by the pararenal aneurysms. Two-year freedom from target vessel instability was nearly 94% for PMEG but only 76% for TAMBE,” Rengel said. “In TAAAs, there was no significant difference: 93.5% for PMEG vs. 89.6% for TAMBE.”

Comparing bridging stent types in patients who had a single type, there was no significant difference in freedom from TAI between those used—VBX and iCast stents.

“We observed that primary patency in part drove the target vessel instability findings,” Rengel explained. “At five years, PMEG maintained to 94% patency versus 83% for TAMBE. Again, we saw that patients with pararenal aneurysms seemed to drive these findings with the two-year primary patency difference of almost 20%, although TAAAs saw a modest difference.

“When looking at laterality for primary patency, we saw again that the right renal artery had a more significant difference in comparison to the left, with five-year primary patency being 93% in PMEG and 80% in TAMBE. We did not observe any differences between PMEG and TAMBE in freedom from branch endoleaks, with TAMBE actually performing slightly better at 98.2% vs. 93.9%. Freedom from reintervention also favored PMEG at five years.”

Cox proportional hazard modeling showed that TAMBE usage and bridging stent diameter were independent risk factors of TAI, Rengel added. “These findings suggest that TAMBE renal branches have higher target vessel instability compared to PMEG, driven by the loss of primary patency and branch reintervention at the right renal artery, and is more pronounced in patients with pararenal aneurysms.”

At the 2025 Eastern Vascular Society (EVS) annual meeting in Nashville, Tennessee (Sept. 4–7), Amanda Rushing, MD, a vascular surgery resident at Mount Sinai in New York, reported on her institution’s experience with the TAMBE device.

Rushing and colleagues looked at eight patients enrolled in the TAMBE clinical trial from June 2021 to May 2024 and a further nine treated after device approval in June 2024. While the indication for all trial patients was aneurysmal and elective, the post-trial group included one emergent rupture and two type A aortic dissections with pararenal aneurysms, Rushing told EVS 2025. Among the post-trial patients, five would not have qualified for the clinical trial.

A higher percentage of post-trial patients had previous aortic coverage and a larger descending aorta compared to trial patients, she continued. “The post-trial patients had a longer length of stay and higher rates of transient spinal cord ischemia,” she said. “Both cohorts had no type I endoleaks, while one post-trial patient had a type III endoleak.”

There were no mortalities, strokes or myocardial infarctions (MIs) at 30 or 60 days among trial patients, whereas there was one MI within 30 days in the post-trial group, Rushing added.

“When looking at TAMBE in our postmarket analysis, patients treated outside the guidelines of the clinical trial had high technical success and comparable outcomes to those performed in the clinical trial,” she concluded.

Also at EVS 2025, Grayson Pitcher, MD, an assistant professor of vascular surgery at the University of Rochester in Rochester, New York, reported on lessons learned from a multi-institution case series of TAMBE cases involving wire wrapping of the celiac and superior mesenteric arteries. Wire wrapping most commonly occurs with celiac and superior mesenteric artery catheterization during interaction with the preloaded guidewires, Pitcher said, urging colleagues to be aware of this phenomenon.

“TAMBE has shown promising results, but something we have found is that stent wrapping can occur and it is important that everyone really be aware of this challenge,” Pitcher said, adding that the cases to which he referred highlighted the importance of using non-contrast cone-beam computed tomography.

TBE in zones 0 and 1

Meanwhile, new data emerged at EVS 2025 on the TBE, including patients receiving treatment in aortic zones 0 and 1, the expanded indication for which was approved by the FDA in June. Rushing, of Mount Sinai, delivered an institutional experience involving 32 TBE procedures between October 2022 and March 2025.

“TBE is the first off-the-shelf single-branch endoprosthesis for the zone 0, 1 and 2,” she told EVS. “Originally for zone 2 alone, this device has recent FDA approval for zone 0 and 1, and few studies have investigated the use of TBE in these zones, and even fewer its use in concomitant procedures, specifically type B aortic dissections [TBAD].”

The retrospective observational review included 25% with a zone 0 or zone 1 repair. Of the three patients who had a zone 0 repair, all involved chronic TBAD. Of five patients who had a zone 1 repair, three were aneurysmal in nature and two were chronic TBAD. Overall, a majority of the repairs (69%) were for TBAD, with the remaining 31% for aneurysm alone.

“For zone 0, all three of these patients underwent a right-carotid-to-left-subclavian bypass, and then transposing the left carotid onto that bypass,” Rushing explained. “In our remaining subset of zone 1 patients, three of the five underwent a left-carotid-to-left-subclavian transposition. This allowed us to cover the origin of the left common carotid artery with our portal into the left subclavian artery, and gaining that zone 1 access just distal to the innominate take off.

“We had a very high percentage of right-sided aortas in this patient population. Two of the 32 patients had right-sided arches,” Rushing continued. “One of these patients underwent a left-carotid-to-left-subclavian bypass with a TBE portal into the right subclavian artery. The other right-sided patient had a bilateral carotid-to-subclavian bypass with the TBE portal into the right common carotid artery. Among our other anatomic anomalies, one patient had aberrant right subclavian artery.”

Intraoperative and 30-day complications included three closure device failures, one patient had a common iliac rupture, two had unplanned partial coverage of a cerebral vessel, and one patient had a radial artery pseudoaneurysm, Rushing said.

Further, there were no patients with transient spinal cord ischemia, one patient had a type III endoleak and all stents were patent at 30-day follow-up. There was one stroke within 30 days and one mortality within 120 days resulting from respiratory failure and subsequent cardiac arrest.

“Of the patients that had follow-up within one to two years, there was no mortality, stroke or MI within this patient subset,” Rushing added.

Patient-facing literature from SVS found to exceed recommended reading level

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Bryan Kay
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Patient-facing literature from SVS found to exceed recommended reading level
Loui Othman

A readability analysis of 15 publicly available patient education materials from the SVS found that all but three exceeded the 8th-grade reading level, the threshold at which the average adult in the U.S. reads. Additionally, all 15 breached the 6th-grade reading level, the ceiling recommended by both the National Institutes for Health (NIH) and the American Medical Association (AMA).

The study was conducted by a team of researchers from Penn State College of Medicine in Hershey, Pennsylvania, led by senior author Faisal Aziz, MD, chief of vascular surgery at the institution, and presented during the 2025 Eastern Vascular Society (EVS) annual meeting in Nashville, Tennessee (Sept. 4–7) by Loui Othman, BS, a second-year medical student at Penn State.

Despite calls for more simplified language in patient-facing resources, previous research has detailed how patient education materials from various specialties exceed readability thresholds and strain patient understanding, Othman told EVS 2025.

The Penn State study used six validated readability tools to assess the difficulty of the SVS patient education materials, covering such vascular conditions as abdominal aortic aneurysm (AAA), carotid disease and peripheral arterial disease (PAD). Among their findings, Othman and colleagues reported that the reading material on AAA recorded the best reading ease score, while that for cerebrovascular disease registered the most difficult—found to be at the college reading level.

The study represented the first comprehensive readability analysis of the SVS materials, said Othman. “We used multiple calculators to enhance our confidence in recording the readability of each handout. Findings are consistent with and support previous research.”

The Penn State team recommend that the readability of the SVS materials be improved in order to enhance patient comprehension, engagement and adherence, he added.

A straw poll conducted at the close of the presentation to determine how many attendees referred patients to SVS materials online saw only a couple of raised hands. “That is also a big issue that needs to be addressed,” remarked moderator Mahmoud Almadani, MD, a vascular surgeon at Maimonides Medical Center in Brooklyn, New York.

Mechanical thrombectomy system for AV access shows promise, study shows

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Bryan Kay
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Mechanical thrombectomy system for AV access shows promise, study shows
Nicole Ilonzo

A retrospective analysis of 64 patients treated between 2022 and 2025 using a novel mechanical thrombectomy system to treat dialysis access thrombus showed function was restored in 91% of those treated.

Data from the study of the InThrill system (Stryker/ Inari Medcial) were presented by Nicole Ilonzo, MD, a vascular surgeon at NewYork-Presbyterian in Brooklyn, New York, at EVS 2025. AV fistulas and grafts

The study included patients with arteriovenous (AV) fistulas and grafts, with 31% of those treated having fistulas. “Clinical success, defined as restoration of access function for dialysis, was achieved in 91% of patients,” Ilonzo told the 2025 edition of the Eastern Vascular Society (EVS) annual meeting in Nashville, Tennessee (Sept 4–7).

“Primary patency at one month was 72%, higher than 40-60% range reported in studies using only balloon maturation techniques.”

Device-related complications were minimal, she said, with 3% experiencing trauma at the access site and another 3% having distal embolization. All were resolved intraprocedurally, Ilonzo added. “Importantly, there were no deaths, vessel perforations or major adverse events.”

The InThrill thrombectomy system “shows promise and is a safe and effective alternative to traditional AV access thrombectomy techniques,” she concluded

STORM-PE finds mechanical thrombectomy superior to anticoagulation alone

By
Jocelyn Hudson
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STORM-PE finds mechanical thrombectomy superior to anticoagulation alone
Robert Lookstein
Robert Lookstein

The use of mechanical thrombectomy, specifically computer-assisted vacuum thrombectomy (CAVT) using the 16Fr Lightning Flash system (Penumbra), with anticoagulation achieves superior reduction in right heart strain compared to anticoagulation therapy alone in patients with acute intermediate-high-risk pulmonary embolism (PE). This is according to data presented at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference (25–28 October, San Francisco, USA) from the STORM-PE randomised controlled trial (RCT).

“These findings mark a pivotal step in advancing care for PE, providing the strongest evidence to date that advanced therapy with CAVT can rapidly and safely improve recovery of the right heart compared to conventional anticoagulation therapy,” said presenter and co-global principal investigator Robert Lookstein (Icahn School of Medicine at Mount Sinai, New York, USA) in a press release announcing the results. “STORM-PE supports the role of CAVT as a more effective therapeutic option for intermediate-high-risk patients and will evolve the paradigm of care by delivering rapid relief with a comparable safety profile to anticoagulation alone.”

The trial enrolled 100 patients across 22 international sites. Patients treated with CAVT demonstrated a greater reduction in right-to-left ventricular (RV/LV) diameter ratio within 48 hours (mean reduction 0.52 vs. 0.24; p<0.001) and nearly 80% of patients had positive treatment effect with CAVT, which was significantly greater than the patients who received anticoagulation alone (78.3% vs. 51.9%; p=0.011), reflecting rapid haemodynamic recovery.

“What’s particularly compelling is that a significantly greater portion of patients treated with CAVT achieved normalisation of RV/LV ratio within 48 hours—a critical indicator of right heart recovery—without an increase in complications,” said Rachel Rosovsky (Massachusetts General Hospital and Harvard Medical School, Boston, USA), co-global principal investigator. “These findings represent a meaningful advancement in optimising early interventions in patients with intermediate-high-risk PE, and we look forward to exploring how changes in RV/LV ratio correlate with other clinical and functional outcomes.”

The rate of major adverse events (MAE) within seven days—including a composite of PE-related mortality, recurrent PE, clinical deterioration requiring rescue therapy, and major bleeding—was comparable between groups (4.3% [2/47] with CAVT vs. 7.5% [4/53] with anticoagulation alone).

“For the first time, we have prospective, level-one evidence demonstrating that CAVT with anticoagulation is superior to anticoagulation alone,” said James F Benenati, chief medical officer at Penumbra. “Combined with Penumbra’s strong prospective data from STRIKE-PE, this randomised evidence from the STORM-PE trial will play a critical role in advancing PE care and supporting the inclusion of CAVT in future treatment guidelines.”

Additional results from the STORM-PE trial are set to be presented at the upcoming VEINS (Venous Endovascular Interventional Strategies) and VIVA (Vascular InterVentional Advances) conference (1–5 November, Las Vegas, USA).

Stanford vascular surgery blends team bonding and exercise in first SVS Step Challenge gathering

By
Marlén Gomez
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Stanford vascular surgery blends team bonding and exercise in first SVS Step Challenge gathering
The Stanford walkers

The Stanford Division of Vascular Surgery launched its first in-person SVS Foundation Vascular Health Step Challenge on Sept. 7, bringing together more than 100 participants to raise awareness for peripheral arterial disease (PAD) during PAD Awareness Month.

Jason Lee, MD, professor of surgery and division chief, assisted in the planning of the event that featured a 1.3-mile walk around Stanford’s campus. Participants collectively logged more than 250,000 steps in just 45 minutes and raised $3,000 for the Foundation’s event.

“We started this summer by trying to gather interest in it,” Lee said. “We realized the beginning of fall was a good time to bring our clinic staff, faculty and trainees together, which is how we were able to get 100 people to show up on a Sunday morning.”

The walk included faculty, fellows, residents, staff and families—many of whom brought children and their four-legged companions. “I was happy to contribute a quarter of a million steps to the Step Challenge,” Lee said. “It was all in the name of raising awareness for PAD.”

Due to the event’s success, the Stanford team is considering making Sunday walks a regular tradition. “It was so much fun, honestly,” he said. “We’re thinking about every Sunday morning moving forward—just getting some bagels and coffee and gathering the vascular team together for a walk.”

The SVS Foundation, an organization dedicated to supporting vascular education and research, will utilize the fundraising efforts from the challenge to make critical research investments, such as the Vascular Care for the Underserved award.

“The Lee family has always been happy to support the SVS Foundation because of how much it has helped my career,” he said. “Now I want to support all the initiatives to help our medical students, trainees and young career faculty.”

Looking ahead, Lee said the team may expand the challenge. “In the upcoming years, we might turn it into a race or a run or a bike challenge,” he said.

SVS Foundation set to launch Enrico Ascher Vascular Innovation Institute at VAM 2026

By
Marlén Gomez
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SVS Foundation set to launch Enrico Ascher Vascular Innovation Institute at VAM 2026
Enrico Ascher

The Society for Vascular Surgery (SVS) Foundation will formally establish the Enrico Ascher Vascular Innovation Institute as a new entity under its research and innovation portfolio, following generous support from the Ascher family.

Set to launch at the 2026 Vascular Annual Meeting (VAM) in Boston, the institute will serve as a forward-looking platform for advancing pioneering ideas, technologies, and leadership in vascular surgery. The event will bring together innovators, mentors, industry partners and SVS leadership to celebrate and activate the program.

The creation of the institute follows years of strategic planning. In 2024, SVS made innovation a core focus by establishing the SVS Innovation Task Force.

This initiative was sparked by a proposal for a national framework to support surgeon-led innovation through education, mentorship and funding. With support from the SVS Executive Board, the task force was charged with defining SVS’s role in the innovation ecosystem and developing a roadmap for future investments.

“The leadership of the Society for Vascular Surgery has identified the topic of innovations as one of its important goals. I am humbled and honored by the fact that this new institute was named after me. I believe this institute will be enriched by great contributions from our members,” said Enrico Ascher, MD, clinical professor in the department of surgery at NYU Grossman School of Medicine in New York.

In 2025, Ascher was honored with the Medal of Innovation in Vascular Surgery during the Society’s Annual Meeting.

“These contributions are not limited to new devices but include innovative open and endovascular procedures, new concepts in training paradigms, new concepts in the medical and surgical management of vascular diseases, and any innovation that contributes to the betterment of the vascular patient,” said Ascher.

The Enrico Ascher Vascular Innovation Institute aims to foster a culture of innovation within the vascular community and provide mentorship and guidance from experienced surgeon-innovators. It will also deliver educational programming on key areas of innovation, offer seed funding for promising ideas and cultivate a growing innovator community anchored at VAM. Planned components of the launch include an innovation competition, a keynote session under the Institute’s banner, a networking event connecting early-career surgeons with industry and funders, and educational content focused on entrepreneurship, technology translation and commercialization strategies.

The institute will also take ownership of the Roy Greenberg Distinguished Lecture, established in 2013 to celebrate innovation in vascular surgery. In further recognition of that legacy, the SVS plans to present the SVS Medal of Innovation in association with the Enrico Ascher Vascular Innovation Institute — directly linking the award to the program that embodies Ascher’s spirit of advancement and excellence.

“Creativity and innovations are essential goals of any medical or surgical specialty that wishes to prosper and lead,” said Acher. “It’s not a secret that we are facing increasingly strong competition from other specialties that manage patients with vascular diseases. While it’s perfectly fine to collaborate with our non-surgical colleagues, we need to continue to lead this race for creativity and innovations in this field.”

A critical element of the institute’s mission is preparing participants to evaluate market needs, navigate regulatory requirements and communicate their ideas effectively. The Innovation Task Force has identified this kind of training as essential, particularly in the early stages of innovation.

To meet this need, the SVS is exploring partnerships with providers of entrepreneurial training. One model under consideration includes a scalable online course covering the fundamentals of innovation and business planning, paired with individualized coaching to help participants prepare professional pitch presentations for review by business advisors or potential funders.

“Let us not forget that a single idea originating from any vascular surgeon can revolutionize our specialty,” Ascher said. “Recognize needs, trust your ideas, and believe you can contribute—no matter your role. If inspiration strikes, jot it down, and if it still makes sense later, pursue it with all your heart. Don’t give up. If needed, reach out to the newly formed Institute for Vascular Innovations.”

The globalization of aortic innovation: A cautionary tale of U.S. regulatory overreach

By
Shahab Toursavadkohi
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The globalization of aortic innovation: A cautionary tale of U.S. regulatory overreach
Shahab Toursavadkohi

In 1954, Dr. Michael DeBakey transformed vascular surgery with a homemade Dacron graft sewn on his wife’s sewing machine. His spirit of innovation laid the foundation for decades of U.S.-led advancement in aortic technology. However, recent trends suggest that this pioneering role is eroding, in large part due to the unintended consequences of regulatory tightening by the Food and Drug Administration (FDA).

The 2015 introduction of the custom medical device (CMD) and investigational device exemption (IDE) revision clause, which requires physician-sponsored IDEs for the use of physician-modified endografts (PMEGs), was intended to formalize oversight and ensure patient safety. But for many in the vascular surgery community, it has become a symbol of bureaucratic overreach that is obstructing progress. The U.S. regulatory burden now stands in stark contrast to the more permissive environments abroad, where innovation in complex endovascular aortic surgery has found fertile ground. To understand this shift, we conducted a scoping review—conducted with data gathering by research fellow Georges Jreij, MD, and medical student Jeffrey Lu, BS, and co-authored by Saurabh Gupta, MD, Khanjan Nagarsheth, MD, Mehrdad Ghoreishi, MD—of 5,197 articles addressing branched, fenestrated or physician-modified endografts, of which 263 met inclusion criteria. The majority (81%) were published after 2015, coinciding with the implementation of the CMD and IDE clause. Before 2015, the U.S. produced nearly 45% of these studies. After 2015, that share dropped to 24.3%, with China, Italy, Germany and Japan all increasing their output significantly. Interestingly, China went from a negligible presence to contributing nearly 14% of publications—an astonishing rise.

The shift is even more pronounced when comparing article types. Prior to 2015, 41% of U.S. publications were clinical trials; this fell to just 6% after 2015. Meanwhile, case reports and series rose to comprise 52% of post-2015 U.S. publications. For the rest of the world, this transition was even more dramatic, with case reports and series comprising 59% of studies post-2015. This increase in lower-tier evidence—while perhaps criticized by some—also reflects where the frontier of innovation is occurring: at the bedside, in real time, unencumbered by regulatory inertia.

Patient volume data echoed this trend. Before 2015, U.S.- based publications represented 66% of all patients treated with advanced endovascular techniques. After 2015, the U.S. share dropped to 52%, while the rest of the world saw a fourfold increase in treated patients—nearly matching the U.S. total. Innovation, quite literally, has moved offshore.

This is not just a matter of publication metrics or national pride. It affects patients and surgeons alike. Only about 10 U.S. sites currently have access to custom-made endografts under IDE protocols, despite the presence of more than 3,000 practicing vascular surgeons across 400 medical centers. The remaining majority are left waiting— not because of a lack of training or need, but because of systemic barriers that favor prolonged clinical trials over physician-led adaptability.

Meanwhile, many of the companies producing these devices are based in the U.S. but now conduct early feasibility studies overseas. The result is that U.S. vascular surgeons are increasingly reliant on global colleagues to define the future of their specialty. While large, structured U.S.-based trials continue to provide high-quality data, they do so at the cost of speed, accessibility, and real-time iteration.

If we are to restore balance between regulation and innovation, one potential solution lies in expanding the role of real-world data collection through established registries. The Vascular Quality Initiative (VQI) and Society of Thoracic Surgeons (STS) databases could be leveraged to track advanced aortic procedures, providing post-market surveillance while allowing broader clinical access. This model has already proven successful in the case of transcarotid artery revascularization (TCAR), which received FDA clearance through VQI-based monitoring. A similar path could allow PMEGs and CMDs to break free of current constraints.

Dr. DeBakey didn’t wait for approval to innovate. He took the initiative, using available tools to solve urgent clinical problems. Today, many of us feel constrained from doing the same—not because we lack ideas or skill, but because we are fenced by red tape. If the U.S. hopes to reclaim its leadership in aortic innovation, we must embrace a more pragmatic, data-informed regulatory pathway—one that enables progress without compromising safety.

Without change, the risk isn’t just falling behind; it’s becoming irrelevant.

Shahab Toursavadkohi, MD, is an associate professor of surgery and co-director of the Aortic Center at the University of Maryland.

Closer to the goal: Shoring up data behind breakthrough imaging technology that plots a radiation-free future in new RCT

By
Bryan Kay
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Closer to the goal: Shoring up data behind breakthrough imaging technology that plots a radiation-free future in new RCT
Andres Schanzer
UMass chief peers down the lens of an if-not radiation-free complex aortic procedural future, then one in which the methods of today will look positively quaint.

“I say this a lot,” says Andres Schanzer, MD, “but I think there is a time within the next five or 10 years when we’ll be talking to medical students and they will say to us, kind of confused, ‘What do you mean you stepped on a pedal the entire time you were doing one of these cases.’”

The University of Massachusetts (UMass), Worcester, chief of vascular surgery is reflecting on the advance of imaging technologies designed to dramatically reduce exposure to radiation, particularly during lengthy complex aortic endovascular aneurysm repair procedures. Several modalities, loosely grouped together under the banner of “radiation-free,” have emerged in this space in recent years. The “radiation-free” tag represents a lofty goal. Or “a very high bar,” Schanzer says, explaining: “I think what we have all come to realize as we have explored these new technologies is that hopefully we can get closer and closer to that goal. But certainly, within the short term, we are not going to get to a complete radiation-free repair.”

Short of that high bar, significant strides forward have been made. And now, those advances have given way to a randomized controlled trial (RCT) designed to test one of these technologies. Playing on the radiation-free moniker, the RadFree unblinded, multicenter, international study places LumiGuide (Philips), powered by Fiber Optic RealShape (FORS), in a head-to-head with conventional X-ray in a bid to firmly establish that it requires less average fluoroscopy time. Several patients have already been randomized, with the first receiving treatment using LumiGuide recently carried out by Darren Schneider, MD, at the University of Pennsylvania in Philadelphia.

Schanzer is a principal investigator in this 11-site RCT. He has been on the radiation-busting trail for some time. His UMass team was involved in some of the earliest cases of FORS in the U.S., reporting a 75% decrease in fluoroscopy use while carrying out a fenestrated endovascular aneurysm repair (FEVAR) of a thoracoabdominal aortic aneurysm (TAAA).

In the period since the technology first received Food and Drug Administration (FDA) approval in 2020, they have been at the center of studies probing its safety and effectiveness, Schanzer details. “We’ve had the opportunity to be involved in several institutional studies looking at our own data and some multicenter studies with other collaborators from the U.S. and around the world, and what we have learned in these early experiences is that use of LumiGuide seems to decrease radiation time, decrease radiation dose, and the hope is that by doing a randomized controlled trial we can definitively show whether or not there is a benefit associated with using this technology.”

The rationale is beyond question. The sheer length of a FEVAR or branched EVAR (BEVAR) can expose care teams to extensive amounts of radiation. Initial concerns around radiation exposure rightly focused on the patient, Schanzer continues. But, all things considered, patients might expect to undergo one or perhaps two procedures. So thoughts soon turned to the fact that providers might take part in several over the course of any given week.

“If you think about it, it’s crazy that we’re standing right up against an image intensifier that is emitting radiation for procedures that can be several hours long, and we’re taking that radiation and exposing the entire care team to it, day in and day out,” says Schanzer. “So, this is a complete paradigm shift, and it has the potential to really be transformative if the results bear out and show that there is a significant reduction in radiation time and dose. Moreover, I’m sure that, as we continue to iterate on the generations of this technology, it will be able to be used for more and more steps of the procedure. It will be an adjunct to radiation use, but I think that we could potentially cut the dose of radiation more than in half by embracing technologies like this.”

The UMass team has completed more than 100 cases using LumiGuide’s FORS technology. Schanzer believes the UMass data and that accumulated elsewhere in the U.S. and in Europe suggests wider use, but only an RCT like RadFree can provide the sort of robust evidence needed to do so. “The initial investigators that started using and testing LumiGuide have been working with Philips for several years now, and really pushing that we need level-1 data to support a larger, broad rollout of this technology,” Schanzer says.

Such technologies tackle some of the most radiation-intensive steps in complex aortic procedures. “There are certainly many technologies that have come along that have helped decrease the radiation necessary with the more modern, hybrid room setups,” Schanzer continues. “But even as we practice good radiation safety behavior, there still is a significant amount of radiation used for these complex procedures. Where we are with this technology is we can now take a lot of the radiation-intense steps and decrease the use of radiation, and eliminate it for several of these steps.” A case in point: cannulation of the vessels during FEVAR. “This is something that can be done entirely—safely and effectively—using LumiGuide,” he adds.

SVS vice presidency

Schanzer’s contributions to driving the vascular field forward—he is also a key player in the trail-blazing U.S. Aortic Research Consortium, which investigates complex aortic repairs through individual investigational device exemption (IDE) studies—continue apace at a time when he is also rising in the Society for Vascular Surgery (SVS) having recently been elected SVS vice president. His rise into the presidential line of succession arrives at a relatively young age, when he is still comfortably positioned as an active clinician. He described his selection by the membership as a privilege, arriving when “a lot of new diverse stakeholders are getting engaged with the SVS.”

Going forward, Schanzer hopes to bring a novel perspective to further the Society’s “outstanding leadership” over the years. “I am still a very active clinician, a very active investigator and take a lot of pride in my vascular division at UMass,” he says. “In some ways, that brings a perspective to SVS leadership that I hope is very relatable and very generalizable to many members of the SVS. I’m not at the stage of my career where I am winding down taking care of patients, or not really doing much of my own clinical or research work anymore. Hopefully that will allow me to better understand the needs of many of our active members in the field. It’s an honor to serve in this role and I will continue to work as hard as I possibly can to continue to move the field forward for all of our members.”

Vascular Specialist–October 2025

By
Bryan Kay
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Vascular Specialist–October 2025

In this issue:

  • TAMBE and TBE: Evolving experiences and piecing together channels of inquiry
  • Randomized data debunks widely used negative pressure wound therapy
  • The globalization of aortic innovation: A cautionary tale of U.S. regulatory overreach
  • Closer to the goal: Shoring up data behind breakthrough imaging technology that plots a radiation-free future in new RCT

 

When to re-intervene: Stent surveillance and the effective use of RevCore mechanical thrombectomy to clear in-stent thrombosis

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When to re-intervene: Stent surveillance and the effective use of RevCore mechanical thrombectomy to clear in-stent thrombosis
Jake Hemingway

This advertorial is sponsored by Stryker/Inari Medical.

How a finely tuned stent surveillance program plays a crucial role in raising the alarm of worsening symptoms in DVT patients and identifies those who might require reintervention with mechanical thrombectomy.

For Jake Hemingway, MD, the key to his practice of treating patients with deep vein thrombosis (DVT) and the long-term effects in those who develop post-thrombotic syndrome (PTS) is not simply a robust, fastidious stent surveillance program, but something he thinks of as a wider DVT surveillance program.

The scope of the patient population is not insignificant, he says. “In a lot of hospital systems, patients with acute iliofemoral DVT get treated. People with superficial disease or varicose veins get treated. But there is a huge proportion of patients in between who have PTS or chronic sequelae of DVT that just aren’t really owned by anyone.”

Hemingway, an assistant professor of vascular surgery at the University of Washington (UW) in Seattle, is guided by a philosophy that includes a commitment to lifelong management and a program designed to capture patients with chronic venous disease of all segments who might otherwise fall through the cracks. He sees patients across the spectrum, but one population stands out: PTS patients who have undergone treatment at an outside facility and have had an early in-stent thrombosis, or those who have received a prior intervention that was ultimately unsuccessful. What unites them is the fact these patients tend to be younger and require long-term care.

“The reality is that nothing is permanent in vascular, so you really do have to deal with problems as they come up,” says Hemingway. So it stands to reason that, after placing a venous stent, “you should see that patient for life.” To that end, he continues, “it’s always easier to take care of a problem before it becomes a serious issue rather than dealing with a chronic occlusion many years later. Tied into that is that you need to understand what you’re doing to patients over the long term.”

Hemingway’s stent surveillance program is standardized. Follow-up appointments are scheduled at the same time as the index procedure. Patients receive an initial duplex ultrasound on postoperative day one. They are then followed at the two-to-four-week mark, after which—if their imaging is clear—they return at the three-, six-, and 12-month timepoints, then yearly thereafter. The surveillance program means issues that arise are picked up “much earlier on,” he adds.

When to re-intervene

Hemingway’s threshold for re-intervention is dependent on a couple of factors. “If a patient has a really challenging reconstruction and has a lot of inflow disease, and I think there might be something I can improve upon, I will look to go in,” Hemingway explains. “Or: if a patient comes in and they are outlining that they are not that symptomatic, but they missed a few days of anticoagulation, and now they have some in-stent thrombosis with an area that looks to be quite narrow and the flow is in continuous wave forms.”

He points to the classic case in point—in the setting of an inferior vena cava (IVC) and bilateral iliofemoral reconstruction. In these cases, the key to success is a combination of listening to the patient and treating recurrent symptoms.

To that end, the asymptomatic patient with a widely open stent will continue to be monitored under surveillance. But what about the patient who reports with either a 50%-or-more narrowing with associated flow abnormality like continuous waveforms peripherally? “We know there is a drop in the volume of flow rate in comparison to their postop day one duplex, especially if that is seen either at the two-week or three-month mark,” Hemingway says. “That’s when I’m much more aggressive about going in because I think you have your best chance of fixing things. With an early stent thrombosis, I will often have a lower threshold to intervene on a patient, especially if there is a narrowing that appears to be fairly significant and associated with more peripheral hemodynamic effects.”

Hemingway also re-intervenes when patients show evidence of stenosis and recurrent symptoms, whether mild or severe. “You see a change in the duplex, you notice some thrombus layering and continuous waveforms, with the patient noticing that their wound was healing well for two weeks, and now, over the last four weeks, it has stagnated or maybe even grown in size,” he explains. Then there are the patients with stents that appear to be clear but symptoms are recurring. “That’s when I start looking at superficial disease. I start to think about reflux, and other pathologies that might be contributing.”

All of which raises the question of treatment modality, and which cases point to which method of re-intervention. In most scenarios, Hemingway outlines, the most effective modality to remove in-stent thrombosis is mechanical thrombectomy with the RevCore thrombectomy catheter (Stryker/ Inari)—except in the setting of couple-of-weeks-old acute stent thrombosis.

“Unless I have a patient where I put a stent in, I have imaging that shows that it is open, and I have imaging that shows that it is occluded and I can definitively say that it is a two-week old-occlusion, then I’m generally likely to reach for the mechanical option because I think it does better with that sub-acute thrombus,” he says.

RevCore mechanical thrombectomy in action

Hemingway recalls a classic case using the RevCore Thrombectomy Catheter that underlines why the modality is his go-to in these types of scenarios.

The patient was a 35-year-old male who presented with worsening back pain, leg swelling and edema that on imaging appeared to point to an acute DVT. Several years prior, he had undergone thrombectomy, IVC stenting and a bilateral iliocaval reconstruction for chronic IVC occlusion and associated iliofemoral thrombosis. The IVC and common iliac vein (CIV) stents were thrombosed.

“Both sides had gone down,” Hemingway explains. “One was thrombosed all the way through, the other had a wisp of flow going through it. I took the patient for a venogram and tried aspiration without success, so then tried the RevCore. What we got out was all white, rubberish, fibrotic material. This is someone in whom, had I opted for aspiration thrombectomy, I would have had to reline the whole stent reconstruction. We were able to clean out the stent and send the patient home without any new stents being placed.”

Post-intervention, the patient was noted to have brisk flow on venogram, no thrombus layering on intravascular ultrasound (IVUS), and no further stenting was required. Now 18-months post-procedure, the patient has sustained full patency and complete symptom resolution.

Decisions around intervention are influenced by timing, Hemingway points out. “If a patient has an occluded stent for six months or longer, I think that the results are less predictable and it is a little harder to know whether you’re going to get great thrombus clearance,” he says. “If it is a case of less than six months and definitely less than three months, my experience has been that RevCore has worked very well for clearing out in-stent thrombosis. If you are patient, and really work the areas, you use the device correctly and really grind away at that thrombus layer by layer, you will get it cleared out. Once it gets to be rock hard or associated with calcification, there’s just some pathology you can’t pull out of there.”

This is an article sponsored by Inari Medical. The HCPs sharing their views and opinions here express their experience with Inari Medical devices. The HCPs’ opinions of these devices were formed independently of Inari Medical and may not represent every experience or outcome with the devices.

Indications For Use: The RevCore thrombectomy catheter is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels and (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The RevCore thrombectomy catheter is intended for use in the peripheral vasculature. Review complete Instructions for Use, Indications for Use, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. For all non-Inari products, please refer to complete manufacturer Instructions for Use/Intended Purpose. All copyrights and trademarks are the property of their respective owners. PRO-2406-USA-EN-v1

A global concern: WFVS seeks to level up vascular education in every corner of the world

By
Bryan Kay
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A global concern: WFVS seeks to level up vascular education in every corner of the world
Palma Shaw
WFVS secretary general details how the organization has evolved in recent years, seeing gains in representation and access to education among members from underserved regions.

In the stew of national and regional vascular societies that dot the globe, the World Federation of Vascular Societies (WFVS) might get somewhat overlooked. You might be peripherally aware of the group, you might have heard the current secretary general talk about it at a podium somewhere in the not-too-distant past, but you might not be too sure what it is and what it does. Those are maladies Palma Shaw, MD, the WFVS secretary general in question, wants to remedy.

“The whole mantra of the WFVS is the haves help the have nots,” Shaw tells Vascular Specialist as she gears up to attend the latest WFVS symposium in South Africa. “We’re here to pool our resources together and we’re committed to that. We’ve spent a lot of time trying to re-establish the federation as an impactful entity. We’ve put on a lot of different sessions to increase the federation’s visibility, and we have really worked to bring together resources that are accessible.”

Shaw runs through a quick refresher on its reason for being: The WFVS is an umbrella organization that unites societies across the globe; a collaborative forum to advance vascular science, education and patient care worldwide; and a network to share expertise and establish global standards of care. In 2021, the federation was revamped with bylaw updates, a new website, and the Society for Vascular Surgery (SVS) taking over day-to-day management.

Shaw says those founding WFVS goals have seen some significant advances in recent times. One of the most prominent: the Global Training Initiative is now established with the aim of bringing together trainees and young surgeons from across the world for accessible programming. “We have representatives from each member society who come together every two months to try to discuss ways we can help them fill in gaps in education,” she explains. “Some have more exposure to different areas of vascular surgery than others. The website is a great enabler of this, helping provide access to trainees and young surgeons in any country, from Africa to South America.” Resources now available include contributions from the SVS, the European Society for Vascular Surgery (ESVS) and the Japanese Society for Vascular Surgery (JSVS).

In person, the WFVS has broadened its footprint at national and international conferences and meetings, including WFVS-dedicated sessions at the SVS Vascular Annual Meeting, the VEITHsymposium and the Charing Cross (CX) International Symposium. And this month sees the WFVS stage its own annual symposium during the Vascular Society of South Africa (VASSA) Congress in Cape Town (Oct. 16–18)—home organization of the reigning WFVS president, Pradeep Mistry, MD—the event for which Shaw is preparing as she outlines the federation’s progress.

Cost is a limitation to expanding the Global Training Initiative, which has in part spurred the development of WFVS’ digital platform and access to its repository of educational resources. But a couple of key face-to-face opportunities have also emerged.

“We now have WFVS International Fellowships, part of a visiting scholar program, to help those from underserved regions who need more hands-on, advanced training,” Shaw continues. One is hosted by Jikei University in Tokyo, Japan, in which scholars spend three months under the leadership of Takao Ohki, MD, the other a 12-month program at Houston Methodist DeBakey Heart & Vascular Center under the guidance of Alan Lumsden, MD.

WFVS is also working with Iman Bayat, MBBS, from the Australia and New Zealand Society for Vascular Surgery (ANZSVS) on the Global Vascular Companionship, a mentorship-based program to create sustainable vascular units in underserved regions. “This is aimed at trying to help specific nations that have the capacity to build vascular units back home, but who just need that education,” Shaw details, pointing to examples of general surgeons in Barbados and Fiji being mentored by vascular surgeons to get units up and running.

“We are endorsing and expanding the reach across the world. We also worked with the Rouleaux Club, the UK and Ireland’s vascular trainee association, to put on the Worrying Foot Competition at CX in London,” says Shaw. The problem is funding for these trainees to do anything. The Worrying Foot Competition provided an opportunity to attend. But if you’re not in Europe it’s an expensive trip, so how do you get that support?”

Further WFVS efforts are afoot to plug the gaps. A collaboration with the Journal of Vascular Surgery-Vascular Insights saw the development of a special edition focused on rare vascular diseases, which is available online and due to be published in print. It features such conditions as carotid body tumors, pediatric aneurysms and popliteal vein aneurysms. A multi-societal effort to bring together experience with uncommon vascular diseases, Shaw says the edition is aimed at providing perspectives from different parts of the world “you may not get if you’re always coming from the U.S. or Europe.” In the same vein, the WFVS is collaborating with the Vascular Low Frequency Disease Consortium to expand global access to data on rare diseases.

Meanwhile, the WFVS council has been expanded. From two per society, the body now includes an additional representative from each constituent member society with an executive leader. “Again, the goal was to try to have more representation rather than less,” Shaw adds.

That inclusive approach extends to helping women vascular surgeons advance, including in areas of the globe where barriers endure. “Speaking to colleagues in different parts of the world, it is clear there is less opportunity for exposure, especially among women,” she says. “There are fewer women vascular surgeons in places like Africa, for example, and, even in a place such as Romania, some of the female vascular surgeons may train but they don’t get to work independently, ending up as surgical assists. So, there are countries where I think that maybe we can help women advance and spread knowledge and experience.”

Shape Memory Medical announces midway milestone in AAA-SHAPE randomised controlled pivotal trial

By
Bryan Kay
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0
Shape Memory Medical announces midway milestone in AAA-SHAPE randomised controlled pivotal trial
Impede embolisation plug, expanded
AAA-SHAPE
Impede embolisation plug, expanded

Shape Memory Medical has reached 50 per cent enrolment in its ongoing AAA-SHAPE pivotal trial, the company announced last week.

AAA-SHAPE is a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behavior when used in conjunction with elective endovascular aneurysm repair (EVAR). The patient was treated by principal investigator Aleem Mirza (Orlando Health Heart and Vascular Institute, Orlando, USA).

AAA-SHAPE will enrol 180 patients with infrarenal AAAs across up to 50 sites in the USA, Europe, and New Zealand. Study participants will be randomized 2:1, either to EVAR plus sac management with Impede-FX RapidFill (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.

The investigational device, Impede-FX RapidFill, incorporates Shape Memory Medical’s novel shape memory polymer, a proprietary, porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood. In AAA-SHAPE, Impede-FX RapidFill is intended to fill the aneurysm blood lumen around a commercially available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.

Prior to the AAA-SHAPE pivotal trial, the AAA-SHAPE early feasibility studies enrolled a total of 35 patients across sites in New Zealand and the Netherlands. Three-year follow-up data from these studies are scheduled to be presented at the upcoming VEITHsymposium (18–22 November, New York, USA).

“We are proud to have treated the 90th patient within the AAA-SHAPE pivotal trial and to contribute to this important clinical milestone,” commented Mirza. “The Impede-FX RapidFill’s unique properties may offer meaningful advantages in improving post-EVAR outcomes, and we look forward to the insights this study will provide.”

Randomized trial finds inferior mesenteric artery embolization ‘may not be effective’ in EVAR

By
Jocelyn Hudson
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Randomized trial finds inferior mesenteric artery embolization ‘may not be effective’ in EVAR
Shigeo Ichihashi
Shigeo Ichihashi

Results from a multicenter randomized controlled trial (RCT) indicate that pre-emptive inferior mesenteric artery (IMA) embolisation during endovascular aneurysm repair (EVAR) does not significantly reduce aneurysm sac volume or rates of type II endoleak.

The CLARIFY IMA study—which the authors note is the first multicenter RCT to provide data on the effectiveness of pre-emptive IMA embolisation during EVAR—was recently published in the European Journal of Vascular and Endovascular Surgery (EJVES).

Opening their paper, Shigeo Ichihashi (Nara Medical University, Nara, Japan) and colleagues write that persistent type II endoleak following EVAR has been identified as a cause of aneurysm sac expansion, which they note can lead to reintervention and aneurysm rupture.

They go on to state that the role of pre-emptive IMA embolisation to prevent type II endoleak and sac expansion “remains controversial,” with the present study aiming to evaluate the influence of IMA embolisation on aneurysm sac change after EVAR.

In the CLARIFY IMA study, which was conducted at 24 centres in Japan, patients with a fusiform abdominal aortic aneurysm (AAA) were randomised to undergo EVAR either with or without pre-emptive IMA embolisation. The primary outcome was defined as the percentage change in computed tomography (CT)-assessed aneurysm sac volume at 12 months, with secondary outcomes including sac diameter changes, prevalence of type II endoleak, freedom from reintervention, and overall survival at six, 12, and 24 months.

Ichihashi and colleagues share that 138 patients with AAA (mean age, 76 years; 117 men) were randomised to either the IMA embolisation (n=70) or the control group (n=68). Of the 70 patients included in the former, the authors report that IMA embolisation was successful in 63 (90%) patients.

The authors add that, at 12 months, there was no statistically significant difference in aneurysm sac volume change between the embolisation group and control group. Furthermore, no statistically significant differences were observed in sac diameter change, rate of type II endoleak, freedom from reintervention, and overall survival at any follow-up time point.

“Unlike previous single-centre RCTs, the findings indicate that IMA embolisation does not significantly reduce aneurysm sac volume or rates of type II endoleak,” Ichihashi and colleagues conclude. “These results suggest that while safe and technically feasible, pre-emptive IMA embolisation may not be effective in EVAR procedures, prompting further investigation into alternative methods for reducing endoleak and sac expansion in clinical practice.”

Ichihashi presented these findings during the Janet Powell session on late-breaking news in clinical trials at the 39th European Society for Vascular Surgery (ESVS) annual meeting (23–26 September, Istanbul, Türkiye). Following his talk, one question from the audience probed possible reasons behind the results.

“Can I ask why you think you did not show a difference?” Richard Bulbulia (University of Oxford, Oxford, UK) posed. “Was your study too small, or was your study too short, or perhaps both were true?”

“I believe two years is long enough,” Ichihashi responded. In their EJVES paper, the authors elaborate on the length of follow-up during discussion of several study limitations. They acknowledge that the follow-up period of 24 months, “while sufficient to observe initial trends,” may not have captured sac behaviour or aneurysm-related death in the long term.

Among other limitations, the authors highlight the fact that the COVID-19 pandemic prevented them from recruiting as many patients to the trial as planned, the incomplete data regarding type II endoleak during follow-up for approximately one-third of the participants who underwent only plain CT, and the possibility that the sample size “may not have been large enough to detect smaller but clinically meaningful differences between the groups”.

Medtronic’s Endurant receives FDA labelling approval to remove rAAA treatment warning

By
Bryan Kay
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0
Medtronic’s Endurant receives FDA labelling approval to remove rAAA treatment warning
Endurant stent graft system

Medtronic recently announced it has received Food and Drug Administration (FDA) labelling approval for the Endurant stent graft system, by adding ruptured abdominal aortic aneurysm (rAAA) clinical evidence and removing the rAAA treatment warning. A press release notes that this FDA labelling approval makes Medtronic the “first and only” company to remove the rAAA warning from its stent graft system instructions for use (IFU).

“This landmark effort harnessed international, real-world data to evaluate the performance of endovascular devices in the treatment of ruptured abdominal aortic aneurysms. The recent FDA labelling approval provides physicians with confidence in an endovascular treatment option for rAAA patients for the first time,” said Adam Beck, MD, chief of vascular surgery at University of Alabama at Birmingham in Birmingham, Alabama. “This milestone validates the importance of rAAA, enabling continued medical education and support for physicians to safely treat these complex, high-acuity cases.”

Medtronic notes that the Endurant is backed by over a decade of clinical evidence from the ENGAGE 10-year global registry to demonstrate safe and effective use.

EACTS 2025 hears new data on aortic arch remodelling device

By
Will Date
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0
EACTS 2025 hears new data on aortic arch remodelling device

Data from the AMDS PERSEVERE and PROTECT trials—both assessing the use of the Ascyrus medical dissection stent (AMDS, Artivion)—were presented in late-breaking science presentations at the 39th European Association for Cardio-Thoracic Surgery (EACTS) annual meeting (8–11 October, Copenhagen, Denmark).

The AMDS PERSEVERE trial presentation highlighted positive 30-day data focused on a subset of patients with visceral and renal malperfusion. The results demonstrate resolution of visceral malperfusion in 83% and renal malperfusion in 74% of affected subjects following AMDS implantation.

Real-world results from the AMDS PROTECT trial further confirm the statistically significant positive clinical outcomes demonstrated in the PERSEVERE IDE study.

Michael Moon (University of Alberta, Edmonton, Canada), steering committee member of the PERSEVERE trial and co-principal investigator of the PROTECT trial, said: “The latest data from these two ongoing long-term studies of AMDS continue to highlight how this critical technology is improving outcomes for some of our sickest patients.”

“We were thrilled to command such a strong presence at EACTS with data from our AMDS clinical trials featured in two late-breaking science sessions,” said Pat Mackin, chairman, president, and chief executive officer of Artivion. “These results further validate the strength of our best-in-class portfolio and reinforce our commitment to advancing innovation in the treatment of aortic disease.”

The PERSEVERE trial is a prospective, multicentre, non-randomised clinical trial to determine if patients with acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS hybrid prosthesis.

The trial is designed to support the company’s forthcoming application to the US Food and Drug Administration (FDA) for premarket approval of the AMDS. The trial consists of 93 participants in the USA, who have experienced an acute DeBakey Type I aortic dissection complicated by malperfusion.

Each participant will be followed for up to five years. Thirty-day trial data met combined safety and primary efficacy endpoints, demonstrating significant reduction of major adverse events (MAEs), including all-cause mortality, stroke, renal failure requiring dialysis, and myocardial infarction, and distal anastomotic new entry (DANE) tears following AMDS implantation. The secondary endpoint relates to remodelling of the aorta.

Results from the PERSEVERE study focus on the assessment of downstream benefits of AMDS, specifically visceral and renal malperfusion resolution at 30-days following AMDS implantation in the 40 study participants presenting with clinical malperfusion of those organs.

Eighty-three per cent of patients with preoperative visceral malperfusion did not develop any significant gastrointestinal events including bowel ischaemia, ileus, bleeding, abdominal pain, the need for laparotomy, or artery stenting.

Seventy-four per cent of patients with preoperative renal malperfusion did not develop renal failure requiring dialysis or the need for artery stenting, and all had radiographic resolution.

Importantly, the analysis evaluated patients with and without preoperative symptomatic malperfusion and found no meaningful difference in clinical outcomes between the two groups, underscoring the consistent performance of AMDS, even in higher-risk patients.

The AMDS PROTECT trial is a real-world, observational, prospective and retrospective, non-randomised, non-interventional study to investigate the performance and clinical benefits of AMDS to treat patients with acute DeBakey type I dissections with or without clinically relevant preoperative malperfusion and/or intramural haematomas.

The registry has enrolled 302 participants in Europe and Canada. The current presentation reports on 141 of 300 participants who have reached the three- to six-month follow-up.

Three to six-month results of European and Canadian multicentre PROTECT registry focused on real-world usage of AMDS across 141 patients. The real-world results from this registry demonstrate excellent outcomes consistent with those of the PERSEVERE and DARTS studies, namely no occurrences of paralysis/paraparesis, aortic rupture, or myocardial infarction and 95.3–100% of patients experienced positive remodelling with true lumen diameter increasing or stable in zones 1, 2, and 3.

Nurea receives US FDA clearance for AI-powered PRAEVAorta 2 software

By
Bryan Kay
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0
Nurea receives US FDA clearance for AI-powered PRAEVAorta 2 software

Nurea’s PRAEVAorta 2 artificial intelligence (AI)-powered software has received US Food and Drug Administration (FDA) 510(k) clearance, a company press release reveals.

According to Nurea, PRAEVAorta 2 provides vascular physicians with advanced automated measurement tools for aortic diameters on contrasted and non-contrasted computed tomography (CT) scans, supporting diagnosis and patient follow-up in aortic aneurysm management.

Nurea details that its PRAEVAorta suite integrating PRAEVAorta 2 helps save time in the patient care pathway by creating registries enabling fast identification of patients eligible for surgery and those requiring continued surveillance—ensuring that no patient is left without follow-up after intervention. The company notes that early detection and consistent monitoring of abdominal aortic aneurysms (AAAs) are critical to reducing mortality.

Furthermore, Nurea states that the PRAEVAorta suite addresses the economic burden of AAA management. The company claims that the software has the potential to cut the US$1.5 billion annual US screening cost in half by enabling incidental detection on both contrasted and non-contrasted CT scans, while smoothly integrating into existing clinical workflows.

“This milestone is the result of years of research, development, and collaboration,” said Florian Bernard, chief executive officer and co-founder of Nurea. “FDA clearance validates our vision and allows us to bring PRAEVAorta 2 to US physicians, helping them diagnose and monitor aneurysms more efficiently, reduce costs, and most importantly, save lives.”

Non-contrast MRI outperforms DSA in detecting below-the-knee arteries in CLTI patients

By
Jocelyn Hudson
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0
Non-contrast MRI outperforms DSA in detecting below-the-knee arteries in CLTI patients
Alexander Crichton at ESVS 2025
Alexander Crichton at ESVS 2025

Researchers have shown that quiescent-inflow single-shot (QISS) magnetic resonance imaging (MRI) is able to identify more below-the-knee vessel segments than digital subtraction angiography (DSA) in patients with chronic limb-threatening ischaemia (CLTI). Taking first prize for best abstract, Alexander Crichton (Houston Methodist Hospital, Houston, USA and University of Birmingham, Birmingham, UK) shared this and other findings at the 39th European Society for Vascular Surgery (ESVS) annual meeting (23–26 September, Istanbul, Türkiye).

“Imaging patients with below-the-knee CLTI is challenging,” Crichton, who was presenting the research on behalf of Trisha Roy and colleagues at Houston Methodist, began. He cited the rise in diabetes and end-stage renal failure as two of the key reasons behind this, noting both cause calcified arterial disease that can “significantly” affect computed tomography (CT) and ultrasound imaging.

“Is digital subtraction angiography—our gold standard of current imaging—showing us what we need to see? Is it similarly affected by this calcium?” Crichton posed to the ESVS audience.

Regarding the available literature on the topic, the presenter referenced a study from the 1990s showing that non-contrast MRI could identify more patent vessel segments than DSA. He noted that this finding changed the researchers’ management of patients in 17% of cases. The problem was, however, that the technique was slow and marred by imaging artifacts. “It never really caught on,” Crichton remarked.

The presenter stated that clinicians now commonly use contrast-enhanced MRI. “But in 2025, do we need to?” he asked, citing newer, non-contrast MRI techniques, such as QISS MRI, that are fast, less affected by artifacts and “give a fantastic image”.

At Houston Methodist, Crichton shared, clinicians offer patients who require an MRI of their lower limbs a QISS MRI followed by a contrast MRI. In the present study, the researchers compared these patients’ QISS MRIs to their DSAs across 14 vessel segments.

The primary outcome of the study was to assess whether QISS MRI could identify more patent vessel segments than DSA, with the secondary outcome being the effect of QISS MRI versus DSA on disease severity scores, namely Trans-Atlantic Inter-Society Consensus (TASC) and Global Limb Anatomic Staging System (GLASS) scores.

In total, the researchers compared QISS MRI to DSA across 752 vessel segments in 56 patients.

Crichton reported that the median time from QISS MRI to DSA was short, at around four days, and that the number of patent vessel segments on QISS MRI was an average of 10% higher than that on DSA, which he detailed was a statistically significant difference.

In addition, Crichton revealed that the difference in the number of visible vessels on QISS MRI compared to DSA became more pronounced the further down the limb the imaging was used. He cited a statistically significant difference of over 30% at the level of the dorsalis pedis artery, for example.

The presenter also noted a “knock-on effect” on both TASC and infrapopliteal GLASS scores. “The mean TASC score and the mean infrapopliteal GLASS score were significantly downgraded when we used QISS MRI to evaluate these arteries,” he said. “This is really important, because this is our language to classify disease severity. It’s what we’ve used in the most recent SWEDEPAD trial.”

To demonstrate the clinical implications of the researchers’ finding, Crichton cited a case example involving the search for a patent dorsalis pedis artery that did not show on DSA, but did on QISS MRI, with the QISS MRI also revealing a patent distal anterior tibial artery. “This changes how we manage this patient. I believe that this gives you more options to treat it,” he commented.

Sharing his take-home messages, Crichton summarised that QISS MRI identifies more arterial segments than DSA, with the difference between the two imaging modalities becoming increasingly significant the further down the limb they are used. He reiterated that QISS MRI also affects both TASC and infrapopliteal GLASS scoring, downgrading both. “But most importantly,” he said in closing, “I truly believe that this could change how we manage our patients. This is easy to integrate into our practice, and I think we could use it a lot more.”

Medtronic fully launches Neuroguard IEP system

By
Bryan Kay
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0
Medtronic fully launches Neuroguard IEP system
The Neuroguard IEP carotid stent

Medtronic has announced the full distribution of the Neuroguard integrated embolic protection (IEP) system for carotid artery disease following its limited market distribution, the company announced. This follows the announcement earlier this year of an exclusive U.S. distribution agreement between Medtronic and Contego Medical, developer of the device.

Neuroguard is marketed as the first carotid stent to offer a 3-in-1 technology, combining a stent, post-dilation balloon and filter. Data from the PERFORMANCE II study of the device demonstrated no major strokes, neurological deaths, stent thromboses or clinically driven target lesion revascularization, despite 34.5% severely calcified lesions at 30 days and one year, the company stated in a press release.

Contego Medical is currently evaluating the Neuroguard IEP system with a next-generation direct transcarotid access and protection system, TCAR-IEP, to demonstrate safety and effectiveness in the PERFORMANCE III trial.

NESVS 2025: Alik Farber takes over as New England Society for Vascular Surgery president

By
Killian Meara
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0
NESVS 2025: Alik Farber takes over as New England Society for Vascular Surgery president
Alik Farber

Alik Farber, MD, surgeon-in-chief at Boston Medical Center and James Utley professor and chair of surgery at Boston University Chobanian and Avedisian School of Medicine, is the new president of the New England Society for Vascular Surgery (NESVS). 

Farber took over from outgoing president Jessica Simons, MD, director of the vascular surgery residency program at UMass Memorial Health in Wocester, Massachusetts, and professor of surgery at the UMass Chan Medical School, during the 2025 NESVS annual meeting in Providence, Rhode Island (Sept. 26–28).

The new NESVS president-elect is Cassius Iyad Ochoa Chaar, MD, associate professor of surgery in the division of vascular surgery and endovascular therapy at the Yale School of Medicine in New Haven, Connecticut.

Kwame Amankwah, MD, chief of vascular and endovascular surgery at UConn Health in Farmington, Connecticut, became the new vice president of NESVS. Amankwah took over from Britt Tonnessen, MD, associate professor of surgery and associate program director of the vascular residency  program at the Yale School of Medicine.

Terumo Aortic and Bentley announce collaboration on US FEVAR study

By
Jocelyn Hudson
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0
Terumo Aortic and Bentley announce collaboration on US FEVAR study
L-R: Sebastian Büchert and Erik Pomp

Terumo Aortic and Bentley today announced their partnership in a clinical study in the USA. The objective is to obtain US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for Terumo Aortic’s fenestrated Treo device, in combination with Bentley’s BeFlared fenestrated endovascular aneurysm repair (FEVAR) stent graft system for FEVAR procedures. The IDE submission is planned for the first half of 2026.

Through this collaboration, Terumo Aortic and Bentley note in a press release that they aim to bring their FEVAR solutions to benefit US patients suffering from complex abdominal aortic aneurysms, namely juxtarenal and suprarenal aneurysms. Following the completion of the joint clinical study and FDA approval, both companies plan to independently market their products in the USA.

Terumo Aortic shares that its fenestrated Treo device offers a patient-specific solution tailored to the anatomical conditions and clinical needs for treating aortic aneurysms. The company details that, to ensure perfusion of vital organs, the device can be designed to include up to five fenestrations, requiring reliable bridging stents to maintain
perfusion to the target vessels.

Erik Pomp, chief executive officer (CEO) of Terumo Aortic, commented: “Bentley’s BeFlared, the world’s first-to-market dedicated bridging stent, is a great fit for our fenestrated Treo platform. With its innovative features, this stent has the potential to become the gold standard in FEVAR procedures, thus complementing our fenestrated Treo platform.”

Bentley adds that BeFlared is the world’s first bridging stent specifically developed for FEVAR procedures. The company notes that the stent is crimped on a specially designed stepped balloon, which will reduce the number of steps that are needed for optimal deployment. Additionally, a third radiopaque marker aids in optimal positioning of the stents in the fenestration. BeFlared has received CE certification from TÜV Süd and the first-in-human procedure was performed by Stéphan Haulon (Université Paris-Saclay and Hôpital Marie Lannelongue, GHPSJ, Paris, France) in November 2024.

“By partnering with Terumo Aortic, we’re advancing BeFlared’s role as the go-to bridging stent for FEVAR. Already available in most key markets, its value is being demonstrated through strong outcomes led by KOLs [key opinion leaders]. This study will further solidify its impact in treating complex aortic aneurysms. Terumo Aortic’s fenestrated Treo platform is an excellent complement, and together, we are setting new standards in patient care,” said Sebastian Büchert, CEO of Bentley.

“The combination of fenestrated Treo and BeFlared is designed to set a new benchmark for FEVAR procedures by offering both ease of use and reduced complications for patients,” the press release reads. “Together, Terumo Aortic and Bentley are driving innovation in the field of aortic disease treatment.”

TADV without venous branch coiling still yields strong limb salvage rates among ‘no-option’ CLTI patients

By
Killian Meara
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0
TADV without venous branch coiling still yields strong limb salvage rates among ‘no-option’ CLTI patients
Anahita Dua

Transcatheter arterialization of deep veins (TADV) done without the coiling of venous outflow branches achieved sufficient distal perfusion after three months among “no-option” chronic limb-threatening ischemia (CLTI) patients, according to results from a study published in the Journal of Vascular Surgery (JVS).

TADV, also known as deep vein arterialization (DVA), is an emerging option for CLTI patients who can’t receive traditional revascularization techniques. Although the coiling of venous outflow branches is a common adjunct procedure to TADV, a lack of data has brought into question how critical coiling off venous outflow branches really is.

To investigate this question, researchers from Massachusetts General Hospital in Boston conducted a retrospective chart review on a cohort of “no-option” CLTI patients who had TADV performed using the LimFlow system (Inari Medical/Stryker) between 2020 and 2024. Flow volumes were assessed at one and three months via ultrasound measurements and clinical outcomes were evaluated at one year.

“The point of this particular study was we wanted to look at the coiling of the branches to see how important it is to actually go and coil off these branches in order to ensure that the DVA actually matures,” Anahita Dua, MD, a vascular surgeon at Massachusetts General Hospital and an author on the study, told Vascular Specialist. “What we found is that for a number of these branches, frankly, the majority of them, you do not have to coil off the branches and the circuit matures anyway.”

Data showed the patients who underwent TADV without venous branch coiling had an 87% limb salvage rate one year after the procedure. The patients also maintained a flow rate of 179.0 mL/min for three months at midstent, as well as a median decrease of 123 mL/min at one month.

“This is not a huge lift,” said Dua. “Most patients do not need you to go back in and shut down this vessel and shut down that vessel. You don’t have to be so paranoid about every single one.”

Dua said because TADV without venous branch coiling is a “one and done” procedure, it is more accessible to vascular teams­—particularly those in lower resource settings. It also could accelerate use in the community, decrease costs and make patients more likely to have it done. “By decreasing the burden of the procedure, both on the provider and on the patient, you make it significantly more accessible across the board,” said Dua.

However, performing TADV without venous branch coiling does come with some risks. Dua said that by not coiling off some branches in the beginning that might be stealing blood, the TADV will not be able to strengthen. This could make the whole operation unsuccessful due to a lack of blood flow, resulting in an unproperly healed wound.

“It is important to ensure that if there are stealing branches that are significant, that they are managed,” said Dua. “It’s also important to recognize it’s not a hammer and everything is not a nail. You don’t have to do every single branch because you can get out of control that way. Being very careful and methodical about what you pick and when is key to the success of the procedure.”

During a session at the 2025 Vascular Annual Meeting (VAM) in June, Dua presented data from a study comparing “no-option” CLTI patients from the PROMISE studies treated with TADV to a cohort of patients from the CLariTI study who were treated using standard of care (SoC). Results from the prospective study showed patients who underwent TADV in the PROMISE cohort had a limb salvage rate of 82.2%, compared to 51.3% in the SoC CLariTI patient cohort.

Additional real-world outcomes data supporting TADV were also recently revealed at the 2025 annual meeting of the Eastern Vascular Society (EVS) in September. Those findings showed limb salvage rates of 71.7% one year after TADV among “no-option” CLTI patients, with a survival rate of 84.7%. Dua said based on all of the data, it’s clear that the procedure does work in the right patient.

“The next question is how do we make it better,” said Dua. “We know it works; patients are keeping their legs. We have to make it easy for providers to be able to do. Because unlike cancer, where a patient can get a bad cancer and they can travel to [MD Anderson Cancer Center] or they can go to [Memorial Sloan Kettering Cancer Center], that’s not the case for peripheral artery disease (PAD) and CLTI. In these patients, if they don’t get something locally, they are going to lose their leg. Being able to ensure that pretty much anybody with wire and catheter skills can do this procedure is important. That is what we all believe—that it’s something that can be done.”

SVS international chapters strengthen global ties in vascular surgery

By
Marlén Gomez
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0
SVS international chapters strengthen global ties in vascular surgery
Wei Zhou
Wei Zhou

The Society for Vascular Surgery (SVS) continues to expand its global footprint through its 13 international chapters, fostering collaboration and visibility for vascular surgeons worldwide. With SVS members now in 59 countries, the International Relations Committee (IRC), formalized in 2005, remains committed to building bridges across borders.

Wei Zhou, MD, chair of the IRC, has worked with several chapters in highlighting their contributions. “It’s important to showcase the international members who have actively engaged with the SVS to forge a collaborative relationship,” said Zhou. For one, the Colombia chapter “has done a wonderful job energizing the local vascular surgery community,” she added.

Ana María Botero, MD, an IRC member and driving force behind the Colombian chapter, shared her experience in helping her colleagues get proper exposure in the vascular community.

“I’ve taken it as a personal mission to bring Colombian surgeons into the SVS fold,” she explained. “Each year at the Vascular Annual Meeting [VAM], I help colleagues prepare and present their cases to make sure they’re seen and heard.”

Botero emphasized the importance of visibility and mentorship, noting that SVS membership offers access to research, publications and scholarships.

The IRC plans to organize a webinar on Oct.15 to address issues focused on overcoming obstacles to international participation, including language barriers.

The SVS will also co-host an international congress in Cartagena, Colombia, Oct. 8–11, 2026. The event—in partnership with the International Union of Angiology, the Colombian Association for Vascular Surgery, and the American Venous Forum—will, according to Botero, chart the future of vascular surgery in Latin America and beyond.

To learn more, visit vascular.org/InternationalRelations.

SVS set to take part in ACC smoking cessation webinar

By
Marlén Gomez
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0
SVS set to take part in ACC smoking cessation webinar

The Society for Vascular Surgery (SVS) will take part in an upcoming webinar titled “Breaking the Habit, Saving Lives: The National Quality Initiative Push for Smoking Cessation” at the 2025 American College of Cardiology Quality Summit, Tuesday, Oct. 14.

The Vascular Quality Initiative (VQI) launched a National Quality Initiative (NQI) special focus on smoking cessation aimed at supporting clinicians in their efforts to help patients quit smoking and improve long-term health outcomes.

The intersection of palliative care and vascular surgery

By
Tara Zielke
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0
The intersection of palliative care and vascular surgery
Tara Zielke

As vascular surgeons, we strive to practice comprehensive vascular surgery care. This entails the medical and surgical management of patients with a wide range of vascular diagnoses. Patients with advanced vascular disease experience significantly reduced quality of life and high healthcare utilization. Palliative care principles are interwoven into the care of these patients. As a vascular surgeon striving to practice comprehensive vascular surgery care, it is essential to be knowledgeable about these topics to provide better patient care.

This article aims to answer several important questions to define what surgical palliative care is, explore the current research literature, redefine misconceptions regarding surgical palliative care, and apply these concepts to the care of vascular surgery patients.

So, what is surgical palliative care? And how can you integrate surgical palliative care principles to improve the care of your vascular surgery patients? Surgical palliative care was defined by Dr. Red Hoffman, an acute care surgeon and associate hospice medical director at Mission Health in Asheville, North Carolina, as “the attention to suffering in all of its manifestations of the patient and the family under surgical care.”1 The tenets of surgical palliative care extend beyond surgical interventions to encompass medical management of vascular disease and social support such as exercise programs, smoking cessation resources, and wound care. Surgical palliative care sees the whole unique person and all aspects of their suffering, to include physical, psychological, social and spiritual.

Although vascular surgeons often implement palliative care through goals-of-care discussions, there remain further opportunities to engage mental health experts, chaplains, social workers and community resources in our approach. Even engagement with advance directives, healthcare proxy documentation, or inpatient/outpatient hospice referral can further our impact. Active implementation of surgical palliative care principles is ultimately a skill that must be learned through understanding available hospital and community resources, but it can ultimately have an immense impact on the lives of our patients.

What does the current research literature say about surgical palliative care in the vascular surgery patient population? One study examined hospital patients who died after vascular surgery, and only 25% received palliative care consultation, with a median interval of only 10 hours between consultation and patient death. Only 14% of patients in this study cohort had a documented advance directive.2 This is extremely low when put into the context that an estimated 36.7% of the U.S. population has a documented advance directive.3 A single-institution, retrospective chart review of all patients who underwent open aortic surgery showed 16.7% of patients had advance care planning documentation prior to open aortic surgery. Palliative care involvement was close to patient death, with a median interval of five (interquartile range [IQR] 2–13) days.4

In the context of peripheral arterial disease (PAD), Dr. Mimmie Kwong and colleagues studied 111 patients who received below-knee amputation for chronic limb-threatening ischemia (CLTI). One-year mortality was 21.9%. The median interval between palliative consultation and amputation was 26 days, whereas the median interval between palliative consultation and death was nine days.5 This study demonstrates a pattern of consulting palliative care closer to death than earlier evaluation after amputation.

Current studies have further demonstrated that when surgical palliative care was utilized in the care of patients with CLTI, patients had less emotional distress and less uncertainty regarding the expected course of their illness.6 Integrating palliative care was also associated with a lower likelihood of in-hospital death and increased likelihood of discharge to hospice (odds ratio [OR] 0.248, p=0.0167; OR 1.283, p<0.001) in patients after major amputation.7

The research literature on this topic is growing, and the current research defines clear opportunities for improvement in our patient care.

What are some misconceptions regarding surgical palliative care? “Why would we consult palliative care? The patient isn’t going to die anytime soon”: as a visiting medical student, I remember this response when a resident suggested consulting palliative care for a patient with debilitating chronic pain and wounds, and no great revascularization option. I was surprised by how many healthcare providers equate palliative care with end-of-life care, or only for geriatric patients. Palliative care is not only for when death is imminent or for those entering the last stages of life. Palliative care is appropriate for any patient with a serious life-limiting illness, or significant pain or distress, to improve quality of life.

Another misconception of palliative care is that consultation is admitting that there is nothing more we can do. Patients with surgical options should not be excluded from the benefit palliative care can provide. We must accept that many of our interventions are ultimately of a palliative nature and may not ultimately extend the life of our patients. However, in situations where there is room to improve our patients’ quality of life and reduce their suffering, palliative care can assist in furthering our impact.

As we progress as a field, it is imperative that we integrate surgical palliative care principles into vascular surgery practice. Enriching our current literature with more studies on multidisciplinary practice and the use of hospital/community resources in vascular-specific pathologies could help us understand how to best serve our patients and provide more comprehensive surgical care.

References

  1. Fox, M. New Surgical Palliative Care Society Aims to Build Community, Alleviate Suffering. American College of Surgeons, Dec. 3, 2021, www.facs.org/for-medical-professionals/news-publications/news-and-articles/bulletin/2021/12/new-surgical-palliative-care-society-aims-to-build-community-alleviate-suffering/
  2. Wilson DG, Harris SK, Peck H et al. Patterns of Care in Hospitalized Vascular Surgery Patients at End of Life. JAMA Surg. 2017;152(2):183–190. doi:10.1001/jamasurg.2016.3970
  3. Yadav, Kuldeep N et al. Approximately one in three US adults completes any type of advance directive for end-of-life care. Health Affairs, vol. 36, no. 7, July 2017, pp. 1244–1251, https://doi.org/10.1377/hlthaff.2017.0175
  4. Barrera-Alvarez A, Brittenham GS, Kwong M. Missed Opportunities for use of Advanced Care Planning and Palliative Care in Open Aortic Surgery. Ann Vasc Surg. 2025 Jan;110(Pt A):205–216. doi: 10.1016/j.avsg.2024.08.005. Epub 2024 Sep 27. PMID: 39343365
  5. Kwong M, Curtis EE, Mell MW. Underutilization of Palliative Care for Patients with Advanced Peripheral Arterial Disease. Ann Vasc Surg. 2021 Oct;76:211–217. doi: 10.1016/j.avsg.2021.07.003. Epub 2021 Aug 14. PMID: 34403753
  6. Cattermole TC, Schimmel ML, Carpenter RL, Callas PW, Gramling R, Bertges DJ, Ferranti KM. Integration of palliative care consultation into the management of patients with chronic limb-threatening ischemia. J Vasc Surg. 2023 Aug;78(2):454–463. doi: 10.1016/j. jvs.2022.12.069. Epub 2023 Apr 23. PMID: 37088444
  7. Morton C, Hayssen H, Kawaji Q, Kaufman M, Blitzer D, Uemura T, Kheirbek R, Nagarsheth K. Palliative Care Consultation is Associated with Decreased Rates of In-Hospital Mortality Among Patients Undergoing Major Amputation. Ann Vasc Surg. 2022 Oct;86:277–285. doi: 10.1016/j.avsg.2022.05.005. Epub 2022 May 18. PMID: 35595211

Tara Zielke, MD, is a PGY-2 integrated vascular surgery resident at Indiana University School of Medicine in Indianapolis.

Comparing office practice models: Should we joint venture?

By
Jennifer Thomas
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Comparing office practice models: Should we joint venture?
Jennifer Thomas

In these challenging days of surviving private vascular practice, I’m sure we’re all considering our options. With rising overheads and reimbursement cuts, considering a joint venture can be an attractive option to share costs and expand growth potential. There are different options for such a partnership, and I’ll do my best to outline the pros and cons as we have experienced them.

The first option is joint venturing with a local hospital system. In our area, we have a medium-sized nonprofit hospital system that has an almost exclusive network of both primary care providers and specialists. I was a part of this system as an employed physician for several years, and, when my partner and I decided more than eight years ago to leave employment, we approached the administration with the idea of joint venturing. At the time, moving our peripheral arteriograms and dialysis work to outpatient made complete sense, as we were routinely neglected by the hospital cath lab in terms of scheduling priorities. Our patients were always at the end of the line of any “emergent” cardiac cath, which often seemed to us to appear out of the blue depending on the cardiologists working that day and their preferences. It was very unfair to our patients, not to mention a constant source of frustration for us. We felt that there was no support to grow our practice, without appropriate resources to schedule our arteriograms.

Unfortunately, despite what we felt to be a well-thought-out proposal of the benefits both to quality of patient care and reimbursements for forming an outpatient vascular lab, the hospital was not interested in joint venturing with physicians at the time of our decision to leave. Even though this was not our course, I would still encourage considering a hospital partnership as a viable option. It takes some forward thinking on the part of your executive leadership, but there is no reason why both the hospital and your group cannot be profitable in such an arrangement. It can be hard to get them to see past your worth in relative value units (RVUs), but learning your value is instrumental in these negotiations. You get the advantage of their insurance contracts, purchasing agreements, and employee benefits (including malpractice coverage), while having more ownership of your office/ treatment facility. This allows you to better control your schedule and the customer service you provide to your patients. In addition, most hospitals (ours included) employ a large network of providers who will support your practice if you are in such a partnership, as opposed to being “the enemy.”

The next model to consider is joint venturing with an industry partner. These days, there are large insurance companies and other medical entities partnering with providers in outpatient cardiovascular centers. Our practice explored this option as it seemed our best way outside of hospital partnership to fund an ambulatory surgery center (ASC). Since we are a combined cardiology and vascular surgery practice, we were particularly interested in potentially shifting some electrophysiology (EP) services outpatient, as well as our surgical dialysis cases. We certainly liked the notion of sharing the build-out costs to convert our office-based vascular lab into an ASC, along with the ability to of a large partner to oversee all the regulatory and accreditation requirements. However, in our experience the goals we had for expansion were not realized as dealing with a large corporate entity often leads to frustrating inefficiencies and loss of control of overhead and cash flow.

Currently, we are back in private practice as a three-owner group. The pros continue to be autonomy in clinical decision-making, with full control over caseloads and patient care standards. Our revenue is not diluted through profit-sharing or institutional overhead. We have been able to adjust our service line based on market demands, most recently scaling our wound care clinic to meet our community needs. We are also able to optimize tax strategies and control our real estate investment since we own our space. The fears that we had in our first few years about being too vulnerable to hospital-owned primary care networks have not been realized. Yes, it seems we are in a constant battle to reassure patients in the community that we are, in fact, in-network and that they, as the consumers, have the choice of their doctor, whether employed or private. But thankfully our community continues to grow, and as long as we continue to offer quality care in a cost-effective, patient-centered environment, it seems that there is hope of survival after all.

Jennifer Thomas, MD, is a private-practice vascular surgeon in Anderson, South Carolina.

FastWave Medical appoints principal investigators for IVL pivotal trial

By
Bryan Kay
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FastWave Medical appoints principal investigators for IVL pivotal trial
Venita Chandra

Venita Chandra, MD, clinical professor of surgery at Stanford Health Care in Stanford, California, will serve as a co-principal investigator for the upcoming investigational device exemption (IDE) pivotal trial of Artero, FastWave Medical‘s peripheral electric intravascular lithotripsy (E-IVL) system. The news emerged today as the company announced the appointment of its principal investigators and steering committee team for the study.

Sahil Parikh, MD, director of endovascular services at Columbia University Irving Medical Center in New York, joins Chandra as a co-principal investigator. They are joined by Eric Secemsky, MD, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston; Marc Bonaca, MD, a vascular medicine and cardiology doctor at the University of Colorado in Boulder; and Daniel Clair, MD, professor and chair of the department of vascular surgery at Vanderbilt University Medical Center in Nashville, who will help guide the trial’s clinical strategy.

The study will evaluate the safety and effectiveness of the Artero IVL system in treating peripheral arterial disease (PAD).

“The key question isn’t just whether a device works, but whether it makes procedures more efficient and provides physicians with a more predictable tool for treating patients with complex arterial disease,” said Chandra. “I’m excited to see how the promise of FastWave’s peripheral IVL system plays out in this study.”

Designated multispecialty CLTI teams may help in amputation fight

By
Bryan Kay
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Designated multispecialty CLTI teams may help in amputation fight

Teams formally defined as specializing in chronic limb-threatening ischemia (CLTI) were associated with a decreased risk of major amputation among a subset of BEST-CLI trial sites, a paper recently published online ahead of print in the Journal of Vascular Surgery (JVS) showed.

Responses from a post-trial electronic survey were used to describe CLTI care providers and characterize centers based on the presence of a “formally defined team dedicated to the care of CLTI patients.”

The research was led by first author Douglas W. Jones, MD, an associate professor of surgery in the Division of Vascular Surgery at UMass Memorial Medical Center in Worcester, Massachusetts.

With an overall response rate of 20.2% and at least one response from 75% of enrolling sites, respondents identified that the specialties most frequently among those primarily responsible for CLTI care at centers with CLTI teams were revascularization specialists—namely, vascular surgery, interventional cardiology or interventional radiology (92%), as well as podiatry (32%) and wound care (22%).

Compared to centers without CLTI teams, podiatrists at CLTI team centers were more likely to have a primary role (32% vs. 11%) and less likely to be unavailable (4% vs. 22%), the authors reported. Similarly, at centers with CLTI teams, wound care specialists were more likely to have a primary role (22% vs. 8%) and less likely to be unavailable (4% vs. 11%). Effectiveness of teamwork among CLTI providers was described as “highly effective” in 71% of respondents with a CLTI team vs. 29% without a team.

On multivariable analysis, presence of a CLTI team was independently associated with decreased major amputation, the researchers found.

Esprit BTK receives Health Canada approval for treating below-the-knee CLTI

By
Jocelyn Hudson
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Esprit BTK receives Health Canada approval for treating below-the-knee CLTI
ABBOTT'S DISSOLVING STENT RECEIVES HEALTH CANADA APPROVAL FOR TREATING BLOCKED ARTERIES BELOW-THE-KNEE.
Esprit BTK system

Health Canada has authorised the Esprit BTK everolimus-eluting resorbable scaffold system for the treatment of below-the-knee (BTK) chronic limb-threatening ischaemia (CLTI), Abbott revealed today in a press release. 

Until this recent Health Canada approval for the Esprit BTK system, Abbott notes that the standard of care has been balloon angioplasty. However, the company notes that treatment with balloon angioplasty alone can have poor short- and long-term results, and—in many instances—the vessels do not remain patent, requiring additional treatment.

Abbott describes the Esprit BTK system as a first-of-its-kind stent that is designed to keep arteries patent and deliver everolimus to support vessel healing prior to completely dissolving.

At the 2024 Vascular InterVentional Advances (VIVA) conference (3–6 November, Las Vegas, USA), Abbott released late-breaking two-year results from the LIFE-BTK trial. The trial demonstrated that, compared to balloon angioplasty, the Esprit BTK system results in improved patient outcomes and 48% fewer repeat procedures over the study period.

Brian DeRubertis

“Health Canada’s approval of Abbott’s Esprit BTK system marks a significant milestone in our fight against peripheral arterial disease below the knee and represents a new era of improved outcomes for people worldwide,” said Brian DeRubertis (New York Presbyterian-Weill Cornell Medical Center, New York, USA), one of the principal investigators of the LIFE-BTK trial. “Abbott is changing the landscape of CLTI therapy by introducing a treatment option that is superior to balloon angioplasty.”

“At Abbott, we’ve recognised the significant burden of disease and limited treatment options for people living with the most severe form of PAD—treatments that typically include high-risk surgery or less invasive options that come with limitations,” said Julie Tyler, senior vice president of Abbott’s vascular business. “Our revolutionary below-the-knee resorbable scaffold technology meets an unmet need that will ultimately help people with PAD live better and fuller lives.”

Multidisciplinary approach to diabetic foot ulcers in rural America leads to NIH grant

By
Marlén Gomez
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Multidisciplinary approach to diabetic foot ulcers in rural America leads to NIH grant
Samantha Minc

Samantha Minc, MD, MPH, associate professor of surgery at Duke University, has been awarded a National Institutes of Health (NIH) R03 grant to support her research project, “Understanding diabetes and peripheral arterial disease [PAD]-related amputation in North Carolina.”

The R03 grant provides short-term funding for small, self-contained research projects, including pilot studies and secondary data analyses. Minc’s study will run from Aug. 12, 2025–July 31, 2027.

Minc’s research focuses on identifying and addressing disparities in diabetes and PAD-related amputations, particularly in underserved communities. Her work began in West Virginia, where she was recruited due to her interest in rural health. There, she conducted a granular geospatial analysis and led focus groups with patients and providers to understand barriers to limb preservation.

“That first step was huge for me,” Minc said, referring to her 2018 Society for Vascular Surgery (SVS) Foundation Clinical Research Seed Grant. “Once that funding came through, we conducted the analysis, published a paper in the Journal of Vascular Surgery [JVS], and it was really well received.”

Following the seed grant and further awards from the West Virginia Clinical and Translational Science Institute, Minc received a K23 award in 2022 from the National Institute of Diabetes and Digestive and Kidney Diseases, with additional support from the SVS Foundation and the American College of Surgeons (ACS). These funds enabled her to implement a trio of interventions in rural clinics: diabetic foot exams, multidisciplinary teleconference and timely referrals.

“Eighty-five percent of diabetes-related amputations are preceded by a foot ulcer,” Minc said. “These are highly preventable, highly morbid issues.”

Primary care doctors and limb flow teams who conduct diabetic foot exams can significantly reduce amputations, but, Minc asks, what does that mean for a place where it’s four hours to the closest quaternary center?

Piloting teleconferencing platforms and providing hotlines for nurses enabled them to effectively triage patients. Primary care doctors could then contact a vascular nurse, who would triage the patient accordingly—either for an emergency visit or within a specified timeframe—and connect them with local podiatrists, serving as the primary intervention.

Her team observed significant improvements, including a drop in foot-related hospital visits from 4% to 0.4% among 268 patients. The success of this feasibility study laid the groundwork for her current project in North Carolina, which involves a larger, more nationally representative population.

Utilizing scientifically validated behavioral change methods, the project aims to encourage clinicians to modify their practices. Throughout the project, data were collected over 12 months, comparing the results with those from the 12 months prior. The findings showed a significant increase across various metrics—including a 242% rise in foot exams and a staggering 2,716% increase in the completeness of those exams—compared to 2–12% of foot exams in other studies incorporating all four components. By the project’s conclusion, 84% of the exams were complete, compared to just 17% at the start. The identification of foot abnormalities also increased by 1,443%, and referrals significantly rose.

Samantha Minc’s foot exam outreach in action

The project utilized a mixed-methods approach, combining quantitative findings with focus groups conducted at various clinics before, during and after the study, and individual interviews with patients, which allowed the team to understand the clinical and structural changes implemented in the clinics.

A key component of Minc’s approach is community engagement, where her team established both provider and community advisory boards to guide the research. One primary concern raised by community members was food insecurity.

“How can you expect us to get better if we’re not taking care of the food?” Minc recalled a community member saying.

In response, the group conducted a food insecurity scan across the rural county using a United States Department of Agriculture (USDA) toolkit. It revealed that most residents relied on gas stations and dollar stores for their groceries, with only two supermarkets serving an area of 8,500 square miles.

An initiative called Project FARMacy was launched as a result of the findings, which enabled the community to raise funds for a local farmer. Doctors can then write prescriptions for their patients with diabetes, allowing them to receive a box of healthy fruits and vegetables throughout the summer. This program lasts for three months, providing participants with fresh produce each week.

The diabetes support group developed an idea after hosting a month-long session on carb counting. “We decided to have members bring their favorite recipes or holiday recipes, which we would then share with our culinary medicine partners to adapt them into diabetes- and heart-healthy options,” said Minc.

Initially organized in November 2023, this idea unexpectedly evolved into a 120-page cookbook. Now completed, the cookbook has been printed and is finally ready for distribution. Minc’s team will continue to educate people about the importance of diabetic foot exams and improve the quality of care for individuals with diabetes. They are focused on disseminating their results throughout West Virginia this year and completed their first event in Pocahontas County over the summer.

“We did our first event in July,” said Minc. “We’re hosting our second event in Princeton, located in the southern part of the state. In two weeks, we’re hosting a large grand rounds session for all providers in the area, discussing vascular disease, diabetes and foot care; then we’re doing a large event in the Eastern Panhandle, which was another amputation hotspot, and plan to hit every part of the state. I have this road map that is part of our final year of our NIH grant that will take us across the state, and then we’ll hit the state capital in the spring and do a policy talk for advocacy programs that the community has identified.”

Minc added: “The plan is to take all this work and repeat it on a much larger scale. We have pilot data showing that we can improve outcomes if we do this. And so the plan is to identify hotspots across North Carolina and then do a more randomized trial where we deploy the intervention in a stepped fashion across the state, and show that we can improve outcomes by doing this.”

Unionization for vascular surgeons: Are you ready to join?

By
Enrico Ascher
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Unionization for vascular surgeons: Are you ready to join?
Enrico Ascher

Vascular Specialist readers may wonder why I am now raising this topic amid current challenges facing vascular surgery, like governmental concerns, low reimbursement, specialty competition, the involvement of advanced practice providers without direct affiliation with vascular surgeons, and discussions regarding independent American Board of Medical Specialties (ABMS) recognition.

Yet, I’m certain that you too have noticed a clear trend: physician job opportunities are increasingly shifting from private practice to full-time roles in academic centers, teaching hospitals, and corporate organizations. Indeed, it is estimated that 70–80% of U.S. physicians are employed in a full-time capacity. In some instances, the type of employment chosen depends on factors beyond the control of the applicant. This is exemplified by young physicians who view a full-time position as the sole viable option due to potentially burdensome costs associated with starting in private practice. Alternatively, other vascular surgeons choose full-time positions to align with their professional objectives.

It is clear that full-time medical work can involve challenges such as working conditions, staffing, safety, patient care standards, fair pay, operational inefficiencies, policy conflicts like ageism, rights violations and other key concerns. If a full-time employee’s concerns or grievances are not resolved by institutional leadership, a collective bargaining approach, such as union involvement, is an alternative that may be considered to pursue such matters.

The concept of a labor union was first crystallized in the U.S. in 1794 in Philadelphia by the Federal Society of Journeymen Cordwainers, a group of specialized shoemakers working with fine leather. In 1935, President Franklyn D. Roosevelt signed the Wagner Act, which gave rise to the National Labor Relations Act (NLRA). Since then, full-time employees have been allowed to form a union.

Accordingly, full-time physicians who are employees of a hospital, clinic, medical group or any other healthcare facility also can unionize. The NLRA requires physician members of a union to give employers 10 days’ notice before engaging in a concerted refusal to work. It is important to note that emergency care for patients must always be available, and hospitalized patients must receive medical care. While this mandate might reduce the union’s bargaining power, it doesn’t eliminate it. Clinic closures, delays in administrative tasks and community resentment towards the institutional leadership may ultimately harm an institution’s finances and standing among other competing institutions.

It is worth mentioning that the National Labor Relations Board (NLRB) received a 57% increase in union election petitions across all types of labor in 2022. More relative to medicine, the NLRB received 44 union petitions filed by physicians from 2000 to 2020, averaging two per year, and this jumped to 33 petitions from 2023 to 2024 with an average of 16.5 petitions per year. This likely reflects both a rise in full-time roles and an increase in physician grievances, as corporate interests may have prioritized profit over care quality and physician well-being.

Some of the advantages of creating a union include—but are not limited to—job security, improved wages and benefits, workplace safety, legal protection, career advancement, and equitable compensation across races and ethnicities. Reported disadvantages are union dues, increased conflicts between management and labor, loss of independence, and potential backlash from patients, peers, supervisors and future employers.

To evaluate the strengths, weaknesses, opportunities and threats associated with the creation of a physician union, one needs to carefully and thoroughly evaluate all options. Since laws vary among different states, reaching out to local labor lawyers is highly recommended. Also, given the limited number of vascular surgeons in the U.S., the path to unionization is expected to involve a collaborative approach with other healthcare professionals.

Equally important is to gauge the interest of vascular surgeons in creating a union. For this, I have created an eight-question survey. The sole intent of this questionnaire was to evaluate if the practicing vascular surgeon was interested in unionizing.

I am thankful to Dr. Kathleen J. Ozsvath, past president of the Eastern Vascular Society (EVS), and Dr. Jean Bismuth, past-president of the Society for Clinical Vascular Surgery (SCVS), for their prompt response to disseminate a questionnaire to their members regarding the creation of a union for vascular surgeons. The findings were quite interesting. Seventy-nine percent of the respondents from both societies stated that they would join or consider joining a union if one existed. The most common reason to join a union was the same for both societies: to have a seat at the table when decisions are made. The two other main reasons cited by EVS members were to improve wages and benefits, and to prevent administrative abuse. For SCVS members, preventing administrative abuse was the second top reason, followed by improving wages and benefits.

Younger vascular surgeons may be especially interested in exploring unionization further. Given the recent increased attention paid to unionization by the medical community, the relevance of this topic should not be questioned.

I believe further study and analysis of the pros and cons of unionization, and potential impacts on vascular surgery and vascular surgeons, is warranted, and I plan to ask the SVS to consider adding this topic to future strategic priorities.

Enrico Ascher, MD, is chair of the SVS Senior Section and a past president of the Society.

MVSS 2025: Ross Milner ascends to Midwestern Vascular Surgical Society presidency

By
Bryan Kay
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MVSS 2025: Ross Milner ascends to Midwestern Vascular Surgical Society presidency
Ross Milner speaks during MVSS 2025

Ross Milner, MD, the Louis Block professor of surgery and chief of vascular surgery at the University of Chicago, became the new president of the Midwestern Vascular Surgical Society (MVSS) in Cincinnati, Ohio, over the weekend.

Milner took over from outgoing President Patrick Muck, MD, chief of vascular surgery at Good Samaritan Hospital in Cincinnati, during the 2025 MVSS annual meeting (Sept. 18–20) in the city.

The new president-elect is Rachael Nicholson, MD, previously MVSS treasurer and director of the Division of Vascular Surgery at the University of Iowa in Iowa City. Jill Colglazier, MD, a vascular surgeon at the Mayo Clinic in Rochester, Minnesota, takes over as treasurer. Matthew Smeds, MD, a professor of surgery and the former division chief of vascular and endovascular surgery at Saint Louis University in Saint Louis, Missouri, became a councilor.

MVSS 2025: Gore iliac branch device ‘equally effective’ in both IDE and registry studies

By
Jocelyn Hudson
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MVSS 2025: Gore iliac branch device ‘equally effective’ in both IDE and registry studies
Meghan Barber

Researchers have reported comparable five-year outcomes of the Gore Excluder iliac branch endoprosthesis (IBE; Gore) in both the investigational device exemption (IDE) and GREAT registry studies of the device.

Meghan Barber, MD, a vascular surgery fellow at the University of Chicago, shared this main finding from a new comparative study at the 49th annual meeting of the Midwestern Vascular Surgical Society (MVSS) in Cincinnati, Ohio (Sept. 18–20).

Barber began by sharing the researchers’ hypothesis that there would be no difference in outcomes between the IDE study of the IBE device and the IBE component of the GREAT registry, representing “ideal” and “real-world” scenarios, respectively.

In order to test their hypothesis, the researchers compared the five-year outcomes of patients included in both the IDE study and the GREAT registry in the period 2013–2016. “We looked at all-cause mortality, aortic-related mortality, aortic rupture, reintervention, fracture, migration, endoleak and aneurysm growth,” Barber tells Vascular Specialist, reporting that the only differences identified between the two groups were that more patients were followed out to five years in the GREAT registry and that there was “slightly higher” all-cause mortality in GREAT. “Otherwise,” she says, “there was no difference between the two sets of patients.”

Barber comments that these results are “really good” for the IBE device. She notes: “The good outcomes we were able to demonstrate in the controlled setting of an IDE trial translated very well to the patients that were in the GREAT registry.”

Going into more detail about the two studies, senior author Ross Milner, MD, chief of vascular surgery at the University of Chicago, explains that the IBE component of GREAT comprises the final group of patients included in the registry. He explains: “When the IBE device got FDA [Food and Drug Administration] approval, it was actually fairly close to the time that we had enrolled the 5,000 patients we were looking for, so we actually have more patients in the registry than the IDE study.” Milner goes on to note that there were roughly 60 patients included in the IDE study compared to around 90 in the IBE component of GREAT.

Considering the take-home message from the new data, Milner says that the ability to use an iliac branch device for internal iliac artery preservation was “equally effective” in both the IDE study and the GREAT registry. He adds that those who perform endovascular aneurysm repair (EVAR) with an IBE can be “confident” their outcomes will mimic those seen in the setting of a clinical trial.

From a strategy standpoint, Milner continues, “most people would prefer to use an internal iliac branch when possible, for preservation.” He does stress, however, that both the IDE study and IBE portion of GREAT are U.S. centric, which “obviously makes it a little bit harder to extrapolate to the rest of the world.”

On the next steps for GREAT, Milner notes that there are now long-term follow-up data available, referencing 10-year results on some of the patients treated with standard EVAR using the Excluder abdominal aortic aneurysm (AAA) endoprosthesis (Gore). “That’s the predominant patient population in the registry,” he says, noting that almost 3,300 patients out of 5,000 in GREAT underwent EVAR with the Excluder.

Milner notes that one of the limitations of GREAT, however, is the lack of core-lab imaging. “We’re completely dependent on the sites for recognition of problems,” he says. In order to address this, Milner explains that Gore has now established the TOGETHER registry, which will feature core-lab imaging and a “more in-depth understanding of patient selection.”

“The goal is to collect 150 IBE patients,” Milner shares, highlighting the main goal of TOGETHER as being to assess branch technology, with the Gore IBE set to be a “big component” of the study.

The pair also consider the Gore IBE as part of the wider treatment landscape. While acknowledging that changes in how patients are treated are inevitable, Barber emphasizes that the IBE is “still a fairly unique device.” She remarks: “I don’t think that much has changed in the last five years at least, but in the next 10 years that may be a different story.”

WVS 2025: David Rigberg takes over as president of Western Vascular Society

By
Bryan Kay
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WVS 2025: David Rigberg takes over as president of Western Vascular Society
Screenshot
David Rigberg

David Rigberg, MD, clinical professor of surgery, at the UCLA Gonda School of Medicine in Los Angeles, has taken over as president of the Western Vascular Society (WVS).

Rigberg became the 2025–26 WVS president at the society’s annual meeting in Ojai, California (Sept. 14-17).

The 2024–25 president, Ahmed Abou-Zamzam, MD, delivered his outgoing presidential address with a look at how the concept of “value” is defined in the vascular surgical specialty and beyond. Abou-Zamzam is professor and chief in the Division of Vascular Surgery at Loma Linda University Health in Loma Linda, California.

SYMPHONY-PE trial demonstrates positive efficacy, efficiency, and safety results

By
Jocelyn Hudson
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SYMPHONY-PE trial demonstrates positive efficacy, efficiency, and safety results

Imperative Care has announced efficacy and safety results from the pivotal SYMPHONY-PE trial evaluating the company’s Symphony thrombectomy system in the treatment of acute pulmonary embolism (PE).

Results of the SYMPHONY-PE trial were presented in a late-breaking session at the Pulmonary Embolism Response Teams—PERT—Consortium 2025 Pulmonary Embolism (PE) Scientific Symposium (17–20 September, San Diego, USA), and published in Circulation: Cardiovascular Interventions.

In the trial, Symphony demonstrated a strong safety profile, high efficacy, and procedural efficiency, the company says in a press release. There were no device-related serious adverse events (SAE), with marked clot-burden reduction, short device-use time, and minimal blood loss.

The prospective investigational device exemption (IDE) trial evaluated 109 patients with acute intermediate-risk PE across 17 US institutions. The trial was led by national co-principal investigators Vivian L Bishay (Mount Sinai Health System, New York, USA), presenter of the late-breaking results at PERT, and Sripal Bangalore (NYU Grossman School of Medicine, New York, USA), lead author of the peer-reviewed paper.

“The trial results demonstrated significant improvements in right ventricle–to–left ventricle (RV/LV) ratio, systolic and mean pulmonary artery pressures (PAP), and clot burden, with no device-related SAE and no mortality reported at 30 days,” said Bishay. “These findings represent clinically meaningful progress in PE treatment, underscoring the device’s excellent safety profile. The ability to bring a large-bore catheter directly to the clot and safely deliver continuous aspiration marks an emerging paradigm shift in PE intervention. I look forward to the device’s continued impact in my practice.”

“Rapid thrombus removal using large-bore mechanical thrombectomy has the potential to improve patient haemodynamics, relieve right-heart strain, and reduce short-term morbidity and mortality in PE,” said Bangalore. “The excellent safety and efficacy demonstrated in this trial, together with short device-use times and minimal blood loss, underscore Symphony’s ability to address a critical unmet need by combining the advantages of large-bore continuous aspiration with the exceptional safety of real-time vacuum control.”

The trial met its pre-specified primary efficacy and safety endpoints, with results demonstrating a mean RV/LV reduction of 0.44±0.42 from baseline to 48 hours. The lower bound of the 97.5 % confidence interval (0.36) exceeded the prespecified performance goal of >0.20 (p<0.001).

On safety, the independent safety board adjudicated the major adverse event (MAE) rate, a composite of all-cause major bleeding, device-related deaths, and device-related SAE rate within 48 hours of the procedure, at 0.9 % (1/109). The 97.5% upper confidence interval bound (5.7 %) was significantly lower than the 15% performance goal (p<0.001).

“Symphony demonstrated an exceptional ability to deliver immediate and sustained objective and subjective improvements, achieving a 12mmHg reduction in systolic pulmonary artery pressure and a 7mmHg reduction in mean pulmonary artery pressure after aspiration, along with a 38.4% decrease in clot burden at 48 hours—all with a notably short device-use time and no safety concerns,” said Dana Tomalty (Huntsville Hospital, Huntsville, USA), the highest enroller in the trial. “These results appear to set a new benchmark for efficiency and safety in PE intervention. I am eager to bring this technology into routine clinical practice to improve outcomes for patients with acute PE.”

“Symphony introduces a new category in venous thromboembolism (VTE) treatment with Pulse Thrombectomy—the unique combination of a large-bore catheter with powerful, continuous vacuum delivered closer to the clot. This technology, paired with a streamlined procedural technique, enables physicians to remove more clot in less time,” said Doug Boyd, senior vice president and general manager of Imperative Care’s Vascular business. “We remain committed to building robust clinical evidence that validates our technologies and extends Symphony’s impact so more patients can receive life-saving care. We are deeply grateful to the patients, investigators, and clinical sites who helped make Symphony available across the USA.”

Terumo Aortic announces ‘significant policy milestone’ with CMS establishing new DRG 209 for complex aortic arch procedures

By
Bryan Kay
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Terumo Aortic announces ‘significant policy milestone’ with CMS establishing new DRG 209 for complex aortic arch procedures
Thoraflex Hybrid device
Thoraflex Hybrid device

Terumo Aortic today announced what it describes as a “significant policy milestone” with the Centers for Medicare & Medicaid Services (CMS) establishing a new Medicare Severity Diagnosis-Related Group (MS-DRG), MS-DRG 209, for complex aortic arch procedures.

A company press release details that this change will take effect on Oct. 1, 2025, and represents an advancement for hospitals treating patients with the Thoraflex Hybrid device in frozen elephant trunk (FET) procedures.

For the last three years, hospitals using the Thoraflex Hybrid device have benefitted from a New Technology Add-On Payment (NTAP), first granted by CMS in 2021, to help offset the high costs of performing complex open aortic procedures. Terumo Aortic petitioned CMS for a permanent reimbursement framework that fully recognizes the real-world costs of developing and delivering this care.

Following CMS’s own analysis of Medicare claims data, they concluded that a new DRG was needed to accurately reflect the resource demands and clinical complexity of these hybrid surgical-endovascular procedures.

Shifting demographics, improved visibility and strides made on Medicare reimbursements

By
Keith Calligaro
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Shifting demographics, improved visibility and strides made on Medicare reimbursements
VAM Convention 2025 in New Orleans
Keith Calligaro

This is the latest monthly update on a few of the critical issues facing the SVS.

Changing SVS leadership demographics

Over the last several years, the SVS Leadership and Appointments Committee made a determined effort to be more inclusive of the full spectrum of SVS members, with a specific focus on early-career and female vascular surgeons. As evidence of these efforts, early-career members comprise about 25% of our membership but 33% of the recent Vascular Annual Meeting (VAM) Program Committee and 50% of the Postgraduate Education Committee (PGEC).

Women comprise about 23% of our membership but 50% of SVS committee and council chairs, and currently serve as SVS president-elect, president of the Association of Program Directors in Vascular Surgery (APDVS), president of the Southern Association for Vascular Surgery (SAVS) and chair of the Vascular Surgery Board (VSB). Additionally, two of the three editors-in-chief of Rutherford’s Vascular Surgery and Endovascular Therapy textbook are women, while the new Journal of Vascular Surgery editor-in-chief is also a woman.

Increasing our visibility

The SVS branding campaign is ongoing, continuing apace with William Shutze, MD, past SVS secretary, leading the “Highway to Health” project, and SVS Advocacy Council Chair Megan Tracci, MD, JD, and Megan Marcinko, the SVS’s senior director for public affairs and advocacy, spearheading our SVS Advocacy Conference in Washington, D.C.

SVS public relations efforts are paying off. Each media outlet calculates their public relations impact via monthly impressions, which are the number of times articles, videos, ads, blogs, social media posts, etc., are consumed. There were 1.1 billion vascular-related impressions when President Donald J. Trump was recently diagnosed with chronic venous insufficiency (CVI).

CMS reimbursements

The Centers for Medicare & Medicaid Services (CMS) released its CY2026 Physician Fee Schedule proposed rule. Overall, vascular surgeons are slated for a combined increase of 5%, although there is an underlying differential based on site of service and case mix. Through the efforts of the SVS Coding Committee and Relative Value Scale Update Committee (RUC)/Current Procedural Terminology (CPT) advisors, CMS proposed to accept the physician work recommendations for all 46 new lower extremity codes. However, CMS is proposing to significantly lower the RUC-recommended work values for thoracic branched endovascular services and to apply an efficiency adjustment to the work relative value units (wRVUs) and intra-service time of most services (2.5% decrease). The vascular surgery Merit-based Incentive Payment System (MIPS) Value Pathways (MVP) was also included in the proposed rule. MVPs are the newest reporting option to assess quality of care. The vascular surgery MVP was designed by the SVS Quality and Performance Metrics Committee (QPMC). Traditional MIPS will be sunsetting by 2029, so vascular surgeons needed an MVP to add additional measures. The QPMC collects data for five MVPs: abdominal aortic aneurysm (AAA), carotid, venous, chronic limb-threatening ischemia (CLTI) and hemodialysis access. Compared to traditional MIPS, MVPs will reduce the reporting burden and improve payments for vascular surgeons.

I want to express our gratitude to Evan Lipsitz, MD, from the QPMC; David Han, MD, chair of the Coding Committee; Mounir “Joe” Haurani, MD, chair of the Government Relations Committee; our Advocacy, Clinical Practice and Quality councils; and especially Megan Marcinko, Carrie McGraw, SVS manager for quality improvement and practice, and SVS professional staff and staff consultants.

Keith Calligaro, MD, is SVS president.

Updated intermittent claudication guidelines reflect a decade of new evidence

By
Marlén Gomez and Bryan Kay
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Updated intermittent claudication guidelines reflect a decade of new evidence
The guidelines were published in the August issue of JVS

The Society for Vascular Surgery (SVS) recently published comprehensive update to its clinical practice guidelines (CPGs) for the management of intermittent claudication (IC), urging clinicians to prioritize conservative treatment strategies and patient-centered care.

The new recommendations, which appeared in the August issue of the Journal of Vascular Surgery (JVS), incorporate nearly a decade of new evidence and mark the first time the SVS has included a formal patient panel in the guideline development process.

The IC guidelines writing group, led by first author Michael Conte, MD, chief of the Division of Vascular and Endovascular Surgery at the University of California San Francisco (UCSF), produced 12 formal recommendations and two best practice statements, focusing on antithrombotic therapy, exercise interventions and revascularization procedures.

The update is intended to provide clinicians with the best available contemporary data on optimal medical therapy (OMT), exercise and interventions to promote an evidence-based framework for the management of IC. The guidelines reaffirm that first-line treatment should include patient education, smoking cessation, risk factor control, optimal medical therapy and structured exercise programs. Revascularization—whether surgical or endovascular—is recommended only for patients with lifestyle-limiting symptoms who do not respond to conservative therapy.

The guideline development process included input from a panel of patient advisors with lived experience of peripheral arterial disease (PAD) and claudication. Their feedback emphasized the importance of clear communication, individualized treatment goals and transparency about risks and benefits.

Despite advances in pharmacotherapy and endovascular technology, the SVS identified several gaps in the evidence base, including limited data on long-term outcomes and the effectiveness of home-based exercise programs.

“The areas selected for focus concern the role of therapeutic interventions for patients with IC,” Conte et al write. “Within the domain of medical therapies, we focused on antithrombotic management because of important new evidence in this arena directly relevant to the patient with IC.”

The updated guidelines aim to shift clinical practice toward a more thoughtful, individualized model of care, encouraging clinicians to weigh treatment options in the context of each patient’s overall health, preferences and life goals.

“In addition to the 2015 SVS guideline document on IC, the reader should refer to other relevant multi-specialty guidelines on general cardiovascular risk management and preoperative evaluation for patients with PAD and IC to supplement this update,” Conte and colleagues add in the update.

In an editorial accompanying the guidelines in the August issue of JVS, Britt Tonnessen, MD, an associate professor of vascular surgery at Yale Medicine in New Haven, Connecicut, and Marc Schermerhorn, MD, chief of vascular surgery at Beth Israel Deaconess Medical Center in Boston, say that such SVS guidelines provide “in-depth, evidence-based updates without recapping every aspect of a vascular condition.”

“The SVS has a responsibility to remain steadfast in the sharing of evidence that helps our patients and members,” they write. “This latest CPG on intermittent claudication is rooted in quality and safety, and encourages a patient-centered approach to the management of intermittent claudication—we would encourage everyone to read and consider which parts may best benefit their patients.”

Visit vascular.org/ICFocusedUpdate.

SVS Highway to Health campaign aims to make PAD a household term

By
Marlén Gomez
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SVS Highway to Health campaign aims to make PAD a household term
SVS patient-facing awareness campaign, Highway To Health, generated 2.7 billion media impressions, more than 3,700 placements and 70 interviews last month

The Society for Vascular Surgery (SVS) is ramping up its national Highway to Health campaign to educate the public about peripheral arterial disease (PAD) and the importance of early detection as part of September’s PAD Awareness Month.

Anahita Dua, MD, a vascular surgeon at Massachusetts General Hospital and a spokesperson for the campaign, said the initiative is rooted in changing how people think about vascular health.

“PAD, if left untreated, can have complications similar to a heart attack or stroke,” said Dua. “It’s the same disease process—blocked arteries—but in the legs. And that means it’s just as serious.”

PAD affects millions of Americans, yet public awareness remains low. The Highway to Health campaign aims to close that gap through media outreach, educational resources and community events. The campaign’s website, YourVascularHealth.org, offers symptom checklists, videos, patient toolkits and guidance on finding vascular specialists.

“If you stop someone on the street and ask what a heart attack is, they know. Ask about PAD, and they have no idea,” said Dua. “That’s the problem. We talk to patients about amputation, but we don’t explain the disease itself.”

This lack of awareness leads to delayed diagnoses and missed opportunities for early intervention, according to Dua, who believes that community education is the key.“We need a national message where people understand PAD. If someone has crampy pain in their leg, they should think, ‘Maybe it’s PAD,’ and know to call their doctor.”

In August, the campaign generated 2.7 billion media impressions, more than 3,700 placements and 70 interviews, according to internal reports.

“You’re not going to be able to explain everything about PAD in one sitting,” Dua admitted. “But if people know what it is, they’ll know what to do next.”

Dua emphasizes that catching PAD early can dramatically change a patient’s outcome. “If you’re able to pick up that a person has PAD early, you can be aggressive about giving them the right medications and the right lifestyle modifications so that the PAD does not progress,” she said. “Because the end stage of PAD is an amputation.”

Dua talks of early detection allowing for interventions that can halt or even reverse the disease, referencing patients with intermittent claudication who commit to a structured walking program who can grow new blood vessels in their legs, reducing pain and improving mobility.

She encourages her patients to stay physically active, noting that regular movement can significantly improve circulation and reduce symptoms. “Movement is medicine,” said Dua. “Walking programs are incredibly effective in helping patients grow new blood vessels and regain mobility.”

Dua emphasized that awareness is the first step toward prevention. “No matter what surgical procedure we do, minimally invasive or open surgery, it won’t work if patients don’t make lifestyle changes,” she said. “So let’s start with awareness. Let’s make PAD something everyone knows about.”

For more information, visit vascular.org/Your-Vascular-Health.

Vascular Specialist–September 2025

By
Bryan Kay
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Vascular Specialist–September 2025

In this issue: 

  • Enduring PROMISE: Real-world outcomes study suggests results continue to flow from transcatheter arterialization of the deep veins
  • SVS Highway to Health campaign aims to make PAD a household term
  • FDA deems enVVeno’s VenoValve ‘not approvable’
  • Unionization: Vascular surgeons, are you ready to join forces?

Gregorio A. Sicard, past SVS president, advocate for Latin American surgeons, celebrated surgical educator, dies aged 81

By
Marlén Gomez
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Gregorio A. Sicard, past SVS president, advocate for Latin American surgeons, celebrated surgical educator, dies aged 81
Gregorio A. Sicard

Gregorio A. Sicard, MD, a transformative figure in vascular surgery and a revered mentor to generations of surgeons, has died. He was 81. 

Sicard was widely recognized for pioneering contributions to the field, particularly in developing and advocating for endovascular procedures. His career spanned more than four decades, during which he helped shape the vascular surgical specialty through clinical innovation, leadership and advocacy.

In 2018, Sicard was honored with the Lifetime Achievement Award by the Society for Vascular Surgery (SVS), the highest distinction bestowed by the SVS. He was celebrated as a “surgeon’s surgeon,” a title that reflected both his technical excellence and his unwavering commitment to advancing the specialty during the rise of minimally invasive techniques.

With his guidance and in close collaboration with Diego Fajardo, MD, Asovascular, the Colombian Association of Vascular Surgery and Angiology, was officially integrated with the SVS in 2010, establishing the Colombian Chapter—the second-oldest international chapter of the organization.

“Dr. Sicard was the strongest academic support we had,” said Fajardo. “There is an important aspect to consider for us Latin Americans, that obtaining an education from a reputable institution is not as easy. Having Dr. Sicard assist Dr. Juan Barrera, one of our previous presidents, who received a research scholarship through him, helped us merge opportunities to gain education from the SVS, which is very important to us. It meant transparency and respect.

“Dr. Sicard was a mentor who helped grow Latin American education and strengthen relationships with the SVS and the Colombian Association. As a friend and someone who was genuinely interested in advancing education, he helped other doctors from Colombia pursue opportunities at his work in Washington University. He was open to sharing his teaching capabilities, which is something you don’t find every day. He was someone we could trust to build bridges and represent us outside of the U.S.”

Sicard speaks in 2013 during an SVS video series on vascular surgery history

Sicard spent nearly his entire surgical career at Washington University School of Medicine in St. Louis, where he completed his residency and fellowship before joining the faculty. In 1983, he founded the Section of Vascular Surgery and, two years later, he received a promotion to professor of surgery. In 1998, he assumed the role of chief of the Division of General Surgery, which included vascular surgery. In 2006, he was named the Eugene M. Bricker Professor of Surgery.

His legacy at Washington University was further cemented in 2011, when the Gregorio A. Sicard Professorship was established in his honor.

Luis Sanchez, MD, FACS, the current Gregorio A. Sicard distinguished professor of surgery and radiology at Washington University, recognizes Sicard as a master of vascular surgery and a professor of countless generations of general and vascular surgeons.

“He was a vascular surgery regional, national and international leader that will always be remembered with special affection for his generosity sharing his extensive knowledge and expertise in vascular surgery,” said Sanchez. “His vision of the future of our field, his contagious laugh, his eternal positive attitude, and his active involvement in the education of medical students, trainees and colleagues alike… I was fortunate to closely work with him for over 20 years and follow him as the chief of vascular surgery at Washington University School of Medicine and Barnes Jewish Hospital, as well as carry the professorship that bears his name since 2011. He is a tremendous loss to our vascular surgery community and he will be greatly missed.”

As SVS president (2004–05), Sicard played a pivotal role in the merger of the SVS and the American Association for Vascular Surgery (AAVS), helping unify the specialty during a critical period of consolidation. He later chaired the SVS Outcomes Committee, working closely with the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) to advocate for evidence-based, patient-centered policies that recognized the essential role of vascular surgeons in endovascular care.

Born and raised in rural Puerto Rico, Sicard was the son of a surgeon and earned his medical degree from the University of Puerto Rico. He graduated in 1972 and went on to mentor more than 50 fellows, publish hundreds of articles and book chapters, and shape the careers of countless vascular surgeons around the world.

Sicard’s legacy lives on in the surgeons he trained, the patients he cared for and the field he helped shape. The vascular community will remember his surgical brilliance as well as his humility, generosity and enduring dedication to vascular surgery.

Enduring PROMISE: Real-world outcomes study suggests results continue to flow from transcatheter arterialization of the deep veins

By
Bryan Kay
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Enduring PROMISE: Real-world outcomes study suggests results continue to flow from transcatheter arterialization of the deep veins
Yana Etkin speaks during EVS 2025
First retrospective analysis shows comparable outcomes data to those found in PROMISE II pivotal trial, authors report.

The first post-approval multicenter analysis of so-called “no-option” chronic limb-threatening ischemia (CLTI) patients treated using a pioneering transcatheter arterialization of the deep veins (TADV) device lays out a set of real-world outcomes that align with those achieved in the PROMISE II pivotal trial of the device, the authors report.

Researchers from Northwell Health in New Hyde Park, New York, MedStar Health in Washington, D.C., and UT Southwestern in Dallas revealed limb salvage rates of 76.1% at six months and 71.7% at one year, respectively, among an 80-patient cohort with a median follow-up of 184 days after TADV (LimFlow, acquired by Inari Medical, now part of Stryker). Furthermore, the study showed survival of 93.1% and 84.7% at six months and one year, respectively. Likewise, the research team reported amputation-free survival rates of 74.2% and 63.6% at the same time points.

The data were revealed during the 2025 annual meeting of the Eastern Vascular Society (EVS) in Nashville (Sept. 4–7) by presenting author Yana Etkin, MD, associate chief of vascular and endovascular surgery in the Zucker School of Medicine at Hofstra/Northwell.

Etkin pointed to six-month results from PROMISE II showing a limb salvage rate of 76%, survival of 87.1% and amputation-free survival of 66.1%. “This first real-world, multicenter retrospective study of LimFlow showed outcomes consistent with PROMISE II,” she told those gathered at EVS 2025. “[TADV] achieves favorable outcomes with a high rate of limb salvage up to one year.”

In an interview with Vascular Specialist ahead of presenting the data, Etkin spoke of the device’s role in the fight against diabetes-driven peripheral arterial disease (PAD) across the U.S. “PAD is on rise in the U.S., specifically because of the really high rates of diabetes,” she says. “Every 11th person in our country has diabetes—that is now the no. 1 risk for PAD—and almost 4 million people have PAD. So, the rate of limb loss continues to increase, and probably about 10% of patients who have PAD have what we call ‘no option’ for revascularization.”

TADV has long been sought after as an alternative means of providing an option for this high-risk CLTI population of patients, Etkin relates. “For years, we have been talking about what to do with these patients, and we’ve tried DVA, where we connect the arteries to the veins, to arterialize the veins, and it has been tried with variable success,” she explains. “Open deep vein arterializations [DVAs] have been described, and percutaneous ones as well, but the percutaneous ones were done randomstance, involving specialists using devices off the shelf, self-made, in very few small series, so not well reported.”

Then along came the LimFlow device, Etkin continues. Approved by the Food and Drug Administration (FDA) in 2023, LimFlow rolled out into the real-world environment off the back of the six-month results’ publication in the New England Journal of Medicine (NEJM). “But the trial is the trial,” Etkin says, “the perfect kind of environment. We started using [LimFlow] in our system when it got approved, and so the idea behind this project was to look at real-world data. Very commonly, after the trials are over, when the devices get to the general population, they don’t perform as well, and then, of course, there is a learning curve.”

With a median follow-up of six months among the 80 patients in the real-world analysis, Etkin points to data showing that of the patients who did not die or lose a limb, stent patency was 70%, with 94% of patients exhibiting either healed or improved wounds. In terms of learning curve of the LimFlow procedure, Etkin can claim 30 of those 80 patients as experience. In that vein, one of the routes to good results involved completing cases together with Northwell vascular surgeon colleague, Jeffrey Silpe, MD, she explains. “The first few cases took a long time, an average of five to six hours,” Etkin says. “But now, after doing these for over a year, we are down to about one-and-a-half to two hours. So, there is definitely a learning curve in probably the first 10 cases.”

She continues, “It is more than just a technical procedure. There is a lot of thought that needs to go into the planning, the intraoperative decision-making. It’s not a straightforward procedure where you have an occluded artery and try to open it up. You’re creating a fistula, and there is a risk that you could steal the blood flow from the native circulation into this fistula, and this fistula is not going to provide enough blood flow for the first six weeks or so because it has to mature. So, you can actually make things worse if you’re not carefully planning and looking at the imaging.”

The procedure is “not going to save everyone,” Etkin says. “This is the first option for these patients who truly have no option.” But, with limb loss associated with “really high mortality,” by saving legs “you’re actually saving people’s lives.”

Work to more fully understand who the right patients are for the TADV procedure continue, Etkin adds. “I think all the results—PROMISE, our results—supports that there is something here that people should really consider including in their treatment algorithm. This is not the first option; this is clearly for when you have exhausted all the options.”

Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system

By
Bryan Kay
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Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system

Microbot Medical today announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for the Liberty system, the first FDA cleared single use, remotely operated robotic system for peripheral endovascular procedures, states the company in a recent press release.

The FDA clearance positions the company to commercialize Liberty in the US, with the goal of transforming the field to enable accessibility to advanced robotics without the traditional constraints of capital equipment and a dedicated infrastructure.

The Liberty pivotal study showed 100% success in the robotic navigation to target, and zero device related adverse events. The study also showed a 92% relative reduction in radiation exposure for physicians. Its remote design is expected to improve ergonomics, which would aid in reducing the physical strain on healthcare providers.

The company believes that Liberty has the potential to enhance procedure efficiency, lower procedure costs, and improve the overall quality of care. The company plans to continue clinical data collection for Liberty during the commercial launch.

Shape Memory Medical completes enrollment in EMBO-PMS registry

By
Bryan Kay
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Shape Memory Medical completes enrollment in EMBO-PMS registry
Impede embolisation plug, expanded
Impede embolisation plug

Shape Memory Medical today announced the completion of patient enrollment in the EMBO postmarket surveillance (EMBO-PMS) registry, the company’s prospective, multicenter registry of the Impede and Impede-FX embolisation plugs, and Impede-FX RapidFill device when used for peripheral vascular embolization.

A press release details that the Impede embolisation plug family of devices utilizes Shape Memory Medical’s proprietary shape memory polymer—a porous, radiolucent embolic material that is crimped for catheter delivery and self-expands to its original shape upon exposure to the warm, aqueous environment of a blood vessel. “This expansion creates a conformable, porous scaffold that supports stable thrombus formation and rapid occlusion throughout its structure,” the release reads.

According to Shape Memory Medical, EMBO-PMS represents the first prospective, multicentre study designed to systematically evaluate the real-world application of the novel shape memory polymer devices in peripheral vascular embolisation procedures. The study encompasses a diverse spectrum of arterial and venous applications, including visceral aneurysms, pre-endovascular aneurysm repair (EVAR) branch vessel occlusion, pelvic venous disorders, and vascular anomalies. To date, sustained occlusion has been observed at early follow-up, with no serious adverse events related to the study devices. One-year outcomes are anticipated next year.

Shape Memory Medical notes that, before the launch of the EMBO-PMS study, the Impede embolization plug underwent initial evaluation in a first-in-human, prospective, single-arm safety study involving 10 patients who underwent peripheral vascular embolisation, and a retrospective review of long-term follow-up imaging demonstrated no evidence of recanalization. The company advises that the latest EMBO-PMS results have been accepted for presentation at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress 2025 (Sept. 13–17) in Barcelona, Spain.

EVS 2025: Eastern Vascular Society reveals 2025–26 officer class

By
Bryan Kay
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EVS 2025: Eastern Vascular Society reveals 2025–26 officer class
Benjamin Jckson

Benjamin Jackson, MD, chief in the Division of Vascular and Endovascular Surgery at Lehigh Valley Heart and Vascular Institute in Allentown, Pennsylvania, became the new Eastern Vascular Society (EVS) president during the 2025 EVS annual meeting in Nashville (Sept. 4–7). Palma Shaw, MD, professor of surgery at State University of New York in Syracuse, was elected as the society’s president-elect at EVS 2025.

Jackson takes over from Brajesh K. Lal, MBBS, a professor of surgery in the University of Maryland School of Medicine in Baltimore.

Elsewhere, Faisal Aziz, MD, Gilbert & Elsie Sealfon professor and chief of vascular surgery at Penn State University in Hershey, became EVS secretary, and Daniel Han, MD, a professor of surgery in the Mount Sinai Health System in New York City, was elected as a councilor-at-large.

Advances in endovascular therapy help drive innovative CPVI training course

By
Marlén Gomez
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Advances in endovascular therapy help drive innovative CPVI training course
Vipul Khetarpaul, at right, oversees a previous CPVI course
The SVS Complex Peripheral Vascular Interventions (CPVI) Skills Course has become a fixture on the vascular surgery calendar over the past couple of years. Here, course director Vipul Khetarpaul, MD, gives Marlén Gomez the rundown on how the evolution of endovascular interventions in the lower extremity gave rise to a now standout event.

Over the past, endovascular therapy has undergone significant advancements, particularly in the treatment of peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI). These developments have shifted the focus from achieving visually appealing angiographic results to prioritizing true perfusion and patient-centered outcomes.

The CPVI course, scheduled for Sept. 20–21, in Rosemont, Illinois, reflects this evolution. The two-day, intermediate-to-advanced training program offers hands-on experience through cadaver and benchtop simulation labs, high-impact lectures, and collaborative case-based discussions. The course is designed to equip vascular surgeons with practical skills that can be immediately applied in clinical practice.

Khetarpaul who is an associate professor of surgery at Washington University School of Medicine in St. Louis, explained that imaging technologies such as intravascular ultrasound (IVUS) have become routine. Device innovation has also accelerated, with the introduction of re-entry tools, crossing catheters, drug-coated balloons and covered stents. Access strategies have expanded to include radial and pedal approaches. Techniques such as tibial and pedal loop reconstruction, and selective deep venous arterialization are now commonly used.

“With the addition of new devices and the explosion of technology, the algorithmic approach to these cases has become significantly more complex,” Khetarpaul said. “It requires frequent updates and refreshers.”

The CPVI course was created to address gaps in vascular surgery education. According to Khetarpaul, opportunities for hands-on training in critical techniques like crossing a chronic total occlusion (CTO) , bailout strategies, pedal access and complication management are often limited in standard curriculum of training.

“The complex peripheral intervention skillset is somewhat unique and not every program is able to offer the same level of expertise in this particular aspect of vascular surgery,” said Khetarpaul. “We wanted to create a thoughtful, real-world approach to these difficult scenarios and have faculty share their unbiased insights.”

Since its inception in 2022, the CPVI curriculum has evolved to reflect technological and procedural advancements. The course now includes modules focused on imaging-first decision-making, structured CTO algorithms, distal and alternate access techniques, and deep venous arterialization. The atherectomy toolkit has been expanded to include vessel modification and thrombectomy strategies. Outdated content is retired.

What sets the CPVI course apart from other vascular surgery training programs is its emphasis on real case failures and its device-agnostic approach. The course prioritizes decision-making frameworks over brand preferences. Participants work in small groups, review complications openly and gain hands-on experience in a safe environment that encourages learning through trial and error.

“The faculty is chosen based on their real-world experience,” Khetarpaul said. “Our goal is to help surgeons feel more confident and capable in all aspects of CLTI care so that their treatment plans are based on what serves the patient best.”

Simulation labs and cadaver training play a critical role in enhancing the learning experience. These sessions allow participants to build muscle memory and practice key techniques such as access angles, wire escalation, re-entry, and bailout strategies on real anatomy.

“Participants can use different atherectomy and thrombectomy tools and navigate pedal loops with live faculty interaction, free from industry bias,” Khetarpaul said.

Attendees of previous iterations have reported higher success rates in CTO procedures, increased use of IVUS, and safer approaches to pedal and alternate access. Several institutions have established limb salvage pathways following their surgeons’ participation in the course. One thing that has changed this year is adding in more case-based discussions based on attendee feedback, recognizing their value in surgical learning.

“By equipping surgeons with clarity and confidence, the CPVI course is shaping the next generation of limb salvage leaders,” added Khetarpaul.

To learn more, visit vascular.org/CPVI25.

Final call for SVS Foundation VC4U project grant applications

By
Marlén Gomez
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Final call for SVS Foundation VC4U project grant applications
The one-year grant supports initiatives aimed at improving vascular care access and outcomes in underserved communities

The Society for Vascular Surgery (SVS) Foundation reminds eligible applicants of the upcoming submission deadline for the Vascular Care for the Underserved (VC4U) project grant. All applications must be submitted by Monday, Sept. 8.

The one-year, $20,000 grant supports initiatives aimed at improving vascular care access and outcomes in underserved communities across the U.S. This year, the SVS Foundation, in collaboration with the SVS Women’s Section, is prioritizing proposals focused on women’s vascular health, including gender-specific interventions and research.

Applicants must be SVS Active Members, Early Active Members, or Society for Vascular Nursing (SVN) Active Members. Trainees, fellows, residents and medical students are not eligible.

Applications must include a detailed project proposal, budget and supporting documentation. Submissions are accepted through the SVS Foundation’s online portal. Grant recipients will be announced later in September.

For more information and to apply, visit vascular.org/VC4U.

Start of PAD Awareness Month heralds joint national effort to prevent amputations

By
Bryan Kay
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Start of PAD Awareness Month heralds joint national effort to prevent amputations
VAM Convention 2025 in New Orleans
Keith Calligaro

The PAD Pulse Alliance—a coalition of leading medical societies that includes the Society for Vascular Surgery (SVS) dedicated to improving vascular health—is urging patients, providers and policymakers to act through its Get a Pulse on PAD Campaign as national PAD Awareness Month kicks off.

“Peripheral arterial disease [PAD] is one of the most underrecognized yet devastating cardiovascular conditions in the U.S., too often diagnosed only after it has advanced and placed patients at risk for amputation, heart attack, or stroke,” said SVS President Keith Calligaro, MD. “The Society for Vascular Surgery is proud to participate in the PAD Pulse Alliance to raise awareness, expand early screening and referral for at-risk populations, and advocate for equitable care. By identifying PAD earlier, addressing risk factors, and connecting patients to life- and limb-saving treatments, we can prevent amputations and improve the lives of millions.”

Nearly 70% of those living with PAD do not know they have it, according to a survey by the PAD Pulse Alliance. Among Black and Hispanic adults, eight in 10 report never having a healthcare provider discuss PAD with them, despite being disproportionately affected. The PAD Pulse Alliance is encouraging legislative action.

“[PAD] is one of the most devastating but overlooked threats to cardiovascular health, particularly in Black and Brown communities where rates of amputation remain alarmingly high,” said Foluso Fakorede, MD, CEO of Cardiovascular Solutions of Central Mississippi and co-chair of the Association of Black Cardiologists (ABC) PAD Initiative. “Too many lives are disrupted because PAD is not detected early enough, despite the fact that it is treatable and preventable. At ABC, our mission is to ensure that no patient is left behind due to systemic neglect or lack of awareness. By advancing screening, education, and equitable access to care, we can stop the cycle of unnecessary amputations and save both lives and limbs.”

The PAD Pulse Alliance is also encouraging patients, families and healthcare providers to download and share its free, interactive PAD Patient Toolkit at PADPulse.org.

Imperative Care announces FDA clearance for Symphony thrombectomy system

By
Éva Malpass
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Imperative Care announces FDA clearance for Symphony thrombectomy system
Symphony thrombectomy system

Imperative Care has today announced Food and Drug Administration (FDA) 510(k) clearance of its Symphony thrombectomy system to treat pulmonary embolism (PE).

This clearance expands the use of Symphony—previously for the treatment of venous thrombosis—to now include PE, providing a comprehensive solution to effectively and efficiently treat the full spectrum of venous thromboembolism (VTE) patient needs.

The clearance follows the successful completion of the SYMPHONY-PE study, a pivotal investigational device exemption (IDE) trial evaluating the safety and efficacy of Symphony for the treatment of acute PE. The study was led under the oversight of the national co-principal investigators, Vivian L Bishay, MD, associate professor in the Department of Diagnostic, Molecular and Interventional Radiology at Mount Sinai Health System in New York, and Sripal Bangalore, professor in the Department of Medicine at NYU Grossman School of Medicine in New York.

“The study data clearly demonstrate Symphony’s safety, efficacy and efficiency, marking a significant advancement in the treatment of patients with pulmonary embolism,” said Bishay. “These results underscore Symphony’s potential to address a critical unmet need by enabling rapid, controlled clot removal while maintaining a strong safety profile. I look forward to incorporating this important new technology into my practice to improve care for patients facing this life-threatening condition.”

“In the treatment of pulmonary embolism, reducing right heart strain is of critical importance. The more rapidly we can remove thrombus and restore stable haemodynamics, the greater the benefit for patients,” said Bangalore. “Based on my initial clinical experience with the Symphony thrombectomy system, I believe it has the potential to advance clinical practice by merging large-bore continuous aspiration with the safety and precision of real-time vacuum control.”

FDA begins ‘real-time’ reporting of adverse event data

By
Bryan Kay
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FDA begins ‘real-time’ reporting of adverse event data
The FDA has begun daily publication of adverse event data

The Food and Drug Administration (FDA) recently announced that it has begun daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS).

The agency says that “this represents a significant step forward in modernizing the agency’s safety monitoring infrastructure and demonstrates its commitment to radical transparency and real-time protection of public health.”

FDA commissioner, Marty Makary, MD, said: “Adverse event reporting should be fast, seamless and transparent. People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public. We’re closing that waiting period and will continue to streamline the process from start to finish.”

FAERS is the FDA’s primary database for collecting and analyzing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and therapeutic biologics. It contains reports submitted by healthcare professionals, consumers and manufacturers.

The FDA says the move “is one of many steps in the FDA’s broader data modernization strategy to streamline all of its adverse event reporting systems and increase reporting frequency across all systems to identify safety signals faster.”

The public can view the latest adverse event data on the FAERS Public Dashboard. The FDA encourages healthcare professionals and consumers to report adverse events to the FDA’s MedWatch site.

SWEDEPAD re-opens paclitaxel safety discussion, finds drug-coated devices do not improve outcomes

By
Jocelyn Hudson
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SWEDEPAD re-opens paclitaxel safety discussion, finds drug-coated devices do not improve outcomes
Mårten Falkenberg presents SWEDEPAD findings at ESC 2025
Mårten Falkenberg presents SWEDEPAD findings at ESC 2025

Drug-coated balloons and stents were not associated with reduced risk of amputation or improved quality of life compared with uncoated devices in the SWEDEPAD 1 and 2 trials. In addition, higher five-year mortality with drug-coated devices in patients with intermittent claudication was noted, leading researchers to stress that the safety of paclitaxel-coated devices is an “ongoing discussion”. These late-breaking findings were presented today at the European Society of Cardiology (ESC) 2025 congress (29 August–1 September, Madrid, Spain) and simultaneously published in The Lancet.

SWEDEPAD 1 and 2 were pragmatic, participant-blinded, registry-based randomised trials that set out to determine the clinical impact of drug-coated technology on patients with peripheral arterial disease (PAD).

Explaining the rationale for the trials, co-principal investigator Joakim Nordanstig (University of Gothenburg, Gothenburg, Sweden), said: “Drug-coated balloons and stents have been shown to reduce restenosis and the need for reinterventions in the endovascular treatment of PAD. However, there are uncertainties regarding whether drug-coated devices improve outcomes that are meaningful to patients, quality of life and reducing amputations, and there are some concerns over safety. We investigated these and other endpoints in two trials in PAD—one in chronic limb-threatening ischaemia [CLTI] and one in intermittent claudication—comparing drug-coated and uncoated devices.”

In SWEDEPAD 1, 2,355 patients with CLTI (Rutherford stage 4–6) undergoing infrainguinal endovascular treatment were randomised 1:1 to drug-coated or uncoated balloons or stents. In nearly all of the drug-coated devices implanted, the drug delivered was paclitaxel (>99%). There was no significant difference in the primary endpoint of time to ipsilateral above-ankle amputation with drug-coated versus uncoated devices (hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.87–1.27) over five years of follow-up. Target vessel reinterventions were reduced in the drug-coated group during the first year (HR 0.81; 95% CI 0.66–0.98), but this difference disappeared with longer follow-up. There was no difference in all-cause mortality or in quality of life (as assessed using the VascuQoL-6 questionnaire).

In SWEDEPAD 2, 1,155 patients with intermittent claudication (Rutherford stage 1–3) undergoing infrainguinal endovascular treatment were randomised 1:1 after successful guidewire crossing to receive either drug-coated or uncoated balloons or stents. All drug-coated devices implanted delivered paclitaxel. There was no difference in the primary efficacy endpoint of quality of life between the drug-coated and uncoated groups at 12 months (mean difference in VascuQoL-6 scores: –0.02; 95% CI –0.66–0.62). Target vessel reintervention rates were not different at one year or over a median follow-up of 6.2 years. All-cause mortality did not differ over 7.1 years (HR 1.18; 95% CI 0.94–1.48), although higher five-year mortality was noted with drug-coated versus uncoated devices (HR 1.47; 95% CI 1.09–1.98).

Summarising the findings, co-principal investigator Mårten Falkenberg (Sahlgrenska University Hospital and the University of Gothenburg, Gothenburg, Sweden), said: “Paclitaxel-coated devices were not effective in preventing amputation in chronic limb-threatening ischaemia or improving quality of life in intermittent claudication. Given the signal of increased mortality with intermittent claudication, clinicians should carefully evaluate the potential risks and benefits when considering these expensive devices. Devices incorporating antiproliferative agents other than paclitaxel warrant further investigation in PAD.”

Paclitaxel mortality issue “an ongoing discussion”

In a press conference at ESC, Nordanstig commented on how the newly presented SWEDEPAD data compare to other trials in the PAD space. He noted that the results are “a bit different” to those of previously conducted pivotal trials and meta-analyses on drug-coated technology in patients with PAD, which “consistently demonstrated” reduced reintervention rates. “The big difference here I think,” Nordanstig said, “is this is a strategy trial rather than a single device trial, and [the SWEDEPAD findings] might be what is happening when broadly introducing these therapies in a more everyday patient population.”

Nordanstig also touched on the finding in SWEDEPAD 2 that higher five-year mortality was noted with drug-coated versus uncoated devices, stressing that the safety of paclitaxel-coated devices is “still an ongoing discussion” following the identification in 2018 by Katsanos et al of a late mortality signal. He remarked: “It’s hard for us to ignore the fact that it seems that we mirrored that signal in SWEDEPAD 2, but not in SWEDEPAD 1.”

Closing the press conference, session chair Dan Atar (Oslo University Hospital Ulleval, Oslo, Norway) commended the researchers for their use of “hard” endpoints in the SWEDEPAD trials. “That’s a very interesting approach to showing outcomes,” he said.

Final patient treated in Cook’s Zenith Fenestrated+ endovascular graft clinical study

By
Jocelyn Hudson
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Final patient treated in Cook’s Zenith Fenestrated+ endovascular graft clinical study
Cook Medical’s investigational ZFEN+ device
Investigational ZFEN+ device

Cook Medical has enrolled the final patient in the global clinical study of its Zenith Fenestrated+ endovascular graft (ZFEN+), signifying completion of patient recruitment in the pivotal study. 

The investigational ZFEN+ clinical study is being conducted under an Investigational Device Exemption (IDE) approved by the US Food and Drug Administration (FDA) and with authorization for a clinical investigation under Medicines and Healthcare products Regulatory Agency (MHRA), the company states in a press release.

The clinical study will assess the safety and effectiveness of the ZFEN+ used in combination with the investigational Zenith universal distal body 2.0 graft (Unibody2), Bentley‘s investigational BeGraft balloon-expandable fenestrated endovascular aneurysm repair (FEVAR) bridging stent graft system and Cook’s commercially available Zenith Spiral-Z abdominal aortic aneurysm (AAA) iliac leg graft (ZSLE). 

Cook shares that the ZFEN+ is predicated on the commercially available Zenith fenestrated (ZFEN) AAA endovascular graft but extends the proximal margin of aneurysmal disease that can be treated endovascularly to include patients with more complex aortic disease involving one or more of the major visceral arteries. The ZFEN+ is an endovascular graft which includes up to five precisely located fenestrations, or a combination not to exceed a total of five made up of fenestrations and one scallop (cut-outs from the proximal margin of the endograft material) to accommodate visceral vessels. Physicians can order fenestrations and scallops specifically to match the patient’s unique anatomy. Overall, the company states, the ZFEN+ allows for the endovascular treatment of patients with aortic aneurysms and maximizes the seal zone to exclude the aneurysm. The product was granted Breakthrough Designation from the FDA in 2021. 

“Amazing work from the clinical research team on the enrollment of the final ZFEN+ patient. The clock is now ticking for us to have a patient-specific solution for complex aortic aneurysms that will optimize seal without compromise,” said Gustavo Oderich, MD, chief of vascular surgery at Baylor College of Medicine and Texas Heart Institute in Houston, the global principal investigator of the clinical study.  

Journal of Vascular Surgery secures new editor-in-chief

By
Marlén Gomez
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Journal of Vascular Surgery secures new editor-in-chief
Audra Duncan

The Journal of Surgery (JVS) has appointed Audra Duncan, MD, of Western University in London, Ontario, Canada, as its new editor-in-chief.

Duncan will lead the journal for a four-year term, renewable for two more years, following the decision of the Publications Committee and the approval of the SVS Executive Board.

She succeeds Thomas Forbes, MD, of the University of Toronto, Canada, who concluded his three-year tenure at this summer’s Vascular Annual Meeting (VAM 2025). Under Forbes’ editorial leadership, JVS continued to grow as a leading platform for cutting-edge vascular research.

Previously serving as an associate editor for the journal, Duncan has been a key contributor to its editorial direction and peer-review standards. Her appointment underscores a commitment to fostering high-quality scholarship.

In her new role, Duncan will champion initiatives that enhance the journal’s reach, promote diversity in research and seek to uphold rigorous scientific standards.

“I am excited for this opportunity to further build the journal that meets the needs of our SVS community and pushes boundaries in innovation and collaboration,” said Duncan. “We are such a strong vascular group; we have the ability to use our journal to showcase the great work we do, and what vascular surgery looks like in 2025.”

Boston Scientific recalls Carotid Wallstent Monorail devices over ‘manufacturing defect’

By
Bryan Kay
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Boston Scientific recalls Carotid Wallstent Monorail devices over ‘manufacturing defect’

Boston Scientific has recalled its Carotid Wallstent Monorail endoprosthesis owing to a “manufacturing defect” that has led to devices having an inner lumen that is smaller than specifications, causing resistance when withdrawing the stent delivery system.

A Food and Drug Administration (FDA) recall notice dated Aug. 22 states that using the affected stent systems could cause serious harm, such as injury to the blood vessel, damage to the stent, or release of debris that could travel to the brain and cause a stroke. As such, this recall has been identified as “the most serious type,” with continued use of the device potentially causing serious injury or death.

As of July 29, 2025, Boston Scientific has reported six cases that required additional intervention to recover the device, but has not reported any deaths associated with this issue.

The FDA recall notice states that, on July 7, Boston Scientific sent all affected customers an urgent medical device removal letter recommending that they immediately stop using affected devices; remove affected devices from inventory, and clearly segregate and return them to Boston Scientific; complete and return a reply verification tracking form, even if no affected devices remain; and share this information with all staff, facilities and customers who may have received the product.

The Carotid Wallstent Monorail endoprosthesis is a self-expanding stent used to open narrowed carotid arteries, and is placed using a catheter over a guidewire or embolic protection device.

More details on the FDA’s device recall notice can be seen here.

Pharmacologic treatment, follow-up in cessation services help drive abstinence in PAD patients

By
Bryan Kay
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0
Pharmacologic treatment, follow-up in cessation services help drive abstinence in PAD patients
Smoking cessation in patients with PAD is achievable with intensive and appropriate management, study suggests

A recent French study suggests smoking cessation in patients with peripheral arterial disease (PAD) is achievable with intensive and appropriate management, with the prescription of a pharmacologic smoking cessation treatment and follow-up with smoking cessation services both identified as important elements that increase abstinence.

The research team behind the findings—led by Anne-Laurence Le Faou, MD, a public health expert at Université Paris Cité in Paris, France—probed data on 3,656 smokers with PAD who were followed in smoking cessation services. They found that 48% smoked more than 20 cigarettes per day, with 65% being “high-nicotine dependent”—among whom 46% reached one month of abstinence. Factors favoring not smoking included equal-to-or-greater-than one previous quit attempt, high confidence in quitting, increasing number of follow-up visits, and taking smoking cessation medications, Le Faou and colleagues report.

The study, which was published in the August edition of the Journal of Vascular Surgery (JVS), comes as the SVS Vascular Quality Initiative (VQI) continues a monthly webinar series on smoking cessation throughout 2025. The educational content consists of a 12-month program—the audience for which includes physicians, advanced practice providers (APPs), nurses and patients—and draws on insights gained by Betsy Wymer, DNP, SVS director of quality, during her training for tobacco specialist certification.

The data in the French study were drawn from a national, multicenter database of 266 nationwide institutions—mostly hospital-based—and cover an 18-year time period. It included current smokers over the age of 18 who reported smoking “every day” or “some days” at the time of their first visit who had PAD and completed at least 28 days of follow-up in a smoking cessation service. Among the near quarter million patients recorded in the national CDTnet database, 12,655 had PAD and 6,984 (55%) visited a smoking cessation service at least once after their first visit. Among retained smokers, 29% were followed for at least 28 days.

Le Faou et al found that most smokers were prescribed a smoking cessation pharmacologic treatment (87%), and more than one-half benefited from two to three follow-up visits and 45% from more than four visits after the first contact. Some 43% of women and 47% of men quit smoking, the researchers discovered. Those who achieved abstinence were most often older smokers (≥65 years; 50%), had a vocational school diploma (49%) or higher education (49%), were retired (52%), referred by primary care professionals (50%), and had high confidence to quit (52%). “The percentage of abstinent patients increased gradually with the number of follow-up visits, so that among those who benefited from seven or more follow-up visits, 74% succeeded in quitting smoking,” the research team notes.

The smokers with PAD with the lowest abstinence rates were female smokers (43%); smokers between 35 and 54 years old; smokers without diplomas (42%); those who were unemployed (35%); smokers with comorbidities, especially diabetes (43%), myocardial infarction and angina (43%), chronic bronchitis and/or chronic obstructive pulmonary disease (COPD) (43%); and the smokers with psychiatric disorders (42%).

Factors negatively associated with quitting were being unemployed, having diabetes, taking antidepressants, presenting with moderate and high nicotine dependence, having consumed cannabis in the previous 30 days, and being prescribed an oral nicotine form solely at the first visit. The findings show that smoking cessation pharmacologic treatment and psychosocial support “are underutilized, hampering the chances of quitting in smokers with PAD,” Le Faou et al comment. “For hospitalized patients, an individual approach with several visits, starting during hospitalization with motivational interviewing techniques, explanations on tobacco addiction, and personalized treatment with subsequent tailored follow-up visits after hospital discharge would be helpful to quit smoking,” they add.

After the recess: Taking a look ahead to a busy September on Capitol Hill

By
Dylan Lopez
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After the recess: Taking a look ahead to a busy September on Capitol Hill
U.S. Congress

Congress entered summer recess after passing the One Big Beautiful Bill Act (OBBBA), which was signed into law by President Donald J. Trump on July 4. This law has various healthcare provisions that will affect Medicare and Medicaid, provider taxes and federal student loans. However, there remain policy areas to be addressed in the annual budget that Congress and the President must put forward before the government funding deadline of Sept. 30.

It is worth noting that there is a possibility that Congress will decide to pass a continuing resolution, which would mean no changes in budgetary policy from the previous fiscal year. However, should that not be the case, let’s take a look at a few decisions facing our lawmakers in Washington.

Medicare and Medicaid healthcare extenders will be considered, as their funding expires on Sept. 30. This encompasses a set of policies that largely touch rural health systems and those that see a disproportionate share of Medicaid payments and telehealth visits.

Affordable Care Act (ACA) subsidies would lose funding on Dec. 31 absent Congressional action. These subsidies, which come in the form of a tax credit, benefit the majority of the 24-plus million people who get their insurance through the ACA marketplace.

Discussions regarding policy proposals for longer-term Medicare payment reform are likely to continue. However, because the OBBBA provided for a positive payment adjustment for CY 2026 there is less urgency to advance any other payment-related provisions in the latter half of the year.

The SVS advocacy team continues to monitor these issues, and others. The September government funding deadline sets up a well-defined deadline for action on Capitol Hill, which is something that lawmakers are generally responsive to.

SVS leads the way: Vascular surgery MVP included in CMS 2026 proposal

The vascular surgery Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) has been included in the Centers for Medicare & Medicaid Services (CMS) Proposed Rule for 2026.

Developed by the SVS Quality and Performance Measures Committee (QPMC), this vascular-based MVP encompasses measures that focuses on scope of vascular care while streamlining reporting and supporting quality.

Once the final rule is approved, the vascular surgery MVP will be available for use in 2026. Educational material will then be available.

Dylan Lopez is the advocacy and public affairs manager for the SVS.

AI: Where it lands today and how it might impact the vascular future

By
Bryan Kay
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0
AI: Where it lands today and how it might impact the vascular future

The speed with which artificial intelligence (AI) is beginning to envelope aspects of the human experience strikes many as jarring. Its entrance into the world of vascular surgery, too, has picked up a pace in recent years, with models and applications beginning to pop up in papers probing aspects of AI uses in care across the vasculature. But what is the extent of its abilities in vascular practice and where might AI lead the field in the future?

There are challenges. But there are also opportunities. That was the argument from Amun G. Hofmann, MD, of Klinik Ottakring in Vienna, Austria, when he spoke about integrating AI in vascular surgery in a recent letter to the editor of the European Journal of Vascular and Endovascular Surgery (EJVES).

In another letter, this time to the editor of the Journal of Vascular Surgery (JVS) entitled “Artificial intelligence and legal implications,” Antonio V. Sterpetti, MD, and colleagues from Sapienza University in Rome, Italy, wrote that, “Recommendations made by AI should remain simple suggestions, which cannot substitute for the opinion of surgeons in a complex clinical analysis, to prevent legal controversies and to preserve the dignity of patients and vascular surgeons.”

Sterpetti and colleagues were responding to a study by Joachim S. Skovbo, MD, of Odense University Hospital in Odense, Denmark, and colleagues, who in JVS had previously outlined the successful development of the SHAPFire AI tool to identify abdominal aortic aneurysms (AAAs) at increased risk of rupture with “significantly higher” accuracy than diameter alone.

AI papers are now myriad. At the 2025 Vascular Annual Meeting (VAM) in New Orleans earlier this summer, a full half of a plenary session was dedicated to emerging AI uses in vascular surgery. At the Eastern Vascular Society (EVS) annual meeting in Nashville, Tennessee, next month, data scientist Yelena Yesha, PhD, is set to speak on the “brave new world” of AI and data science in the field.

So what does that brave new world look like right now?

One of the papers at VAM 2025 looked at the use of a large language model—in common parlance the ChatGPTs of the world—to accurately extract aortic information from abdominal imaging reports in a large, real-world, multicenter database in San Francisco, California. Robert Chang, MD, assistant chair of vascular surgery at Kaiser Permanente Northern California, and Colleen Flanagan, MD, chief resident in the UCSF Division of Vascular and Endovascular Surgery, who led the study, found that an open source or “off-the-shelf ” large language model was able to extract critical information about the aorta from 16,000 AAA imaging reports from across 16 years. This “was consistent” across multiple imaging modalities, they noted. “The accuracy of the model, LLaMa 3.3, was over 90% overall and across a number of these subcategories,” Chang and Flanagan told Vascular Specialist. “We think this could support our ability to closely track AAAs.”

The same VAM 2025 session saw Justin Bader, MD, present a paper outlining the creation of a prediction model for safe contrast volume thresholds to prevent post-contrast acute kidney injury (PC-AKI) after endovascular aneurysm repair (EVAR). The research team is now using AI to harness the model’s future potential. Bader, a general surgery resident at Yale School of Medicine in New Haven, Connecticut, explains that the team used data from 49,417 patients in the Vascular Quality Initiative (VQI) database to create a “calculator” that allows physicians to generate a recommended contrast volume to minimize PC-AKI risk by inputting 13 patient-specific variables. “It serves as a guideline for surgeons when they’re operating,” he says. The research team—led by Cassius Iyad Ochoa Chaar, MD, associate professor of surgery at Yale School of Medicine—reported that the model is “working extremely well,” Bader tells Vascular Specialist. The team is presently collaborating with statistics experts at Yale on advanced AI and machine learning techniques to get to “higher order relationships between variables to make it an even more accurate calculator.”

Ben Li, MD, a resident in the Division of Vascular Surgery at the University of Toronto, Canada, and colleagues had two AI papers at VAM 2025, one in the plenary session, the other a poster. The plenary paper looked at developing an AI model to predict one-year mortality after major lower extremity amputation, the poster to predict one-year successful clinical use of an arteriovenous access for hemodialysis. Using the VQI for both, they found that in both cases their machine learning models could “very accurately predict” outcomes and performed better than logistic regression. Li has tracked the development of AI uses in vascular surgery over the years in a review and found that though the number of papers on the topic has been increasing and the quality improving over the years, they remain “suboptimal.” A few AI applications are starting to be routinely implemented into clinical practice, Li observes, but stresses the importance of “developing the models in a robust way that follow guidelines.”

Meanwhile, the VAM session also saw data from Prem Chand Gupta, MD, head of vascular surgery at CARE Hospitals in Hyderabad, India, and colleagues that looked at the correlation of imaging characteristics of carotid plaque with clinical and histopathological features, and the application of AI. “We found that routinely performed ultrasound by us was better than CT [computed tomography] angiography and MR [magnetic resonance] angiography in deciding whether the plaque was vulnerable or not,” he tells Vascular Specialist. “Since ultrasound is very subjective, we applied AI to make the study more objective. So far, we have found the machine learning can recognize the carotid artery, and if there is a more than 50% narrowing, there is 96% chance it picks up that narrowing. We still have a long way to go because the machine learning will still require a lot more images.”

So where is AI in vascular surgery headed? Chang and Flanagan cite programs such as that highlighted in their use case: streamlining the running of an AAA surveillance program. “Other areas potentially include understanding the basis of vascular disease such as computer vision to assess aneurysm or plaque characteristics, cell and molecular modeling for drug discovery, and more advanced predictive analytics to help inform operative risk,” they say.

For Gupta, the idea that “not only could AI replace the diagnostics” but that it could be combined with robotics and “actually replace surgery too” is impossible to predict from the vantage point of today. “As of now, what we know is, even when we look at current evidence based on which we try to treat patients, there is always a physician modifier. I may not go by the evidence because my gut tells me, which AI is not going to be able to pick up. Similarly for surgery, there are just too many variables which come into surgery too. It is going to be very difficult for AI to have enough data to deal with different variables unless there is a human to guide it.”

Abbott’s Esprit BTK system receives CE mark

By
Bryan Kay
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0
Abbott’s Esprit BTK system receives CE mark

Abbott today announced it has received CE mark approval in Europe for the Esprit BTK everolimus-eluting resorbable scaffold system (Esprit BTK system), a technology designed for the treatment of below-the-knee (BTK) peripheral arterial disease (PAD). 

Abbott notes that the Esprit BTK system is the first resorbable scaffold of its kind for use below the knee. At VIVA 2024, Abbott released late-breaking clinical data on the LIFE-BTK trial two-year results. The trial demonstrated that, compared to balloon angioplasty, the Esprit BTK system results in improved patient outcomes and 48% fewer repeat procedures over the study period.

“For too long, patients with severe PAD below the knee have had limited treatment options and were often faced with potential amputations,” said Dierk Scheinert, MD, from University Hospital Leipzig in Leipzig, Germany. “With CE mark, the Esprit BTK system offers a resorbable scaffold backed by strong data and proven superiority over balloon angioplasty—giving physicians a novel, innovative tool to treat the most severe forms of PAD more effectively and improve patient outcomes across Europe.”

The Esprit BTK system received Food and Drug Administration (FDA) approval in April 2024.

Celebrity-prompted awareness in vascular surgery

By
Saranya Sundaram
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Celebrity-prompted awareness in vascular surgery
Saranya Sundaram

The vascular surgery field received a rare moment in the public spotlight recently as President Donald J. Trump was diagnosed with chronic venous insufficiency (CVI). The White House press secretary and appointed physician to the president even made statements on this condition, noting it as a “benign” cause of swelling/bruising in the legs and “common in people over 70.” Suddenly, articles addressing the causes and symptoms of CVI appeared on every major news outlet, including CNBC, CNN and the New York Times. The American Heart Association publicly addressed this issue on its website in an effort to bring reliable, evidence-based perspectives on CVI to the forefront.

This is not the first-time vascular pathologies have had a public spotlight. In 2016, actor Alan Thicke unfortunately passed away from complications related to an acute aortic dissection. Many of the articles reporting his death linked to the John Ritter Foundation for Aortic Health, founded in honor of another actor (John Ritter) who passed away from a thoracic aortic dissection in 2003. In cases such as these, conscious media efforts to highlight serious medical conditions (which are often directed by family/friends of the affected high-profile figure) can offer productive public discussions that may be able to reach an affected patient who would be otherwise unaware of their medical risks.

Actress Phylicia Rashad (otherwise known as Claire Huxtable from The Cosby Show) has been outspoken about her diagnosis of peripheral arterial disease (PAD). She has even taken part in a campaign co-sponsored by the PAD Coalition as a part of National PAD Awareness Month. Her efforts go above just simply raising awareness for those who consume popular culture media; her high-profile status also brings engagement with a nationally recognized, non-profit organization.

There can be a downside to the “media frenzy” that accompanies the spotlight for celebrity diagnoses. For example, a private vein clinic website has an article published to their website reporting “celebrities who have suffered or died from varicose veins & DVT [deep vein thrombosis].” But not a single celebrity listed died from complications from their varicose veins. Predatory practices can take advantage of the public’s inability to distinguish specific conditions that fall under a similar umbrella pathology (i.e. DVT versus varicose veins) to promote their interventional practice. If a celebrity almost died from this condition, shouldn’t I get my varicose veins fixed? Though this sounds absurd between vascular colleagues, it can undermine the efforts of our field to provide appropriate care.

In short, the surge in CVI interest from President Trump’s recent statements offers an opportunity for the public to educate themselves on a medical condition and can, in turn, profit the providers that evaluate/ manage these vascular conditions (i.e. vascular surgeons).

However, it is important for vascular surgeons and non-profit medical societies to guide this awareness to evidence-based literature, best practice advisories or non-profit foundations that do not gain from increased treatment interest.

Without conscious signaling from vascular experts on the most appropriate pathways to manage these conditions, the public can fall victim to those engaged in predatory practices that use “surges in awareness” to capture newly concerned but poorly informed patients.

References:

  1. What Is Chronic Venous Insufficiency? Trump’s Diagnosis, Explained. Time. time.com/7303280/what-is-chronic-venous-insufficiency-trump/. 17 July 2025
  2. What Is Chronic Venous Insufficiency? American Heart Association. newsroom.heart.org/news/what-is-chronic-venous-insufficiency. 17 July 2025
  3. Experts: Uncommon condition killed Alan Thicke. USA Today. usatoday.com/story/life/nation-now/2016/12/23/experts-uncommon-condition-killed-alan-thicke/95807532. Dec 23 2016
  4. Cosby Star Tackles a Silent Heart Threat. ABC News. abcnews.go.com/Health/Healthday/story?id=4508727&page=1. March 24, 2008

Saranya Sundaram, MD, is Vascular Specialist’s resident/fellow editor. She is a vascular surgery resident at Medical University of South Carolina in Charleston.

FDA grants approval for IDE study on Advance Evero 18 everolimus-coated balloon catheter

By
Bryan Kay
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0
FDA grants approval for IDE study on Advance Evero 18 everolimus-coated balloon catheter
Advance Evero 18

The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Advance Evero 18 everolimus-coated percutaneous transluminal angioplasty (PTA) balloon catheter, the company reported today.   

The clinical study will assess the safety and effectiveness of the Evero drug-coated balloon (DCB) when compared to commercially available paclitaxel-coated balloons for the treatment of peripheral artery disease (PAD). Currently there are no everolimus-coated balloon devices commercially available in the U.S., and this IDE study is the first U.S. head-to-head evaluation of everolimus- and paclitaxel-coated balloons to treat lesions of the superficial femoral and popliteal arteries, according to Cook.

The EVERO trial is a prospective, U.S. multicenter, stratified, blinded, randomized control trial (RCT) with a parallel pharmacokinetic (PK) study. Cook intends to enroll 410 patients in the pivotal trial and 30 patients in the PK evaluation. The primary safety endpoint is a composite of freedom from device- or procedure-related death at 30 days, freedom from target limb major amputation at 12 months, and from target lesion revascularization (TLR) at 12 months. The primary effectiveness endpoint is primary patency, defined as peak systolic velocity ratio (PSVR) ≤2.4 at 12 months and freedom from clinically driven TLR (CD-TLR) at 12 months.

FDA deems Envveno’s VenoValve ‘not-approvable’

By
Jocelyn Hudson
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0
FDA deems Envveno’s VenoValve ‘not-approvable’
VenoValve
VenoValve first-in-human
VenoValve

The Food and Drug Administration (FDA) has issued a letter to Envveno Medical stating that its VenoValve technology is “not-approvable,” a company press release published today reports. The letter was issued in response to Envveno’s premarket approval (PMA) application for VenoValve—a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).

According to Envveno, the letter indicates that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA for the VenoValve in its current form. “In particular, the FDA indicated that the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the [SAVVE] study to show clinical improvement, together with the improvements in pain scores and venous-specific quality-of-life indicators was not sufficient on its own to determine favorability of the benefit risk profile for the VenoValve,” the company press release reads. “Without a specific hemodynamic measurement that correlates with patient improvement, the FDA raised concerns about bias and the possibility that clinical improvement occurred as a result of the patients being enrolled in a study.”

The FDA also focused on safety concerns which were attributed to the VenoValve open surgical procedure, and that required rehospitalizations. Envveno notes that it “would not expect to see similar safety events with a non-surgical replacement valve”.

“We are obviously disappointed by the FDA’s decision. The results showed that a high percentage of the patients in the SAVVE study, who all previously failed standard-of-care treatments, showed significant clinical improvement after receiving the VenoValve. With the VenoValve being the only difference in their care, it is hard to not attribute the improvement to the VenoValve,” said Robert Berman, Envveno’s chief executive officer, in the press release. “We remain committed to the 2.5 to 3.5 million patients suffering from severe deep venous CVI in the US and who have no effective treatment options and will continue to work with the FDA on new criteria to demonstrate the safety and effectiveness of our devices.”

Envveno advises that it is reviewing the feedback from the FDA and is assessing all options, which may include a meeting to discuss requirements for a potential resubmission of the VenoValve or appeal of the decision along with appropriate next steps. The company adds that it also expects to apply the “key learnings” from this FDA approval process as it advances Envve, its non-surgical replacement venous valve for which it is preparing an investigation device exemption (IDE) application.

The benefits of a heart and vascular institute

By
Vikram Kashyap
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The benefits of a heart and vascular institute
Vikram S. Kashyap
Vikram S. Kashyap, MD, pushes back against a recent editorial from Vascular Specialist medical editor Malachi Sheahan III, MD, in which the latter called into question the value of heart and vascular centers to the vascular surgical specialty.

I am risking professional harm debating Dr. Mal Sheahan. After witnessing his wit, charm and persuasiveness firsthand, I know I may never recover from writing this commentary. However, as the chair of the Frederik Meijer Heart and Vascular Institute (HVI), I feel obliged to respond to Dr. Sheahan’s piercing commentary published in Vascular Specialist in May 2025. He argues vehemently how HVIs are bad for vascular surgeons. I will try to convince you that is not uniformly the case. I have worked at three institutions with HVIs—Cleveland Clinic, University Hospitals/Case Western Reserve University and Corewell Health—and each has been different in structure, strategy and operational effectiveness. There are multiple reasons that HVIs can function well and will likely be the dominant organizational structure going forward.

First, Dr. Sheahan focused on the vascular surgeon and how HVIs negatively affect us as a group. If you look at HVIs from a patient’s viewpoint, there are many positives. Healthcare can be confusing, even for those of us in medicine. Patients must navigate a complex matrix to find the right doctor and get the right care. Coordinating and simplifying the delivery of care is accomplished when cardiovascular care is under one roof. Patients are not subjected to disparate, poor quality and inappropriate care when all cardiovascular specialists (cardiology, cardiothoracic surgery, vascular surgery and affiliated areas) are aligned to the same strategic goals. Aligning goals and ensuring the highest quality care is more feasible in an institute or service line model, and this benefits patients.

Organizational structure in a HVI is critical.1 We have more than 1,000 team members in our HVI, and we strive to collaborate and not compete. Clinical and operational leaders work together and focus on strategic growth in multiple clinical areas (coronary, structural heart, electrophysiology, aortic, limb salvage, wound care, etc.). Growing the pie becomes more important than fighting over the pie.

An HVI can provide a home for all cardiovascular specialists. Vascular surgeons have more in common with other specialists in aortic disease, peripheral arterial disease (PAD), complex venous care, prevention, etc. What are the other options for vascular? Historically, we have been sections/divisions in a general surgery department—has that gotten us very far? Alternatively, we can lobby for a separate vascular surgery department. In most institutions, this would be a small area with limited clinical and fiscal impact. In 2024, the Frederik Meijer Heart and Vascular Institute performed more than 4,000 surgical procedures, 10,000 catheterizations and 95,000 cardiovascular imaging studies, leading to over $1 billion in gross revenue. This fiscal impact allows us to provide resources that otherwise would not be available. For instance, we opened our fourth hybrid operating room (OR) last year. We have started or completed 61 heart and vascular clinical trials in the last five years, coupled with significant coordinator and statistical support. We have six training programs, including both a vascular surgery residency and fellowship. Recently, we lobbied and were approved to expand the residency to two spots per year. Many of these developments would not have occurred without the fiscal heft of an HVI. In my experience, a department of surgery may not support many of these priorities and a small independent department of vascular surgery would not be able to accomplish these initiatives.

Dr. Sheahan states that the real reason for an HVI (or service lines) is to capture downstream revenue, especially from ordering tests. In fact, we are piloting different value-based care models that will decrease the cost of care, increase appropriateness of care and ensure seamless quality. We are working with our payors to formalize this for patients with certain conditions, including heart failure, atrial fibrillation and claudication.

An HVI provides fiscal stability and additional options for our surgeons. We offer competitive salaries and can mitigate the downward reimbursement pressure due to our size. We are opening an ambulatory surgery center (ASC) as a joint venture between Corewell Health and our physicians. This will lead to performing endovascular procedures in an efficient, less costly venue, while also providing additional revenue for vascular surgeons who are investors.

I do agree with Dr. Sheahan on some of his suggestions. Most importantly, we need to continue to track outcomes across specialties and ensure seamless quality. Vascular surgeons specializing in an area allows focus on clinical improvement, standardized protocols, and leading multidisciplinary conferences, whether it be in PAD, cerebrovascular disease, aortic disease or other areas. Of course, if you have seen one HVI, you have only seen one HVI. Local circumstances (and local leaders) may impact the landscape—for better or worse—for vascular surgeons. Still, I believe an HVI provides the best structure for both patients and their doctors. Vascular surgeons should actively participate in an HVI and should lead or co-lead the entity. This will be the best way to ensure high-quality care for our patients and our long-term professional growth.

Reference

  1. Mansour MA, Kashyap VS. The business of healthcare vascular care in a heart and vascular institute. Journal of Vascular Surgery-Vascular Insights 2025; 3:100242

Vikram S. Kashyap, MD, is the endowed chair at the Frederik Meijer Heart and Vascular Institute, vice president of Cardiovascular Health at Corewell Health and professor of surgery at Michigan State University College of Human Medicine in Grand Rapids, Michigan.

VAM 2026 chairs discuss pathways to podium, poster presentations

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Marlén Gomez
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VAM 2026 chairs discuss pathways to podium, poster presentations
Jason Lee and Claudie Sheahan

Whether you’re a seasoned vascular surgeon or a first-time attendee, Society for Vascular Surgery (SVS) Program Committee Chair Jason Lee, MD, and Postgraduate Education Committee (PGEC) Chair Claudie Sheahan, MD, want you to know there’s a place—and a pathway—for everyone at the Vascular Annual Meeting (VAM).

The SVS invites all aspiring presenters, including clinicians, researchers, students and international colleagues to participate at VAM 2026, scheduled for June 10–13 in Boston.

“Each of these pathways offers a different way to submit to participate in VAM. All of the submissions and ideas are valuable to the education of our members,” Lee said. “We’re always looking for more volunteerism related to that.”

Education sessions, which constitute nearly 50% of daily programming, are ideal for those interested in both clinical and nonclinical topics. These sessions cater to diverse practice settings through various formats, including interactive discussions, case-based learning, didactic lectures and hands-on workshops. VAM typically features 18–22 education sessions held concurrently during breakfast and afternoon slots from the Wednesday to Friday of VAM.

The new submission process, as proposed by the PGEC, will include sessions that require a full speaker and presentation list as part of proposals in addition to the previous submission fields.

The education sessions prioritize five core topics important to the specialty every year: cerebrovascular disease, aortic disease, dialysis access, peripheral vascular disease and venous disease. Sheahan explains how they prioritize other topics that haven’t been featured, usually on a three-year cycle. “What we want to do is offer expert content to our entire membership and expert content delivered by diverse experts; we don’t want our presenters always to be the same,” she said.

Sheahan broke down the numbers for this past VAM, where over 60% of the presenters were headed to the VAM podium for the first time.

Submission for the education sessions opened July 16 and will close Aug. 20. New for 2025 and continuing into 2026 is the “Hot Topics” format, where individual lectures grouped into a single session highlight emerging issues in vascular surgery. “The hot topics will include single-topic presentations that are current and highly relevant. These presentations are important to present, even if there isn’t a need for a full 90-minute session,” Sheahan explained.

Sheahan uses recent trial results as an example for a “Hot Topic” session. “These are trials that have just been completed and weren’t included in our educational materials. However, we believe it is important to discuss these findings and present them in an educational format,” she said.

Submissions for the “Hot Topics” sessions will open Sept. 17 and close Oct. 15.

SVS section sessions and resident and student programs do not require formal submissions; interested parties should coordinate directly with SVS staff liaisons. Lee explains how different sections and new members can further participate in the VAM planning, such as the Young Surgeons Section, which assists in creating the visual abstracts for accepted plenary papers.

For those with original research or clinical studies, the plenary, international, Vascular and Endovascular Surgery Society (VESS) and poster tracks offer excellent visibility and competitive opportunities. Plenary sessions feature either rapid-paced or full-length presentations, with a full manuscript required for consideration by the Journal of Vascular Surgery (JVS).

“The acceptance of a plenary paper allows for a slightly expedited review, enabling simultaneous publication at the VAM. Last year, over two-thirds of our plenary papers were published simultaneously; as you listen to a talk, you can see that it was immediately published, allowing you to access the details right away. It also provides insights into more granular data that can help shape your interpretation of the paper and influence your practice,” Lee said.

With its scientific sessions, VESS continues its partnership with the SVS and VAM, with its content taking place on the first day of the meeting. To submit an abstract for the VESS sessions, either the submitting author or a co-author must be a VESS member.

“While many abstracts may not be chosen for the plenary sessions, there are still numerous excellent scientific contributions that will be considered for the VESS scientific sessions on that Wednesday,” he added. “I greatly appreciate the contribution of VESS to VAM and recognize their significant support.”

The International Plenary Session and the International Young Surgeons Competition offer a global platform for emerging voices in vascular surgery.

Posters are categorized into three types: interactive, competition and international. The winners from the Poster Competition and the International Poster Competition advance to the Poster Championship on Saturday morning, allowing for podium presentations. The submission window for plenaries, VESS sessions, international, posters and competitions will be from Nov. 12–Jan. 7, 2026.

Late-breaking abstracts—returning for the 2026 meeting—will showcase cutting-edge data and innovative studies. “With late-breaking and Hot Topic abstracts, we will explore the submissions and determine how to organize a session around them. Our goal is to provide opportunities for those who may not have a complete session idea but still want to present. This way, everyone has a chance to share their work,” Sheahan said.

Late-breaking abstract submissions will run from Feb. 4–March 2, 2026.

In addition to submitted content, VAM 2026 will feature invited sessions selected by the SVS Executive Board (EB) and the Program Committee, with suggestions from the SVS membership. These include the James S.T. Yao Resident Research Award, W. Stanley Crawford Critical Issues Forum, Roy Greenberg Distinguished Lecture on Innovation, Frank J. Veith Distinguished Lecture on Advances in PAD and Limb Salvage, the awards ceremony and SVS Presidential Address.

Meanwhile, the SVS Keynote Series will enter its third year at VAM. Lee discusses how various groups have collaborated to incorporate feedback from previous years, allowing them to develop a keynote series that is impactful for the membership.

Regarding the distinguished lectures, Lee highlights opportunities for the SVS leadership to focus on current ideas, concepts and innovations, allowing SVS members to engage directly with the EB and elected officers to share their suggestions.

“At the end of the day, it’s the SVS members who attend VAM. The Program Committee and the EB want to hear from you, the members, about your feedback on these invited sessions and any suggestions for improvement. I’m always encouraged by the ideas our members have to make VAM even better,” said Lee.

For more information on VAM 2026, visit vascular.org/VAM.

Not all carotid procedures are equal after patients suffer a postoperative stroke

By
Bryan Kay
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0
Not all carotid procedures are equal after patients suffer a postoperative stroke
Mohammed Hamouda and Mahmoud B. Malas
Comparative analysis looks at stroke-related disability and mortality after three modes of carotid revascularization.

Strokes after transfemoral carotid artery stenting (TFCAS) were “the most disabling and lethal” when compared with transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) in a multicenter, retrospective analysis of Vascular Quality Initiative (VQI) data using modified Rankin Scale (mRS).

The study, recently published in press in the Journal of Vascular Surgery (JVS), Mohammed Hamouda, MD, a postdoctoral fellow at UC San Diego in San Diego, California), and Mahmoud B. Malas, MD, the Joan Klein Jacobs endowed chair in surgery and chief of the Division of Vascular and Endovascular Surgery at UC San Diego, and initially presented as a plenary presentation during a Vascular and Endovascular Surgery Society (VESS) session that took place during the 2025 Vascular Annual Meeting (VAM) in New Orleans ( June 4–7).

The VQI database was queried from September 2016–August 2024 for patients who suffered a postoperative stroke after their carotid revascularization procedure, with the magnitude of the event quantified using mRS 0–6, where 0 is a stroke with no symptoms and 6 is a stroke leading to death. A severe stroke was defined as one having mRS>4.

Hamouda and colleagues found a total of 2,752 patients suffered a postoperative stroke after all three procedures. Overall, 22.5% of the postoperative strokes had mRS>4, the researchers discovered. When stratifying by procedure type, TFCAS had the highest rate of severe strokes—CEA 21.2% vs. TCAR 19.1% vs. TFCAS 30.7% (p<0.001). After adjusting for confounding variables, “there was no significant difference between TCAR and CEA in terms of odds of severe stroke, odds of a lethal stroke (mRS=6/dead) even after stratifying by symptomatic status (p>0.05),” they report. However, TFCAS-related strokes had 75% (adjusted odds ratio [aOR] 1.75, confidence interval [CI] 1.26–2.43), p<0.001) and 45% (aOR 1.45, CI 1.05–2.00, p=0.024) increased odds of being severe compared to CEA and TCAR, respectively.

“After stratifying by symptomatic status, there was no significant difference observed in asymptomatic patients, however, symptomatic TFCAS patients had more than double the odds (aOR 2.21, CI 1.47–3.33, p<0.001) of severe strokes compared to CEA and 72% increased odds of severe stroke (aOR 1.72, CI 1.12–2.67, p=0.014) compared to TCAR patients,” Hamouda and colleagues write in JVS.

Likewise, risk of dying following postoperative stroke was the highest with TFCAS—“the odds being 79% and 47% higher compared to CEA and TCAR, respectively.” In terms of one-year outcomes, patients who underwent TFCAS complicated by a stroke were at higher risk of recurrence and mortality compared to those getting a stroke after CEA, the investigators continue.

Similarly, TFCAS-related strokes were associated with “higher hazard of death during the first year of follow-up” compared to the TCAR group, but there was no difference in ipsilateral stroke recurrence. “Finally, there was no significant difference between TCAR and CEA in any of the one-year outcomes,” they add, with strokes after CEA and TCAR in the study “of a very similar magnitude in terms of postoperative functional outcomes as well how the index stroke impacts one-year recurrence or mortality.” Concluding, Hamouda and colleagues note, “CEA exhibited the highest unadjusted stroke-free survival rate” among the three procedures.

Legacy teams lead the way in Vascular Health Step Challenge

By
Marlén Gomez
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0
Legacy teams lead the way in Vascular Health Step Challenge
The Vascular Health Step Challenge officially begins Sept. 1

The Society for Vascular Surgery (SVS) Foundation is placing a spotlight on its “Legacy Teams”—those who have gone the extra mile, literally!—to make the annual Vascular Health Step Challenge a success year after year.

This year will see the return of two standout legacy teams: The Heart Hospital Pulse Patrol and Team FAB, who have played a role in the challenge’s growth and success. Their continued leadership is helping to build early momentum for this year’s campaign.

“I look forward to the Vascular Step Challenge every year. It has become a fixture for me as summer transitions into fall. The motivation to walk every day, the friendly competition with my vascular colleagues and the money raised to support the foundation’s mission are win, win, win in my book,” said William Shutze, MD, a member of the Heart Hospital Pulse Patrol, based out of Plano, Texas.

The challenge officially begins Sept. 1, coinciding with Peripheral Arterial Disease (PAD) Awareness Month. Participants are encouraged to walk 60 miles throughout the month to symbolize the 60,000 miles of blood vessels in the human body. The challenge is open to both individuals and teams, with registration having opened on Aug. 1.

The Heart Hospital Pulse Patrol and Team FAB have consistently demonstrated a strong commitment to promoting vascular health and inspiring their communities to engage in physical activity through their participation in the challenge.

Team FAB has been a part of the Step Challenge since 2022 and has walked more than 9,000 miles while raising more than $19,000. Last year, they won the title of the top team in the challenge, clocking a total of 3,188 miles.

“Team FAB is proud to unite vascular surgeons from across the country in support of the Step Challenge. We’re preparing with team-based step goals, weekly check-ins and fitness tracking to stay motivated,” said Leigh Ann O’Banion, MD, a member of the group, from the University of California, San Francisco-Fresno (UCSF Fresno). “The challenge not only promotes wellness among our colleagues, but also deepens our commitment to raising awareness of vascular health and encouraging patients to take simple, impactful steps, literally, toward preventing PAD. It’s a meaningful way for us to lead by example and stay connected as a national team.”

The Heart Hospital Pulse Patrol has changed their strategy this year to ensure their placement in the leaderboard is unchallenged.

“I’m thrilled to be partnering with Dr. Shutze and the SVS for this year’s annual Vascular Health Step Challenge,” said Vanessa Ferris, RN. “We’re aiming to expand our hospital’s participation and inspire even more people to join us in promoting vascular health and wellness for a great cause.”

Other legacy teams returning to the walk—and looking to take the top spot— include IU Health Vascular Surgery, Team Bowling Green, KY Happy Feet and the Piedmont Triphasics. Together they have covered more than 9,000 miles and raised more than $7,000 in support of the challenge.

“The Step Challenge is not only an inspiring way to raise awareness and critical funds for the vascular community, but also a fun and meaningful opportunity to ignite friendly competition among SVS members. We are thrilled to welcome back these incredible legacy teams. Their participation brings renewed energy and excitement to the event. We hope their example motivates even more walkers to step up and get involved,” said Catherine Lampi, SVS Foundation director.

Every step taken during the challenge helps raise awareness of PAD and supports the SVS Foundation’s goal of raising $60,000 for vascular research, education and outreach. Participants are encouraged to invite friends, family and colleagues to join their teams and walk together in support of better vascular health.

While these teams may be legacy steppers, the path to the top of the leader board is wide open. The Step Challenge welcomes everyone, whether first-time walkers or challenge veterans, to compete for first place while inspiring others to act and make a difference, one step at a time.

Visit vascular.org/StepChallenge for more information.

THRIVE study demonstrates a CAVT-first approach lends itself to better outcomes when compared to surgery in patients with acute limb ischemia

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THRIVE study demonstrates a CAVT-first approach lends itself to better outcomes when compared to surgery in patients with acute limb ischemia

The THRIVE study – which shows that computer-assisted vacuum thrombectomy (CAVT™) is associated with reduced related readmissions and complication rates in the management of lower extremity acute limb ischemia (ALI) when compared to surgical embolectomy – offers “compelling evidence that this is the right therapy for our patients,” says Charles Bailey, MD, medical director of limb preservation and peripheral arterial disease (PAD) at Emory University School of Medicine in Atlanta, in a video interview with Vascular Specialist at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7).

Bailey had just delivered THRIVE data demonstrating that U.S. patients who underwent a CAVT procedure to manage lower extremity ALI had significantly shorter length of stays, higher discharge-to-home rates, reduced complications and fewer related readmissions compared to other modalities.

“If we have a therapy that can offer a patient a shorter length of stay, a greater likelihood that they are going to go home, and is associated with not only good, improved clinical outcomes, but a greater freedom from adverse events, greater freedom from complications or potentially readmission, we should embrace that therapy,” Bailey explains.

This video was sponsored by Penumbra.

Wound care online modules empower vascular care teams, participants say

By
Marlén Gomez
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0
Wound care online modules empower vascular care teams, participants say
The Wound Care Curriculum offers a blended learning model

Healthcare professionals from multiple disciplines are embracing the Wound Care Curriculum, a flexible online learning experience tailored to meet the evolving needs of vascular care teams.

Developed collaboratively by the SVS, including the former Physician Assistant (PA) Section (now part of the Advanced Practice Provider [APP] Section), the Society for Vascular Nursing (SVN), and the American Podiatric Medical Association (APMA), the curriculum offers a blended learning model that combines the convenience of online education with the depth of hands-on experience.

“The SVS wound course was an invaluable and enriching educational experience,” said Jessica Neff, FNP-C, a nurse practitioner from Albuquerque, New Mexico. “With my background in wound care, I found the curriculum to be both an excellent refresher and a source of new, evidence-based strategies that have deepened my understanding of complex wound management. The expert-led discussions and practical insights gained will greatly enhance my clinical skills as a vascular nurse practitioner and directly improve the quality of care I provide to patients.”

Available now, the curriculum features 27 short, on-demand videos that participants can access anytime, anywhere. This format allows busy healthcare professionals to absorb key concepts at their own pace, revisit material as needed and integrate new insights into their clinical practice.

“As a physician assistant in vascular surgery, the wound care curriculum provided a comprehensive, evidence-based framework for managing complex wounds,” said Rachel Breault, PA-C, a physician assistant from Palos Heights, Illinois. “It deepened my understanding of adjunctive therapies and reinforced a practical, multidisciplinary approach I can apply directly to patient care.”

Each module includes pre- and post-tests to assess knowledge acquisition, helping participants track their progress and identify areas for improvement.

In addition to the online content, the curriculum features hands-on workshops held in conjunction with the Vascular Annual Meeting (VAM) in 2026, 2027 and 2028, offering opportunities for in-person skill development and peer collaboration.

The Complex Wound Care Masterclass workshops, in-person at VAM, feature short didactics followed by complex cases and a panel discussion with an interprofessional team of vascular surgeons, PAs, vascular nurses and a podiatrist. The confirmed themes for 2026 are methods of debridement and dressing management, and oxygen therapy.

The SVS designates the online curriculum for a maximum of 6.25 AMA PRA Category 1 Credits™. The curriculum also offers continuing medical education (CME), continuing education units (CEUs) and continuing education (CE) credits in podiatric medicine, ensuring that professionals across specialties benefit from the program.

To learn more or to purchase access to the modules, visit vascular.org/WoundCare.

Vascular Verification Program opens doors for early engagement, quality improvement

By
Marlén Gomez
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0
Vascular Verification Program opens doors for early engagement, quality improvement
The SVS partnered with the ACS to craft its Vascular Verification Program

You don’t have to be too far down the path to get started. That’s the message William Shutze, MD, chair of the Society for Vascular Surgery (SVS)-American College of Surgeons (ACS) Vascular Verification Program (VVP), wants vascular specialists across the country to grasp as they take the first step toward participating in the VVP, even if they’ve only just downloaded the standards.

The SVS, in collaboration with the ACS, launched the VVP as a national quality verification initiative designed to enhance the care and treatment of patients undergoing vascular surgical and interventional procedures in both inpatient and outpatient settings. The program offers two levels of participation, enabling institutions to engage based on their current capabilities and guiding them toward ongoing quality improvement.

“Even if you’re just beginning to explore the standards, we want to hear from you,” said Shutze. “The ACS quality team is eager to support you early in your journey and help you move toward a successful site review.”

The VVP organizes its framework around 12 domains that cover the five phases of care: preoperative, immediate preoperative, intraoperative, postoperative and follow-up.

These domains ensure that institutions not only have standardized protocols in place but also actively collect and analyze data to drive improvements.

A recent systematic review published in the Journal of the American College of Surgeons (JACS) analyzed over 150 studies and found that programs like the VVP led to:

  • A 1.9-day reduction in average hospital stay
  • A $1,763 decrease in cost per admission
  • Fewer complications across the board
  • Empowering conversations with the C-suite

One of the barriers to adoption, according to Shutze, is that many vascular specialists don’t feel equipped to make the case for the program to their hospital leadership. To address this, the SVS is developing a toolkit that includes a brochure outlining the value of vascular surgery, return on investment (ROI) data and executive testimonial videos featuring hospital leaders who have seen the benefits firsthand. “We want our members to feel empowered when they walk into those meetings,” said Shutze. “This package will help them speak the language of the C-suite.”

As of this summer, eight programs have already been approved, with several more in the pipeline. Seven additional institutions are scheduling site visits, and a few are completing the final steps for certification. Shutze, of Texas Vascular Associates, also extended thanks to R. Clement Darling III, MD, Anton Sidawy, MD, and Anil Hingorani, MD, for their leadership, as well as the Vascular Quality Program Task Force. For institutions considering participation, the first step is straightforward: visit the ACS Quality Programs website at facs.org/vascular and start the process.

Advancing the SVS mission to provide patients with expert vascular care

By
Keith Calligaro
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Advancing the SVS mission to provide patients with expert vascular care
VAM Convention 2025 in New Orleans
Keith Calligaro

During the upcoming year, I plan to provide a monthly summary of critical issues the SVS is facing to keep you better informed. There are more than 100 projects SVS committees, councils and task forces are working on, so I will focus on three or four issues each month.

I want to thank the many SVS members who devoted their time and efforts on behalf of our society and thank the SVS staff for their invaluable assistance.

SVS dues and finances

There have been several recent inquiries from members relating to senior dues and SVS finances. Tom Forbes, MD, the SVS treasurer, at the request of the Executive Board, prepared a comprehensive response, which was posted on SVSConnect on July 2.

Board status

SVS Past President Joseph Mills, MD initiated a Task Force two years ago to examine the pros and cons of a free-standing (“independent”) Vascular Surgery Board (VSB) vs. maintaining the current federated VSB (part of the American Board of Surgery). Past President Mike Dalsing, MD, served as chair of the task force, which was composed of a balance of members for and against this proposal. Past President Matthew Eagleton, MD, continued the project, and the task force met monthly for more than a year, including a two-day live meeting at SVS HQ.

The SVS hired an external financial expert to analyze the costs of working towards a free-standing board and an external polling agency to help develop a non-binding questionnaire. The survey was emailed to all board-certified SVS members in the spring, along with a summary of the task force findings. The response rate was very high (30%) and yielded statistically valid results. The responses were 49% in favor of a free-standing board and 51% favoring the federated board. The SVS bylaws and American Board of Medical Specialties (ABMS) rules state that the Executive Board can only recommend a course of action but cannot be directly involved in operating a free-standing board. And after two years of thorough evaluation by a dedicated task force, the SVS Executive Board has decided not to pursue the creation of a free-standing VSB at this time.

ACS/SVS Vascular Verification Program

The SVS and ACS embarked on a Vascular Verification Program several years ago with the goal of certifying high-quality hospitals and vascular ambulatory care sites as vascular centers of excellence based on SVS standards and linkage to a registry such as the SVS Vascular Quality Initiative (VQI) database. The SVS Clinical Practice Council and many SVS members contributed a great deal of time and effort to this project, but the applications have been fewer than desired. To lead by example, improve the application rate, and demonstrate we are committed to this project, we requested our SVS leadership, namely the 30 members of the SVS Strategic Board of Directors (SBOD), apply immediately to the program. I will establish deadlines to track progress of this initiative. Although the application process is rigorous, those centers that have completed the process found doing so greatly improved their quality of care. The cost of the program to the hospital or center is approximately $20,000, but we should approach hospital administrators enthusiastically and emphasize the value of vascular surgeons to the centers and to our patients. Since the Vascular Annual Meeting (VAM), I am glad to report that 21 new applications have been submitted.

External review

The SVS has grown exponentially in the last 10 years and has provided many more additional services with the creation of new and exciting committees and sections. As a result, the expenses incurred by the SVS increased significantly. I recommended a comprehensive evaluation of all services to see where we can contain costs and not burden our members with increased dues and VAM registration fees nor count on increased industry sponsorship. I will lead a search committee to hire an outside firm to objectively review the strategic alignment of priorities and resources as well as to seek new sources of revenue.

If you have a particular issue or question you would like addressed, please email me at governance@vascularsociety.org.

Keith Calligaro is the 2025–26 SVS president.

Aquedeon Medical receives FDA approval to expand clinical trial of Duett vascular graft system

By
Bryan Kay
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0
Aquedeon Medical receives FDA approval to expand clinical trial of Duett vascular graft system
Duett Vascular Graft System
Duett vascular graft system

The Food and Drug Administration (FDA) has approved the expansion of Aquedeon Medical’s investigational device exemption (IDE) clinical trial evaluating the Duett vascular graft system, a company press release reveals. Duett is a novel device designed to facilitate open surgical repair of aortic arch aneurysms and dissections, including hybrid procedures.

Aquedeon Medical notes that it is developing the Duett system “to address a critical need in open surgical thoracic aortic arch reconstruction, a complex and high-risk procedure typically performed during deep hypothermic circulatory arrest (DHCA) while the patient is on cardiopulmonary bypass”.

The Duett system, Aquedeon Medical shares, is engineered to “simplify and accelerate” the vascular anastomosis process, with the goal of reducing DHCA duration and re-establishing cerebral perfusion more rapidly.

Aquedeon Medical launched its two-stage IDE clinical trial in 2024 to evaluate the safety and effectiveness of the Duett system. With the recent FDA approval, the study will now expand to enroll up to 90 patients across additional clinical sites in the U.S.

In wake of President Trump’s chronic venous insufficiency diagnosis, SVS steps up to educate public

By
Bryan Kay
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In wake of President Trump’s chronic venous insufficiency diagnosis, SVS steps up to educate public
William Shutze

News that U.S. President Donald J. Trump has a vascular condition may have simultaneously revealed that a substantial seven-figure vascular surgery branding campaign was starting to yield tangible results, and provided a singular opportunity to platform the specialty as the go-to vascular experts.

The Society for Vascular Surgery (SVS) launched a multi-pronged branding effort last year in an effort to help vascular surgery become an instantly recognizable specialty inside and outside of the hospital. The Society and vascular surgeons at large have long sought avenues to broaden awareness of what a vascular surgeon does, and the comprehensive and longitudinal nature of the care they provide after a patient is diagnosed with a vascular condition.

Well, opportunity knocks: when it was revealed to the world in mid-July that the president had been diagnosed with chronic venous insufficiency (CVI), vascular disease was thrown into the media grinder and the press corps began dissecting what CVI is, what it means and what the prognosis might be. Step forward vascular surgery. In the immediate aftermath of the news breaking, vascular surgeons began populating the pages and airwaves of the world’s media. They laid out the facts of CVI and what Trump might—or might not—be looking at down the road.

Vascular surgery, vascular surgeons and the SVS were name-checked across the news media, from international broadcast platforms like the BBC, to domestic newspaper powerhouses such as the New York Times. That broad footprint, says William Shutze, MD, who led the SVS branding campaign from its earliest stages, seems to indicate vascular surgery is now firmly on the journalistic map. “I was excited to see the amount of engagement of the press with actual vascular surgeons compared to what we have seen in the past, where these types of vascular situations like the president’s CVI diagnosis come up and they may not even get anybody from the cardiovascular space,” he says. “That has still happened with this event,” Shutze points out, but vascular surgeons were prominent and not absent or overlooked for other specialists in the vascular space, like interventional radiologists or cardiologists, as has been the case in the past. “To me, this seemed to be transformative based on the amount of interview requests for which vascular surgeons were sought out.”

While Shutze can’t say for certain that the thick of vascular surgical voices among the voices contextualizing President Trump’s CVI diagnosis owed much to the SVS branding efforts, “it is either a great coincidence or this is the first tangible moment where we can say, ‘Yes, it’s working.’”

The Plano, Texas-based vascular surgeon counted no fewer than 20 vascular surgeons who were quoted across 49 different media placements amid the initial blitz after news of Trump’s condition broke. A few days on, after the initial furor had settled, Shutze says content that contained a vascular surgeon as the resource had amassed 1.1 million impressions. “I think we had 23 primary placements in global, national and some regional media outlets. Of those, there were 22 outlets that picked these up secondarily, re-purposing them.” Among others, Shutze listed BBC News, The Star of Kenya, Hindustan Times, National Geographic, NBC News, ABC News and Newsweek.

“One I was really excited to see was AARP [formerly the American Association of Retired Persons]: If we are on AARP’s radar now, that is great. That is the geriatric population, those over 55, the heart and soul of the age group we treat. They have a wide circulation of the media content they produce for their members. It was great to have a vascular surgeon represented as the expert on a vascular condition for the president among that population.” The vascular surgeon in question was Mikel Sadek, MD, the vascular surgery program director at NYU Langone Health in New York City, who told AARP that anyone who has a known vein issue and any symptoms of CVI should see a vein specialist.

“It’s worthwhile getting checked out,” Sadek was quoted as saying, adding, “People always think of varicose veins [and CVI] as a purely cosmetic or aesthetic issue, but it’s often far more than that.”

Shutze encouraged all vascular surgeons to consider joining the branding effort by engaging with their local media: “Is the juice worth the squeeze? I would say that, yes, this is our first tangible evidence [that the branding campaign] is working.”

Vascular Specialist–August 2025

By
Bryan Kay
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Vascular Specialist–August 2025
In this issue:
  • Artificial intelligence: Where it lands today and how it might impact the vascular future
  • In wake of President Trump’s chronic venous insufficiency diagnosis, Society for Vascular Surgery steps up to educate public
  • Guest editorial: Vikram Kashyap, MD, makes the case for the benefits of a heart and vascular center
  • Carotid disease: Not all carotid revascularization procedures are equal

Regional vascular societies gear up for fall annual meetings

By
Bryan Kay
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Regional vascular societies gear up for fall annual meetings
Last year, the EVS staged its first-ever day of service during its annual meeting in Charleston, South Carolina

The glut of early fall regional vascular society annual meetings is just around the corner, with no fewer than five slated for the month of September. Several have recently made announcements about standout events taking place at their conferences, with one unveiling a new scholarship opportunity.

First up early in the month is the annual meeting of the Eastern Vascular Society (EVS), hosting its 36th gathering in Nashville, Tennessee (Sept. 4–7), with a second annual day of service one of the highlights of this year’s program. Organized in collaboration with the American Venous Forum (AVF), the event is set to take place on Friday, Sept. 5, from 6:30–8:30 p.m. at Jefferson Street Missionary Baptist Church in the Music City. Taking the form of a community health fair, it will include free health screenings, food and beverages, and vascular health educational sessions.

The Midwestern Vascular Surgical Society (MVSS) will host its 49th annual meeting in Cincinnati, Ohio (Sept. 18–20), with organizers putting out a recent call for fellow and senior vascular surgery residents to apply for its Technology & Techniques Vascular Simulation Program, which is slated to take place Thursday, Sept 18, from 7:30 a.m.–12 p.m. Around 30 Midwest trainees will be selected to take part on a first-come-first-served basis, with priority given to those in their final year of training. The winner will be invited to participate in next year’s Society for Clinical Vascular Surgery (SCVS) annual meeting Top Gun Program. For more information, email mvss@administrare.com.

The New England Society for Vascular Surgery (NESVS)—which hosts its 52nd annual meeting in Providence, Rhode Island (Sept. 26–28)—announced a new Equity in Interviewing Travel Scholarship worth $1,500. The grants will be awarded to two medical students who attend medical school at an accredited MD/DO school in New England and who are applying to integrated vascular residency programs in the 2025–26 cycle. Students must also be candidate members in the NESVS or apply to be, concurrent with the scholarship application. The deadline for submissions is Sept. 10, 2025 at 5 p.m. Eastern time. To apply, visit nesvs.org/equity-in-interviewing-travel-scholarship.

Meanwhile, the regional meetings slate in September also includes the 40th Western Vascular Society annual meeting in Ojai, California (Sept. 14–17), and the 47th Canadian Society for Vascular Surgery (CSVS) annual meeting in Hamilton, Ontario (Sept. 26–27).

SVS Executive Board votes against creating free-standing Vascular Surgery Board

By
Marlén Gomez
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SVS Executive Board votes against creating free-standing Vascular Surgery Board
Keith Calligaro

After two years of careful deliberation, the Society for Vascular Surgery (SVS) Executive Board (EB) has voted against pursuing the creation of a free-standing Vascular Surgery Board (VSB), opting instead to maintain the current federated board structure under the American Board of Surgery (ABS).

SVS President Keith Calligaro, MD, announced the decision following a discussion and vote on July 25–26, shared on the SVSConnect platform. The EB cited two primary reasons for its decision.

First, there was no decisive majority from the membership in favor of the initiative. The EB concluded that it would be inappropriate to divert significant SVS resources from other strategic priorities, such as branding, advocacy, education and vascular verification without broad consensus.

Second, fewer than half of the survey respondents expressed a willingness to contribute financially to the establishment and maintenance of a free-standing board. Given the significant costs involved and limited financial backing, the board deemed the initiative unfeasible.

“We recognize that regardless of the EB’s recommendation, half of the survey respondents may be disappointed,” Calligaro said in the SVSConnect post. “The SVS leadership fervently implores all members to remain unified and continue to support our parent vascular society. We remain committed to advancing our specialty, fostering unity and positioning vascular surgery for a strong future.”

This initiative was formed under past SVS President Joseph Mills, MD, who established a task force to explore the potential benefits and drawbacks of an independent board. Chaired by fellow past President Michael Dalsing, MD, the task force included a mix of members, both in favor of and opposed to the proposal. Under the continued leadership of Immediate Past President Matthew Eagleton, MD, the group met monthly for over a year, including a two-day in-person session at the SVS headquarters in Rosemont, Illinois.

The Society enlisted an external financial expert to assess the financial implications of a free-standing board, estimating costs at $5 million over two years or $10 million over four years. A polling firm conducted a non-binding survey of SVS members, with nearly 1,000 members responding, representing a 30% participation rate. The results revealed a near-even split, with 49% in favor of a free-standing board and 51% preferring the current federated model.

Calligaro and the EB emphasized that while this matter is considered resolved for now, it may be revisited should significant developments arise. A subcommittee will be formed to prepare essential components for rapid application if the need emerges.

Analysis of BEST-CLI, PREVENT III reveals significant improvement in vein bypass outcomes over 20-year period

By
Bryan Kay
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Analysis of BEST-CLI, PREVENT III reveals significant improvement in vein bypass outcomes over 20-year period
Mohamad A. Hussain

A post-hoc comparison of the BEST-CLI and PREVENT III multicenter, prospective, randomized controlled trials (RCTs) aimed at evaluating outcomes of vein bypass in chronic limb threatening ischemia (CLTI) patients over the past two decades found that they had “significantly improved” during the study period, “even amidst concerns about declining case volume and training.”

That was the headline finding of a paper presented during a Vascular and Endovascular Surgery Society (VESS) session that took place during the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7), delivered by presenting author Mohamad A. Hussain, MD, an assistant professor of surgery at Harvard Medical School in Boston.

With BEST-CLI demonstrating superiority of vein bypass compared with endovascular treatment for patients with CLTI and the rise in endovascular techniques as vein bypass procedures decline, the authors sought to elucidate concerns over whether open surgery can still be safely and effectively carried out.

The study included 2,114 patients who underwent vein bypass for CLTI—710 in BEST-CLI (2014–2019 and 1,404 in PREVENT III (2001–2003), with the study findings revealing that the primary outcome measure of one-year major adverse limb event (MALE) or death was lower in BEST-CLI at 21% compared with PREVENT III at 38% (adjusted hazard ration [HR], 0.50; 95% confidence interval [CI], 0.40-0.62; p<0.0001). This was an observation found to be consistent across subgroup analyses, which included comparisons between patients in which single-segment great saphenous vein was available for use and those where it was not; those who underwent a femoropopliteal bypass and those who did not; and those aged below 65 and those equal to or above 65.

Meanwhile, major reinterventions—new bypass, surgical revision, thrombectomy or endovascular intervention for graft occlusion—were also lower in BEST-CLI (7.2% vs. 18.4%; adjusted HR, 0.40; 95% CI, 0.28-0.57; p<0.0001) at one year, although rates of any reinterventions were similar (25.8% vs. 29.3%; adjusted HR, 0.90; 95% CI, 0.72-1.14; p=0.39), Hussain and colleagues discovered. The gains detected in the comparison between the two trials “are likely driven by better risk factor optimization, refined surgical techniques and advancements in perioperative care,” Hussain told VESS, acknowledging that the need for graft surveillance and maintenance was underscored by the data showing that the overall burden of reinterventions was consistent between BEST-CLI and PREVENT III.

Speaking to Vascular Specialist, Hussain hailed progress made over the years.

“It’s encouraging to see that patients undergoing vein bypass surgery for CLTI are doing significantly better today than they were two decades ago,” he said. “Thanks to advances in surgical techniques, medical therapy, and overall care, we’re seeing fewer amputations, fewer complications, and better survival—real progress for a population that faces serious health challenges.”

Early bird pricing deadline for coding workshop falls tomorrow

By
Bryan Kay
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Early bird pricing deadline for coding workshop falls tomorrow

The early bird pricing deadline for this year’s SVS Coding & Reimbursement Workshop is tomorrow.

With significant coding changes going into effect for vascular surgery on Jan. 1, 2026, the Society is urging vascular surgeons, trainees, advanced practice providers (APPs), coders and practice managers to consider signing up for the workshop’s expert-led, practical instruction on maintaining compliance, avoiding delays and navigating the latest coding updates “with confidence.”

Registering by tomorrow, Aug. 6, ensures savings through early pricing. Both the main Coding & Reimbursement Workshop and the optional E/M Coding Workshop are available in person and virtually. Attending in-person offers deeper engagement, printed materials and a live Q&A with faculty, the SVS notes.

The workshop takes place Nov. 3–4 in Rosemont, Illinois. Visit vascular.org/Coding25.

‘Critical’ importance of lifelong surveillance after EVAR headlines newly published 10-year ENGAGE data

By
Jocelyn Hudson
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‘Critical’ importance of lifelong surveillance after EVAR headlines newly published 10-year ENGAGE data
Hence Verhagen
Hence Verhagen

Ten-year data highlight the long-term efficacy and durability of the Endurant stent graft (Medtronic) in abdominal aortic aneurysm (AAA) patients who survived beyond five years post-enrollment in the ENGAGE registry. However, researchers also draw attention to the incidence of late events in this extended follow-up cohort, which they say underscores the need for lifelong surveillance. These findings were recently published online in the European Journal of Vascular and Endovascular Surgery (EJVES).

ENGAGE is a Medtronic-sponsored, observational, multicenter, non-randomized, prospective global registry designed to shed light on the long-term outcomes of endovascular aneurysm repair (EVAR). In their EJVES paper, Hence Verhagen, MD, professor and chief of vascular surgery at Erasmus University Medical Centre Rotterdam in Rotterdam, the Netherlands, and a team of co-investigators from across Europe, the USA and Canada note that the registry will be the first to report long-term outcomes of real-world, global AAA patients with the Endurant stent graft.

Verhagen and colleagues share that inclusion criteria for the registry were “minimal” and allowed for the incorporation of patients who fell outside the instructions for use guidance. Exclusion criteria, meanwhile, were “high probability of non-adherence to follow-up requirements, or concurrent participation in another trial that could confound results.” The authors note that clinical and imaging data were continuously collected to evaluate treatment efficacy through 10 years.

Of the 1,263 patients enrolled in the ENGAGE registry, Verhagen and colleagues state that 390 reconsented for follow-up from more than five through 10 years, constituting an extended follow-up cohort. The remaining 873 patients made up a non-extended follow-up cohort.

In EJVES, the authors report the continued long-term efficacy and durability of the Endurant stent graft. They share that freedom from site-reported all-cause mortality and clinical event committee (CEC)-adjudicated aneurysm-related mortality for the extended follow-up cohort was 75.7% and 97.3% through 10 years, respectively.

Furthermore, through 10 years, Verhagen et al note that each rate for freedom from aneurysm-related rupture (96.2%) and aneurysm-related interventions (71.4%) was comparable with the respective rate through the first five years.

Among several other datapoints, the authors detail that late re-interventions (n=72) were associated with type Ia endoleaks (18/72), type II endoleaks (18/72), and type Ib endoleaks, adding that, at 10 years, 64.1% of patients exhibited sac regression, 19.2% were sac stable, and 16.8% had sac expansion.

Verhagen and colleagues do highlight some limitations of their paper. “Potential bias was introduced as a subset of patients and sites did not reconsent from the original ENGAGE population when the protocol was amended and thus the data in the extended follow-up cohort (more than five to 10 years) do not represent the full ENGAGE cohort,” they write, for example. However, the authors state that event rates in the extended and non-extended follow-up cohorts were similar from zero to five years and that the team provided baseline differences in the extended follow-up cohort “to allow readers to put outcomes in context and be transparent with any potential bias of the patient population.”

The lack of a control group was another potential drawback, Verhagen and team note. Consequently, the results “could only be indirectly compared with results from other clinical studies.” Among other limitations, the authors highlight the fact that follow-up compliance over the more than five to 10-year period decreased due in part to challenges with data collection during the COVID-19 pandemic.

In the conclusion of their paper, the authors also draw attention to the fact that “this study was the first to demonstrate long-term performance and durability of the Endurant stent graft for aortic aneurysm treatment.” They also home in on the incidence of late events. “Different factors led to reintervention in the later years,” they state, noting that this supports current recommendations of lifelong surveillance.

“The authors suggest that lifelong surveillance is critical for EVAR patients due to the incidence of late events,” Verhagen and colleagues write.

New APP Section: A ‘professional home’

By
Marlén Gomez
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New APP Section: A ‘professional home’
Female nurse assisting patient undergoing renal dialysis in hospital room
The new APP Section was birthed in May 2025

There’s no place like home within the newly established SVS Advanced Practice Provider (APP) Section, where vascular advanced practice registered nurses (APRNs) and physician assistants (PAs) aim to provide a “professional home” for APRNs and PAs working in vascular care settings.

The groups finalized the change in May 2025 with the integration of the former PA Section into the APP Section. This collaborative effort includes the SVS, the Society for Vascular Nursing (SVN) and the old PA Section.

Chris Owen, MS, and Erin Hanlon, PA-C, will co-chair the new section to ensure proper representation.

Owen, a past president of the SVN and a practicing nurse practitioner, has seen firsthand the impact of a unified, collaborative voice in advancing the profession and improving patient outcomes.

“Team-based care is essential to the future of healthcare—ensuring that all providers, regardless of background, are respected for their contributions,” Owen said. “I’m honored to be part of this collaborative inaugural SVS APP Section and grateful for the recognition of the vital role we all play in caring for vascular patients.”

The APP Section offers numerous benefits, including opportunities for professional networking and peer mentoring, as well as leadership development through engagement with SVS committees. The SVN Annual Conference will feature education specifically tailored to APPs. Additional perks include discounts on SVS events and subscriptions to the Journal of Vascular Surgery (JVS), Vascular Specialist and the weekly Pulse e-newsletter.

Members will also gain access to the APP Section community on SVSConnect, an exclusive online platform for collaboration, communication and engagement with fellow vascular professionals.

For more membership information, visit vascular.org/APPSection.

Deadline extended for SVS Foundation grant focused on women’s health

By
Bryan Kay
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Deadline extended for SVS Foundation grant focused on women’s health
Audra Duncan

The Society for Vascular Surgery (SVS) Foundation has extended the deadline for a Vascular Care for the Underserved (VC4U) project grant focused on women’s vascular health to Sept. 8.

The $20,000 award, in partnership with the SVS Women’s Section, is focused on women’s vascular health research and will fund research that addresses the unique needs of women, and combats the longstanding exclusion of women from vascular research and clinical trials.

This initiative aims to address disparities in vascular care with a focus this year on advancing women’s vascular health in underserved communities. The initiative supports efforts to improve early detection, expand research inclusion and develop gender-specific interventions for vascular disease.

“Too often, women—especially those in underserved communities—are left out of the vascular health conversation,” said Audra Duncan, MD, chair of the SVS Women’s Section. “The VC4U grants are a powerful step toward changing that narrative.”

Ideal proposals will define the target underserved population, identify disparities in care and propose actionable, scalable solutions. Applications are open to SVS Active Members, Early Active Members and Society for Vascular Nursing (SVN) Active Members.

Learn more at vascular.org/VC4U.

Inari Medical, now part of Stryker, launches InThrill thrombectomy system

By
Bryan Kay
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Inari Medical, now part of Stryker, launches InThrill thrombectomy system
InThrill thrombectomy system
Inari Stryker
InThrill thrombectomy system

Inari Medical—now part of Stryker—has announced the launch of its next-generation InThrill thrombectomy system.

The company stated in a recent press release that this is the “first and only purpose-built” small vessel and arteriovenous (AV) access thrombectomy system that can deliver fast, full luminal clot removal.

The second-generation of InThrill is an 8F over-the-wire system comprising the InThrill thrombectomy catheter and sheath. The features include increased radial force, an offset single open mouth, internal struts and a redesigned backend.

On May 19, 2025, Joshua Pinter, MD, and Anish Ghodadra, MD, interventional radiologists at the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania, performed the first commercial case using the new system.

Countdown to Capitol Hill: SVS Advocacy and Leadership Conference nears

By
Marlén Gomez
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Countdown to Capitol Hill: SVS Advocacy and Leadership Conference nears

The Society for Vascular Surgery (SVS) is gearing up for its inaugural Advocacy and Leadership Conference, taking place Sept. 14–16, in Washington, D.C. With less than two months to go, the SVS is encouraging members at all career stages to register and take part in this landmark event designed to empower vascular professionals to shape the future of their specialty.

This first-of-its-kind conference will unite vascular surgeons, trainees, fellows and other key stakeholders to engage directly in the policymaking process. Attendees will gain insights into the most pressing legislative and regulatory issues affecting vascular care, participate in hands-on advocacy training, and meet face-to-face with members of Congress and senior policy staff during scheduled Capitol Hill visits.

“Vascular surgeons across the country are feeling the strain on our healthcare system and demanding change,” said Megan Tracci, MD, chair of the SVS Advocacy Council. “During the inaugural Advocacy and Leadership Conference coming up, the SVS is offering our surgeons a chance to participate in driving that change.”

She adds, “This is a unique opportunity to examine the pressing issues facing the vascular surgery specialty, meet leaders and policymakers, learn how to be an effective advocate and participate—personally—in transforming the healthcare landscape through visits with members of Congress and policy staff on Capitol Hill.”

Space is limited, and interest is high. Register today at vascular.org/AdvocacyConference25.

First patient enrolled in AngioDynamics’ AMBITION BTK trial for CLTI

By
Jocelyn Hudson
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First patient enrolled in AngioDynamics’ AMBITION BTK trial for CLTI
Anahita Dua
Anahita Dua

AngioDynamics today announced enrollment of the first patient in AMBITION BTK, a randomized study of the Auryon atherectomy system in patients with below-the-knee chronic limb-threatening ischemia (CLTI).

A press release details that AMBITION BTK is a prospective, multicenter, randomized controlled trial (RCT) designed to investigate the clinical safety and effectiveness of the Auryon atherectomy system combined with standard balloon angioplasty, compared to balloon angioplasty alone, in treating infrapopliteal lesions in patients with CLTI. The primary endpoint will be evaluated using a win-ratio approach, comparing the two treatment groups based on the following components in a hierarchical manner at 12 months: freedom from major amputation, freedom from clinically driven target lesion revascularization (CD-TLR), and primary patency.

The RCT will include up to 224 patients at up to 30 sites. In parallel, a companion registry will enroll up to 1,500 additional patients who are ineligible for the RCT and are treated with the Auryon system above or below the knee.

The first patient in the trial was treated by Anahita Dua, MD, a vascular surgeon at Massachusetts General Hospital and Harvard Medical School in Boston, co-principal investigator of AMBITION BTK.

“I’m excited to perform the first patient case in the AMBITION BTK study. Patients with below-the-knee disease often face limited treatment options and poor long-term outcomes,” said Dua. “Across the world, there has been a significant increase in patients with below-the-knee (BTK) disease, which is, unfortunately, resulting in an amputation epidemic. Having new tools and techniques to restore blood flow to the foot, allowing wounds to heal, and patients to preserve both their limbs and lives, is critically important and the focus of this trial. This trial will allow us to collect high-quality, real-world data using a robust research design, helping us truly evaluate the impact of laser technology in BTK disease.”

Corner Stitch: How to say ‘I messed up’

By
Anonymous
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Corner Stitch: How to say ‘I messed up’
When cases hurt and continue to hurt: ‘Having people around you for support is crucial’
An anonymous vascular resident offers some advice for dealing with a troubling case in the latest edition of our Corner Stitch column by and for vascular surgery trainees.

Little, if anything, in life prepares you for when you eventually cause harm to another human. Intentional or not, medical errors cause significant morbidity and mortality to those we care for. But how do we manage our errors and mitigate moral injury?

As a PGY2 in the surgical intensive care unit (ICU), I found myself in front of an elderly man who underwent emergent surgery overnight for cecal volvulus. He was extubated, stable, and his daughter was at bedside. When I introduced myself, the daughter recognized my last name on my white coat and asked if I was related to a local cardiologist who had performed her father’s transarterial aortic valve replacement. I said yes and immediately she trusted me. I found out later she was an RN who knew my father personally.

His postoperative course was wholly unremarkable. We determined on rounds that, given his elevated CHADSVASC score, to restart anticoagulation on postoperative day two. The surgeon of record was even present to endorse hemostasis gained with low risk of bleeding and concluded the benefits of anticoagulation outweighed those risks. I ordered the heparin drip.

On postoperative day 3 the patient faltered in his otherwise unremarkable post-operative course. He now refused to ambulate and was in atrial fibrillation with rates of 150. He subsequently began to complain of worsening abdominal pain, decreased urinary output, and now had a fever to 102. The team decided on a complete blood count (CBC) in the afternoon to check on his white count. His partial thromboplastin time (PTT) was therapeutic, and his white blood cell (WBC) was 10. Focused on those details, when I checked the WBC, I neglected the hemoglobin drop from 10 to 8.5. In hindsight, he was bleeding. But in the moment, I was concerned with postoperative infection or possible leak/missed enterotomy. I continued to monitor him until end of shift and updated the daughter, who was reassured by my presence said she would see me again tomorrow. I left the hospital. Overnight the covering resident physician found the patient decompensating and repeat CBC showed a hemoglobin of 4 after fluid resuscitation for hypotension. I arrived at the hospital the following morning to find the patient being rolled back to the operative suite in extremis, blood hanging on the IV pole connected to the hospital bed.

I was filled with dread. I missed something. After rounds I made my way into the operative room to check in with the attending and chief resident scrubbed in the case. They found two liters of blood in the abdomen, which they controlled, and the patient was in the lethal triad (hypothermic, acidotic and coagulopathic). He was closed and brought back to the ICU for me to continue resuscitative efforts. I spent the entire shift in his room attempting to correct the error I knew I had played a part in. I warmed him back to normothermia, corrected his coagulopathy and acidosis back on the first night. The following day I battled atrial fibrillation with rapid ventricular response and hypotension. I tried everything. Eventually I was able to correct his hypotension, but I was using multiple vasoactive peptides. Near the end of my shift, I placed an ultrasound probe on his chest, and I couldn’t see his left ventricle contracting as well as I’d like, so I obtained a formal transthoracic echocardiogram and placed a Swan-Ganz catheter in the interim, which confirmed the diagnosis I had been dreading. The reading cardiologist called at one point wondering if the patient was even still alive. He told me over the phone the ejection fraction was maybe 5%, but he was unsure given how little the heart was contracting. My management changed to cardiogenic shock, and I reached out to the inpatient cardiology team to assist in efforts.

The following day was status quo. We started to see some improvement with de-escalation of the multiple drips the patient was receiving. I even started to feel better with newfound hope that he might recover, but I knew the only reason the patient is in the situation he’s in is because of my error. That night during sign-out I wrote out as many potential paths the patient may take, and detailed “if this, then that” scenarios and communicated with the overnight resident to follow the Swan numbers to keep track of the systemic resistance. I was losing control of the patient’s status but doing everything I thought possible to keep him from spiraling down. Overnight, the patient decompensated with what appeared to be distributive shock. I immediately sent blood cultures and started antibiotics, but it was too late. His family ultimately went for comfort measures only, and he passed shortly after. The following day his blood grew pseudomonas.

This case hurts, and it continues to hurt. I will never forget looking at the patient and his daughter knowing they trusted me. I let them down. I don’t think any possible experience can fully prepare you for making a medical mistake that leads to a patient’s death. I regret that during the patient’s last hours I could not care for them. I was too emotional and was unable to think clearly. Thankfully, my covering attending for the weekend was present and took over for me. She conducted the CMO discussions and managed the patient until he passed while I hid in the call room alone. I regret this decision daily.

I think the toughest concept to reconcile was that the patient and his daughter trusted my medical decision making based on their experience from working with my father. I felt like I not only let them down, but my family as well. I missed a diagnosis that is sacrosanct in surgery and not a day goes by where I don’t think about this case. I lost countless hours of sleep, liters of tears, and a lot of my confidence. I know people say this kind of experience helps you avoid making the same mistake again, but it makes me sick to my stomach that in this situation, someone lost their loved one. Someone and their family put their trust in my management only to end up losing their loved one.

I learned many lessons from my failure. Failure is necessary for growth. It allows us to learn and be better for it. But in a profession where failure might mean morbidity or mortality for someone, making those mistakes comes with a heavy burden to bear. Our training as surgical residents is extensive and demanding. Not just physically, but mentally. It is easy to say to yourself or an attending that you will improve, but that feeling of failure is always present. It can easily consume you until you find yourself in a dark place, alone. Having people around you for support is crucial. You are expected to compartmentalize emotions to allow yourself to care for the next patient, even when you’re hurting, but no one really teaches you this firsthand. Being a surgeon is not just about being technically excellent, else we would be robots. It is an all-encompassing, lifelong endeavor.

I hope by sharing my experience I can empower those with similar stories, or those who will one day find themselves caring for critically ill people, to take care of yourself as well. That way, that next patient and family you find yourself in front of will get 100% of you caring for them.

This commentary was submitted anonymously by a PGY-2 integrated vascular resident.

Step Challenge: Walk for wellness

By
Marlén Gomez
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Step Challenge: Walk for wellness

Get ready to join the Society for Vascular Surgery (SVS) Foundation this September for the 2025 Vascular Health Step Challenge.

Hosted during National Vascular Disease Awareness Month, the annual challenge promotes healthy vascular habits and raises critical funds for research, education and awareness initiatives.

This year’s challenge will feature new prizes, competitions and ways to fund the future of vascular health.

Registration for the challenge opens Aug. 1. Learn more at vascular.org/Step2025.

Complex PAD skills course registration is open

By
Marlén Gomez
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0
Complex PAD skills course registration is open

Registration is now open for the Society for Vascular Surgery (SVS) Complex Peripheral Vascular Interventions (CPVI) Skills Course, taking place from Sept. 20–21 in Rosemont, Illinois.

The two-day course will provide participants with hands-on training in the latest techniques and technologies for treating complex peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI).

Attendees will benefit from expert-led presentations and case-based discussions. This year, registration offers more than $400 off while maintaining the same high-caliber education.

Learn more at vascular.org/CPVI25.

First patient treated with InterVene’s Recana thrombectomy catheter system

By
Jocelyn Hudson
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First patient treated with InterVene’s Recana thrombectomy catheter system

InterVene announced today that the first patient has been treated with its Recana thrombectomy catheter system for venous in-stent restenosis (ISR).

The company shares in a press release that Recana is the first fully integrated mechanical thrombectomy system designed specifically to address the long-term complications of venous disease, including ISR and native vein obstructions. The case was performed at University Hospital Galway in Galway, Ireland, by interventional radiologist Gerry O’Sullivan.

“The long-term sequelae of venous obstructions, whether in-stent or native vessel, are a devastating consequence of deep venous thrombotic disease. There remains a considerable gap in effective interventional treatments for physicians and their patients living with persistent symptoms related to venous outflow obstructions,” said O’Sullivan. “I had previously tried and failed to recanalise this patient’s vessels on four separate occasions—Recana succeeded in just one. This technology offers real promise for patients with limited treatment options.”

The case was a result of collaboration between InterVene and the University of Galway Institute of Clinical Trials. “We are proud to see Recana become one of the first innovations to enter clinical use in Ireland through the Hypercare initiative,” said Fidelma Dunne, director of the Institute for Clinical Trials at the University of Galway. “This first-in-human procedure reflects Hypercare’s core mission to streamline the clinical trial process and accelerate patient access to breakthrough therapies.”

“This successful first-in-human procedure comes after several years of rigorous work to prove a transformative design to address a major unmet need in venous disease,” stated Jeff Elkins, chief executive officer of InterVene. “We are proud to support Dr O’Sullivan in caring for patients suffering from the life-limiting effects of ISR. Completing this first case marks an important milestone in bringing our technology to patients affected by the long-term complications of venous disease.”

SVS highlights landmark paper on functional popliteal artery entrapment syndrome

By
Bryan Kay
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0
SVS highlights landmark paper on functional popliteal artery entrapment syndrome
Jason Lee during VAM 2025

The Society for Vascular Surgery has highlighted findings from a comprehensive 20-year clinical study that demonstrate treatment of functional popliteal artery entrapment syndrome—particularly in combination with fasciotomy for exertional compartment syndrome—has shown highly effective outcomes, with 82% of patients returning to prior level of athletics.

As the largest reported cohort to date, this research summarizes two decades of experience in standardized radiographic evaluations and surgical decompressive treatments.

The paper was presented at VAM 2025 in New Orleans and simultaneously published in the Journal of Vascular Surgery (JVS).

The senior author of the study was Jason Lee, MD, chief of vascular surgery at Stanford Health Care in Palo Alto, California.

MHRA announces UK medical device regulation amends

By
Éva Malpass
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0
MHRA announces UK medical device regulation amends

MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced important new steps to secure access for patients to the latest medical technologies available in Europe and other advanced countries.

As well as improving patient access to technologies, the proposals will boost med tech industrial growth by reducing duplicative regulatory costs faced by manufacturers and instead focuses the domestic approvals route on first-in-market innovative technologies, including artificial intelligence (AI) as a medical device.

The MHRA has now published the government’s response to its public consultation on future routes to market for medical devices in the United Kingdom, designed to modernize regulation and improve patient access to the latest innovative technologies.

In direct response to stakeholder feedback, the MHRA is also announcing its intention to consult later this year on the indefinite recognition of CE-marked medical devices.

In parallel, new international reliance routes will be introduced to allow swifter access to medical devices from trusted regulators in Australia, Canada and the U.S. This will allow eligible products to follow a streamlined pathway to market, helping bring the latest technologies to patients more quickly.

The MHRA will support removing the requirement for physical UKCA (UK Conformity Assessed) markings on products and packaging once unique device identification (UDI) requirements are in place. This will reduce barriers to entry to the market while strengthening traceability and safety monitoring. 

SVS Foundation VC4U grants advance vascular equity for underserved women

By
Marlén Gomez
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0
SVS Foundation VC4U grants advance vascular equity for underserved women
SVS
Grant applications for 2025 are being accepted until Aug. 1

The Society for Vascular Surgery (SVS) Foundation is currently accepting applications for its 2025 Vascular Care for the Underserved (VC4U) project grants until Aug. 1.

The VC4U Project Grants help to address disparities in vascular care across the United States, providing $20,000 in funding for innovative, one-year projects.

This application cycle specifically supports projects dedicated to advancing women’s vascular health, encouraging bold, creative approaches to advance equity and outcomes in the field.

The SVS Foundation is proud to offer this award in partnership with the SVS Women’s Section. This initiative aims to address disparities in vascular care with a focus this year on advancing women’s vascular health in underserved communities. The initiative supports efforts to improve early detection, expand research inclusion and develop gender-specific interventions for vascular disease.

“Too often, women—especially those in underserved communities—are left out of the vascular health conversation,” said Audra Duncan, MD, chair of the SVS Women’s Section. “The VC4U grants are a powerful step toward changing that narrative.”

Ideal proposals will define the target underserved population, identify disparities in care and propose actionable, scalable solutions. Applications are open to SVS Active Members, Early Active Members and Society for Vascular Nursing (SVN) Active Members.

Learn more at vascular.org/VC4U.

‘Parenthood in vascular surgery a personal choice, not a professional deadline’

By
Marlén Gomez
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0
‘Parenthood in vascular surgery a personal choice, not a professional deadline’
VAM attendees gather for a session on parenthood in vascular surgery

When is the right time to start a family in vascular surgery? That was a core question posed during the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7) in a dedicated session aimed at tackling issues around parenthood for those practicing in the specialty. A panel of vascular surgeons and trainees sought to address the crucial conundrum.

One answer: There is no definitive timeline for pregnancy in the operating room, said Christina Cui, MD, a vascular resident at Duke University in Durham, North Carolina, and a moderator and panelist representing the trainee perspective. She emphasized that pregnancy is a personal decision that individuals must navigate with their families, not with hospitals or program directors.

“There is so much self-imposed stigma around this topic,” she explained. “As women, we go through a lot of these issues on our own; the mental load you have to deal with on your own and [with] your partner—understand you can share that bargain.”

The session, titled “Carrying the Weight: Parenthood in Vascular Surgery,” featured perspectives from trainees, faculty from private practice, and others sharing personal experiences.

Dawn Coleman, MD, division chief of vascular and endovascular surgery at Duke University, raised a question from the audience about the challenges vascular surgeons face in balancing patient care and team dynamics when a team member takes leave. She noted the emotional implications for both the individual on leave and the rest of the team.

“If we can solve this, we can solve world peace,” answered Dejah R. Judelson, MD, a vascular surgeon at UMass Memorial Health in Worcester, Massachusetts, and a panelist from the academic perspective.

Judelson pointed out that past discussions have focused on the additional workload for the remaining team members. The panel agreed that it is not practical to merely front-load or back-load calls to compensate for someone on leave. Instead, she believes the solution involves cross-field conversations to find equitable ways to address these situations.

“In terms of training, it’s crucial for attending physicians to step in and take on primary calls when needed,” Judelson said. During her first pregnancy, she chose to front-load her calls to avoid being a burden to her partners. However, during her subsequent pregnancies, she realized that she didn’t have that bandwidth or functional ability.

“It’s essential to acknowledge that everyone has their limits while also being sensitive to others’ feelings and opinions. We all need to support one another, regardless of the circumstances,” Judelson added.

A self-fulfilling prophecy based on a fourth-year medical student’s misinformed decision

By
Sarah Lauve
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A self-fulfilling prophecy based on a fourth-year medical student’s misinformed decision
Sarah Lauve

“How many programs conducted in-person interviews this year?” “Which programs conducted in-person interviews?” “Oh wow, I didn’t realize that many programs were conducting in-person interviews.”

All of these are questions gleaned from last year’s Match process. To be sure, the Association of Program Directors in Vascular Surgery (APDVS) has demonstrated a tireless commitment to finding best interview practices, developing new residency programs, and increasing training resources and recruitment. Looking at the 2024 Electronic Residency Application Service (ERAS) preliminary data, the APDVS efforts have clearly been successful. Diagnostic radiology and integrated vascular surgery were the two specialties experiencing the largest growth, characterized by increases in applicant numbers, average applications submitted per applicant, and average applications received per program. Despite this demonstrated growth and the efforts of the APDVS, these sentiments from the interviewers during the 2024 interview cycle identified a large discrepancy between the success the APDVS has had in these measures and the current interview process for a residency position in this field.

The Match process was a frequently discussed topic at the Houston Methodist intern boot camp. Out of curiosity, I began intentionally interviewing my fellow incoming interns about their experiences. I fully expected the first interview to fail, assuming people either wouldn’t participate or the conversations would be vague and superficial. Wrong. I was met with a shocking level of engagement that catapulted more interviews, shared experiences and inquisitive questions. I was excited to share what these conversations uncovered and knew if anyone would be interested in my findings, it would be my program director, Dr. Malachi Sheahan. In his 2021 article, “It is time to end the interview,” Dr. Sheahan thoroughly describes the faults of our current surgical trainee and faculty selection processes, impressions vs. assessment tools, the interviewer’s bias, and the overly confident assumption that we make as humans that we conduct interviews well. The guidelines made by the APDVS during the 2024 interview cycle for best interview practices were followed by only 64 programs. Eleven programs conducted in-person interviews, and one program conducted a combination of in-person and virtual interviews. Thus, my first question was born: how are integrated vascular surgery residency applicants affected by their own bias in the current in-person/virtual/hybrid interview era?

In their 2023–2024 guidance statement, the APDVS references the data from the VISIT (Vascular in-person for students in the Match) trial to showcase the impact that in-person visits have on an applicant’s rank list. The VISIT trial reported that the most impactful factors to applicants when visiting a program were esprit de corps of the program, the people and physical setting. Within minutes of conducting the first conversation it was evident that a program’s reputation, as it pertains to the experiences of fellow applicants during away rotations and the opinions of an applicant’s mentor, far outweighed anything gained from an interview, regardless of format or an in-person visit. It is well known that many applicants also vet their impression of a program with a mentor or trusted colleague. This is especially influential in vascular surgery, which is a smaller, well-connected field. Placing highest value on a mentor’s, resident’s or another applicant’s opinion/experience was reported by nearly all the matched applicants with whom I spoke. This was reported regardless of presence/absence of a home program, and if their most positive and impactful experience was in-person or virtual. This was one of, if not the most, influential factors for both females and males when making their rank lists, yet the characteristics of their rank lists were drastically different. Roughly 30 interns were at the Houston Methodist boot camp, representing roughly a third of current vascular interns in the country. There was not a single female intern who ranked a program number one at which she hadn’t completed an away rotation, interviewed at in person, and/or visited in person. There were several males who ranked a program number one at which they had only interviewed virtually. Although it is uncertain if these trends are significant, the VISIT trial cohort consisted of a similar number of residents that responded and completed the survey—similar in size to the number who participated in my discussion. The VISIT trial was used by the APDVS to make recommendations for best interview practices this past interview cycle, but should other factors—such as the effects of gender—be included? Are females affected differently than their male colleagues by the increasing number of programs conducting in-person interviews? If so, can the APDVS utilize this information to reduce bias and create a more consistent interview experience?

This led me to reflect on my own experience with away rotations and how this influenced my rank list. I decided to then ask how recently matched interns selected away rotations to apply to and subsequently attend. Again we saw the influence of word of mouth. Every single person I asked said they chose to apply to and accept at least one away rotation solely based on program reputation and/or their mentor’s opinion. Additionally, the entire cohort of interviewees said they would significantly change where they applied and attended away rotations after having completed interview season. All interns I spoke with wished there was more information about programs provided by the programs themselves, either on their websites or by the SVS/APDVS. The SVS currently provides a full listing of Accreditation Council for Graduate Medical Education (ACGME)- accredited vascular surgery training programs. Program descriptions are listed if available but vary drastically in the information provided. In my experience, this is not specific to integrated vascular surgery residency applicants. Feeling uninformed when applying to and selecting away rotations is a sentiment commonly expressed by many fourth-year medical students. However, if integrated vascular surgery—one of the fastest growing residency programs—is a specialty so heavily impacted by networking and away rotations, should opportunities such as these be a topic addressed by the APDVS? Other specialties have begun to implement changes to address away rotation and interview practices. Integrated plastic surgery has created a specific task force dedicated to away rotations. This task force has been responsible for developing numerous resources for prospective applicants, including well-organized, updated and consolidated information on away rotations, application cycle webinars, and application process advice.

Integrated vascular surgery residency is one of—if not the only—residency specialty to not utilize signaling. Surprisingly, this was a topic of large debate amongst the recently matched integrated vascular surgery interns. Some advocated for the implementation of signaling within our specialty, others argued against this, and still others were neither for nor against but instead focused on risk/benefit analysis. Those who advocated for the implementation of signaling are simply of the mindset that if other specialties are utilizing it, then vascular should as well. Some argue that away rotations are the equivalent of signals in vascular surgery and the use of signals would compensate for the issues regarding away rotations. Those who are adamantly against the use of signals appreciate that uniqueness and lack of conformity of our specialty, and vote against signaling as they do not wish to go with the status quo. Others value that many vascular programs individually review applications and the use of signaling may negate this.

I think the process of interviewing for residency will forever be a complex task that is met with constructive—and sometimes not so constructive—criticism. I do not think any one specialty has or will ever figure out the “perfect” system. However, with the completion of the 2024–25 interview season, my curiosity regarding the interview practices within vascular surgery persists.

Are our current practices affecting genders differently? Are we lagging behind other specialties that are experiencing less growth? Most importantly, were the opinions expressed by interns in Houston specific to that class of interns, or do these trends persist amongst newly matched students?

Sarah Lauve is a second-year integrated vascular surgery resident at Louisiana State University (LSU) in New Orleans.

Coding workshop to cover 2025 updates

By
Marlén Gomez
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0
Coding workshop to cover 2025 updates

Registration for the annual Society for Vascular Surgery (SVS) Coding and Reimbursement Workshop—and optional evaluation and management (E/M) coding workshop—opened July 9 with early-bird registration available until Aug. 6.

This 1.5-day intensive program, scheduled for Nov. 3–4 in Rosemont, Illinois, will provide expert guidance and actionable strategies to ensure proper reimbursement and compliance.

The course will address significant coding changes made in 2025, with faculty breaking down new developments and their implications for practice. Major vascular surgery coding changes will go into effect in January 2026. Those will include a major restructuring of lower extremity revascularization coding, as well as coding changes for thoracic branch endografts and baroreflex activation therapy. The optional E/M coding workshop will have updates available focused on coding and documentation rules for choosing a correct E/M category and level of service.

Learn more at vascular.org/Coding25.

New SVS president seeks to enhance communication with members, tighten focus on outcomes

By
Marlén Gomez
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0
New SVS president seeks to enhance communication with members, tighten focus on outcomes
VAM Convention 2025 in New Orleans
Keith Calligaro

With another Vascular Annual Meeting (VAM) in the books, that means the flag unfurls on a new presidential year. And that means Philadelphia-based vascular surgeon Keith Calligaro, MD, now leads the Society for Vascular Surgery (SVS) as president. And Calligaro, who brings decades of experience to the role, has outlined a clear vision for his year at the helm, and he has his sights fixed on helping address some of the key areas of priority for vascular surgery and the SVS.

“At the end of the year, I want our members to reflect on the projects we have completed or at least made significant progress on. To me, this will be the measure of our success in achieving our priorities,” he tells Vascular Specialist after the conclusion of VAM 2025 in New Orleans (June 4–7).

Calligaro’s presidency comes at a pivotal time for the SVS, as the organization continues to evolve in response to changes in healthcare delivery, technology and growing membership. He says three key initiatives will define his term: a resolution on the current deliberations regarding the optimal model for the Vascular Surgery Board (VSB), promoting the uptake of the Vascular Verification Program (VVP), and engaging in strategic realignment and rebalancing of the SVS’ primary efforts.

“One of the biggest lessons I’ve learned is the value of getting input from others,” he explains. “I always like to hear different perspectives, especially on controversial issues. It helps shape my thinking.”

He highlights the importance of having a clear structure and a sense of accountability in leadership roles. His approach to leadership and oversight emphasizes discipline and the establishment of deadlines—without these elements, tasks often remain unfinished, he says. Transparency and accountability are principles he consistently aims to instill in the teams with which he collaborates, and this will continue in the SVS.

The SVS has recently completed an assessment of the pros and cons of supporting the current VSB within the American Board of Surgery (ABS) or moving toward the establishment of a free-standing—or independent—board for vascular surgery. After a year of deliberation, the task force presented survey results at VAM 2025, indicating a near-even split among members’ opinions. Calligaro aims to provide further clarity on this issue, recognizing the members’ desire for a resolution on what the SVS Executive Board (EB) recommendation will be. He plans to finalize a governance decision during the EB retreat at the end of July. The EB will communicate the decision to members shortly thereafter. Calligaro emphasizes that the rapidly evolving healthcare environment requires flexibility and adaptability. Therefore, any decisions made at this moment will likely require ongoing monitoring, he says.

The VVP, developed in collaboration with the American College of Surgeons (ACS), aims to recognize hospitals and outpatient centers as vascular centers of excellence. Calligaro notes that participation has lagged since the program’s establishment.

To address this issue, Calligaro plans to schedule meetings and set deadlines with the Strategic Board of Directors (SBOD), comprising approximately 30 members, as well as with centers that have a high volume of participation in the Vascular Quality Initiative (VQI) registry. These discussions will focus on providing strategies for applying for the program.

With the SVS’ rapid growth over the past decade and projections to reach close to 8,000 members by 2030, Calligaro believes the time is ripe to reassess the organization’s top-most priorities, as well as its volunteer and staff support structure. “We’ve expanded significantly, but our members have likely hit their limit regarding increases to dues going forward, and we can’t expect ever-increasing support from the same group of loyal sponsors,” he says. “We need to prioritize and streamline our efforts to ensure sustainability while we also explore expanding the pool of potential sponsors and seek new sources of revenue.”

Calligaro plans to address the growing demand for vascular surgeons, particularly in underserved areas. He points to the SVS Foundation’s Vascular Care for the Underserved (VC4U) program, which supports research and workforce development in less populated regions. “About 50% of trainees stay where they train, so we need to be strategic,” he explains. “We’re also exploring telemedicine as a way to extend care and expertise to remote areas.”

As vascular surgery continues to evolve, Calligaro underscores the need to support mid-career surgeons. “We must be open-minded and adaptable,” he says. “Through the Clinical Practice Council and simulation-based learning, the SVS is working to optimize education and help surgeons stay current.”

So, what is his vision for his presidency? “Transparency,” he responds. “I want members to know what we’re doing and why. Even if there’s disagreement, we must speak with one voice and always act in the best interest of the Society,” he adds. “I hope people will say that I—and the Executive Board—did our best to serve the vascular community with honesty, openness and a commitment to excellence.”

SVS launches partnership to help private practice vascular surgeons cut costs

By
Marlén Gomez
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0
SVS launches partnership to help private practice vascular surgeons cut costs
VAM 2025 attendees during a SAVC session in New Orleans

The Society for Vascular Surgery (SVS) has announced a new partnership with group purchasing organization (GPO) Provista in an effort to help provide a cost-slashing benefit to private practice physicians amid ongoing financial pressures in outpatient care.

The initiative, unveiled during a Section on Ambulatory Vascular Care (SAVC) session at the 2025 Vascular Annual Meeting (VAM) on June 6 in New Orleans, aims to help smaller practices reduce expenses by leveraging collective buying power.

“The GPO is something that the SVS has been working on for a while, and it’s finally come to fruition,” said Anil Hingorani, MD, chair of the SAVC. “This is a potential lifeline for smaller outpatient practices.”

Hingorani noted that rising costs and inflation have led to the closure of many office-based labs (OBLs) in his area. He emphasized that the GPO model allows smaller practices to access the same discounted pricing typically reserved for large hospital systems.“For example, a small group like ours with three practitioners might pay half a cent per piece of gauze,” Hingorani said. “But when a larger group buys in bulk, they might pay a quarter of a cent. The GPO brings those smaller practices together to achieve similar savings.”

He continued: “We did some beta testing with practices of various sizes, asking them to identify their top 10 or 20 high-cost items. The results were promising, especially for smaller practices that don’t already benefit from economies of scale.”

Email sections@vascularsociety.org or visit vascular.org/GPO.

Getinge’s iCast covered stent system approved as bridging stent in US

By
Bryan Kay
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0
Getinge’s iCast covered stent system approved as bridging stent in US
iCast
iCast

Getinge recently announced that it has received Food and Drug Administration (FDA) premarket approval (PMA) for the iCast covered stent system. The device is now available as a bridging stent for the treatment of patients with aneurysmal disease.

Getinge states that this new indication enables physicians to preserve blood flow between a branch vessel and an endovascular graft that is approved for use with the iCast covered stent.

In March 2024, Getinge and Cook Medical entered into a distribution agreement under which Cook assumed sales, marketing, and distribution responsibilities for the iCast covered stent system in the U.S. The product, now with its expanded bridging stent indication, will continue to be distributed by Cook Medical.

Danish study suggests patients with AAA could benefit from high-dose statin use

By
Jocelyn Hudson
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0
Danish study suggests patients with AAA could benefit from high-dose statin use
L-r: Joachim Skovbo (lead author) and Jes Sanddal Lindholt (senior author)

A five-year prospective cohort study—using longitudinal registry data from two population-based screening trials—has found that high-dose statin use was associated with decreased abdominal aortic aneurysm (AAA) growth rates and lowered risk of undergoing repair, rupture, and death. Researchers therefore suggest high-dose statins should be “strongly considered” for patients with small AAAs.

Writing in Circulation, authors Joachim S. Skovbo, MBBS, from Odense University Hospital, in Odense, Denmark, and colleagues state that AAAs present with high morbidity and mortality when they occasionally rupture. Multiple meta-analyses have identified both metformin and statins as potential treatments, the authors go on to note, but neither has successfully been proven to reduce AAA growth. The present study, therefore, aimed to investigate a relationship between statin use and AAA growth rates and risk of undergoing repair, rupture, or death.

Skovbo and colleagues detail that the study population included all men with screening-detected AAAs—ranging in diameter from 30–55mm—from two large, population-based screening trials: the Viborg Vascular Screening trial and the Danish Cardiovascular Screening trial, which included patients in the years 2008–2011 and 2014–2018, respectively. The authors add that the clinical database was supplemented with data from the nationwide Danish Healthcare Registries, including prescription and outcome data. In order to evaluate the risk of repair, patients were followed from inclusion until surgery, rupture, death, five-year follow-up, or Dec. 31, 2021.

The researchers included a total of 998 aneurysmal men with a mean age of 69.5 years and a median AAA diameter of 35.4mm in the study. They report in Circulation that statin use was “significantly associated with reduced AAA growth rate,” sharing that an increase of one defined daily dose statin per day was associated with an adjusted change in growth rate of -0.22mm per year.

Additionally, Skovbo and colleagues relay that the five-year adjusted hazard ratio for undergoing repair per doubling of statin dose presented a “significantly reduced adjusted hazard ratio” of 0.82, which they note was significant after 2.5 years.

“Statin use was associated with a significantly lower risk of the composite outcome (surgery, rupture, and death) in a dose-dependent manner,” the authors continue, citing an adjusted hazard ratio of 0.83 per doubling of statin dose.

Skovbo and colleagues write that their findings were “robust” in several sensitivity analyses and conclude that high-dose statin use was associated with a dose-dependent reduction in AAA growth rates and a lower risk of undergoing repair, rupture, and death during a five-year follow-up period.

“These findings study suggest that high-dose statins may offer direct protection against AAA progression, beyond cardiovascular risk reduction alone,” Skovbo and colleagues write.

Considering the clinical implications of their work, the authors advise that, “Because of their proven cardiovascular benefits, safety profile, and cost-effectiveness, high-dose statins should be strongly considered for patients with small AAAs, particularly those without contraindications.”

“Although randomized trials may be ethically challenging,” the authors continue, “further high-quality observational studies are needed to validate these findings and inform clinical guidelines.”

Generalisability concerns

In their Circulation paper, Skovbo and colleagues highlight certain limitations that curb the generalizability of their findings. For example, they note that the study included only male patients, reducing the generalizability of the results to the female population.

Furthermore, the authors recognize that the study cohort primarily consists of White individuals from a Western society between 60 and 74 years of age, going on to note that “caution is warranted when extrapolating these findings to other racial and ethnic groups, age groups, or different societal contexts.”

Recognizing the difficulties of performing randomized controlled trials to assess to treatment options for patients with AAA, the authors instead “advocate for observational studies with a similar design, emphasizing precise exposure measurement and detailed dose-response outcome, to replicate and further validate our findings especially in women and ethnic groups.”

Medtronic enrols first patient in Onyx liquid embolic IDE clinical study

By
Bryan Kay
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0
Medtronic enrols first patient in Onyx liquid embolic IDE clinical study

Medtronic today announced that the first patient has been enrolled in the Peripheral Onyx liquid embolic (PELE) clinical trial, which will evaluate the safety and effectiveness of the Onyx liquid embolic system (LES) for embolization of arterial hemorrhage in the peripheral vasculature. The first procedure was performed by Christopher Stark, MD, a vascular and interventional radiologist at Albany Medical Center in Albany, New York.

Data from the PELE investigational device exemption (IDE) clinical study is intended to evaluate the safety and effectiveness of Onyx LES in the treatment of patients with active arterial bleeding in the peripheral vasculature that are deemed suitable for embolization treatment. In this study, peripheral vasculature is defined as outside of the brain and heart.

“Embolic agents are an important tool to address hemorrhage. In this case, the patient experienced bleeding due to a ruptured blood vessel following a routine medical procedure. Onyx LES was administered into the target vessel to successfully facilitate embolization,” said Stark.

This pivotal, prospective, multicenter, non-randomized, single-arm study will enroll up to 119 patients from up to 25 sites in the U.S. The primary safety and efficacy endpoints will be evaluated through 30 days following treatment with Onyx LES.

Medtronic advises that, in the U.S., the use of Onyx LES for embolization of arterial hemorrhage in the peripheral vasculature is investigational and has not been approved or cleared by the Food and Drug Administration (FDA).

Vascular Specialist–July 2025

By
Bryan Kay
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0
Vascular Specialist–July 2025
In this issue:
  • Vascular unity: ‘Let’s stop standing on the sidelines while others define what vascular care looks like’
  • Vascular surgery history: Putting specialty on the map in a broader sense
  • SVS launches partnership to help private practice vascular surgeons cut costs
  • A self-fulfilling prophecy: A fourth-year medical student’s misinformed decision

SVS president calls time on disengagement and disunity: ‘It’s time for a change’

By
Urmila Kerslake and Stanley Evans-Power
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SVS president calls time on disengagement and disunity: ‘It’s time for a change’

Vascular surgeons should come together to present a unified voice in the world of medicine—it’s time for a change, to recommit, build bridges and find common ground across a fragmented membership, and time for leaders who are willing to engage across specialty lines without compromising vascular surgery’s core values. That was the word from outgoing Society for Vascular Surgery (SVS) President Matthew Eagleton, MD, at the 2025 Vascular Annual Meeting (VAM; June 4–7) in New Orleans, during in his presidential address.

“Vascular surgery is proud of our growth and our expanding heterogeneity, yet we also suffer from it. […] Our biggest internal challenge right now is fragmentation and disunity. And it’s been a problem growing over the past several years. […] We’re not just disagreeing—we’re disengaging. And that weakens us. It weakens our credibility. It weakens our voice,” he said during the address.

“[…] So, one of the things I’m asking for, and one of the things that prior presidents have asked for, is for our groups, despite their differences, to come together so we can represent a unified voice in the world of medicine,” Eagleton tells Vascular Specialist.

Medtronic to distribute FMD’s peripheral guidewires for transradial access in US

By
Bryan Kay
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0
Medtronic to distribute FMD’s peripheral guidewires for transradial access in US

Medtronic today announced it has entered into an exclusive U.S. distribution agreement with Japan-based Future Medical Design Co (FMD) to sell specialty and workhorse peripheral guidewires. This agreement includes the first 400cm, 0.018″ peripheral guidewire available in the U.S., expanding the Medtronic portfolio for transradial access for the treatment of peripheral arterial disease (PAD).

Medtronic shares that it is the sole distributor of 10 new F-14 and F-18 peripheral stainless steel guidewires, available in 300cm and 400cm lengths. According to the company, the 0.018” 400cm wire, along with the 200cm working length IN.PACT 018 drug-coated balloon and Pacific Plus percutaneous transluminal angioplasty (PTA) catheter, provides physicians with a comprehensive suite of tools needed to reach lesions from a transradial approach.

Medtronic details that the FMD guidewires are engineered for crossability, trackability, and tip retention, allowing for the treatment of complex cases.

Cook announces US launch of Zenith iliac branch device

By
Bryan Kay
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0
Cook announces US launch of Zenith iliac branch device
Zenith iliac branch device

Cook Medical has announced that its Zenith iliac branch device (ZBIS) is now commercially available in the U.S. with Food and Drug Administration (FDA) approval as an endovascular treatment option for aortoiliac or iliac aneurysmal disease. 

The company has also shared that first implantations of the ZBIS were performed at several centers in the U.S.

According to Cook, the ZBIS—when used with the necessary additional components (Zenith AAA and a covered bridging stent)—is indicated for the endovascular treatment of patients with an aortoiliac or iliac aneurysm to preserve internal iliac arterial blood flow when the distal sealing site in the common iliac artery is insufficient for the abdominal aortic aneurysm (AAA) device alone and when the vessel morphology is suitable for repair.

Letter to the editor: Physicians and APPs should work together to address complex needs of vascular patients

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Letter to the editor: Physicians and APPs should work together to address complex needs of vascular patients
Doctor holding touching hands Asian senior or elderly old lady woman patient with love, care, helping, encourage and empathy at nursing hospital ward : healthy strong medical concept

Dear editor,

As members of the Society for Vascular Nursing (SVN) Board of Directors, the Society for Vascular Surgery (SVS) Advanced Practice Provider (APP) Section, and representatives of our broader membership, we feel compelled to respond to Dr. Arthur Palamara’s recent opinion piece published online April 29. While Dr. Palamara rightly identifies concerns about physician shortages and systemic challenges in healthcare, his characterization of advanced practice providers (APPs) warrants a more nuanced discussion based on current evidence.

The value of APPs in vascular care extends far beyond the mere “substitution” of physicians. Multiple studies demonstrate that APPs improve healthcare delivery through collaborative practice models. A systematic review published in the Journal for Nurse Practitioners found consistent evidence supporting the quality of care provided by nurse practitioners across various settings.1 This directly contradicts the assertion that APPs provide “negligible success” in healthcare delivery. Comprehensive analysis shows that when properly integrated into care teams, APPs contribute significantly to positive patient outcomes, enhanced access to care and cost-effectiveness.2 The statement by Dr. Palamara that APPs are “utterly unqualified to diagnose and treat patients” misrepresents our training and expertise. In a 2023 study, APP utilization in a single specialty surgical practice was found to reduce complications, decrease postoperative readmissions, and improve physician accessibility to see new and more complex patients.3 Another recent study published in the Journal of Trauma Surgery and Acute Care showed that APP utilization can improve healthcare costs, length of stay, time to consultation and treatment, overall mortality, and patient satisfaction.4

Regarding the Hattiesburg Clinic study referenced by Dr. Palamara, it’s important to note this study evaluated APPs functioning with separate patient panels rather than in collaborative team-based models that characterize modern vascular care. This distinction is crucial, as research shows optimal results occur when APPs practice within their scope as part of integrated care teams. A systematic review and meta-analysis demonstrated that nurse practitioner-led care in patients with cardiovascular disease was associated with positive outcomes comparable to physician-led care.5 Additionally, a comprehensive review concluded that outcomes for patients under the care of nurse practitioners were comparable and, in some ways, superior to those of physicians alone.6

Our collective experience in vascular care demonstrates that APPs facilitate smooth transitions across care settings, enhance patient education, improve adherence to follow-up protocols and allow surgeons to focus on complex surgical cases where their specialized training is most needed. Multiple studies have documented that APPs in surgical specialties contribute to shorter hospital stays, reduced readmission rates, improved patient satisfaction and more efficient use of healthcare resources. Vascular surgery hospitalist programs have demonstrated improved surgeon satisfaction, resource utilization, timeliness of patient care, and enhanced communication among referring physicians and staff.7 Research specific to vascular surgery has shown that integrating nurse practitioners into outpatient vascular clinics significantly increased patient satisfaction scores, with substantial improvements in metrics such as “likelihood to recommend” and perceptions of staff collaboration.8

The future of vascular care depends on collaborative models that leverage the complementary skills of all team members. Rather than promoting divisive rhetoric, we should focus on optimizing team-based care where physicians and APPs work together to address the complex needs of vascular patients. The evidence overwhelmingly supports that APPs enhance, not diminish, the quality of care when properly integrated into specialty practices. As we face growing demands for vascular services amid physician shortages, we must move beyond outdated paradigms to embrace collaborative solutions that serve our patients’ best interests while supporting the well-being of all healthcare providers.

Respectfully submitted,

The SVN Board of Directors and the SVS APP Section

References

  1. Stanik-Hutt J et al (2013). The quality and effectiveness of care provided by nurse practitioners. The Journal for Nurse Practitioners, 9(8), 492-500. https://doi.org/10.1016/j.nurpra.2013.07.004
  2. Swan M et al (2015). Quality of primary care by advanced practice nurses: A systematic review. International Journal for Quality in Health Care, 27(5), 396-404. https://doi.org/10.1093/intqhc/mzv054
  3. Hollenbeck BK et al. Effects of advanced practice providers on single-specialty surgical practice. Ann Surg. 2023 Jan 1;277(1):e40-e45. doi: 10.1097/SLA.0000000000004846. Epub 2021 Mar 3. PMID: 33914476; PMCID: PMC8989058
  4. Lasinski AM et al. Advancing the practice of trauma: utilizing advanced practice providers to improve patient outcomes through a collaborative team approach. Trauma Surg Acute Care Open. 2024 Aug 21;9(1):e001281. doi: 10.1136/tsaco-2023-001281. PMID: 39175840; PMCID: PMC11340716
  5. Smigorowsky MJ et al (2020). Outcomes of nurse practitioner‐led care in patients with cardiovascular disease: A systematic review and meta‐analysis. Journal of Advanced Nursing, 76(1), 81-95. https://doi.org/10.1111/jan.14229
  6. Newhouse, RP et al (2011). Advanced practice nurse outcomes 1990-2008: A systematic review. Nursing Economics, 29(5), 230-250.
  7. Cull, DL et al (2013). The influence of a vascular surgery hospitalist program on physician and patient satisfaction, resident education, and resource utilization. Journal of Vascular Surgery, 58(4), 1123-1128. https://doi.org/10.1016/j.jvs.2013.04.052
  8. Dunlap E, Fitzpatrick S, Nagarsheth K (2022). Collaboration with advanced practice registered nurses to improve patient satisfaction in outpatient clinic. The Journal for Nurse Practitioners, 18(9), 1009-1012. https://doi.org/10.1016/j.nurpra.2022.06.012

Vascular surgery history: Putting specialty on the map in a broader sense

By
Bryan Kay
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0
Vascular surgery history: Putting specialty on the map in a broader sense
Jerry Goldstone

The people, discoveries, innovations and events that brought the vascular surgery profession to where it is today formed the bedrock of the subject matter for this year’s John Homans Lecture—“Who put the vascular in vascular surgery?”—at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7).

Jerry Goldstone, MD, an adjunct professor at Stanford University College of Medicine, pored over some of the most important developments in the field since the founding of the SVS in 1946, an occurrence which set the stage for the modern vascular surgical specialty.

“When the 31 founding members were gathered for their first meeting in 1947, how could they possibly have imagined what vascular surgery is like today,” Goldstone told Vascular Specialist. “They formed this organization because there was no organization devoted to vascular surgery. Most were general surgeons with a special interest in vascular, some were cardiac people with a special interest in vascular.”

What they helped shape yielded some tremendously important advances over the years, minting vascular surgery as a bona fide, standalone specialty in its own right, Goldstone told VAM 2025. After canvassing colleagues in the field, he landed on “about 10 of the
most important things that got us from 0 to a place, now, where there is one big society, 6,000 members, our own journals, recognition internationally, good science,”
he explained.

Among the topics he charted were the formation of the SVS and its merger with the American Association for Vascular Surgery (AAVS), previously the North American Chapter, International Society for Cardiovascular Surgery (NA-ISCVS); the development of grafts; the coming of the vascular lab and duplex ultrasound; carotid endarterectomy (CEA); two innovations in venous disease in the shape of the Greenfield filter for pulmonary embolism (PE) and laser ablation of the great saphenous vein; the founding of the Journal of Vascular Surgery (JVS); and the birth of the vascular surgery fellowship.

For one, the merger that created the modern SVS in 2003 brought together a society that was exclusive with one that bore a larger, more unlimited membership base “into one
big organization that has 6,000 members.”

That’s one of the major developments, Goldstone related. But much earlier, the development of grafts brought vascular surgery from a place of few repair options to one in which, from the early 1950s, a vein graft became available for the lower extremity, continuing on with further developments for larger vessels. The coming of the first textile graft emerged and “changed everything,” Goldstone continued. “So now, by the mid-50s, we’ve got grafts that can basically repair any artery anywhere—that’s a huge jump forward for the profession.”

The vascular lab and duplex ultrasound machine, meanwhile, “literally changed the nature of the diagnosis,” he said. They brought diagnosis directly into the hands of vascular surgeons, now with the tools in their offices. “You get real anatomic information, and at the time all of this was going on, angiography existed, but it’s risky, painful, expensive and it’s a little complicated. So, now [with the lab and ultrasound], we have non-invasive things that allow for better diagnosis, follow-up and management of patients.”

The rise of CEA helped push the vascular specialty further forward, Goldstone said. “After all, we are a surgical specialty, and known by the operations we do, and one of the most common and distinctive is CEA,” he explained. “It put vascular surgeons into contact with other people, in other specialties, and elevated the profession beyond its own little cocoon, as maybe a little different from general surgery. It put vascular surgery as a profession on the map in a broader sense.”

Goldstone also focused on important developments in venous disease treatment, referencing how the surgeon for whom the lecture is named, John Homans, MD, had a special interest in veins. “One was the Greenfield filter, because PE is still a common problem and still can be deadly,” he noted. “In the old days, they were tying off veins to prevent clots from going to the lung, and there had been a bunch of efforts to do things to the vena cava that didn’t work very well, and then Greenfield came up with this filter that really changed the management of that condition.”

Researchers examine safety of prophylactic spinal fluid drainage in open and endovascular TAA and TAAA patients

By
Jocelyn Hudson
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0
Researchers examine safety of prophylactic spinal fluid drainage in open and endovascular TAA and TAAA patients
Lucas L. Skoda

“Spinal fluid drainage be considered when the risk of spinal cord injury from the procedure is greater than the risk of severe complications from spinal fluid drainage.” This was one of the concluding findings of a study presented during the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7) by submitting and presenting author Lucas L. Skoda, DO, assistant professor of anesthesiology at the University of Wisconsin in Madison, Wisconsin.

Skoda was presenting the results of a study that aimed to review the use of prophylactic spinal fluid drainage (SFD) for the prevention of spinal cord injury (SCI) in open and endovascular thoracic (TAA) and thoracoabdominal aortic aneurysm (TAAA) repair and evaluate the complications of SFD.

Skoda and colleagues’ study included all patients treated at a single institution from 1987–2023 for open and endovascular TAA and Crawford type I, II, III and IV TAAA. Skoda noted that prophylactic SFD was used in open TAA and TAAA surgery and endovascular surgery planning >12cm of aortic coverage.

SFD was part of a multifactorial strategy to reduce SCI, and cardiac anesthesiologists placed all drains and managed spinal fluid drainage according to a strict protocol, including rescue drains placed for delayed SCI, the presenter detailed.

Of 1,445 patients included in the study, Skoda shared that 1,007 had prophylactic SFD, a figure that included 777 open repairs and 230 endovascular repairs.

Outlining the study results, Skoda revealed that six (0.6%) patients had neurologic complications from spinal fluid drainage—five (0.77%) in open repair and one (0.43%) (0.43%) in endovascular repair. Four of the six patients with neurologic deficits from SFD died.

Concluding, Skoda stated that severe complications from SFD should be defined as those resulting in neurologic deficit, and that the appearance of bloody fluid during SFD is an indicator of possible intracranial blood, but without neurologic symptoms it is benign.

The presence of prophylactic SFD can be performed with “acceptable risk of severe complications” in open and endovascular repair, Skoda continued, adding that safer SFD requires “consistent teams and management protocols.” The senior author for this paper was Martha M. Wynn, MD, emeritus professor at the University of Wisconsin School of Medicine & Public Health in Madison.

VQI to host webinar on updated smoking cessation variables

By
Marlén Gomez
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0
VQI to host webinar on updated smoking cessation variables

The Society for Vascular Surgery (SVS) Patient Safety Organization (SVS PSO) will host a webinar on Tuesday, July 15, at 1 p.m. Eastern Time to present updates to the National Quality Initiative Smoking Cessation variables within the SVS Vascular Quality Initiative (VQI) Registry.

Caroline Morgan, PSO director of clinical operations, will lead the one-hour session and highlight recent revisions, as well as other registry changes.

Humacyte announces Symvess ECAT approval from US Defense Logistics Agency

By
Bryan Kay
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0
Humacyte announces Symvess ECAT approval from US Defense Logistics Agency
Human Acellular Vessel
ATEV
Symvess

Humacyte announced today that Symvess has been awarded Electronic Catalog (ECAT) listing approval from the U.S. Defense Logistics Agency.

ECAT is an internet system that provides the Department of Defense (DOD) and other federal agencies with access to manufacturers’ and distributors’ products. The approval makes Symvess available to healthcare professionals treating military service members, veterans, and other patients receiving care at DOD and U.S. Department of Veterans Affairs facilities.

Symvess (acellular tissue engineered vessel-tyod) was approved in the extremity vascular trauma indication by the Food and Drug Administration (FDA) in December 2024.

“We are pleased that Symvess is now listed in the ECAT system, making the product more readily available to healthcare professionals treating military personnel and their families,” said Laura Niklason, president and chief executive officer of Humacyte. “We have received positive feedback in our interactions with a number of DOD hospitals, and we look forward to making Symvess available to more patients in need.”

Humacyte advises that, for uses other than the FDA approval in the extremity vascular trauma indication, the acellular tissue engineered vessel (ATEV) is an investigational product and has not been approved for use or sale by the FDA or any other regulatory agency.

Gore announces MDR expanded indication for the Viabahn VBX balloon-expandable endoprosthesis as a bridging stent

By
Bryan Kay
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0
Gore announces MDR expanded indication for the Viabahn VBX balloon-expandable endoprosthesis as a bridging stent
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Viabahn VBX balloon expandable endoprosthesis

Gore today announced CE-mark approval of an expanded indication for the Gore Viabahn VBX balloon-expandable endoprosthesis (VBX stent graft) when used as a bridging stent with branched and fenestrated aortic endografts in the treatment of aortic aneurysms involving the renal and mesenteric arteries.

“This is a landmark indication for a stent graft, equipping physicians with an on-label solution for more patients in complex pathologies,” said Luca Bertoglio (Spedali Civili Brescia, Brescia, Italy), co-ordinating investigator of the EMBRACE registry.

A total of 259 patients were enrolled in EMBRACE. Gore reports high rates of patency and freedom from endoleaks, target vessel instability and reinterventions were observed with the VBX stent graft in both branched and fenestrated endovascular aneurysm repair (BEVAR and FEVAR) cohorts at one year.

“We have studied performance in both fenestrated and branched cohorts, and the results demonstrate that we can safely and effectively treat these patients with the VBX device,” Bertoglio added.

This multicentre, retrospective and prospective registry was conducted to evaluate the clinical performance and safety of the VBX stent graft as a bridging stent. A total of 14 centres in Europe enrolled 259 patients who have had treatment with the VBX stent graft. These patients will have prospective follow-up visits up to five years after the index procedure.

“Physicians have waited some time for an approved bridging stent indication for fenestrated and branched repair. Having a CE-marked indication is very important, as it is certainly of relevance to the endovascular community and the eligible patient population,” said Mauro Gargiulo (IRCCS S Orsola Hospital and University of Bologna, Bologna, Italy), principal investigator of the EXPAND registry. “I applaud Gore for recognising the need for a CE-mark indication and for being committed to conducting such thorough and expertly run clinical studies like EXPAND and EMBRACE.”

In the coming weeks, hospitals will start implanting the newly indicated VBX stent graft in BEVAR and FEVAR procedures. The official launch is planned after summer when many European and local congresses are taking place.

Gore shares that the VBX stent graft offers precise delivery and supports positive outcomes in a variety of complex applications. The device was developed utilising the small diameter, ePTFE stent graft technology from the Gore Viabahn endoprosthesis. The VBX stent graft is available in a range of diameters from 5 to 11mm and lengths of 15, 19, 29, 39, 59 and also 79mm. It is currently the longest balloon-expandable stent graft available, according to Gore, covering a wide variety of treatment needs. The company adds that the VBX stent graft offers the largest range of diameter adjustability in a single device, with a maximum post-dilated diameter of up to 16mm with 8L or 11mm devices.

Novel MRI technique for CLTI poised to address ‘medieval problem in modern medicine’

By
Éva Malpass
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0
Novel MRI technique for CLTI poised to address ‘medieval problem in modern medicine’
Trisha Roy

“We want to change global standards. What we’re doing isn’t working. Patients are getting hurt and devices are failing—we want to be able to make sure devices we’re using today are safe, so that we can build new devices that are going to meet our needs for tomorrow.”

This was the statement made by Trisha Roy, MD, from Houston Methodist Hospital in Houston, Texas, during a 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7) talk on image-guided precision in peripheral arterial disease (PAD) management. Her talk introduced a novel magnetic resonance imaging (MRI) method aimed to turn “clinical failures into new innovations,” tackling the “often demoralizing” battle to save limbs in the treatment of chronic limb-threatening ischemia (CLTI).

Referencing Wednesday’s session titled “Who should not undergo endovascular treatment for CLTI,” Roy admitted that the average VAM attendee came away with “more questions than answers.” In her view, “a big problem [with treatment for CLTI] is that we’re making these life-altering decisions based on diagnostic angiograms that show you contrast in lumen, but nothing about plaque, its composition, or about how hard, soft or malleable [the lesion] is going to be. And I don’t think that’s acceptable in 2025.”

To address this, Roy described the three-pronged approach that she and her colleagues take to treating CLTI—see it, treat it, know it. First, Roy described her team’s novel MRI method that addresses which patients have problematic lesions in advance of treatment.

“CLTI is a medieval problem in modern medicine, even with imaging and endovascular treatment we still have a very high immediate technical failure rate, mostly due to an inability to cross the lesion,” said Roy. To provide lesion characteristic details to potentially address this failure rate, Roy and colleagues’ MRI method uses T2 weighted and ultra-short at-the-time imaging to provide “unique signatures that show you whether something is fat, thrombus, soft matrix or hard materials like collagen and calcium,” Roy explained.

“When we use this in our prospective patient study, MRI predicted endovascular failure, need for adjunctive devices and reintervention rates. I think it’s important because not only are you identifying modes of failure—or who’s going to be high risk—but you can plan your procedures and set yourself up for success by knowing what tools you need,” continued Roy.

Addressing their second pillar: treat it, Roy placed emphasis on using “failure as a blueprint for innovation.”

“You know, we have a lot—a lot—of tools at our disposal. We don’t really know how to choose them appropriately,” Roy stated. “We’ve had so many recent device recalls and failures and I think those were preventable.” She described her team’s peripheral vascular device core which tests “real devices in real patients to identify failure modes before they become clinical events.”

Presenting a united front to address vascular surgery’s structural and financial challenges

By
Bryan Kay
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0
Presenting a united front to address vascular surgery’s structural and financial challenges
The 2025 Crawford Forum in New Orleans

Vascular surgeons must present a unified front in order to address structural and financial challenges facing the specialty, Society for Vascular Surgery (SVS) President-Elect Keith Calligaro, MD, said in summing up this year’s E. Stanley Crawford Critical Issues Forum at the 2025 Vascular Annual Meeting (VAM) in New Orleans. This year, the annual forum explored ways to “empower” the vascular community to confront these head on and covered topics ranging from vascular surgery’s position within heart and vascular centers, to unionization and fair financial reimbursement.

First up, Malachi Sheahan III, MD, chair of surgery at the Louisiana State University Health Sciences Center in VAM host city New Orleans, addressed one of the thorniest topics: the issue of heart and vascular centers and vascular surgery’s position within them. Fundamentally, he asked whether the specialty’s role is being a peripheral part of the heart and vascular center?

“If we cohabitate heart and vascular, I just see no way we are going to come out on top,” he told those gathered. “For most of us here, we are at too much of a disadvantage for this to be a successful paradigm for our care.”

Next, Faisal Aziz, MD, the chief of vascular surgery at Penn State University in Hershey, Pennsylvania, contemplated the position of departments of vascular surgery in both academic and community hospital settings, ultimately asking, “Are they worth fighting for?” “The best interests of vascular surgery are not served by being a part of heart and vascular institutes, or by departments of surgery—I think it is about time that we declare our independence,” he said.

Sunita Srivastava, MD, assistant professor of surgery at Massachusetts General Hospital in Boston, addressed how vascular surgeons can attain fair financial reimbursement from a marketing and fair compensation perspective. Her talk, based on a report of the SVS Population Health Task Force, looked at outside pressures impacting fair compensation. “The financial advantage of a vascular surgeon to healthcare is severely underestimated and very difficult to measure,” she told VAM 2025 attendees. “We contribute the technical revenue to a service, we are not given credit for it. When our operative assistance is needed, we drive the complexity, we drive the financial value, and the contribution margin to the hospital.”

Last up, Enrico Ascher, MD, professor of surgery at New York University in New York City and CEO of the Vascular Institute of New York, tackled the question of potential unionization, asking, “How can vascular surgeons unionize when 95% of payments come from Medicare?” he said. “As issues with full time employees and patients increase, the topic of unionization is not going to go away, it is just going to become deeper and [more] robust.”

Calligaro, at the time SVS president-elect, now SVS president following the conclusion of VAM 2025, identified the need for vascular surgery unity. “The overriding theme from this whole session is that we need to be unified. There are disagreements on certain issues, but we really need to speak as one voice, get together and try to figure out what we can by working together.”

Calligaro, who as the incoming SVS president was responsible for organizing the forum, assembled the panel of four leading vascular surgeons to tackle some of the hottest topics of the day that speak to how vascular surgery is structured in hospitals and medical centers, as well as how vascular surgeons are reimbursed and organized.

“Fundamentally, we want to inform our SVS members what they can do to become better positioned with their hospital administrations and compared to other specialties, so that we are in a better position to take care of our patients for ourselves,” the chief of vascular surgery at Pennsylvania Hospital in Philadelphia told Vascular Specialist ahead of the event.

RESCUE II results on Thrombolex’s Bashir endovascular catheter for PE published

By
Bryan Kay
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0
RESCUE II results on Thrombolex’s Bashir endovascular catheter for PE published
Bashir endovascular catheter
PE
Bashir endovascular catheter

Thrombolex recently announced the publication of RESCUE-II study results in JACC: Advances.

The RESCUE-II study was a single-centre, prospective study evaluating the safety and feasibility of on-the-table (OTT) pharmacomechanical lysis (PML) without postprocedural infusion when treating patients with acute intermediate-risk pulmonary embolism (PE). Nine patients were enrolled and successfully treated with low dose r-tPA (4mg per pulmonary artery) using the Bashir endovascular catheter (BEC).

Thrombolex reports that, at 48 hours, the mean right ventricle to left ventricle (RV/LV) ratio decreased by 22.3%, and pulmonary artery obstruction, as measured by the Refined Modified Miller Index, was reduced by 29.2%. There were no major bleeding events, no deaths or serious adverse events through 30-day follow-up.

Thrombolex advises that an independent data safety monitoring board adjudicated all clinical events for the RESCUE-II study, while imaging data were assessed by an independent Core laboratory.

Cook Medical issues Class I recall for Beacon Tip angiographic catheters

By
Bryan Kay
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0
Cook Medical issues Class I recall for Beacon Tip angiographic catheters
Beacon Tip catheters (Cook Medical)
Cook Medical
Beacon Tip catheters

Cook Medical has initiated a Class I recall of its Beacon Tip 5F angiographic catheter.

This follows reports of tip separation that could result in serious injury or death. The recall, identified as the most serious type by the Food and Drug Administration (FDA), involves the removal of affected devices from clinical and commercial use.

In its notification to customers, Cook advised immediate examination of inventory to identify and quarantine any unused affected devices. Distribution and use of the affected catheters must cease immediately. The manufacturer also stressed that the recall information should be communicated throughout relevant departments and to any third parties who may have received the devices.

Cook Medical initiated the recall after field complaints revealed that catheter tips were separating both before and during patient procedures. Tip separation poses significant clinical risks, including catheter fragmentation and embolization, which may lead to severe complications such as sepsis, vessel perforation, thrombosis, embolism, cardiac arrhythmia, or death.

To date, three serious injuries linked to this issue have been reported, with no associated deaths.

Beacon Tip catheters are used by trained physicians to facilitate angiographic procedures, which provide imaging of blood vessels. These devices are commonly employed in combination with vascular access sheaths and guidewires using standard interventional techniques.

Healthcare providers and consumers in the U.S. are encouraged to report any adverse reactions or quality concerns related to this device to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

SCAI publishes chronic venous disease management guidelines

By
Jocelyn Hudson
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0
SCAI publishes chronic venous disease management guidelines
Photo by Wesley Tingey on Unsplash
Photo by Wesley Tingey on Unsplash

The Society for Cardiovascular Angiography & Interventions (SCAI) has released new, evidence-based clinical practice guidelines to support the treatment of chronic venous disease (CVD).

Published in JSCAI with an accompanying technical review, the document offers recommendations on a range of therapeutic options—from compression therapy and wound care to ablation, sclerotherapy, phlebectomy, and deep vein stenting. The Society for Vascular Medicine has endorsed the guidelines.

“These are the first SCAI guidelines focused on chronic venous disease, and they come at a time of increasing recognition of the burden it places on patients and healthcare systems,” said Robert Attaran (Yale School of Medicine, New Haven, USA), chair of the guideline writing committee and member of the SCAI Vascular Disease Council. “CVD may present with discomfort, heaviness, and swelling, but it can progress to venous ulcers that are difficult to heal and severely impair quality of life. Our recommendations aim to provide clinicians and patients with a roadmap for personalised, evidence-informed care.”

The guideline panel addressed eight clinical scenarios, culminating in nine formal recommendations and multiple identified knowledge gaps. The guidelines provide practical insights on which patients may benefit most from conservative therapy alone and when to consider escalating to more invasive options.

The recommendations were categorised as either ‘strong’ or ‘conditional,’ depending on the certainty of the evidence and other contextual considerations, including patient values and preferences. Among the key recommendations:

  • Compression therapy is suggested for patients with symptomatic varicose veins (conditional recommendation) and strongly recommended for patients with venous ulcers (strong recommendation).
  • Ablation therapy in combination with conservative management, is suggested for patients with symptomatic reflux in the great or small saphenous veins and ulcer-associated perforator vein reflux (conditional recommendations) in combination with conservative management.
  • Foam sclerotherapy and phlebectomy, when applied in patients without truncal vein reflux or with persistent symptoms after treatment of truncal veins, may be considered in combination with conservative therapy (conditional recommendations).
  • Venoplasty or stenting may offer improved quality of life and symptom relief for patients with iliocaval venous obstruction, though with low certainty of evidence (conditional recommendation).

In addition to formal recommendations, the guidelines introduce two treatment algorithms, one for patients with symptomatic varicose veins and another for those with venous ulcer disease, to help guide clinical decision-making in real-world settings. The document pays close attention to patient-centred care, shared decision-making, and the potential trade-offs associated with each treatment modality, particularly in the context of comorbid conditions such as peripheral arterial disease (PAD) or prior surgical history.

“These guidelines reflect SCAI’s commitment to bringing high-quality, evidence-based standards to areas where our members are increasingly practicing,” said SCAI President Srihari S Naidu (New York Medical College, New York, USA). “As interventional cardiologists take a larger role in managing chronic venous disease, a common problem affecting millions of people, these recommendations will help ensure that patient care remains both consistent and personalised. SCAI is proud to support this milestone publication and its vision of advancing patient outcomes through collaboration across disciplines, which ultimately increases the quality and quantity of patient access to much-needed treatment options.”

StentIt launches first-in-human trial of bioresorbable stent to treat below-the-knee CLTI

By
Bryan Kay
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0
StentIt launches first-in-human trial of bioresorbable stent to treat below-the-knee CLTI

StentIt has announced the successful implantation of its Resorbable Fibrillated Scaffold (RFS). As part of the VITAL-IT 1 study, patients with chronic limb-threatening ischemia (CLTI) below the knee have successfully been treated using the RFS implant. In this clinical procedure, revascularization was achieved using an endovascular approach to restore blood flow to the foot.

StentIt’s RFS device is a bioresorbable stent built from microfibers, providing structural support to instantly open, and facilitate the reconstruction of the artery. Due to the porous design of the implant, patient’s own cells infiltrate into the mesh, triggering the formation of new vascular tissue. While the artery is being reconstructed from the inside-out, the synthetic implant gradually resorbs and ultimately disappears over time. 

VITAL-IT 1 (NCT07006467) is a prospective, non-randomized feasibility study, designed to evaluate StentIt’s RFS device in up to 10 patients with below-the-knee CLTI. This single-centre study is being conducted at the Medical University of Graz, Austria. All study patients will be monitored for 24 months.

“This first-in-human clinical study will provide an important indication on the translational potential of this new technology in CLTI patients,” said Marianne Brodmann, MD, from Medical University of Graz in Graz, Austria. “This device combines key attributes of temporary structural support with regenerative properties, which could minimize the need for reinterventions.”

Vivasure Medical submits premarket approval to FDA for PerQseal Elite closure system

By
Bryan Kay
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0
Vivasure Medical submits premarket approval to FDA for PerQseal Elite closure system

vivasure medicalVivasure Medical has announced the submission of a premarket approval application to the Food and Drug Administration (FDA) for its PerQseal Elite vascular closure system for arterial procedures.

In a recent press release the company has stated that the submission builds upon the successful results of the PATCH study as well as positive clinical use in Europe, reinforcing the system’s potential safety and performance profile. In addition, the company received European CE mark approval for an expanded indication for PerQseal Elite covering large-bore venous closure. This follows its first CE mark approval in April 2025 for arterial procedures and positions PerQseal Elite as the first fully bioresorbable, sutureless solution in Europe for both arterial and venous access closure.

The PerQseal Elite vascular closure system is designed for fully absorbable, sutureless closure following percutaneous cardiovascular procedures. Currently, there are no fully bioresorbable devices available on the market for closure following large-bore procedures. Moreover, unlike other current devices, PerQseal Elite does not require any pre-procedure steps, further simplifying the process.

The PerQseal Elite vascular closure system is placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques and returning the vessel to its natural state without leaving materials like collagen, metal implants, or sutures behind.

Three honored in VAM 2025 Poster Competition

By
Marlén Gomez
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0
Three honored in VAM 2025 Poster Competition
From left: Jason Lee, Dawn Coleman, Hassan Chamseddine and Matthew Eagleton

The final day of the 2025 Vascular Annual Meeting (VAM) in New Orleans honored three winners in the championship round of the SVS Poster Competition. The audience voted to select the winners from more than 100 entries highlighting innovative research.

Hassan Chamseddine, MD, took first place and a $1,500 prize for “Time is intestine: The impact of timely intervention on acute mesenteric ischemia outcomes.”

Ben Li, MD, earned second place with a $1,000 prize for “Predicting one-year successful clinical use of an arteriovenous access for hemodialysis using machine learning.”

And Samantha Fountain, MD, was awarded third place and a $500 prize for “Racial disparities in cardiac risk index calculators for vascular surgery complication rates.”

ATEV shows promise in high-risk patients on hemodialysis

By
Jocelyn Hudson
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ATEV shows promise in high-risk patients on hemodialysis

Results from the CLN-PRO-V007 pivotal phase 3 clinical trial of the acellular tissue engineered vessel (ATEV; Humacyte) in arteriovenous access for patients at high risk of autologous arteriovenous fistula (AVF) maturation failure with end-stage renal disease were presented at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7).

The trial’s results, presented by Mohamad A. Hussain, MD, an assistant professor of surgery at Brigham and Women’s Hospital and Harvard Medical School in Boston, demonstrated the superiority of ATEV over autologous AVF in high-risk patients with end-stage kidney disease (ESKD).

CLN-PRO-V007 was a prospective, multicenter, two-arm, randomized controlled trial comparing the efficacy and safety of ATEV and AVF in ESKD patients on hemodialysis undergoing single-stage surgical vascular access creation.

AVF is the preferred method for vascular access in hemodialysis patients as, when successful, it can reduce long-term catheter use and associated complications. However, women and patients with obesity and diabetes are at higher risk of AVF maturation failure, meaning the fistula doesn’t develop adequately for use in dialysis, often resulting in prolonged catheter dependence and increased morbidity.

ATEVs are bioengineered blood vessels grown from human vascular cells, designed to restore, replace, or enhance the function of damaged or diseased vascular tissue.

The trial enrolled a total of 242 ESKD patients, of which 110 were specified as high-risk of fistula non-maturation (defined as all as females and males with a body mass index (BMI) ≥ than 30kg/m2 and having diabetes).

Humacyte previously announced positive topline results from the trial in October 2024, whereby the ATEV demonstrated superior function and patency at six and 12 months (co-primary endpoints) compared to autogenous fistula.

In the latest study ATEV was observed to have better functional patency, usability, and a comparable access-related complication profile compared to AVFs in this high-risk subgroup of patients.

The safety profile of the ATEV was reported to be comparable to AVF, with similarly low rates of infections. The cohort of patients treated with ATEV had more thrombosis and stenosis events compared to AVF, however the majority were successfully treated. Patients treated with ATEV had a lower need for maturation and surgical revision procedures compared to AVF.

“Often, we see patients who are considered high-risk and in end-stage kidney failure needing multiple interventions and autologous arteriovenous fistulas often failing,” said Hussain, the lead author of the study. “Acellular tissue engineered vessels are a new and exciting technology in regenerative medicine that has the potential to make a great impact in how we treat a vulnerable population.”

Authors note, a currently enrolling randomized control study is looking specifically at high-risk ESKD female patients across multiple centers in the U.S. who receive ATEV or AVFs to further analyze the effectiveness specifically in the female population. For uses other than Food and Drug Administration (FDA) approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Claim CME credits from 2025 vascular meetings

By
Marlén Gomez
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Claim CME credits from 2025 vascular meetings

Attendees of the 2025 Vascular Annual Meeting (VAM), Vascular Quality Initiative (VQI) Annual Meeting, and Society of Vascular Nursing (SVN) Annual Conference are reminded to claim their continuing medical education (CME) credits by 10:59 p.m. Central Time on July 7.

Participants can secure their credits by logging into the VAM 2025 Online Planner or Mobile App with their SVS credentials. From there, click the blue “Credits and Certifications” icon or select “Claim Credits” from the left-hand menu and follow the instructions.

For assistance, contact the education team at education@vascularsociety.org.

Join us: SVS goes to Washington

By
Marlén Gomez
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Join us: SVS goes to Washington

The Society for Vascular Surgery (SVS) invites members to register for its inaugural Advocacy and Leadership Conference, taking place Sept. 14–16, in Washington, D.C. The conference will bring together vascular surgeons, trainees, fellows and other key contributors to engage in the policymaking process and advocate for the specialty and the patients they serve.

Attendees will learn about crucial legislative and regulatory issues impacting vascular care, sharpen their advocacy skills through interactive training sessions and engage in direct discussions with members of Congress and senior policy staff during scheduled Capitol Hill visits.

SVS members at all career stages can register. Space is limited. To register, visit vascular.org/Advocacy.

Award-winning basic science research targets ‘highly complex’ process of vascular calcification

By
Jocelyn Hudson
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Award-winning basic science research targets ‘highly complex’ process of vascular calcification
Sujin Lee

“We were really excited to know that the SVS [Society for Vascular Surgery] is supporting our research,” Sujin Lee, MD, told Vascular Specialist on receiving the SVS Foundation James S.T. Yao Resident Research Award for a paper examining the role of the FNDC1 protein in vascular calcification.

Lee, a vascular surgery resident at Massachusetts General Hospital in Boston, presented the paper—“FNDC1 is implicated in small- and large-vessel arterial disease and induces vascular calcification via PI3K/AKT signaling and the nicotinamide adenine dinucleotide [NAD] salvage pathway”—during the recent Vascular Annual Meeting‘s William J. von Liebig Forum, the premier plenary session at the conference.

The focus of the research project, which Lee noted has spanned more than three years, is the “highly complex and active pathobiological process” that is vascular calcification. Despite its prevalence in vascular surgery patients, Lee highlighted that there are currently no therapies that directly target vascular calcification—a gap in the literature that she and colleagues hope to address.

“The goal of this project was to really understand the mechanisms behind vascular calcification,” Lee said. “We wanted to look at the convergence between small and large vessel calcification to determine the molecular pathways that drive the phenotypic change of vascular smooth muscle cells to bone-like cells.”

To do so, Lee explained that the research team looked at two different models of vascular calcification: calciphylaxis (to model small-vessel disease) and coronary artery disease (to model large-vessel disease).

Lee continued: “We did human transcriptomic studies to look at the differentially expressed transcriptomes and the different pathways that are perturbed in the disease state for both of these disorders of vascular calcification.”

Subsequently, Lee shared that the top 10 upregulated genes in each of the two disease states were validated at the protein level on immunofluorescent staining.

“We were able to narrow down that list to one protein, which is FNDC1, or fibronectin type III domain-containing protein 1,” Lee said, going on to note that knockdown and overexpression experiments using vascular smooth muscle cells demonstrated that FNDC1 was necessary to induce the calcific phenotype switch of smooth muscle cells in vascular calcification. She then looked at the mechanism of action before conducting further network analyses.

Summarizing this part of the study, Lee outlined that there are two major pathways that FNDC1 might be activating to induce vascular calcification: the PI3K/AKT signaling pathway and the NAD biosynthesis pathway, “which deals with metabolic reprogramming of the cell.”

Furthermore, Lee noted that the genetic deletion of FNDC1 attenuated aortic calcification and improved survival in two mouse models of vascular calcification. The researchers also found that the administration of a small molecule inhibitor of one of the downstream targets of FNDC1 protected against calcification, which Lee stated are promising results for a potentially new therapy targeting calcification in humans.

Finally, Lee reported that the team conducted a further study using the UK Biobank to assess whether FNDC1 can be used as a biomarker in both calciphylaxis and coronary disease in large human cohort studies. “There were 43,000 patients within the UK Biobank that seemed to have an association between FNDC1 and cardiovascular morbidity and mortality,” Lee revealed.

Beyond the research presented at VAM, Lee detailed that the next step is to “continue to build on our understanding of the mechanisms of vascular calcification and to ultimately develop a therapy.”

The James S. T. Yao Resident Research Award is intended to motivate physicians early in their training to pursue their interest in research that explores the biology of vascular disease and potential translational therapies.

Senior vascular surgeons: 10 options beyond the operating room

By
Kenneth Ouriel, Daniel Clair, Alan Dietzek and Enrico Ascher
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Senior vascular surgeons: 10 options beyond the operating room
Clockwise from top left: Kenneth Ouriel, Daniel Clair, Alan Dietzek and Enrico Ascher

As vascular surgeons advance in their careers, many begin to consider alternative professional paths that draw upon their clinical expertise, while offering greater flexibility, intellectual stimulation or new challenges outside the traditional confines of full-time clinical practice. Whether motivated by physical demands, shifting professional interests or a desire to contribute in new ways, seasoned vascular surgeons have a wide array of fulfilling and impactful options. These career directions are open to those from clinical, academic or hybrid backgrounds.

1. Clinical research and leadership in clinical research organizations

Experienced vascular surgeons often move into roles centered on clinical research. Their procedural knowledge and understanding of patient care position them well to serve as principal investigators or advisors within clinical research organizations (CROs) or their academic-based counterparts, academic research organizations (AROs). Responsibilities in these roles span protocol development, site selection, safety endpoint adjudications, evaluation of study outcome data, review of core laboratory images, and assisting with the overall operational aspects of the clinical trial.

In AROs and CROs, surgeons can advise on regulatory and scientific strategies for clinical studies and can ensure that trials measure outcomes and endpoints that truly matter to patients and clinicians. Awareness of clinical workflows enables the identification of practical challenges a priori, helping to develop realistic, relevant study designs that avoid impediments to efficient enrollment and adequate patient follow-up. These positions are frequently structured for part-time or hybrid work and may be performed remotely.

2. Part-time or locum tenens practices

In later years, a surgeon may wish to continue clinical practice, but at a slower pace or with reduced call commitments. This may be accomplished by moving to a remote hospital setting affiliated with a larger healthcare system. With the shortage of vascular surgeons expected to worsen over the next decade, this option offers community and physician benefits. Many practices would welcome even part-time coverage or assistance. Further, there may be opportunities to assist in the outpatient setting in a larger practice or to see patients in an outreach clinic. Sharing a practice with either another senior peer or, alternatively, a younger surgeon who may have significant out-of-hospital personal commitments may satisfy a desire for both individuals to stay clinically active at a desirable, individualized pace. Sometimes these arrangements can be done with periodic travel so that the senior surgeon can maintain their current residence.

3. Transition to non-operative practice

As senior vascular surgeons contemplate transitioning to retirement, they may consider alternatives short of completely leaving their practice. One such alternative is to shift to a solely office-based, non-operative practice. This approach is less technically and physically challenging and can be done on either a full- or part-time basis. An office-based practice allows senior vascular surgeons to continue to be involved with patient care, utilizing their vast experience and wisdom to evaluate and nonoperatively manage patients.

By referring patients who require interventions or open surgical procedures to practice associates, senior vascular surgeons can increase the overall efficiency of the practice and enhance physician satisfaction. Additionally, performing office-based minimally invasive procedures—for instance, venous procedures or wound care—can bring personal fulfillment while providing a continued source of income.

4. Academic teaching and mentorship

Education remains a natural extension for many vascular surgeons. For some, teaching residents and fellows was always a part of their responsibilities. As clinical responsibilities diminish, there’s an opportunity to expand this role. Senior surgeons may take on responsibilities as clinical faculty, giving student and resident lectures, bedside teaching on patient rounds, and participating in simulation training. Some academic institutions are open to part-time faculty appointments, making this an attractive option for surgeons to ease into semi-retirement. In some academic systems, senior surgeons can act as mentors or coaches for junior faculty to help guide younger surgeons’ academic, teaching or clinical careers. In addition, as junior surgeons may struggle with entering clinical practice, having a senior surgeon to assist with complex operations may be a role that provides professional fulfillment for a senior surgeon, and real value to the more junior surgeon and the healthcare organization.

Separate from face-to-face interactions, teaching can also take the form of medical writing and engaging in contributions to literature in the form of white papers, original research articles or chapters in textbooks.

5. Board and advisory services in healthcare organizations

Vascular surgeons increasingly contribute to governance roles on hospital boards, nonprofit foundations, health systems and professional societies. Their clinical insight can offer invaluable perspective to discussions on quality improvement, strategic direction and innovation. These roles often involve participation on quality or finance committees, or advisory input on clinical initiatives. Structured as part-time commitments, these roles can provide meaningful engagement without the demands of full-time clinical practice. Working for non-healthcare non-profit organizations or local community organizations can be equally rewarding.

Surgeons can also serve roles in larger healthcare systems by providing guidance and oversight for specialty care at regional practices where they exist. There are also often roles for individuals to oversee pricing and product standardization across a healthcare system. In addition, surgeons have long considered the electronic medical record (EMR) as a barrier to patient care efficiencies. Leveraging clinical experience to enhance the EMR can be a service well appreciated by all stakeholders in the system.

6. Medical director positions in startup medical device and biotechnology companies

Some vascular surgeons move into entrepreneurship—founding companies or advising early-stage ventures. Many early-stage companies seek part-time medical directors with firsthand clinical experience. Vascular surgeons are especially valued in companies developing endovascular tools, imaging platforms or artificial intelligence (AI)-enabled solutions. These engagements may be structured as short-term projects or long-term relationships, and often align well with surgeons who enjoy innovation, collaboration and problem-solving.

These positions are often remote, involve minimal travel and offer compensation through consulting fees, equity, or both. Surgeons in these roles influence clinical trial design, user interface development and postmarket strategies. They also often contribute to fundraising pitches, serve as key opinion leaders, and guide regulatory or reimbursement planning.

7. Executive medical leadership at large medtech companies

Some surgeons take on full-time leadership roles within major medtech firms—such as divisional chief medical officers or medical affairs directors. Responsibilities may include global trial oversight, regulatory engagement, physician education and management of key opinion leader networks.

These positions require strong communication skills and the ability to collaborate across clinical, engineering and commercial functions. In some roles, surgeons may assist in the management of clinical studies, or guide direction outside of their primary specialty, working with physicians across specialties and procedures. Though demanding, these roles allow surgeons to influence device strategy and patient care. Surgeons in these roles often serve as a critical link between practicing clinicians and corporate leadership, ensuring that innovation remains clinically grounded.

8. Regulatory service with the FDA

An often-unrecognized path is service within the Food and Drug Administration (FDA), either on a full- or part-time basis. The Center for Devices and Radiological Health (CDRH) routinely recruits physicians with domain-specific expertise to review premarket submissions, participate on advisory committees (panels), and guide the design of postmarket surveillance study design.

Vascular surgeons bring a unique ability to critically evaluate clinical evidence while understanding device function in real-world practice. Opportunities at the FDA include full-time roles or work as special government employees (SGEs) on a consulting basis.

9. Legal consulting and expert witness services

Legal consulting is another avenue that allows surgeons to remain intellectually engaged while working flexibly. Vascular surgeons may offer litigation support, conduct case reviews, or testify in malpractice or patent-related legal matters. Since this work mandates maintenance of at least part-time clinical activities, it is a nice option for surgeons interested in a transition out of full-time practice.

These roles appeal to those who enjoy applying clinical knowledge in high-stakes analytical contexts and can be pursued independently or through legal advisory networks. However, the choice of working exclusively for plaintiffs or defendants can sometimes create personal or ethical conflicts. Attorneys may exploit such decisions by questioning a surgeon’s impartiality before a jury, underscoring the importance of consistency, transparency and preparation in this line of work.

10. Insurance adjudication and utilization review

Another growing area of opportunity for senior vascular surgeons is in the insurance and healthcare payor sector. In these roles, surgeons participate in the adjudication of claims and conduct utilization reviews to assess the appropriateness and necessity of vascular procedures and hospital stays. With their deep clinical experience, surgeons can evaluate the medical justification for treatments and ensure alignment with evidence-based guidelines.

These positions can be structured on a part-time or consulting basis and are almost always performed remotely.

Conclusion: Designing a fulfilling late career

Vascular surgeons are not confined to a binary choice between clinical practice and full retirement. The options outlined here are not the only choices available, and the choices one has to transition a career are continuing to expand. An increasing range of meaningful, intellectually rich, and flexible roles are available for those who wish to remain active contributors in the field.

It is also important to recognize that a senior surgeon need not be limited to a single, ultimate career transition choice.

Kenneth Ouriel, MD, is executive vice president of medical device contract research organization NAMSA in New York; Daniel Clair, MD, is chair and professor of vascular surgery at Vanderbilt University Medical Center in Nashville; Alan Dietzek, MD, is chair of vascular surgery at Jersey Shore University Medical Center in Neptune, New Jersey; and Enrico Ascher, MD, is a clinical professor of surgery at New York University.

Advancing dialysis access outcomes with extravascular support: A triangulated clinical research approach

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Advancing dialysis access outcomes with extravascular support: A triangulated clinical research approach
C. Keith Ozaki

This advertorial is sponsored by Laminate Medical.

Arteriovenous fistula (AVF) creation remains one of the most frequent, yet frustrating procedures performed by vascular surgeons. While AVFs stand as a cornerstone of care for end-stage kidney disease (ESKD) patients, the reality is more than half of AVFs fail to mature without additional interventions.1 The downstream impacts of maturation failure are prolonged central venous catheter (CVC) dependence, procedure fatigue for patients and families, financial penalties for dialysis centers, and increased cost to hospitals, payors, and patients. Over recent decades, multiple basic research teams— including our own—recognized the complex interplay among physical hemodynamic forces, including circumferential wall strain, patient phenotype and vascular remodeling.

Building upon this science, the VasQ extravascular support device (Laminate Medical) was designed as a scaffold to guide AVF remodeling into an optimized configuration to produce a more laminar flow profile, while providing mechanical reinforcement against wall tension from excessive transluminal pressure that can lead to juxta-anastomotic stenosis. VasQ is the first to close this translational gap with a Food and Drug Administration (FDA)-approved product and the clinical research continues to support its adoption.

VasQ device

VasQ’s body of evidence includes 15 peer-reviewed publications to date, all reporting significant patient benefit, including a randomized-controlled trial in the United Kingdom.2 Our group actively participated in several of the U.S. initiatives, and here I provide a high-level overview of three recently published peer-reviewed U.S. studies, which converge to form a compelling, triangulated argument for VasQ’s safety, efficacy and impact in selected patients.

In summary, VasQ patients experienced higher functional success rates at earlier timepoints, as well as reduced intervention rates and reduced CVC exposure at six months when compared to traditional AVF patients.3-5 Each of these three studies fills a distinct and essential gap in our understanding of VasQ’s impact.

Pivotal study: A foundation of safety and efficacy3

Published in the Journal of Vascular Surgery, the U.S. pivotal study by Dillavou et al was a prospective, single-arm, 16-center trial that assessed AVFs created with VasQ in 144 patients. The results demonstrated:

  • Excellent safety profile, with no device-related adverse events
  • Primary endpoint met: 66% six-month primary patency vs. 55% performance goal (p=0.021)
  • 88% functional success (two-needle cannulation) by a median of 56 days in dialysis patients compared to 72% and 81 days in the HFM study1
  • 1.07 interventions/patient-year compared to the 1.8 reported for AVFs in the U.S.6
  • 68.3% CVC removal by six months compared to 47.2% reported by the USRDS7
  • 76.6% cumulative patency at 24 months compared to 53.7% from a recent meta-analysis8
  • 0.7% aneurysms and 4.2% steal requiring revision at two years compared to 14% and 9% in literature9

The U.S. pivotal study established that VasQ-supported AVFs can reliably achieve faster, more frequent functional success in the short term, with fewer complications over the longer term.

Matched claims analysis: A broader US concept4

Despite its strengths, the pivotal study lacked a control group for direct comparison. To address this, Lucas et al conducted a matched comparative effectiveness study using Medicare claims data from the same surgeons and institutions that participated in the pivotal study . Key findings from the 144 VasQ patients vs. 782 matched controls included:

  • Higher primary patency at six months (66% vs. 36%; odds ratio 3.27; p<0.0001)
  • Reduced interventions (0.97 vs. 1.91 per patient-year; p<0.0001)
  • Greater functional success at 90 days (43.4% vs. 26.7%; p=0.005) and 180 days (72.5% vs. 53.7%; p=0.004)
  • Lower CVC exposure at six months (31.3% vs 47.2%; p<0.001)

Although claims data lack granularity in AVF type or vessel diameter, the scale and rigor of this study provide powerful external validation of VasQ’s benefits in a real-world setting.

Retrospective vessel-matched analysis: Controlling for anatomy5

To complement the matched claims data and address its limitations, Hussain et al next applied the same pivotal study inclusion/ exclusion criteria in a retrospective chart review to generate a control with matched fistula type and vessel diameters from six of the pivotal study centers.

In this direct, site-matched comparison (52 VasQ vs. 52 controls), they found:

  • Shorter time to first use (56 vs. 85 days; p=0.04)
  • Fewer interventions to support maturation (0.23 vs. 0.51 per patient; p=0.035)
  • Higher unassisted functional success at three months (46% vs. 23%; p=0.013) and six months (65% vs. 45%; p=0.03)
  • Multivariate analysis identified VasQ implantation as the only factor significantly associated with improved success and reduced reintervention
  • Statistical significance was observed for unassisted functional success at three months (p=0.013) and six months (p=0.03). Statistical differences were not observed between any other functional status. These findings not only reinforce the Lucas et al claims study conclusion, but do so while addressing the anatomical and procedural variables that may impact successful AVF creation.
Implications for contemporary practice

Early functional success and reliable long-term accesses correlate with reduced CVC dwell times, fewer infections and lower mortality. The VasQ device addresses core mechanical and hemodynamic vulnerabilities that impede AVF maturation10 by enhancing functional success of one of our worst operations, and has the potential to minimize the need for additional procedures.

In an era that demands value-based care, VasQ not only delivers better clinical outcomes but has the potential to lower system costs by reducing reinterventions and comorbidities that occur with CVC dependence.

And, with the VasQ’s durable inflow regulation, one can speculate that the device may prevent long-term high flow driven complications (cephalic arch stenosis, steal, heart failure, arm edema, etc.).

We finally have a truly novel adjunct to our traditional hemodialysis access creation practices that moves us toward better outcomes, including AVFs that succeed more often, sooner, and with fewer interventions. Certainly, the VasQ device provides us with a real tool to move the hemodialysis access creation field truly toward “catheter last.”

References

  1. Allon et al. Am J Kidney Dis 2018 May; 71(5):677–689
  2. Karydis et al. Am J Kidney Dis 2020 Jan; 75(1):45-53
  3. Dillavou et al. J Vasc Surg. 2023; 78:1302-12
  4. Lucas et al. J Vasc Access (in press)
  5. Hussain et al. J Vasc Surg-VI (in press)
  6. Yang et al. J Vasc Access 2017;18 (Suppl. 2):8-14
  7. Leake et al. J Vasc Surg 2015; 62:123-7
  8. Hajibandeh et al. Vascular 2022; 20:1021-33
  9. Arnaoutakis et al. J Vasc Surg 2017; 66(5):1497-1503
  10. Bozzetto et al. J Vasc Access 2024; 25(1): 60–70

C. Keith Ozaki, MD, is a vascular surgeon at Mass General Brigham, Harvard Medical School, in Boston.

‘Rise together’: Harris urges unity in Women’s Vascular Summit presidential address

By
Jocelyn Hudson
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‘Rise together’: Harris urges unity in Women’s Vascular Summit presidential address
Linda Harris

Society for Vascular Surgery (SVS) Vice President Linda Harris, MD, extolled the values of “co-elevation” in her presidential address at the 7th annual Women’s Vascular Summit (May 2–3), invoking lessons on teamwork from the world of sport to argue that a united vascular specialty is greater than the sum of its parts.

Harris, professor of surgery and past chief of vascular surgery at the University at Buffalo in Buffalo, New York, addressed the summit as its founder and first outgoing president.

“Dr. Linda Harris has established her legacy as a trailblazer in vascular surgery on all fronts,” said incoming president Palma Shaw, MD, as she introduced Harris at the Chicago gathering.

Harris’ address centered on uniting those involved in vascular care across lines of geography, sex, race and specialty. “We have to talk together, and we have to walk together,” she opined, “otherwise we will not succeed, and that goes for working with our friends across the pond, men and women, Black and white, private practice and academic, vein and artery,” emphasizing also the importance of collaborating with interventional radiology and cardiology colleagues.

Focusing on the summit and its associated International Society for Women Vascular Surgeons (ISWVS)—which Harris founded in 2023 to promote education about vascular disease in women and promote women in the vascular field—the presenter paid homage to the team around her, in particular Shaw, Kathleen Ozsvath, MD, Kellie Brown, MD, and Joann Lohr, MD.

Harris stressed that a strong, unified team was central not only to the creation of the summit and ISWVS, but will also be key to their longevity. “I don’t ever want an organization or something I create to be at the best when I create it or when I’m leading,” she said. “I want it to be the best it’s been to that date, but I want it to be better when my successors come along, because otherwise I’m not succeeding.”

To ensure unity within a team, Harris proposed the concept of “co-elevation.” She explained: “Leaning on someone does not mean you’re weak. It means you recognize your areas of weakness, and you complement them with someone else’s strengths, and they do the same for you and you rise together.”

“We will not succeed if we leave people behind,” Harris continued. “We need to encourage deliberate, intentional inclusivity and encourage people to learn their unconscious biases.”

To support her argument, Harris shared lessons to be learned from the world of sport about sacrificing personal gain for the greater good of group success. In the first of several sporting references, Harris shared the words of football coach Vince Lombardi: “Individual commitment to a group effort is what makes a team work, a company work, and a civilization work.”

“Other sports legends have echoed the same thing,” the presenter continued, noting that blue chip basketball player Michael Jordan has previously said that “talent wins games, but teamwork and intelligence is what wins championships.”

Harris used another basketball reference to demonstrate how individual ambition can lead to a divided, unsuccessful team. Referencing Los Angeles Lakers teammates Kobe Bryant and Shaquille O’Neal, She stated: “When they were put together, the team actually did worse because they were both ‘the guy who had to be the guy,’ and they weren’t willing to work in a united fashion. They had to be the superstar.”

Caveating her argument for unity, Harris was keen to stress that this should not be confused with uniformity, urging the audience to avoid “groupthink.” Instead, the presenter encouraged discussion of differing viewpoints as a core tenet of any successful team.

‘Listen to each other’

Speaking to Vascular Specialist following her summit address, Harris homes in on the ways in which teams can unify. “I think the simplest thing that we need to do is we need to get in groups together, either virtual or real, and actually listen to each other,” she says, highlighting a current problem of individuals “digging their trenches” instead of working collaboratively.

Looking ahead, Harris notes that she intends for unity to be a key theme of her future SVS presidency, which is due to commence in 2026.

Harris will be the second woman to assume the lofty role, which she hopes will soon become a moot accolade. “Obviously it’s an amazing honor,” Harris remarks, “but I want to get to a point where it’s not a unique honor because I’m a woman. It’s just an honor.”

The focus, Harris believes, must rest firmly on her skillset, and, in particular, her “ability to bring people together and to empower and to help to elevate those around [her].”

Fostering unity, Harris posits, will allow the specialty to deal with a multitude of current and future challenges. “There are so many things that we need to deal with,” she comments, referencing artificial intelligence (AI), entrepreneurship and advocacy as just three of several key topics that the specialty “needs to work together on.”

Shaw assumes WVS presidency

Following the address, Harris passed the torch to Shaw, who she described as the “next great leader” and one she hopes will “surpass [her] success.” “I have every belief she will,” Harris remarked, “as will those who follow behind her.”

Shaw, professor of surgery at Upstate Medical University in Syracuse, New York, tells Vascular Specialist that her aim for the summit is to lead by Harris’ example, and continue to promote unity and collaboration. Specifically, she intends to do so on a global scale.

“What I bring to the table is the international component,” Shaw shares, highlighting her experience as president of the International Society of Endovascular Specialists (ISEVS), secretary general of the World Federation of Vascular Societies (WFVS) and—from September—Society for Vascular Surgery (SVS) U.S. representative to the European Society for Vascular Surgery (ESVS).

Shaw details that she intends to take the summit and ISWVS to the world stage via dedicated sessions at the Pan American Vascular Congress 2025, VEITHsymposium 2025 and Charing Cross (CX) International Symposium 2026. “I want to try to expand our international membership, and maybe set up international chapters,” Shaw notes, alongside “continuing to add to the fabric of everything that Linda has already developed.”

CGuard Prime carotid stent gains US and European approvals for stroke prevention

By
Jamie Bell
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CGuard Prime carotid stent gains US and European approvals for stroke prevention

InspireMD has been granted premarket approval (PMA) from the Food and Drug Administration (FDA) for its CGuard Prime carotid stent system in the U.S.—news that follows the company’s recent announcement of CE-mark approval under the European Medical Device Regulation (MDR).

“The C-GUARDIANS clinical trial provides strong scientific evidence to support the neuroprotective benefits of the next-generation MicroNet mesh technology of the CGuard Prime carotid stent system, and results are consistent with the large body of evidence from outside of the USA with this device,” said Christopher Metzger, MD, an interventional cardiologist from OhioHealth in Columbus, Ohio. “As U.S. primary investigator for this pivotal IDE [investigational device exemption] trial, I am proud of the scientific rigor and integrity of the data, which demonstrate the lowest event rates—stroke, death and MI [myocardial infarction] to 30 days, and ipsilateral stroke at one year—ever reported in any trial of carotid revascularization. These excellent results were in patients who were at high risk for carotid endarterectomy, a quarter of whom were symptomatic. CGuard Prime now offers an important frontline, proven technology for treatment of US patients with obstructive carotid artery disease, and continued benefits to patients worldwide.”

An InspireMD press release details that the FDA’s PMA is backed by “best-in-class evidence” from the C-GUARDIANS pivotal trial, first presented at the Leipzig Interventional Course (LINC) in May 2024. The study—which enrolled 316 patients across 24 sites in the USA and Europe—evaluated the safety and efficacy of CGuard Prime for treating carotid artery stenosis. CGuard Prime demonstrated the lowest 30-day (0.95%) and one-year (1.93%) primary endpoint major adverse event rates of any pivotal study of carotid intervention, the company claims.

InspireMD’s announcement of FDA approval for the CGuard Prime carotid stent system triggers the second of four milestone-driven warrant tranches pursuant to the private placement financing of up to US$113.6 million announced by the company in May 2023. InspireMD says gross proceeds from this warrant tranche are expected to be US$17.9 million if exercised in full, and proceeds—if available—will be used to support the imminent commercial launch of the device in the U.S., as well as initiating new regulatory pathways for advanced applications of the CGuard stent platform and developing new products.

In a separate press release announcing the CE-mark approval of CGuard Prime under the European MDR, InspireMD notes that development of the device incorporated extensive user feedback to optimise deliverability and deployment of the original CGuard stent. With its proprietary MicroNet mesh, CGuard is designed to reduce both early and late embolic events by trapping debris against the vessel wall, preventing plaque prolapse and embolisation that can potentially cause stroke, the release adds.

Gore Tag thoracic branch endoprosthesis receives expanded FDA approval for endovascular aortic arch repair

By
Bryan Kay
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Gore Tag thoracic branch endoprosthesis receives expanded FDA approval for endovascular aortic arch repair
Gore Tag
Gore
Gore Tag

Gore has announced that the Gore Tag thoracic branch endoprosthesis (TBE) is now approved by the Food and Drug Administration (FDA) for use in Zones 0 and 1, expanding its indication for the endovascular repair of lesions in the aortic arch and descending thoracic aorta while preserving flow to a single aortic arch branch vessel.

The device becomes the first off-the-shelf, single-branch thoracic endoprosthesis indicated across Zones 0, 1 and 2, enabling or expanding minimally invasive aortic repair of all lesions involving the arch, the company has stated in a recent press release.

“With broader indications, we can confidently address a wider range of complex arch pathologies using a trusted solution that streamlines procedure planning and—critically—helps improve patient outcomes,” said Michael Dake, MD, national co-principal investigator of the Gore Tag TBE clinical trial. “Of the 77 patients enrolled in the Zone 0/1 pivotal trial, more than 90% were treated in Zone 0 with no instances of device migration or wire fracture through 12 months, as well as low rates of type I and III endoleak.”

For Zone 0 and 1 procedure, TBE provides an on-label alternative to open surgical repair and reduces the overall impact of procedures like sternotomy, cardiopulmonary bypass and circulatory arrest.

First approved in the U.S. in May 2022, this new indication for the use of TBE in Zones 0/1 further demonstrates how Gore is advancing the care of complex aortic disease with minimally invasive approaches for patients.

Increased experience with off-the-shelf TAAA endograft sees reduction in complications but no effect on mortality

By
Jocelyn Hudson
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Increased experience with off-the-shelf TAAA endograft sees reduction in complications but no effect on mortality
Michele Piazza

Michele Piazza, MD, informed attendees of the 2025 Vascular Annual Meeting (VAM) that increased experience with the E-nside (Artivion) off-the-shelf preloaded inner branch endograft for branched endovascular aneurysm repair (BEVAR) leads to a “significant” reduction in intraprocedural complications, but does not affect early mortality, major adverse event, or midterm results.

“The E-nside is an off-the-shelf preloaded inner-branched device for thoracoabdominal aortic aneurysm (TAAA) repair that was introduced in the European market in 2020,” Piazza, of the University of Padua in Italy, explained during the event in New Orleans (June 4–7). He noted that several cases have been performed with the device in the five-year period since then, with the objective of the present study being to report on the impact of the learning curve on the outcomes for the E-nside.

Piazza shared that he and colleagues used data from the multicenter, prospective Italian branch registry of E-nside endograft (INBREED) for the study, using data from 2021– 2024. The endpoints included technical success, mortality, intraprocedural adverse events, and major adverse events. The presenter noted that patients were divided into early and late cohorts based on the median date of the procedure in each center.

“Of a total of 215 cases, what was interesting was that, in the late phase, there was an increased selection of anatomical characteristics like those patients with chronic degenerative aneurysm or dissection, or degenerative aneurysm with a narrow paravisceral aorta less than 25mm,” Piazza commented, detailing patient characteristic insights.

Looking at the intraoperative technical results, Piazza reported that there was an increase in the use of femoral access with steerable sheaths over preloaded systems from the arm, an increase in the number of balloon-expandable bridging stents used, and a reduction in the number of adjunctive thoracic endografts deployed.

Piazza highlighted a reduction in the number of intraoperative complications that was statistically significant in the late cohort, but no difference in either technical success or major adverse event rates.

Stroke was reduced in the late cohort, Piazza continued; however, he specified that this was not statistically significant, and that there was no difference in the rate of freedom from target vessel instability at two years.

“Overall, the national trend showed a reduction in intraoperative complications,” Piazza commented, “but there were no differences between the early and the late phase for major adverse events.”

Highlighting results on the center-specific learning curve, Piazza noted that centers that faced more complex cases like extent II and III TAAAs or urgent cases “have an increase in the learning curve.” With regard to major adverse events, he underscored the fact that those centers with a low volume of cases had an increase in the learning curve over the first period which stabilized after the first five cases.

In conclusion, Piazza shared that experience with the E-nside led to a shift in patient selection, procedural techniques and materials. He continued that increased experience led to a significant reduction in intraprocedural complications, but stressed that this did not affect early mortality, major adverse event or midterm results.

During subsequent discussion time, an audience member asked Piazza if he could “dive a little bit deeper” into the learning curve comparing centers who had had a “robust experience,” perhaps with other platforms, versus those for which the E-nside was their “entry-level platform.”

Piazza responded that the study included two main different center experiences: those with an initial experience with BEVAR overall and those with a large experience with a different device before moving to the E-nside.

“In general,” he said, “what happens is that the second group is based on high-volume centers that all have experience in BEVAR, so this aspect by itself did not impact on the learning curve. What did have an impact on the learning curve was the number of cases performed with this device.”

Penumbra’s STORM-PE randomized trial completes enrollment

By
Bryan Kay
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Penumbra’s STORM-PE randomized trial completes enrollment
STORM-PE is a first-of-its-kind clinical trial comparing computer assisted vacuum thrombectomy (CAVT™) using Penumbra’s Lightning Flash™ with anticoagulation versus anticoagulation alone in the treatment of acute intermediate-high risk pulmonary embolism

penumbra

Penumbra has announced the completion of enrollment in the STORM-PE clinical trial.

The pivotal, prospective, multicenter randomized controlled trial enrolled 100 patients to evaluate computer assisted vacuum thrombectomy (CAVT) using Penumbra’s Lightning Flash plus anticoagulation versus anticoagulation alone for the treatment of acute intermediate-high risk pulmonary embolism (PE).

Conducted in partnership with The PERT Consortium, a multidisciplinary group dedicated to improving the care of patients with PE, the trial aims to provide high-quality evidence on the role of CAVT in improving right heart function and clinical outcomes in this critically ill patient population.

The Lightning Flash catheter is made with MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip design. They are designed to help remove blood clots with speed, safety and simplicity, allowing physicians to better navigate the body’s complex anatomy and deliver high power aspiration for clot removal, the company state.

Aventus thrombectomy system gains FDA clearance for PE treatment

By
Bryan Kay
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0
Aventus thrombectomy system gains FDA clearance for PE treatment

Inquis Medical has announced that its Aventus thrombectomy system has received 510(k) clearance from the US Food and Drug Administration (FDA) for an expanded indication to treat pulmonary embolism (PE).

The Aventus System is a next-generation mechanical thrombectomy platform developed in close collaboration with physicians to address critical limitations of current technologies.

The Aventus thrombectomy system was previously cleared by the FDA for use in the peripheral vasculature. Additionally, the Aventus clot management system received FDA clearance for use with the Aventus thrombectomy system to enable autologous blood transfusion, allowing reinfusion of filtered aspirated blood and supporting efficient, blood-conserving clot removal. This most recent clearance extends the platform’s indication to include the treatment of pulmonary embolism.

This regulatory milestone follows the successful completion of the AVENTUS pivotal trial, the first U.S. investigational device exemption (IDE) study to evaluate aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE patients.

The trial demonstrated “excellent” safety and performance across a broad range of clinical settings, with no device-related major adverse events and rapid improvement in right heart strain, according to the company. The results were presented as a late-breaking clinical trial at the 2025 Society of Cardiovascular Angiography and Interventions (SCAI) scientific sessions (May 1–3) in Washington, D.C., and were simultaneously published in JSCAI.

Heart and vascular centers: ‘It’s a financial thing, that’s the whole reason for their existence’

By
Urmila Kerslake and Stanley Evans-Power
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Heart and vascular centers: ‘It’s a financial thing, that’s the whole reason for their existence’

“The reason to avoid a heart and vascular paradigm is [that] there really is no paradigm. There’s no set standard for how these things should function. There’s certainly no evidence that they benefit patient care,” says Malachi Sheahan III, MD, newly elected Society for Vascular Surgery (SVS) secretary.

He continues: “And really what they’re set up as is a trap. And it’s a trap for the downstream financial revenue that’s generated by cardiologists, interventional radiology, CT surgeons and vascular surgeons. […] I think when we scale us to that size, we’re going to fail.”

Sheahan is a professor of surgery at Louisiana State University Health Sciences Center (LSUHSC) in New Orleans. He serves as chair of the Department of Surgery and chief of the Division of Vascular and Endovascular Surgery. He is also the medical editor of Vascular Specialist, the SVS newspaper.

VAM 2025: Crawford Forum probes four reasonable strategies to empower vascular surgeons

By
Urmila Kerslake and Stanley Evans-Power
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VAM 2025: Crawford Forum probes four reasonable strategies to empower vascular surgeons

“Go back home and get a vascular center or […] get a vascular department, or, you know, assess the compensation [survey] results and, at least start considering a union, if it’s something feasible.” That was the new Society for Vascular Surgery (SVS) President Keith Calligaro’s distillation of the burning issues and strategies to empower vascular surgeons at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7).

Are heart and vascular centers beneficial to vascular surgeons? Does the way vascular surgery is structured within a division under general surgery, or as a department on its own matter? What does the SVS compensation study in the US reveal? Should vascular surgeons unionize? This year’s E. Stanley Crawford Critical Issues Forum at VAM sought to address some of the structural and economic issues facing vascular surgeons as individuals—and those that challenge the specialty as an entity. Calligaro is chief of vascular surgery at Pennsylvania Hospital in Philadelphia, and as the incoming SVS president was responsible for organizing the forum.

“[…] The point of the meeting was, how do I empower vascular surgeons to better position ourselves? But also, how to help our patients by using the same mechanisms?” he asked.

New THRIVE data on CAVT technology for acute limb ischemia show ‘fewer complications, hospital resource use’

By
Jocelyn Hudson
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New THRIVE data on CAVT technology for acute limb ischemia show ‘fewer complications, hospital resource use’
Charles Bailey

Recent THRIVE study data show that Penumbra’s computer-assisted vacuum thrombectomy (CAVT) technology not only has the potential to improve outcomes for lower extremity acute limb ischemia (LE-ALI) patients, but may also reduce healthcare resource use, thus potentially lowering overall costs for the healthcare system. 

The latest data were presented at the 2025 Vascular Annual Meeting (VAM; 4–7 June, New Orleans, USA) by Charles Bailey (Emory University School of Medicine, Atlanta, USA).

The data show that US patients who underwent a CAVT procedure to manage LE-ALI had significantly shorter length of stays, higher discharge-to-home rates, reduced complications, and fewer related readmissions compared to other modalities.

“The THRIVE analysis reveals that LE-ALI patients who receive advanced therapies, such as CAVT, ultimately experience fewer complications and utilize fewer hospital resources compared to embolectomy,” said Bailey. “By showing important benefits for both patient care and healthcare system economics, these findings support the continued adoption of CAVT as a frontline therapy for LE-ALI.”

The THRIVE study compared CAVT to embolectomy alone and embolectomy with adjunctive bypass, and the results showed that CAVT was associated with:

  • A 99.1% limb salvage rate
  • 2.3 to 2.4 times lower amputation rate
  • 46–75% higher rate of patients discharged to home
  • 26–46% shorter total hospital length of stay
  • 33–55% lower 30-day LE-ALI-related readmission rate, excluding mortality

The researchers performed the analysis by utilizing the Vizient clinical database to identify adult patients discharged with LE-ALI over a three-year period. Sg2, a Vizient company, used propensity score matching at a 1:1 ratio based on demographics and comorbidities, payer, and hospital type to match CAVT patients (Lightning 7 and Lightning 12) to embolectomy alone and embolectomy with adjunctive bypass patients, and completed the analysis with 2,619 patients in total.

SVS announces election results for new leadership

By
Marlén Gomez
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SVS announces election results for new leadership

The Society for Vascular Surgery (SVS) has elected Andres Schanzer, MD, as the incoming vice president and Malachi G. Sheahan III, MD, as the new secretary, revealed during Friday night’s Annual Business Meeting, as part of the 2025 Vascular Annual Meeting (June 4-7) in New Orleans.

As vice president, Schanzer will help coordinate the activities of SVS councils and committees. His term as vice president will be followed by terms as president-elect and president, ensuring continuity of leadership.

“I am incredibly honored and humbled to serve in this role,” said Schanzer. “My goal is to bring together all our diverse members and to advance our society to best serve our patients.”

Schanzer, the Cutler distinguished chair, professor and chief of the vascular and endovascular division at UMass Medical School in Worcester, Massachusetts, is noted for his commitment to vascular surgery education and has taken on numerous leadership roles within regional and national surgical societies. His involvement has extended to quality and safety committees, as well as the development of SVS guidelines.

Schanzer serves as the principal investigator for CARPE-CMD, a physician-sponsored investigational device exemption trial focusing on complex aortic repair. His output includes over 250 peer-reviewed manuscripts and more than 300 invited lectures presented globally.

Malachi G. Sheahan III

As secretary, Sheahan will serve a three-year term, overseeing strategic alignment and coordination of SVS communications outreach through SVSConnect, vascular.org and social media platforms.

“This is a pivotal time for our field,” he noted. “I am excited to work for the SVS and its members as we come together to increase public awareness and improve outcomes for our patients.”

Sheahan is a professor of surgery at Louisiana State University Health Sciences Center (LSUHSC) in New Orleans. He serves as chair of the Department of Surgery and chief of the Division of Vascular and Endovascular Surgery. He currently leads a team of 11 vascular surgeons providing care across community and academic hospitals, a pediatric hospital and a Veterans Affairs hospital.

Sheahan chairs the surgery department at LSU Health Shreveport (LSUHSC) and conducts research in skills testing, burnout and vascular conditions, earning numerous publications and awards for his work. He serves as the medical editor of Vascular Specialist, the SVS newspaper.

Two-year data show continued clinical improvement with VenoValve

By
Jocelyn Hudson
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Two-year data show continued clinical improvement with VenoValve
Cassius Iyad Ochao Chaar

Implantation of the VenoValve (enVVeno Medical) continues to promote stabilization of symptoms in patients with deep venous reflux at two-year follow-up. This is the headline finding of data shared yesterday during Plenary Session 6 at VAM 2025.

In the abstract outlining their findings, submitting and presenting author Cassius Iyad Ochoa Chaar, MD, associate professor of surgery at Yale School of Medicine in New Haven, Connecticut, and colleagues highlight that patients with advanced venous disease and deep venous reflux have no surgical options for treatment.

The VenoValve, they note—a bioprosthetic monocusp valve surgically implanted into the femoral vein—is currently being tested in a clinical trial to address this clinical need.

In the prospective, multicenter SAVVE trial, patients with deep venous reflux and no superficial venous reflux or venous outflow obstruction underwent surgery for symptoms of advanced venous disease consistent with CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification C4b–C6.

“The one-year results showed significant improvement in clinical endpoints and quality-of-life measures,” the authors share. The goal of their present paper was to outline the two-year results of the total cohort of patients.

At VAM 2025, Chaar and colleagues reported that clinical improvement—as measured by revised Venous Clinical Severity Score (VCSS)—showed sustained benefit at two years in the 43 patients who reached this follow-up milestone. Specifically, the mean rVCSS at two years was 9.8, which was slightly lower than the mean score at one year, but “significantly lower” than the baseline score of 15.6. Among several other data points, Chaar and colleagues will report on pain scores. The authors note in their abstract a slight decrease in Visual Analogue Scale (VAS) score from 2.2 at one-year follow-up to 1.9 at the two-year mark. Again, however, this was “significantly lower” than the baseline of 4.3.

The people and devices that put ‘the vascular in vascular’

By
Bryan Kay
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0
The people and devices that put ‘the vascular in vascular’
Jerry Goldstone

The people, discoveries, innovations and events that brought the vascular surgery profession to where it is today will form the subject matter for this year’s John Homans Lecture—“Who put the vascular in vascular surgery?”—at VAM 2025.

Jerry Goldstone, MD, an adjunct professor at Stanford University College of Medicine, will pore over some of the most important developments in the field since the founding of the SVS in 1946, which set the stage for the modern vascular surgical specialty.

“When the 31 founding members were gathered for their first meeting in 1947, how could they possibly have imagined what vascular surgery is like today,” Goldstone mused in an interview with VS@VAM ahead of his lecture, which takes place this morning on Morial CC’s Second Floor (Room 208–210) from 10:45–11:15 a.m. “They formed this organization because there was no organization devoted to vascular surgery. Most were general surgeons with a special interest in vascular, some were cardiac people with a special interest in vascular.”

What they helped shape yielded some tremendously important advances over the years, minting vascular surgery as a bona fide, standalone specialty in its own right, Goldstone says. After canvassing colleagues in the field, he landed on “about 10 of the most important things that got us from zero to a place, now, where there is one big society, 6,000 members, our own journals, recognition internationally, good science.”

Among the topics he will chart are the formation of the SVS and its merger with the American Association for Vascular Surgery (AAVS), previously the North American Chapter, International Society for Cardiovascular Surgery (NA-ISCVS); the development of grafts; the coming of the vascular lab and duplex ultrasound; carotid endarterectomy (CEA); two innovations in venous disease in the shape of the the Greenfield filter for pulmonary embolism (PE) and laser ablation of the great saphenous vein; the founding of the Journal of Vascular Surgery (JVS); and the birth of the vascular surgery fellowship. The rise of CEA helped push the vascular specialty forward, Goldstone remarks. “After all, we are a surgical specialty, and known by the operations we do, and one of the most common and distinctive is CEA,” he explains.

“It put vascular surgeons into contact with other people, in other specialties, and elevated the profession beyond its own little cocoon, as maybe a little different from general surgery. It put vascular surgery as a profession on the map in a broader sense.”

Vascular surgery maintains popularity, becomes ‘more competitive’ after switch to virtual interviews

By
Bryan Kay
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0
Vascular surgery maintains popularity, becomes ‘more competitive’ after switch to virtual interviews
Christina Cui
Christina Cui

A study aimed at assessing the impact of a pandemic-related switch to virtual recruitment from in-person interviews on the Match for vascular surgery residents demonstrated that the transition had no impact on the popularity of the specialty.

This is among the findings set to be delivered by presenting author Christina Cui, BS, a fourth-year medical student at the University of California, San Diego, during VESS Session 1b on Wednesday (2:20–3 p.m.) on the Second Floor, Room 228–230 during the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7).

Cui was part of a research team looking at residency application and Match-related data collected from National Resident Matching Program (NRMP) reports for in-person interview cycles from 2010–2019, compared with virtual interview cycles from 2020–2024.

Cui and colleagues found that the total number of vascular surgery programs, positions and applicants were significantly higher during the virtual interview cycles, with similar increases noted in total ACGME-accredited equivalents, ultimately finding that vascular surgery became a “more competitive residency,” with fewer applicants matching at their first choice.

International Chapter highlights pressing need to document PAD and CLTI prevalence in South Asia

By
Bryan Kay
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0
International Chapter highlights pressing need to document PAD and CLTI prevalence in South Asia
Prem Chand Gupta

There is an urgent need for epidemiological studies to map out the prevalence of chronic limb-threatening ischemia (CLTI)—and peripheral arterial disease (PAD) in general—in South Asia, attendees of the International Chapter Education Session at VAM 2025 heard yesterday morning. That was the message from Prem Chand Gupta, MBBS, clinical director and head of vascular surgery at Care Hospital in Hyderabad, India, as he peeled back a curtain on the extent of amputation and limb preservation in Asia through his native country of India, highlighting how patients on the continent present with more advanced CLTI, are more likely to require urgent intervention, and have worse postoperative outcomes compared to patients in the West.

“Asia also has the highest prevalence of diabetes and CKD [chronic kidney disease], so this makes these patients more prone to develop the disease and also makes the disease more difficult to treat,” Gupta tells VS@VAM in an interview after his talk.

“In many of our countries, we do not know the prevalence of PAD and CLTI,” he says. “And how many of our patients are actually able to access proper care? We don’t know. Many patients end up with primary amputation as the first option.”

Gupta detailed for the VAM audience some of the reasons behind these statistics, among them a culture in rural areas where bare-foot walking remains common, and the fact the primary care physicians and general surgeons whom many patients visit for help don’t often appreciate the magnitude of the vascular problem with which they are confronted.

“We have had some attempt at studying the prevalence of disease in India but it’s grossly inadequate,” he explains to VS@VAM. Access to care varies across parts of the continent, with Southeast Asia, especially Thailand and Malaysia, technically better off, he continues, where healthcare is funded by taxes and government subsidy. In South Asian countries such as India and Bangladesh, on the other hand, public-private partnerships tend to predominate healthcare, with only pockets of excellence in the public system, Gupta continues.

“In India, nearly 50% of patients will pay out of pocket for medical care, so there is no insurance scheme they are covered under,” he says. “We have expertise and infrastructure, but the numbers are grossly inadequate. Vascular surgeons perform open and endovascular procedures and have all the latest tools available to them.”

But there are few multidisciplinary care teams, Gupta notes, “and we know that when they work together, they tend to improve outcomes.”

The gravity of the amputation and limb preservation problem in India is stark, he says. “India probably has the worst amputation epidemic in the world. The reasons? We have few vascular surgeons: it’s one per 3 million of the population. Most patients, even in the urban areas where we have a lot of vascular surgeons or specialists, they quite often end up with a primary care physician or a general surgeon or sometimes with a wound care surgeon or podiatric surgeon, and they often have minor amputations.”

In this crucible, in the absence of the vascular surgeon, the wrong approach often prevails, Gupta goes on. “There is patchy presence of specialists in the public sector and preventive care is very infrequently applied to these patients.” But there are positives to healthcare in South Asia, he adds. The pace of access to a specialist, if a patient can get in front of one, tends to be quick when compared to some countries in the West. Care can be dramatically cheaper. “For example, some of the bypasses that would cost $10–20,000 in high-income countries are $1,500–3000 in India,” says Gupta.

An attempt to unmask the extent of the CLTI burden in India through the prism of an epidemiological study is on Gupta’s radar for this calendar year. In the meantime, he says, “we need more vascular specialists, and we are working towards that. From the time when I trained in the late 90s, when we had one training program, we now have more than 50. So we are putting out more vascular surgeons every year. People are understanding the importance of multidisciplinary care teams and are tending to come together to work, and that will improve care and improve the chances of limb preservation in these patients with CLTI. We need to work on primary care physicians and general surgeons, and educate them.”

Vascular Specialist@VAM Conference Edition 3

By
Jocelyn Hudson
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0
Vascular Specialist@VAM Conference Edition 3

In this issue:

  • Transatlantic multicenter experience highlights effectiveness of total endovascular aortic repair with F/BEVAR but 5% risk of major stroke
  • SVS president will stake ‘reclaiming center’ in VAM 2025 address
  • Innovation: Learn from other fields to enhance your practice, vascular surgeon innovators told
  • International Chapter highlights pressing need to document PAD and CLTI prevalence in South Asia

Learn from other fields to enhance your practice, vascular surgeon innovators told

By
Will Date
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Learn from other fields to enhance your practice, vascular surgeon innovators told
Alan B. Lumsden

“A lot of solutions to your problems exist in somebody else’s operating room, or somebody else’s cath lab, but you never actually go there.”

These were the words of Alan B. Lumsden, MD, of the Houston Methodist Hospital in Houston, Texas, delivering the keynote talk at yesterday’s Innovation and Entrepreneurship in Vascular Surgery session, during which speakers sought to chart a course through the complex landscape that budding innovators must navigate to take potentially practice-changing ideas from the drawing board into the operating room.

“Get out of your space,” was among the abiding message from Lumsden’s presentation, where he compelled vascular surgeon innovators to bring ideas, skills and expertise from other fields—borrowing from “the other guy’s toolkit”—in order to enrich their own specialty, whether these be from other areas of medicine or further afield. Lumsden drew upon examples from as far and wide as the plastic surgery specialty to the energy and aerospace sectors to illustrate his point that vascular surgery innovators must spread their net widely to draw on the best ideas to serve their practice.

However, speakers in the session were in agreement that translating ideas from bench to bedside is not without its risks and significant hurdles. “You are surgeons primarily. You can give up your practice and roll the dice, that is financially shaky,” Lumsden said. “You are going to have to make a decision about why you want to get involved in this space. One of the motivating factors is that you as a physician are not scalable, you treat one patient at a time. But, if you develop something you are really doing population health, you can affect hundreds of thousands, potentially millions of people.”

The session laid bare the tortuous pathway facing surgeon innovators once they have chosen to take this step, with financing and intellectual property among the pain points. Presentations by Bryan W. Tillman, MD, and David Minion, MD, underscored the importance of securing intellectual property rights to protect promising ideas, but highlighted some of the challenges inherent in establishing a patent for new innovations. Stephen Von Rump, MS, delivered lessons on what financiers are looking for when they consider which start-ups to support.

The session also outlined some of the support and resources available to ease this path. To this end Jonathan Bath, MD, outlined details of ongoing work by the SVS to support innovations in the field, with the recent establishment of an Innovation Task Force with a mission to nurture new device and procedural concepts.

“Surgeon innovators have a rich history. This is why the SVS has put an emphasis on trying to provide some resources and an actual formalized structure to help the innovators get, eventually, to a product,” said Bath. To date there has been a shortage of guidance, resources and education to support this agenda, he noted, adding that the Task Force would seek to fill this gap.

The focus of the Task Force’s actions will be around three pillars, Bath detailed, notably education, networking, and resources, all geared to help “fertilize” the innovation process.

One of the support routes currently open to academic innovators is via biomedical accelerator programs which can provide funding, mentorship, and resources to early-stage companies and research projects. Jaya Ghosh, PhD, program director of the University of Missouri (MU) Coulter Biomedical Accelerator gave an overview of how programs such as these select which projects are suitable for support, and outlined a number of areas in which they are able to help bring new concepts to commercial reality, including regulatory strategy, reimbursement, manufacturing and scalability. “It truly takes a village to turn an idea into a real-world product, and these programs offer the training, funding and project management needed to de-risk early-stage innovations and help bring visionary ideas to life,” said Ghosh.

SVS president will stake ‘reclaiming center’ in VAM 2025 address

By
Urmila Kerslake
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0
SVS president will stake ‘reclaiming center’ in VAM 2025 address
Matthew Eagleton

One of the singular highlights of VAM 2025—the presidential introduction and address—will take place this morning from 11 a.m.–12 p.m. on Morial CC’s First Floor (Great Hall A), with SVS President Matthew Eagleton, MD, centering his focus on the Society’s anchor in a community commitment to patients and a spirit of shared purpose. The SVS seeks to lead, unite and rebuild vascular surgery’s future, he will tell the VAM audience.

“This isn’t just a speaking opportunity— it’s a moment of reflection, connection and responsibility. A responsibility to those that welcomed me into this specialty, and a responsibility to those of you here now who are part of our current and future vascular community,” Eagleton, chief of the Division of Vascular and Endovascular Surgery at Mass General Brigham and Harvard Medical School in Boston, will say.

Like many other vascular surgeons, Eagleton’s journey into surgery came via a patient, his grandfather, who had had complications from a redo coronary bypass. The presence of a calm, focused Dr. DeWeese, who practiced both cardiac and vascular surgery, and who looked after his grandfather, profoundly changed something in the young “uncertain and unfocused” college sophomore. As Eagleton will put it: “I did not go looking for vascular surgery, it found me.”

Even early on, Eagelton recognized that people in the vascular community exerted incredible influence on others aspiring in the field. Take the late Roy Greenberg, MD, an intern then, and Karl Illig, MD, a senior resident, who were both major influences when he started out. They would go on to grapple with the future of aortic repair, as well as introduce Eagleton to invaluable future mentors such as Dick Green, MD, and Ken Ouriel, MD—”people who didn’t just do vascular surgery, but lived it. The intensity, the pace, the sense of urgency at times—it was a world I couldn’t turn away from,” he will say.

Eagleton was convinced, even as a fourth-year medical student, that one of the great strengths of vascular surgery was in its ability to deliver longitudinal care. And the early experience of presenting his research at a regional conference opened the door to interaction with the giants in the field, like Frank Veith, MD.

“Be prepared. Vascular surgery doesn’t hand you anything. But if you’re willing to show up, stay humble and learn fast— it gives back in ways few other fields can,” Eagleton will reflect.

The new president will forefront the successes that the SVS has achieved, but he will also list the numerous challenges, notably a heterogeneous and growing group of members that confronts the organization. The faultlines of the struggle he says lie in fragmentation and disconnection.

“Our biggest internal challenge right now is fragmentation and disunity. And it’s been a problem growing over the past several years,” he will note. “We’re not just disagreeing—we’re disengaging. And that weakens us. It weakens our credibility. It weakens our voice.

“Internally, we’re also seeing generational gaps. Different expectations. Different styles of communication. Different priorities. And unless we find ways to bridge those differences, we risk becoming two—or more—societies moving in parallel at best,” Eagleton will suggest.

Yet, patients and purpose are always at the heart of vascular surgery, Eagleton will argue. And beyond this dual bedrock, he will press for a different kind of leadership, one that is layered, brave and collaborative, which can chisel a culture shift embedded in hope and meet the moment.

“We need bridge-builders. People who can bring together our fragmented membership—who can sit in a room of differing opinions and find common ground without compromising our core values,” he will say.

Vascular surgery’s relationship with other specialties—particularly interventional cardiology and interventional radiology—has too often been defined by tension, Eagleton will tell attendees. And yet, the volume of vascular disease is rising fast, and “we are not enough. We can’t serve this population alone. That doesn’t mean we dilute our identity.

“It means we must instead lead with clarity, not defensiveness. We invite collaboration without losing our center. We don’t leave the table when there are disagreements. We stay. We debate. We work to discover and provide scientific evidence. We strengthen bridges. We advocate. We keep the patient the center of all of our missions.”

In his call to recommit and pull together, Eagleton will expand: “The decisions we make now—the way we lead, the way we treat one another, the way we structure this society—will define what kind of field we’re handing off. We’re at an inflection point. And we can either drift further apart, or choose to come together with clarity, courage, and conviction.”

He will define the context of the importance of this mission. “Let’s stop standing on the sidelines while others define what vascular care looks like. […] Because this is our house. And if we want it to be strong, future-ready, and worthy of the next generation—we have to take care of it.”

Transatlantic multicenter experience highlights effectiveness of total endovascular aortic repair with F/BEVAR but 5% risk of major stroke

By
Jocelyn Hudson
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0
Transatlantic multicenter experience highlights effectiveness of total endovascular aortic repair with F/BEVAR but 5% risk of major stroke

Staged total endovascular aortic repair (TEAR) utilizing arch branched and thoracoabdominal fenestrated and branched endografts is effective, but identified predictors of morbidity and mortality—including stroke—highlight the importance of individualized risk assessment to optimize outcomes. These are some of the key findings of a study presented during yesterday’s Plenary Session 3.

Submitting and presenting author Enrico Gallitto, MD, associated professor of vascular surgery at the University of Bologna in Italy, was speaking on behalf of the transatlantic TEAR study group, which includes four sites in the U.S. and 12 in Europe.

The study aimed to identify outcomes of TEAR extending from the ascending to the infrarenal aorta or iliac arteries with arch-branched en-dovascular aneurysm repair (ARCH-BEVAR) in combination with thoracoabdominal-fenestrated/ branched EVAR (TAAA-F/BEVAR). “There are very few patients who are reported in the literature up to now,” Gallitto commented.

The investigators retrospectively analyzed 95 patients who underwent TEAR from 2014–2024. These patients had a mean follow-up of 32±29 months, the presenter noted, adding that 45 (47%) and six (6%) had undergone previous ascending and TAAA surgery, respectively.

“I’d like to stress the concept that these patients were historically treated by aortic arch replacement followed by open thoracoabdominal aneurysm repair, with high postoperative morbidity and mortality, and for these reasons up to 40% of patients did not complete the second procedure; thanks to this less invasive approach, the rate of not completed procedure was 3%,” Gallitto told VS@VAM following his presentation.

Gallitto reported that a staged approach, with the first stage involving ARCH-BEVAR followed by TAAA-F/BEVAR, was consistently used, with a mean time between two stages of 11±5 months.

One (1%) rupture occurred between the staged procedures, the presenter reported, detailing that this was successfully managed with off-the-shelf TAAA-BEVAR.

Gallitto specified that custom-made and off-the-shelf TAAA- F/BEVAR devices were used in 79 (83%) and 16 (17%) cases, respectively. Among 351 abdominal target arteries, he continued, 208 (59%) utilized fenestrations, and 143 (41%) branches. Iliac branch devices and prophylactic cerebrospinal- fluid drainage were used in 33 (35%) and 11 (12%) cases, respectively.

Gallitto reported that there were 12 (13%) transient ischemic attacks (TIAs)/strokes (10 associated with ARCH-BEVAR and two with TAAAs-F/BEVAR), with five (5%) having a modified Rankin Scale score (mRS) >3. He detailed that independent determinants of stroke included degenerative TAAAs and previous TAAA surgery.

Furthermore, it was noted that 16 (17%) patients experienced SCI (two associated with ARCH-BEVAR and 14 with TAAAs-F/BEVAR) with three (3%) cases of paraplegia. Independent determinants of SCI included major adverse events and iliac branch device use.

Regarding mortality, Gallitto noted that four (4%) patients died within 30 days, with independent determinants of 30- day mortality including stroke with mRS >3, and that aortic- related mortality was 2%.

Out of 67 (71%) patients with available one-year follow-up, Gallitto shared that there were six (9%) target artery instabilities and five (7%) cardiovascular events, respectively.

The estimated three-year survival and freedom from reintervention rates were 79% and 66%, respectively, with Gallitto noting that independent predicted of survival included previous abdominal aortic surgery, postoperative acute kidney injury, and cardiovascular events within one year.

Concluding, Gallitto informed the VAM 2025 audience that staged TEAR utilizing ARCH-BEVAR in combination with TAAAs-F/BEVAR is effective, “demonstrating satisfactory early and midterm outcomes, with low aortic-related mortality and acceptable freedom from reintervention and target artery instability rates.”

Additionally, Gallitto warned that the risk of stroke and SCI remain “significant” and “must be carefully weighed during patient selection and treatment planning.” In addition, the presenter noted that cardiac dysfunction at one year is not rare—citing a rate of 7%—and affects mortality. With this in mind, he suggested that specific cardiac evaluation is needed to investigate the potential role of aortic stiffness.

Gallitto also outlined some limitations of the study, underscoring its retrospective nature and the fact that the timeframe of 10 years introduces the variables of technological innovations and operators’ learning curves. He added that the small sample size, limited follow-up, and the inclusion of only a single brand—Cook Medical—within the study are further limitations.

In the discussion following Gallitto’s presentation, session co-moderator Thomas Forbes, MD, professor and chair of the Division of Vascular Surgery at the University of Toronto in Toronto, Canada, brought up the time between stages. “I notice that the time interval between stage one and stage two was a mean of 11 months, with some variability. That seems a little long to me,” he commented, going on to ask for an explanation. “This is a great point, because 11 months is probably too high in our routine clinical practice,” Gallitto responded, noting that one of the main determinants would have been the factor of recovery time from the first stage of the procedure.

Vote for your favorite projects at the Poster Competition

By
Marlén Gomez
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0
Vote for your favorite projects at the Poster Competition

Don’t miss the chance to witness the creativity and hard work of the Poster Competition participants as they compete for top honors, taking place Friday afternoon at VAM 2025 from 12:30–2 p.m. in First Floor, Hall B.

This competition offers an opportunity to engage with innovative research, showcasing 10 rows of posters featuring up to 12 projects. Each row will have a dedicated moderator from the Program Committee to guide the process.

Presenters will kick off the competition by delivering three-minute presentations for each poster, followed by a two-minute discussion. After each discussion, attendees will participate in a quick voting session using their mobile devices. Participants will have the opportunity to evaluate each poster on a scale of one to 10.

After all presentations, winners of each row will be announced, and the first-place recipients will advance to the Championship Round on Saturday morning. In that final round, they will compete for significant cash prizes: $1,500 for first place, $1,000 for second, and $500 for third.

Acellular tissue engineered vessel outperforms AVF in high-risk hemodialysis patients

By
Bryan Kay
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0
Acellular tissue engineered vessel outperforms AVF in high-risk hemodialysis patients
Female nurse assisting patient undergoing renal dialysis in hospital room

Results from the CLN-PRO-V007 randomized controlled trial of Humacyte’s acellular tissue engineered vessel (ATEV) are set to be shared today during VAM 2025 Plenary 6 (10–11 a.m., First Floor, Great Hall A), showing several clinical benefits when compared to arteriovenous fistula (AVF) in hemodialysis (HD) patients with a high risk of fistula maturation failure.

“ATEV provides better functional patency, usability, and a comparable access-related complication profile to AVFs in high-risk subgroups of ESKD [end-stage kidney disease] patients,” submitting and presenting author Mohamad A. Hussain, MD, vascular and endovascular surgeon and assistant professor of surgery at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues write in their abstract.

The authors write that this key conclusion “makes ATEV a promising alternative to vulnerable populations requiring HD access and highlights its potential to address unmet needs in patients with complex clinical profiles.”

The objective of CLN-PRO-V007—a phase 3, prospective, multicenter, two-arm, randomized controlled trial—was to compare the efficacy and safety of ATEV with autologous AVFs in ESKD patients on HD. Patients were randomized 1:1.

At VAM 2025, Hussain is set to share that functional patency at six months and secondary patency at 12 months were significantly higher in ATEV recipients compared with AVF among 110 high-risk ESKD patients included in the trial out of 242 enrolled in total.

In addition, Hussain will report that duration of access usability over the first year trended higher in the ATEV group, further noting that these results were consistent across individual subgroups of female patients and male patient with a body mass index (BMI) ≥30kg/m2 and diabetes.

With regard to safety, the authors found similar rates of serious adverse events (SAEs) for ATEV patients and AVF patients and comparable infection rates between the two groups.

Greenberg Lecture encourages ‘move beyond’ binary aortic disease classification

By
Jocelyn Hudson
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0
Greenberg Lecture encourages ‘move beyond’ binary aortic disease classification
Sherene Shalhub

Sherene Shalhub, MD, set out a new biologically informed framework that “captures the diverse spectrum of arterial fragility and repair outcomes across inherited and acquired aortic disease” during today’s Roy Greenberg Distinguished Lecture on Innovation at VAM 2025.

Shalhub, chief of vascular surgery at Oregon Health and Science University (OHSU) in Portland, Oregon, introduced the Aortic and Arterial Vulnerability Spectrum (AAVS) in her talk ‘The aortic vulnerability spectrum: Reshaping the future of aortic surgery’.

Speaking to VS@VAM ahead of the lecture, Shalhub noted that the AAVS was designed to address a gap between molecular and ultrastructural pathology and clinical decision-making and aims to “move beyond binary classifications” to better predict procedural durability, remodeling potential, and long-term risk.

“We always think about aortic disease in a binary manner,” Shalhub commented. “In reality, we should think of aortic disease as a spectrum, where you have some people who have extreme manifestations of the disease and then have other people with milder manifestations of the disease.”

Shalhub asserts that “everybody falls somewhere on that spectrum,” encouraging a shift in thinking to inform better patient care.

Homing in on some of the specifics of her work, Shalhub highlighted the use of ultrastructural skin biopsy analysis as a surrogate for aortic and arterial biology as “one of the most transformative innovations.” She explained: “In patients with aortic aneurysms and dissections, the skin provides a minimally invasive, accessible tissue that mirrors the extracellular matrix and connective tissue vulnerabilities found in the aorta, offering a unique window into the aorta.”

In addition, Shalhub considered how her work continues the legacy of Roy Greenberg ahead of delivering this year’s eponymously named lecture at VAM. “Dr Roy Greenberg pioneered customized endovascular solutions long before FDA [Food and Drug Administration]-approved devices were widely available,” Shalhub says. “He understood that durable repair requires more than device deployment; it demands alignment between anatomy, hemodynamics, and biology. That philosophy resonates directly with AAVS, which seeks to individualize care based on biologic vulnerability, not just anatomy. AAVS can be seen as a biologic extension of Greenberg’s legacy: just as he matched devices to anatomy, we now aim to match interventions to underlying arterial biology.

“His legacy inspires today’s push toward precision vascular medicine where genotype, and substrate, guide care.”

SVS president Matthew Eagleton, MD, selected Shalhub to deliver this year’s Greenberg Lecture. Commenting on his choice of speaker, Eagleton told VS@VAM: “The intent of the Greenberg Lecture was to highlight a physician who was interested in progressing the field of endovascular care through research. Dr Shalhub’s research on the genetic component of aortic disease would be very interesting to Roy. In particular, her focus on how that may affect what treatment options we offer our patients. He would love this year’s topic and to hear Dr Shalhub’s address.”

Shalhub’s introduction to the AAVS has also been published online in the Journal of Vascular Surgery (JVS).

Impact report finds no major change in balance between CAS and CEA following Medicare expansion

By
Éva Malpass
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0
Impact report finds no major change in balance between CAS and CEA following Medicare expansion
Courtenay M. Holscher

An evaluation of trends in the utilization of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) has found there to be “no major change” to tip the balance following the 2023 US Centers for Medicare and Medicaid Services (CMS) expansion of CAS coverage to include standard-risk patients with symptomatic ≥50% and asymptomatic ≥70% carotid artery stenosis.

Courtenay M. Holscher, MD, at Johns Hopkins Hospital in Baltimore, Maryland, presented her team’s findings during yesterday’s Plenary Session 2.

Using 100% Medicare fee-for-service claims data to identify patients who underwent CAS or CEA between January 2017 and December 2024, Holscher and colleagues identified 385,067 carotid revascularizations—45% symptomatic vs. 55% asymptomatic disease, and 77.1% CEA vs. 22.9% CAS.

The proportion of carotid revascularization procedures performed by vascular surgeons versus other specialties increased from 46% in 2017 to 55% in 2024. Holscher detailed that CEA was mainly performed by vascular surgeons, cardiothoracic surgeons, and general surgeons, and CAS was commonly performed by vascular surgeons, cardiologists and interventional radiologists.

The proportion of carotid revascularizations performed using CAS significantly increased over time (2017: 13% vs. 2024: 37.5%), 25% in symptomatic and 31% in asymptomatic patients. Holscher reported a slight decrease in CEA use after the expansion of CAS in 2023, but this was not found to be statistically significant.

“The utilization of stenting has significantly increased over time and it’s quite reassuring that there is an increasing share of vascular surgeons performing these revascularization procedures,” said Holscher. “It’s difficult to see how the CMS-required ‘shared decision-making’ discussion between CEA and CAS procedures can realistically occur when a physician cannot offer both procedures.”

Transcatheter arterialization of the deep veins: Comparative analysis probes whether emerging modality is worth pursuing

By
Bryan Kay
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0
Transcatheter arterialization of the deep veins: Comparative analysis probes whether emerging modality is worth pursuing
Anahita Dua presents during VAM 2025

“We’re living in a new world order” when it comes to “no-option” chronic limb-threatening ischemia (CLTI) patients, says Anahita Dua, MD. In recent years, into this arena has stepped transcatheter arterialization of the deep veins (TADV), raising hopes of reducing amputation rates amid a rise in diabetes and other disease affecting microvascular dissemination. Yesterday morning, the vascular surgeon at Massachusetts General Hospital in Boston put forward data from a new study comparing no-option CLTI patients enrolled in the PROMISE studies treated with TADV to a CLariTI study cohort who were treated using standard of care (SoC). So, “is TADV worth it?” she pondered. The one-year comparative data she presented—during the William J. von Liebig Forum—seemed to provide an answer in the affirmative.

Positive PROMISE I and II data have seen TADV, also known as deep vein arterialization (DVA), gain traction, Dua told VAM 2025, but the “real question remains,” she said. “If you’re going to do a [TADV] procedure on a patient, then go forward with all the wound care, all the phone calls, and all the pain for the next six months to try to salvage the limb, does it really lead to better wound healing, better limb salvage rates and better amputation-free survival?”

With no randomized clinical trial data to call upon in the space to measure a difference between TADV and standard of care, Dua and colleagues compared the combined patient groups from PROMISE I and II to the real-world CLariTI group to “see whether or not limb salvage rates genuinely decrease” when the former modality is deployed.

“We did CLariTI after PROMISE, so we were able to design the study to match the PROMISE studies so that we could ensure we had matching across groups,” she explained. “As you can see, most importantly this is, again, a real-world study, with a significant number who were Black or African American, had Rutherford 5/6, and a significant history of CKD [chronic kidney disease].”

The data showed limb salvage rates of 82.2% vs. 51.3% in the TADV/ PROMISE I/II group and CLariTI, respectively; and amputation-free survival (AFS) rates of 71% for TADV vs. 34.1% for standard of care.

“For wound healing, 78% of patients at one year were either fully healed or healing in the DVA group versus the standard of care,” said Dua. “Going out, because durability matters, in the patient cohort for CLariTI—we are still collecting our data, because that was after the PROMISE study—but for the PROMISE data, we are at two years now and the limb salvage rate is still at 68%, which is excellent compared, already, to the 51% at one year for the standard of care.”

Overall, Dua concluded, “I think the data is relatively clear. Even though we don’t have an RCT, we have an excellent matched set from CLariTI compared to patients that have DVA and it is clear that DVA does have clinical benefit in patients selected appropriately. These benefits are consistent, especially if you use the LimFlow system [Inari Medical], which is kind of like the TCAR [transcarotid artery revascularization] of the leg in that you are able to do the same thing every time. The off-the-shelf DVA that exist—and the data around that—is very variable so that is not included in any of this.”

Remember to cast your votes in 2025 SVS elections

By
Marlén Gomez
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0
Remember to cast your votes in 2025 SVS elections

SVS members in good standing can still cast their votes for key leadership positions and important bylaw changes in the 2025 elections to have their voices heard. Also on the ballot is a vote on a proposed bylaw change regarding Senior Membership.

The election will remain open until 2 p.m. Central Time on Thursday, June 5, and the results will be announced during the SVS Annual Business Meeting on June 6 at 5:15 p.m. Central Time (Second Floor, Room 208–210).

“As the vascular surgery community gathers for VAM 2025, SVS reminds all eligible members that voting in the election is still open, but not for long,” said Nominating Committee Chair Ali AbuRahma, MD. “By voting, you help ensure that SVS remains a strong, unified voice, representing vascular surgery, advancing our profession and promoting the issues that matter most to you.”

The candidates nominated for vice president are Andres Schanzer, MD, and William P. Shutze, MD. For the secretary position, the nominees are Rabih A. Chaer, MD; Michael S. Conte, MD; Sherene Shalhub, MD; and Malachi G. Sheahan, MD. Learn more about the candidates at vascular.org/Election.

This year, for the first time, SVS has four candidates running for Secretary. When there are more than two candidates, the SVS executive board requires rank order voting, meaning members will rank the secretary candidates in order of their preference, from one (your first choice) to four (your fourth choice).

SVS members can rank as many or as few candidates as they would like but must rank at least one unless they wish to abstain from voting. No two candidates may receive the same ranking. In rank-order voting, election officials initially count only the first-choice votes. If no candidate receives a majority (more than 50%), the candidate with the fewest number of votes is eliminated. Ballots for that candidate are then redistributed to the next preferred candidate on those ballots. This process continues until one candidate has a majority.

Before voting on the bylaw referenda, members should review the proposed bylaw changes and rationale related to Senior Membership. This referendum includes several related changes that form a single policy update. You may vote in favor, against or choose to abstain. A single vote applies to the entire set of proposed changes.

With elections often decided by just a few votes, SVS urges all eligible members to participate and help shape the future of the Society and the vascular surgery profession.

Long-term VQI-VISION analysis sheds light on PVI versus bypass in aortoiliac occlusive disease

By
Jamie Bell
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0
Long-term VQI-VISION analysis sheds light on PVI versus bypass in aortoiliac occlusive disease
Open bypass

Today’s Plenary Session 4—Hosted in Great Hall A, First Floor from 10:45 a.m.–12 p.m.—will feature a presentation of five-year findings from the VQI-VISION database indicating that aortobifemoral bypass (ABF) remains a more durable long-term treatment option compared to endovascular intervention for aortoiliac occlusive disease.

Elonay Yehualashet, BA, a medical student at Georgetown School of Medicine in Washington, D.C., is presenting these findings, which are also being discussed by senior author Natalie Sridharan, MD, assistant professor of surgery at the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania. “In medically appropriate patients, ABF may be beneficial and should be considered given its long-term results,” Yehualashet told VS@VAM.

For the present analysis, researchers queried the Vascular Quality Initiative (VQI) database for de novo aortoiliac interventions—ABF or supra-inguinal peripheral endovascular intervention (PVI)—and linked them to Medicare claims from 2010– 2019. Emergent cases and interventions for aneurysm or dissection were excluded.

The researchers’ primary endpoint was five-year estimates of freedom from major adverse limb events (MALE; major amputation or reintervention) or death, while a notable secondary endpoint consisted of freedom from major amputation or death. Kaplan-Meier analysis compared outcomes between patients undergoing ABF versus PVI and, additionally, subgroup analyses compared patients presenting with chronic limb-threatening ischemia (CLTI) versus claudication.

A total of 4,282 cases were identified—931 of which were ABFs (21.7%), 3,351 PVIs (78.2%). Over the study period, there was a trend toward increased PVI utilization, including 32.2% from 2010–2014 and 67.8% from 2015–2019 (p=0.01). Patients undergoing PVI were more likely to be older, live in urban areas and have higher rates of cardiovascular comorbidities, and had a greater likelihood of presenting with claudication, the researchers found.

As per their primary endpoint, the five-year rate of freedom from MALE or death was 58.7% in the ABF group and 38.2% in the PVI group (p<0.0001). Sequential Cox regression analysis demonstrated that the observed difference in the MALE/death rate between groups favoring ABF “persisted and remained significant” after adjustment for covariates of known clinical significance (adjusted hazard ratio [aHR] for PVI, 1.889; 95% confidence interval [CI], 1.648–2.166; p<0.0001)—a trend that remained true for patients undergoing treatment for both claudication (aHR, 1.807; 95% CI, 1.498–2.18; p<0.001) and CLTI (aHR, 1.959; 95% CI, 1.605–2.392; p<0.0001).

Freedom from major amputation or death at five years was 70.5% in the ABF group and 60.1% in the PVI group (p<0.0001), and—as per subgroup analyses—PVI was only associated with increased risks of major amputation or death among CLTI patients (aHR, 1.665; 95% CI, 1.311–2.114; p<0.0001), but not among those with claudication. The researchers speculate based on this finding that more prevalent MALE in patients undergoing PVI for claudication is related specifically to increased numbers of reinterventions.

“Despite the shift toward an endovascular-first approach for aortoiliac occlusive disease, the durability of suprainguinal PVI may not persist long-term,” Yehualashet and colleagues conclude. “In medically appropriate patients, ABF may offer CLTI patients improved limb preservation, while patients with claudication may experience reduced reintervention rates.”

Drilling into controversies in field of asymptomatic severe carotid stenosis management

By
Bryan Kay
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0
Drilling into controversies in field of asymptomatic severe carotid stenosis management
Ali AbuRahma

Some of the enduring controversies in the management of asymptomatic severe carotid stenosis will underpin an educational session set to take place today.

The session tackles debate around the deployment of carotid revascularization strategies in both standard- and high-risk patient populations. It takes place on the Morial Convention Center’s Second Floor (Room 208–210) from 3:30–5 p.m. and will be hosted by carotid disease luminaries Ali AbuRahma, MD, former SVS president and chief of vascular surgery at West Virginia University/Charleston Area Medical Center, alongside Raghu Motaganahalli, MD, chief of vascular surgery at Indiana University School of Medicine in Indianapolis.

AbuRahma will open the session with an introduction to controversies in the field.

Bruce Perler, MD, another former SVS president and vascular chief emeritus at Johns Hopkins University School of Medicine in Baltimore, Maryland, will argue that carotid endarterectomy (CEA) should be the first-line therapy in standard-risk patients, before Marc Schermerhorn, MD, chief of vascular surgery at Beth Israel Deaconess Medical Center in Boston, makes the case for transcarotid artery revascularization (TCAR). Peter Schneider, MD, professor of surgery at the University of California, San Francisco will argue for transfemoral carotid artery stenting (TFCAS).

Brajesh Lal, MD, professor of vascular surgery at the University of Maryland in Baltimore, will update attendees on the status of the much-anticipated CREST-2 trial.

Similarly, three vascular surgeons will make the respective cases for the same three carotid revascularization strategies as the first-line therapy in high-risk asymptomatic patients: Wei Zhou, MD, chief of vascular surgery at the University of Arizona in Tucson, for CEA; Caitlin Hicks, MD, associate professor of surgery at the Johns Hopkins, for TCAR; and Sean Lyden, MD, chairman of vascular surgery at the Cleveland Clinic in Cleveland, Ohio, for TFCAS. The session will finish with a specific look at female patients by Yana Etkin, MD, associate professor of surgery at Zucker School of Medicine at Hofstra/Northwell in New York.

Vascular Specialist@VAM Conference Edition 2

By
Bryan Kay
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0
Vascular Specialist@VAM Conference Edition 2

In this issue:

  • One-year TAMBE data highlight low mortality, importance of renal branch assessment
  • Transcatheter arterialization of the deep veins: Comparative analysis probes whether emerging modality is worth pursuing
  • Lower extremity access appears preferable in real-world study of patients undergoing BEVAR
  • Optimal CLTI care demands proficiency in both open and endovascular treatment, study finds

 

Speaking in code: How a decline in Medicare reimbursement affects vascular care

By
Éva Malpass
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0
Speaking in code: How a decline in Medicare reimbursement affects vascular care
Kirthi S. Bellamkonda presents during VAM 2025

Concerns were raised yesterday’s Plenary Session 2 over the recent decline in Medicare reimbursement at a national level. Querying current figures, speakers revealed discrepancies which highlight the importance of accurate reporting to ensure sustainable provision for the future of vascular care.

Opening the session, Kirthi S. Bellamkonda, MD, and colleagues at the Darthmouth-Hitchcock Medical Center in Lebanon, New Hampshire, briefed the VAM audience on the foundations of their research, outlining that hospitals are reimbursed by Medicare based on diagnostic related groups (DRGs) stratified based on existing comorbidities or in-hospital complications. Medicare severity (MS-DRGs) is used to code each admission as those with comorbidities or complications (CC) or major comorbidities or complications (MCC).

“If a CC or MCC is missed by coding teams, the result is under coding, which substantially reduces hospital payment,” said Bellamkonda. The research team hypothesized that data harnessed from the Medicare-linked Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) Registry could be used to identify cases appropriate for DRGs with CC or MCC, to avoid underbilling by hospitals.

The research team analyzed 40,822 admissions for Medicare beneficiaries who underwent PVI treatment at 231 VQI centers from 2010–2019. The research team then created a multivariable model to predict whether standard MS-DRG or MS-DRG with CC/MCC was billed for the admission.

Reporting a 0.816 C-statistic for the model, Bellamkonda and team believe they found a “strong predictive association” between the VQI data and current MS-DRG billing. Among key VQI variables associated with CC/MCC MS-DRG billing were dialysis dependence, dependent functional status and congestive heart failure.

In-hospital events included renal and pulmonary complication, amputation during admission and length of stay exceeding six days. “We saw fewer CC/MCC admissions billed than expected in 39% of hospitals, which would have resulted in an estimated total of $9 million in lost reimbursement,” stated Bellamkonda.

She continued: “Based on the accuracy of this model, VQI hospitals could receive a report that estimates the probability that each PVI admission might qualify for DRG billing with CC or MCC. Hospitals could then set their own probability level to select indications for coding review.”

From the audience in encouragement, Linda Harris, MD, SVS president-elect and professor of surgery at the University at Buffalo in Buffalo, New York, urged the team to take this “another step” by prospectively trialing their model in a handful of centers.

“If you can show in say five centers that we have saved you a million dollars here and there that would really make a big difference in promoting the benefits of our C-suite,” said Harris.

Shifting focus to examine Medicare billing as it varies by region and physician specialty, Daniel J. Koh, MD, and colleagues at the Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, specified that Medicare Part B reimbursements have been declining at the national level.

Seeking to identify trends in Medicare reimbursement for endovascular lower extremity interventions, the team consulted the 2018–2022 Medicare Physician and Other Practitioners by Provider and Service dataset for eight lower extremity CPT codes. The data were stratified by setting (facility, hospital vs. non-facility), Centers for Medicare and Medicaid Services (CMS) region, and physician specialty.

In the study period, reimbursement decreased in all but three regions; the Southeast, South and West Coast saw an increase of 1%, 7%, and 9%, respectively. Mountain West and Pacific Northwest regions had the largest declines in facility reimbursements at -19% each. For non-facility locations the average reimbursement was declined in all ten regions, while facility reimbursements declined by an average of -7%.

Out of the eight included procedures, only iliac stent placement (2%), femoropopliteal atherectomy (10%), and infrapopliteal atherectomy (14%) had an increase in facility reimbursements. Intravascular ultrasound (IVUS) and femoropopliteal stent placement had the largest declines at -19% and -17%, respectively. In non-facility settings, the average reimbursement declined by -24%, with femoral-popliteal atherectomy (-43%) and IVUS (-36%) having the largest decreases. Physician specialties all experienced a similar decline in facility and non-facility reimbursements.

Discussant Omid Jazaeri, MD, vascular surgeon at Advent Health in Denver, Colorado added that these data reveal the “disproportionate effect on populations already facing barriers to vascular care” such as those in underserved and rural regions.

He continued, pointing out that Koh’s conclusions “stop short of proposing solutions or policy considerations to mitigate inequities in reimbursement,” advising their research team to recommend areas for “CMS reform, support for providers in high-risk areas or targeted funding opportunities to ensure equity of patient care.”

One-year TAMBE data highlight low mortality, importance of renal branch assessment

By
Jocelyn Hudson
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0
One-year TAMBE data highlight low mortality, importance of renal branch assessment
Mark Farber presents TAMBE data at VAM 2025

The four-branch Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE) device demonstrated low mortality at one year with renal artery occlusion being the predominant device-related event associated with small renal arteries and pararenal aneurysms. So concluded Mark A. Farber, MD, presenting the latest TAMBE data during yesterday’s William J. von Liebig Forum.

Drawing a take-home message from the new findings—which were simultaneously published online in the Journal of Vascular Surgery (JVS)— Farber advised: “During follow-up, attention should be focused on renal branch assessment to identify patients at risk for occlusion.”

The chief of the Division of Vascular Surgery and professor of surgery at the University of North Carolina at Chapel Hill was presenting one-year results from the pivotal trial of the Gore TAMBE to treat extent IV thoracoabdominal aortic aneurysms (TAAAs) and pararenal aortic aneurysms (PRAAs). Farber detailed that this prospective, non-randomized, multicenter study included 102 patients, 59 of whom had an extent IV TAAA and 43, a PRAA, adding that the mean maximum aneurysm diameter was 59.4mm.

The presenter shared that, at one year, eight patients were lost to follow-up and six patients died, specifying that one death was device-related, one was procedure-related, and four were due to unrelated causes. He stated that, in total, 88 patients completed a follow-up visit at one year.

Moving on to key results, Farber revealed that freedom from all-cause mortality at one year was 94.1% and that target vessel occlusions occurred in 14.7% of patients. This figure included one celiac artery, one superior mesenteric artery (SMA), eight right renal and six left renal artery occlusions.

Farber continued that reintervention was attempted in six of the renal arteries and involved additional target vessel stenting in three patients, thrombolysis and embolectomy in two, and angioplasty in one. “Although branch vessel occlusion events were more common in pararenal aneurysms compared to extent IV TAAAs, this was not significant,” he said.

Looking at renal patency, Farber reported that renal artery patency was influenced by renal artery diameter, with renal arteries of less than 5mm in diameter being three times more likely to occlude. He also noted that acute kidney injury requiring dialysis occurred in 1.96% of patients and that renal deterioration— defined as a greater than 25% decrease in glomerular filtration rate (GFR) over two consecutive visits—was 18.9% through one year. Additionally, Farber revealed that renal artery primary patency at one year was 91.8% and “nearly identical between the right and left renal arteries.” Primary patency with respect to renal arteries greater than 5mm in diameter, he continued, was 95.1%, while for those less than 5mm it was 82.5%.

Farber shared that 94.2% of target vessels were free from target vessel instability events through one year. At the individual vessel level, he noted that Kaplan-Meier estimates for freedom from target vessel instability were 99%, 97.1%, 90.8% and 89.8% for the celiac, SMA, right renal and left renal arteries, respectively.

Furthermore, Farber outlined device effectiveness data at one year, which included no major endoleaks, aortic enlargement in 5.4% of patients, and loss of device integrity in 16.3%, which he specified included wire fractures in 3.6% and compression in 12.2%. Farber reiterated that renal deterioration was seen in 18.9%, and that reintervention occurred in 15.6%.

“With respect to the reinterventions,” Farber outlined, “approximately one-quarter were major and included thrombectomy or thrombolysis in five, [and] one exploratory laparotomy for aortic bifurcation rupture to control bleeding.”

Minor reinterventions, the presenter continued, included treatment of target vessel stenosis in eight patients, target vessel occlusion in two and branch-related endoleak treatment in three.

Revealing overall device performance data, Farber shared that combined device effectiveness was achieved in 60.5% and 78.7% of the pararenal and type 4 TAAAs, respectively. “This difference was mainly driven by a higher incidence of target lesion growth and branch vessel occlusion in pararenal aortic aneurysms,” the presenter commented.

In the discussion following Farber’s presentation, Wes Moore, MD, of David Geffen School of Medicine at UCLA in Los Angeles, asked how the new data might weigh up to those for physician-modified endovascular grafts (PMEGs).

“It’s hard to compare those results because we’re talking about a four-branch off-the-shelf device, and the majority of the PMEGs are probably fenestrations or laser fenestrations depending upon where you are, and so it’s hard to compare those,” Farber responded. “The important part about the manuscript is that we know that there are renal events that occur and that the goal of this manuscript is to talk about how you can help select your patients better. We have some renal events and 95% patency if you’re greater than 5mm at a year. If you have a patient who has small renal arteries, you need to think about how this might impact them since renal function is linked to survival.”

A subsequent question from Dawn Coleman, MD, of Duke University in Durham, North Carolina, homed in on the reliability of the device in question. “I was struck by the data around the loss of integrity of 16% at one year,” she remarked. “That’s a striking number.” Coleman went on to ask Farber how he would interpret this figure, and whether he has any insights on which patients were at most risk.

Farber first addressed the 3.6% rate of wire fractures. “Where they have the constraining sleeve, Gore identified a manufacturing issue which was corrected during the study, so that number should go down and we’ll have to look at that in the future because this issue involves both primary and secondary arm patients,” Farber commented.

Moving on to address the 12.2% rate of device compression, he detailed that the trial saw 11 compressions in total, including nine in the branch vessels. “Of those, about half of them had an occlusion and were reintervened upon such that at one year, seven of the nine compressions were patent.”

Farber advised conducting a “3D spin” at the end of a procedure to look for compressions and “fix those problems as they occur.”

No power, no problem! VAM 2025 pivots as early-morning power outage delays meeting opening

By
Bryan Kay
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No power, no problem! VAM 2025 pivots as early-morning power outage delays meeting opening
The lights went out just as VAM 2025 was about to commence—but the SVS had a back-up plan

The vascular surgery world is used to pivoting on a dime. So it was as VAM 2025 was about to commence yesterday morning, and power outage problems led to a delayed start to this year’s SVS annual meeting.

“We talk in vascular surgery about having to have multiple plans as we go into the operating room,” quipped SVS President Matthew Eagleton, MD, as attendees corralled into an alternative meeting room due to the technical difficulties besetting the main plenary hall.

“Welcome to plan C,” he added to a chorus of audience laughter. “This is just a test to see if you can get your steps in for the [SVS] Step Challenge. So, in about 30 seconds, we are going to walk back to the other room. Welcome to VAM 2025, our new motto: No power, no problem!”

Matthew Eagleton belatedly opens VAM 2025

On a more serious note, Eagleton reminded members that voting in this year’s leadership elections for SVS vice president and secretary ends at midday on Thursday. “If you have not voted, stop by one of the QR places and register your vote,” he said.

Across VAM’s four days of programming, a total of 62 plenary papers and 21 postgraduate education sessions populate the program. “The vision of the VAM program is to provide all of you with the best science impacting vascular surgical care for all of the membership,” said SVS Program Committee chair Jason Lee, MD. “We are committed to making sure this program is fair and that the process remains transparent to allow everybody’s voice to be heard.”

Vascular Specialist@VAM Conference Edition 1

By
Bryan Kay
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Vascular Specialist@VAM Conference Edition 1
In this issue:
  • Crawford Forum: Empowering vascular surgeons
  • SVS Foundation Resident Research Award: Targeting highly complex process of calcification
  • VTE: Evolving landscape of interventions for PE
  • Vascular injury: Imaging choice and aortic trauma

Training smarter, not harder: Analysis finds no negative impact of reduced core surgical requirements

By
Éva Malpass
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Training smarter, not harder: Analysis finds no negative impact of reduced core surgical requirements
Emily Y. Fan

Since the 2018 Accreditation Council for Graduate Medical Education (ACGME) reduction of core surgical requirements from 24 to 18 months during integrated vascular surgery residency, vascular residents’ operative experience has been unaffected, suggesting improved training optimization and efficiency.

This was the salient conclusion drawn from a recent retrospective analysis led by Emily Y. Fan, MD, a vascular surgery attending and associate program director at the University of Massachusetts Chan School of Medicine, Worchester, Massachusetts, and set to be presented by Dominique M. Dockery, MD, vascular surgery PGY2 resident, during the SVS-VESS Scientific Session 2a (3:15–4 p.m.) today at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7).

Fan and colleagues’ review of public ACGME case logs compared the five years prior (2013–2017) to the post-reduction period (2018–2022), marking trends in numbers of surgeon chief/junior cases over four categories including: general surgery open, general surgery laparoscopic, vascular surgery open, and vascular surgery endovascular in three anatomic regions: head/neck, thoracic, and abdominal.

Dominique M. Dockery

“We found that reducing core surgery requirements did not negatively impact overall operative volume or the proportion of general and vascular surgery cases,” said Dockery and Fan, speaking to VS@VAM ahead of today’s session. In the post-reduction period, an average of 260 cases were logged by integrated residents per year—general surgery accounted for between 34–38% of total operative volumes, with an average of 95.3 cases. The research team found no significant changes in operative experience by anatomic region.

The research group also found that general surgery and laparoscopic cases in all three anatomic regions remained stable, while total operative volume, open surgical cases—including open abdominal aortic aneurysm repair—and the proportion of general versus vascular surgery cases also remained unchanged between pre- and post-reduction periods.

“Rather, there were shifts in the types of general surgery cases being done, with trends towards increased open cases and decreased laparoscopic cases,” Dockery explained. “This suggests our trainees are utilizing core surgery time in a more efficient manner.” The results showed a decrease in general surgery laparoscopic averages in the post-reduction era from 49.8 to 44.8 cases, with concomitant minor increases in general surgery open thoracic and open abdominal averages.

In the absence of evidence showing that reduced core surgical requirements for vascular residents negatively impacts training opportunities, Fan and colleagues’ results indicate that working smarter, not harder may be beneficial.

“Trainee education is an integral part of our specialty, and it’s important to continuously assess our training paradigms,” Fan added.

Endorsing further reassessment, the research group hope that an additional reduction in general surgery requirements to 12 months should be considered a feasible option without compromising surgical training quality. “We hope this research will help inform potential future changes in training requirements as we continue to adapt and optimize our training programs,” Fan stated.

Register for the Women’s Networking Event

By
Marlén Gomez
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Join your colleagues for engaging Women’s Networking Event on Thursday evening at 7 p.m. at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7).

Set in the Camp Room on the Third Floor of the Hilton Riverside, this event provides a valuable opportunity for attendees to connect, share insights and engage in meaningful conversations.

For those still looking to strengthen their professional network, registration will be available on-site, making it easy to participate in this networking experience. Highlighting the night, Ruth Bush, MD, will deliver a brief talk about her career, offering inspiration and motivation for all attendees.

Explore the future of vascular surgery at Touchpoint@VAM

By
Marlén Gomez
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Explore the future of vascular surgery at Touchpoint@VAM
Touchpoint@VAM explores new technology in vascular surgery

Today, 2025 Vascular Annual Meeting (VAM) attendees are encouraged to engage in an eye-opening experience at Touchpoint@VAM for an interactive event that will showcase the latest advancements in vascular surgery technology.

The event will be held on the host venue’s First Floor, Rivergate Room, from 1–5 p.m.

Touchpoint@VAM is set to revolutionize surgical techniques featuring cutting-edge devices, immersive simulations and state-of-the-art virtual reality technology.

A host of leading companies will participate in this year’s event, including Boston Scientific, Cook Medical, Endologix, Gore, Haemonetics, Johnson & Johnson MedTech, Penumbra, Reflow Medical and Teleflex.

Next gen: Pair of sessions tailored for medical students lay out keys to the specialty

By
Marlén Gomez
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Next gen: Pair of sessions tailored for medical students lay out keys to the specialty
Medical student session introduces students to vascular surgery

Medical students attending the 2025 Vascular Annual Meeting (VAM) will have two unique opportunities to deepen their understanding of vascular surgery through sessions designed specifically for their level of training.

On Thursday, June 5, the Society for Vascular Surgery (SVS) will host two concurrent sessions, each tailored to different stages of medical education.

The Introduction to Vascular Surgery session, aimed at first- and second-year medical students (MS1-2), will run from 6:30–8 a.m. on the host venue’s Second Floor, Room 224. The session will open with remarks from Silviu Marica, MD, and Gabriela Velazquez-Ramirez, MD, followed by a welcome on SVS leadership delivered by SVS Vice President Linda M. Harris, MD, of the University at Buffalo.

Topics will include an overview of the specialty, the role of vascular surgeons in hospitals and guidance on gaining exposure to the field.

Speakers such as Omar Selim, MD, of Harvard Medical School and Kimberly T. Malka, MD, of Maine Medical Center will share insights on mentorship and career customization. The session will conclude with personal journeys into vascular surgery, including a talk by Mikayla Lowenkamp, MD, of the University of Pittsburgh Medical Center.

Simultaneously, third- and fourth-year medical students (MS3-4) can attend the How to Succeed as a Vascular Surgery Residency Applicant session in Room 220- 222. Moderated by Venita Chandra, MD, of Stanford and Natalie D. Sridharan, MD, of the University of Pittsburgh Medical Center (UPMC), the session will also begin at 6:30 a.m. Central Time.

SVS President Matthew Eagleton, MD, from Harvard Medical School, will deliver the SVS leadership welcome, followed by a series of presentations covering the residency application process, what program directors seek in candidates and how to excel during sub-internships and interviews.

Speakers include Zachary AbuRahma, MD, Kathryn L. DiLosa, MD, and Luigi Pascarella, MD, among others.

Both sessions emphasize the importance of mentorship, research and career flexibility within vascular surgery, offering students a comprehensive look at the specialty and practical advice for advancing in the field.

For more information on VAM 2025 programming, visit vascular.org/OnlinePlanner.

First-in-man results to show promise for robot-assisted HIFU in PAD treatment

By
Will Date
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First-in-man results to show promise for robot-assisted HIFU in PAD treatment
Non-invasive, robotic-assisted high intensity focused ultrasound

Results of a first-in-human study of non-invasive, robotic-assisted high intensity focused ultrasound (HIFU) for the treatment of peripheral arterial disease (PAD), to be presented Friday morning, will show that the therapy appears to be safe and feasible for the treatment of PAD localized in the femoral artery.

Robert M Wiggers, MD, a vascular surgery PhD candidate at University Medical Center Utrecht in Utrecht, The Netherlands, will present findings of the safety and feasibility study, which includes results following the treatment of 12 patients treated using the therapy, during the International Plenary taking place 6:30–8 a.m. on the Second Floor, Room 224, at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7).

Robot-assisted HIFU creates thermal lesions with submillimeter resolution enabling precise targeting of atherosclerotic plaques, Wiggers will detail. Preclinical studies have demonstrated the safety of the treatment, which it is hoped may be associated with fewer perioperative risks.

This first-in-human, non-randomized pilot study includes symptomatic PAD patients with a primary stenosis of the common femoral and/or proximal superficial femoral artery. Primary outcomes of the study include the major complication rate and technical feasibility. Secondary outcomes included clinical endpoints, such as the ankle-brachial index, and imaging parameters.

Between June 2019 and April 2024, investigators screened 232 limbs in 205 patients for treatment, ultimately treating 12 patients with unilateral lesions using HIFU treatment. They found that the mean treatment time was 113±28.2 minutes and technical success was achieved in all patients. No major complications occurred within 30 days of the procedure, or during the three months of follow-up.

Throughout a median clinical follow-up of 19.8 months, one patient underwent endovascular target lesion reintervention (TLR), while the other patients remained free from TLR, Wiggers is due to report. Eight patients (66.7%) underwent additional ipsilateral imaging after the study follow-up, after a median 25.9 months. Of these, four (50%) no longer had significant (>50%) stenosis of the target artery, as judged by independent radiologists.

Experts to examine ‘evolving landscape’ of vascular intervention in PE management

By
Jamie Bell
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Experts to examine ‘evolving landscape’ of vascular intervention in PE management
Natalie Sridharan

A number of topics relating to pulmonary embolism (PE) management—including lytic therapy versus thrombectomy, risk stratification and device selection—will feature this afternoon during an educational session. Taking place from 3:15–4.45 p.m. on the Second Floor (Room 217–219) at the 2025 Vascular Annual Meeting (VAM) in New Orleans, the session will also see experts discuss current evidence and the role of vascular surgeons within the “evolving landscape” of PE management.

The session is set to be moderated by Natalie Sridharan, MD, MS, assistant professor of surgery at the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania, and Linda Le, MD, assistant professor of clinical cardiovascular surgery at Houston Methodist Hospital in Houston, Texas.

“PE remains a highly lethal problem, with mortality rates relatively unchanged in recent times,” Sridharan told VS@VAM. “Catheter-directed interventions for PE have grown in popularity with a rapidly proliferating number of devices designed for thrombus removal. The evidence basis for intervention is also growing, but has somewhat lagged behind device development.”

Efthymios Avgerinos, MD, associate professor of vascular surgery at the University of Athens in Athens, Greece, will kick off the session by outlining existing evidence on PE intervention—posing the question: is there a mortality benefit, and does it matter?

Risk stratification in acute PE will feature next, with Patrick Muck, MD, chief of the Section of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio, taking to the podium to discuss methods for determining which patients will truly benefit from interventional treatments as well as ensuring these patients are treated in a timely fashion.

Following this, a debate over whether catheter-directed lysis versus percutaneous thrombectomy can be a “data-driven decision” will be contested by Fanny Alie-Cusson, MD, assistant professor of vascular surgery at Atrium Health in Charlotte, North Carolina, and Zachary AbuRahma, DO, assistant professor of vascular surgery at Charleston Area Medical Center in Charleston, West Virginia.

These discussions will be followed up by a talk from Steven Abramowitz, MD, chair of the Department of Vascular Surgery at MedStar Washington Hospital Center in Washington, D.C., who will present on device selection in PE intervention and ask: is bigger always better when it comes to thrombus removal?

Sridharan will subsequently take to the podium herself for the session’s penultimate presentation, providing insights on “how to deal with PE in transit,” including advice on when and how to intervene safely.

The session is set to conclude with a presentation from Dennis Gable, MD, chief of vascular and endovascular surgery at the Baylor Scott and White Heart Hospital in Plano, Texas, who will shine a spotlight on the role for vascular surgeons as a part of PE response teams—drilling down into whether they should be considered “leaders, or spectators.”

“Vascular surgeons need to be leaders in the management and treatment for PE, and all thromboembolic disorders,” Gable told VS@VAM.

“Vascular surgeons are the experts of the vascular system—both arterial and venous. However, vascular surgeons remain underrepresented in the management of PE and leadership of PE response teams,” Sridharan added. “Remaining not only involved but at the forefront of PE management is important for the well-rounded vascular program.”

VQI LEAF surveillance protocol set to be unveiled during VQI@VAM

By
Marlén Gomez
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0
VQI LEAF surveillance protocol set to be unveiled during VQI@VAM
Philip K. Goodney

Philip P. Goodney, MD, is unveiling a pivotal monitoring tool during the Vascular Quality Initiative (VQI) Annual Meeting, VQI@VAM, today—the Long-Term EVAR Assessment and Follow-up (LEAF) surveillance protocol, a multi-stakeholder initiative aimed at enhancing long-term monitoring of endovascular aneurysm repair (EVAR) outcomes.

The presentation, being delivered by the section chief at Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, highlights the importance of post-market, observational surveillance in improving patient outcomes and device performance over a 10-year period.

To improve the quality, safety, and effectiveness of vascular care after EVAR, the LEAF surveillance protocol uses fully anonymized and de-identified real-world evidence and data from the VQI VISION’s registry-claims linked datasets and Kaiser Permanente datasets, which represents over 52,000 patients from more than 400 centers. The protocol will provide device-specific long-term safety evaluation for endpoints such as reintervention, rupture and mortality.

The LEAF surveillance protocol was created in collaboration with industry device manufacturers Cook Medical, Gore, Endologix, Medtronic and Terumo Aortic and approved by the Food and Drug Administration (FDA). The protocol will ingest real-world data to provide insight into long-term outcomes in a sustainable manner. The multi-year initiative will generate annual device-specific clinical outcomes reports to ultimately provide a 10-year view into EVAR outcomes, with the ultimate goal of improving quality care for patients. All collected data are generated as reports without patient specific details in compliance with the rules and regulations of registry and Medicare beneficiaries.

“Improving outcomes is always a top priority for the SVS VQI and our industry partners,” said Philip Goodney, MD, chair of the SVS VQI LEAF Steering Committee, speaking ahead of his presentation. “This protocol is a testament of our commitment to quality. Real-world data provided by the SVS VQI registry is a vital tool for the analysis of medical products and devices.”

Key clinical endpoints on the LEAF surveillance Protocol include overall mortality, aneurysm-related mortality, rupture, reintervention and conversion to open surgery. Imaging endpoints will track changes in aneurysm size, endoleak classification and device patency. Follow-up will be conducted according to each site’s standard of care, with the next major data report scheduled for release this fall at the 18-month mark. Goodney emphasized the collaborative nature of the initiative, calling it “a critical step forward in ensuring the long-term safety and effectiveness of EVAR technologies in everyday clinical practice.”

A message from the SVS president

By
Matthew Eagleton
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A message from the SVS president
Matthew Eagleton

As we come together for VAM 2025, I want to take a moment to reflect on the remarkable progress we’ve made over the past year and to thank each of you for your dedication to our shared mission.

This past year has been one of bold action, strategic growth and meaningful impact. With the guidance of our SVS Executive and Strategic boards, and the tireless efforts of more than 560 volunteers across over 40 committees, taskforces, and writing groups, we’ve continued to advance the Society’s vision in powerful ways.

A key milestone was the expansion of our Executive Board from nine to 11 members, including five new at-large positions. This restructuring enhances our ability to respond to the evolving needs of our profession and ensures broader representation across our increasingly diverse membership.

Among our most visible accomplishments was the launch of the Highway to Health national branding campaign. This initiative introduced vascular surgery to the public with unprecedented reach: over 1.5 billion media impressions and over 3,500 placements since in launch last October.. It also brought to life our new patient-facing website, YourVascularHealth.org, a vital tool for education and outreach.

In advocacy, the SVS remained a strong and consistent voice in Washington. We engaged in critical conversations around physician payment reform, Centers for Medicare and Medicaid Services (CMS) fee schedules and legislation impacting both providers and patients. I encourage you to join us this September for our inaugural SVS Advocacy Conference in Washington, D.C., where we will continue to shape the future of vascular care together.

Our commitment to quality and innovation remains a cornerstone of our work. The Vascular Quality Initiative (VQI) continues to lead nationally in data-driven improvement. We celebrated the first community hospital verification through the Vascular Verification Program, and we launched a new Advanced Practice Provider Task Force to explore collaborative care models.

We also reaffirmed our commitment to outpatient and office-based care. The newly renamed Section on Ambulatory Vascular Care (SAVC) released the OBL Handbook, a valuable resource for our members.

As the pace of change accelerates, so too must our strategy. We are committed to evolving the Society to meet new challenges and seize emerging opportunities. Every dollar contributed, through dues, donations, or program support, helps us do just that. Your support is not only appreciated, it is essential.

Our membership continues to grow and diversify, now approaching 6,400 strong. The creation of the Young Surgeons Section (YSS) has energized early-career engagement, while the newly approved Senior Section ensures continued value and connection for our later-career members.

We also launched a new and improved VascuLEARN platform, offering accessible webinars, micro-learning, and short videos, an online hub for vascular education that has already served over 1,300 learners in the past three years.

In publishing, we reached a major milestone: the Journal of Vascular Surgery-Vascular Science (JVS-VS) has been indexed and will now carry an Impact Factor, thanks to the leadership of Dr. Alan Dardik, Tyler Cosgrove and our partners at Elsevier.

Finally, our Voices of Vascular campaign celebrated the stories of an assortment of stand-out SVS members, and our community came together to fund a new Vascular Care for the Underserved (VC4U) grant, which supports innovative solutions for populations affected by peripheral arterial disease (PAD).

These achievements are a testament to the strength of our community. They reflect your dedication, your expertise and your belief in the power of collective action. As we celebrate our progress and look ahead, I am inspired by what we can accomplish together.

Thank you for being part of this journey. I look forward to the conversations, collaborations and innovations that will emerge from this year’s meeting.

Matthew Eagleton, MD, DFSVS

SVS President

Crawford Forum: Empowering vascular surgeons

By
Bryan Kay
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Crawford Forum: Empowering vascular surgeons
Keith Calligaro
This year’s E. Stanley Crawford Critical Issues Forum at the 2025 Vascular Annual Meeting (VAM) in New Orleans, from 11:15 a.m.–12:15 p.m., on the Morial Convention Center’s First Floor (Great Hall A) seeks to address some of the structural and economic issues facing vascular surgeons as individuals—and those that challenge the specialty as an entity.

Empowering vascular surgeons all fronts—professional, financial and emotional— while addressing some of the over-arching issues faced by the vascular surgical specialty underpin the aim of this year’s Crawford Forum, SVS President-Elect Keith Calligaro tells VS@VAM ahead of VAM 2025.

Calligaro has a assembled a panel of four leading vascular surgeons to tackle some of the hottest topics of the day that speak to how vascular surgery is structured in hospitals and medical centers, as well as how vascular surgeons are reimbursed and organized.

“Fundamentally, we want to inform our SVS members what they can do to become better positioned with their hospital administrations and compared to other specialties, so that we are in a better position to take care of our patients for ourselves,” says the chief of vascular surgery at Pennsylvania Hospital in Philadelphia, who as the incoming SVS president is responsible for organizing the forum.

First speaker Malachi Sheahan III, MD, chair of surgery at the Louisiana State University Health Sciences Center in New Orleans, is set to address one of the thorniest topics: the issue of heart and vascular centers and vascular surgery’s position within them.

“He is going to ask, ‘Are heart and vascular centers beneficial to vascular surgeons?’, explore issues around the fact that when you combine a heart and a vascular center, most of the finances and effort go to the heart center, not really to the vascular center,” explains Calligaro. “So, his point, and what I think the audience should question is, should hospitals promote a vascular center independent of a heart center, and would that empower vascular surgeons to hopefully get more funding?”

There is also a marketing dimension to the heart and vascular center question, Calligaro says: “You don’t want vascular patients going to a heart and vascular center to be seen by a heart specialist when they should be seen by a vascular specialist.”

Similarly, next at the podium, Faisal Aziz, MD, the chief of vascular surgery at Penn State University in Hershey, Pennsylvania, will contemplate the position of departments of vascular surgery in both academic and community hospital settings, ultimately asking, ‘Are they worth fighting for?’

“There are probably some positives and negatives to having a vascular surgery department as opposed to a division,” Calligaro continues. “A division is part of an overall Department of Surgery, but if you can form your own independent Department of Vascular Surgery, the big advantage is you don’t have to necessarily answer to a different chair. You don’t have to go to conferences that are not beneficial to vascular trainees or to vascular staff. You are in charge of your own financials, which hopefully would benefit your own staff. It’s more a matter of establishing vascular as its own specialty, as opposed to being part of an overall department of surgery.”

Shifting gears to matters related to vascular surgery compensation, next speaker Sunita Srivastava, MD, assistant professor of surgery at Massachusetts General Hospital in Boston, is set to address how vascular surgeons can attain fair financial reimbursement from a marketing and fair compensation perspective. Her talk, based on a report of the SVS Population Health Task Force, addresses outside pressures impacting fair compensation.

“One of the issues is that inflation has been steadily rising, as has the cost of living, but reimbursements for vascular surgeons have remained the same over the last 20 years or so,” says Calligaro. “But we are still expected to put in the long hours and come in for emergency cases at night and at weekends, and be available 24 hours a day to bail out other surgeons when they get into a vascular complication. The cost of supplies is increasing if you have an outpatient, office-based lab. But the reimbursements have stayed flat. The salaries for your staff have been rising. But the reimbursements stay flat. The rent has been rising. But the reimbursements stay flat. The bottom line is vascular surgeons almost certainly make less from an overall standpoint than they did 20 years ago, and that’s what she’ll be addressing.”

Last up, Enrico Ascher, MD, professor of surgery at New York University in New York City and CEO of the Vascular Institute of New York, will tackle the question of potential unionization, asking, ‘How can vascular surgeons unionize when 95% of payments come from Medicare?’

“That’s very debatable,” Calligaro considers. “There’s a lot of reasons not to do so. One of the biggest problems—and that’s why it’s in the title—is what is the benefit of forming a union, and how can you form a union when the vast of majority of payments comes from Medicare. You can’t form a union against Medicare. He’s going to address ways to potentially get around that, how to do it, should we do it, what are the benefits of doing it, and, in the end, will it give vascular surgery either more independence, help us financially, or help us legally from the likes of malpractice lawsuits. He is going to look into whether it is worth it for vascular surgeons to join up with other surgeons or even all other physicians to form a union, which is where it gets really complicated because everyone has their own interests. It is something he has been a champion of, but whether or not it is going to be realistic is going to be a question.”

Uniting all of the topics is their focus on helping vascular surgeons achieve the ultimate aim, Calligaro adds: “All four of these things can address better patient care and better patient outcomes. Vascular surgeons need to consider all reasonable strategies to empower themselves to provide better care for their patients and to optimally position themselves when dealing with hospital administrators.”

What the cost of cancer care teaches vascular specialists

By
Will Date
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What the cost of cancer care teaches vascular specialists

How does the cost of treating critical limb-threatening ischemia (CLTI) in the U.S. stack up to cancer care? That was the question at the heart of research conducted by Richard W. Walsh, MD, and colleagues at the University of Texas Health Science Center in San Antonio, Texas, to be presented during the 2025 Vascular Annual Meeting (VAM) Plenary 2, Wednesday (10:20–11:15 a.m.) on the First Floor (Great Hall A). Ahead of the presentation, Walsh spoke to VS@ VAM to unpack the findings and how he believes they could hold important lessons for vascular care.

VS: What is the background to the research?

CLTI is a severe disease that is complicated by multiple medical comorbidities, each of which add cost for patients. These typically require multiple operations and reoperations over the course of a progressively debilitating disease, culminating in either limb salvage, amputation or eventual death.

On the other hand, we have seen how multidisciplinary care, research and targeted interventions have improved cancer survival and likely cost over time. The top four cancers in the U.S. are well studied and have strong data-driven treatment plans for most scenarios, offering a juxtaposition to CLTI patients, whose treatments can be highly provider, patient and region dependent. Comparing the costs of these two very different treatment approaches serves to illustrate the severity of CLTI costs, using cancer costs as a benchmark.

VS: What were your findings?

Within the limitations of the study, based on available data published on cancer and CLTI within the U.S., the annual per capita cost of CLTI was greater than the top four cancers—breast, prostate, colorectal and lung—in various stages, with multiple factors that increase this including medical comorbidities. Our manuscript references how renal or cardiac complications add a $11–20,000 price tag to any hospitalization.

VS: What do you expect is driving this?

CLTI is a chronic, uncurable disease with patients requiring multiple interventions, operations and reoperations. As endovascular approaches improve and innovate, these new technologies likely bring an increased element of expense. The latest peer-reviewed data are from 2011 and only show a difference of around $500 between surgical and endovascular approaches. We speculate the true cost of CLTI is greater.

Another factor involves the severity of cancer compared to CLTI. To most patients, cancer is a serious and potentially deadly disease. Effective screening programs are under constant study to catch cancers at a lower stage. Strong multidisciplinary teams are activated and provide continuity of care to the patients as they journey through cancer care, whereas most centers seeing CLTI patients do not have this level of resource.

Unfortunately, screening for—and finding early signs of—CLTI remains a challenge where literature has demonstrated patients with signs of CLTI are missed in the primary care setting.

Finally, CLTI is a chronic disease that continues to worsen over time, whereas early-stage cancers may be curable. This curative treatment leads to long and relatively healthy lives where the only remaining expenditures will be continued surveillance.

VS: What do you hope the vascular community will take away from the research?

This study does not aim to detract from the critical work and strong need for cancer research and innovation, with cancer research having led to revolutionary outcomes that have translated to reduced healthcare costs. Additional research aimed at prevention, treatment, management and screening can potentially offer additional patient outcome benefits and, by extension, reduced costs.

Cancer is feared by patients for relatable reasons. In the clinical setting, we have not seen an equal level of concern coming from CLTI patients, especially in early disease. At the late stage of the disease, where patients are afflicted by tissue loss, independence loss, and complications from treatments or comorbid conditions, we start to see greater understanding surrounding the severity of CLTI. Improvement in awareness of CLTI may provide a benefit to patient outcomes in the form of prevention or earlier disease recognition and this may lead to cost savings.

Furthermore, strong efforts are taken in cancer centers to ensure a patient has funding and means to avoid being lost to follow-up. Having a combination of vascular surgeons, wound care specialists and medical physicians with expertise in cardiac and renal complications within one clinic would allow for streamlined care to patients with CLTI.

As clinicians, we have all seen patients with poorly controlled comorbid disease. If this can be better managed, this offers a small start to improving outcomes. Investing in proper chronic disease management can provide a measure for cost reductions in the form of lengthening intervals between operations and, in theory, can reduce the number of total operations.

Finally, continued efforts on the development of evidence-based guidelines are needed.

A New Orleanian’s guide to New Orleans

By
Malachi Sheahan III
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A New Orleanian’s guide to New Orleans
Malachi Sheahan III

Welcome! Our city is humid, crumbling and vaguely supernatural. Make the right choices and you will never forget your time here. Double that if you make the wrong ones. Here are some personal favorites.

Restaurants: Lilette, Clancy’s, Paladar 511 and Jacques-Imo’s are essential. Can’t go wrong with Atchafalaya, Shaya or Commander’s Palace. In Treme, visit Dooky Chase’s, where the late Leah Chase once fed Martin Luther King Jr. and the Freedom Riders. Nearby, Willie Mae’s Scotch House also serves world-class fried chicken. In the Warehouse District, Peche is chef Donald Link’s seafood-focused flagship.

Bars: Napoleon House is an authentic, old-school experience. Order the Pimm’s Cup. Bacchanal Wine is a backyard bottle shop slash live-music sanctuary. Cure and Jewel of the South are excellent upscale options. Columns and the Elysian are also superb. Los Jefes, Pat O’Briens and Tchoup Yard are affordable alternatives where you are likely (regrettably) to encounter an LSU vascular resident.

The Posh Corner for Fancy People, (sponsored by Sam Money and Claudie Sheahan) Shopping: Magazine Street between Octavia and Nashville, also between Washington and Napoleon. And Sak’s, of course. Dining: Emeril’s and Doris Metropolitan. Drinks: Hotel St. Vincent.

Kids: National WWII Museum (all ages really), the Cool Zoo, Honey Island Swamp Tours, and the aquarium. Some of the Haunted History tours are appropriate for older kids. Are the stories true? My wife seems to think so.

Art: New Orleans Museum of Art for looking, Terrance Osborne and Studio Be for buying. MS Rau is like a museum with price tags (ask for a tour, pretend a vascular surgeon could afford that Monet). Julia Street is nearby and packed with art galleries.

Music: Preservation Hall—no frills, no booze, no amplification. It’s jazz church. Also check the schedule at Tipitina’s or visit Frenchmen Street. The music is good everywhere, except for Bourbon St., which is for drunk tourists. I’ll let you self-select.

Exercise: There are running paths in Audubon Park and along the levee… oh settle down Prefontaine. It’s hot as hell, get your butt inside and drink and eat with the rest of us.

Vascular Specialist–June 2025

By
Bryan Kay
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Vascular Specialist–June 2025

In this issue:

  • Helping OBL vascular surgeons fight the squeeze
  • ‘Rise together’: Harris urges unity in Women’s Vascular Summit presidential address
  • Senior surgeons: Options beyond the operating room
  • New BEST-CLI cost-effectiveness data drop

 

Cost-effectiveness outcomes defy expectations in latest BEST-CLI data drop

By
Jocelyn Hudson
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Cost-effectiveness outcomes defy expectations in latest BEST-CLI data drop
Alik Farber (left) and Matthew Menard

The open surgical approach will prove to be “slightly superior” to endovascular intervention in terms of cost per life year gained, while the latter will be slightly superior to open surgery with regard to cost per quality-adjusted life year gained, pending results from a cost-effectiveness BEST-CLI analysis show.

The data, revealed during the 2025 Charing Cross (CX) International Symposium (April 23–25) in London, England, were part of a series of four podium-first presentations from the landmark BEST-CLI and BASIL-2 trials delivered at the meeting that aimed to add nuance to the ongoing conversation around the best treatment option for chronic limb-threatening ischemia (CLTI) patients.

Sharing the main conclusion from new BEST-CLI cost-effectiveness data, Matthew Menard, MD, from Brigham and Women’s Hospital in Boston, told CX 2025: “I can tell you that, based on the data that we have— with the caveat that the final results are pending—we would predict that open will prove to be slightly superior to endo[vascular] with regard to cost per life year gained and that endo[vascular] will be slightly superior to open with regard to cost per quality-adjusted life year gained.”

Topline results from this trial were shared at the American Heart Association (AHA) scientific sessions in 2022, with investigators revealing that surgical bypass with adequate single-segment great saphenous vein is a more effective revascularization strategy for patients with CLTI who are deemed suitable for either an open or endovascular approach. Both strategies were deemed safe and effective for CLTI treatment.

At CX, Menard added a further prediction that “given the small and statistically insignificant magnitude of the differences in the relevant inputs, it is very unlikely we will detect any meaningful cost-effectiveness difference,” noting that more granular data will be released later in the year. Andrew Holden, MD, from Auckland City Hospital, New Zealand, moderating, expressed surprise at the results. “Before you shared these data,” he said, “I intuitively thought that endovascular, while not being successful overall, was going to be more cost-effective and I thought it would be driven by lower hospital stay and certainly lower intensive care stay, but you actually found the opposite, so I find that counterintuitive.”

Holden asked Menard whether he could explain the findings, to which Menard responded that “our goal was to undertake a very comprehensive analysis, in which all costs associated with the initial index procedure and hospitalization were captured, along with all of the costs of follow-up reinterventions, hospitalizations and rehabilitation care. The challenge is figuring out what’s relevant to the disease,” he said, adding that “this is how the data are looking” when all of the costs that are associated with CLTI revascularization are assessed in aggregate over time. Hospital stay—almost always the key driver in cost-effectiveness analyses, he stressed—appears to be the “key metric” in their evaluation as well.

BASIL-2 trialist Matthew Popplewell, MD, from the University of Birmingham in Birmingham, England, noted that he was “quite relieved” on hearing the new findings. He explained that the length of stay in the BASIL-2 health economic analysis has been criticized for being “really long,” with the suggestion being that this could be due to a healthcare system issue. “Clearly it’s not, because it’s happening on both sides of the pond,” Popplewell commented.

Holden added that a “new lesson” to take from these cost-effectiveness data is that the driver of shorter hospital stay in these patients is perhaps not a less invasive procedure but, instead, making progress with wound healing to facilitate discharge.

Could primary endo ‘actually burn bridges’?

Subsequently, Alik Farber, MD, from Boston Medical Center in Boston, shared a new subset analysis from BEST-CLI. “We found that primary endo may actually burn bridges for secondary bypass,” the presenter concluded, noting that primary bypass was associated with “significantly better” outcomes. Farber went on to add that the BEST-CLI dataset is a “treasure trove for CLTI research” and will continue to add to a “badly needed evidence base.”

A question from the audience probed whether there are enough granular data available to know how a primary endovascular intervention “actually burns the bridge.” Farber responded: “There are many potential reasons as to how endovascular therapy may burn bridges for a future bypass. It may occur due to disruption of vulnerable plaque, wire injury, compromise to collateral vessels, damage to run-off vessels, compromise of a bypass target, progression of tissue loss and concomitant loss of optimal window for intervention, or it could simply be a marker for a higher-risk patient or disease pattern. Which of these reasons are at play is not clear; however, our findings do show that the amputation rates are higher after secondary bypass.”

Here, Farber pointed to future research that might bring answers. He shared that the Novo Nordisk Foundation has provided a grant to the BEST-CLI team to fully unpack the BEST-CLI dataset. Menard added that the National Institutes of Health (NIH) has granted the BEST-CLI team permission to look more closely at the first major adverse limb event (MALE) data in the trial: “We have been able to obtain the source data and so will be able to look at the etiology of treatment failures. We are hopeful this will help us understand the important questions related to the need for reinterventions following an initial open or endovascular revascularization.”

Summarizing this part of the discussion, Holden remarked: “I think it’s fair to say that we are learning that endo may burn bridges, and I never used to like to hear that, but I think it is potentially true.”

Vascular Quality Initiative to host annual meeting at VAM 2025

By
Marlén Gomez
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Vascular Quality Initiative to host annual meeting at VAM 2025
Jens Eldrup-Jorgensen

The Vascular Quality Initiative (VQI), in collaboration with the Society for Vascular Surgery (SVS), will convene its ninth annual conference (June 3–4) during this year’s Vascular Annual Meeting (VAM 2025) in the Morial Convention Center (Second Floor, R08–R09) in New Orleans, bringing together healthcare professionals to advance the quality and safety of vascular care.

This two-day event will spotlight VQI’s latest achievements, including the expansion of its registry network, the launch of a new educational series, and enhancements to its data reporting platform. With more than 1,000 participating centers and more than one million vascular procedures recorded, the VQI continues to be a cornerstone of data-driven quality improvement in vascular health. According to the 2024 SVS VQI Annual Report, the initiative has seen steady growth, now encompassing a diverse mix of academic institutions (26%), teaching hospitals (30%), and community hospitals (44%). Physician participation spans multiple specialties, with vascular surgeons making up 42% of contributors, followed by interventional cardiologists, radiologists and other specialists.

“The impact of VQI data on clinical practice and patient outcomes cannot be overstated,” said Jens Eldrup-Jorgensen, MD, the SVS Patient Safety Organization (PSO) medical director. “Our collaborative efforts have not only improved care delivery but also fostered global partnerships through the International Consortium of Vascular Registries [ICVR].”

This year’s conference introduces a number of updates:

  • Renaming of Participation Awards: The SVS VQI Participation Awards program, launched in 2016, has been renamed the Commitment to Vascular Quality Improvement Award to better reflect its mission of encouraging active engagement in quality initiatives.
  • New VQI Centers: Northwestern Medicine Palos Hospital (Mid-America) and Our Lady of Lourdes Memorial Hospital, Inc. (Mid-Atlantic) have joined the VQI network.
  • Smoking Cessation Educational Series: A 12-part monthly series that launched in January 2025 will provide comprehensive education on smoking cessation. Developed by Director of Quality Betsy Wymer, DNP, the series is open to physicians, nurses, advanced practice providers (APPs) and patients.

“Smoking cessation remains the most important task healthcare workers can offer their patients,” said Kendra Smith, RN. “This series is a powerful tool for change.”

On Tuesday, June 3, attendees will receive updates on the Fivos PATHWAYS platform, the secure, cloud-based system that powers VQI’s real-time data collection and long-term outcomes tracking. Enhancements include security toolkits to enhance the security posture of its systems.

Wednesday’s sessions will focus on the third National Quality Initiative (NQI), introduced in 2023, with a deep dive into the Smoking Cessation NQI. This underscores the VQI’s commitment to addressing modifiable risk factors and long-term outcomes.

“As the VQI continues to grow and evolve, its mission remains clear: to harness the power of data and collaboration to elevate vascular care. With new tools, expanded participation and a renewed focus on education and equity, the 2025 conference promises to be a pivotal moment in the journey toward better vascular health for all,” said Eldrup- Jorgensen.

For more information, visit vqi.org.

Taking the lead: The vascular surgeon in the pediatric vascular surgical space

By
Bryan Kay
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Taking the lead: The vascular surgeon in the pediatric vascular surgical space
Dawn Coleman

It’s a bit like realigning the narrative, ever so slightly. “I want us to feel, as a collective specialty, that pediatric vascular care falls under our purview,” says Dawn Coleman, MD, a leading voice in the vascular surgical care of pediatric patients, as she emphasizes an emerging need for her vascular surgeon colleagues to own their role in the space. Or, put another way: when vascular surgeons look at colleagues like Coleman who are deeply entrenched in the care of pediatric patients with vascular pathologies, the message is: don’t overlook or diminish the role vascular surgeons can play in the care of these patients.   

Vascular and pediatric surgical collaboration has been the emblem of efforts in recent years to optimize the multidisciplinary approach to pediatric vascular care. But for the flagship session organized by the SVS Pediatric Vascular Surgery Interest Group at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7), that collaboration is momentarily giving way to a laser focus on vascular surgery’s pivotal role.

“This year, we are being quite intentional, urging and empowering our peers to realize, as vascular surgeons, the critical role we play in this space, even those who may not be super comfortable caring for these kids independently,” Coleman, chief of vascular surgery at Duke University in Durham, North Carolina. “In the past, we have been intentionally inclusive of our APSA [American Pediatric Surgical Association] partners in these sessions. This year, while not intending to be exclusive of our partners, the omission of our pediatric surgical colleagues and the focus on vascular surgeons aims to emphasize our professional accountability to this patient demographic. We believe that our invited speakers will help our members realize their value in this space, as surgeons and multidisciplinary collaborators, and be inspired not just to engage in the care of these children, but to be leaders in that care.”

The intentionality of this session—on Friday, June 6 (2–3:30 p.m.), on the Morial Convention Center venue’s Second Floor (Room 217-219)—is captured in the title, The Critical Role of Vascular Surgeons in the Children’s Hospital. Zoom out from the vascular workforce operating in pediatric care to the vascular surgery workforce at large, and a similar picture of some of the specialty’s existential concerns—declining population of surgeons, valuation in hospital systems, public branding and visibility—begin to form. “As our workforce continues to feel incremental patient volume, complexity and burden of operational inefficiencies, more than ever our hospitals need us,” explains Coleman.  “The SVS is committed to helping comprehensive entities appreciate how much value we bring to an institution. We want to emphasize, with this session, that pediatric hospitals need us also, and that we add value. For example, if you are going to have a level 1 pediatric trauma center, you must have the capability of vascular surgeons to support that. If you’re going to have a major pediatric surgical oncology program, you must have capability for vascular reconstruction.”

The coming together of the SVS and APSA was intentional too. Coleman is a co-chair alongside John White, MD—who will also co-moderate the VAM session—on the SVS side of a joint taskforce with APSA to tackle pediatric vascular surgery issues. As the ability to extend the lives of children improves and population health threats continue to rise, says Coleman, the incidence and nature of pediatric vascular problems is ever increasing in frequency and complexity. The taskforce continues to pursue meaningful interventions to advance the understanding and care of these low-volume but critical pediatric vascular problems, alongside shifts in training paradigms that may impact the comfort levels of surgeons from both specialties, Coleman explains. There are “major educational gaps, and clinical gaps regarding what best practice can and should be,” she says. “And disappointingly, we continue to often extrapolate from adult vascular care.”

The session explores pediatric iatrogenic vascular injury, oncovascular reconstruction, rare cases of pediatric venous anomalies, and the nuances of pediatric dialysis care. For Coleman, overlap with other specialties in areas of pediatric vascular care underscores the need for vascular surgeons to step up. “At a local level, hospitals find the teams and build the teams that the kids need,” she says, “and I think vascular surgeons should be valued as critical assets and leaders on these teams.”

SVS continues success with smoking cessation webinar series

By
Marlén Gomez
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0
SVS continues success with smoking cessation webinar series

The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) is hosting a monthly webinar series throughout 2025 on smoking cessation, which so far has garnered positive participant feedback.

The educational content consists of a 12-month program that draws on insights gained by Betsy Wymer, DNP, SVS director of quality, during her training for tobacco specialist certification.

The audience for this series includes physicians, advanced practice providers (APPs), nurses and patients.

To register for the webinars, visit vqi.org/smoking-cessation-webinar-series.

Grandfather of Vascular Quality Initiative retires from Fivos

By
Marlén Gomez
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0
Grandfather of Vascular Quality Initiative retires from Fivos
Jack L. Cronenwett

Jack L. Cronenwett, MD, considered the “Grandfather of the VQI,” will retire as the chief medical officer (CMO) for Fivos, the medical data solutions technology partner for the Vascular Quality Initiative (VQI). Cronenwett took on the role of CMO at Fivos after completing his term as medical director of the VQI in 2016.

His tenure was marked by significant efforts to collaborate with the Food and Drug Administration (FDA) and vascular device manufacturers to promote the use of real-world evidence for postmarket device evaluation.

During this time, Fivos developed multiple such projects to evaluate vascular devices more efficiently using VQI data. One important project was launched to obtain funding from the Centers for Medicare & Medicaid Services (CMS) for surveillance of transcarotid artery revascularization (TCAR).

Cronenwett began his training in surgery at the University of Michigan. In 1984, he transitioned from Michigan to Dartmouth, an institution he considers as having a long history of quality improvement. The Dartmouth Institute for Health Policy and Clinical Practice, founded by Jack Wenberg, MD, in 1988, emphasizes quality improvement and catalyzed the creation of the Vascular Study Group of New England—the seeds of the VQI—in a bid to improve the quality of vascular healthcare.

“The key concept that we focused on when we first developed the VQI was that all physicians want to achieve the best results, and if they’re provided with data that shows that they have an opportunity to improve, they will act to make improvements. That concept remains the cornerstone of the VQI,” said Cronenwett.

Cronenwett also served as Society for Vascular Surgery (SVS) president from 2002–2003, during which time he collaborated with Thomas Riles, MD, for the merger of the SVS with the American Association for Vascular Surgery (AAVS), creating the organization that the SVS is today.

As he gets ready to leave his position, Cronenwett shared some parting wisdom for his successor. “If you aim to move quickly, work solo; if you intend to achieve great distances, collaborate with others,” he said. This advice stems from his experience working collaboratively with others who share optimism for a project, urging leaders to disregard inevitable critics, he explained.

“There will always be naysayers about any new idea,” said Cronenwett, emeritus professor of surgery at Geisel School of Medicine at Dartmouth in Hanover, New Hampshire. “Eventually, when it becomes successful, the naysayers will come around. It was difficult to convince the SVS to take over the then-nascent VQI in 2011, when it was starting to expand beyond New England. But there were several influential people within the SVS at that time who recognized the potential and were able to work with us to achieve that.”

The VQI’s 14 registries contain demographic, clinical, procedural and outcomes data from more than a million procedures performed across the U.S., Canada and Singapore, with each record including information from the patient’s initial hospitalization and at one-year follow-up.

Helping OBL vascular surgeons fight the squeeze

By
Bryan Kay
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0
Helping OBL vascular surgeons fight the squeeze
Anil Hingorani
SVS Section on Ambulatory Vascular Care (SAVC) set to announce set of new initiatives designed to help office-based lab (OBL) vascular surgeons combat rising costs and stagnant payments during jam-packed session focused on the outpatient setting at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7).

The way Anil Hingorani, MD, sees it, vascular surgeons operating in the OBL outpatient setting are feeling the pinch amid an unforgiving economic climate. With the omnipresent threat of Medicare cuts, stagnant or decreasing payments, and escalating inflationary pressure, they are hurting, the SAVC chair explains. Many private-practice specialists behind OBLs are choosing to shutter their practices. Others with the means are converting their facilities into the OBL’s outpatient cousin, ambulatory surgery centers (ASCs). For many vascular surgeons in this OBL, the personal costs run high, Hingorani, a vascular surgeon in Brooklyn, New York, details. “This is putting a lot of stress on private practitioners who have invested very heavily in OBLs—personal investment quite a bit of the time—and they are often personally liable,” he says.

So, the SVS and its section dedicated to the issues facing outpatient practices are taking action through a series of new initiatives aimed at helping OBLs cut costs. The exact details of the SVS plans are set to unveiled toward the end of the pair of back-to-back SAVC sessions taking place at VAM 2025 on Friday, June 6 (2–5 p.m.) in the Morial Convention Center host venue (Second Floor, Room 224).

“Without revealing too much ahead of time, these SVS initiatives are about cost-savings for OBLs amid the cuts, and I think these will be especially important for the smaller practices, because those are the ones that are being hurt the most,” says Hingorani, who will be one of the moderators of the SAVC sessions. “They are the ones that I think we can help the most. We’ve done some preliminary work on this already, and I would say is going to be a key component, for one-, two- or three-practitioner practices. And, these don’t have to be just vascular-surgeon-only practices; they can be multispecialty groups as well.”

The economic headwinds impacting on OBL surgeons and driving the SVS and SAVC to action are stark, Hingorani explains. “Some of the transition going on is being dictated by CMS [the Centers for Medicare & Medicaid Services]. Some of it is because the RVU [relative value unit] conversion rate has not increased for 30 years, and inflation has clearly been going up over the last couple of years,” he continues. “So, if you’re in the OBL, you’re getting it from both ends. If your costs are increasing and your payments are the same—or decreased in some parts of the OBL—that’s a squeeze financially. That’s one of the reasons why these OBLs are being converted into ASCs. That also takes considerable investment. A lot of reasons why places open as OBLs is that ASCs are expensive, have much higher regulation and require a lot more investment, so it is a higher-stakes game to convert a pre-existing OBL to an ASC. Hopefully some of these new SVS initiatives will make a significant impact.”

The SAVC sessions at VAM 2025 feature the spectrum of issues related to practice in OBLs and ASCs.

Highlights include a couple of talks that focus on artificial intelligence (AI) use in ambulatory centers. Uwe Fischer, MD, an assistant professor of surgery at Yale School of Medicine in New Haven, Connecticut, is bringing expertise on AI’s use to improve vascular diagnostics and treatment outcomes, while Alisha Oropallo, MD, a professor of surgery at Hofstra University/Northwell in Lake Success, New York, will offer insight on how AI chatbots might improve chronic vascular wound management outcomes in OBLs and ASCs. Much of the work presented comes from SAVC research and seed grants, and recaps prior years as well as points ahead to new work coming up. Meanwhile, the annual Excellence in Community Practice Awards will again take place toward the end of the SAVC program, Hingorani notes.

SAVC’s focus on research in this arena seeks to fill a void, the section chair points out. “The reason why we are trying to open up this space for research is because there really has not been a lot in the OBL or ASC space,” he says. “I think part of that has been financial directives of the field and trying to stay afloat but also support.

“Part of the reason why we have this session is to give a platform for people to present heir work, but also for the seed grants. Specifically, this is to give support to hire statisticians, get a database, or to help input the data, analyze the data, present the data—to help the process of actually getting your research out. If we say that more than 50% of lower extremity angioplasties are performed in the outpatient space, where are the data? We have the numbers. But where are the results, what are the challenges, what are the opportunities, what are the changes that take place when you start doing these procedures as an inpatient and then transfer them to an outpatient?”

Answering the questions of appropriate outcome measures after intervention for deep reflux as promising venous valve technology emerges

By
Fedor Lurie
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0
Answering the questions of appropriate outcome measures after intervention for deep reflux as promising venous valve technology emerges
Fedor Lurie
Fedor Lurie

“The path from initial trials to meaningful clinical data will not be easy,” writes Fedor Lurie (Toledo, USA) of new venous valve technologies.

There is an old saying that goes, “As surgeons, we change the anatomy to improve physiology”. Correction of physiological abnormality should, then, result in clinical improvement. The assumptions behind such a three-step logic (anatomy-functionclinical outcome) are frequently challenged, modified and, sometimes, refuted when subjected to scientific examination. Recent developments in the field of chronic venous disease (CVD) make clear the need for such scientific examination of several basic assumptions, one of which is the role of reflux.

Epidemiological studies and clinical observations consistently demonstrate that patients with primary CVD have either deep or superficial venous reflux, or both. Superficial reflux is relatively easy to treat. Multiple clinical trials have shown that ablation leads to clinical improvement. Deep reflux data are less convincing. The introduction of surgical repair for deep venous valves generated several observational studies showing excellent long-term functional and good clinical outcomes.1,2 However, this operation requires the presence of a correctible valve, while most patients with deep reflux have valves damaged by the thrombotic process. Since valvuloplasty was universally performed in patients with terminal venous disease, consensus statements and guidelines restricted recommendations for deep vein reconstruction to patients with venous ulcers.3,4 More than 50 years of clinical experience performing deep reflux correction still did not answer the question of its role in the progression of CVD and the degree to which such correction changes the natural history of this disease process.

There is a definite need for a practical solution for deep reflux correction. Correction in patients with both primary and secondary CVD—preferably in nonterminal stages of the disease—should answer this question and define the place for such a procedure in clinical practice. Fortunately, several devices are currently in pre-clinical and clinical stages of testing, and the hope is that some solutions will be available soon. However, the path from initial trials to meaningful clinical data will not be easy.

The first challenge is patient selection. Haemodynamics plays an important role in the early stages of venous disease, but has minimal influence in advanced stages.5 The terminal stage is much more a chronic wound process, and correction of haemodynamic abnormalities, although beneficial, has a less clear benefit compared to earlier stages. Limiting the use of deep reflux correction to patients with venous ulcers will not answer the question of whether such a procedure can prevent disease progression. An additional challenge is choosing outcome measures that are related more to haemodynamic correction than to other aspects of ulcer management. The only prospective randomised trial of deep venous valvuloplasty showed that patients with stable disease, or those that remained in the same clinical class for five years before surgery, do not benefit from deep valve repair, while those who progress to more severe disease have a significant clinical improvement.6 This suggests that it is reasonable to use reflux correction procedures in patients in early CVD stages who experience relatively fast progression.

Another challenge is to demonstrate the relationship between improvement in haemodynamics and clinical outcomes. Existing measures of venous haemodynamics and the severity of venous disease are far from perfect and likely to be inadequate for addressing this challenge. The current definition of reflux, although clinically useful, has no meaning in terms of physiological or fluid dynamics. Reverse flow in venous segments is frequently a normal event, even when all valves are competent.7 The time of reversed flow depends on many factors outwith the presence or absence of valvular incompetence. The variability of reflux time measurements is so large that the same patient can be classified as having reflux if tested at different times by the same sonographer using the same procedures and equipment.8 Which parameters of reversed flow are physiologically relevant remain unknown. Suggested candidates range from the volume of blood refluxing back, the flow rate, velocity, vein wall sheer stress and near-wall sheer rate, to a combination of all these measures. Even if the specific factor is defined, ultrasound-based measurements provide information only on one venous segment at a time. The impact of a single segmental reflux correction on the global haemodynamics of extremities is more likely to be clinically relevant and important to assess. Unfortunately, the only existing test for assessing global haemodynamics is plethysmography, which is even less reliable than ultrasound.

The instruments that are used to assess CVD severity were developed by expert consensus (the Venous Clinical Severity Score, or VCSS) or even by a single person (the Villalta score). They reflect more on current perceptions of what constitutes more-or-less severe disease, rather than on scientifically based indicators of disease severity. The exception would be some of the patientreported outcomes—such as VEINES-QOL—that were psychometrically constructed and tested for several aspects of validity.

Like the physiological questions about deep venous valves, the question of appropriate outcome measures of reflux correction is likely to be answered by future clinical experience with valve correction devices.

As practitioners managing patients with venous disease, we are at an exciting juncture—when many questions can be answered and the health of our patients can be improved. All we need is a solution that is practical and efficient at correcting deep venous reflux.

References:

  1. Kistner RL. Surgical repair of the incompetent femoral vein valve. Arch Surg. 1975 Nov;110(11):1336–42.
  2. Masuda EM, Kistner RL. Long-term results of venous valve reconstruction: A four- to twenty-one-year follow-up. J Vasc Surg. 1994 Mar;19(3):391–403.
  3. Lurie F et al. Invasive treatment of deep venous disease. A UIP consensus. Int Angiol. 2010 Jun;29(3):199–204.
  4. O’Donnell TF Jr et al. Management of venous leg ulcers: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2014 Aug;60(2 Suppl):3S–59S.
  5. Welkie JF et al. Hemodynamic deterioration in chronic venous disease. J Vasc Surg. 1992 Nov;16(5):733–40.
  6. Makarova NP, Lurie F, Hmelniker SM. Does surgical correction of the superficial femoral vein valve change the course of varicose disease? J Vasc Surg. 2001 Feb;33(2):361–8.
  7. Lurie F. Anatomical Extent of Venous Reflux. Cardiol Ther. 2020 Dec;9(2):215–218.
  8. Lurie F et al. Multicenter assessment of venous reflux by duplex ultrasound. J Vasc Surg. 2012 Feb;55(2):437–45.

Fedor Lurie is a associate director of the JOBST Vascular Institute in Toldeo, USA.

SVS releases updated guidelines for intermittent claudication

By
Marlén Gomez
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0
SVS releases updated guidelines for intermittent claudication
Michael S. Conte

The Society for Vascular Surgery (SVS) has issued a comprehensive update to its clinical practice guidelines for the management of intermittent claudication, urging clinicians to prioritize conservative treatment strategies and patient-centered care.

The new guidelines, published in April 2025, reflect the latest evidence on antithrombotic therapy, exercise interventions and revascularization procedures. They replace the SVS’s 2015 recommendations and aim to provide a more nuanced, evidence-based framework for treating patients with intermittent claudication.

“Intermittent claudication is a complex condition that affects millions of people worldwide,” said Michael S. Conte, MD, chair of the guideline writing group and professor of surgery at the University of California, San Francisco. “Our updated recommendations are designed to help clinicians tailor treatment to the individual patient, based on their symptoms, comorbidities, and personal goals.”

Conte will moderate a session at the 2025 Vascular Annual Meeting (VAM) in New Orleans on Friday, June 6  (2–3:30 p.m.) in the Morial Convention Center (Second Floor, Room 228–230) titled Translation of Clinical Guidelines to Practice: A Patient-Centered Approach to Management of Intermittent Claudication, which includes six talks, followed by discussion.

The guidelines reaffirm that first-line treatment for intermittent claudication should focus on education, smoking cessation, risk factor control, optimal medical therapy and structured exercise programs. Revascularization, whether surgical or endovascular, should be reserved for patients with lifestyle-limiting symptoms who do not respond to conservative therapy.

Bernadette Aulivola

“Too often, patients are rushed into procedures without fully exploring non-invasive options,” said Bernadette Aulivola, MD, a vascular surgeon at Loyola University Chicago, and co-author of the guidelines. “We want to change that narrative.”

The updated guidelines include 12 formal recommendations and two best practice statements. Among them are:

  • Dual pathway antithrombotic therapy—combining low-dose rivaroxaban (2.5 mg twice daily) with aspirin—is suggested for patients with intermittent claudication and high-risk comorbidities such as diabetes, heart failure or polyvascular disease, as well as for those who have undergone revascularization. This approach has been shown to reduce the risk of cardiovascular events, though it carries a modest increase in bleeding risk.
  • Supervised exercise therapy (SET) is recommended as the gold standard for improving walking performance. Patients should walk at least three times per week for 12 weeks. For those unable or unwilling to participate in SET, structured home-based walking programs are recommended.
  • Revascularization should only be considered after conservative measures have failed. Shared decision-making is essential and should include a discussion of potential risks-including mortality, major adverse cardiovascular events and limb complications-as well as expected benefits such as improved mobility and quality of life.
  • Infrapopliteal interventions are discouraged in patients with IC due to a lack of evidence supporting their benefit and concerns about potential harm.
  • For femoropopliteal lesions longer than 5cm, the use of drug-coated balloons, drug-eluting stents or bare metal stents is recommended over plain balloon angioplasty to reduce the risk of restenosis and reintervention.

The guideline development process included a panel of patient advisors, individuals with lived experience of PAD and claudication. Their input helped shape the recommendations and underscored the importance of clear communication, individualized treatment goals and transparency about the risks and benefits of various therapies.

Patient advisors also called for the development of a “patient-friendly” version of the guidelines and expressed interest in peer support networks where individuals considering treatment could speak with others who have undergone similar procedures.

Despite advances in pharmacotherapy and endovascular technology, the SVS identified several critical gaps in the evidence base. These include a lack of large-scale comparative effectiveness studies, limited data on long-term outcomes following revascularization and insufficient research on the optimal design of home-based exercise programs.

Ultimately, the updated guidelines aim to shift the focus from a one-size-fits-all approach to a more thoughtful, individualized model of care. Clinicians are encouraged to weigh the risks and benefits of each treatment option in the context of the patient’s overall health, preferences and life goals.

Terumo announces commercial availability of Roadsaver carotid stent system

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Terumo announces commercial availability of Roadsaver carotid stent system
Roadsaver stent

Terumo Interventional Systems has announced the early commercial availability of its US Food and Drug Administration (FDA)-approved Roadsaver carotid stent system. Indicated for use with Terumo’s Nanoparasol embolic protection system, Roadsaver is intended to treat carotid artery stenosis in patients with an increased risk of adverse events following carotid endarterectomy (CEA).

“An inner micromesh layer with a pore size four times smaller than any carotid stent, which provides sustained embolic protection, makes the Roadsaver stent system a leading technology in the evolution of CAS [carotid artery stenting],” said Michael Martinelli, chief medical officer of Terumo Medical Corporation. “This is supported by the results of clinical trials, which demonstrated that using Roadsaver for symptomatic patients with high-risk lesions is safe and effective, with a low complication rate.”

Terumo claims that its Roadsaver stent system is the only CAS device with an innovative, dual-layer micromesh—also noting in a recent press release that it is designed as “a closed-cell stent with the flexibility of an open-cell stent”, providing increased flexibility and wall apposition in complex anatomies. According to the company, Roadsaver is the first dual-layer micromesh carotid stent approved in the USA as well.

The device’s intended use is to contain plaque to the vessel wall and prevent plaque protrusion, protecting against distal embolisation in carotid artery stenosis patients.

Available in sizes from 5–10mm in width and 22–47mm in length, the Roadsaver stent system has a rapid-exchange shaft length of 143cm. It is fully re-sheathable and repositionable—even after 50% of the stent’s length is deployed—and has a low-profile 5Fr design, which enhances its ‘crossability’, Terumo claims.

“The Roadsaver stent system is yet another example of our unrelenting pursuit of achieving better outcomes for patients,” commented Chris Pearson, executive vice president of US Commercial Operations at Terumo Interventional Systems. “Its rapid delivery and accurate placement drive procedure predictability and efficiency, differentiating it from other carotid artery stents on the market and providing a level of confidence unmatched in the industry.”

A limited market release of the Roadsaver carotid stent system is planned for the summer of 2025, with a full market release anticipated later in the year.

The Survivalist’s Guide to Heart and Vascular Centers

By
Malachi Sheahan III
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The Survivalist’s Guide to Heart and Vascular Centers
Malachi Sheahan III
Malachi Sheahan III, MD, produces notes on a quixotic quest to find meaning in one of medicine’s most meaningless endeavors.

Here’s how it happens. One day, you are walking through your hospital, and you notice a pack of incongruously well-dressed young people. You try to process this visual. Is it dermatology resident interview day? You’d better hope so. Because if not my friend, you’ve got consultants. Next thing you know, you’re in a room trying to figure out what the hell is happening. Dashboards, silos, ROI, market differentiation. But wait, there’s more. Let’s formulate a SWOT analysis with a laser focus on operationalizing our insights to create a paradigm shift to future-proof our data-driven strategies. OK, sure. Wait, what??

I’ve been in my job for 20 years. I have seen a healthcare system destroyed and rebuilt from the literal ground up, both with—and more often despite—corporate consultants. This is not my first “30,000-foot view” rodeo. So, by the time you sit down with them for your interviews, know that it is already too late. You are getting a heart and vascular center.

 

 

 

In fact, to save you some time and suspense, I’ll tell you what their recommendations will be. Here is your personalized plan:

The (insert your hospital name here) Cardiovascular Service Line: Key Points

Integrate cardiology, cardiac surgery, vascular surgery, imaging and rehab into a unified, patient-centered model.

Optimize throughput, reduce care variability, and improve quality metrics.

Capture downstream revenue and strengthen value-based reimbursement positioning.

Differentiate as a regional center of excellence in comprehensive heart and vascular care.

Accelerate growth through a phased launch, unified leadership and strategic market expansion.

The purpose of a heart and vascular center, I presume, is to improve the care of cardiovascular patients. The problem with my supposition is that after 30 years of existence, there is absolutely zero evidence for their efficacy, at least in terms of patient outcomes. Recently, in an attempt to find any data, I turned the search over to a deep research artificial intelligence (AI) model (this story is 100% true, by the way). Thrillingly, it produced a well-referenced 25-page document. Unfortunately, when I tried to find any of the relevant references on the internet, I came up empty. After asking the AI model to produce a link, I was told:

I apologize for any confusion caused by the previous mention of a 2021 article by Kline et al. titled “Sustainable Growth in Cardiovascular and Vascular Health” in the Journal of Healthcare Management. After a thorough search, I could not locate this specific article in the available literature. It is possible this reference does not exist.

In fact, of the 24 references provided, only one was not fabricated: a Vascular Specialist editorial I had written in 2017. The question of why AI had chosen to pacify me with lies was a bit too meta to consider in the moment.

Never fear though, like Jane Goodall and the primates, I have studied hospital CEOs. Observed them in their habitats. Watched as they speak their language to each other. Between all of the scalable models, cross-functional collaborations and force multipliers, if you listen carefully, you will see they are attempting to communicate with us. And the best way to understand them is to go to the source.

U.S. spending on cardiovascular care increased more than $100 billion between 1996 and 2016. A 2018 Merritt Hawkins survey showed that cardiovascular surgery was the top generating medical specialty at an average of $3,697,916 per institution. Invasive cardiology was second at $3,484,375. A recent study by K. Reddy et al from the University of Pennsylvania looked at the contribution margins of cardiovascular procedures. Heart transplant was the highest at $106,916, followed by surgical left ventricular assist device (LVAD), $46,960; coronary artery bypass grafting (CABG), $10,038; amputation, $8,942; transcatheter aortic valve replacement (TAVR), $7,997; and abdominal aortic aneurysm (AAA), $6,919. When factoring volume, CABG and TAVR were the two highest total financial contributions to their institutions, although amputation was third.

This data alone, however, still doesn’t explain why our specialties are being crammed together under one umbrella. It can’t just be our beneficial profit margins. No one tried to shove neurosurgery and orthopedics together and said, “I dunno, ortho guys like to lift, call it Brains and Gains.”

There are many purported financial benefits of a heart and vascular center. Branding, research funding, efficiency and alignment with value-based care models are the most commonly cited. But none of them really account for the amount of time and effort hospitals are willing to burn to develop such a center. In fact, I am absolutely convinced that I know the true incentive to create this unholy matrimony between cardiology, vascular surgery and cardiothoracic surgery—we order similar tests. Your hospital CEO will likely tell you that they can’t factor downstream revenue into any financial account of your services. This is the big lie. Downstream revenue is so critical that your simple free-standing vascular clinic represents an existential threat to the hospital. Think of all the computed tomography angiographies (CTAs), stress tests, magnetic resonance imagings (MRIs) and blood work that you order. What if they were performed at (gasp) an outside institution? Double that for the cardiologists.

So rather than risk this downstream revenue going down a stream to another facility, your hospital wants to put a wall around you and your cardiology friends. Everything under one roof. Their roof.

I’m not sure exactly what edition of the heart and vascular institute/service line we are on in my institution. Three I think. Last year, I received an invitation to participate in the development of a new system-wide cardiovascular service line. The announcement stated our goal was to become the premier destination for “cardiology care” in the Gulf South.

At the first meeting I was presented an org chart proposal for an executive steering committee. At the top was a chair and a vice chair (cardiologist, cardiologist). Next to them was a service line administrator and a CEO partner (suit, suit). Under that was a system service line advisory panel consisting of eight “voices.” I, as chief of the only medical or surgical specialty to provide unified coverage across our entire healthcare system, including a Veterans Administration (VA) and two medical schools, was assigned Voice #6.

Two weeks earlier, I had taken off an afternoon to see our son, Luke, in his school play. After looking at the program I offered (perhaps ungenerously), my disappointment that I took time away to see him as Fern #3: well, it seems Luke had a bigger role to play in Geology Rocks! than I would in our heart and vascular center.

The challenges for vascular surgeons in a heart and vascular center clearly outweigh the benefits. Marketing dollars and resource allocation are limited. Will these assets go to you or to a transplant program that promises a contribution margin of $50–100k? Who will control the scheduling conflicts, case competition and strategic decisions? Likely the cardiologist they put in charge.

Finally, consider your referral patterns. It is likely that a wide range of specialists and primary care physicians send you patients. The average age of a patient requiring a vascular procedure is 63. The average age of a first-time referral to a cardiologist is 50. So, when you are co-located with the cardiologist, who will the patient referred to you for a vascular issue see? You or the cardiologist they have an established relationship with?

Now, I am sure a few of you will tell me that your heart and vascular center works well for them and I don’t know what I’m talking about. To those folks, I want to make two important points. Number one, everything is local and your experience is not typical. And second, everyone hates you.

We are at 1,400 words and I haven’t even laid out what a heart and vascular center/institute/service line is. Probably because I don’t know. There are no standard models, quality metrics or milestones. U.S. News and World Report does not rank these entities. There is absolutely no patient outcome data. It’s almost as if the idea did not even come from medicine.

The best way for a vascular surgeon to mitigate the risks of a heart and vascular institute is not to be in one. If the process is inevitable, here are the steps to take:

  1. Appoint a vascular surgery service line director: Ensure dedicated leadership and control over operational, strategic and quality planning.
  2. Allocate dedicated hybrid operating room time and vascular lab access: Ensure access for elective and urgent vascular cases.
  3. Develop a limb salvage and complex vascular pathway: Formalize vascular referral protocols for chronic limb-threatening ischemia (CLTI), dialysis access and complex aortic disease, ideally to you.
  4. Establish multidisciplinary conferences led or co-led by vascular surgery: For aortic disease, CLTI, carotid revascularization, venous thromboembolism.
  5. Create dedicated vascular research support: Assign staff or seed funds to initiate vascular-specific research or industry partnerships.
  6. Track and share outcomes transparently: Publish service-line dashboards by condition (not just by specialty). Include: amputation rates, stroke-free survival, hybrid case utilization, door-to-intervention times. Benchmark against vascular and cardiology registries.
  7. Align incentives: This is the biggie. A lot of the turf issues will evaporate if the salaries/payments/ bonuses can be aligned and linked to service-line metrics rather than individual case volume.

Good luck out there. Please send in your experiences. If nothing else, maybe we can start to provide some data.

Malachi Sheahan III, MD, is the medical editor of Vascular Specialist.

SVS names candidates for vacant officer positions

By
Bryan Kay
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SVS names candidates for vacant officer positions

The Society for Vascular Surgery (SVS) announced the nominees for the vice president and secretary positions in April. Voting in this year’s SVS elections is now open.

Early Active, Active and Senior SVS members are eligible to vote during the voting period, May 15–June 5. The candidates nominated for vice president are Andres Schanzer, MD, and William Shutze, MD.

For the secretary position, the nominees are Rabih A. Chaer, MD; Michael S. Conte, MD; Sherene Shalhub, MD; and Malachi Sheahan III, MD. With four candidates for the position of secretary, the SVS will also utilize rank-ordered voting for the first time.

Details associated with this process are available on the elections webpage: vascular. org/Election. The election results will be announced on June 6 during the Annual Business Meeting at the 2025 Vascular Annual Meeting (VAM) in New Orleans.

SVS leadership figures reflect on roles ahead of elections

By
Marlén Gomez
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SVS leadership figures reflect on roles ahead of elections
William Shutze and Linda Harris

The Society for Vascular Surgery (SVS) is entering a transformative period as Vice President Linda Harris, MD, transitions to the role of SVS president-elect, while Secretary William Shutze, MD, completes his term, making way for the election of their successors. Here, the SVS leadership tandem reflect on the importance of effective leadership in furthering advancements in vascular surgery.

Harris portrays herself as an accessible leader for SVS members, which she considers essential. She highlights the importance of open communication in providing organizational support and creating an equitable environment that prioritizes the wellbeing of patients and the community.

“Our members need to have forums and channels to reach physician leadership and our staff professionals if they have questions,” Harris says. “Organizations can often be large and complex, leaving people unsure where to start. We must work to simplify that process.”

The SVS secretary serves a three-year term, while the vice president serves for one year, followed by a year as president-elect before becoming SVS president. Nominations for vice president and secretary positions were announced in April, with active voting scheduled from May 15–June 5.

“The role of secretary has allowed me to be involved with our strategic priorities at a higher leadership level and provide meaningful input,” Shutze says.

Shutze notes that one of his proudest accomplishments during his tenure was his role in reorganizing the Communications Committee into the Communications and Branding Committee.

In 2024, the SVS launched Your Vascular Health, a comprehensive, patient-focused website designed to bridge the information gap between patients and vascular care providers. This site helps individuals navigate the complexities of vascular health with easy-to-understand resources.

Shutze played a crucial role in launching the site, which included a dedicated day of syndicated programs featuring more than 20 interviews about the SVS’ new Highway to Health campaign.

“The intensity of the work required for the campaign and its rollout was significant,” he says. “The good news is that vascular surgeons are skilled at managing time.”

Shutze believes branding and public awareness will remain central to the role as the secretary’s duties evolve. Currently, he has regular meetings with SVS professional staff to ensure progress.

“As the SVS collaborates more with other societies and specialties, the secretary will play a larger role in fostering cooperation and collegiality,” he says.

In her position, Harris supported the president and president-elect with various initiatives. The most memorable of these began before she assumed her current role, specifically the task force formed to explore the status of the Vascular Surgery Board. “We need unity, regardless of opinions on a free-standing board or financial issues before Congress, whether inpatient or outpatient,” Harris says. “The new vice president must continue breaking down barriers to foster collaboration.”

Both leaders plan to assist incoming officers during the transition by offering guidance on their roles. Reflecting on future challenges, Harris adds, “Regardless of the vote or decision, we need to support one another; for divisive issues, bringing together those with differing views will help us move forward.”

Bylaw referendum: SVS Executive Board proposes changes to Senior membership to meet modern demographic challenges

By
Kenneth M. Slaw
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Bylaw referendum: SVS Executive Board proposes changes to Senior membership to meet modern demographic challenges
Kenneth M. Slaw

A new Society for Vascular Surgery (SVS) bylaw referendum proposes changing the name attached to the membership status of Senior members as part of an effort to help distinguish the category from involvement in the Society’s recently launched Senior Section. The proposal also aims to help the SVS meet the realities of shifting demographics.

The bylaw amendment would see the membership designation shift from “Senior” to “Legacy” member, the status that defines benefits and privileges within the SVS. Any subsequent participation in the Senior Section, on the other hand, would be elective and involve engagement with the activities of fellow interested Senior members in this specific community within the organization.

Under the direction of the SVS Executive Board, the Society has conducted a series of strategic discussions about Senior membership, driven by growing interest, need and challenges to sustain value and engagement of Senior members.

The SVS has been in an ongoing cycle of adaptation to its members’ changing and increasingly variable clinical and cultural needs. This has led to numerous proposed and ratified changes to the bylaws regarding the election of officers, the composition of the Nominating Committee and Executive Board, the establishment of a separate Executive Board and Strategic Board, and updating requirements and the structure of early-career membership, to name a few.

Building on the evolution and success of the SVS establishing a section model, Calligaro proposed establishing an SVS Senior Section, which recently gained Executive Board approval. The effort, which included input from more than 150 later-career members, is now led by Enrico Ascher, MD, recently appointed chair by the Executive Board. This section establishes a voice for the later-career community on the SVS Strategic Board and seeks to meet the needs of its members through education and other engagement programs.

“Establishing the section and understanding the needs and opportunities has been a big advance for the SVS,” said SVS President Matt Eagleton, MD. “Now comes the hard work of cultural and organizational change, and establishing a contemporary model of membership, engagement and resource support that is sustainable for both members and the SVS long term.”

What’s in a name?

As the Executive Board began discussing a future model for Senior membership within the SVS, confusion was immediate: the challenge became making clear the Society was working to maintain a Senior member membership category while also establishing a new Senior Section. For this reason, the SVS conducted a nomenclature review of terminology used by other medical societies to inform a change for the SVS. This process allowed for broad consideration of potential names, with both the SVS Membership Committee and Executive Board ultimately deciding against options such as “Senior,” “Emeritus,” or “Honorary.” Consensus was eventually found for moving forward with the new “Legacy” name to represent the community’s membership status.

One size no longer fits all

A second significant challenge came in understanding the demographics of the later-career population of members, and it became clear that members approach later-career transition at vastly different times, for different reasons, and with very different capacities. The current bylaws for Senior members, developed decades ago, were intended for vascular surgeons who were fully and completely retired from practice and experienced a significant decline in professional income but desired to stay engaged. The bylaws permitted members to notify the SVS of the change and, once affirmed, move from full Active status to Senior member, going from paying full dues to $0.

Advance the clock 20 years, and the conditions of today are quite different. Many vascular surgeons are choosing to retire or semi-retire from practice in their 50s and 60s, and retirement does not necessarily imply a significant decline in professional income, as many members seek new opportunities and career transitions. Many vascular surgeons are working well into their 70s, remaining fully active in practice.

As a result, determining eligibility for Senior membership has become more challenging. Following deliberations between the Membership Committee, Senior Section leadership and the Executive Board, agreement was reached that applying strict “means-testing” or “policing” does not fit well with the SVS’s desired culture.

Therefore, the bylaw referendum proposes a shift from “means-testing” over the nature of career transition to “age-based” eligibility and choice that can be applied to all. In short, the referendum proposes that eligible members may select the tier of Legacy membership that best suits their needs and interests. The first Legacy membership tier is optionable at age 70, the second at age 78—each with significant adjustments in dues and commensurate changes in benefits and privileges. The second Legacy tier will also be accessible for members who require special accommodations.

Building a sustainable model

Currently, 875 Senior members have transitioned from Active member status ($700) to Senior ($0). This number is increasing by about 100 per year and is likely to accelerate due to the fact that more than one-third of Active members is aged 60 and over. A strong consensus is that later-career members should have significant discounts on dues and other program-related fees and benefits. There is also a strong consensus that, as a Society, all members have a responsibility to help support the ongoing mission of the SVS.

“The current reality—where a quarter to a third of SVS members is paying $0 dues, with a greater percentage expected in coming years—is simply not a sustainable financial model,” noted SVS Treasurer Thomas Forbes, MD. “Thankfully, the SVS is very financially sound, and, due to great diversity in revenue sources, only 13% of total revenue comes from dues. This is very healthy and shows good management by the Society, but none of our practices could stay viable if 25–33%% of our patients went from full-pay to no-pay status, expecting the same level of care and services.” The Senior Section has a number of ideas and plans to build value for later-career members, explained Ascher. “I support this bylaw referendum because it takes resources and support to create new opportunities for Senior engagement.”

The bylaw referendum charges the Executive Board with developing and approving a dues, benefits and privileges schedule to fit the two new tiers of Legacy membership. A pro forma model has been developed to achieve the desired balance. Those who elect Legacy membership at age 70 will receive a 40% discount in dues, while those who opt for the category at age 78 will be asked to pay a nominal fee of less than $100 each year. Should the referendum pass in June, the Executive Board will finalize the dues and benefit grid in consultation with the SVS Membership Committee and Senior Section leadership. It would then be implemented for 2026.

Kenneth M. Slaw, PhD, is executive director of the SVS.

Wound healing in space: Vascular surgeons produce wide-ranging review

By
Bryan Kay
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Wound healing in space: Vascular surgeons produce wide-ranging review
How a group of vascular surgeons is working to plug gaps in knowledge and inspire colleagues to recognize the specialty’s essential role in future space travel.

It’s not so much a case of where-no-vascular-surgeon-has-gone-before as making sure aspects of the vascular surgery toolkit are optimized and available onboard to effectively support the mission. A vast scoping review of wound healing and care during long-duration spaceflight, recently published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL), harbors big ambitions—to lay out how vascular surgery and other complementary specialties can help build a bridge and fill in knowledge gaps between terrestrial care and aerospace medicine.

The work is no small feat. The study team—including first author Dóra Babócs, MD, from the Advanced Aortic Research Program at Baylor College of Medicine in Houston, and M. Mark Melin, MD, a vascular surgeon focused on wound care at the Mayo Clinic in Rochester, Minnesota—scoured more than 4,000 scholarly articles, covering a diverse study population in both space and terrestrial environments, to assemble a comprehensive picture. Not unlike the vastness and unknown quantities of the future endeavors their work seeks to support, Babócs, Melin—both members of the Space Surgery Association—and colleagues pieced together a rich tapestry of the state of wound healing in space: what is known about the subject, what is unknown and where opportunities for progress linger.

Dóra Babócs

“One of the things we realized is that while we have so many approaches related to wound care and wound healing, we still don’t know enough yet,” explains Babócs. “Many of these cannot really be addressed without people being trained in this field. So, we are also trying to encourage and inspire vascular surgeons to participate more in aerospace medicine and space surgery because there are so many gaps in knowledge that require a collaboration between aerospace medicine professionals and vascular surgeons, general surgeons and interventional radiologists. Space and spaceflight are going to be a huge project for humanity if we are to go back to the moon and even go to Mars. We are trying to bridge Earth-based vascular surgery with aerospace medicine.”

But it’s not just about evaluating the effectiveness of current wound-healing treatments in interventional and exposure areas like the International Space Station (ISS), terrestrial high- and low-volume vascular settings, and low-resource austere environments such as Antarctica. It’s also about spin-offs for care back on Earth, says Melin. For instance, information gleaned from a deep vein thrombosis (DVT) event that occurred in the internal jugular vein of an astronaut in space not only changed how women who want to use menstrual suppressants during space travel are cared for, but also those who do so back on terra firma. It’s these types of spin-offs that underscore the essential role of vascular surgeons in the space race, Melin relates.

M. Mark Melin

“There are applications that we are using all the time in terms of fluid shift,” he says. “On Earth, we see a lot of fluid shifts to the legs. The astronauts are dealing with fluid shifts to the head and neck that create retinal changes, even swelling in the brain that takes a full two years to fully go away. And it changes how people heal. All of this medical knowledge is really important to what we are doing in terms of research here on the ground as well. There are great connections here.”

The JVS-VL paper—which also includes as authors Baylor’s chief of vascular surgery Gustavo Oderich, MD, and Monika Gloviczki, MD, formerly of Mayo’s Gonda Vascular Center—targets the NASA Human Research roadmap as part of the effort to fill knowledge gaps.

“We wanted to include the pathophysiological background, why events have happened, how can we prevent them and, once they have already happened, what we can do about them,” explains Babócs.

And, going forward, the stakes could not be higher for those aboard space missions, she continues. “Until now, humanity’s goal was to go onto the ISS and do research there. Now, because of lunar and Mars missions, these are going to be so much longer in duration, and the distances are going to be significantly farther. If something happens on the ISS requiring any invasive or surgical treatment, we have the opportunity to evacuate to Earth, where the patients can receive definitive treatment at an Earth-based clinical hospital facility. But, if something happens halfway to Mars or on the moon, we are not going to have this opportunity, because just a one-way trip to Mars is going to be nine to 11 months. If something happens, we will inevitably have communication delays, and so it will be very useful to have a comprehensive manual on how to prevent these problems, or for what to do when they have already happened. Even if only some smaller surgical procedure, for example stitching a wound or closing a wound, everything is going to be different. The behavior of the tissue is going to be different. The regeneration of the cells is going to be different. We need to get ready.”

The team behind the JVS-VL paper, which also includes Rowena Christiansen, MD, from the University of Melbourne Medical School, Australia, and medical students Krishi Korrapati and Cooper Lytle, has published extensively on the topic, and, for Melin, future surgeons like Babócs, a postdoctoral research fellow at Baylor, hold the key to progress in this niche area. “Dóra is inspiring vertically and horizontally,” he says. “She is inspiring old guys like me, but also the next generation coming up, because it’s those folks who are going to make really significant sacrifices and take on servant leadership to be able to accomplish much of this. It also creates this aspirational view, where it just creates a whole new vantage point: it’s really energized me late in my career for what we are doing bedside with patients to be able to improve outcomes.”

Reality check: Study brings ‘significant’ gap between randomized and real-world vascular patient populations into sharp focus

By
Jocelyn Hudson
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Reality check: Study brings ‘significant’ gap between randomized and real-world vascular patient populations into sharp focus
Lead author Kasia Bera
randomised
Lead author Kasia Bera

The randomized data foundation on which clinicians base decision-making for vascular surgery patients is derived from populations that do not represent the patients they see and treat on a day-to-day basis, a new research paper has found.

The review, recently published in BJS Open, involved a comparison of 307 randomized clinical trials including 66,449 patients and UK National Vascular Registry (NVR) data for 119,019 patients. Based on their results, authors Joseph Cutteridge (York and Scarborough Teaching Hospitals NHS Foundation Trust, York, UK) and colleagues conclude: “There are significant differences in demographic and clinical factors between patients recruited to vascular surgery randomized clinical trials and the real-world [NVR] vascular surgery patient population.”

Specifically, the UK-based research team found that randomized clinical trial patients were younger across all operations and that, for carotid endarterectomy, bypass and major lower limb amputation trials, there were differences in female patient representation. The authors note that further comparisons were limited by the insufficient baseline data reporting across randomized clinical trials, and that there was no consistent reporting of ethnicity, body mass index (BMI) or alcohol consumption in the NVR.

Speaking to Vascular News following publication of the study, lead author Kasia Bera (University of Oxford, Oxford, UK) notes that the importance of basing clinical decisions on the best available evidence, and specifically randomized clinical trials, is instilled in medical school. Often, however, she notes that “the evidence doesn’t fit the patient in front of us,” highlighting a gap between the data on paper and the patients presenting in clinical practice.

“It is difficult to know if the evidence we have— and we have some really good evidence in vascular surgery—applies to our patients,” Bera says. “If I see someone in clinic who is diabetic, might be of Asian origin and might be female, I look at the trials and there are just very few patients who are like this.”

Bera posits that the vascular surgery specialty “needs to do better” with regard to making research more representative of the population, which should in turn help clinicians to “make treatment more personalized”.

Proposing some specific recommendations, Bera and colleagues suggest in BJS Open that minimum reporting standards for baseline data should be defined to allow future randomized clinical trials to represent “real-world” patient populations and ensure the external validity of their results.

Bera shares that agreeing on these reporting standards is the “first step” and one that can realistically be achieved within the next year. The next step is awareness, with Bera underlining the importance of ensuring support from funding bodies and journal editors. “There’s a lot of power in a journal saying we’ll only publish your study if you adhere to minimal reporting standards,” she says.

In addition, Bera highlights the need for clinical units to be active in research. She comments that this is something currently done “pretty well” in the UK, before stressing the importance of “making sure everyone in the country has access to a research-active unit rather than having a few hubs”. The result, Bera suggests, would be that “no matter where you live, you have the option to participate in research, and that means the whole country is much better represented”.

Taking a step back, Bera is of the opinion that there is a need to look outside of vascular surgery for some “novel ideas” when it comes to improving randomized trial design. For example, she references the success of adaptive platform trials such as the RECOVERY trial conducted during the COVID-19 pandemic, as well as the concept of randomised, embedded, multifactorial adaptive platform (REMAP) trials that are being used in the critical care space.

“I think we should really learn from some of these methodologies and use them for our trials to make them even better in the future,” Bera suggests. “I think historically we didn’t have the computational power to do this sort of thing, whereas now we don’t have that excuse, so we should be able to have trials where the default would be for all patients who want to participate having the choice to do so.”

Bera also encourages a move away from the laser-focus on randomized clinical trials. While these have long been considered the ‘gold standard’ when it comes to research, Bera stresses the importance of considering registries too, and seeing both as complementary. “We must not see one as better than the other,” she says, suggesting that artificial intelligence (AI) and machine learning will improve both study types in the future, streamlining data collection and allowing for the more targeted recruitment of patients.

Bera is also keen to stress that the intention of the BJS Open paper is not to criticize the design of previously conducted trials, stating that it is important to consider the context in which many of them were set up in order to improve design moving forward. She notes, for example, that some US trials were historically done in veterans, who were more likely to be male. She also shares some insight from first-hand experience designing trials: “When you conduct a trial, you have to be quite pragmatic in many ways, so I think it’s very easy for someone to say you should have done better, but you always have to make a compromise and ask ‘what can we do?’ and ‘what’s possible?’”

“I think trials are getting better, but there’s still a long way to go,” she says.

In the BJS Open paper, Bera and colleagues home in on some randomized clinical trials that are setting new standards regarding representation of demographic and clinical factors, including WARRIORS. This trial, led by a team from Imperial College London (London, UK), is set to assess whether women with small abdominal aortic aneurysms (AAAs) currently are treated too late in their clinical course.

“I think WARRIORS is a great trial because we will actually get some evidence for women, which has been long neglected, and I think looking back often this was probably a pragmatic decision because lots of the vascular surgical conditions are more prominent in men,” Bera comments.

Finally, despite setting out a clear path forward, Bera recognizes a notable challenge in the form of there being limited time for research in a healthcare system as “stretched” as the UK National Health Service (NHS). “We have so many pressures and to deliver research alongside clinical work when we all know that clinical work is so important is often difficult,” she says.

However, Bera reiterates the need to see research as a core component of optimal patient care. “We know patients who are in trials get better outcomes,” she notes.

“I think that’s the biggest change in mindset, that we have to make research an important part of care,” Bera says. “We have all these targets, we measure all the time, and I think how good we are at delivering research alongside clinical care should be a key metric we consider because it will make the clinical care better, I think.”

Here Bera suggests that clinical academic pathways for trainees and more support for academic and research delivery alongside clinical work could represent the way forward.

In the nearer term, Bera encourages feedback and discussion. “I think it would be great to hear from others and see what everyone thinks,” she tells Vascular News. “And I think bringing people together in the future is important, so we can actually decide how we can take this forward.”

“If our paper is a starting point [for] a discussion, that would be great.”

Survey suggests greater exposure to mini-incision carotid endarterectomy during training may dispel perceived limitations to approach

By
Bryan Kay
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Survey suggests greater exposure to mini-incision carotid endarterectomy during training may dispel perceived limitations to approach
Alan Dietzek
Alan Dietzek
While a recent survey found that a majority of those who responded had performed mini-incision carotid endarterectomy (CEA) at least once in their practice careers, most answered that they did not perform the surgery routinely.

In the world of general surgery, no one would opt for a large abdominal incision if they could perform a mini-incision laparoscopic procedure, ponders Alan Dietzek, MD, the chair of vascular surgery at Jersey Shore University Medical Center, Hackensack Meridian Health, in Neptune, New Jersey. Yet, “in the vascular world,” he says, “for whatever reason, having a large neck incision is still acceptable versus having a small one.”

Dietzek was speaking to Vascular Specialist in the aftermath of a recent survey that showed more than 65% of those who responded had carried out a mini-incision CEA on at least one occasion and 19.2% always did so. Furthermore, respondents who performed the operation less frequently were significantly more likely to report that it provides less exposure and that patients are unconcerned about incision size.

The survey, sent to 1,110 Society for Clinical Vascular Surgery (SCVS) members, garnering a 13% response rate, sought to establish barriers to routine use of mini-incision CEA. The results were presented at the 2025 SCVS Annual Symposium in Austin, Texas (March 29-April 2) by Keerthivasan Vengatesan, MD, a general surgery resident at Dietzek’s previous institution, Danbury Hospital in Danbury, Connecticut.

Dietzek says that among those barriers, as outlined by the survey, was “the fact that surgeons are afraid there won’t be enough exposure.”

More importantly, he continues, “if they have never done mini-incision carotid surgery, they are not likely to do it. Those who are coming out of training are likely to do the surgery if someone else in their practice is already doing the surgery. Or if they haven’t learned it in training, but if there are others in their practice that are doing mini-incision carotid surgery, there is a good chance that they will likely perform mini-incision carotid surgery.”

The survey laid out that only 31.5% of respondents were trained to perform mini-incision CEA prior to beginning practice, and that those surgeons were significantly more likely to have performed the operation in practice. Additionally, surgeons who always performed the surgery with patch angioplasty were significantly more likely to do so even in patients with higher-risk features such as high bifurcation, short or obese neck, and redo surgery, although this was not observed in those who always utilized shunts during mini-incision CEA, Dietzek and colleagues established.

Although the CEA patient population tends to be slightly older and less concerned with cosmetic outcomes, Dietzek considers, “I don’t think anybody would prefer to have a larger incision than a smaller incision unless they thought their outcomes would be worse.” To this end, Dietzek points to data in the literature showing outcomes after mini-incision CEA “are just as good as any other incision for carotid surgery.”

Therefore, Dietzek says, teaching fellows and residents how to do the operation is the most important factor in them then adopting it when they head out into practice.

“Having done this for more than 20 years, I would say that I can’t even recall having to extend the incision during an operation because I’ve had inadequate exposure,” Dietzek adds, explaining how the exposure—sometimes measuring as low as 4cm or less—is achieved by dividing the platysma muscle beyond the skin incision, enabled with the use of retraction. “It does occur but it’s so uncommon that it is not the kind of thing where you have to be fearful that you’re going to be boxed in when you are doing the operation in this manner. If you do have to extend the incision, that’s something you probably may have to do early on when you are first learning how to do it.”

Equivalent outcomes seen among female, male patients in real-world analysis of paclitaxel-eluting stent use

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Bryan Kay
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0
Equivalent outcomes seen among female, male patients in real-world analysis of paclitaxel-eluting stent use
Maria Peñuela

The use of a paclitaxel-eluting stent to treat femoropopliteal occlusive disease led to equivalent outcomes in male and female patients in “a diverse and complex real-world cohort,” a new study found, set against previous question marks over the effectiveness of the technology in women.

A research team from the University of South Florida (USF) in Tampa retrospectively looked at their institutional experience with the Zliver PTX device (Cook Medical), analyzing major adverse limb events (MALEs), amputation-free survival and freedom from target limb revascularization out to five years.

Maria Peñuela, MD, a vascular surgery resident at USF, delivering the data during the 2025 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Austin, Texas (March 29–April 2), laid out how the Zilver PTX randomized trial data demonstrated clinical durability with improved freedom from target limb revascularization and primary patency at five years compared to bare metal stents. However, she said, the question of whether these data were “reflective of real-world utilization and outcomes” remained, as 91% of the included patients presented with claudication, 34% were female and the mean lesion length was less than 100mm.

The USF single-center retrospective review, therefore, sought to assess the long-term clinical effectiveness of Zilver PTX stents over a seven-year study period from 2013–2019. With a primary outcome measure of MALE at one, two and five years, the review looked at 252 patients with 265 treated limbs that met inclusion criteria. The cohort bore a median age of 65 years and was made up of 37% female patients.

“Overall, the female and male groups were similar with respect to demographics and preop comorbidities; however, male patients more frequently had hyperlipidemia and tobacco use,” Peñuela told SCS 2025.

MALE was defined as reinterventions, stent occlusion or major amputation, she explained, with overall rates similar between both groups and stent occlusion representing the most common event among male and female patients in the cohort, she continued. “Overall mortality was similar between both groups at five years, and amputation-free survival rates were similar across time points for both groups,” Peñuela said. Treatment length did not have any influence on MALE, overall survival or amputation-free survival based on Kaplan-Meier or univariate analysis, she added.

Acknowledging study limitations, Peñuela pointed out the single-center, retrospective nature of the review, further conceding that “we also lacked an institutional endo-comparator, and we had minimal anatomic data, such as calcium burden or GLASS [Global Limb Anatomic Staging System] scores.”

Vascular Specialist–May 2025

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Bryan Kay
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0
Vascular Specialist–May 2025

In this issue:

    • Wound healing in space: How a group of vascular surgeons is working to plug gaps in knowledge and inspire colleagues to recognize the specialty’s essential role in future space travel
    • Bylaw referendum: SVS Executive Board proposes changes to Senior membership to meet modern demographic challenges
    • From the Editor: The Survivalist’s Guide to Heart and Vascular Centers
    • The Outpatient: Exploring embolization performed in the office-based lab (OBL) setting

Carotid endarterectomy outperforms stenting amid overuse of both procedures in 10-year cohort study

By
Jocelyn Hudson
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0
Carotid endarterectomy outperforms stenting amid overuse of both procedures in 10-year cohort study
Eric Steinmetz

A retrospective, nationwide cohort study has revealed carotid endarterectomy (CEA) performed better than carotid artery stenting (CAS) in France over the course of a decade, while also highlighting the overuse of both procedures in the same period. Based on their findings, the research team calls for the suspension of interventions for carotid artery disease until appropriate studies are conducted.

The investigation—which authors Eric Steinmetz (CHU Dijon Bourgogne, Dijon, France) and colleagues note involved the largest cohort of asymptomatic carotid procedures ever studied—was recently published as an Editor’s Choice paper in the European Journal of Vascular and Endovascular Surgery (EJVES).

Steinmetz et al begin by stating that it was their objective to compare peri-procedural stroke or death within 30 days of a procedure in patients who underwent either CEA or CAS.

The researchers used data from the PMSI (Plan de financement à l’acte) hospital database, including in their study all patients who underwent either CEA or CAS between 2010 and 2019 in France.

Steinmetz and colleagues share that, between 2010 and 2019, 164,248 patients underwent a carotid artery procedure in France, comprising 156,561 CEA and 7,687 CAS procedures. They note that asymptomatic women made up around 25% of the total cohort and high-risk patients, 40%.

The authors report in EJVES that the rate of peri-procedural stroke or death within 30 days was 1.5% overall, 1.3% in asymptomatic patients, and 3.3% in symptomatic patients. They detail that, after matching and adjustment, the risk of peri-procedural stroke or death within 30 days was statistically significantly greater in patients who underwent CAS than in patients who underwent CEA.

In their conclusion, Steinmetz et al stress that many patients in the study—specifically asymptomatic women, high-surgical-risk patients, and patients undergoing CAS—received procedures that were more likely to be harmful than beneficial, according to the results of past randomised trials.

In addition, the authors write that “despite the huge number of asymptomatic carotids treated in the present sample, there is currently no proven benefit for asymptomatic carotid intervention compared with best medical treatment alone, or for screening for carotid artery disease”.

Based on these conclusions, Steinmetz and colleagues propose there “should be a moratorium on procedures for carotid artery disease until appropriate studies are conducted to determine whether [these procedures are] beneficial and for whom,” adding that studies are warranted to assess whether screening to detect carotid stenosis improves outcomes compared with non-invasive care directed only by clinical risk factors and without arterial imaging.

Furthermore, Steinmetz et al highlight a “tremendous overuse” of carotid procedures and an “urgent need to reconsider guidelines that encourage carotid artery procedures when there is no evidence of procedural benefit, and concurrent ongoing proof of procedural harm and significant cost”.

Imperative Care announces completion of enrollment in the SYMPHONY-PE study

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Bryan Kay
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0
Imperative Care announces completion of enrollment in the SYMPHONY-PE study

Imperative Care has announced the completion of patient enrollment in its SYMPHONY-PE study, a pivotal investigational device exemption (IDE) trial evaluating the safety and efficacy of the company’s Symphony thrombectomy system for the treatment of acute pulmonary embolism (PE).

Designed to expand Symphony’s current indication for use to include PE, the study was conducted at 19 leading interventional radiology, interventional cardiology and vascular surgery centers across the USA.

“While progress has been made in the treatment of pulmonary embolism, there is still a need for therapies that may offer improvements in safety, efficiency and long-term patient outcomes,” said interventional radiologist Vivian L. Bishay, from Mount Sinai Health System in New York City, and national co-principal investigator of the SYMPHONY-PE study. “This study represents a promising step forward in evaluating next generation technology to expand treatment options for physicians and their patients.”

Three-year VenoValve first-in-human trial data published

By
Bryan Kay
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0
Three-year VenoValve first-in-human trial data published
VenoValve
VenoValve first-in-human
VenoValve

Envveno Medical has announced that its manuscript titled, “Three-year outcomes of surgical implantation of a novel bioprosthetic valve for the treatment of deep venous reflux,” has been published in the in the peer-reviewed journal, Annals of Vascular Surgery.

The VenoValve was surgically implanted in the femoral vein of 11patients with active or healed venous ulcers (CEAP classifications C5–C6). Eight subjects completed three-year follow-up, with key findings including:

  • Primary patency: 79% (Kaplan-Meier curve) at three years
  • Symptom relief: Seven-point improvement Venous Clinical Severity Score; 84% reduction in pain on the Visual Analog Scale (VAS)
  • The VenoValve remained safe and effective, achieving target patency and maintaining competence and clinical benefits

The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with chronic venous insufficiency (CVI). The company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve.

A press release issued by the company states that it has submitted a premarket authorization (PMA) application for the VenoValve to the Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025.

Endospan announces positive 30-day outcomes from TRIOMPHE IDE study

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Bryan Kay
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0
Endospan announces positive 30-day outcomes from TRIOMPHE IDE study
Nexus stent graft system
Nexus

Endospan recently announced the presentation of 30-day results from the statistical dissection primary arm of the TRIOMPHE investigational device exemption (IDE) clinical study. The data were presented during the late-breaking trial session at the American Association for Thoracic Surgery (AATS) annual meeting (2–5 May, Seattle, USA).

The TRIOMPHE study is a prospective, multicentre, three-arm trial designed to assess the safety and effectiveness of the Nexus aortic arch stent-graft system in patients with aortic arch pathologies (dissection, aneurysm, penetrating aortic ulcer [PAU]/intramural haematoma [IMH]).

It was reported during the session that the 30-day results from the TRIOMPHE study are promising for aortic arch treatment in zone 0 with the Nexus system. Announcing the results in a press release, Endospan notes: “The study results suggest the Nexus device may be an acceptable alternative to open aortic arch replacement in select patients at high risk for open surgery.”

Results

TRIOMPHE (n=54)

Operative mortality

0.0%

30-day mortality

9.2% (n=5)

Overall disabling stroke (bypass + Nexus)

Post bypass

Post Nexus

5.6% (n=3)

1.9% (n=1)

3.7% (n=2)

Renal failure

0.0%

Paraplegia

0.0%

 

Further, core lab analysis of stent-graft sealing shows no type Ia, no type Ib and no type III endoleaks, suggesting good sealing at 30 days.

“The 30-day data from the TRIOMPHE study are highly encouraging for the treatment of aortic arch disease,” said Brad Leshnower (Emory University School of Medicine, Atlanta, USA), national cardiac principal investigator. “The low stroke rate, in particular, is a significant achievement. This data is very promising while we await one-year follow-up of the study patients.”

“As a vascular surgeon, I am excited about the potential of the Nexus aortic arch stent-graft to provide a less invasive treatment option for patients with complex aortic arch pathologies,” said Ross Milner (UChicago Medicine, Chicago, USA), national vascular principal investigator.

VVT Medical welcomes Antonios Gasparis to medical advisory board

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Bryan Kay
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0
VVT Medical welcomes Antonios Gasparis to medical advisory board
Antonios Gasparis
Antonios Gasparis

VVT Medical recently announced the appointment of Antonios Gasparis, MD, to its medical advisory board.

A press release notes that Gasparis brings over two decades of expertise in vascular surgery, with a distinguished career dedicated to advancing the treatment of venous diseases.

Gasparis currently serves as the system chief for the ambulatory vascular and vein programme at Northwell Health in New York, where he is spearheading the development of a comprehensive venous disease program across the health system. He previously held prominent roles at Stony Brook University, New York, including professor of surgery, director of the Center for Vein Care, and director of the phlebology fellowship.

Gasparis’ leadership has extended to national platforms, having served as president of the American Venous Forum (AVF). He is also the founder and co-director of the Venous Symposium.

In joining VVT Medical, Gasparis said: “I am excited to collaborate with VVT Medical in advancing innovative solutions for venous disease. Their commitment to improving patient outcomes aligns with my passion for enhancing vascular care.”

Inquis Medical’s Aventus thrombectomy system found safe and effective for patients with PE

By
Bryan Kay
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0
Inquis Medical’s Aventus thrombectomy system found safe and effective for patients with PE

Inquis Medical recently announced results from its AVENTUS trial evaluating the safety and efficacy of the company’s Aventus thrombectomy system.

The results were presented by Jun Li, MD, from University Hospitals Harrington Heart & Vascular Institute in Cleveland, the trial’s national co-principal investigator, at the 2025 Society of Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions (May 1–3) in Washington, D.C. The results were simultaneously published in the society’s peer-reviewed journal, JSCAI.

A press release notes that the AVENTUS trial successfully met its primary endpoints, demonstrating both safety and efficacy in the treatment of acute intermediate-risk pulmonary embolism (PE) patients. Results showed significant improvement in right ventricular (RV) function, reduction in clot burden, minimal blood loss, and short intensive care unit (ICU) and total hospital stays with no device-related major adverse events. The trial also reported meaningful improvements in patient-reported quality of life and a significant increase in six-minute walk test (6MWT) distance through 30 days.

“There remains a clear need for next-generation technologies that can address some of the limitations of current PE devices,” said Li. “The AVENTUS trial confirms that this system not only performs safely and effectively, but also supports meaningful improvements in clinical efficiency and outcomes, marking an important advancement in PE care.”

The AVENTUS trial is a prospective, single-arm, multicenter investigational device exemption (IDE) trial that enrolled a total of 130 patients with acute intermediate-risk PE across 22 sites in the USA with 49 unique investigators. Patients aged 18–80 years of age with symptomatic computed tomography angiography (CTA)-documented acute intermediate-risk PE of ≤14 days duration were eligible for enrollment. Intermediate-risk PE was defined as RV/left ventricular (LV) ratio ≥0.9 per international guidelines.

Complex Wound Care Masterclass now set to commence at VAM 2026

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Marlén Gomez
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0
Complex Wound Care Masterclass now set to commence at VAM 2026
New wound care workshops initially set to start at VAM 2025 will now commence at VAM 2026

The Society for Vascular Surgery (SVS), in collaboration with the Society for Vascular Nursing (SVN) and the American Podiatric Medical Association (APMA), has postponed the Complex Wound Care Masterclass workshop, initially scheduled for June 7 after the 2025 Vascular Annual Meeting, will now be held alongside the VAM from 2026–2028.

The workshops are a part of the new Wound Care Curriculum, which includes an online module containing 27 short on-demand videos currently available on the SVS VascuLEARN website. The videos provide learners with the fundamentals of wound care for vascular surgeons, physician assistants, vascular nurses and podiatrists.

The workshops will be the hands-on companion to the online content tailored to vascular care teams’ unique needs. The confirmed agenda for 2026 includes topics such as methods of debridement, dressing management and oxygen therapy.

Proposed topics for 2027 include skin substitutes, and both fluorescence and infrared imaging, while the proposed agenda for 2028 will cover total contact casting and removable devices, with final confirmation slated for the summer before each event.

For more information and to access educational resources, visit vascular.org/WoundCare.

Visiting professorship recipient announced

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Bryan Kay
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0
Visiting professorship recipient announced
Nathan Liang

The SVS Young Surgeons Section (YSS) has selected Nathan Liang, MD, of the University of Pittsburgh, to receive its 2025 visiting professorship.

Liang will present his research on the application of artificial intelligence (AI) in managing patients with complex aortic disease at the University of Chicago, with the exact date of his presentation to be confirmed.

Each year, the YSS Award Selection Committee honors a recipient within the first 10 years of their practice with a $1,000 travel stipend and a $1,500 honorarium to support their activities as a visiting professor.

For more information on how to join the YSS, visit vascular.org/YSS.

SVS seeks feedback on VESAP6 mobile app

By
Marlén Gomez
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0
SVS seeks feedback on VESAP6 mobile app

The Society for Vascular Surgery (SVS) is inviting users to participate in a brief survey regarding their experiences with the sixth edition of the Vascular Education and Self-Assessment Program (VESAP6)—which bears 600 questions—on mobile devices.

The insights gathered will aid the SVS in understanding customer access to the program as plans are made for the next edition.

To learn more, visit vascular.org/VESAP6survey.

Highway to Health: SVS to stage virtual how-to session

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Marlén Gomez
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0
Highway to Health: SVS to stage virtual how-to session

The Society for Vascular Surgery (SVS) will hold a virtual Highway to Health informational session exclusively for members on Wednesday, April 30, at 7 p.m. Central time. This session aims to provide members with a comprehensive overview of the Highway to Health campaign.

Last October, the Highway to Health initiative was launched in conjunction with the SVS’s patient-focused website, YourVascularHealth.org. It seeks to educate the public on the symptoms and risk factors associated with vascular disease.

During the session, SVS members will learn how to effectively leverage the Highway to Health member toolkit to promote the campaign.

To register, visit vascular.org/H2Hsession.

VAM 2025 set to feature dedicated session on artificial intelligence and machine learning

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Marlén Gomez
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0
VAM 2025 set to feature dedicated session on artificial intelligence and machine learning
VAM 2025 takes place in New Orleans from June 4–7

The upcoming Vascular Annual Meeting (VAM), taking place June 4–7 in New Orleans, will see Jason T. Lee, MD, and Claudie Sheahan, MD, at the forefront of educational programming. Both have stepped into pivotal roles, with Lee serving as VAM program chair and Sheahan taking on the position of Postgraduate Education Committee (PGEC) chair following the conclusion of last year’s conference.

Lee, chief of vascular surgery at Stanford, has been attending VAM since his time as a medical student and continues to show enthusiasm for the latest scientific discoveries within the specialty.

“I’ve had the fortunate opportunity to be on the Program Committee in various positions for over a decade and have watched this meeting continue to get better at providing education, larger in scope and more inclusive for all members,” said Lee. “I’m honored to have the chance to work on the program directly this year with many amazing volunteers and the support staff from the SVS.”

In 2025, Lee will celebrate his 25th anniversary of attending VAM. Over the years, he has felt a strong desire to be present at the meeting, not only to witness the advancements in cutting-edge science and technology that can impact practices and research, but also to emphasize the importance of highlighting and networking with the younger, up-and-coming professionals in the field.

According to Lee, themes to expect at VAM 2025 are essential for the “modern and contemporary vascular surgeon.” Topics submitted by SVS members will shape the programming, including new innovations and outcomes related to aortic disease, peripheral arterial disease (PAD), carotid disease, hemodialysis access, venous disease, wound care and the application of artificial intelligence (AI) and machine learning, the latter of which will be featured in a set of papers on Saturday morning.

“The VAM program is only as good as what the membership submits. This year, we received 849 submissions for the 62 available spots in the program. We take our responsibility seriously to ensure that the program is current, and the process is fair and transparent, and reflects the important clinical and research work our members are engaged in,” said Lee.

The abstract selection for VAM is a blinded, peer-reviewed process that allows for the submission of a wide range of scientific topics covering the entirety of the vascular specialty.

Beyond the scientific abstracts presented, this year’s VAM program will include innovative networking and social events, including “SVS Connect@VAM: Welcome to New Orleans!” The event is scheduled for the Wednesday night of VAM.

“I want VAM to be the can’t-miss event of the year for all individuals connected to vascular surgery, and I hope our membership will all make plans to attend and encourage other partners and mentees to attend. Our committee’s vision for VAM 2025 builds on the years of creative changes to the annual meeting and to have something meaningful for every attendee,” said Lee.

Sheahan, from New Orleans’ own Louisiana State University School of Medicine, has been a part of the PGEC for the last three years and has a similar sentiment to Lee on her vision for enhancing the science at VAM while serving as PGEC chair.

In addition to this year’s core topics, educational issues are being featured on such platforms as a Dialysis Summit, and in sessions on deep venous obstruction, “My Worst Cases” and aortic dissection. New this year is an educational summit on trauma similar in style to a Ted Talk presentation. Sheahan anticipates that this session, “Critical and Current Issues in the Management of Vascular Trauma,” as a standout session for attendees.

“It’s very effective when you have a speaker so passionate about a topic. Making a complex topic appear simple and concise is very difficult to do, and you have here some of the leading experts in our country on vascular trauma who will be able to do that,” she said.

Sheahan pinpoints a parenthood session, “Carrying the Weight: Parenthood in Vascular Surgery,” as one of the top-rated submissions gaining early traction. Topics will cover all aspects of parenthood from the perspective of the vascular surgeon and trainees, including insight from same-sex couples and from those working in different type of clinical practice.

“This interview style session is, no doubt, going to provide a lot of great discussions that will make the audience get very involved and, hopefully, learn a lot,” said Sheahan. “I feel it will be tough to keep the session on time because the discussion will be robust.”

As the PGEC chair, Sheahan aims to ensure that everyone attending VAM can find a topic that resonates with them, regardless of their experience level. Her objective is to ensure that the time, money and effort invested by attendees are meaningful.

“During my tenure as PGEC chair, my goal is to make sure that we give our membership expert content at our annual meeting,” said Sheahan. “Expert content delivered by diverse experts is the overriding principle, and the material should be the most up-to-date information available.”

For more information on VAM’s programming, visit vascular.org/ OnlinePlanner

Audible Bleeding luminaries podcast looks back at its origins in vascular education

By
Marlén Gomez
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0
Audible Bleeding luminaries podcast looks back at its origins in vascular education
Adam Johnson

In 2018, a group of dedicated vascular surgery trainees recognized a notable gap in educational resources within their specialty. This realization sparked the creation of the Audible Bleeding podcast, a platform designed to enhance vascular surgery education through engaging discussions and insights. Fast forward to 2024, and the podcast has achieved notable success, with an average listenership of 100,000 per year, the acquisition of a dedicated industry sponsor and a steady flow of new episodes.

The podcast’s inception can be traced back to the original team of editors from the New York-Presbyterian vascular surgery program, including Kevin Kniery, MD, Matt Smith, MD, Adam Johnson, MD, Nicole Rich, MD and Sharif Ellozy, MD, the latter of whom served as fellowship director at the time and provided mentorship throughout the project.

“The four of us were excited about the project and started together because we were local to each other, and then Dr. Sharif Ellozy helped us launch our initial episodes through his extensive network,” said Johnson.

Initially, the episodes featured interviews with various vascular surgeons, focusing on unique stories that listeners might find engaging and insightful. Ellozy emphasized the podcast’s role as a vital resource, particularly for trainees in the field, offering a behind-the-scenes look at groundbreaking papers and the experts behind them.

Imani McElroy

In 2020, the Society for Vascular Surgery (SVS) partnered with Audible Bleeding, enhancing the podcast’s management and expanding its reach. As part of this partnership, Imani McElroy, MD, was appointed senior editor overseeing episode distribution.

“What I’m excited about is that the podcast has partnered not just financially with the SVS, but fundamentally to highlight the great work happening across the vascular community,” said Johnson of the initial partnership.

Though Johnson has stepped back from active participation in the podcast, he remains an avid listener, eager to explore new episodes.

“The episodes amplify and build on the great work already happening in our vascular society, providing it in a different format and showcasing the incredible efforts within our community,” he commented.

“As Audible Bleeding continues to evolve, it stands as a shining example of how a simple idea can transform into a vital educational tool, enriching the vascular surgery community and inspiring future generations of surgeons,” said McElroy. “Our team is dedicated to releasing content relevant to our listeners who want to be at the forefront of vascular surgery education.”

To learn more, visit audiblebleeding.com.

New study validates BEST-CLI trial results, ‘suggesting generalizability’

By
Bryan Kay
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New study validates BEST-CLI trial results, ‘suggesting generalizability’
Jeremy Darling

A new propensity-matched analysis of more than 1,100 lower extremity revascularization procedures carried out in patients with chronic limb-threatening ischemia (CLTI)—which aimed to help solve the puzzle of why the BEST-CLI trial did not lead to a pick-up in the rate of surgical bypass in the year after its publication—validated the landmark study’s results, according to the senior author.

The Beth Israel Deaconess Medical Center (BIDMC) retrospective review showed that, like in BEST-CLI cohort 1, the primary outcome measure of major adverse limb events (MALE) and MALE/death was noted to be significantly decreased following a bypass with single-segment great saphenous vein (GSV) as compared to percutaneous transluminal angioplasty with or without stenting at five years (51% vs. 60% and 75% vs. 79%, respectively). “These findings correlated with a 29% and 20% reduction in the aforementioned events,” first author Jeremy Darling, MD, reported as he delivered the findings during the 2025 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Austin, Texas (March 29–April 2). And, similar to BEST-CLI cohort 2, in which patients did not have a suitable GSV for conduit, significant differences in MALE and MALE/death were not noted.

The analysis grew out of a prior Vascular Quality Initiative (VQI) study conducted by Boston-based BIDMC researchers in which they discovered that there had been no increase in bypasses placed for CLTI 12 months on from BEST-CLI, despite the trial demonstrating that surgical bypass with adequate single-segment GSV is a more effective revascularization strategy in those who are deemed suitable for either an open or endovascular approach.

Darling and colleagues, led by Marc Schermerhorn, MD, BIDMC chief of vascular surgery and the analysis’ senior author, theorized that the lack of pick-up could have been influenced by specialists not believing that the BEST-CLI results were generalizable. “We were able to mimic cohorts 1 and 2 from the study, we matched all of the outcomes,” explained Schermerhorn in an interview with Vascular Specialist. “All of the proportions are fairly similar to BEST-CLI. We did have more dialysis patients than they had in BEST-CLI, but otherwise it was fairly similar.” The results, he said, validate the differences BEST-CLI demonstrated, with just one exception. “The only thing that they saw in BEST-CLI that we did not see in cohort 1 was the difference in amputation rates, where we had an amputation rate that was just as low in the angioplasty patients as in the bypass patients.”

The correlation “suggests generalizability” of BEST-CLI, Schermerhorn said. He hopes the results of the analysis stimulate more specialists to consider a bypass-first strategy when they are confronted with a patient who has extensive CLTI and a viable single-segment GSV. “I do think people should re-think their treatment protocol,” he argued. “They should routinely evaluate the saphenous vein before they go to the angiosuite, and that knowledge of whether there is a good single-segment saphenous vein available should have a significant impact on the choice to attempt an endovascular revascularization, as opposed to going right to bypass.”

In a similar vein, the research group have also tackled the results from BASIL-2 in an analysis due to be presented at this year’s Vascular Annual Meeting (VAM). “We re-structured the cohort and to tied to mimic the BASIL-2 trial,” Schermerhorn added. “That is also one of the reasons why people may not be changing their practice patterns based on the BEST-CLI trial, because there were somewhat conflicting results from BASIL-2.” The latter trial, which included 345 patients, showed that a best endovascular treatment-first revascularization strategy was associated with better amputation-free survival than a vein bypass-first strategy in those who required an infrapopliteal repair.

‘The leader must own everything in his or her world, own every mistake and credit the team for successes’

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Bryan Kay
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‘The leader must own everything in his or her world, own every mistake and credit the team for successes’
Jean Bismuth concludes his SCVS 2025 presidential address

“We can almost be considered a specialty of colonizers, acquiring borrowed techniques. Why, then, do we see ourselves as the keepers of vascular care? Why do we think that we are the ones that can deliver the best vascular care? Without losing our identity, should we not look to partner with the other specialties providing vascular care?”

Those were some of the words uttered by outgoing Society for Clinical Vascular Surgery (SCVS) President Jean Bismuth, MD, as he delivered the 2025 SCVS presidential address under a theme of challenging the vascular surgical specialty to provide better and greater leadership.

Bismuth, the Tampa General Hospital and University of South Florida chief of vascular surgery, told those gathered that “the leader must own everything in his or her world, own every mistake and credit the team for successes” during the organization’s Annual Symposium in Austin, Texas (March 29–April 2).

Recalling national media coverage in recent years that placed inappropriate vascular interventions in the mainstream spotlight, he argued that vascular surgery “cannot blame every other specialty for our problems” and that “we need to own the solutions.”

“We need to own our own destiny and be accountable for what we do,” Bismuth continued. “There are bad players in every specialty. Let’s not think we are above reproach.”

His plea to reach beyond specialty lines was accompanied by a call for greater unity within the vascular surgery tent. “No different than our cardiology and radiology colleagues, the private practice vascular surgeon carries a huge load of vascular work and is generally doing excellent work,” he said. “We need to stop alienating our partners in vascular care.

“It is imperative that we appreciate that leaders are responsible for nurturing the growth of their teams, along with fostering individual strengths, over being threatened by honors not attributed to themselves.”

The imperative is mathematical, Bismuth pointed out: while there are 350 million people in the U.S., there are just 3,000 practicing vascular surgeons. “There is no way we can manage all of the vascular disease, so why are we so preoccupied with the noise of what other specialties are doing?”

Vascular surgery grew to become a specialty in its own right in the 1980s, with its forefathers cardiothoracic surgeons, Bismuth observed. “So, as we see how vascular surgery has evolved over the last 50-plus years, we could say that we have developed out of multiple specialties, including radiology with the innovations of Charles Dotter,” he said.

“To think that we alone can provide appropriate vascular care is probably somewhat misguided.”

To be a specialty that inspires, “provides safety and fosters fulfillment,” strong, capable leadership is required to make this vision a reality, Bismuth said, noting that the rising generation of vascular surgeons and future leaders, millennials, are more effective, transparent and open communicators than the generations who came before them. “If we truly embrace and prioritize effective communication, we could reshape both the perception and reality of personality dysfunction, leading to greater satisfaction, improved outcomes and a stronger ability to attract the best and brightest from then next generation.”

As the specialty confronts “a frontal assault” on reimbursements and associated “administrative harms,” unity across practice settings is necessary, which emboldens the need for effective leaders, Bismuth said. “We must become better ambassadors for our specialty,” he added.

Standing on the banks of the Rubicon

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Arthur E. Palamara
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Standing on the banks of the Rubicon
Arthur E. Palamara

“Where have all the doctors gone?” is the headline on the cover article of the January/February 2025 edition of the AARP Bulletin. Perhaps it should include, “or are going?” The article, which is quite extensive, explores why patients have a difficult time finding a physician, let alone seeing a specialist. The article is quite sympathetic to physicians. Admitting that primary care doctors make $250,000 per year, and specialists twice that, it explores the harsh financial realities of becoming a physician: that students graduate with educational debt of over $250,000—added to the number of years of study needed to achieve mastery of their specialty—make success quite an achievement. One-in-four students drop out before graduation, finding the demands, pressures and lifestyle just too onerous. These negative impediments result in an America burdened with a physician shortage. Our aging population will keenly appreciate this loss of expertise since their avuncular family physician will exist only in faded yellow copies of the Saturday Evening Post.

We will explore the significance of this article later, but it is notable that the AARP Bulletin chose to publish the piece as its cover article.

Challenges of pursuing a medical career

One would think that a generous salary and comfortable lifestyle would attract more young people to pursue medicine, but the exact opposite has happened. Those bright young students discovered that they could make more money at a younger age without the painful years of medical school, on-call nights in residency, and emotional burdens of patient care (not all cases go well). The need to postpone customary milestones, such as getting married, buying a home, and raising a family, disincentivizes many students who might otherwise be attracted to the profession.

My youngest son experienced the challenge. As a third-year college student at a major Florida university, he had all the attributes necessary to be a great physician: intelligence, drive, motivation and compassion. I arranged for him to spend the day with the dean of a medical school to discover if he would find the profession appealing. The dean was both hospitable and gracious. My son had a very enjoyable day. At about 4:30 p.m., as I was finishing a difficult case, my phone rang. It was him. I asked how it went. His voice was polite but non-committal. He thoroughly enjoyed the day, raved about how nicely the dean treated him, and found the visit interesting.

Well, I asked, did you find your experience stimulating enough to pursue medicine? His response was blunt. “It would take me another year of college, four years of medical school and at least another four years of residency. That’s nine years.”

“Dad,” he went on, “I’ve seen how hard you’ve worked, sacrificing time with us, Saturdays, Sundays, leaving at night, and I appreciate your dedication. I’ve seen you upset when you’ve lost a patient, or someone didn’t take good care of your patient. And, after working all those years, you could have a patient go bad, get sued and, even if it’s not your fault, lose everything that you’ve worked for all these years. Why would I want to do that?”

Why indeed? Perhaps it’s a calling from which we enjoy tremendous gratification. For the sake of completion, my son is a very successful attorney who is married with children and thoroughly enjoys his life (and his profession). His story exemplifies life choices that are available to young people without the rigors and sacrifice that we accept as part of our profession.

For those who have become doctors, the most attractive alternative after completing residency is to become employed. This guarantees a steady income and more predicable hours. Student debt weighs heavily on their choices. Close to 80% of recent doctors are now employed. But employment comes at a price. They have never enjoyed physician autonomy. In terms of this article, physician autonomy is doing what you believe is best for the patient, without a corporate entity telling you how to practice. But that is changing.

Intense patient dissatisfaction

The December assassination of the UnitedHealth Group executive exposed a deep undercurrent of dissatisfaction among patients. There was no outpouring of sympathy for the deceased but rather public ennui, reflecting little concern for the loss of a rich executive who only made life worse for millions of people. I am sure Austria felt the same way when Archduke Franz Ferdinand was assassinated. Andrew Witty, the president of UnitedHealth, admitted that the system needs to function better, as reported in his remarks Jan. 12, 2025, in Fortune magazine. He went on to add: “Ultimately, improving healthcare means addressing the root cause of healthcare costs,” which he blames on over-usage and high pharmacy prices.

Going further, he offered, “Seniors recognize value, which is why the majority of them choose Medicare Advantage.” He ignored the fact that seniors cannot afford co-insurance and the deductibles that come with it, and have no alternative. He also ignored the fact that the Federal Trade Commission (FTC) revealed that UnitedHealth severely overcharged cancer patients for life-saving drugs. And UnitedHealth owns its own pharmacy benefit managers, which allows the company to make a huge profit from pharmaceuticals.

He theorizes that too many people want too much care, and we can’t afford to provide that level of care for everyone. Absent from his assertion is the financial reality that America spends twice as much as any developed country, yet our outcomes are worse than many other countries, having the highest infant mortality rate and the lowest life expectancy among 11 high-income countries, according to a Lancet report from Dec. 7, 2024. Our government is reluctant to spend more. Physician Medicare reimbursement has not risen in 25 years, while physician payments have been drastically reduced. Since hospitals are not likely to lower their fees, and GLP-1 agonists are not going to be discounted, physicians should not expect increased compensation. We who actually deliver care—doctors—have been poorly compensated. What this means for the employed physician is that employers place more demands on them.

Corporate medicine increase demands on employed physicians

Relative value units (RVUs) will be taken seriously, and the 95th percentile will be the new standard. Fifteen minutes a visit computes to four patients an hour, placing a premium on speed rather than meeting patients’ needs. New patients require significantly more time to provide good care. Past records and computed tomography (CT) images have to be checked. While an orthopedic surgeon can do a cast check in 15 minutes, delivering proper care requires time, conversation and compassion—attributes not found in artificial intelligence (AI). Those essentials will not be possible in the enhanced corporate medical world.

How many bypasses or aneurysms can a vascular surgeon perform in a day without jeopardizing care of the patient? Our specialty has already debated who should police unnecessary venous ablations. The pressure to maintain income (and profit margins) will lead to marginally indicated procedures. Administrative types and corporate leaders have little knowledge of—or regard for—how medicine is practiced. Their concern is for efficiency, RVUs and number of cases. As long as outcomes are acceptable and their bottom line is robust, they have accomplished their goal.

In an effort to increase efficiency (and profitability), mid-level providers have been substituted with negligible success. Nurse practitioners (NPs) and physician assistants (PAs) are utterly unqualified to diagnose and treat patients without supervision. They actually increase healthcare costs, as demonstrated in a 2022 study by Mississippi’s Hattiesburg Clinic. Replacing physicians with PAs and NPs resulted in higher costs of more than $28 million annually. Increased costs came from tests, specialist referrals and patients sent to emergency departments. Beyond that, are we fulfilling our responsibility to a patient when a PA or NP performs the initial consultation and then is signed off with a cursory physician review?

Currently, hospitals are able to sustain high physician salaries since a portion of their compensation is derived from hospital reimbursement. As healthcare dollars become scarce, the net result is that physician incomes are expected to decrease. And those doctors employed by private equity firms had better expect demands to work “harder,” see more patients, do more procedures, and maximize their billing. High-level executives in boardrooms care little about patient outcomes. As insurers, hospitals and pharmaceuticals try to protect their shares, these entities refuse to yield. Doctors and patients are caught in the middle.

The December assassination in New York pulled the scab off the purulent healthcare wound and exposed intense patient dissatisfaction.

The medical profession’s grand challenge

The challenge to doctors looms large. Having lost leadership in healthcare, what remedies can physicians avail our patients and ourselves to correct this monstrously distorted delivery system? While the American Medical Association (AMA) has proposed a strong legislative initiative, it is unlikely to be successful since the bipartisan AMA bill has no Senate sponsor. Some medical leaders opine that the AMA should become more “muscular.” What those muscular approaches include are yet to be defined.

Unionization has been discussed at the highest levels. Consideration is being given to class action lawsuits against health insurance companies, specifically targeting the prior authorization process, low compensation and downcoding, to name a few. Again, using the powerful legal arm of the AMA, initialing a class action lawsuit against pharmacy benefit managers is also on the table. Advocacy against hospitals that have engaged in oppressive practices is necessary. Their abhorrent facility fees create hardship for patients and obstacles to physicians trying to provide care.

To be successful, physicians have to be cognizant that our success depends solely on advocacy for our patients. Patients lack the organizational structure to challenge these trillion-dollar adversaries, and are utterly without resources when sick and confronted with enormous expense.

Which is why it was refreshing to see the article in the AARP Bulletin sympathetic to physicians. Perhaps the story was a journalistic nudge for physicians to cross healthcare’s Rubicon and strongly advocate for the needs of their patients and themselves.

Arthur E. Palamara, MD, is a vascular surgeon practicing in Hollywood, Florida, for 44 years. He is active in county, state and national medical organizations.

Acute limb ischemia: Enhancing limb salvage rates with computer-assisted vacuum thrombectomy

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Acute limb ischemia: Enhancing limb salvage rates with computer-assisted vacuum thrombectomy

This advertorial is sponsored by Penumbra, Inc.

Daniel Clair
Daniel Clair, MD, reflects on the STRIDE study of 30-day outcomes in patients who undergo first-line use of the Indigo Aspiration System and Lightning® (Penumbra) device portfolios for acute limb ischemia (ALI). He also weighs in on the growing weight of evidence in favor of percutaneous mechanical thrombectomy with the computer-assisted vacuum thrombectomy (CAVT™).

Labeling STRIDE “an effective limb salvage study of patients presenting with ALI,” Clair, chair of the Department of Vascular Surgery at Vanderbilt University Medical Center in Nashville, Tennessee, charts the move from open surgery to endovascular intervention, through thrombolysis and mechanical thrombectomy, and the emergence of CAVT’s suction technology.

Overall, says Clair, the effectiveness of CAVT is underscored by a “very low rate of embolization—a key benefit of using aspiration technology in the management of patients with ALI.”

What are the primary factors that have influenced your practice’s shift from traditional open surgical embolectomies to more endovascular interventions?

For most procedures that involve the vascular system, there is an understanding among vascular specialists—and vascular surgeons in particular—that minimally invasive techniques are easier and quicker for patients to recover from and, in most instances, they limit the impact of the procedure. In addition, historically, even through the 1990s, studies looking at thrombolysis alone have shown similar outcomes between patients who had an initial approach with minimally invasive technologies and procedures versus open surgical thrombectomy. Those data influence people extensively, and the fact there have been improvements with continued advancement in the mechanical thrombectomy world has made it even safer for these patients to have thrombus and embolic lesions treated with a primary approach that involves percutaneous mechanical thrombectomy.

How have improvements in percutaneous thrombectomy devices impacted the efficacy and safety of endovascular procedures compared to open surgery?

Without question, in the past this percutaneous approach involved the use of thrombolysis, but enhancement in aspiration technology—and mechanisms to apply that aspiration—to identify thrombus, and when the aspiration device is within the thrombus, has dramatically improved. It enhances the clot removal power while limiting the amount of blood loss that occurs.

What are the results of the STRIDE study showing and how are such data impacting patient selection and treatment planning?

STRIDE is an important study because, if you compare the historical outcomes of patients with ALI, the expected acute limb loss—that is within 30 days—is usually somewhere between 7–12%, or even 15%.1 And in the STRIDE study, that 30-day limb salvage was 98%.1 It is an effective limb salvage study for patients presenting with ALI. Even out to 12 months, the STRIDE data show limb salvage close to 90%.2 Right now, in our practice, the vast majority of patients who present with ALI are treated primarily with percutaneous approaches, and we think the aspiration technology is a very good way to deal with those patients and also enhance limb salvage rates—particularly in the periprocedural period.

Can you provide an overview of STRIDE II and how it differs from STRIDE?

STRIDE looked at 119 patients who presented with ALI. STRIDE II is an expansion of that population to 300 patients, with broader target vessel criteria, and will be done globally. It will incorporate an enhanced clot identification technology within the Lightning Bolt catheters. Within that 300-patient group, there will be a 50-patient subset where we will be looking at the use of this technology in previously stented or intervened-upon segments of the peripheral vasculature. That is important because, currently, there really is no well-studied mechanism to assess outcomes for percutaneous thrombectomy through areas of stenting.

In what ways does the use of CAVT contribute to a shift from open surgery to endovascular treatments?

For the vast majority of our patients with ALI, we see aspiration as great to use. We experience limited impact to the endothelium from these catheters because they are flexible and very compliant. The Bolt technology has a mechanism by which suction is rapidly modulated. This provides a benefit in that there is some disruption to the thrombus or embolus as we aspirate. It enhances the ability to break this clot up and bring it into the catheter. In many instances, we’re not using the addition of the clot disruptor [Separator] that comes with the catheter, just because of how effective the Bolt technology is on its own.

How is CAVT different from other endovascular technologies?

Other technologies involve application of a stent-like structure to the vessel wall to drag the thrombus back into a funnel. Those technologies are beneficial as well, but I would say there is an increased potential for vessel wall injury. The CAVT technology allows you to maintain wire access if need be and limits the amount of repeat interventions that we have had to do. This means that after 15–20 minutes of application, we’ve been able to clean out the clot enough to allow perfusion and retention of the limb with just anticoagulation after that.

How do you see the future of vascular surgery evolving as endovascular devices and techniques continue to advance?

I would venture to guess that we are going to see enhancements in, and application of, the aspiration technology in such a way that it will allow lengthy clot segments to be treated effectively, without the need for lysis at all. Right now, we are seeing the expansion of this application. One other area that, at times, is a struggle is dealing with chronic embolic material. But, here again, the use of modulated aspiration that comes with CAVT is very beneficial and has been helpful in breaking up these clots in the catheter. Advancements of these CAVT algorithms are going to be more helpful— even enhance the aspiration.

References

  1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5-S67. doi: 10.1016/j.jvs.2006.12.037
  2. Maldonado TS, Powell A, Wendorff H. et al. One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia. J Vasc Surg. 2024; 80 1159-1168 E5

This interview was sponsored by Penumbra, Inc. Daniel Clair is a consultant for Penumbra.

Procedural and operative techniques and considerations are illustrative examples from physician experience. Physicians’ treatment and technique decisions will vary based on their medical judgment. The clinical results presented herein are for informational purposes only and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Summary Statements, please visit www.peninc.info/ risk. Please contact your local Penumbra representative for more information.

Debate verdict: Carotid endarterectomy maintains its golden hue

By
Bryan Kay
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Debate verdict: Carotid endarterectomy maintains its golden hue
Michael Stoner

The established “gold-standard” approach to carotid revascularization remained enshrined as the go-to operation as far as a 2025 Charing Cross (CX) International Symposium audience was concerned.

Some 76% of those who voted in the post-debate poll sided with Barbara Rantner, MD, chief of vascular surgery at Ludwig-Maximillian University Hospital in Munich, Germany, after she made the case for carotid endarterectomy (CEA), long established as the gold-plated method of tackling carotid disease requiring intervention. Transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (CAS) each drew 12% of the audience share apiece, with the proposition for TCAR put forward by Michael Stoner, chief of vascular surgery at the University of Rochester in Rochester, New York, and that of CAS made by Christopher Metzger, MD, an interventional cardiologist at OhioHealth in Columbus, Ohio.

Rantner, a co-chair of the 2023 European Society for Vascular Surgery (ESVS) carotid guidelines, looked at CEA through the prisms of gender, age and timing of procedure. “There is no gender issue, there is no age issue, there are no limitations in timing of treatment,” she declared, pointing out the absence of a superiority trial showing an alternative revascularization option that has been proven to perform better than CEA. “Is endarterectomy the gold standard? Yes.”

Among the articles invoked in support, she referenced 10-year ACST-1 trial results that showed surgery equally benefitted male and female asymptomatic patients. Symptomatic females undergoing CAS in CREST, Rantner said, “suffered from significantly higher periprocedural complications” when compared to CEA, she said. Focusing on age, trial analysis showed that CAS was not a benefit for patients aged 65 or older. “Implementing endarterectomy remains standard of care, and also in the elderly population of 80 years and older,” Rantner added. In terms of timing, data demonstrated CAS “very significantly increased risk when we looked at early treatment onset”, she said.

The case for TCAR, meanwhile, rests in its minimal-access benefits for high-risk patients, the fact the procedure takes embolic risk in the aortic arch off the table, its safety profile, which is “as good—or better—than CEA,” the fact that is it “highly reproducible and scalable,” and its “rapid learning curve for contemporary vascular surgeons,” argued Stoner. He led attendees through the three CEC-adjudicated ROADSTER studies which produced data in support of TCAR, and looked at how the procedure compares to CAS. “TCAR is safer than CAS in any trial that has looked at this,” Stoner said. “How does it compare to CEA, the ‘gold standard’? Well, the gold standard doesn’t fare as well as TCAR. We have equivalent stroke/death rates, improved myocardial infarction, post-procedural hypertension and length of stay, and thus one can see a sustained benefit for TCAR.”

“Percutaneous CAS is plagued by procedural embolic risk and worse outcomes over time in at-risk patients,” Stoner summarized. “TCAR solves the CAS embolic problem. Hard outcomes are equivalent to CEA or even better, and there is a strong patient preference toward minimal access surgery. As such, I’ll submit that TCAR is now the contemporary gold standard for carotid revascularization.”

Taking up the case for CAS, Metzger reasoned that all of the carotid revascularization strategies “are excellent” and that there is no single gold standard for the procedure. Clear-cut gains for transfemoral stenting include no general anesthesia and less stress on older or sicker patients, he said. Disadvantages, on the other hand, include the fact that not all patient anatomies are suitable for CAS, Metzger noted. The case for CAS includes four randomized trials in which the strategy went up against CEA and, in one, medical therapy. “The last four randomized trials of carotid stenting versus endarterectomy have produced outstanding results for both therapies and their equivalent,” he said. With newer carotid stents emerging and contemporary results in CREST-2, “the results keep getting better.”

The three strategies are complementary rather than competitive, Metzger concluded. “We should individualize our approach and, in 2025, with patient selection and good technique, all of these therapies are phenomenal therapies.”

In post-debate discussion, a comment from the audience took issue with Stoner’s description of the ROADSTER studies as “trials.” “None of the data you have shown are from trials,” the audience member observed. “You need to be careful about terminology and you need to be careful about head-to-head comparisons,” based on non-randomized, observational data, a point conceded by Stoner.

Another commenter from the floor challenged both Stoner and Metzger to offer the situation in which they go against the grain and, respectively, proceed with transfemoral CAS in the case of the former and with CEA in the case of the latter.

“Transfemoral versus TCAR? Based on the common carotid artery, I do think you can cheat somewhat on the length, but you can’t cheat on the quality of artery,” Stoner responded.

“If it’s heavily calcified, has bad tortuosity or thrombus, it gets the knife for me,” answered Metzger.

R3 Vascular announces first patient treated in ELITE-BTK pivotal trial

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Bryan Kay
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R3 Vascular announces first patient treated in ELITE-BTK pivotal trial

R3 Vascular recently announced that the first patient in its ELITE-BTK pivotal trial has been treated by Brian DeRubertis, chief of vascular surgery at New York-Presbyterian and Weill Cornell Medicine in New York City.

The trial evaluates R3 Vascular’s next-generation drug-eluting bioresorbable scaffold, Magnitude, for below-the-knee (BTK) peripheral arterial disease (PAD).

DeRubertis commented on the importance of the ELITE-BTK pivotal trial, saying: “I have spent much of my career researching novel devices for vascular disease, including bioresorbable scaffolds, and, while there have been some recent successes in the BTK PAD trial landscape, there remain significant unmet needs in this area.

“We expect the results of this important trial will reveal Magnitude’s unique potential to further advance treatment and improve patient outcomes for patients with vascular disease.”

From Olympic triumph to healthcare advocacy: Jim Craig to deliver VAM 2025 keynote address

By
Marlén Gomez
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From Olympic triumph to healthcare advocacy: Jim Craig to deliver VAM 2025 keynote address
Jim Craig

Jim Craig, a longtime support and vascular advocate, will deliver the annual keynote address at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7). Craig is known as the goaltender for the 1980 U.S. Olympic hockey team and has been praised for his pivotal role in the “Miracle on Ice” victory.

“I’m delighted and honored to have an icon like Jimmy Craig as our speaker,” said Jason T. Lee, MD, chief of vascular surgery at Stanford University and chair of the SVS Program Committee. “We can learn much from him about adversity, leadership, vulnerability and creating a positive culture. In today’s operating rooms, our vascular teams can draw valuable lessons from successful leaders in other industries.”

This year’s keynote is titled “Inside the winning operating room: Building trust, leading under pressure, and achieving excellence as a team.” The presentation will utilize a TED Talk interview format, which Lee hopes will help provide valuable insights and inspiration to attendees.

After years in the vascular space for personal reasons and collaboration with numerous vascular surgeons, Craig considers being selected as this year’s keynote “the highest honor” and an opportunity to be part of a larger team. To Craig, success in the operating room relies on the entire team’s efforts, rather than on any single person’s rank.

“It’s not just the vascular surgeon; it’s a whole team of people who must be prepared, organized and able to work together. They must also hold each other accountable and have the courage to speak up,” said Craig.

Craig’s commitment to the vascular community is rooted in family. Eight years after the 1980 Olympics, his father, Don, passed away from an undetected ruptured abdominal aortic aneurysm (AAA). After experiencing this tragedy, Craig dedicated his life to advocating for awareness and screenings for AAA. By educating himself about the disease, Craig encouraged his brother to get screened, leading to successful early detection of the condition in his sibling. Ultimately, Craig’s efforts played a crucial role in saving his brother’s life.

Since 2007, he has been a leading spokesman for the Saving Abdominal Aortic Aneurysm Very Effectively campaign, or the Ultimate SAAAVE.

Craig stresses the importance of conferences like VAM in creating proper programming to educate medical professionals and keep them informed, ultimately saving lives.

CX 2025: New VenaSeal data suggest cyanoacrylate closure be added to the venous “toolkit”

By
Bryan Kay
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CX 2025: New VenaSeal data suggest cyanoacrylate closure be added to the venous “toolkit”

Twelve-month outcomes of the VenaSeal Spectrum venous leg ulcer (VLU) trial, assessing time to ulcer healing following treatment with the VenaSeal (Medtronic) closure system, have demonstrated an 81.3% ulcer healing rate at one year.

Manj Gohel (Cambridge, United Kingdom) presented the results in a podium-first presentation during Thursday afternoon’s deep venous challenges session. The VenaSeal system uses cyanoacrylate glue to treat underlying venous insufficiency.

The single-arm study prospectively assessed time to ulcer healing in patients with an active venous leg ulcer classified as C6 as the primary endpoint, and a secondary endpoint of vein closure through 12 months. Gohel stated that studies have frequently evaluated the C2 to C5 ulcer population, leaving “an evidence gap” where C6 ulcers are concerned.

The Spectrum VLU trial included 125 venous leg ulcer patients with a median ulcer age of 169 days and a maximum of 6,816 days (18 years and eight months). Gohel stated that the chronicity of the ulcers included was indicative of the severity of disease in their patient cohort, representing a “much harder to treat population than most other randomised studies”, he said.

On healing potential, Gohel reported 81.3% ulcer healing, 82% anatomic closure and 83% freedom from ulcer recurrence at one year, after healing had occurred.

Gohel highlighted safety and effectiveness endpoints, which underwent review by an independent committee. He stated that the VenaSeal system-specific events were consistent with prospective literature, and that events included hypersensitivity (0.8%), phlebitis (8.8%), granuloma (1.6%), and ablation-related thrombus extension (2.4%).

No device- or procedure-related deaths were recorded; however, eight serious adverse events occurred following treatment. These were identified as four infections, three superficial vein thromboses, and one granuloma.

Gohel stated that the high rate of other serious adverse events unrelated to the procedure or device, with 8% mortality within one year of the study, demonstrates the level of comorbid conditions prevalent in this patient population. This fact was also seen via quality-of-life measures, as patients often scored poorly across assessments prior to treatment.

These metrics did improve following treatment—however—providing “good evidence across a number of domains”, said Gohel.

“This is the largest prospective study of patients with C6 disease treated with cyanoacrylate in terms of effectiveness. Healing rates are good and comparable to other studies,” said Gohel. “I would suggest that there is good evidence that this can be a part of the toolkit to manage patients with C6 disease.”

Following his talk, an audience member queried Gohel on the ulcer recurrence rate in the VenaSeal data. In response, he highlighted that deep venous reflux and obese patients were included in the study, both of which have venous hypertension for a number of reasons. “That kind of recurrence rate is very typical in this population, and these are patients that are always going to be at high risk of ulceration,” he stated.

Correction: An earlier version of this article, which appeared in CX Daily News, incorrectly stated an 80% rate of mortality within one year. This has been updated to correctly state that the rate was 8%. This correction was made on 25 April to ensure accuracy.

CX 2025: Sirolimus implant fails to meet fistula maturation endpoint in ACCESS 2 trial

By
Will Date
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CX 2025: Sirolimus implant fails to meet fistula maturation endpoint in ACCESS 2 trial

Results of the ACCESS 2 study, evaluating arteriovenous fistula (AVF) outcomes following use of the Sirogen (Vascular Therapies) sirolimus-eluting collagen implant, have shown that the device failed to meet non-inferiority for clinical fistula maturation compared to control at six months.

Nicholas Inston (Birmingham, United Kingdom) delivered the results in a podium-first presentation during Wednesday morning’s vascular access masterclass—where he commented that the trial’s failure to meet its primary endpoint may be attributable to the overperformance of the standard-of-care arm against expectations.

Sirogen was developed as a means of intraoperative local, perivascular drug delivery at the time of index AVF surgery to improve outcomes in patients requiring an AVF. The device consists of a sirolimus and collagen matrix for targeted local drug delivery, which is bioabsorbable within 12 weeks.

Despite an earlier randomised prospective multicentre study—ACCESS—showing no statistical difference between Sirogen and controls in prespecified endpoints, post-hoc analysis from the trial showed improved fistula maturation and secondary patency in patients with end-stage renal disease aged ≥65 years.

Investigators went on to initiate the ACCESS 2 study to validate these findings and further evaluate the effectiveness of Sirogen to improve outcomes in patients requiring an AVF. The multicentre randomised study enrolled 136 patients across 17 centres in the United States and the United Kingdom, with a primary endpoint of fistula maturation at six months.

Inston reported that 66.8% of patients in ACCESS 2’s Sirogen arm achieved clinical fistula maturation compared to 63.2% in the control— representing a 3.6% point improvement—but falling short of the 18% point improvement goal set for the trial. Comparing against past studies, Inston said that Sirogen performed largely in line with previously observed results, but the performance of the control arm versus historical benchmarks ultimately tipped the dial towards primary endpoint failure.

“Unfortunately, we failed to meet the primary endpoint here and it is really due to this freaky outcome from the control group rather than anything else,” Inston said. “It is quite reassuring that the sirolimus group has performed as it has in all the other studies.”

Trial participants saw a 10-day mean time to functional maturation improvement; however, Inston said that a study involving thousands of patients would be required to study this outcome properly.

The trial remains blinded, with 12-month secondary endpoint data collection still in progress, and secondary endpoints, which include time to first dialysis, fistula suitability for dialysis and secondary patency, may provide additional important insights, according to Inston. “I think these might actually be more important than this simple primary endpoint. There will be number of interventions raised to get there, how will these be done, what type of interventions are required to keep this group going,” he explained.

“This result questions whether strict trial design represents real-world experience,” Inston told CX Daily News in summing up his appraisal of the trial.

CX 2025: EVAR founding fathers invoke revolutionary past to predict path ahead for aortic stent graft development

By
Bryan Kay
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CX 2025: EVAR founding fathers invoke revolutionary past to predict path ahead for aortic stent graft development

The next spring forward in aortic stent grafting will be rooted in a greater understanding of the biomechanical forces acting upon devices alongside continued advances and specialization in imaging, according to some of the founding fathers of endovascular aneurysm repair (EVAR) who were gathered at CX on Wednesday morning in a session that marked more than four decades of EVAR development.

“When you think about aortic aneurysms, all of the devices are rigid, they are stiff, and the body changes with time,” said Christopher Zarins (Torrance, United States), a vascular surgeon involved in early development efforts at Stanford University. “For example, when you’re 6ft tall at the age of 20, you’re 5ft tall at the age of 80. You shorten, but the stent graft doesn’t… so we need to look at new materials and new devices that can reflect on the changing environment of the body itself.”

(L-r): Michael Dake, Rodney White and Christopher Zarins

As imaging modalities progress, added Rodney White (Torrance, United States), also involved early on at Stanford, and “we can look more at diseases and the natural history—and the devices and how they need to change—I think we are all going to become imaging specialists, which is going to drive where these changes come from and show us how we have to progress.”

These visions of the future came as the assembled faculty reflected on the seminal moments of stent graft technology in the 1970s and into the early 1980s. Krassi Ivancev (Lund, Sweden) summarized the broad sweep of device development, including the revolutionary work of the late Nicolai Volodos in Soviet Ukraine and Juan Parodi (Buenos Aires, Argentina) between the Cleveland Clinic in the United States and in his homeland, which exhibited the simultaneous efforts taking place in the east and west as the pioneering journey proceeded. From the Gianturco stent in the earliest moments, through the advanced devices of today, the roots are clear, Ivancev said. “No question, Volodos was the first, but what started the revolution with stent grafting was Parodi, and that was reinforced by several teams working together worldwide.”

Echoing White, Ivancev also called on vascular specialists to “immerse yourself in imaging.”

Contributing thoughts via a prerecorded video, Parodi remembered how his work started in 1976, culminating in his first clinical case for an abdominal aortic aneurysm (AAA) in 1990. “That was a long journey, a lot of work, a lot of opposition,” he said, as he described performing the first AAA case in the world in the Argentinian capital with Julio Palmaz, who was behind the balloon-expandable stent.

Also in a video message, Frank Veith (New York, United States), involved in the first EVAR performed for a AAA Stateside, reflected how despite early resistance and scepticism, younger vascular specialists helped eventual widespread adoption. “We wanted to do everything that hadn’t been done before, so every one of our cases was a first,” he said. “This included ruptured aneurysms and things of that nature. We were treated as pariahs when we thought that we should be treated as messiahs.”

Fellow pioneer Michael Dake (Tucson, United States), an interventional radiologist who led the first placement of an aortic stent graft for a thoracic aneurysm in the United States at Stanford, pondered what could be ahead in the thoracoabdominal space as devices are approved and specialists try to understand which patients should be treated. “For me, the still unsolved issue is in dissection: we do not have a definitive way to treat dissection yet,” he added. “That is the challenge and goal we all have to focus on in the next few years because it is not going to be easy.”

Getting governmental agencies involved early will be another important lever to spur stent graft technology development going forward, added White. “The FDA [US Food and Drug Administration] sponsored many of us to have investigator IDEs [investigational device exemptions], where we could work with manufacturers, get their devices and then be able to progress that way too,” he said. “That kind of collaboration, particularly because we all have to get approval and government payment for these things … helps to move it along.”

Vascular Specialist–April 2025

By
Bryan Kay
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Vascular Specialist–April 2025

In this issue:

  • The question of Vascular Surgery Board independence: Federated or free-standing
  • From Brazil to Baylor: Gustavo Oderich lands at cardiovascular powerhouse
  • BEST-CLI: Landmark trial validated in single-institution retrospective review
  • Vascular Annual Meeting set to feature dedicated session on artificial intelligence

 

Redefining ‘optimal medical therapy’ for vascular patients

By
Sophie Wang, Lars Stangenberg, Glenn LaMuraglia and Allen Hamdan
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Redefining ‘optimal medical therapy’ for vascular patients
Closeup of white pils and colorful capsules. Heap of pills - medical background

Vascular and endovascular surgeons are frequently the only specialists other than primary care involved in the longitudinal care of their patients afflicted with clinically active vascular disease. As such, while scrutinizing the longitudinal and periprocedural outcomes in their patients, involvement in the management and counseling of the patients and their primary care providers in their cardiovascular risk factor modification has become a logical sequence of their overall care. The ongoing effort of understanding procedural and patient outcomes towards quality improvement has led to significant standardization of vascular interventions along the whole spectrum of care—from preoperative evaluation to postoperative surveillance.

The term “optimal medical therapy” (OMT) is often used within this framework to describe the standard pharmacological management of vascular patients. In practice, this equates to an antiplatelet agent, usually aspirin, and an aggressive first-line cholesterol-lowering medication, typically a statin. However, this one-size-fits-all approach to pharmacologic management of cardiovascular risk factors may be insufficient in improving long-term outcomes. Recent data from the Vascular Quality Initiative (VQI) raises concerns about the efficacy of the current paradigm. A recent analysis of survival rates for patients with chronic-limb threatening ischemia (CLTI), with 87% on aspirin and 86% on a statin, reported a dismal 30% five-year survival rate.1 The majority of these patients were on OMT, yet their longevity was dismal. This raises the question: does the use of statins and aspirin represent OMT? Clearly, the definition of OMT needs to be reconsidered and possibly redefined to improve the longevity and outcomes of this patient population.

The primary cardiovascular risk factors that vascular surgeons and primary care physicians currently focus on include smoking, dyslipidemia (particularly hypercholesterolemia), hypertension, chronic kidney disease (CKD) and diabetes. In most practices, vascular surgeons may take a few minutes during a clinic visit to discuss with the patient a plan for individual risk-factor modification. The first focus is often on smoking. But smoking cessation is notoriously difficult—less than 10% of smokers who tried quitting were successful in 2022.2 Many surgeons will offer general advice to patients to use the Quitline or a nicotine patch, but few are organized to provide targeted resources or a well-structured plan. Often, hypertension and CKD are acknowledged as they relate to periprocedural considerations, but the management is deferred to the patient’s medical providers. Similarly, lipid panels to evaluate whether patients are meeting their low-density lipoprotein (LDL) targets, and hemoglobin A1C levels may be noted, but these are also deferred to the patients’ medical providers. As such, though it may be noted, surgeons often fail to take a broader view of the patient’s metabolic health in their assessments and planning of their procedures.

Metabolic syndrome is one of the strongest predictors of cardiovascular outcomes—it is associated with higher rates of death, stroke and myocardial infarction.3–5 These predictors, which can be considered to reflect “optimal metabolic health,” are quantified by five metrics: systolic blood pressure, fasting blood glucose, high-density lipoprotein (HDL) cholesterol levels, triglyceride levels and waist circumference (body mass index). Current cross-sectional population studies have identified that only 10–20% of the American population is metabolically healthy.6 The rates are alarmingly low, even in normal-weight individuals. A recent report calculated that 60% of the U.S. population would be eligible for “weight-loss drugs” like Ozempic.7 This would obviously be higher in patients with vascular disease.

To identify patients with metabolic syndrome, one of the most important things to quantify and target is insulin resistance. This hallmark of metabolic syndrome can be easily quantified in a clinic setting, either through a HOMA-IR (homeostatic model assessment for insulin resistance), which is based on fasting glucose and insulin, or through a surrogate marker like the triglyceride to high-density lipoprotein ratio (TG/HDL). A TG/HDL ratio above 1.5 suggests metabolic syndrome, and a ratio above 4 strongly predicts extensive coronary disease.8 Many patients have lipid panels readily available, and those that have significant insulin resistance or dyslipidemia—especially in the setting of early onset of cardiovascular disease or recurrent treatment failures—may benefit from targeted counseling. This centers on high-yield dietary changes and involves focus on simple, practical diet modifications to reduce refined carbohydrates and increase healthy fats and proteins. Most patients are very receptive to this type of counseling and, over time, with these changes can reverse their insulin resistance and stop their diabetes medications with simple lifestyle changes.9

As vascular surgeons have the privilege of following their patients longitudinally and have their patients as a captive audience, this presents a unique opportunity to make a greater impact on patient outcomes by altering their risk factors, including metabolic syndrome. Vascular surgeons are more than just proceduralists—they are advocates for comprehensive, long-term care and want their patients to have the best possible outcomes. We can work closely with primary care providers to better optimize medication management, particularly when LDL cholesterol and blood pressure targets are not met.

In addition, we can advocate to check lipoprotein(a) levels, especially in precocious patients with atherosclerosis or those with very positive family history, as 20% of the population will be positive, and it is becoming the most potent predictor of adverse outcomes.10 Patients can be counseled on dietary changes and we can advocate for daily exercise programs. Those who may benefit from GLP-1 receptor agonists and SGLT-2 inhibitors can be identified and referred to endocrinologists or other medical providers trialing these medications for our patients with diabetes and CKD in whom mortality and renal protective benefits have been demonstrated.11

The key takeaway is that OMT needs to be redefined into a broader concept in patients with vascular disease, encompassing optimal metabolic health, rather than simply a checklist of medications. Managing vascular patients requires an integrated approach to address the underlying metabolic abnormalities that drive vascular disease progression. The focus should be expanded to include not only traditional medications but also lifestyle modifications, especially diet, exercise and emerging therapies that target the root causes.

Ultimately, by adopting a more comprehensive approach to managing vascular patients, both short-term outcomes and long-term survival rates can be improved.

There is much to gain for our patients as vascular specialists need to embrace this new path forward—one where the patient’s care provided is truly “optimal” in every sense of the word.

References

  1. Levin, S. R. et al. Five Year Survival in Medicare Patients Undergoing Interventions for Peripheral Arterial Disease: a Retrospective Cohort Analysis of Linked Registry Claims Data. Eur. J. Vasc. Endovasc. Surg. 66, 541–549 (2023).
  2. VanFrank, B. et al. Adult Smoking Cessation — United States, 2022. MMWR. Morb. Mortal. Wkly. Rep. 73, 633–641 (2024).
  3. Hosseini, K. et al. The association between metabolic syndrome and major adverse cardiac and cerebrovascular events in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Sci. Rep. 14, 697 (2024).
  4. Lakka, H.-M. The Metabolic Syndrome and Total and Cardiovascular Disease Mortality in Middle-aged Men. JAMA 288, 2709 (2002).
  5. Sundström, J. et al. Clinical value of the metabolic syndrome for long term prediction of total and cardiovascular mortality: prospective, population based cohort study. BMJ 332, 878–882 (2006).
  6. Araújo, J., Cai, J. & Stevens, J. Prevalence of Optimal Metabolic Health in American Adults: National Health and Nutrition Examination Survey 2009–2016. Metab. Syndr. Relat. Disord. 17, 46–52 (2019).
  7. Shi, I. et al. Semaglutide Eligibility Across All Current Indications for US Adults. JAMA Cardiol. (2024). doi:10.1001/jamacardio.2024.4657
  8. Sultani, R. et al. Elevated Triglycerides to High-Density Lipoprotein Cholesterol (TG/HDL-C) Ratio Predicts Long-Term Mortality in High- Risk Patients. Hear. Lung Circ. 29, 414–421 (2020).
  9. Unwin, D. et al. Insights from a general practice service evaluation supporting a lower carbohydrate diet in patients with type 2 diabetes mellitus and prediabetes: a secondary analysis of routine clinic data including HbA1c, weight and prescribing over 6 years. BMJ Nutr. Prev. Heal. 3, 285–294 (2020).
  10. Nordestgaard, B. G. et al. Lipoprotein(a) as a cardiovascular risk factor: current status. Eur. Heart J. 31, 2844–2853 (2010).
  11. Bhattarai, M. et al. Association of Sodium-Glucose Cotransporter 2 Inhibitors With Cardiovascular Outcomes in Patients With Type 2 Diabetes and Other Risk Factors for Cardiovascular Disease. JAMA Netw. Open 5, e2142078 (2022).

Sophie Wang, MD, Lars Stangenberg, MD, Glenn LaMuraglia, MD, and Allen Hamdan, MD, are Boston-based vascular surgeons.

Early feasibility study for Velocity pAVF system now fully enrolled

By
Bryan Kay
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Early feasibility study for Velocity pAVF system now fully enrolled
Velocity implant

Venova Medical has announced the completion of patient enrollment in the company’s VENOS-2 early feasibility study of the Velocity percutaneous arteriovenous fistula (pAVF) system for hemodialysis access.

The multicenter study is being performed under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA) and is intended to provide proof-of-concept and initial clinical safety data.

“Percutaneous AV fistulas provide a minimally invasive alternative to surgically created fistulas and potentially a shorter time to fistula maturation, reducing the exposure to and risks associated with hemodialysis catheters,” said vascular and interventional radiologist Rishi Razdan, MD, from Jacksonville, Florida, a VENOS-2 study investigator. “The Velocity system is designed to be intuitive and facilitate the user’s ability to rapidly create an AV fistula with minimal learning curve and limited need for additional procedures to achieve fistula maturation.”

SVS International Committee’s 2025 scholars named

By
Marlén Gomez
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SVS International Committee’s 2025 scholars named
Rahel Abebayehu Assefa

The SVS International Relations Committee (IRC) has announced the recipients of the 2025 International Scholars Program, recognizing the achievements of three distinguished professionals: Sohei Matsuura, MD, from Japan; Rahel Abebayehu Assefa, MD, from Ethiopia; and Prajna Kota, MD, from India.

They will spend approximately two weeks in the U.S., visiting various universities and clinics, as well as attending the 2025 Vascular Annual Meeting (VAM), being held June 4–7 in New Orleans.

Throughout their time in the U.S., the recipients will work closely with their mentors, gaining critical insights and knowledge from institutions and hospitals in the U.S. and Canada. Wei Zhou, MD, the International Relations Committee chair, hopes this immersive experience enhances their professional development and strengthens global connections in vascular surgery.

Upon completing their tours, each scholar must submit a comprehensive report detailing their experiences and will participate in the International Forum during VAM, where they will formally receive their awards.

Assefa’s application to the program stood out for the IRC, which resulted in her selection as a recipient of the award, being the first female vascular surgeon in Ethiopia.

“I was initially in shock because I expected to possibly reapply next year, because this was my first attempt at applying for this program. I was in disbelief and extremely honored,” said Assefa.

Search for new JVS editor-in-chief has commenced

By
Marlén Gomez
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0
Search for new JVS editor-in-chief has commenced
April 2025’s issue of JVS

The Society for Vascular Surgery (SVS) has launched a search for a new editor-in-chief (EIC) for its flagship publication, the Journal of Vascular Surgery (JVS). The selected EIC will oversee the academic and editorial quality of JVS and collaborate closely with key editorial staff, including the senior managing editor, publisher, executive editor and fellow editors-in-chief.

Candidates interested in the position must submit a cover letter, curriculum vitae, a vision statement for JVS and confirmation of institutional support. More information is available at vascular.org/EICRFA.

JVS—a hybrid subscription and open-access monthly title—receives nearly 2,000 submissions annually.

The new EIC is expected to begin his or her term in July 2025, with an initial four-year appointment and the potential for a two-year renewal. Responsibilities will average 12–20 hours per week, including managing the editorial workflow and participating in regular meetings.

Additionally, the EIC will have support from the editorial leadership, including current EIC Thomas Forbes, MD, and the JVS family of peer-review titles Executive Editor Ronald Dalman, MD.

To fulfill the position, attendance at the Vascular Annual Meeting (VAM) and an EIC retreat at SVS headquarters each fall is required. The SVS Executive Board will decide the successful candidate.

From Brazil to Baylor: Oderich assumes coveted role at cardiovascular ‘powerhouse’

By
Jocelyn Hudson
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From Brazil to Baylor: Oderich assumes coveted role at cardiovascular ‘powerhouse’
New Baylor vascular chief Gustavo Oderich

Following in the footsteps of some of the pioneers of cardiovascular surgery, Gustavo Oderich, MD, recently stepped into position as the Michael E. DeBakey distinguished chair in surgery, professor of surgery, chief of vascular and endovascular surgery and director for the Center for Aortic Surgery at Baylor College of Medicine and Texas Heart Institute in Houston. Steeped in history, the Baylor and Texas Heart Institute names add to an already illustrious career for Oderich that has crossed countries and climates.

From medical school in Brazil through the Mayo Clinic in Rochester, Minnesota, to his most recent post at the University of Texas (UT) Houston, Oderich has followed in the pioneering footsteps of some of vascular surgery’s most noted forefathers. Now he has landed at the place where two of its finest, Michael E. DeBakey, MD, the name behind his distinguished chairmanship, and Denton Cooley, MD, minted Houston’s status as a cardiovascular powerhouse.

In this interview, Oderich tells Vascular Specialist what the Baylor College of Medicine and Texas Heart Institute legacy means to him and the mark he hopes to make through his clinical and research endeavors.

Baylor represents the holy grail of U.S., if not world, cardiovascular surgery through its association with the likes of pioneers like DeBakey and Cooley. What does their legacy mean to you?

GO: It’s a privilege and honor to work at the Baylor College of Medicine and Texas Heart Institute. I’m very much attached to the legacy of these giants and what has been accomplished here during the last century. In terms of cardiovascular surgery, Baylor College of Medicine and Texas Heart Institute have consistently been a powerhouse, and a lot of the things we do nowadays started here in the late 1950s with the work of Drs. DeBakey and Cooley and, subsequently, Drs. Stanley Crawford and Joseph Coselli, among so many prominent surgeons. I am so grateful for the work of Dr. Joseph Mills, our immediate past chief of vascular surgery at Baylor, who successfully established the division at the institution. The aorta is where I spend most of my time clinically and is also the focus of my research, so working in the place where the first of these operations were performed, where modern aortic surgery was really invented, is an incredible honor. It is an honor beyond anything I could have imagined holding the title of inaugural Michael E. DeBakey distinguished chair in surgery. Dr. DeBakey was arguably one of the most accomplished and influential surgeons the world has ever seen.

What do you hope to bring to the Michael E. DeBakey Department of Surgery at Baylor?

GO: The department has 280 full-time faculty and 18 divisions or sections and, under the leadership of Dr. Todd Rosengart, has seen the number of clinical cases, research grants, scientists, and high-impact publications skyrocket over the last decade. Dr. Rosengart was able to show me a clear vision of what we could accomplish at Baylor College of Medicine and Texas Heart Institute, which I was most excited to learn in the interview process.

Baylor College of Medicine has played a leading role in contemporary complex open surgical aortic repair, largely due to the massive experience of Dr. Coselli and remarkable improvements in clinical outcomes. Yet, the endovascular aortic program had not yet been fully developed into a premier, advanced endovascular program capable of handling most complex cases and leading future developments in this field. That’s the know-how that I can bring to the department, in addition to continue to advance the work of Dr. Mills. The way I see it, Drs. DeBakey, Cooley, Crawford and Coselli climbed a huge mountain, they wrote many chapters and formed the foundations for what we do today; I’m here to continue this climb, write new chapters, as well as preserve, maintain and be loyal to the work that they
have done.

We have seen you go from the Mayo Clinic to UT Houston and now Baylor. Could you speak a bit about these career moves?

GO: I’m originally from Brazil and finished my medical school there in 1995. However, after completing two years of surgery in the country, it became clear to me that I wanted to advance my career and become involved in academic surgery and complex endovascular techniques. I realized this would be very difficult to accomplish in Brazil at that time.

I was very fortunate to be accepted for general surgery and vascular training at the Mayo Clinic in the late 1990s and to join the faculty in 2006. Becoming a Mayo surgeon was the highest accolade of my career. Only a few are cut out to meet the true Mayo surgeon definition. At Mayo, I was trained to be a “navy seal” of open surgical vascular surgery. Later, working with Drs. Roy Greenberg, Dan Clair and colleagues at the Cleveland Clinic, I perfected endovascular skills and broadened my horizons to complex endovascular work. At Mayo, I witnessed a place that went from offering traditional, classic open surgery, to a hub of advanced endovascular surgery. To give you an idea of the scale of the shift, when I started at Mayo, we were in one or two device trials; when I left, we were in 26. For most of those, we were the number one enroller.

Mayo is the best hospital in the world; it has mastered clinical practice and is very patient-focused. But I am a native of Brazil and, culturally, it was very difficult to live in the Midwest. And the weather… if you imagine cold, you don’t know what cold is. We had a polar vortex more than once, and it’s a very long winter. There are two seasons in Rochester: July and winter.

UT offered a great opportunity, but there was not a complex endovascular program and so I had several concerns. One of them was whether I could reproduce our outcomes from Mayo at UT, but I soon learned that we could. And I learned that it’s not only about the surgeon, it’s about the team and the infrastructure. We created all that at UT and, in fact, recently published our outcomes, with a 1% mortality for thoracoabdominal aortic aneurysms [TAAAs], both at Mayo and UT, among more than 600 patients. I now have to reproduce that here at Baylor, but I’m confident we can do it.

Homing in on your current work, you are at the forefront of endovascular aneurysm repair (EVAR) advancements and pushing the envelope with complex devices through the U.S. Aortic Research Consortium (ARC). What is some of the key evidence that has been coming out of this project?

GO: I was part of the American Heart Association (AHA) writing committee for management of aortic diseases that was published in 2022. When we started discussions for how to treat TAAAs, complex endovascular repair was not even on the radar of several members of the writing committee. There were several reasons for this, mostly due to the fact that the body of literature was all single-center experiences, with short follow-up, plagued by reinterventions and by limited access to devices. In fact, there was no commercially approved device for TAAAs in the U.S. at the time. All that changed with ARC. Offering probably the highest level of evidence for complex aortic work, this is a prospective, monitored and adjudicated registry of 10 ongoing prospective non-randomized physician-sponsored investigational device exemption [IDE] studies that annually report outcomes to the Food and Drug Administration [FDA]. The 10 physicians involved are at the top of their game and have well overcome the learning curve. I think it shows the world what can be done when you have an experienced team, centralization, skill, access to technology and volume, and the work is remarkable.

Some of our most important work to date was published last year in Circulation. This was a series of over 1,100 elective TAAA repairs, with a mortality of 2.7%. That is a three-fold reduction in early mortality compared to the best open surgical series of a single center, and about a five-fold reduction on large data from Medicare.

What’s next on the horizon for U.S. ARC?

GO: There is a lot of room for improvement. There are still many patients who die from other, non-aortic diseases and reintervention rates remain an issue. That’s where I think new research has to focus.

Looking to the future, ARC 2.0 is going to be when we have all the digital and clinical data immediately available at our fingertips so that we can use artificial intelligence [AI] algorithms to look at phenotypes of patients to plan appropriate procedures and assess likely outcomes.

There will be several challenges when we reach this stage, including HIPAA [Health Insurance Portability and Accountability Act]. This currently prevents us from having access to many aspects of personalized data points, such as dates for example, which are needed for time-dependent outcomes. Also, we don’t have easy access to imaging or other personalized data, and, given we’re moving towards personalized medicine, that’s going to be a big challenge.

Can you talk a little more about some of the work that’s being done on the journey toward precision care?

GO: AI will be used in the entire patient experience, from preoperative diagnosis to treatment planning, operation, postoperative care and surveillance. We could talk about several examples. Randy Moore’s work with the ViTAA technology is certainly landmark, but it does involve access to very detailed imaging data from patients, which is something we have to work on—how we make data-sharing and image-sharing agreements between centers more streamlined. I’m working now with the International Multicenter Aortic Research Group [IMARG], which has 30 sites worldwide and is going to be the United Nations version of the U.S. ARC for the entire world, but it’s a mountain of work to make all the countries and regulatory agencies happy.

I’m also very enthusiastic about the work of Drs. David Murdock and Dianna Milewicz at UT with facial phenotypes. Basically, this would involve taking a photograph of the patient and knowing with extreme accuracy whether they have Loeys-Dietz or Marfan syndrome, or in fact any genetic disorder. That is going to be very important because these patients show up in the emergency department and you don’t have time to take the DNA and check whether they have a genetic condition. You need to know right away.

There’s lots of work being done with digital twins too to predict how the anatomy is going to relate to an outcome, which is similar to the work of Randy Moore [in Calgary with ViTAA Medical], but a little bit different.

Vascular surgery has been defined by several “revolutions.” What is the next one?

GO: I think that what we foresee in the future is a combination of a lot of work on AI algorithms that will make things more personalized, more accurate, faster, simpler, more efficient, and will allow us to better select patients and have better outcomes. I do think that there is going to be need for centralization because medicine is becoming hyper-specialized. Both the minimally invasive as well as the open surgical parts of it are becoming extremely difficult, and that means a
group of physicians must be able to do those procedures.

Also, we need to move away from using radiation, and I think that, hopefully, we’re going to see more options aside from this initial phase that we already have. We have Fiber Optic RealShape [FORS] technology [Philips], we have the IntraOperative Positioning System [IOPS; Centerline Biomedical], but we need to go to the next level where this is seamless, can be used in a larger portion of the procedure, and is more effective.

The question of Vascular Surgery Board independence: Federated or free-standing?

By
Bryan Kay
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The question of Vascular Surgery Board independence: Federated or free-standing?
Members of an SCVS focus session panel discuss the subject of VSB status with meeting attendees during the Society’s recent 2025 Annual Symposium
A survey recently went out to Society for Vascular Surgery (SVS) members asking them to contribute their voice to an opinion poll over whether the Vascular Surgery Board (VSB) should remain a constituent board of the American Board of Surgery (ABS)—or become free-standing.

It’s a question that has come into and out of view in the vascular surgery community for the better part of three decades: should vascular surgery break away and form a fully independent board to certify vascular surgeons, or continue under the auspices of its current, federated structure as a component of the ABS?

On the one hand, advocates of a fully independent board advocate the strengthened voice the specialty would have with its own seat at the table of key decision-making bodies like the American Board of Medical Specialties (ABMS), or on the American Medical Association (AMA) RVS Update Committee (RUC) when recommendations are made over Medicare reimbursement. On the other, proponents of the status quo VSB-ABS structure argue that vascular surgery’s voice is more powerful under the much larger ABS umbrella, and can call upon a far greater pool of resources as a result.

Both sides were articulated during a recent focused session at the 2025 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Austin, Texas (March 29–April 2), which came in the wake of a recently disseminated Society for Vascular Surgery (SVS) survey which puts the question directly to the SVS membership.

In Austin, Alan Dietzek, MD, a vascular surgeon at Hackensack Meridian Health in Edison, New Jersey, put the case forward for a free-standing board, saying that the current VSB has done “an outstanding job” in the role it currently performs but is limited owing to the need for approval of its work in conjunction with the ABS. “There have been no issues to date, but who can predict tomorrow,” he said.

“A desire for an independent board is not a vote against the current VSB. It is a vote to change where the VSB sits.” That would include “a permanent seat on the ABMS” and “a critical seat” on the AMA RUC, he noted. In addition, Dietzek called out the need for such an independent board to have its own Accreditation Council for Graduate Medical Education (ACGME) Residency Review Committee (RRC), as do the 44 current boards of the ABMS. This would enable sub-specialization, the creation of new programs, the recruitment of more medical students and trainees, and possibly increase the number of diplomates,
he said.

As a currently serving director of the VSB, Rabih Chaer, MD, chief of vascular surgery at the University of Pittsburgh, laid out the role of the board as it currently operates. “The VSB essentially defines and oversees all the requirements and processes required for vascular surgery certification—all of it,” he said. “By being affiliated with the ABS, vascular surgery has a larger voice; we speak with the ABS voice in terms of ACGME and ABMS affairs. In addition, we clearly take advantage of their resources.” The VSB only requires ABS approval when the issue at hand involves “a large financial situation,” Chaer continued. The VSB plays no part in issues such as the Match, reimbursements, hospital credentialing and turf wars, he added. Of current representation on the ACGME Surgery RRC, Chaer said three vascular surgeons serve on the committee “and this hasn’t really hampered our ability to get things done.”

For some, at odds is the question of what the present VSB does, or can do. Kellie Brown, MD, a session moderator, chair of the VSB and a professor of surgery at the Medical College of Wisconsin in Milwaukee, argued during discussion that many of the perceived benefits of a free-standing board are conflated with the responsibilities of other vascular surgical bodies. Malachi Sheahan III, MD, the current VSB vice chair and chair of surgery at Louisiana State University in New Orleans, outlined the VSB’s function in the session introduction. “What does the Board actually do?” he posed. “It’s dull and boring, but we define and oversee certification.” He explained: “When you think about what we need as a specialty—more training programs—that’s probably going to come from the ACGME. Addressing burnout? That’s probably coming from the SVS. Increasing our workforce? That’s complicated—multiple institutions would need to be involved. Our public profile? That’s probably the SVS. Government advocacy, that’s the SVS and the ACS [American College of Surgeons]. None of these things is really what a board does, and it gets conflated a lot in what we would gain.”

It was left to Keith Calligaro, MD, SVS president-elect and chief of vascular surgery at Pennsylvania Hospital in Philadelphia, to explain the context behind the findings of the SVS Task Force on Free-Standing or Federated Board Certification, which were recently disseminated to SVS members along with the survey that seeks their input. An eight-month process yielded a report that summarizes equivocal findings, among which it is stated that the ACGME “is not in a financial position to grant a separate RRC to any group”; findings that favor the current VSB structure, including financial costs associated with creating an independent board structure; and findings that favor a free-standing board, such as the standalone votes such an entity would cast at the ABMS and the fact it would have its own seat at the AMA RUC.

The specter of cardiology’s recent American Board of Cardiovascular Medicine (ABCVM) application for independent board status to the ABMS, subsequently rejected, also consumed considerable task force deliberation, explained Calligaro. “This one factor we have now moved away from the list of things favoring a free-standing board [to being an equivocal factor] because, on the one hand it got turned down, but, on the other hand, if they re-apply in two years, and they get it, will all SVS members be saying, ‘What the heck are you guys doing? How can cardiology have their own board, but vascular surgery does not?’”

The results garnered from the survey sent to SVS members will form part of the process by which the SVS Executive Board will come to a final decision on whether to recommend to the VSB that the status quo continue or a free-standing board should be sought,
Calligaro added.

All board-certified and board-eligible SVS members have been sent numerous reminder emails to complete the five-minute survey, the SVS announced as it revealed more than 800 members have already submitted responses. The emails come from Avenue M, the survey company retained by the SVS to field the survey. Any questions should be directed to governance@vascularsociety.org. The survey will close at 5 p.m. on Thursday, April 17.

Founding fathers of EVAR set to gather to mark 40 years of aortic stent graft development

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Bryan Kay
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Founding fathers of EVAR set to gather to mark 40 years of aortic stent graft development

The 40-year history of endovascular aneurysm repair (EVAR) of the aorta wends a circuitous route, from behind the Iron Curtain in Soviet Ukraine, to Buenos Aires, Argentina, points east and west in the U.S., and far beyond. It’s a journey being illuminated during the 2025 Charing Cross (CX) International Symposium in London, England (April 23–25), to honor EVAR’s founding fathers four decades on from their trail-blazing work, with some of the key figures among the assembled faculty at CX.

Marking four decades of development, the session will chart the course of EVAR with a historical perspective provided by interventional radiologist Krassi Ivancev, MD, of Lund, Sweden, who himself figures in EVAR development after he produced a stent graft system that incorporated the iliac arteries in early 1993.

The origins of EVAR in the aorta recalls two seminal figures: the late leading vascular surgeon in the Soviet Union, Nicolai L. Volodos, MD, of Kharkiv, Ukraine, and Argentinian vascular surgeon Juan C. Parodi, MD, of Buenos Aires. The former was the first to treat a thoracic aortic aneurysm with a stent graft and the latter performed the first EVAR on an abdominal aortic aneurysm (AAA).

Founding father Parodi will be one of the faculty taking part in the panel discussion that follows Ivancev’s presentation. Interventional radiologist Michael Dake, MD, of Tucson, Arizona, who led the first aortic endograft placement for treatment of a thoracic aortic aneurysm in the U.S. in 1992, will also be present, and joined by former Society for Vascular Surgery (SVS) President Frank Veith, MD, of New York City, the surgeon behind the first stent graft placed for AAA in the U.S., also in 1992.

In a write-up of their European Society for Vascular Surgery (ESVS) 2019 Volodos Honorary Lecture in Hamburg, Germany, in the May 2020 issue of the European Journal for Vascular and Endovascular Surgery (EJVES), Ivancev and co-author Robert Vogelzang, MD, from Chicago, commented on how multiple centers and individuals spread out across the world had made independent contributions to the development of EVAR, pointing out that  “the contributors to this concept came from different areas of subspecialties, such as interventional radiologists and cardiovascular surgeons, thus underlining the critical step of repurposing knowledge from one area, interventional radiology, to another area, vascular surgery.”

Veith remembers the revolutionary period after the first U.S. AAA case he performed alongside Parodi, fellow vascular surgeon Michael Marin, MD, also of New York City, and interventional radiologist Claudio Schonholz, MD, of Charleston, South Carolina, on Nov. 22, 1992. “Remarkably his aneurysm was excluded, and his severe pain was totally relieved,” he recalls of the patient.

Veith says he realized vascular surgeons had to carry out these procedures in patients who could not undergo open surgery. “Our treatment was surprisingly successful in these patients, and by 1994 we had used our surgeon-made endografts to treat more than 150 patients,” he says.

At the helm of the Eastern Vascular Society (EVS) in 1994, then the Society for Vascular Surgery (SVS) in 1996, he used his presidential addresses to compel his colleagues to become “endocompetent or they would become extinct as vascular doctors.”

The other assembled faculty will be vascular surgeon Rodney White, MD, of Torrance, California, who contributed to the early development of hand-made endoluminal stent grafts and worked to help spur adoption, and Christopher Zarins, MD, another former SVS president, of Stanford, California, who also made contributions to EVAR technology development and understanding of vascular mechanics. Themes the panel were set to discuss include some of the challenges faced during EVAR’s early stages, game-changing moments, key contributions, and where they feel the field may be headed next.

Zarins recalls arriving at Stanford shortly after Dake had completed the first U.S. aortic endograft in 1992, describing a time of great innovation. “I worked with Tom Fogarty who was developing a stent graft—later to become the AneuRx device—and we were all together in the Stanford Vascular Center where collaboration and innovation was the name of the game,” he says.

Terumo Neuro receives FDA approval for carotid stent system

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Bryan Kay
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Terumo Neuro receives FDA approval for carotid stent system
Terumo’s carotid stent

Terumo Neuro has announced that its carotid stent system has received premarket approval (PMA) from the Food and Drug Administration (FDA).

This milestone marks the first dual-layer micromesh carotid stent approved in the U.S., offering physicians a clinically proven option to improve patient outcomes in carotid artery disease treatment, as per a Terumo Neuro press release.

The company’s carotid stent system is indicated for the treatment of carotid artery stenosis in patients at increased risk for adverse events following a carotid endarterectomy procedure.

The device is intended to treat patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in the internal carotid arteries, or at the carotid bifurcation, with ≥50% stenosis in symptomatic patients or ≥80% stenosis in asymptomatic patients—as determined by angiography.

According to Terumo Neuro’s recent release, the device also accommodates vessel reference diameters between 3.5mm and 9mm at the target lesion.

VenoValve: Analysis finds similar improvement among both primary and thrombotic deep venous reflux patients

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Bryan Kay
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VenoValve: Analysis finds similar improvement among both primary and thrombotic deep venous reflux patients
Cassius Iyad Ochoa Chaar

A new subanalysis of the SAVVE (Surgical antireflux venous valve endoprosthesis) trial found that there was no difference in the level of improvement in clinical outcomes and quality-of-life measures between patients who have either primary or thrombotic deep venous reflux.

The data were presented during the Society for Clinical Vascular Surgery (SCVS) 2025 Annual Symposium in Austin, Texas (March 29–April 2) by Cassius Iyad Ochoa Chaar, MD, associate professor at Yale School of Medicine in New Haven, Connecticut, one of the trial’s site principal investigators and a consultant for the company behind the device.

SAVVE enrolled 75 patients with deep venous reflux in CEAP (Clinical, Etiological, Anatomical and Pathophysiological) categories C4b, C4c, C5 and C6 who were implanted with the novel bioprosthetic venous valve replacement, known as VenoValve (enVVeno Medical), across 21 U.S. sites. The overall one-year SAVVE trial data were first revealed during the 2024 VEITHsymposium in New York City (Nov. 19–23), showing that 85% of the patients achieved a clinically meaningful benefit of a three-or-more-point improvement in revised Venous Clinical Severity Score (rVCSS); a 7.91-point average rVCSS improvement among the rVCSS responder cohort; a clinically meaningful benefit in all CEAP diagnostic classes of patients enrolled; and a 97% target vein patency rate. Additionally, patients also experienced a median reduction in pain of 75% at one year as measured by Visual Analog Scale (VAS).

Among patients with venous ulcers (C6), the median ulcer area was reduced by 87% at 12 months. Patient-reported outcomes demonstrated improvements in quality of life and disease symptoms (VEINES-QOL/Sym).

The latest SAVVE subanalysis compared chronic venous insufficiency patients with primary reflux to those who presented with thrombotic reflux—with the latter defined as those who had a history of venous thromboembolism (VTE), with 80% of the participants bearing a thrombotic etiology.

The only “real difference between the two subgroups of patients was that the thrombotic patients were more likely to be on anticoagulation,” Chaar told SCVS 2025.

More than 50% of trial participants had ulcerations, with the average ulcer area 17cm2. The subanalysis showed that there was no difference between the two groups.

At baseline, the mean reflux time among the entire cohort was three seconds, with an rVCSS score of 16, Chaar continued. “There was no difference between the two groups. Looking at the outcomes of the patients enrolled at one year, there was a significant decrease in the mean rVCSS score in both groups, both the thrombotic and the primary, with an average 6.2- and 8.7-point drop, respectively.

“If you look at the clinically meaningful improvement in rVCSS score, you can see that 85% of the patients achieved that, with an average improvement of 7.5 [thrombotic] and 9.3 [primary] points, respectively,” he said.

“The pain improvement in VAS was significantly increased at one year, with an average of 2.5 points [for both groups], and patient-reported quality-of-life and symptomatic reports also significantly improved at one year in both groups,” Chaar said, adding that, in terms of ulcer area, “the primary reflux group seemed to have a little better reduction in their venous ulceration, with a decrease of 6.6cm2 [thrombotic] and 14.2cm2 [primary], respectively.”

Chaar concluded: “The VenoValve is an effective treatment for patients with deep venous reflux with no other options for treatment. Improvement starts at three months and is persistent at one year, and improvement in clinical patient-reported outcomes and quality of life seems comparable between patients who have thrombotic or primary reflux.”

Cagent Vascular initiates patient enrollment in Serranator vs. plain balloon angioplasty OCT study

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Bryan Kay
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Cagent Vascular initiates patient enrollment in Serranator vs. plain balloon angioplasty OCT study
Serranator PTA serration balloon catheter
Serranator
Serranator

Cagent Vascular has announced its first patient enrolment in the Serranator versus plain balloon angioplasty optical coherence tomography (OCT) study.

This prospective, randomized (2:1 treatment to control) dual-center study will enroll up to 60 patients. The study will utilize intravascular OCT imaging to demonstrate the mechanism of action (MOA) of the Serranator and compare the serration MOA to conventional angioplasty across a wide range of lesion morphologies in below-the-knee arteries.

The study will be taking place at Columbia University Medical Center and Weill Cornell Medicine, led by co-principal investigators Sahil Parikh, MD, an interventional cardiologist, and vascular surgeon Brian DeRubertis, MD. A company press release reports that this will be the first study of its kind, a randomized trial utilizing OCT imaging to compare acute outcomes between serration angioplasty and plain balloon angioplasty.

“OCT provides a novel visualization of vascular disease and therapeutic results. With 10x the resolution of IVUS [intravascular ultrasound], we believe this study will allow us to understand how serration angioplasty and plain balloon angioplasty interact with the intima, internal elastic lamina, and media. We’re eager to assess this visually and quantitatively in this first-of-its-kind study,” stated DeRubertis.

SCVS 2025: Rowe becomes SCVS president

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Bryan Kay
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SCVS 2025: Rowe becomes SCVS president
Vincent Rowe

Vincent Rowe, MD, from the University of California, Los Angeles (UCLA), became the 2025–26 Society for Clinical Vascular Surgery (SCVS) president during the Society’s 52nd Annual Symposium in Austin, Texas (March 29–April 2).

Falling in line behind him are Peter Faries, MD, from Icahn School of Medicine at Mount Sinai in New York City, as president-elect; Alik Farber, MD, from Boston Medical Center in Boston, as vice president; Audra Duncan, MD, from Western University in London, Ontario, Canada, as secretary, and Leila Mureebe, MD, from the Duke University Health System in Durham, North Carolina, as a member-at-large.

Jean Bismuth, MD, from the University of South Florida in Tampa, completed his presidency at the close of the SCVS meeting in Austin.

Mentorship takes center stage at VRIC 2025

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Marlén Gomez
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Mentorship takes center stage at VRIC 2025

The Vascular Research Initiatives Conference (VRIC) will spotlight the crucial role of mentorship in advancing the fields of vascular surgery and research during its upcoming event on April 22. This year’s conference will run concurrently with the American Heart Association’s Vascular Discovery 2025 Scientific Sessions, themed “From Genes to Medicine,” which will explore the pathway from genetic discovery to clinical application.

This year’s conference theme is “Deploying Multiomics to Reveal New Therapeutic Targets in Vascular Biology.” Conference organizers have noted that contributions on topics like chronic limb-threatening ischemia (CLTI) and aneurysms will be a significant part of the discussions, emphasizing the importance of fundamental biology within cellular environments.

Kathryn L. Howe, MD, a surgeon-scientist at the University Health Network in Toronto, Canada, and chair of the SVS Basic and Translational Research Committee, has been an enthusiastic attendee of the VRIC since 2016. Her journey to the conference began with a mentor’s recommendation, underlining the event’s significance for emerging vascular surgeon-scientists.

Reflecting on her inaugural experience, Howe described it as “mind-blowing” and emphasized the importance of early participation in the event to foster community connections. “I can’t say enough about the importance of going early and then being part of that community feeling, building upon it every year that you go,” Howe said.

This year, the VRIC promotes robust discussions on cutting-edge basic science and translational research topics while ensuring that conversations remain rooted in current evidence-based practices and science. Mentorship and collaboration are at the forefront of this initiative, exemplified through Howe’s partnership with her mentee, Sneha Raju, MD, a third-year vascular surgery resident at the University of Toronto.

Raju recently completed her PhD research on endothelial cell communication in atherosclerosis and expressed her excitement about engaging with various vascular pathologies at the conference. “It’s inspiring to see vascular surgeon-scientists not only surgically manage vascular pathologies but also tackle the biological challenges behind these diseases to enhance patient diagnostics and treatments,” Raju said.

Having first attended the conference during the COVID-19 pandemic, Raju noted the uplifting atmosphere that emerges when leaders in the field come together to address vascular disease. “[VRIC] is a great place to build collaborations and advance scientific questions by recruiting insights from members with varied experiences,” Raju said.

With its emphasis on exchanging knowledge in basic and translational vascular science, VRIC encourages thoughtful dialogue to explore solutions to vascular patients’ pressing issues. Howe emphasized the crucial need for these discussions in today’s research climate: “When it comes to making sure that our science is seen and heard and valued, and therefore we have a platform to continue to advocate for additional funding, this is crucial.”

To register, visit vascular.org/VRIC25.

SVS prepares to educate latest group of vascular leaders

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Marlén Gomez
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SVS prepares to educate latest group of vascular leaders
Manuel Garcia-Toca

The Society for Vascular Surgery (SVS) has launched registration for the sixth cohort of its Leadership Development Program (LDP). The curriculum is drawn from the highest quality evidenced-based model on leadership, the book The Leadership Challenge, written by James M. Kouzes and Barry Z. Posner, with an intense focus on applying this knowledge to the real-life challenges vascular surgeons face in the field.

The aim is for the participants to reach their full potential as leaders and make a positive impact in the specialty, in their workplace and community, and in other areas of importance in their lives.

After five years, the program is changing its formatting to better fit the needs of vascular surgery leaders. The program will kick off at the 2025 Vascular Annual Meeting (VAM 2025) in New Orleans, with an orientation and luncheon, followed by a more condensed program to cater to the needs of busy vascular surgeons.

“Kicking off the program in an in-person setting really sets the tone,” said LDP Chair Manuel Garcia-Toca, MD.

“Giving everyone the opportunity to meet the other cohort members allows them to establish relationships that can be built upon throughout the rest of the program.”

After the kick-off at VAM 2025, the program will consist of webinars, short on-demand videos, and mentoring calls, concluding with an in-person workshop and graduation ceremony in October. Participants will identify a leadership challenge, working through the process using the skills and tactics they will be learning about from leaders in the field.

“The Leadership Development Program presents its participants with the unique opportunity to learn from people who were once in their shoes,” said Garcia-Toca.

“I believe each participant walks away with tangible tactics to move past barriers they experience in their everyday practice, making them a more effective leader, not only at work, but in their personal life as well.”

Past LDP participants are currently invited to apply for a Mastery Grant to receive up to $3,000 to help them reach their leadership goals. Visit vascular.org/Leadership for more information.

SVS, medical organizations launch comprehensive Wound Care Curriculum

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Marlén Gomez
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SVS, medical organizations launch comprehensive Wound Care Curriculum
Joseph Mills

The Society for Vascular Surgery (SVS), in collaboration with the Society for Vascular Nursing (SVN) and the American Podiatric Medical Association (APMA), has designed an interprofessional curriculum to meet the needs of vascular wound care teams. As the collaborating organizations emphasize, this initiative marks the first of its kind in vascular-specific wound care.

The organizations have shared several promotional videos on social media featuring specialists who promote the course, highlighting the necessity of collaboration between the organizations.

“To prevent amputations takes a team—you can have the best vascular surgeons in the world and the best podiatrist, and if they’re not part of a cohesive team that includes ultrasound techs, nurses, nurse practitioners, advanced providers and wound care people, you’re not going to get the results that you want,” said Joseph Mills, MD, Reid professor and chief of the Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine in Houston, in one of the circulating videos.

The Wound Care Curriculum is a combination of on-demand content and an in-person hands-on workshop. The SVS VascuLEARN platform includes 27 on-demand short videos covering essential wound care topics for the online portion. Registrants can purchase the online module independently or participate in a hands-on workshop immediately following the Vascular Annual Meeting (VAM) in New Orleans on June 7.

Additional workshops will be held in conjunction with VAM 2026 and VAM 2027. Each workshop will focus on hands-on practical application

of wound care procedures/techniques and showcase advancements. The 2025 workshop will focus on debridement techniques, dressing management and oxygen therapy.

“Our APMA members, podiatrists, collaborate with members of the SVS and SVN every day to care for patients, so it makes sense for us to work together at the association level to put on the Wound Care Curriculum,” said Dyane E. Tower, DPM, vice president of clinical affairs and the medical director of the APMA.

Tower points out that collaboration and the Wound Care Curriculum highlight the increasing focus on teamwork among professions and that “each provider type has a specific role to fill in caring for these patients.”

VAM has previously presented content on wound care, but the results from the 2021 and 2024 Educational Needs Assessments revealed significant gaps in wound care knowledge and practices within vascular teams.

In response to these findings, Alisha Oropallo, MD, and Kathleen Raman, MD, developed a comprehensive Wound Care Curriculum to address these issues. Both vascular surgeons presented the concept of the curriculum through an official business plan request to the SVS Education Council. Following approval of the concept, the SVS team worked to formally partner with the SVS PA Section, the SVN and the APMA.

Oropallo calls the curriculum “groundbreaking, as it fills a critical educational gap for interdisciplinary vascular wound care teams.”

Through its hybrid course, the Wound Care Curriculum will offer registrants “a foundational understanding of vascular wounds and then exposure to real-world cases that are addressed in daily practice,” said Orapallo.

Alan J. Block, MD, DPM, a podiatry specialist, shared his perspective on the potential impact of a unified approach to wound care. Drawing from his experience at Ohio State University, Block illustrated how a thorough understanding of patients’ health issues could lead to more effective treatment. For instance, he noted the importance of interpreting ankle-brachial index (ABI) test results, stressing that even subtle abnormalities, such as a reading of 0.9, require urgent attention, especially in asymptomatic patients.

“We wouldn’t ignore a cancer diagnosis until it reaches stage four; similarly, we must address vascular issues before they escalate,” said Block. He detailed the significance of monitoring ABI values, explaining that higher readings could indicate calcification, progressing toward critical limb ischemia if left untreated. Block will participate as faculty in the masterclass workshop in June.

The curriculum offers continuing medical education (CME), continuing education units (CEUs) and continuing education (CE) credits in podiatric medicine, ensuring that participants are well-equipped to tackle the challenges of vascular wound care in the future.

“Our mission is to equip healthcare professionals with the knowledge and skills to provide state-of-the-art care, ultimately improving patient outcomes and enhancing the quality of life for countless individuals facing vascular wounds,” said Raman.

To learn more, visit vascular.org/WoundCare.

Novel phenotypic AAA classification may help better stratify aneurysm risk

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Bryan Kay
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Novel phenotypic AAA classification may help better stratify aneurysm risk
Randy Moore speaks during CIA 2025

Inspection of aortic lumen, wall and thrombus volume changes throughout the cardiac cycle enables novel classification of abdominal aortic aneurysms (AAAs) into four types “representing the complex wall-lumen-thrombus interaction,” a new study delivered during the 2025 Critical Issues America (CIA) in Aortic Endografting meeting in Miami (Feb. 7–8) showed.

The finding is among the latest results brought by Randy Moore, MD, a vascular surgeon at the University of Calgary in Alberta, Canada, who is one of the driving forces behind an emerging technology aimed at providing an algorithm-driven route to precision care—RAW (Regional Areas of Weakness) Maps (ViTAA Medical Solutions).

The current investigation of the technology from Moore and colleagues involves patients who were selected from two studies—one including patients who underwent surgical repair of AAA from 2016–2023, and those in a retrospective study of AAA growth at 12 months based on surveillance imaging, also from 2016–2023. Multiphase computed tomography (CT) of 14 patients were obtained from Peter Lougheed Hospital in Calgary, with the geometries of the aortic wall and lumen segmented from the images, Moore explained.

Writing in the Journal of Vascular Surgery-Cases, Innovations and Techniques (JVS-CIT), where the findings were recently published, Moore and colleagues—led by first author Alice Guest, PhD, from the University of Calgary’s Department of Biomedical Engineering—laid out how “the relative changes of wall, lumen and thrombus volumes throughout the cardiac cycle classified AAAs into the four types.” These are described as type I (aneurysms with a minimal wall movement, negative lumen expansion and positive intraluminal thrombus expansion); type II (aneurysms whose lumen undergoes small expansion, while the expansion is accommodated by the intraluminal thrombus and wall); type III (a transition type characterized by lumen, wall and thrombus expansions); and type IV (characterized by lumen expansion matching or exceeding wall expansion, while the thrombus exhibits very small or negative deformation).

This phenotypic classification of AAA based on complex interactions has not been previously described, Moore and colleagues reveal. The AAA classification system can improve the assessment of clinical risk for aneurysms, they report, with type I “associated with a stiff aneurysm wall that resists thrombus deformation and may be related to the risk of dissection.” Types II and III are “transition types,” and type IV “is associated with the formation of permeable channels and thrombus cracks which may indicate possible risk of rupture.”

At CIA 2025, Moore described how ViTAA analysis of the aortic wall during 4D scanning identifies wall weakness (RAW Maps), concluding, “4D analysis of wall-lumen-thrombus kinematics allows for phenotypical classification of the aortic wall.”

Surmodics announces commercial release of Pounce XL thrombectomy system

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Bryan Kay
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Surmodics announces commercial release of Pounce XL thrombectomy system

SurmodicsSurmodics has announced the commercial release of the Pounce XL thrombectomy system for endovascular removal of acute or chronic clot from peripheral arteries.

Intended for removal of thrombi and emboli from peripheral arteries ranging from 5.5–10mm in diameter­­, sizes typical of iliac and femoral arteries, the Pounce XL thrombectomy system accompanies the Pounce and Pounce low-profile thrombectomy systems.

The Pounce XL thrombectomy system has been in limited market release (LMR) since January 2025. Anna Marjan, MD, a vascular surgeon at Allina Health Mercy Hospital in Coon Rapids, Minnesota, was among the physicians who used the Pounce XL thrombectomy system during the product’s LMR, a Surmodics press release states.

“Removing organized clot from large peripheral arteries without a surgical cutdown can be very challenging,” she said. “In our first use of the Pounce XL thrombectomy system we were able to extract a large amount of acute and subacute clot from the infrarenal aorta and common iliac arteries in a severely ischemic patient with just three passes of the device.”

An interim analysis of the PROWL registry showed that in 74 patients with acute, subacute, and chronic native infrainguinal vessel limb ischemia, average Pounce thrombectomy platform use time was 20.3 minutes, with 79.7% of patients receiving no additional clot removal treatment of the target lesion after the platform’s use. Device-related adverse events were limited to one report of flow-limiting dissection.

Gore announces FDA approval and first commercial implant of large-diameter thoracic tapers

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Bryan Kay
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Gore announces FDA approval and first commercial implant of large-diameter thoracic tapers
CTAG tapers
CTAG tapers

Gore recently announced the expansion of the Gore Tag conformable thoracic stent graft with Active Control system product line, following Food and Drug Administration (FDA) approval of four new large-diameter tapered designs: 34x28mm, 37x31mm, 40x34mm and 45x37mm.

News of the approval comes in conjunction with the first U.S. commercial implant, completed at Keck School of Medicine of USC in Los Angeles by Sukgu Han, MD, chief of the Division of Vascular Surgery and Endovascular Therapy.

For Han, the new large-diameter tapers “provide a welcome addition to the available treatment options for patients and expands applicability for the existing Gore technology,” he shared in a Gore press release.

First approved in 2019, the Gore Tag conformable thoracic stent graft with Active Control system is indicated for the endovascular repair of all lesions of the descending thoracic aorta, including aneurysms, transections and type B dissections.

“The right device sizing is always critical,” Han emphasized, “and even more so when treating in a narrow true lumen. These additional tapered designs will help us achieve optimal sizing for a broader range of aortic diameters while continuing to leverage the proven performance and properties of this device system.”

“The Gore Tag conformable thoracic stent graft with Active Control system is an outstanding technology. I found the device to perform with reliable conformability and [a] controlled, staged delivery mechanism. And now, I know that I have the sizes I need for more of the patients I need to treat,” he concluded.

SCVS 2025: TBE device provides ‘safer’ option than TEVAR for blunt thoracic injuries in setting of zone 2 coverage

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Bryan Kay
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SCVS 2025: TBE device provides ‘safer’ option than TEVAR for blunt thoracic injuries in setting of zone 2 coverage
Kathryn DiLosa

Use of the Gore Tag thoracic branch endoprosthesis (TBE) “offers a safer alternative” to traditional thoracic endovascular aortic repair (TEVAR) with left subclavian artery (LSA) coverage in blunt thoracic aortic injury (BTAI) requiring zone 2 coverage for zone 2 or proximal zone 3 injuries without requiring a concomitant or delayed subclavian revascularization, according to a new study delivered at the 2025 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Austin, Texas (March 29–April 2).

Kathryn DiLosa, MD, a vascular surgery resident at the University of California, Davis in Sacramento, California, revealed how from 2005–2024, 13 patients had TBE repair for BTAI at UC Davis, with 48 receiving TEVAR with LSA coverage. Technical success—device delivery with exclusion of injury—was 100% in both groups. Among the TEVAR cohort, nine patients had LSA revascularization. There were no complications in the TBE cohort, DiLosa and colleagues found, while 12 patients in the TEVAR cohort experienced a complication, including wound infection, arm ischemia, stroke, endoleak and retrograde dissection. No aortic-related mortalities were observed. TBE side branch patency and BTAI exclusion was 100% at mean follow-up of 18.5 days. Similarly, BTAI was excluded in all TEVAR patients at follow-up.

The UC Davis experience is characterized by the institution’s geographical surroundings in tandem with its early access to the TBE device, explains DiLosa in an interview prior to SCVS 2025. “Here at UC Davis, we are surrounded by tons of very rural highways—mountain highways—so there is a lot of blunt trauma that we deal with,” she says. “As a result, we have a massive collection of patients who have had prior blunt thoracic aortic injuries that we have managed and that has given us a nice cohort to look at some unique features of those injuries and the management of them.”

DiLosa highlights the significance of the UC Davis findings: “Previously, it has been suggested covering the LSA is reasonable, especially if somebody has a bad injury, and they just need it done quickly, where you can come back later. This has been the teaching. But I think now, as we’re seeing new devices that offer something that can be done relatively quickly and efficiently with an off-the-shelf device, our recommendations need to change to match the evolution of endografts.”

The data, says DiLosa, confirm a number of prior studies showing that “15–30% of patients that have coverage of the left subclavian may need revascularization at some point or other.

“We observed that roughly 20% of patients in our cohort needed revascularization for one reason or another, or had revascularization. When you are considering that one-in-five patients that gets a repair for an emergent situation will potentially need a bypass, our practice has generally shifted to use the TBE device in any repairs that are going to require coverage of the left subclavian, because, in our experience, we are fairly facile with the device and we are able to complete that repair in just over an hour.”

When the device is available, the TBE should be considered if coverage of the LSA is required to prevent adverse outcomes, DiLosa and colleagues conclude. “One thing that should be made clear is that not all patients with a blunt aortic injury need a repair that involves coverage of the subclavian artery,” DiLosa adds. “However, when coverage is necessary, a branched endograft maintains subclavian artery perfusion, and minimizes stroke and extremity ischemia risk.”

ACC.25: Semaglutide improves walk distance for PAD patients with diabetes

By
Will Date
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ACC.25: Semaglutide improves walk distance for PAD patients with diabetes
Marc Bonaca at ACC.25. Photo by © ACC/Phil McCarten 2025
Marc Bonaca at ACC.25. Photo by © ACC/Phil McCarten 2025

Semaglutide significantly improved maximal walking distance in people with symptomatic peripheral arterial disease (PAD) and type 2 diabetes in a trial designed to evaluate the use of a GLP-1 agonist to manage PAD.

In addition to improvements in walking ability and function, people taking semaglutide also saw significant improvements in both symptoms and quality of life compared with those taking a placebo.

These are the main findings of the STRIDE trial, presented during a late-breaking clinical trial session at the American College of Cardiology (ACC) 2025 scientific session (29–31 March, Chicago, USA) and simultaneously published online in The Lancet.

“Even at very early stages of PAD, people can’t walk well, but they often don’t know it’s PAD. They may say, ‘I’ve just slowed down,’ ‘I’m getting older,’ or ‘I have arthritis,’ but they’re actually severely functionally impaired and they often will self-limit what they are doing,” said Marc P Bonaca (University of Colorado School of Medicine, Aurora, USA), the study’s lead author.

“The only drug we have available and is guideline recommended for symptoms is contraindicated in people with heart failure, has no benefits beyond improvement in symptoms and causes a lot of side effects, so overall it’s used in less than 10% of people and so we really have limited options to improve function in PAD.

“The [issue] is that as PAD progresses, patients go on to get revascularisation procedures to open arteries and become at high risk for adverse cardiovascular and limb events.”

GLP-1 agonists are a class of medication currently used to treat type 2 diabetes, obesity, kidney disease, cardiovascular disease including atherosclerotic vascular disease and heart failure.

In the trial, 792 people with type 2 diabetes and early-stage symptomatic PAD were enrolled at 112 medical centres in 20 countries. Participants were on average 67 years old, about 25% were women and 67% were white. All were randomly assigned to receive semaglutide (1mg) or placebo for one year (52 weeks).

Researchers assessed maximal walking distance—the maximum distance that patients were able to walk on a treadmill at 2 miles per hour at a 12% grade (similar to walking up a moderate hill). Function was assessed at baseline (median maximal walk distance was 186 metres), week 26, week 52 (primary endpoint) and week 57 (five weeks after stopping treatment).

“Despite the fact that people were recruited on the basis of reporting early-stage PAD, we observed that they were actually severely impaired and could only walk about one-tenth of a mile with symptom onset significantly earlier,” Bonaca said. “We saw that the drug clearly worked. There was a clear early benefit at six months that continued to increase at one year.”

Overall, patients in the semaglutide arm had a median improvement in walking distance of 26 metres and an average improvement of 40 metres, representing a statistically significant 13% improvement at one year.

“To put that into context, we usually think an increase in walking distance of 10 metres to 20 metres is clinically important in PAD, so this exceeded those expectations,” he said.

The results were further supported by confirmatory secondary endpoints showing significant improvements in quality of life (as measured by the Vascular Quality of Life Questionnaire-6 score), including pain-free walking distance and sustained improvement in maximal walking distance at five weeks after stopping therapy. Safety was similar to earlier trials, with non-serious gastrointestinal side effects the most reported side effect among patients taking semaglutide.

Patients’ ankle brachial index, a measure of blood flow in the legs, was significantly improved among those taking semaglutide compared with placebo. A post-hoc analysis looking at time to rescue treatment (the need for revascularisation due to worsening symptoms) or death was also lower. Within one-year of treatment, patients taking semaglutide had a 54% reduction in their risk of dying or needing a medication or procedure to open blocked arteries in their legs due to worsening symptoms compared with those receiving a placebo (14 patients vs. 30 patients).

“Taken together, the data support semaglutide for people with PAD and type 2 diabetes mellitus as a therapy that has cardiometabolic, cardiovascular and kidney benefits and improves function, symptoms and quality of life,” Bonaca said.

“There is more work to be done to understand the mechanism of benefit as the population had a median [body mass index] of 28.6 and the relationship between the outcome and weight loss was very weak. This coupled with the increase in ankle brachial index really suggests a direct vascular effect. This also raises the question of whether patients with PAD and without type 2 diabetes mellitus could benefit and that should be investigated in future studies.”

The study was limited in that it was only in patients who also had type 2 diabetes. In addition, approximately 14% of the study population was enrolled in North America, while 57% were enrolled in Europe and 29% in Asia. As a result, there were few Black patients.

This study was funded by Novo Nordisk.

SCVS 2025: Multicenter data show favorable role for FEVAR over chimney grafts

By
Bryan Kay
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0
SCVS 2025: Multicenter data show favorable role for FEVAR over chimney grafts
A type Ia endoleak following two-vessel (left and right renal arteries) ChEVAR

A multi-institutional analysis has demonstrated fenestrated endovascular aneurysm repair (FEVAR) could be a “safer and more durable option” than chimney EVAR (ChEVAR) in elective juxtarenal abdominal aortic aneurysm (AAA) cases with suitable anatomy, offering potentially “greater generalizability to real-world practice.”

Clayton Brinster

ChEVAR was associated with significantly higher rates of type I endoleak and reintervention than FEVAR in a study of juxtarenal AAA cases carried out at five geographically distinct institutions with high-volume centers, the 2025 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Austin, Texas (March 29–April 2), heard. In addition, FEVAR patients demonstrated significant sac regression, while those undergoing ChEVAR showed “a concerning trend” of early sac regression followed by late re-expansion.

The study data were delivered by Clayton Brinster, MD, an associate professor in the Section of Vascular Surgery and Endovascular Therapy at UChicago Medicine and the co-director in the institution’s Center for Aortic Diseases.

Each center enrolled at least 25 consecutive cases of FEVAR and/or ChEVAR, Brinster explained. Some 130 cases were analyzed in total: 77 FEVAR and 53 ChEVAR. Significantly more patients in the ChEVAR group had persistent type I endoleak at one year—15 of the 53 patients, or 28%— vs. 6/77, or 7.8%, following FEVAR. Ten reinterventions were required in 8 of 77 (10.4%) FEVAR patients vs. 20 reinterventions in 16 of 53 (30.2%) ChEVAR patients. Significant sac regression was seen at 12 months (55mm, -7mm) and 24 months (51mm, -11mm) following FEVAR, Brinster told SCVS 2025. Sac regression was not significant at 12 months (59mm, -5mm) following ChEVAR, and sac re-expansion was observed in this group between 12 and 24 months (59 to 63mm, +4mm), he added.

Speaking to Vascular Specialist ahead of the meeting, Brinster said the multi-institutional consortium behind the data was started four years ago and sought to elucidate granular institutional data on two widely used techniques.

“Although FEVAR and ChEVAR have both been around now for over a decade, there is a lack of granular institutional data,” he explained. “There have been maybe five or six solo institutional studies that incorporate some degree of parallel stenting versus FEVAR, but most include a comparison to open surgery or branched devices, or PMEGs [physician-modified endografts], so the data are not so clean. Besides that, it’s really just registry data with short-term follow-up.”

Brinster said the consortium’s strength is not only rooted in the fact it is regionally diverse, but it has also produced “granular institutional data.” The medical centers involved include the University of Chicago, Ochsner Health in New Orleans, NYU Langone Medical Center in New York City, the Mayo Clinic, in Scottsdale, Arizona, and the University of Rochester in Rochester, New York. “The data is therefore perhaps more generalizable to other institutions,” he continued. “It offers that advantage when compared to either national registry data or the U.S. Aortic Research Consortium, because those are very sophisticated surgeons at the very best centers with the very best imaging, with carefully selected patients in general.”

Brinster said that some may argue the fact there were more endoleaks and reinterventions with ChEVAR was “a foregone conclusion,” but noted that there are many surgeons in the field who are experienced with parallel grafting and produce good results. In effect, the study aimed to answer—“for once and for all”—which of the two techniques is better.

“With fenestrated grafting, there are anatomic constraints, and many patients fall outside the IFU [instructions for use],” he said. “ChEVAR has both the advantage of possibly being able to treat those patients and the disadvantage that inherently those patients are more anatomically complex and more prone, perhaps, to gutter leak, endoleak and reintervention.”

Looking into sac behavior, Brinster pointed out the “unexpected” finding of FEVAR inducing sac regression. In the early stage, he said, ChEVAR induced sac regression, “but when we looked out to two years, there was a statistically significant increase in sac size, and that is particularly concerning.”

“I wanted to look into this because it has become an increasingly hot topic in our field,” he added. “It has been linked to late rupture, late intervention and late mortality after EVAR. There are some data out there looking at those outcomes for standard EVAR, but they only go out to one year in those studies—and it is registry data. There are two industry-sponsored registries looking at sac behavior after EVAR at one, three and five years, and that was the basis whereby now Medtronic can firmly recommend endoanchors, or ESAR [endosuture aneurysm repair], in certain anatomic circumstances to improve late outcomes by inducing sac regression. The main pinnacle there was that even stable sac size over time was linked to late poor outcomes.”

Vascular Specialist–March 2025

By
Bryan Kay
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Vascular Specialist–March 2025

In this issue:

  • Multicenter data show favorable role for FEVAR over chimney grafts
  • SVS, medical organizations launch comprehensive Wound Care Curriculum
  • Guest editorial: Redefining ‘optimal medical therapy’ for vascular patients
  • The Outpatient: The pursuit of academic research in community practice
  • Obituary: Vascular community mourns loss of renowned investigator Janet Powell, MD

 

One-year WAVE trial results show patency advantage for Wrapsody versus PTA

By
Will Date
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0
One-year WAVE trial results show patency advantage for Wrapsody versus PTA

Wrapsody deviceMerit Medical Systems has announced that the six-month results from the randomized arm of the Wrapsody arteriovenous access efficacy—WAVE—trial are scheduled for publication in the April issue of Kidney International, ahead of the presentation of 12-month results from the trial at the Society of Interventional Radiology’s 50th annual scientific meeting (March 29–April 2) in Nashville, Tennessee.

The creation of an arteriovenous fistula (AVF) to achieve long-term access to blood vessels is required for patients undergoing hemodialysis. However, narrowing of blood vessels in and around the AVF can interfere with hemodialysis delivery, resulting in potentially life-threatening consequences. The Wrapsody cell-impermeable endoprosthesis (CIE) is designed to help clinicians restore vascular access in patients on hemodialysis who experience stenosis in their venous outflow circuit.

The WAVE trial is a multicenter, international, investigational device exemption (IDE) trial designed to evaluate the Wrapsody CIE’s safety and efficacy over two years. In the randomized arm of the trial, 245 patients on hemodialysis who experienced stenosis in the venous outflow of their AVF were treated with the Wrapsody CIE (n=122) or standard percutaneous transluminal angioplasty (PTA, n=123).

Treatment efficacy was defined as the proportion of patients who did not require an intervention due to clinically driven target lesion revascularization or target lesion thrombosis (target lesion primary patency). An additional efficacy endpoint was the proportion of patients without loss of vascular access anywhere within the circuit from the time of their initial treatment to the need for reintervention or abandonment of vascular access (access circuit primary patency).

Primary safety was defined as the proportion of patients with safety events that negatively affected the vascular access or venous outflow circuit, excluding target lesion revascularization or thrombosis, which resulted in reintervention, hospitalization, or death.

Initial results at six months demonstrated that the target lesion primary patency was significantly higher for the Wrapsody CIE vs. PTA (89.8% vs. 62.8%, p<0.0001). Similarly, the access circuit primary patency was significantly higher for the Wrapsody CIE vs. PTA (72.6% vs. 57.9%, p=0.015). No significant difference in the safety outcome was observed between treatments.

At 12 months, the Wrapsody CIE remained significantly higher than PTA for both target lesion primary patency (70.1% vs. 41.6%, p<0.0001) and access circuit primary patency (58.1% vs. 34.4%, p=0.0003).

“The Wrapsody CIE’s positive outcomes at one year address an important knowledge gap regarding the potential durability of the device,” said Dheeraj K. Rajan, MD, from the University of Toronto, Toronto, Canada, and WAVE trial investigator. “It is encouraging to know there is a new device available to help us prolong functional vascular access in our patients.”

The Wrapsody CIE received premarket approval (PMA) from the Food and Drug Administration (FDA) in December 2024. Merit began commercialization of the device in the U.S. in January 2025. The device previously received the CE mark for commercial use in the European Union (EU) and is available in Brazil.

Study details radiation exposure learning curve among vascular trainees 

By
Bryan Kay
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Study details radiation exposure learning curve among vascular trainees 

The importance of radiation safety training for vascular surgery trainees was highlighted by a recent study that detailed a learning curve effect between first- and second-year fellows performing fluoroscopically guided interventions. 

Using optically stimulated dosimeters fitted outside and under lead aprons, researchers at the University of Texas (UT) Southwestern in Dallas detected that median thyroid (82μGy vs. 44μGy; p=0.009) and sternal (89μGy vs. 54μGy; p=0.007) radiation dose was significantly higher for postgraduate year (PGY) 6 (first year) compared to PGY7 fellows.  

“When we analyzed regional doses, these were significantly higher for first-year fellows in comparison to second-year fellows,” explained presenting study author Antonio Solano, MD, a UT Southwestern postdoctoral research fellow. “There was a higher DAP [dose area product] for second-year fellows, higher thyroid and sternum doses for the first-year fellows, and the procedure scatter fractions were also higher for the first-year fellows.” 

The data were presented during the 2025 Southern Association for Vascular Surgery (SAVS) annual meeting held in St. Thomas, the U.S. Virgin Islands (Jan. 22–25). 

Solano set the scene by pointing to the existence of better radiation safety training and awareness of best clinical practices for fellows in other interventional specialties. While there is variation in radiation safety training institution-to-institution, he said, vascular surgery trainees tend to learn techniques on the job, “which can result in higher radiation exposure.” 

The researchers analyzed radiation exposure for patients, vascular surgeons and trainees during fluoroscopic interventions according to level of training in a prospective cohort study over a five-month period. Operator radiation dose was calculated based on a calibration coefficient factor to estimate radiation at 80kVp. Procedural reference air kerma (RAK), fluoroscopy time, DAP and patient body mass index (BMI) were recorded. Scatter fractions were measured with thyroid and sternum counts to DAP ratio and DAP/RAK ratio. Paired Wilcoxon and chi-square tests were performed to identify statistical significance of training stage on radiation dose exposure and radiation reduction performance. 

“When we analyzed the outcomes for attending surgeon dose, we saw that there were no statistical differences between when they were either operating with the first-year fellow versus the second-year fellows,” Solano said. 

He acknowledged limitations, including that the study involved just one vascular surgeon at a single site. “We did not control for the amount of time that the fellow performed as the primary operator during the procedure, and we did not include vascular surgery integrated residents.”  

Imperative Care expands Symphony thrombectomy portfolio with new FDA approval

By
Jocelyn Hudson
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Imperative Care expands Symphony thrombectomy portfolio with new FDA approval
Symphony
Symphony

Imperative Care today announced Food and Drug Administration (FDA) 510(k) clearance of the 82cm version of its Symphony 16F catheter, the company’s latest innovation designed to elevate care for patients with venous thrombosis.

The company also announced the successful completion of initial patient cases using the catheter. Several of these were completed by Bennet George, MD, an interventional cardiologist at Vital Heart & Vein in Houston, Texas.

“In my early experience, I’ve been able to consistently achieve 97% clot removal in, on average, two passes, with minimal blood loss (<120ml) in less than ten minutes. With a large-bore catheter and powerful deep vacuum, Symphony allows me to effectively treat highly challenging clot morphologies in minutes and in a blood-efficient way, ensuring the best possible outcomes for my patients,” said George. “The customized length of the 16Fr 82cm catheter gives me an additional capability to address both acute and organized clot in my venous procedures, and I look forward to its continued impact on the patients we treat.”

This latest innovation expands the Symphony thrombectomy system offering to include 16F 82cm, 16F 117cm and 24F 85cm catheters.

Imperative Care details that Symphony has an integrated controller that delivers nearly three times the clot removal force compared to legacy aspiration systems. Additionally, the system includes the ProHelix Mechanical Assist, a tool designed to facilitate clot ingestion, along with the Imperative Care Generator, an aspiration pump.

Download SVS Highway to Health member toolkits

By
Marlén Gomez
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Download SVS Highway to Health member toolkits

The Society for Vascular Surgery (SVS) has developed a comprehensive member toolkit to equip healthcare professionals, particularly vascular surgeons, with essential resources through its “Highway to Health: Fast Track Your Vessel Health” campaign.

With millions of Americans at risk for developing vascular conditions, awareness about these potentially life-threatening issues remains alarmingly low. The Highway to Health campaign seeks to address this gap by encouraging individuals to engage in timely evaluations and treatments.

The Member Toolkit includes materials such as a fact sheet, frequently asked questions, a template press release, social media content and newsletter/web copy for individual use. The toolkit features training tips, a C-suite letter and a graphics/media library, all designed for use across personal social media channels and at both internal and external speaking engagements.

The SVS emphasizes the importance of proactive health discussions, urging individuals to talk to their healthcare providers about potential vascular issues and to consider referrals to vascular surgeons. The success of the “Highway to Health” initiative depends significantly on the engagement and advocacy of medical professionals who recognize the vital importance of vascular health.

For more information and to access the toolkit, visit vascular.org/H2Hresources.

SVS webinar to explore AI innovations

By
Marlén Gomez
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SVS webinar to explore AI innovations

The Society for Vascular Surgery (SVS) will host a webinar titled “Harnessing AI in Vascular Surgery: Leading the Next Frontier” on March 27 from 6 to 7:30 p.m. Central Time. This event aims to heighten awareness of artificial intelligence (AI) within the vascular surgery community, presenting the latest advancements in AI technologies and encouraging healthcare professionals to engage in the evolving landscape of AI-driven research and practice.

The webinar seeks to enhance participants’ knowledge and expertise, ultimately fostering innovation in patient care and research. Attendees can anticipate in-depth discussions on several critical topics, including emerging AI-powered technologies and research developments specific to vascular surgery, key terminology related to AI-based medical research, the challenges faced in implementing AI projects and practical strategies to overcome these barriers. Additionally, the session will provide valuable insights into the regulatory landscape and ethical considerations surrounding using AI tools in medical practice and research.

Moderated by Shivprasad Nikam, MD, a vascular surgeon at Geisinger Wyoming Valley Medical Center in Pennsylvania, the webinar will feature a distinguished panel of speakers, including Andrew A. Gonzalez, MD, Uwe Fischer, MD, Sharon C. Kiang, MD, William J. Yoon, MD, and Paula K. Shireman, MD.

This event presents a unique opportunity for practitioners to join the conversation and help shape the future of AI in vascular surgery. To register, visit vascular.org/AIWebinar.

EVC 2025: Multidisciplinary, multi-stakeholder efforts key to setting venous disease research priorities

By
Jocelyn Hudson
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EVC 2025: Multidisciplinary, multi-stakeholder efforts key to setting venous disease research priorities
Ulka Sachdev-Ost

Addressing the audience at the 28th European Vascular Course (EVC 2025) in Maastricht, The Netherlands (March 9–11), Ulka Sachdev-Ost, MD, from the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania, set out a method to ensure limited funding is directed to the most pressing venous disease research needs.

“As everybody here in this room knows,” Sachdev-Ost began, “funding for research from a federal level—at least in the U.S. and I’m sure it’s similar in other countries—is actually pretty poor given the impact of venous disease for our patients and for the global population.”

Providing a more specific example, Sachdev-Ost homed in on chronic venous disease, which, the presenter shared, “affects quality of life for millions and millions of patients globally.” She also noted that the disease tends to be progressive and is associated with disability, depression, and immobility. “These are things that may not be life- or limb-threatening but certainly can affect how people are living their daily lives,” the presenter highlighted.

Sachdev-Ost also underlined a considerable financial burden associated with managing chronic venous disease, which is estimated to cost the US healthcare system $15 billion per year in some analyses.

Despite these considerable patient and monetary costs, Sachdev-Ost pointed out that there is very limited research focused on chronic venous disease. Citing a PubMed search, the presenter noted that the term ‘chronic venous disease’ yields around 24,000 hits compared to 211,000 for “coronary artery disease” and over three million for “cardiovascular disease.”

Against this backdrop, the presenter laid out her argument that venous specialists must “focus on identifying high-yield topics that would benefit from dedicated research dollars”. To do this, she proposed, venous research topics must be prioritized.

Sachdev-Ost highlighted the importance of multidisciplinary, multi-stakeholder projects to define research priorities, referring to the UK-based James Lind Alliance (JLA) as an example of such an initiative. “A big part of [the JLA] is to include patients,” she said. “You must include stakeholders if you’re going to come up with the appropriate research priorities.”

The presenter also detailed a recent multidisciplinary, research priority-setting effort she was involved in with the American Venous Forum (AVF).

Sachdev-Ost shared that she was chair of the AVF research committee in 2024–2025 and was tasked with materializing an idea from the former chair to come up with research priorities in the management of C2 disease, which she presented at the recent AVF annual meeting (Feb. 16–19) in Atlanta, Georgia.

The aim was to approach research priorities in a “transparent” way, Sachdev-Ost told the EVC audience. “We hypothesized that an open forum of brief presentations, open panel discussions and ranking surveys would identify scientific priorities in C2 disease and provide a foundation to design future research efforts,” she said.

The presenter explained that the forum comprised a 10-person multidisciplinary team from specialties including vascular surgery, interventional radiology, vascular medicine, and phlebology.

“We had a really, really good discussion,” Sachdev-Ost recalled, with topics—determined based on multiple discussions with the group—focusing on varicose vein management. “We ranked before and after the talk and found that really the etiology of varicose veins and equity were some of our big components.”

Concluding, Sachdev-Ost shared that the next step would be to include patients in the discussion to ensure that all stakeholders are involved in setting research priorities related to venous disease.

A question from Stephen Black, MD, from Guy’s and St Thomas’ NHS Foundation Trust and King’s College London in London, England, during discussion time highlighted further the importance of Sachdev-Ost’s point regarding patient involvement in setting research priorities.

“In the broader context of prioritizing venous disease against all the other disease states that we fight with,” Black began, “the challenge we face is that the impact of death and limb loss for aortic and arterial disease seems to always outweigh the significant quality-of-life destruction that venous patients have, and it becomes hard to challenge that. How do you go about doing that from a point of view of increasing the potential long-term impact of venous disease versus the other priorities?”

Sachdev-Ost responded: “I think that’s an area in which pulling in maybe more of the patient-centered perspective can be very helpful. For many years, peripheral arterial disease and the impact on the muscle was not really given a lot of attention but now a lot more interest I think is there in how much peripheral arterial disease can decrease mobility and create a whole other host of downstream problems that have enormous impacts on spending dollars etc. for the healthcare system. So, I think similar types of things can be done with venous disease and pulling in different stakeholders can really help define those metrics.”

VOYAGE scholarship program for young vascular surgeons

By
Marlén Gomez
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0
VOYAGE scholarship program for young vascular surgeons

Th e Society for Vascular Surgery (SVS) Foundation, in partnership with the SVS Young Surgeons Section, has launched the VOYAGE Scholarship Program. This initiative will provide $1,000 scholarships to assist early-career vascular surgeons during their formative years in the profession.

The recipients can use the funds to continue medical education courses, professional development events, and other relevant educational pursuits that will help them build their professional networks and connect with the vascular surgery community.

Applications are due by Tuesday, April 1. Eligible courses for funding include a range of educational events, such as the Vascular Research Initiatives Conference (VRIC), the Vascular Annual Meeting (VAM) and the SVS’ Complex Peripheral Vascular Intervention Skills Course, which is set to take place in Rosemont, Illinois (Sept. 20–21).

To qualify, applicants must be active members of the SVS Young Surgeons Section. Vascular trainees, residents and medical students are not eligible to apply. Each applicant is eligible to receive one VOYAGE Scholarship per calendar year.

Learn more about the scholarship program at vascular.org/VOYAGE.

Novel thrombectomy system for VTE used successfully in first tranche of first-in-human cases

By
Bryan Kay
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0
Novel thrombectomy system for VTE used successfully in first tranche of first-in-human cases
SonoThrombectomy catheter

SonoVascular has announced the successful completion of an initial set of eight deep vein thrombosis (DVT) cases using its SonoThrombectomy system as part of a first-in-human (FIH) study of the device.

All cases achieved a complete Marder score reduction as assessed by an independent core laboratory, while significant improvements from baseline in Villalta score, revised Venous Clinical Severity Score (rVCSS) and Numeric Pain Rating Scale scores were observed at 30-day follow-up, the company reported. There were no device-related adverse events, major bleeding, or deaths.

The data were recently shared during the 2025 American Venous Forum (AVF) in Atlanta, Georgia (Feb. 16–19) by William Marston, MD, professor of surgery at the University of North Carolina at Chapel Hill School of Medicine.

“The results obtained thus far in SonoVascular’s FIH study demonstrate the SonoThrombectomy system has the potential to become a disruptive technology that would effectively overcome the shortcomings of available therapies for the treatment of DVT,” he said.

“In the initial cases, the SonoThrombectomy system has demonstrated its ability to eliminate intravenous clot in a single treatment session with no blood loss and with preservation of venous valves. The system is not limited by the presence of previously implanted filters or stents and is highly steerable for treatment of specific areas of residual thrombus.”

The SonoThrombectomy system—designed for the treatment of venous thromboembolism (VTE)—delivers ultrasound energy and microbubbles directly to clots through the Resonator catheter, inducing microbubble-mediated cavitation, which mechanically breaks down clots, according to SonoVascular. Additionally, a very low dose of tissue plasminogen activator (tPA) is infused in combination with the microbubbles through the catheter to further improve clot breakdown.

Insights from the GREAT registry: ‘We have achieved freedom from aortic-related mortality in just over 95% of patients’

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Insights from the GREAT registry: ‘We have achieved freedom from aortic-related mortality in just over 95% of patients’

Dennis Gable, MD, from The Heart Hospital Baylor Plano in Plano, Texas, discusses the unique imprint of the five-year follow-up from the GREAT registry and analyses the results in patients with aortic dissection.

“We have just over 97% of patients that achieved some form of follow-up during the five-year window,” says Gable particularly emphasizing the outcome of freedom from aortic-related mortality.

“We see that we have achieved freedom from aortic-related mortality in just over 95% of patients. We see that there is an all-cause mortality of just over 70%, which is certainly in line with all of the published data. But what that’s showing is that these patients are succumbing to issues unrelated to their aorta, but related, more than likely, to various other issues,” he adds.

This registry has collected real-world data from patients treated not only in high-volume, big academic centers, but also those treated by physicians with good experience with the device that may not have the same volume, explains Gable,

Lowering the bar for treatment with a stent-graft

Gable points out that “this [data] may lower the bar a little bit to allow us to treat some more patients [with aortic dissection], to give them a little bit more peace of mind.” Patients typically see good remodelling of the aorta, resolution of any pain they were having, and get back to a relatively normal state of life, knowing that they’ve been treated and the people that get this treated actually have good outcomes,” he concludes.

This video was sponsored by W.L. Gore  & Associates.

‘How to thrive, not just survive, as a vascular surgeon’

By
Bryan Kay
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0
‘How to thrive, not just survive, as a vascular surgeon’
Misty Humphries

Outgoing Vascular & Endovascular Surgery Society (VESS) President Misty Humphries, MD, used her presidential address to outline how trainees and young vascular surgeons can “thrive and not just survive as a vascular surgeon.”

The University of California, Davis interim chief of vascular surgery provided five lessons she has learned to help enable her success during the VESS Annual Winter Meeting in Breckenridge, Colorado (Feb. 6–9).

Working in reverse order, she opened with a call to “maintain connection beyond your immediate circle.” Humphries said: “Not everyone you meet will stay with you for the entire length of your journey, and that’s OK, because those people were only meant to be there for that moment. But the people who matter—they will be there at the finish line.”

Next, she urged those gathered to “celebrate and remember the good things.” Vascular surgeons are notoriously superstitious, Humphries said, but urged, “Find a way to keep track of the wins.”

Also, she said, “let go of the emotions that are not serving you.” Vascular surgeons tend to hold themselves to impossible standards, she noted, “constantly replaying the things we should have done differently, but perfectionism is an illusion, and it doesn’t make you better—a lot of times it will just make you feel worse.”

“Surrender to the hard, let go of the idea of balance,” Humphries continued. Vascular surgery has some of the highest stakes in all of medicine, she said. Paralysis after an aneurysm repair, stroke after a carotid repair, a failed bypass leading to limb loss. Invoking the world of sports, she said, “The great masters recognize the difficulty, and they repeatedly run back into the fire. It’s part of their job—it’s part of our job, part of our lives.” If greatness is the goal, Humphries added, “then there will be no balance.”

Finally, she said, “the best way to thrive as a vascular surgeon is to stand up, even if you are the only one in the room standing.” Vascular surgery is difficult,” Humphries said. “Not everyone understands it, quite honestly, and I think we have to give a little bit of grace there sometimes.”

Meanwhile, at the close of the meeting, Ravi Ranjani, MD, a professor of surgery at Emory University School of Medicine in Atlanta, took over as VESS president.

SVS Foundation celebrates Women’s History Month

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Marlén Gomez
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SVS Foundation celebrates Women’s History Month

The SVS Foundation has various initiatives in place to celebrate Women’s History Month, including member profiles and patient-focused facts. New this year is fundraising for the launch of a new Vascular Care for the Underserved (VC4U) award, focused on women’s vascular health research.

For the first time, the Foundation and the SVS Women’s Section will collaborate to raise $30,000, from March 1–31, in order to fund the VC4U project grants.

“The VC4U project grants aim to address significant disparities in vascular surgery care across the U.S., and the funds raised for the grant will support projects that advance women’s health,” said Audra Duncan, MD, chair of the SVS Women’s Section Steering Committee.

A $20,000 grant will be awarded to an SVS or Society for Vascular Nursing (SVN) member for an innovative, community-based initiative that addresses the challenges faced by underserved populations affected by peripheral artery disease (PAD), emphasizing improving diagnosis, treatment and patient education.

Applications for the award closed on March 3. To learn more, visit give.vascular.org/WHM25.

SVS issues call for members to serve on committees

By
Kristin Spencer
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SVS issues call for members to serve on committees
Keith Calligaro

The Society for Vascular Surgery (SVS) has opened its 2025 call for volunteers to serve on committees. In the member announcement that went out via email on Feb. 25, Keith Calligaro, MD, chair of the SVS Appointments Committee, said that committee members lie at the heart of the SVS, and that serving on a committee allows members to contribute to the vision and strategic priorities of the organization.

Members can apply to serve on no more than two committees. While they will be required to disclose any conflicts of commitment, relationships with industry is not a disqualifier.

Any member is eligible to apply to serve on committee by the March 25 deadline. Application submission does not guarantee acceptance as each year, there are more applicants than there are open positions. Those who have applied in the past and have not been selected to serve are invited and encouraged to submit their application again this year.

Anyone interested in serving on a committee should visit vascular.org/CommitteeVolunteers to fill out a brief application. Questions can be directed to governance@vascularsociety.org.

Vascular surgery trainee autonomy driven by well-being, study finds

By
Bryan Kay
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Vascular surgery trainee autonomy driven by well-being, study finds
Margaret Reilly

A new cross-sectional analysis as part of the SECOND trial found that most vascular surgery trainees are satisfied with their operative and clinical autonomy but that those who are not had increased odds of professional dissatisfaction, personal life dissatisfaction, burnout, thoughts of attrition and suicidal ideation.

The findings were presented during the 2025 Southern Association for Vascular Surgery (SAVS) annual meeting held in St. Thomas, the U.S. Virgin Islands (Jan. 22–25), by Margaret Reilly, MD, a vascular surgery resident at Northwestern Medicine in Chicago.

The research team sought to address concerns around the graduated autonomy of trainees as training paradigms shift and increasing comorbidities among vascular disease patients. They analyzed trainee perceptions of autonomy and evaluated associations with wellness metrics in a voluntary survey performed after participants took the Vascular Surgery In-Training Exam (VSITE) from 2020–2024.

Autonomy was evaluated around whether trainees have appropriate amounts of time in the operating room and participation in clinical decision making, as well as level of operative autonomy. The survey involved the Likert rating scale, dichotomizing between “disagree” and “agree.”

In assessing learning environment domains, the analysis looked at efficiency and resources, organizational control, mistreatment and faculty engagement.

The primary outcome measure was burnout, with secondary measures including suicidal ideation, thoughts of attrition, professional satisfaction and personal satisfaction.

The analysis did not find any differences in satisfaction of autonomy based on postgraduate year, Reilly reported, “and this was also the case when we grouped trainees based on seniority.”

She continued, “We did find significant differences in gender, where male trainees were more likely to be satisfied with their autonomy as compared to female trainees. And this was also true when comparing community and academic programs, where trainees at community programs were more likely to be satisfied with their autonomy as well.”

Bivariable analysis of learning environment factors and their associations with satisfaction with autonomy revealed significant differences for all learning environment factors, Reilly told SAVS 2025. Among them, the results showed that trainees who felt that their educational time was protected, who felt belonging and cooperation among trainees and support staff, and who felt they had adequate and appropriate attending mentorship were all more likely to be satisfied with their autonomy.

Multivariable logistic regression of predictors of training autonomy showed that satisfaction with faculty engagement was associated with 4.8 times more odds of being satisfied with the level of autonomy, while being satisfied with efficiency and resources in a training program was associated with 10 times more odds of being satisfied.

“We then evaluated wellness metrics and their associations with satisfaction with autonomy,” Reilly said. “We found that trainees who were satisfied with their autonomy were less likely to report suicidal ideation, less likely to report thoughts of attrition, and also less likely to have weekly symptoms of burnout.

“When looking at work-life integration factors, we found that trainees who were satisfied with their autonomy were more likely to be happy with their decision to pursue vascular surgery and with their personal life, and also more likely to be satisfied with their ability to perform personal health maintenance tasks.”

Future analysis of surgical milestones and Entrustable Professional Activities (EPAs) “will ultimately help to contextualize the possible interventions that will help improve trainee perception of autonomy,” Reilly concluded.

Insights from the GREAT registry: ‘We had a follow-up of over 95% for all patients’

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Insights from the GREAT registry: ‘We had a follow-up of over 95% for all patients’

Dennis Gable, MD, from The Heart Hospital Baylor Plano in Plano, Texas, principal investigator for the thoracic component of the GREAT registry, explains that this is a real-world evaluation of use of WL Gore’s aortic products in the abdomen and in the thoracic aorta. The multicenter dataset drew from 113 centers, over 14 countries and four continents.

Speaking on the subset of 578 patients, who were “all comers” that have thoracic pathology, including aneurysmal disease, dissection, intramural hematoma or aortic penetrating ulcer, Gable said: “We had a follow-up of over 95% in general for all patients. This is now providing the long-term follow-up that we did not have before.”

Further key highlights from the dataset were findings such as the overall rate of freedom from aortic-related mortality of just under 95% and an all-cause mortality of just over 66%. Gable noted: “Fortunately [these patients] are not succumbing to issues related to their aorta after they’ve been treated with these devices.”

Analysis of the data on complications further showed very low rates of reintervention, spinal cord ischemia and low rates of stroke. All this, despite the fact that nearly 44% of all patients were treated off-label, emphasized Gable.

This video was sponsored by W.L. Gore & Associates.

Obituary: Janet Powell

By
Jocelyn Hudson
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Obituary: Janet Powell

Janet Powell, the clinical trial investigator who played a pivotal role in several landmark abdominal aortic aneurysm (AAA) studies, has died at the age of 79. At the time of her death, Powell was professor of vascular biology and medicine at Imperial College London (London, UK). 

Powell was born in Oxford on 1 August 1945. After obtaining a BSc in chemistry from the University of Oxford (1968) and a PhD in biophysics in London (1972), Powell moved to the USA to study medicine at the University of Miami School of Medicine, graduating in 1981. She then returned to the UK to complete clinical training in pathology, specializing in cardiovascular risk.  

Initially interested in the pathophysiology of elastic tissues, Powell told Vascular News in a 2015 profile interview that her research interests turned to the aorta specifically through her work with Roger Greenhalgh, with whom she collaborated over many decades.  

As part of the Imperial College Vascular Surgery Research Group, Powell was involved in numerous clinical trials in AAA management, including the UK Small Aneurysm Trial, EVAR-1, EVAR-2 and IMPROVE. 

When asked in her 2015 Vascular News profile interview which piece of research she was most proud of, Powell highlighted a central focus of her work: the patient. “Anything that improves outcomes for patients,” she responded, “including all the randomized trials of abdominal aortic aneurysm management, as well as an early piece of pathology research which showed the importance of inflammation in the developing aneurysm… a theme still being investigated by vascular biologists and evaluated in randomized trials.” 

Powell was the chief investigator of the IMPROVE randomized controlled trial, which compared open repair with an endovascular strategy for ruptured AAA. Initial trial results were published in the British Medical Journal (BMJ) in 2014, with one-year results presented at the 2015 Charing Cross (CX) Symposium and published in the European Heart Journal the same year. “We think that the results of this trial support the increasing use of endovascular repair and that it should always be available, so there’s equity of access to care for patients,” she told Vascular News in an interview on the one-year results. 

Powell was actively involved in vascular disease research until her passing. Alongside Imperial College London colleagues Colin Bicknell and Anna Pouncey, she was co-chief investigator of the ongoing WARRIORS trial—her last research project—which aims to examine early endovascular aneurysm repair (EVAR) in women. 

“The disadvantage of women with AAA can no longer be ignored, and we hope that you will support us, in what will hopefully be a major step towards readdressing the imbalance in AAA outcomes for women and men,” she urged Vascular News readers in an interview on the trial in 2022.  

Powell has been recognized by several societies for her contributions to the vascular field. In 2012, she received a Lifetime Achievement Award from the Vascular Society of Great Britain and Ireland (VSGBI), while the European Society for Vascular Surgery (ESVS) hosts a named lecture at its annual meeting to honor Powell’s advocacy of evidence-based medicine. 

Powell is survived by her son Duncan (46) and daughter Tamsin (48), as well as five grandchildren.

Colleagues have shared with Vascular News their memories of working and collaborating with Powell, as well as considered her legacy as a renowned clinical trial investigator.

Colin Bicknell, professor of vascular surgery at Imperial College London, said: “I think it is true to say that we are all in shock at the sudden announcement of Janet’s passing. Janet delivered numerous trials over the years and has unquestionably changed the way that every vascular surgeon in the world practices daily. Not many can claim that accolade.

“She has been a mentor to me and countless others, a role that she took so very seriously, building a cohort of researchers for the future. I and everyone will miss her every day, but I hope we can make her proud in delivering vascular trials in the future to practise evidence-based medicine in the way she taught us.” 

Anna Pouncey, NIHR clinical lecturer in vascular surgery at St George’s, University of London (London, UK), remarked: “I could write for pages about the achievements of Janet Powell. No doubt others will do so, but she didn’t care for recognition. Rather, I will describe her as she was. 

“The sight of Janet’s diminutive frame walking up to the microphone could send a grown vascular surgeon quaking in their boots, for they knew that, with a tilt of her bowed head and a characteristic stare, she would deliver a single line that cut through all their pomp and glamour—a line that went straight to the heart of the matter. Over the years, time and time again, she held the vascular community to account, reminding us all of what really mattered—not egos or career profiles, but rather scientific rigor, integrity, and, most of all, the patient. 

“When Janet moved, she moved quietly. Like pebbles dropped into a pond, the ripples of her actions were often only noticed much later. Now, as we look back, we realize that she helped shape vast swathes of our discipline. She was kind and loyal to those she cared for, rescuing and defending many a vascular surgeon in times of need. By doing so, she built not only a wealth of scientific evidence but also a living legacy within the vascular community. 

“I suppose some might say I came to know Janet in her ‘twilight years’. But in working with her on her last project, the WARRIORS trial, she burned brighter than ever. Inspired and enthusiastic, she led by example, working so relentlessly that it was difficult to keep up! Through WARRIORS, she hoped to bring greater equity to the treatment of women and to build a model of international collaboration for the vascular world to follow. She was tremendously excited for what was to come, and I hope those she inspired will see it brought to life. RIP JTP.” 

Ian Loftus, consultant and professor in vascular and endovascular surgery at St George’s University Hospitals NHS Foundation Trust (London, UK), immediate past president of the ESVS and Vascular News editorial board member, commented: “Professor Janet Powell was unsurpassed in her achievements, to promote evidence-based vascular practice. Her work has changed the way we work, through numerous ‘landmark’ clinical trials, but also a rigorous interpretation of scientific and clinical research, contributions to a number of ESVS Clinical Guidelines, and other international collaborations. She was chair of the ESVS Board of Directors for many years, and her contributions to the Society and its Journal, were immense. It is right that these will be honored formally at the forthcoming annual meeting in Istanbul in September.

“One of her great contributions was to ask the questions of research that others sometimes feared to ask. More often however, others just didn’t think of these questions. She always saw others’ work through a different and often probing eye, but always with an inquisitive perspective.

“Vascular surgeons have always loved a good debate, with some especially legendary duels taking place at the CX symposia over the years. These debates deliberately take the ‘one therapy is better than the other’ mantra, to challenge the evidence and the audience to decide. But of course, the real world is very different to this mantra. On a shared journey back from the Milan meeting last December, where her contributions were as sharp as ever, I asked her if she ever found this frustrating. With the usual glint in her eye and wry smile, she said ‘better to debate, than not debate at all!’

And of course, she was a master at debating along with all aspects of her professional life, because no one knew the literature as well as she did. But for someone who spent her life in full time research, she never forgot that the patient should be at the heart of everything we do. That should, and I am sure will be, her legacy.”

Pinar Ulug, a clinical trial manager at Imperial College London who worked with Powell for 15 years, told Vascular News: “A superb scientist and outstanding researcher, Professor Powell was extremely dedicated to improving outcomes for patients through collaborative research and high-quality randomized clinical trials. She was integral to landmark UK trials on the management of abdominal aortic aneurysms and made unparalleled contributions to vascular surgery with lasting impact not only in the UK, but throughout the world. Janet was committed to creating consensus and she never shied away from speaking out about difficult or unpopular issues. Her intellectual rigor, dedication to scientific excellence, and ability to foresee and resolve complex challenges in the trials she led set her apart as a brilliant leader and hugely inspirational mentor.

“She leaves behind a lasting legacy, both professionally and personally, and her influence on surgical practice is immeasurable. Janet’s passing is a tremendous loss to the vascular surgery community, but her remarkable career and extraordinary contributions will continue to inspire for years to come. She will be deeply missed by all of us who had the privilege of working with her.”

Frank Veith, chair of the VEITHsymposium and professor of surgery at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University (Cleveland, USA) and New York University Medical Center (New York, USA), said: “Janet was a superstar scientist and researcher and a good friend. She was a superb critical thinker with an uncanny knack to be correct on most issues. She was a major star contributor to our annual VEITHsymposium for decades. Janet was a genuinely good person and a great doctor/scientist who will be sorely missed on both sides of the Atlantic.”

Alun Davies, professor of vascular surgery at Imperial College London, shared: “Janet was a delightful colleague with an international reputation, with whom I had worked for 30 years. She was adored by all her colleagues and students. She also had a unique long-term research collaboration with Roger Greenhalgh. Janet will be sadly missed.”

Photos courtesy of Janet Powell’s son, Duncan.

Grappling with the healthcare vision of a new administration

By
Dylan Lopez
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Grappling with the healthcare vision of a new administration

As the new administration headed up by President Donald Trump gets underway, work has begun on his vision for a fundamental transformation of the federal government, including some aspects of the healthcare delivery system.

While the specialty will continue to engage in specific policy debates in the coming months and years, it is important to think about them in the context of this administration’s broader plans for the healthcare system.

Here are a few trends to watch when it comes to the healthcare players and policy goals of this new administration in Washington D.C.

First and foremost, the specialty should be focused on changes at the Centers for Medicare and Medicaid Services (CMS). At the time of going to press, the Senate appeared likely to confirm Dr. Mehmet Oz as the administrator of CMS.

During his campaign for Senate in 2022, Oz championed Medicare Advantage and has spent time since then promoting the plan and recommending it to his social media followers.

Given this historical perspective and the Trump administration’s desire to run the government more in the guise of a business, it is likely that Oz will seek policies that allow CMS to operate more like a profit-seeking business rather than a service.

Additional spending reduction targets in this administration’s agenda come from other agencies within the Department of Health and Human Services (HHS), namely the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).

Any reductions in these areas, especially as they relate to research, could have drastic impacts across the healthcare community. The Society for Vascular Surgery (SVS) is monitoring these developments closely and engaging with other health-related organizations to ensure a collaborative approach for interfacing with administration officials.

This maximalist strategy of taking a sledgehammer to agencies’ spending raises the topic of Elon Musk and his so-called Department of Government Efficiency (DOGE).

Musk’s quasi-governmental department is attempting to usurp Congress’s power of the purse and adds an additional layer of complexity in the realm of budget negotiations, especially for the remainder of this year.

We anticipate a high level of continued judicial review for additional forthcoming executive orders, as well as DOGE-related activities.

While these unprecedented actions can be dispiriting for us as advocates in the vascular health space, it is important to take on policy fights one at a time and tailor our methods to reflect this new normal.

Some battles will require us to reach out to Congress; some will require us to build public support to pressure the executive branch; and some will require us to do both. This nimble, multi-pronged approach will increase our chances of success on issues that matter to you and your patients.

The SVS is ready to empower our doctors on all of these fronts. We will continue to work with you and advocate in Congress on issues such as Medicare reimbursement, while also working with you on the public affairs side to build support for our practice in the realm of debates around issues like public health spending.

Dylan Lopez is the SVS advocacy and public affairs manager.

Corner Stitch: Becoming a community-engaged vascular surgeon

By
Lindsey Olivere
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Corner Stitch: Becoming a community-engaged vascular surgeon
Lindsey Olivere

At the end of my intern year, I was tired. It had been a long year of rounding, placing orders, seeing consults and refining basic suturing skills on primarily general surgery rotations—an experience not dissimilar from many of my fellow integrated trainees. I was looking forward to attending the 2022 Vascular Annual Meeting (VAM), not only as a reprieve from intern responsibilities, but also as a mental reset and reminder of why I chose to become a vascular surgeon. I stuck around until the end of the meeting for one of the final Saturday sessions, which I had been eagerly anticipating: “Improving Vascular Care in Underserved Communities.” In this small conference room, I heard about truly amazing community engagement and outreach projects in Oklahoma, Sacramento, Houston, San Antonio and Morgantown (among others). I was incredibly inspired by the passion and perseverance of the men and women who shared their successes and failures, in building these programs and initiatives, primarily with the goal of improving limb salvage in the highest-risk communities.

It was the first time I had ever considered what it truly meant to be a community-engaged vascular surgeon. I had spent four years learning about healthcare disparities as a medical student, another year experiencing them as a bright-eyed intern, and I was preparing for a lifetime of justifying to family and medical colleagues why I chose a field where I was seemingly fighting a losing battle against amputations. It was beyond exciting to know that mentors in the field were also ready to do something to challenge and change the status quo.

In the years since I was so impacted as an audience member, I have continued to follow the progress of the growing number of programs and outreach initiatives aimed at improving awareness of vascular disease and promoting limb salvage. It continues to inspire me that we, as surgeons, can become leaders, not only in the operating room, but also in the community and in guiding multidisciplinary teams to make a real difference in patient care.

A growing number of publications and general publicity and financial support from the SVS, and organizations like the Foundation to Advance Vascular Cures and the American Limb Preservation Society, continue to promote patient-engagement programming aimed at limb salvage.1,2 The community engagement sessions were well incorporated into last year’s VAM. There is consistent buzz about efforts like community diabetic foot screenings, outreach to patients experiencing homelessness,3,4 rural cardiovascular education initiatives5—the list, excitingly, goes on. Even the front page of the November issue of Vascular Specialist touted the novel “Days of Service” at the most recent American Venous Forum and Eastern Vascular Society meetings—a testament to the ever-growing visibility and recognition of building this cadre of community-engaged vascular surgeons.

I am proud that I am now using my academic time to do what I can to learn the necessary skills to engage with my local Pittsburgh community and join forces with existing programming to build awareness of PAD and diabetic foot care. I am collaborating with a multidisciplinary team to improve amputation care at my institution. I am lucky to have mentors who paved the way in establishing programming to provide foot exams and cardiovascular disease education to patients experiencing homelessness that I am now excited to continue and expand.

There are, without a doubt, a growing number of patients with diabetes and advanced cardiovascular disease manifestations like chronic limb-threatening ischemia (CLTI). Despite improved therapies and novel interventions, the incidence of amputations remains high, particularly in the most socioeconomically disadvantaged communities.6 While this admittedly feels particularly daunting, especially as many of my fellow trainees and I are on the precipice of our careers, it is not the time to be tired. I am so thankful for all those that have paved the way in establishing a precedence for community engagement and continue to bring awareness to the role vascular surgeons can play in outreach and beyond.2

References

  1. Minc SD, Powell C, Drudi LM, et al. Community-engaged research in vascular surgery: An approach to decrease amputation disparities and effect population-level change. Seminars in Vascular Surgery. 2023/03/01/ 2023;36(1):100-113. doi:https://doi. org/10.1053/j.semvascsurg.2022.12.001
  2. Kempe K. Vascular surgeons are positioned to fight healthcare disparities. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2024;12(1) doi:10.1016/j.jvsv.2023.08.013
  3. Boelitz KM, Lee J, Pepin MD, et al. Utilizing Multidisciplinary Mobile Outreach Clinics To Provide Comprehensive Diabetic Foot Care To Patients Experiencing Homelessness. JVS-Vascular Insights: An Open Access Publication from the Society for Vascular Surgery. doi:10.1016/j.jvsvi.2024.100183
  4. Benadda I, Lozano-Franco R, Coutu F-A, et al. A Preliminary Assessment of Barriers and Facilitators to Accessing Foot Care in Homeless Shelters: A Scoping Review. Annals of Vascular Surgery. 2025;111:279- 289. doi:10.1016/j.avsg.2024.10.026
  5. CHAMPIONS: Comprehensive Heart and Multidisciplinary Limb Preservation Outreach Networks. 2025. https://www.championshealth.org/
  6. Creager MA, Matsushita K, Arya S, et al. Reducing Nontraumatic Lower-Extremity Amputations by 20% by 2030: Time to Get to Our Feet: A Policy Statement From the American Heart Association. Circulation. 2021;143(17):e875-e891. doi:doi:10.1161/CIR.0000000000000967

Lindsey Olivere, MD, is a vascular surgery resident at the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania.

Inari Medical, now part of Stryker, launches Artix thrombectomy system

By
Bryan Kay
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Inari Medical, now part of Stryker, launches Artix thrombectomy system
Artix thrombectomy system
Artix thrombectomy system

Inari Medical, now part of Stryker, recently announced the launch of its Artix thrombectomy system. Purpose-built for the needs of the peripheral arterial system, Artix is a combined aspiration plus mechanical thrombectomy solution.

Stryker notes that the Artix system builds on Inari’s venous thrombectomy devices and is its first entry into the arterial space.

Jonathan Bowman, MD, section chief of vascular surgery at Norwalk Hospital in Norwalk, Connecticut, performed the first commercial case with Artix on Oct. 19, 2024. “The Artix thrombectomy system marks a significant advancement in peripheral arterial thromboembolism treatment,” said Bowman. “With Artix, I finally have a solution that effectively addresses a wide range of clots while enabling me to maintain vessel access and retain control throughout the entire case. I expect Artix will take the place of open surgical repair in many of my arterial cases.”

Senate scrutiny of HHS nominees poses key moment for vascular surgery advocacy

By
Dylan Lopez
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Senate scrutiny of HHS nominees poses key moment for vascular surgery advocacy
U.S. Congress

When it comes to a presidential administration’s impact on our healthcare system, personnel is policy. So, a presidential transition is always a critical juncture for the direction of our federal government’s healthcare policy. That is especially the case for a transition like this one, where the incoming administration differs from the outgoing administration on so many fundamental issues.

The makeup of the incoming administration’s healthcare policy team, from the top down, will be largely dependent on the Senate’s advice and consent power. So, it will be important for the SVS and its members to advocate and inform senators proactively about the potential effects of presidential nominations on the practice.

The secretary of health and human services (HHS) nominee is likely to be the subject of much public attention in this space. To the extent that he has any relevant experience for the job, Robert F. Kennedy, Jr., can be described as an advocate around issues that fall more into the Food and Drug Administration (FDA) jurisdiction than issues directly affecting doctors. Kennedy “has been met with mixed feelings on Capitol Hill.” His nomination will draw national attention, and the final vote should be closely contested, as Senate Republicans have been reluctant to express support thus far.

Outside of Kennedy, the next-most senior nominee to watch for vascular surgeons will be Dr. Mehmet Oz, the expected nominee to lead the Centers for Medicare & Medicaid Services (CMS). Oz similarly lacks relevant experience for this job. However, he does have more relevant publicly stated opinions, having made a serious run for the Senate in Pennsylvania in 2022. He has touted his support for Medicare Advantage and has generally talked about running the service more like a business. Oz’s nomination will also be closely contested, though he has some solid support among key Senate Republicans and even has been met with open minds among some Senate Democrats.

Whether it’s Kennedy, Oz or any of the other incoming Senate confirmation fights at HHS, vascular surgeons have a voice and should be heard. SVS members and supporters can get involved in the SVS’s formal advocacy efforts and reach out to their Senators via constituent feedback, letters to the editor, and staying informed and active.

It is important to remember that it’s not just about the yes-or-no vote to confirm, though that does matter. The Senate’s advice and consent role is also about asking tough questions of these nominees, putting them on the record, probing them, educating them, and fostering a transparent policy-driven process. Senate offices consider their constituents’ opinions, so vascular surgeons need to be engaged now more than ever.

Dylan Lopez is the SVS advocacy and public affairs manager.

VAM 2025 registration launches

By
Marlén Gomez
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VAM 2025 registration launches

Registration for the 2025 Vascular Annual Meeting (VAM 2025) is now open. This year’s meeting will take place in New Orleans, Louisiana, June 4–7.

VAM 2025 will consist of three full days of education covering the latest updates in the vascular surgery field and two full days of a packed exhibit hall featuring the newest technology in the specialty and more.

SVS members will see an additional discount on their rates when compared to those of nonmembers. Any nonmember wanting to take advantage of the member discount can apply for SVS membership by May 1 to receive the refunded difference, pending application approval.

Housing for VAM 2025 opened March 5. To register and get more information, visit vascular.org/VAM.

Philips issues Class I recall for Tack endovascular system

By
Bryan Kay
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Philips issues Class I recall for Tack endovascular system

philips featuredPhilips has recently announced that it will no longer sell its Tack endovascular system in the U.S. following a Class I recall issued by the Food and Drug Administration (FDA).

A Class I recall is the FDA’s most serious classification, which denotes that the continued use of the affected product could result in severe injury or death.

The FDA’s decision follows reports that the Tack endovascular system—designed to treat arterial dissections—has posed challenges for users, sometimes necessitating additional interventions to retrieve or remove the implant. The self-expanding device is composed of nitinol, a nickel-titanium alloy.

The device is used following angioplasty, a procedure that widens narrowed or blocked arteries. While rare, tears in blood vessels can be a serious complication, and the Tack implant is designed to repair these by securing damaged tissue to the artery wall.

The FDA warned that continued use of the device could lead to significant health risks. Short-term complications include partial or complete blockage of blood flow, perforations in the artery’s inner lining or full-thickness arterial tears. Long-term consequences may involve pain, tissue loss, re-narrowing of the vessel and, in more severe cases, bypass surgery, amputation or death.

Philips has reported 20 injuries linked to the Tack system but has not received any reports of fatalities.

The Tack system was initially approved by the FDA in April 2020. It was developed by Intact Vascular, a cardiovascular company acquired by Philips for $275 million later that year.

So you want to marry a surgeon?

By
Malachi Sheahan III
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So you want to marry a surgeon?
Malachi Sheahan III
In the second of a two-part series of editorials, Vascular Specialist Medical editor Malachi Sheahan III, MD, offers further insight into the world of surgeon-surgeon marriages with a little help from a few friends.

Welcome to the first Vascular Specialist editorial of 2025. If your spouse did not learn from social media that you wrote an article about your marriage, your year is already off to a better start than mine. As promised, here is the second part of our series, examining surgeon-surgeon marriages. I have assembled an all-star cast of married surgeons to offer advice, counsel and condolences. Participating were vascular surgeons Sunita Srivastava, MD, and Matthew Eagleton, MD; vascular surgeon London Guidry, MD, and surgical oncologist John Lyons, MD; vascular surgeon Kelli Summers, MD, and plastic surgeon Michael Borrero, MD; vascular surgeon Marie Unruh, MD, and plastic surgeon Adam Hauch, MD; pediatric surgeons Fabienne Gray, MD, and Jenny Stevens, MD; and a few others who learned from my misadventures and requested anonymity. I have presented their guidance unattributed, loosely categorized under a few broad topics.

❤ Selecting a spouse

– It’s important to identify a spouse who understands the urgency and the unpredictability of surgery as a job. Surgery requires the doctor to leave planned family gatherings unexpectedly when duty requires. This can be very frustrating for a non-medical spouse, therefore it is vital to select a spouse who is understanding and tolerant of this unpredictability.

– We met in training and early career. We both wish we’d had the opportunity to meet each other in “normal lives.” There is a whole experience of “normal dating” that just didn’t happen for us (or for anyone in medicine, in particular surgery). It wouldn’t have changed anything, but sometimes we feel like we missed out on the fun aspect of courtship.

– I have observed that having a spouse in healthcare is helpful for my female surgeon colleagues, and another surgeon is preferable. Non-MD/healthcare husbands don’t seem to understand the obligations of their spouses.

– I think we both wish we’d met outside of the hospital and could’ve gotten to know each other in a more natural habitat, as was previously said. But it’s really hard to meet people when you’re mired in this world. I met so many fascinating people as I moved from city to city for research, and residency and fellowship, but it was always hard to find someone who understood/had time for/could handle the significance of the job (time constraints, emotional toil, prolonged schooling). That said, I am so frankly impressed (with myself ) by the person I found to share it all with. Being at different points in our careers certainly made it harder. Conflicts between supportive partner, “back in my day” historical narratives, and mentoring opportunities were confusing and not always handled correctly (by me). As we all know, the muted highs from a case that went well and the devastating lows of any complication are simply not fully grasped by those who don’t do this.

– I think it’s very different if you’re asking a male surgeon versus a female surgeon. I think female surgeons have a narrower criteria than males (and no, not because we are “picky”). I think there are still societal norms in place for male versus female roles in the house, and being a female surgeon breaks a lot of those rules. We have to find someone who understands and accepts a busy work and call schedule, is willing to work as a team (cannot have a breadwinner mentality), and is OK with picking up our slack. Also, we have to physically find someone, which can be challenging when we are working all the time. If you don’t find a spouse before med school, I think it’s probably more likely that a woman will find a male physician as her partner (no, I don’t have data). Another physician automatically meets most of the criteria.

– We met while I was still early in training and there was an instant connection that was beautiful. However, we knew that the next 5–10 years of making a relationship work while one of us was moving across the country trying to accomplish the goal of becoming a pediatric surgeon would be very challenging. There are advantages and disadvantages of having a spouse in surgery. One thing that I think has been wonderful for us is having someone to talk through difficult cases with, to bounce ideas off of, to work through a bad outcome, etc. We have a deep understanding of the intricacies of this job and how it impacts us as humans, and it has been nice to have a partner to walk through that with. It is fun to learn things about surgery from each other and to celebrate our wins, and also to grieve our losses together. I am thankful for that.

– Your heart will choose who your heart will choose. Then your brain will have to spend the rest of your life trying to figure out how the hell to make it work. (Editor’s note: OK, some of these are mine. You’ll have to find the rest.)

Vascular surgeon tandem, Claudie and Malachi Sheahan
❤ Balancing work obligations

– If you operate together, pick who will be in charge and who will assist. There are no co-surgeons in marriage.

– I still don’t think we’re doing this right, but she is the person I trust completely. And it is really nice that she has a handle on most of the players in the script. We both have really worked on learning to step out of ourselves and listen to each other without our personal opinions playing too much of a factor.

– I think it’s important to try to get work done on the fringes of family time—early in the morning/late in the evening. One has to be smart about their schedule, penciling in and protecting family time in order to balance both. You have to make best use of down time when the family is less likely to miss you.

– We were once told by a vascular leader: “You both cannot be successful. Choose which of the two of you that should be, and the other just shouldn’t plan on having a successful career, especially in academics.” I think this was a motivating statement for us. This is completely false.

– We are often viewed as one employee or partner, and there are a lot of issues with this. People think we share practices and should be responsible for each other’s patients (NOT!). We share benefits and salaries, so we should be compensated less. Benefits available to other surgeons should only be available to us as a couple and not as individual surgeons. We take too much time away at the same time, which makes more work for the rest of the team. People think we will use our “power couple” dynamic to influence the department’s direction. The truth is we frequently do not agree on programmatic issues.

– This has been hard as I have been in training for the entirety of our relationship up to this point. My hours and flexibility have not been great. Additionally, I have spent a lot of time over the last few years living in another city or even state. At the same time, my wife is a full-time pediatric surgeon with a demanding schedule and career goals of her own. I think we have tried to value both of our dreams and goals, and support each other in accomplishing those. When we live together, we try to schedule our calls in a way that allows time off together, or that supports the other one during a difficult week/ month.

❤ Balancing home obligations

– Have a “call” bedroom.

– You’ve got to pick your battles. Especially as a mom. You aren’t going to be able to have it all so you have to prioritize. If your kids or spouse are getting antsy about you being gone too much, then you have to give up some stuff that you might want to do at work or for yourself (i.e. morning workouts or journal clubs).

– Call schedules done a year in advance are always helpful, so at least you have some idea of holidays and weekends.

– When one spouse is on call, the other spouse just keeps the routine. Don’t wait to eat! The routine works so much better, especially when the kids are in school.

– Committees work well for some decisions but not for running a home. Make sure every responsibility is clearly assigned to one of you.

– Both spouses need to be OK with the fact that the division of labor will sometimes be uneven due to forces that are out of your control.

– We outsource everything we can (house cleaning, drivers to take our kids to sports practice, etc.).

– With one of us being a trainee traveling between cities and then living long-distance for research (during COVID!), and now for fellowship, we’ve mostly had to maintain separate homes. It’s been hard when we do share a living space as it takes a minute to figure out life together (you should also bring a glass of water to bed if you are going to want some water in the middle of the night) and chore responsibilities. Sometimes, amidst these difficult times, work is the common denominator that we can always agree on and more easily navigate. Outsourcing is extremely helpful, and also educational.

– We split chores. I like doing the laundry, and I hate grocery shopping. My spouse cooks, and I only do that if it is a special occasion; otherwise, I’m an Uber Eats person.

– At home, we work as a team. The person who is not as busy picks up the slack. He does the trash and I do the laundry. I guess we still have some traditional roles.

– This is a tricky one for us, as we have not lived together for the majority of our relationship due to surgical training. We also added a child into the mix 15 months ago and that drastically changed the “responsibilities and obligations” at home. We try to have certain chores that are split in order to offload some of the mental load of those things for the other person. Admittedly, I think we are still in the process of figuring this one out. Understanding that we can’t do this alone and having help (nannies, cleaning services, etc.) have been helpful, I think. Right now, we live in separate states and each have our own home and home responsibilities. I think this is a challenge but will hopefully help us learn the best way to divide labor once we live together again.

– We “outsource” many things. I now have the nanny do our child’s laundry and the housekeeper does most of our laundry. We have the meal delivery service for our baby. The housekeeper comes once a week. The nanny does our dishes and does some food prep/meals for us.

❤ Time for your spouse

– Scheduling time for each other is mandatory, and unfortunately the first to get cut when there are work needs.

I think all marriages have ups and downs, and this is amplified for those with dual-surgeon families. Currently, we are both working harder and more hours than we have ever worked, including residency (we are not accomplishing more though). I think we are learning that children are a great grounding force for the family. We are empty nesters and had high aspirations of dating each other again, traveling, getting to know each other as individuals all over again—and hoping we still liked each other (we do). That’s not happening on the timeframe we had hoped, as work sucks the life out of us.

– One day, I hope to have this. I think we have to wait until the baby is about 5 years old. I will then be old, but she’ll still be younger than I am now. So, maybe they can bond over visiting me in the nursing home.

– We are always prioritizing, and the first person to fall off the list of priorities is our spouses. We just assume they’ll understand (and they do, but it gets old sometimes. No, it gets old all of the time). This is in both directions.

– The advantage is that my partner is everything to me and the person I most want to hang out with. Making your partner the priority is hard with competing needs and work. You always regret not choosing your partner.

– One of the things I love about my wife is her love for community and life outside of the hospital. She has always been involved in so many aspects of life in New Orleans, and one of the things I think we do really well is prioritize time outside of the hospital for fun (Mardi Gras, going out to dinner, Saints games, Jazz Fest, travel). As we have added a child into the family, we are in a new phase of figuring out what time for the two of us together looks like.

– My biggest piece of advice is to maintain and cherish common interests and each other.

❤ Children

– Our kids are all exactly three years apart. That’s how long it takes to realize that you will never have life under control, so you might as well have another kid.

– Building a network of other parents is my saving grace. You will be underwater, and these people will throw you a lifeline. Let them into your world of chaos, and you will be surprised by how many will be there to help you. A pro tip: you do not need to do in-person, 10-minute parent-teacher conferences, but you can definitely be available by phone, and so can your husband. On that note, if you have a good school from pre-K to 12th grade and multiple children, life is way easier with one drop-off and pick-up point.

– There was some time consideration as a woman who had completed training at the tender age of 38. Female surgeons have a 50% serious complication rate. It was hard to be the birthing parent and pause my job, while my partner was still working so hard to finish her training. We have a long way to go with him, and our nannies are arguably the best thing that ever happened to our household. But our village is strong, and I hope we continue to provide the time and loving home for him that he needs and deserves.

– You have to get a good nanny if you are a two-surgeon family. Period. It’s not gonna happen any other way. You have to be OK with the fact that, at least once, your kids are going to call that person “Mom” if the nanny is female. It’s awful, but it’s going to happen.

– We try to always do vacations with our kids, which is not true for a lot of our non-medical friends. People definitely think we are crazy for having taken our kids to Iceland when they were one and three, but they loved it, and they still talk about it to this day. So, I guess I try to take the time I’m with them and be really present and focused on them so they feel special whenever I’m around.

– Our children used to get annoyed when we would talk work at home, especially during dinner. We ultimately set a timer—10 minutes each to vent/ talk/question when we were all together. Timer goes off, and you’re done.

– I think if you have two physician parents, it is very difficult to have the children in every single extracurricular activity. That is very challenging in today’s climate of travel sports and over-scheduled children. Additionally, it’s important to make time to be present at the children’s extracurricular programs. It is unreasonable to think that you can make every one, but you should attempt to make some of them (prioritize the big ones).

– Children forced at least one of us to be available somehow. And that meant the other pitched in more in the hospital or with other obligations. We scrutinized our travel more rigorously. And we said no more. We really relied on each other to make it work. I trust no one in the world more than my spouse—and she has never let me down. Our children specifically are not choosing medicine because they do not want to live the chaotic, uncontrolled lives we have. They are not bitter towards us, they are just potentially prioritizing things differently. I don’t think they feel like they have missed out on anything, but I do think they feel for us for not getting to relax more.

– We had our son 15 months ago, and he is an absolute joy and the love of our lives. Having said that, the process of getting pregnant, having the baby and the first year of life has been one of the hardest experiences for us. Having kids is so hard. And as a same-sex couple, there were additional challenges for us. We went through IVF (part of which we did while I was still away for my research years) and had to balance that process while both still practicing as surgeons. The pregnancy was not easy, but as many female surgeons experienced, there were difficulties. I was in my chief year of residency when our son was born, and then left for fellowship for two years. Being away has been really hard, and my wife is now doing the bulk of the work at home. We have been saved by having an amazing nanny who is basically a part of our family now. I hope that we can show our son that a life in medicine and as a surgeon is hard but is also extremely rewarding. My father is a physician and the reason that I went into medicine, and I hope that I can pass the joy of medicine down.

– With our initial nanny difficulties we really had to balance work obligations because we were unexpectedly without childcare multiple times. We constantly compared schedules to see how long each person’s day would be and who could go in a little later or come home earlier to avoid paying overtime. We had to make sure our operating room days weren’t the same and we were never on call at the same time. Another strategy for some people is having a live-in nanny.

– When your kids are young, they don’t recognize that you have made a choice, but when they are older, they do. So they may grow to resent your jobs and time away.

❤ Miscellaneous

– I’ll throw a couple of trite phrases in here: the hours were long, but the years were short; and enjoy the journey—there is no destination

– Sometimes I wish I could quit it all and just hang out with my spouse. We see each other less now than we ever have. Working in the same hospital does not ensure you will have time together.

– I will offer a few things I would tell my younger self! Take out loans, borrow from family and friends, use credit cards, beg, borrow or steal to make your life as easy as possible. Hire a cleaning service, get childcare for a few hours on the weekends you are off and work out or sleep, have a delivery food service, always have childcare backup no matter the cost, and stop worrying because you will make the money to pay it back.

– You continually grow together. There are so many stages of adulthood and surgery life, and it’s fascinating to do it with another person, as we all learn things at different times and in different ways. The things I’ve learned from my wife about surgery, from her perspective and work habits and thought processes, and the “how does that staff do it?” are innumerable. I learn about her from her responses and about myself from mine. Adaptability and resourcefulness are things we develop as surgeons, and things that I depend upon in myself and my spouse.

– It also feels really cool to have a partner who is doing something they love and care about as much as I love and care about my job, basically because it’s the same damn job and it’s the best job (for us).

– As two surgeons, understand your spouse’s aspirations and be supportive. Make sure each of you has friends you can lean on in your respective fields.

– We are a same-sex couple in surgery and I think that is an even more rare thing. There are not a lot of examples to look up to as mentors or as a guide of how to navigate life in this unique space. One of the challenges of that has been that there are no true “gender roles” at home or at work. That is unique when it comes to raising children and obligations at home, etc. We are working through all of that and learning a lot about each other in the process, and I hope that we can be a resource for others that find themselves in this unique space in the surgery community.

– Overall, it’s amazing that my spouse is a surgeon too. Our main topics of conversation are how amazing our son is and cases. I love that he truly understands what I deal with, and I find that helps me immensely with the emotional toll this job can sometimes take.

– Some final tips: try and leave work frustrations at work, but also recognize that’s not always possible, so give your partner some grace.

– Make sure you keep hospital communication and home communication styles separate. Your partner is not a resident or PA, etc., that you are dictating orders to. Be a team. It will never be equal so don’t try and make it 50/50.

Malachi Sheahan is the Claude C. Craighead Jr. professor and chair in the division of vascular and endovascular surgery at LSU in New Orleans. He is Vascular Specialist medical editor.

Stereotaxis seeks to broaden use of its robotic magnetic navigation system into multiple endovascular fields

By
Will Date
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Stereotaxis seeks to broaden use of its robotic magnetic navigation system into multiple endovascular fields

Stereotaxis has announced a Food and Drug Administration (FDA) regulatory submission for the first robotically navigated catheter designed to expand usage of robotic magnetic navigation into the broader endovascular field.

Emagin 5F is the first in a family of robotically navigated endovascular devices being developed by Stereotaxis. The Emagin brand—short for Endovascular Magnetic Intervention—will encompass a portfolio of robotic catheters and wires.

Emagin 5F is a catheter guide with a 5Fr diameter used to navigate tortuous venous and arterial vasculature. Robotic navigation of the catheter directly from the distal tip, using precise magnetic fields, is designed to enable efficient and safe navigation to otherwise difficult-to-reach vascular anatomy.

It expands the established benefits of Robotic Magnetic Navigation into multiple new clinical applications including minimally-invasive procedures used to treat stroke, cancer, and cardiovascular disease.

Stereotaxis submitted a 510(k) application for Emagin 5F with the FDA and expects to submit the catheter for European CE mark clearance this month. Emagin 5F was designed and is manufactured by Stereotaxis’ fully-owned subsidiary Access Point Technologies in Minnesota.

Stereotaxis expects to launch Emagin 5F following anticipated approvals in the second half of this year, with a focus on demonstrating clinical value for Robotic Magnetic Navigation in multiple new endovascular applications.

Shockwave Medical announces US launch of intravascular lithotripsy catheter

By
Bryan Kay
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Shockwave Medical announces US launch of intravascular lithotripsy catheter
Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD).
Shockwave Medical
Shockwave Javelin

Today, Shockwave Medical announced the U.S. launch of its Shockwave Javelin peripheral intravascular lithotripsy (IVL) catheter, a platform designed to modify calcium and cross narrowed vessels in patients with peripheral artery disease (PAD).

The platform is designed to modify calcium and cross calcified occlusive disease or extremely narrowed lesions where a wire will cross but devices might not.

Shockwave Javelin has a working length of 150cm and features a single distal emitter that creates up to 120 shockwave pulses. Each shockwave pulse creates a spherical energy field that extends beyond the tip of the catheter. This novel design delivers lithotripsy closer to calcium than the balloon-based platform, the company reports.

Despite the challenging nature of the calcified lesions studied, the clinical outcomes from the FORWARD PAD investigational device exemption (IDE) trial demonstrated that Shockwave Javelin has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters, a press release states.

‘Battlefield first aid’: A peer-to-peer prescription for dealing with adverse surgical outcomes

By
Bryan Kay
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‘Battlefield first aid’: A peer-to-peer prescription for dealing with adverse surgical outcomes
John Eidt

“Battlefield first aid” after a colleague has a bad case as the cornerstone of peer-to-peer support in vascular surgery was the feature of the recent Jesse E. Thompson, MD, Distinguished Guest Lecture at the 2025 Southern Association for Vascular Surgery (SAVS) annual meeting in St. Thomas, the U.S. Virgin Islands (Jan. 22–25).

John Eidt, MD, the chief of vascular surgery at Baylor, Scott & White Heart and Vascular Hospital in Dallas and a former SAVS president, asked attendees to consider what they do in response to an adverse outcome during the course of their clinical care; how they treat their colleagues after they have a bad case; whether they have sought professional counseling after an adverse surgical event; and how they teach trainees to deal with these adverse events.

“We all have patients who have left an indelible mark on us,” Eidt told those gathered at SAVS 2025. “The asymptomatic carotid that has a stroke in the recovery room. The routine EVAR that goes bad. The claudicant that winds up with an amputation.”

He highlighted the importance of peer support and not suffering in silence. “In vascular surgery, our actions and inactions have immediate consequences,” he said. “There is no delay like a recurrent hernia. There is no shifting blame. Our memories may be vivid and precise and filled with details like patients’ middle names, and children’s faces and spouses’ occupations. Sometimes we can see the operations like it was yesterday, but, in other cases, we just see fragments, those that haunt our memories and invade our dreams, though we never fully forget.”

Eidt raised the specter of the “second victim” concept, which describes the doctor who makes a mistake and needs help too. Under this definition, he described how in the absence of mechanisms for healing, physicians find dysfunctional ways to protect themselves. They respond to their own mistakes with anger, projection of blame and may act defensively or callously, and blame or scold the patient or other members of the healthcare team, Eidt said. “Distress escalates in the face of a malpractice suit. In the long run, some physicians are deeply wounded.” They may lose their nerve, burn out, or seek solace in alcohol or drugs, he added.

“I think that’s an unfortunately accurate picture of how sometimes we do respond to these situations.”

But “second victim” is an ill-fitting term in this arena, Eidt continued. “Victim” most commonly refers to those who experience devastating loss at the hands of others, he pointed out. “Placing both clinicians and patients in this category after medical error seems erroneous given the degree of intentionality and violent harm that the word victim connotes,” Eidt said. “It’s not really a good illustration of how we all experience these events.”

The potential consequences from bad outcomes for physicians are well reported: for instance, the literature documents that more than 90% of surgeons reported an emotional impact from adverse surgical outcomes. These included anger, anxiety, guilt, shame— “all the stuff you know you’ve felt after a bad case,” Eidt said. “It can mess up your sleep, how you’re thinking, even how you relax. And it can change practice patterns if you stop doing evidence-based medicine and start doing anecdote-based medicine.”

Women and minorities might carry added burdens, he considered. “It’s bad enough for a White guy, but if you have extra scrutiny, it may even be harder.”

In light of all of this, the question becomes how surgeons deal with the reality of facing up to bad outcomes, Eidt continued. “The most common way surgeons want to deal with these things is to talk to each other. We have a lot of evidence that adverse clinical events have a significant bad impact on you, but we tend not to seek professional help. We know the reasons why: there is so much stigma, all kinds of negative connotations.”

What surgeons do like is peer-to-peer support, he said. “It’s got to be confidential, available 24/7. They are almost inevitably, though, not point of care.” Surgeons also prefer something longitudinal, as well as thoughtful critique, with questions like, “What would you have done? How can I do better?” Eidt added.

There are four tiers of peer support, with “self ” peer support, hospital-level structured support and professional counseling among them. But it is the second tier where the greatest value might be yielded, Eidt argued: that is, battlefield first aid. At the base of this approach, he said, is “reaching out to each other, listening, offering support, providing acceptance, offering trust, confidentiality, providing a safe space, normalizing talking about feelings.”

There are also don’ts, he pointed out. That means don’t isolate, pry, place blame, try to fix it, minimize it or give false reassurance, Eidt reasoned. “What we tend to do is pretend it didn’t happen. Everyone knows it went south, but no one is talking about it, and that creates more paranoia.”

The torrid number of hospital mergers and integrations do not create value for our healthcare system

By
Bhagwan Satiani
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The torrid number of hospital mergers and integrations do not create value for our healthcare system
Bhagwan Satiani

It is now common to see headlines like “When hospital prices go up, local economies take a hit” (Wall Street Journal), “Hidden hospital prices harm patients: Can this new pricing tool make a difference?”(USA Today) or “Hospital mergers and health care price increases: A primer for reporters” (from the Association of Healthcare Journalists). And yet, large mergers and acquisitions (M&A) have continued at a torrid pace. Robert Pearl calls it a “conglomerate of monopolies” pointing out that “the 40 largest health systems own 2,073 hospitals, roughly one-third of all emergency and acute-care facilities in the United States.” Let me summarize our recent publication in the Journal of the American College of Surgeons.1 My co-authors are David Way, David Hoyt and Chris Ellison. I will be using the term M&A as a proxy for hospital and health system consolidation/integration, and for simplicity will include horizontal (two or more hospitals joined) or vertical integration (hospital and physicians merged) within M&A.

We systematically reviewed 384 of the 1,297 articles discussing healthcare M&A from 1990–2024. We then selected 37 studies, which measured at least one of three measures of value: quality, price and cost/spending. Some 77% of studies measuring quality of care showed either no change or lower quality of care after M&A. Of the six showing improvement, five showed better care management processes (CMPs) (for instance health screenings, patient satisfaction or more nurse clinicians), and only one showed improved mortality. Some 93% of studies demonstrated increased prices, and 81% focusing on healthcare spending showed either higher cost or no change.

Hospital and health system M&A has continued to trend upwards, purportedly to create operational, strategic and financial value. While the concept of M&A can be traced back to the Mayo Clinic in 1892, “corporatization” has now advanced even in states where it is banned by law due to weak enforcement efforts. Health systems now own about 68% of all hospitals in the U.S., and the largest health systems own one-third of all hospitals in the U.S. Furthermore, hospitals now employ 55% of U.S. physicians and another 23% are employed by other corporate entities.2

The premise of M&A in healthcare includes: cost savings (economy of scale, elimination of redundancies, better asset leverage), better quality of care (expertise due to access to talent, innovation and best practices, better care coordination and continuum of care, improved outcomes), financial benefits (greater revenue, value chain integration, access to capital and new markets), intellectual capital (health and technology workforce) and stronger branding.

We report that the premise that M&A would result in cost savings by relieving competitive pressure and improving price-cost margins has not been convincingly demonstrated. Furthermore, increased market share, particularly in concentrated markets, has not led to significant and consistent cost savings. When M&A has shown savings partly because of strong negotiating positions with insurers, the savings have reportedly not been passed to commercially insured patients, resulting in higher premiums for the patient and employers. In one study, the average Affordable Care Act (ACA) marketplace premiums increased from 5% to 12% because of higher concentrations of healthcare organizations competing for the same patients.3

Similarly, M&A largely failed to show consistent and significant relationships between M&A and improved quality of care. In most studies we reviewed there was no change after M&A and, in some cases, system ownership may have reduced the care quality. An interesting question is whether the quality of care improves after “vertical integration” (physicians becoming hospital employees). One such study compared 803 “switching hospitals” (hospitals changed to employing physicians) to 2,084 non-switching hospitals, looking at common measures such as risk-adjusted hospital-level mortality rates, 30-day readmission rates, length of stay, etc. Matched for year and regions, two years later no improvement was identified between the two groups in four quality metrics.4 Where there has been improvement in “quality,” this has been almost entirely due to process measures, not true outcome metrics that surgeons are used to.

A recent study by the National Bureau of Economic Research also concluded, after reviewing 304 hospital mergers between 2010 and 2015, that hospital mergers led to higher inpatient and outpatient prices for patients, with 40% of hospitals involved in mergers increasing prices by 5% or more. The American Hospital Association disputed their findings. While we did not measure the extent of price increases, a 20–40% increase in prices following horizontal integration and a 15–33.5% increase after vertical integration have been reported. The Urban Institute tied hospital concentration to debt on household financial well-being and health across the U.S. They report that medical debt as indicated by credit card reports in 2022 has been a major burden for almost 27 million U.S. consumers.

Of concern is the deluge of hospital M&A leaving markets susceptible to antitrust scrutiny by state and federal regulators for monopolistic behavior. One study by Zack Cooper pointed out that only 1% (13 of 1,164) of mergers of acute-care hospitals between 2002 and 2020 had enforcement actions taken by the Federal Trade Commission (FTC). The lax antitrust enforcement has not gone unnoticed. There has been a recent backlash against hospital mega-mergers. The FTC and Department of Justice (DOJ) have started more enforcement actions by asking for a request for information (RFI) to collect more information about corporate and private equity control over healthcare services. However, their success so far with litigation efforts is mixed at best.

Our study has several limitations detailed in the manuscript, chiefly the fact that most studies do not have consistent definitions for cost/spending, price and quality of care, making it difficult to arrive at valid comparisons or definitive conclusions. This is because the true cost is either not known or not shared, and prices are misleading. Despite efforts at transparency, our healthcare system remains opaque. Hospital care accounts for close to $1.6 trillion, or almost a third, of our total healthcare expense of roughly $4.9 trillion. However, not many hospitals or service lines know or disclose how much they spend (not billed or charged amount) on each patient. Do we have national, consensus-based true quality measures, regardless of payor, which every hospital, ambulatory surgery center (ASC) or office-based lab (OBL) should be required to disclose? Only a single study in our systematic review showed improved mortality, whereas even CMPs, which are essentially payor incentive measures, were improved in six, but either worse or showed no change after M&A in 20 of 26 studies.

Some but not most M&As in our review have indeed demonstrated value. Can hospital M&A achieve value for our healthcare system and patients given the right combination of changes? Yes. An example may be to rescue failing hospitals in “hospital deserts” in poor areas or rural hospitals that need financing for upgrades, new technology, or physician coverage. However, although the evidence is mixed, we do not find that the past 20 years of M&A have achieved significant and consistent value in terms of improved quality, reduced cost/ spending, or price. It appears that M&A alone is insufficient to lead the U.S. to a value-based (quality/cost) healthcare system and “cannot be achieved through mergers alone without the infrastructure, methodology, and discipline to achieve this state of value.”1

Can physicians make a difference in leading our healthcare system to value? I believe so. There is enough evidence to support physician executives successfully leading healthcare organizations. We laid out some necessary skillsets to lead healthcare systems almost 15 years ago.5 There are recent examples of successful physician CEOs of large health systems. Joon Sup Lee, MD, CEO of Atlanta-based Emory Healthcare has achieved a “16% revenue spike after a leadership reboot” within two years. Neurosurgeon Steven Kalkanis went from chair to chief academic officer and senior vice president, then CEO of the medical group before he was appointed CEO of Henry Ford Hospital. These are good examples of the path to CEO roles.

The increasing complexity of healthcare “requires leadership and management competencies encompassing systems thinking, self-awareness, self-management, social awareness, and relationship management domains.”1 The scope of learning and experience required for a CEO role is broader than obtaining an MBA degree. There is no requirement to be a financial wizard. A good understanding of budgets and financial statements is enough. Leadership and soft skills are much more important.

The leadership pipeline can be facilitated by fast-tracking physicians interested in a leadership track. My most meaningful professional endeavor has been to start the Faculty Leadership Institute and help train faculty interested in the leadership track. In younger hands now, our medical center is in its 13th year of training faculty in leadership skills.6 In a senior executive dyad structure, well-rounded physicians trained in leadership skills should be given hands-on experience and the independent authority to commit to a patient-centered quality and safety culture, and change processes to allow evidence-based care. Physician leaders need to be able to get back to our roots of being able to effect change and ensure that the patient comes first. Physicians and other clinical leaders leading quality-of-care efforts should be at par with senior executives and reporting to health system boards directly, whose job it is to monitor quality. It seems to me a much better return on investment when artificial intelligence can be realized to arrive at cost, spending and price transparency in our massive healthcare system. Someone please send a tweet to Elon Musk (@elonmusk) and see if he has time with his numerous other interests! Be sure to copy me, @SatianiBhagwan.

References

  1. https://pubmed.ncbi.nlm.nih.gov/39636013/
  2. https://www.healthaffairs.org/content/forefront/rise-health-care-consolidation-and-do
  3. https://pubmed.ncbi.nlm.nih.gov/30933578/
  4. https://pubmed.ncbi.nlm.nih.gov/27654704/
  5. https://journals.sagepub.com/doi/abs/10.1177/1538574407309320?journalCode=vesb
  6. https://pubmed.ncbi.nlm.nih.gov/24360239/

Bhagwan Satiani is an associate editor for Vascular Specialist.

AVF: From good to great

By
Bryan Kay
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AVF: From good to great
Ruth Bush

Ruth Bush, MD, used her 2025 American Venous Forum (AVF) presidential address to highlight the organization’s elevation and path to “level 5 leadership.”

Level 5 leadership is seen across the organization’s activities, the University of Texas Medical Branch, Galveston, professor of surgery and associate dean, told AVF 2025, held in Atlanta, Georgia (Feb. 16–19).

The concept, which describes the highest level of leadership, as detailed in the book Good to Great by Jim Collins, applies to the AVF, which is “ambitious and forward-thinking but with humility and a giving spirit,” she said.

SVS leadership and membership integral to ‘far-reaching’ BEST-CLI trial

By
Beth Bales
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SVS leadership and membership integral to ‘far-reaching’ BEST-CLI trial

Support from the Society for Vascular Surgery (SVS) and, later, funding from the SVS Foundation were integral to the BEST-CLI trial, said one of the landmark trial’s leaders.

BEST-CLI sought to determine the best revascularization treatment strategy—surgical or endovascular—for patients with chronic limb-threatening ischemia (CLTI). The trial was initially funded by the federal National Heart, Lung and Blood Institute at the National Institutes of Health (NIH). The Society for Vascular Surgery (SVS), the Society for Clinical Vascular Surgery (SCVS) and a host of other regional and national vascular societies contributed funds toward BEST-CLI. The SVS Foundation provided a $100,000 bridge grant at a critical juncture to ensure the trial could run through to its conclusion.

In late 2022, Novo Nordisk Foundation contributed $3.9 million to further fund the investigators to undertake a full analysis of the wealth of data the trial produced.

SVS members Matthew Menard, MD, and Alik Farber, MD, were two of the trial’s principal investigators. They first conceived of the idea in 2007, began preparations in 2009 and received funding in 2013. The trial randomized and followed 1,830 patients between 2014 and 2021, and the headline results were announced in late 2022. BEST-CLI found that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective initial revascularization strategy for patients with CLTI who are deemed to be suitable for either an open or endovascular approach. The principal investigators also found that both strategies can be accomplished safely and are generally a very effective treatment for CLTI.

“The work of analyzing the large volume of data we have is ongoing,” said Farber. Many articles have been written about the trial since the initial publication of data. Vascular Specialist alone has published more than 20 follow-up articles on various facets of the BEST-CLI data. The interest, said Farber, indicates the trial’s significant impact and also highlights the SVS Foundation’s role in funding such critical research.

Menard indicated that “all of the things we have been able to achieve with regard to completion of the trial, as well as analysis and dissemination of the results directly stem from the funding we received during the early phase of our critical need. The SVS Foundation support represented the first contribution at a national society level. Its critical endorsement set the stage for other national societies to follow suit, and then for our industry partners to additionally champion our efforts. It is impossible to underestimate the impact of this critical initial sponsorship.”

Farber said that up to 40 supplemental secondary analyses have either been completed and published or are underway to bring additional important key findings to light.

These secondary analyses are helping to put the trial into appropriate context, by elucidating the results of the trial in different patient subgroups of interest. Farber and Menard are hoping the additional analyses will further help surgeons and other vascular care providers better understand the relevance of the trial to their own patients.

“These supplemental studies will help all of us better understand and interpret the results, and be better able to formulate treatment plans that are most suitable to individual CLTI patients,” Farber said.

SVS Foundation grants are meant to stimulate innovative research and thinking, said Menard. “It was always part of our goal to inspire the next generation of scientific investigators, and for them to build on the foundation established by BEST-CLI.”

They noted that high-quality research within the vascular surgical community is increasing. While judging BEST-CLI’s impact on this trend is difficult, Farber said, “we do think it was very important to demonstrate that vascular surgeons can lead high-quality trials and research. A number of trials that are currently works-in-progress are, in some ways, direct descendants of BEST.” He added that a great many SVS members are leading the secondary analyses of the BEST-CLI dataset. “It’s a very far-reaching effort,” he said.

What is one way of measuring Menard’s regard for the SVS Foundation? He’s now on the Foundation’s board of directors, and, as such, helped the body in its efforts to reach its fundraising goal before the year’s end. “There is no question that the support of the Society has been incredibly important to Alik and me as we journeyed through this trial experience. We have always been very aware that we would not have been able to achieve what we did without the incredible encouragement and assistance of both the Society leadership and its membership,” Menard said.

“The trial was completed because of the collective efforts of so many dedicated members of the Society, who, along with the wider vascular community, believed in what we were trying to do and, through their hard work and unwavering endorsement, brought it across the finish line.”

Open surgery, endovascular intervention and robotics: The coming ‘third revolution’ in vascular surgery

By
Bryan Kay
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Open surgery, endovascular intervention and robotics: The coming ‘third revolution’ in vascular surgery
Alan Lumsden delivers the 2025 SAVS presidential address
The 2025 Southern Association for Vascular Surgery (SAVS) presidential address featured the hashtag phrase #OnlyUs, an allusion to the specialty’s “unique” differentiator.

SAVS 2024–25 President Alan Lumsden, MD, returned to a familiar recent theme for his address to the 49th annual meeting of SAVS in St. Thomas, the U.S. Virgin Islands (Jan. 22–25): the topic of robotics in vascular surgery.

The twist this time around was that it was his SAVS presidential address, and he carved his pitch for robotic vascular surgery in bolder terms: digital surgery and robotics will form the third revolution in the specialty in the coming years. Only vascular surgeons are capable of being positioned at the epicenter of open surgery (the first vascular revolution), endovascular intervention (the second) and robotics, he said, “working in that space where we can integrate these things, which I think is going to allow us to be branded differently, to market us differently and will fundamentally differentiate us.”

Lumsden, the medical director of Methodist DeBakey Heart and Vascular Center at Houston Methodist in Houston, Texas, said robotics were the epitome of digital surgery and are “going to change the way we practice.” Referencing the long-running Pumps & Pipes collaboration between Houston industries sparked by a conversation between Lumsden and an oilfield engineer, he told SAVS 2025 that a lot of the solutions to vascular surgery’s problems “exist in somebody else’s toolkit.”

He said, “I submit to you that you’re going to see in the next few years digital surgery and robotics as the third revolution, and I think you’re eminently capable of managing that,” coining the social media phrase #OnlyUs in suggesting only vascular is poised to pull off the feat.

In the case of the endovascular revolution, the empowering technology was real-time imaging, Lumsden explained. “There were headwinds, so the message to younger people is, ‘Don’t always listen to your seniors, they don’t always know exactly what is going on in the future. So challenge what the dogma is.”

Right now, vascular surgery has two products: open surgery and endovascular intervention, the latter of which is not unique to the vascular specialty, Lumsden said. “Have we gone too far with this?” he asked. Open case volumes are diminishing, with advances in technology “that we have been good at embracing having a knock-on effect on our volumes.”

Then there is the competition. Interventional radiologists and, crucially, cardiologists, who are “bigger, better organized—and they can control the patients.”

Displaying a Venn diagram showing the intersecting realms of open surgery, endovascular intervention and robotics, Lumsden stated that “only you and I can play in this pace.” The “secret weapon” at the heart of it are the 100–120 fellows per year who join the specialty with a certificate in robotic surgery. “People like me have traditionally said, ‘Waste of time, I’m never going to use that again.’ We are in the endo world—but so are many others.” Robotic surgery, Lumsden said, offers the prospect of combining the “best long-term therapeutic intervention” of open surgery with a superior delivery system in the form of endovascular intervention. “What if we could actually go back to using some of those principles and apply both, and can we do this?”

Lumsden tackled the difficulty factor. “How hard is this going to be? Not nearly as hard as going from open to endo: we had no pre-existing skillsets [then]; a lot of headwinds from other people who didn’t really want us to do it; the cost for participation was massive; we didn’t have catheters, we didn’t have wires, we didn’t have imaging.” On the other hand, the robots exist, though there are credentialing challenges and costs to consider.

Fundamentally, he said, this is “uniquely differentiating for the vascular surgery community if we can embrace it.” Integrating imaging gave vascular surgery high volume and low risk, with the patient “actually benefiting from the [endovascular] procedure. You need the same thing from robotics in order to be able to scale it up,” he added.

Lumsden’s “ah-ha moments” over the role played by robotics in vascular procedures, only at the hands of other specialists, are well-documented. In that vein, he alluded to the vascular “firemen” concept, in which vascular surgeons come to the aid of other specialties. “Increasingly you and I are not going to have to deal with problems that are being generated unless we learn how to do this,” he said. “A lot of the procedures that we need to incorporate into these robotic training programs already exist. And we have to focus on how we bring this together. The gynecologists are using it; the urologists, the thoracic surgeons are using it; the cardiac surgeons are using it. Need I say more?”

Key to developing a robotic surgery program is identifying who on the team has the largest skillset, and case volume needs to be pushed on to that individual who is able to perform the procedures safely, Lumsden said. “There needs to be graded risk.” A mistake in the robotic world “is leaping to the aorta too early,” he observed. “Gradually increase the skillset,” he said.

The challenge remains that there is no indication for vascular on the existing robot, Lumsden pointed out, citing the need for a database to collect cases with a view to achieving Food and Drug Administration (FDA) approval.

“There are a lot of different tools that we are completely oblivious to but your fellows coming into your programs are well aware of, and that’s the advantage we’ve got,” he added.

Maiden Roger M Greenhalgh Lecture brings robotics into global focus

The World Federation Vascular Societies (WFVS) late last year staged its inaugural Roger M. Greenhalgh Lecture in honor of his work as pioneer in the field of vascular surgery. The memorial lecture took place during the 31st Annual Meeting of the Vascular Society of India in Jaipur, India (Oct. 17–19), and was presented by Lumsden.

Fittingly, the talk focused on the frontier-pushing topic that was also the subject of the SAVS 2025 presidential address: robotic vascular surgery and artificial intelligence.

Like Greenhalgh, Lumsden hails from the United Kingdom and is known for pushing the envelope in the field of vascular surgery. Lumsden’s team at Houston Methodist DeBakey Heart & Vascular Center is at the vanguard of efforts to bring robotics into the vascular surgical space.

In the lecture, entitled “Robotics and AI: Next revolution in vascular surgery,” the chair of cardiovascular surgery outlined a roadmap for bringing robotic vascular surgery into the fold of clinical practice.

Lumsden referenced his moment of clarity around the concept, how he realized major vascular operations were being handled robotically by other specialties, and how vascular surgery must not miss the boat.

He looked at ways of evaluating feasibility; selecting faculty with the necessary skillset to carry out robotic procedures; mitigating risk in getting teams up to speed; identifying high-frequency, low-risk procedures; expanding the pool of procedures that can be performed; using training resources to test in cadavers; and obtaining Food and Drug Administration (FDA) approval in order to obtain a vascular indication.

Lumsden cast robotic vascular surgery against the current treatment landscape of open surgery versus endovascular intervention. With open surgery, he said, the core therapeutic component is both “excellent and proven”, while the delivery system—via open exposure—is “unacceptable.” Endovascular treatment, on the other hand, bears an “excellent”, minimally invasive delivery system, but a “less durable” core therapeutic component. The question becomes, he said, whether robotics can provide an excellent delivery system while retaining an excellent core therapeutic component.

2024 in review: Message from the SVS executive director

By
Kenneth M. Slaw
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2024 in review: Message from the SVS executive director
Kenneth M. Slaw
The Society for Vascular Surgery (SVS) takes a moment to recognize the dedication, achievements and progress made over the past year. In a letter to members, SVS Executive Director Kenneth M. Slaw, PhD, highlights the Society’s unwavering focus on quality, advocacy and education while celebrating the collective efforts that have shaped the year’s successes.

Thank you for your relentless commitment to quality and safety in the care of patients with vascular disease, as well as your commitment and dedication to vascular surgery and the SVS. Last year was another fast-paced 12-month period, filled with challenges, opportunities and milestone achievements, none of which would be possible without the leadership and efforts of more than 560 member volunteers serving on over 40 committees, task forces and writers groups, and an incredible professional staff. I am delighted to refresh your memory regarding a few highlights.

Hello America, we are vascular surgery

Under the leadership of the Executive Board and Strategic Board, led by William Shutze, MD, and the Communications and Branding Committee, and an implementation team led by Megan Marcinko, the SVS launched its national branding initiative “Highway to Health.” In just the first three months, the media airways were flooded with video, social media and media interviews, reaching 452 million media impressions, close to 1,000 media placements and what soon will be over 40 live media interviews. It has been a very successful launch with our public relations firm partner, BRG, and this is just the beginning. Phase one of the launch introduced vascular surgery to the public, including SVS’s new Your Vascular Health patient website. In 2025, the focus will shift to referring providers and the healthcare system C-suite. Please watch your social media apps for SVS Highway to Health messaging.

Back to the future on health policy and advocacy

It was another year of struggle, challenge and intensive advocacy to protect and preserve physician payment and numerous pieces of legislation protecting both physicians and patients, including Centers for Medicare & Medicaid Services (CMS) fee schedules, budget neutrality, inflation adjustments, pre-authorization, wellness and many more issues. The SVS is front and center at the table for key discussions and is a highly respected source of expertise on Capitol Hill. With the return of the Trump administration, it will never be more important for the voice of vascular surgery to be unified and strong and show strength through its political action committee (PAC) and face-to-face advocacy efforts. New in September 2025 will be the SVS’s first Advocacy Leadership Summit and Hill visit. We hope you will join us in September to become a trained leader in health policy and advocacy, and march up to the Hill to educate members of Congress and their staff to make our case loud and clear.

Quality and quality improvement define our core

The core of the SVS’s reputation and expertise is derived from its focus on best science and quality improvement. The SVS Patient Safety Organization Vascular Quality Initiative (PSO VQI) is second to none among medical specialty registries in moving the needs on quality. The PSO VQI achieved its landmark one-millionth entry in 2024 and has over 1,200 subscribing institutions contributing data. The 17 regional meetings are focused on moving the quality improvement bar on selected procedures and disease states. This year’s true milestone was the launch of the Na tional Smoking Cessation Initiative, making the PSO/VQI among the first data registries to mobilize around prevention and preventive factors in vascular disease.

Another milestone in 2024 was the development and acceptance by CMS of a new vascular quality measure now up for public comment. If accepted, this will be a new measure developed by vascular surgeons for vascular surgeons who qualify for the CMS MIPS Value Pathways (MVP) payment program. Many thanks to Evan Lipsitz, MD, and an incredible Quality and Performance Measures Committee and staff for a wonderful achievement.

Leadership education commonly states that leaders must not just “talk the talk” but “walk the walk.” If SVS members truly believe in quality, they need to engage in quality improvement, and a fantastic way to walk the walk is to encourage health systems to become verified as a Vascular Center of Excellence by the American College of Surgeons (ACS)-SVS Vascular Verification Program (VVP). Launched in 2023, the VVP added eight new practices in 2024. The focus in 2025 will be support for the Outpatient Standards Program. All SVS members are encouraged to practice through the program.”

Media coverage in the vascular arena became a national issue in 2023, focusing on the appropriateness of vascular care across practice settings. Due to a strong response and leadership from the SVS, building relationships and educating medical journalists and the launch of the branding/ PR initiative, the headlines and stories in 2024 have slowly shifted attention from a small number of outliers in practice to the standards, guidelines, and quality improvement initiatives that define the vast majority of vascular surgeons’ practices.

Translation to transformation in clinical practice

To address a major gap in credible data, the SVS organized a national compensation study and program for vascular surgery in 2023 to answer a long-standing query and need from SVS members and address a major gap in credible data. Having worked hard to achieve the requisite 20% of eligible SVS members to privately and confidentially input their financial data, under the leadership of Keith Calligaro, MD, and Compensation Task Force, the first aggregate report of vascular surgery compensation data was accepted for publication in the Journal of Vascular Surgery (JVS) in 2024.

It was a busy year for developing and publishing clinical practice guidelines, and in 2024, the SVS continued its popular “Translating Guidelines into Practice” webinar series, focusing on varicose veins.

In 2023–2024, hundreds of SVS members heard about the translation of the global chronic limb-threatening ischemia (CLTI) guidelines, Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial results, as well as updated varicose veins clinical practice guidelines. To further this work, the SVS was awarded a $100,000 educational grant from the Council of Medical Specialty Societies (CMSS) to further these translational efforts and support the inclusion of patient perspectives.

Coming in 2025? An update on the SVS claudication guidelines! Emphasizing its ongoing commitment to office and outpatient care in the community, the SVS Section on Outpatient and Office-Based Care (SOOVC), now named the Section on Ambulatory Vascular Care (SAVC), developed an outstanding OBL Handbook released to SVS members in 2024. The SVS recognizes the value and importance of research and promotes data collection, analysis and new research in the outpatient space. This helps with safety and cost-effectiveness and expands patients’ access to care.

Meeting member needs and challenges

Each month of the year brings new ideas, energy and opportunities, as well as new challenges and threats that make strategy and change a universal constant for the SVS. The pace of change is accelerating and has become its own unique challenge. The SVS leadership remains committed to continue evolving the Society to address new opportunities and challenges, which is a challenge in itself, given the need to prioritize finite resources. Members contribute every dollar through dues, donations or program support, an essential lifeline to help the SVS continue to embrace new opportunities. The SVS is very fortunate to have a diverse revenue portfolio, relying on member dues for only 14% of its revenue, but each of those dollars is vitally important.

The SVS membership continues to grow and diversify, with total membership now closing in on 6,400 members.

The 2022 establishment of the Young Surgeons Section (YSS) has fostered and accelerated value and engagement for Early Career members, and, in 2024, the SVS approved a new Senior Section to maintain membership, value and engagement amongst later-career members. Many thanks to Enrico Ascher, MD, for his leadership in this.

The value and strength of SVS Affiliate membership is substantial—with over 500 vascular physician assistants (PAs), nurse practitioners and nurses—and essential as the SVS sculpts the future of vascular care delivery. In 2024, the SVS convened an Advanced Practice Provider (APP) Task Force to discuss future models for integrating the engagement of all APPs working with vascular surgeons.

Some five years ago, the SVS embarked on a series of assessments and potential governance changes to increase the diversity of perspectives. In 2024, the last of these governance changes—a change to the structure of the SVS Executive Board—was ratified by the voting membership and implemented. Congratulations to new EB members Chelsea Dorsey, MD, Yazan Duwayri, MD, Katherine Gallagher, MD, Vikram Kashyap, MD, and Robert Molnar, MD, who now join the SVS officers.

If quality is the core of the SVS, education is its cornerstone

By all accounts and perspectives, the Vascular Annual Meeting (VAM) 2024 in Chicago was superb and groundbreaking, thanks to Andres Schanzer, MD, who finished his term as VAM Program chair. More than 92% of VAM 2024 attendees rated the educational programming as excellent or good; international attendance doubled in size from 2023 to 2024; and a track specifically designed for the early career surgeon was piloted, leading to the highest participation from young surgeons of any VAM to date. VAM also introduced a track specifically designed for medical students/general surgery residents, specific educational programming and networking opportunities, and a Residency Fair with over 150 residency programs represented. We hope to see you all in New Orleans!

Beyond VAM, the Education Council, led by Kellie Brown, MD, has continued to develop innovative education opportunities for members.

The third Annual Complex Peripheral Vascular Interventions (CPVI) Hands-On Skills Course had another successful year, featuring 20 trainees able to attend with scholarship support.

The SVS launched its new and updated VascuLEARN learning management system (LMS), which is now the home for accessible webinars, micro-learning and short videos. This creates a one-stop online hub for educational content. Over the past three years, 1,365 vascular experts and trainees have taken advantage of these resources.

The SVS launched the sixth edition of the Vascular Education and Self-Assessment Program (VESAP6), with over 700 users burning through the questions and testing their knowledge.

Coding and reimbursement remains one of the top non-clinical content areas requested in the 2021 and 2024 education needs assessments. In addition to the live Coding Course, the SVS launched three new on-demand foundational videos and created a forum for submitting monthly questions, ensuring your questions are answered. The Coding Course will likely sell out quickly, with the potential of new lower extremity codes coming in 2025, so watch for registration in late spring.

The SVS held its fifth successful Leadership Development Program, with 96% of cohort five participants reporting they intended to incorporate changes into their practice following the course. Over the past five cohorts, the SVS has trained over 140 vascular surgeons in leadership skills. Registration for Cohort 6 will launch in April.

Finally, the SVS launched a new Wound Care Curriculum in February 2025. This collaborative effort between the SVS, the Society for Vascular Nursing (SVN), and the American Podiatric Medical Association (APMA) includes faculty members who are vascular surgeons, vascular nurses, vascular PAs and podiatrists. The curriculum consists of on-demand videos and in-person hands-on workshops held in conjunction with VAM 2025, 2026 and 2027.

Another milestone was hit in our scholarly journal publishing. Thanks to the leadership of Alan Dardik, MD, staff member Tyler Cosgrove, and our publisher Elsevier, the Journal of Vascular Surgery-Vascular Science (JVS-VS) has been indexed and will now have an impact factor, helping to establish it as the premier journal for vascular basic science research.

Our SVS Foundation, led by Joseph Mills, MD, and staff members Catherine Lampi and Sarah Murphy, is evolving, thriving,and garnering renewed attention through a “lights out” 2024 Gala at the Museum of Science and Industry at VAM, where the new James S. T. Yao Lectureship was announced.

Whether they attended our annual gala, walked for PAD awareness during the annual Vascular Health Step Challenge, shared their story during the Voices of Vascular campaign or made a charitable contribution, their support has been invaluable in advancing our mission. The Voices of Vascular campaign highlighted the accomplishments of 17 SVS members; Step Challenge donors came together to fund a new Vascular Care for the Underserved grant that will support an innovative project that addresses the unique challenges faced by underserved populations affected by PAD; SVS donors stepped up during Giving Tuesday, smashing our fundraising goal, raising more than $34k in 24 hours.

Finally, SVS member volunteers have pressed forward to sculpt the future with numerous new task forces in 2024, including in pediatric vascular care, patient engagement, innovation in vascular care, and clinical trials. The Vascular Board Certification Task Force is completing an assessment of progress made over the past 20 years, looking toward a future that strengthens the specialty.

Alignment to ‘True North’

Last year was one of significant achievements for the SVS, its Foundation, PSO and PAC. We hope you are as proud of these accomplishments as we as your staff are.

As we look down the lens of 2025 and the year ahead, the SVS remains steadfast in its commitment to championing quality and safety in patient care, the best science in the field, and advancing vascular surgery through meaningful collaboration, innovation, and letting the world know how special you are as vascular surgeons. I extend my sincere gratitude to each member for their invaluable contributions.

Intermittent Topical Wound Oxygen: ‘It needs to no longer be seen as late-stage therapy’

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Intermittent Topical Wound Oxygen: ‘It needs to no longer be seen as late-stage therapy’
Anahita Dua and David Dexter

This advertorial is sponsored by AOTI.

Two prominent vascular surgeons discuss a rising tide of evidence pointing toward benefits of adjunct use of cyclically pressurized Topical Wound Oxygen (TWO2) therapy in the treatment of vascular ulceration.

The best way to think about modern-day limb salvage, says Anahita Dua, MD, is through the analogy of what would constitute a fully functioning car. Underpinning the chassis, you might have the perfect set of tires, that never puncture, to enable motion, she relates, but without a multitude of other vital components—an operational engine, safe, working seatbelts—the vehicle is going nowhere. Without them, “that is not a car,” Dua explains.

Substitute in limb salvage for the car, and a similar picture emerges, the associate professor of surgery at Harvard Medical School in Boston and a vascular surgeon at the Massachusetts General Hospital continues. “The approach to limb salvage has historically been very much, ‘What is my silo? I’m a vascular surgeon. I am good with blood flow. I am going to increase your blood flow.’ That’s great, but if someone is not doing good wound care, and someone is not putting you on antibiotics, and you, as the patient, are not stopping smoking, your leg is going to get amputated.”

In the case of the car, an operational vehicle is more than the sum of its parts. In the case of limb salvage, the contributions of a multidisciplinary team yield better results than individual specialties operating in isolation. Fitting squarely into the heart of this picture is the role of patient-applied at home TWO2 therapy (AOTI) in aiding ulcer healing following revascularization. Dua points to a classic case to demonstrate how crucial the therapy is to successful wound salvage (see figures 1–4).

“This patient, a 68-year-old male with diabetes and end-stage kidney disease [ESKD], is absolutely someone who would have been amputated, but on whom we carried out a deep-vein arterialization [DVA] procedure, allowing blood flow to get to the foot,” she says. “That process takes time, and, during that time, you don’t want the wound to disintegrate, get infected and the person end up getting amputated. This being a patient with diabetes and ESKD, we are talking about the worst of the worst type of blood vessels. In spite of that, we healed this wound with, of course, great wound care: good blood flow was formed from the DVA, and then came TWO2 therapy.”

David Dexter, MD, an assistant professor of clinical surgery at Eastern Virginia Medical School and a vascular surgeon at Sentara Vascular Specialists in Norfolk, Virginia, sees the role of multimodality TWO2 therapy in a similar way. In the setting of arterial disease, he explains, both macro-and microvascular problems need to be tackled. An array of major technologies exists for the former while therapies for the latter remain in their infancy, Dexter says, but there is also the issue of ischemic skin changes—and these “need to be addressed in order that continued ongoing tissue loss be reversed and healed.”

“We have the ability to revascularize a limb that’s functionally dead, but without the ability to heal the wound after we’ve removed necrotic tissue after we’ve fixed the macrovascular problems, we’re at a loss,” he explains.

That’s where Dexter sees TWO2 performing a crucial role, not only in tackling the totality of the disease process but also in returning patients to normal, everyday life.

“First, I would say it needs to no longer be seen as late-stage therapy to bring wound care adjuncts like TWO2 in,” he continues. “There must be a plan: that when somebody comes in with CLTI [chronic limb-threatening ischemia] and ulceration, or with gangrene that will lead to tissue loss, we say, ‘How do I get this patient back to a functional foot that they can walk on?’ If you have a wound that you’re going to create, do you have the ability to surgically close this wound, or will advanced local, topical therapy assist me in that? Because the longer the wound is open, the longer the patient is off their extremity floor and non-ambulatory, the worse they are going to do from a protoplasmic standpoint.”

Both Dua and Dexter are unequivocal in how TWO2 functions to help heal wounds. Referencing the same case involving the 68-year-old diabetic ESKD patient who underwent DVA and then received TWO2 therapy, Dua tackles the counterargument of the same patient receiving the same treatment plan, minus TWO2.

“What if you did everything that you did, but you didn’t do the cyclical compression oxygen therapy?” she explains. “Would it have made a difference? The studies show that when you randomize patients to two groups, the ones who got TWO2 therapy did better.”

An international randomized controlled trial [RCT], conducted by Robert G. Frykberg, DPM, and colleagues, showed that cyclical pressurized topical oxygen therapy adjunctive to optimal standard of care is significantly superior to standard care alone in healing diabetic foot ulcers (DFUs) at 12 weeks and one year.

For Dexter, the venous side, on the other hand, reveals what he describes as the flip side of the coin. “The number is debatable, but 15% of all venous ulcers do not heal, have not healed and likely will not heal, and they become a chronic health problem for these patients,” he says. “They don’t lead to amputation, they are ambulatory, they are at their normal state of health but still have this wound that changes their everyday function and everyday life,” he continues, adding, “that’s where the increased oxygenation uptake of giving local topical hyperbaric oxygen therapy with some moisture directly to a wound comes in. If you can heal half of that 15%, that’s a huge magnitude of patients we have helped.”

Dexter tackles the subject of how oxygen therapy is traditionally viewed: full-body hyperbaric oxygen delivered in dive tanks. “I don’t think any of the skeptics argue with the math,” he says. “There is very clear evidence you can hypersaturate with hyperbaric pressure oxygen and deliver more to wounds both intravascularly and directly through the skin surface. From a cost standpoint, it becomes prohibitively expensive to dive, or pressure chamber, the number of patients we have. We have restricted that resource across the world for three generations. So the reason we don’t have data is it’s impossible to get enough people into trials doing things like this.

“TWO2 therapy allows at-home application for a fraction of the cost, both to the payor and to the patient. We are in a position where we are ready for an appropriately powered randomized controlled trial in venous leg ulcers [VLUs], to support existing published observational cohort studies, looking at wound healing rates and wound healing percentages.”

Fundamentally, says Dua, returning to her earlier argument, the types of wounds in question here are not those that “would have healed anyway.” These are vascular patients who see marked wound healing through the use of TWO2 therapy in the setting of severe vascular disease, she explains.

“If I told you the wound would heal seven days faster than if you didn’t use it, but it costs a million dollars, you’re going to say, ‘You know what, I’m just going to wait the week and heal it.’ Why would I spend a million dollars, right? That’s the whole point about cost effectiveness, but all of those situations are about wounds that are ‘going to heal anyway.’ These wounds I’m talking about would have probably progressed and the patient may have become an amputee.”

The therapy won’t work for every patient, every time, Dua adds. Like the tires on a car, “this is an adjunct, a piece of the puzzle that is going to help you save legs” and obviate wound complications down the road before they get the chance to develop.

The future of vascular surgery (and the role a hybrid OR plays in it)

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The future of vascular surgery (and the role a hybrid OR plays in it)
Siemens Healthineers ARTIS pheno

This advertorial is sponsored by Siemens.

Two leaders in vascular surgery preview the future of interventional imaging and consider the emergence of the hybrid operating room (OR) as a future model for success.

The hybrid OR is emerging as a cornerstone development in the future of interventional imaging. With seamless integration of advanced imaging technologies with traditional surgical tools, hybrid ORs will deliver real-time, high-resolution visuals during new and complex interventional procedures. The expected result will be greater precision, faster decision making coupled with improved patient outcomes.

As minimally invasive techniques continue to evolve, hybrid ORs will enable multidisciplinary teams to collaborate in new ways to enhance the safety and efficiency of treatments.

The continued development and adoption of hybrid ORs will undoubtedly transform the landscape of modern medicine, pushing the boundaries of what can be achieved in surgical and interventional care.

The future of vascular surgery and the role a hybrid OR plays in the space took center stage at the 2024 edition of the VEITHsymposium in New York City (Nov. 19–23).

Daniel Clair, MD, chair of the Department of Vascular Surgery at Vanderbilt University Medical Center in Nashville, Tennessee, and Alan Lumsden, MD, the Walter W. Fondren III presidential distinguished chair, at DeBakey Heart & Vascular Center, Houston Methodist Hospital, in Houston, Texas, weighed in on how new advances and changing concepts in interventional imaging will transform tomorrow’s interventional imaging suite.

A hybrid OR is a surgical space that combines traditional operating equipment with imaging technology. This allows surgeons to perform both open and minimally invasive procedures in the same room, without moving the patient. Houston Methodist Hospital and Vanderbilt University Medical Center both leverage the features of ARTIS pheno from Siemens Healthineers.

The robotic C-arm will play an important role in future interventional imaging solutions, where high-quality imaging must be met with robust flexibility to satisfy the demand for mixed, multi-modality solutions.

What does the future of vascular surgery look like for you, and how does medical imaging play a role in that future?

DC: As I think about the future of vascular surgery, we’re already seeing indications of what’s to come with a move towards less invasive procedures, more outpatient procedures, and the combination of open and interventional procedures. Almost all of it involves imaging in one way or another.

I do think that as we move forward, mechanisms to reduce radiation dosing for physicians and for patients is going to be a critical aspect of imaging and its integration with imaging as well.

Houston Methodist’s hybrid OR

AL: We’re an imaging-dependent specialty. Again, let’s talk about what imaging is to us. It’s ultrasound, and obviously Siemens Healthineers is a big player in the ultrasound space.

Vascular surgery always plays a major role in vascular ultrasound, but it’s also about computed tomography (CT), magnetic resonance (MR) and intravascular ultrasound (IVUS) and all the other imaging modalities.

Our specialty uses what I call applied imaging. What we really try to do is figure out how to use the imaging modalities to better treat the patients.

In the past, you got a CT scan and then you diagnosed an aneurysm. It’s not like that anymore. Now, we take that CT scan, we diagnose the aneurysm, we fuse that on top of the patient, and we deploy complex devices based upon the CT scan.

So, the CT scans must be good. That really was one of the things that pushed us into getting involved in the preoperative CT scan.

The nice thing is that the CT scans are generic, but not completely. So, understanding how that CT scan is acquired and the timing of the contrast is important for us.

We’re fortunate at Methodist because the DeBakey Heart and Vascular Center owns the cardiovascular movement. It’s all done by clinicians. I think that’s a big advantage in helping me understand what I need to know to execute all of these complex procedures.

DC: The integration of imaging in fluoroscopy rooms, and in rooms with imaging that is based on them—combining different modalities of imaging and using them virtually in the OR—is increasingly going to be something we do.

It is something we will need to have the capacity to do. That’s certainly true for interventional procedures, and I actually think it’s true for open procedures as well. It’s kind of a mixed reality assessment of the patient.

AL: Here’s an example. When we want to do a case, we don’t access a blood vessel without using ultrasound—and that’s transformed our ability to utilize many different blood vessels to perform ever more complex interactions safely.

So, we use ultrasound to get access. We use a CT scan to fuse with our pheno image. And we use fluoroscopy to monitor the procedure. The hybrid OR is the forum by which we can mix these different imaging technologies.

We spend a long time planning endovascular procedures, and then we just go and do an open operation without having looked at the CT scan. All that information is still there.

Increasingly, I think we need to educate residents so that they know there is a retroaortic renal vein because it’s on the CT scan. If we go to type II endoleaks, we ought to know where the lumbar arteries are and how we’re going to localize them, because they are all right there on a high-quality CT scan.

Using cinematic rendering, we can make the CT scan look ever more like surgical anatomy. As we explore robotics, this can be valuable in planning open and robotic procedures.

Vanderbilt University’s hybrid OR
You’re starting to use robotics and navigation with no radiation. Where do you see these two capabilities coming into play in the future?

DC: I do think that robotics are going to be a significant part of how we evolve [as a specialty]. There are portions of what we do in vascular surgery that are not going to convert over to interventional or endovascular therapies. There is no question that if you look at recovery times and impairment and morbidity from larger vascular procedures—or larger procedures of any kind—these variables are reduced with the use of robotics. That’s number one.

Number two, if you are just looking at non-fluoroscopy or virtual imaging as a method of doing interventions, there is no question that it provides better guidance with good imaging and reduces the time and radiation exposure for the patients, staff and physicians.

All of that will be a significant part of what we do in the future.

AL: We must parse this out into endovascular robotics and surgical robotics. I know endovascular robotics has had its challenges. [But]I still think it’s going to come back.

Look at the relationship you have with Intuitive or on the Ion [Robotic Bronchoscopy] platform. Most people here do not even know what the Ion is. And that’s an example of how, if it is not happening within your own specialty, you have no direct line of sight to it.

I think about the bronchi as long thin tubes, just like blood vessels. What Intuitive has done—and part of it is partnering with Siemens Healthineers—is you’ve got a preoperative CT scan, and you see a lung nodule. You bring your C-arm in and allow fusion to occur. You then diagram a path for the endobronchial robot, through those long thin tubes, to a peripheral target using fused imaging.

So, I think robotics can take you to one level. And then I think imaging can take you to another level. The power is going to be in putting these two things together, so now the imaging is space-specific and driving the robots. It is saying that either, “No, you cannot go in that area,” or, “This is the path that you are going to take to get there.”

If it can be done in the bronchi, I see no reason why it can’t be done in the blood vessel.

We’ve discussed a lot of technologies. How can they be used together in a hybrid OR?

AL: We need to have someone who translates the imaging capability and understands what the physician needs and helps make that bridge. That’s the physician at the moment, but there is a real need for imaging specialists who bridge the gap between what the imaging can provide and what we need. How you find those people is a challenge. That is the difference between creating a CT scan and creating an imaging modality that we can actively engage with.

DC: As clinicians there is a lot that we want in terms of imaging and its integration through multiple modalities. That interaction between engineers who design the systems and physicians who use them is what is going to drive the changes we need to see. That interaction will help us bridge the gap between what we need and what is actually possible.

All of us need to be involved. Without that interaction, it is difficult. That interaction allows us to be able to say, “I’d like this to do endobronchial, but what if we combined it with a thoracoscopic intervention done by a robot at the same time so that we can divide the blood vessels directed to that area?” This is the integration and the interaction that improve what we’re doing.

Hybrid ORs in interventional imaging integrate multiple imaging modalities to provide more accurate, real-time and comprehensive guidance during minimally invasive procedures. They are equipped with imaging systems and robotic equipment that combine the strengths of the different imaging technologies to improve diagnostic accuracy, procedural precision and patient outcomes.

Nationally ranked Houston Methodist DeBakey Heart & Vascular Center is home to four such operating rooms within its Texas Medical Center campus, bringing highly advanced care to patients in the Houston area. The rooms combine advanced medical imaging devices and an operating room. In short, these new hybrid ORs will allow for more minimally invasive procedures for both cardiovascular surgery and neurosurgery.

Cardiovascular surgeons, cardiologists, neurosurgeons and neurologists from these centers believe that the advanced technology in this building will transform clinical care for the future and will serve as the new standard for similar facilities around the country.

In 2022, Vanderbilt University Medical Center opened two of the latest generation of hybrid ORs, and each combine a traditional operating room with the latest advanced imaging equipment, simplifying procedures and allowing them to be more efficient and safer for patients.

Though Vanderbilt has built a handful of such rooms in recent years, these are the medical center’s first that will be shared by a multidisciplinary cohort. Teams performing cardiology and electrophysiology procedures as well as cardiac and vascular surgery will benefit from the sophisticated technology in the room—and from each other.

Both medical centers leverage the advanced robotic imaging capabilities of the ARTIS pheno from Siemens Healthineers. ARTIS pheno significantly improves precision and workflow during complex procedures. It delivers high-definition, 3D imaging with a level of detail that helps surgical teams visualize anatomical structures in real time, facilitating more accurate interventions.

The robotic design enables flexible and precise positioning, ensuring optimal imaging angles without the need for time-consuming manual adjustments. This efficiency not only accelerates the procedure but also reduces radiation exposure for both patients and medical staff.

With its ability to seamlessly integrate into the hybrid OR environment, ARTIS pheno supports a wide range of minimally invasive surgeries, ultimately enhancing the overall success of interventional procedures and improving patient outcomes.

The robotic imaging system was built to expand a hybrid OR’s ability to perform multiple surgical and interventional procedures. More than 1,350 hybrid operating rooms and interventional radiology suites worldwide are using the versatility of ARTIS pheno in order to advance their case mix and better facilitate more complex procedures.

To learn more about the role of the robotic ARTIS pheno in hybrid ORs, visit www.siemens-healthineers.com/en-us/clinical-specialties/surgery/surgery-product-portfolio/hybrid-or/artis-pheno.

AVF 2025: A call for ‘second-generation steps’ in venous stenting

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Bryan Kay
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AVF 2025: A call for ‘second-generation steps’ in venous stenting
Erin Murphy presents during AVF 2025

The need for a revolutionary second generation of venous stents are among the gaps and unmet needs currently at play in deep venous surgery, the 2025 American Venous Forum (AVF), held from Feb. 16–19 in Atlanta, Georgia, heard.

Erin Murphy (Atrium Health’s Sanger Heart and Vascular Institute, Charlotte, USA) was talking through the most common complications she deals with in practice as she identified a series of gaps in indications for venous stenting during a combined Society for Vascular Medicine-European Vascular Forum-AVF session at the AVF’s VENOUS 2025 annual meeting.

Patients report with swelling and lack of improvement, she told the meeting, and “most of the time, if we look at why, it’s because we’re treating physiologic but not pathologic compression.” Though less common at this juncture, Murphy said, stent migration represents the most dangerous of the complications venous specialists confront. Illustrating her point with a case example where a stent has migrated into the inferior vena cava (IVC), she again highlighted the specter of compression, or lack thereof, where venogram and intravascular ultrasound (IVUS) imaging suggested compression, whereas on post-migration computed tomography (CT), there appears to be no compression. “So we have an education gap in a lot of cases,” Murphy said.

Which raised the potential for technology that might “help us differentiate that this is truly pathologic versus anatomic compression,” she said. There have been advances with the coming of dedicated venous stents, Murphy noted. But IVC stenting would seem to remain “a big gap,” with the Viafort stent (Gore) for the treatment of symptomatic IVC obstruction with or without combined iliofemoral obstruction, still under pivotal trial, “our first real big move in this direction,” she added.

What about “second-generation steps” in venous stenting? Murphy pondered. “We haven’t seen any second moves, so is there something with drug elution like they do in the arteries that we could take advantage of; is there a game changer in the field? What I’ve seen is that there’s really no push for competition right now.”

Ketamine reduces postoperative opiate use and pain scores as part of spinal cord protection protocol for TAAA repair

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Bryan Kay
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Ketamine reduces postoperative opiate use and pain scores as part of spinal cord protection protocol for TAAA repair
Sam Tyagi at the SAVS 2025 podium

The introduction of ketamine into a spinal cord ischemia (SCI) protection protocol used during thoracoabdominal aortic aneurysm (TAAA) repairs led to significant reductions in postoperative opiate administration and patient-reported pain scores, a randomized controlled trial (RCT) performed by a team of researchers at the University of Kentucky in Lexington, Kentucky, demonstrated.

The 20-patient doubled-blind RCT showed that among the 10-patient cohort who received ketamine as part of their SCI protection bundle, estimated mean six-hour oral morphine-equivalent use over the first 48 hours was 49mcg (95% confidence interval [CI] 28.7–69.3) vs. 110mcg (95% CI 89.8– 130.3) in the saline placebo cohort (p=0.019). The estimated six-hour mean pain score for the cohort given ketamine, meanwhile, was 1.9 (95% CI 0.4–3.4) vs. 4.2 (95% CI 2.6–5.8) for those who received the placebo.

The data were delivered during the 2025 Southern Association for Vascular Surgery (SAVS) annual meeting in St. Thomas, the U.S. Virgin Islands ( Jan. 22–25) by senior investigator Sam Tyagi, MD, an assistant professor of surgery at the University of Kentucky. Tyagi received the prestigious SAVS Founders’ Award for the paper.

Tyagi and colleagues sought to address the specter of low-dose naloxone, a component of the SCI protection bundle, in worsening perioperative pain scores and increasing the need for postoperative opiate administration.

The study grew out of a previous multidisciplinary retrospective analysis aimed at identifying a pain management strategy to alleviate perioperative pain and reduce opiate reliance alongside, later, an informal conversation in which the potential for the use of ketamine in the mix emerged, Tyagi explained.

That study demonstrated that patients who received a continuous infusion of naloxone with their SCI protection bundle recorded pain scores that were statistically significantly higher and were receiving more morphine-equivalent pain medications when compared to patients who had similar operations but were under no SCI protection protocol.

“So, not only were we giving them much higher doses of opiates, we were also poorly controlling their pain on top of that,” Tyagi explained.

That’s when the suggestion to incorporate ketamine emerged during a holiday season chat with his physician brother. After some investigation, the project was set in motion.

The RCT saw patients randomized by the University of Kentucky pharmacy team before arriving in the operating room for their TAAA procedure, where ketamine administration—or the placebo—was initiated and continued during the time they were on the SCI protection protocol. “Nothing else was changed,” Tyagi said.

Results showed that no patients had adverse outcomes related to the ketamine, though one died from procedural-related complications. Another enrollee withdrew from the study several hours after randomization.

“The amount of morphine equivalents [administered] was essentially half in the ketamine group versus the placebo saline group,” Tyagi told SAVS, with pain scores showing “a 2.3 [point] difference in the ketamine vs. placebo group.”

Among future directions of study, the researchers aim to quantify the impact of incisions on pain scores, explore excitatory amino acids in cerebrospinal fluid in the setting of ketamine, as well as expand on the 20-patient RCT itself.

FFRCT diagnosis of coronary ischemia with ischemia-targeted coronary revascularization more than halves five-year risk of cardiac death and MI following CEA

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Bryan Kay
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FFRCT diagnosis of coronary ischemia with ischemia-targeted coronary revascularization more than halves five-year risk of cardiac death and MI following CEA
Dainis Krievins

Preoperative diagnosis of lesion-specific ischemia using coronary computed tomography (CT)-derived fractional flow reserve (FFRCT) and ischemia-targeted coronary revascularization after carotid endarterectomy (CEA) can reduce the five-year risk of cardiac death and myocardial infarction (MI) by more than 50% and improve long-term-survival, new data show.

The findings, from a single-center observational study, represent the latest results from Dainis Krievins, MD, and colleagues from Pauls Stradins Clinical University Hospital in Riga, Latvia, on the use of FFRCT in patients undergoing vascular procedures. The data were presented at the 2025 Southern Association for Vascular Surgery (SAVS) annual meeting in St. Thomas, the U.S. Virgin Islands ( Jan. 22–25).

Fundamentally, Krievins et al sought to determine whether FFRCT-guided coronary revascularization improves long-term survival of CEA patients, under the theory that if coronary CT angiography identifies coronary stenosis, FFRCT more precisely shows functional significance of lesions.

The cohort study included 200 patients with no cardiac history or coronary symptoms undergoing elective CEA from 2017–2019, Krievins outlined. Half received preoperative cardiac evaluation with FFRCT to identify asymptomatic ischemia-producing coronary stenoses with ischemia-targeted coronary revascularization following CEA, compared to matched controls with standard preoperative cardiac evaluation and no elective coronary revascularization. In the FFRCT cohort, lesion-specific ischemia was defined as FFRCT ≤0.80 distal to >30% stenosis, and severe ischemia as FFRCT ≤0.75. Endpoints included all-cause death, cardiac death, MI, stroke and major adverse cardiovascular events (MACE) at five-year follow-up.

Of those patients in the FFRCT cohort, coronary CT revealed ≥50% stenosis in 48 patients, with lesion-specific coronary ischemia present in 57 FFRCT patients, severe ischemia in 44, multivessel ischemia in 28, and left main ischemia in seven patients. Forty-three patients had no coronary ischemia (FFRCT >0.80). The status of coronary ischemia in the control cohort was unknown, Krievins noted.

Elective coronary revascularization was performed one to three months following CEA in 33 patients: 27 patients underwent percutaneous coronary intervention (PCI) and six coronary artery bypass grafting (CABG).

Krievins revealed that, at five years, there was a two-fold reduction in all-cause death in the FFRCT group compared to controls—24% vs. 11%. Annual mortality in the control group was 4.8% compared to 2.3% among the FFRCT cohort. Further, there was a four-fold reduction in risk of cardiac death, seven-fold reduction in the risk of MI, and three-fold reduction in MACE, he added. There was no difference in stroke rate.

A subgroup analysis of patients with significant ischemia who underwent coronary revascularization showed that all-cause mortality was similar to those who had no ischemia, Krievins continued. Further, among those with significant ischemia but who did not undergo coronary revascularization, all-cause mortality was similar to the control group.

Five-year survival was 76% in the control group and 89% among the FFRCT cohort. “Improved survival is associated with diagnosed treatment of asymptomatic ischemic-producing coronary stenosis,” Krievins said, concluding: “Patients with no known coronary artery disease undergoing CEA have a high prevalence of silent, or asymptomatic, coronary ischemia, which is a marker for high risk of death and MIs. This single center study showed that preoperative diagnosis of lesion-specific ischemia using coronary CT-derived FFR together with ischemia-targeted coronary revascularization following CEA can improve five-year risk of cardiac death and MI by more than half and improve long-term survival.”

Validation of the results require multicenter randomized trials, one of which, SCORECAD, is currently underway, Krievins added.

Humacyte announces commercial launch of Symvess for extremity vascular trauma

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Jocelyn Hudson
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Humacyte announces commercial launch of Symvess for extremity vascular trauma
Human Acellular Vessel
ATEV
Symvess

Humacyte today announced the commercial launch of Symvess (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularisation is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.

The US Food and Drug Administration (FDA) granted a full approval for Symvess on 19 December 2024. A press release reports that the FDA has now completed its required review of commercial batch information and has authorised Humacyte to commence commercial shipments.

“This is a great moment for Humacyte but, more importantly, for patients in urgent need of arterial repair options to help save their limbs or lives,” said Laura Niklason, founder and chief executive officer of Humacyte. “After more than 20 years of research and development, we are thrilled to be able to deliver Symvess to hospitals and surgeons who are committed to improving patient outcomes. This commercial launch signifies a new era in vascular surgery and patient care and is the next growth phase for Humacyte. Our commercial team will continue to work closely with healthcare providers to ensure that Symvess is available to patients nationwide.”

Humacyte notes that, in clinical studies, Symvess has been utilised by vascular and trauma surgeons in Level 1 trauma centres throughout the USA and Israel to repair severe limb-threatening and life-threatening injuries, and in front-line hospitals in Ukraine to treat wartime injuries.

“In contrast to harvesting a vein from the patient, which causes further injury and takes valuable time, Symvess is available off-the-shelf, and does not require further injuring the patient,” a press release reads.

Humacyte’s biologics license application (BLA) included positive results from the V005 pivotal Phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid programme. Symvess has been used to treat many types of injuries arising from car accidents, gunshot wounds, blast wounds, and industrial accidents. Results from these civilian and wartime trauma studies were published in JAMA Surgery on 20 November 2024. In the clinical studies, Symvess was observed to have high rates of patency, or blood flow, and resulted in low rates of limb amputation and infection.

To communicate the health economic value of Symvess, Humacyte has developed a budget impact model (BIM) based on the clinical results supporting the BLA, and the estimated reduction in clinical complications potentially achievable with the use of Symvess versus the current standard of care. Based on the BIM, the overall per-patient cost of treating patients with Symvess is estimated to be less than the cost of treating trauma patients with synthetic grafts, cryopreserved allografts, or xenografts. The major drivers of cost savings associated with Symvess stemmed from reductions in the rates of amputation and vascular conduit infection. Humacyte shares that a paper describing the BIM has already been accepted for publication in a major medical journal.

Prognostic tool for CVO stenting set to enhance therapeutic decision-making and scientific reporting

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Jocelyn Hudson
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Prognostic tool for CVO stenting set to enhance therapeutic decision-making and scientific reporting
L-R: Houman Jalaie and Mohammad E Barbati

With the aims of predicting and comparing venous stent outcomes, aiding in communication with patients, and enhancing therapeutic decision-making, researchers have proposed an anatomical classification system for patients with chronic venous obstruction (CVO) of the iliofemoral tract undergoing interventional procedures.

In a paper published in the European Journal of Vascular and Endovascular Surgery (EJVES), Houman Jalaie, Mohammad E Barbati (European Venous Center, Clinic of Vascular and Endovascular Surgery, RWTH Aachen University Hospital, Aachen, Germany) and colleagues—including the International CVO Classification Study Group—outline the results of a retrospective, multicentre study on the newly proposed classification system.

The authors write that their study analysed data from 13 vascular centres and included 1,033 patients with CVO who were treated between 2015 and 2019. They note that patients were classified into five category types: 1) non-thrombotic iliac vein lesion; 2) CVO of the iliac segment; 3) CVO of the iliofemoral segment above the common femoral vein confluence; 4) CVO of the iliofemoral segment extending into the femoral vein or deep femoral vein; and 5) CVO of the iliofemoral segment involving both the deep femoral vein and the femoral vein.

Jalaie and colleagues detail that the mean age of the patients included in the study was 44, with just under 60% being women. They specify that a median of two stents was used for unilateral cases, while a median of five was used for bilateral cases.

Writing in EJVES, the researchers report that primary patency rates for types one to five were 94.9%, 90.3%, 80.8%, 60.6%, and 39.4%, respectively, at 12-month follow-up. “These rates were strongly correlated with the extent of CVO and showed significant differences between each type,” the authors comment.

CVO classification

In addition, Jalaie and colleagues reveal that univariable analysis identified predictors of primary patency loss as the type of CVO, history of deep vein thrombosis, and the total number of stents. In multivariable analysis, they continue, the significant independent predictors of primary patency loss were the type of CVO and the total number of stents.

“The decrease in primary patency over time based on the extent of pathology is indicative of the prognostic value of the proposed classification of the iliofemoral CVO in this analysis,” the authors write in their discussion.

Based on their findings, the authors conclude: “The proposed anatomical classification of iliofemoral CVO will help to predict intervention outcomes and facilitate comparison of stent outcomes in future studies.” However, they stress that “further evaluation and validation in prospective studies are needed to confirm the utility of this classification”.

Highlighting some limitations to their study, Jalaie and colleagues recognise that its retrospective nature, the absence of a core lab for patency determination, and a lack of standardised outcome analysis such as post-thrombotic syndrome scoring, clinical venous severity scores, and quality of life scores, all impact the strength of their conclusions.

Speaking to Venous News following publication of the study, Barbati comments: “In essence, this classification system not only enhances the clinical management of patients with CVO but also contributes to the broader understanding and treatment of venous diseases, ultimately leading to improved patient care and health outcomes.”

New analysis details learning curve effect behind ‘significant improvement’ in performance of PE mechanical thrombectomy over time

By
Bryan Kay
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New analysis details learning curve effect behind ‘significant improvement’ in performance of PE mechanical thrombectomy over time
Perry Diaz presents during SAVS 2025

A multisite hospital system analysis of the safety and procedural learning curve behind the performance of percutaneous mechanical thrombectomy for pulmonary embolism (PE) shows significant reductions in both fluoroscopy and procedure times alongside contrast volume over time.

The data, the senior author behind the study says, lend weight to the argument that vascular surgeons need to become more involved in performing this type of procedure in this part of the vasculature.

“Vascular surgeons can do this, we can do it safely, and, with practice, we can do it even better,” explains Jason Chin, MD, a vascular surgeon at Cleveland Clinic Abu Dhabi, the United Arab Emirates, and previously with MedStar Health in Baltimore, Maryland, where the study was carried out. “And this is a conversation vascular surgeons need to get involved in now or get left behind.”

Jason Chin

The MedStar analysis—presented during the 2025 Southern Association for Vascular Surgery (SAVS) annual meeting in St. Thomas, the U.S. Virgin Islands ( Jan. 22–25)— involved 420 patients undergoing PE mechanical thrombectomy from January 2020 to July 2024.

In addition to detecting statistically significant falls in fluoroscopy and procedure times and contrast volume, the researchers identified institutional plateaus for improvement of 55 and 138 cases for fluoroscopy time and procedure time, respectively.

Averaged across the number of surgeons participating, it would take an individual surgeon 3.4 cases to become proficient in imaging-related efficiency and 8.6 cases to become proficient in broader procedural efficiency. Additionally, presenting author Perry Diaz, a medical student at Georgetown University School of Medicine, told SAVS 2025, they found no statistically significant differences between the first and last 50 cases in hospital or intensive care unit (ICU) length of stay or complications. The overall mortality rate was 4.49%.

“Importantly, we also saw that, with the first 50 cases and the last 50 cases out of the 400 we did, we still had good results for both, which I think says good things about being able to start a program, and still do it safely,” Chin details in an interview with Vascular Specialist. “But I think that as we gather more data, within our system and among PE interventionalists at large, we’ll certainly see that improvement in ICU and hospital length of stay, and in some of these outcomes that we saw trends in.”

Navigating the heart is not an area in which vascular surgeons are traditionally trained but the data—which represent different types of practice settings and operators—illustrate they can perform the PE procedure safely and with good results in this part of the vasculature, Chin says. “Certainly, putting a 24F sheath through multiple chambers of the heart can be a little bit nerve racking the first time you do it,” he says, “but when I look at vascular surgeons compared to other interventionalists, in our field we work with these wires, these sized devices, at least as much if not more than any of those other fields.

“Maybe we haven’t always crossed the right atrium and the right ventricle with them, but I think our skillset and the natural anxiety we might have about some of the complications we might have to deal with from related procedures, it does make us safe in that section of the vasculature, and it’s a natural extension of a lot of the deep venous work we do.”

Chin also drew reference to the scale of venous disease circulating among the population at large. “Venous thromboembolic disease—and venous disease in general—is at least as common, if not a lot more common than arterial disease. And maybe it isn’t as limb or necessarily life threatening compared to arterial disease, but it’s still out there and still affects a lot of people,” he adds.

Vascular Specialist–January/February 2025

By
Bryan Kay
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Vascular Specialist–January/February 2025
In this issue:
  • US ARC uncovers ‘dramatic’ decrease in use of prophylactic spinal drains at same time as spinal cord ischemia steeply declines
  • Interview: Daniel Clair, MD, discusses deep vein arterialization and how much remains to be learned about the procedure, but how its use is poised to expand in patients with less severe ischemia
  • Part two of a series from our chief medical editor: ‘So you want to marry a surgeon?’
  • PAD: Textbook outcomes are ‘very rare’ after revascularization for CLTI, new study finds

Foundation grant projects

By
Marlén Gomez
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Foundation grant projects

Here’s a closer look at a funded partially through grants from the Society for Vascular Surgery (SVS) Foundation.

Samantha Minc, MD, received a Clinical Research Seed Grant in 2018 and a National Institute of Diabetes and Digestive and Kidney Diseases-funded K-23 award in 2022 (with additional funding by the SVS Foundation and the American College of Surgeons) to help with her project to implement interventions and amputation prevention in underserved areas across the country.

Her seed grant started her on intense mapping in the highly rural, very underserved community in West Virginia where she worked to understand and identify “amputation” hotspots, followed by qualitative work with focus groups with people dealing with amputations and amputation prevention. She has since relocated to Duke University in North Carolina.

“Funding helped me engage and empower stakeholders in those areas to work together with me to build our actual amputation prevention intervention,” she said.

“The seed grant funding got me the preliminary information I needed to help empower the communities being disproportionately affected by amputation.”

Shape Memory Medical announces first European enrolment in AAA-SHAPE pivotal trial

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Bryan Kay
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Shape Memory Medical announces first European enrolment in AAA-SHAPE pivotal trial
Impede embolisation plug, expanded

Shape Memory Medical today announced the first European enrollment in the AAA-SHAPE pivotal trial, the company’s prospective, multicenter, randomized, open-label trial to determine the safety and effectiveness of the Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR). The patient was treated by Jan Heyligers and Patrick Vriens at Elisabeth TweeSteden Hospital in Tilburg, The Netherlands.

“We congratulate Dr Heyligers, Professor Vriens, and the clinical study team at Elisabeth TweeSteden Hospital for being the first centre in Europe to enrol in the AAA-SHAPE pivotal trial,” said Marc Schermerhorn (Beth Israel Deaconess Medical Center, Boston, USA), AAA-SHAPE national principal investigator. “This milestone reflects the unwavering dedication of the physician investigators to advance embolisation solutions and enhance patient care worldwide.”

A press release details that AAA-SHAPE (Abdominal aortic aneurysm sac healing and prevention of expansion) will enrol 180 patients with infrarenal AAA across up to 50 sites in the U.S., Europe, and New Zealand. Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.

“We are proud to be the first site in Europe to treat a patient in this groundbreaking trial,” said Heyligers. “Research shows that 60% of aneurysms either fail to regress or expand within a year after EVAR, often leading to rehospitalizations, additional interventions, and higher mortality rates. The results of this study will be essential in determining whether the Impede-FX RapidFill, with its unique properties, can significantly enhance post-EVAR AAA outcomes and elevate the standard of patient care,” continued Heyligers.

Impede-FX RapidFill, the investigational device, incorporates Shape Memory Medical’s novel shape memory polymer, a proprietary, porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood. In AAA-SHAPE, Impede-FX RapidFill is intended to fill the aneurysm blood lumen around a commercially available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.

The AAA-SHAPE pivotal trial builds upon the AAA-SHAPE early feasibility study which enrolled 35 patients in New Zealand and The Netherlands to assess the use of Impede-FX RapidFill for AAA sac embolisation during EVAR.

Stryker completes acquisition of Inari Medical

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Bryan Kay
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Stryker completes acquisition of Inari Medical

Stryker announced today that it has completed the acquisition of Inari Medical. A press release notes that the addition of Inari brings an established peripheral vascular position to Stryker in the fast-growing venous thromboembolism (VTE) segment.

“The acquisition of Inari Medical marks a significant milestone in expanding our interventional endovascular portfolio,” said Kevin Lobo, chair and chief executive officer, Stryker.

The company states that Inari’s product portfolio is “highly complementary” to Stryker’s neurovascular business and includes two novel mechanical thrombectomy solutions—the FlowTriever system for the treatment of pulmonary embolism and the ClotTriever system for thrombectomy in the peripheral vessels—as well as emerging therapies.

Reflections from VESS: Internal mentoring, external inspiration and really good skiing

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Bryan Kay
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Reflections from VESS: Internal mentoring, external inspiration and really good skiing
Claire Motyl

Just over a week ago, I was racing my medical school vascular surgery attending, Dr. Adam Doyle, down a Breckenridge run memorably named “The Devil’s Crotch.” We were celebrating fresh powder, the conclusion of an excellent fellows program, and the opportunity to reconnect with old students (for him), and with familiar faculty and friends (for me). The conference also gave me the opportunity to reflect on the start of my chief years (I am currently a 4th-year integrated resident), and on the lessons I took away from the course.

As other residents and I swapped stories from the trenches, we frequently shared tales about those who came before us—the residents who raised us. One or two stood out, and when I thought about why this was—why we all talked about them with such high regard—I realized that these were residents who not only cared about teaching us but trusted us enough to give us the opportunity to fail. As a medical student, these were residents who told me how to pull a drain and didn’t supervise me the second time I did it; as a resident, this was the difference between the residents who showed me how to use the Perclose for the 1 millionth time, and the ones who let me deploy them and accepted the consequences.

Succeeding in these training-level-appropriate quests builds confidence for both parties and sets the stage for unlocking the next level. As we enter the era of Entrustable Professional Activities (EPAs), I think that, within the arena of internal mentoring (resident to resident), we should consciously consider entrustable training activities. While turning away and letting someone else do something for the first time is actually hard (a recent discovery), I do think it is as important as ever to ensure that, as chief residents, we are giving junior residents and medical students time and opportunity to execute independently. Although letting a junior discover the “vein of pain” independently might result in a little extra work for the supervisor up front, that resident will certainly not forget where it lives the next time (thank you, Victoria, if you’re reading this, and to the general surgery resident who learned this last month: you’re welcome).

As important as it may be to look upwards for inspiration, so too is it important to look outwards. A second personal (and potentially more controversial) takeaway from the Vascular and Endovascular Surgery Society (VESS) Annual Winter Meeting 2025 (Feb. 6–9) in Breckenridge, Colorado, can be summed up as “do as they do, not as they say.” During an industry-sponsored session on leadership in vascular surgery, one of the panelists described how she performed the first transcarotid artery revascularization (TCAR) at her institution, only to have this practice suspended by the division chiefs of two other departments. Subsequently, a patient presented who was anatomically best suited for a TCAR; those chiefs asked her to intervene, and TCAR then gained a foothold at this institution. While this person’s advice was “ask first, don’t make the same mistake I did,” my takeaway was the complete opposite. Do the right thing, ride the waves you make, and, ultimately, something good might come of it.

Both Dr. Doyle and I are former ski racers, so the concept of tolerance of a certain level of risk is familiar to us, which explains how we ended up on the “Devil’s Crotch.” But whether the memorable event is a ski run, performing an entrustable training activity for the first time, or making waves performing an intervention at a new institution (and asking for forgiveness, not permission), making it memorable is well worth the effort.

Claire Motyl is an integrated vascular surgery resident at the University of Alabama at Birmingham.

Study demonstrates textbook outcomes occur less than a quarter of the time after CLTI revascularization

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Bryan Kay
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Study demonstrates textbook outcomes occur less than a quarter of the time after CLTI revascularization
Jayer Chung

Textbook outcomes remain “very rare” after revascularization for chronic limb-threatening ischemia (CLTI), with the main driver being an enduring inability to attain complete wound healing and to return patients to their preoperative ambulatory status, according to the lead researcher behind a new study looking into a version of the performance outcome metric.

Jayer Chung, MD, an associate professor in the Division of Vascular Surgery and Endovascular Therapy at the Michael E. DeBakey Department of Surgery, Baylor College of Medicine, in Houston, Texas, was speaking to Vascular Specialist shortly after presenting data at the 2025 Southern Association for Vascular Surgery (SAVS) annual meeting in St. Thomas, the U.S. Virgin Islands (Jan. 22–25), describing how current outcome metrics do not capture the totality of a patient’s CLTI journey.

“Textbook outcomes at one year were rare,” Chung told SAVS 2025. “They occurred in less than quarter of our population. And what’s significant is that when you split the [textbook outcome] composite, we see that the traditional metrics used to measure clinical success such as survival, limb salvage, freedom from 30-day complications were met,” he continued. “Yet, many of the patient-centric metrics such as wound healing, ambulation and freedom from wound-related procedures were not met. Complete wound healing and a return to ambulatory status were achieved in approximately two thirds, almost half of our patients underwent another revascularization at one year, and only two thirds of our patients were able to get by with one or less wound-related procedure.”

Chung and colleagues performed a nine-year retrospective, single-center analysis of consecutive CLTI patients undergoing revascularization (open, endovascular or hybrid). Textbook outcome was defined as a composite of survival, limb-salvage, no reinterventions (wound or vascular), freedom from major complications, less than one wound-related procedure and complete wound-healing at one year.

“Patients with WIfI [wound ischemia and foot infection] stage 1 had more than 2.5-fold odds of achieving a textbook outcome compared to all of the other WIfI stages, whereas taking anticoagulants at baseline, diabetes at baseline or residing in an assisted living facility were independently less likely to achieve a textbook outcome,” Chung added during SAVS 2025. “In our opinion, current performance metrics overlook the true procedural burden of revascularization, therefore we feel that our definition of textbook outcomes should be factored into future patient education and treatment selections, in outcome evaluations, in clinical trials and quality assessments.”

Chung later expanded on why he believes the textbook outcome metric better elucidates CLTI care.

“Our current outcome metrics fail to capture the full depth and scope of the patient experience,” he told Vascular Specialist. “It misses particular functional outcomes like ambulation and domiciliary status, as well as fails to truly capture the impact of wound care and the progress that patients have on the journey to try and salvage their limb. The current metrics that are used to track performance across clinical trials or quality assessments, for instance, overestimate the quality of care that is being given. It causes us to misappropriate resources to some extent, as well as misjudge the true quality when we are comparing two different therapies.”

Chung added: “I think utilizing a comprehensive metric like textbook outcome to adjudicate and help educate our patients ahead of time is going to be critical going forward as we try to improve the care of our patients overall.”

Members: Take advantage of Mentor Match

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Marlén Gomez
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Members: Take advantage of Mentor Match
In this high angle view, a group of medical students stand in their classroom. They look up and smile for the camera.

Society for Vascular Surgery (SVS) members have the opportunity to give and receive career guidance by participating in the Society’s Mentor Match program.

The SVS has expanded the program—originally designed for medical students and general surgery residents—to include all SVS members in good standing.

Mentors help mentees explore the specialty, grow in their careers and achieve professional goals, such as publishing and research opportunities, training pathways and involvement in a number of arenas, including within the SVS itself.

The program is run on the online, members-only SVSConnect platform. Its description tells members to “engage with fellow members, exchange ideas and cultivate relationships to help propel your career forward. Join the conversation today and unlock the power of networking on SVSConnect!”

Currently, approximately 35 mentees have the attention of nearly 20 mentors; some mentors have multiple mentees and some mentees have multiple mentors.

With a diverse trainee population, the program needs a varied group of mentors, from all practice types, and from all over the country and the world.

Christine Shokrzadeh, MD, regards the program as one of the top benefits of SVS membership. Now an attending vascular surgeon at the University of Texas Medical Branch in Galveston, Texas, when she was still a trainee a more senior member helped her with a query about academic medicine.

Now, she said in a video, “I’m able to pay it forward by helping medical students and residents who are interested in a career in vascular surgery.”

Learn more and sign up at svsconnect.vascular.org.

Countdown to New Orleans: VAM 2025 set to explore innovation

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Marlén Gomez
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Countdown to New Orleans: VAM 2025 set to explore innovation

The 2025 Vascular Annual Meeting (VAM) will take place in New Orleans, Louisiana, from June 4–7, with a particular focus this year on innovation.

Key program highlights coming up this year include case-based learning sessions entitled “Optimal Management of the ‘No Option’ CLTI Patient” and “Spinal Cord Ischemia,” as well as interactive courses with topics like “Carrying the Weight: Parenthood in Vascular Surgery.”

The scheduled programming is designed to accommodate vascular professionals at various career stages, offering sessions tailored to diverse interests and practice environments. Attendees can expect discussions on complex cases, advancements in vascular care and skill-enhancing activities.

“With VAM 2025 set in New Orleans, attendees can look forward to enriching their professional knowledge through discussions on complex cases, advancements in vascular care, and skill enhancing activities,” said Program Committee Chair Jason T. Lee, MD. “From engaging plenary sessions to hands-on learning, VAM25 offers essential education and networking opportunities.”

Visit vascular.org/VAM for updates on session topics, keynote speakers and special events.

BEST-CLI trial spline model analysis breaks new ground in assessing the impact of CKD severity on CLTI outcomes

By
Bryan Kay
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BEST-CLI trial spline model analysis breaks new ground in assessing the impact of CKD severity on CLTI outcomes
Mahmoud B Malas
Mahmoud Malas

A new analysis of the BEST-CLI trial has produced the first evidence-based glomerular filtration rate (eGFR) value—30 mL/min/1.73 m2—as the cutoff below which patients with chronic limb-threatening ischemia (CLTI) experience significantly worse outcomes after revascularization regardless of the treatment modality performed.

The data were part of a deep dive into the landmark study in an attempt to unpick the impact of chronic kidney disease (CKD) severity on outcomes from both open bypass and endovascular intervention for lower extremity infrainguinal revascularization.

Results from the analysis, led by UC San Diego chief of vascular and endovascular surgery Mahmoud Malas, MD, were delivered during the 2025 Southern Association for Vascular Surgery (SAVS) annual meeting in St. Thomas, the U.S. Virgin Island (Jan. 22–25) and simultaneously published by the Journal of Vascular Surgery.

“We identified GFR of less than 30 as the inflection point that is associated with double the risk of MALE [major adverse limb events] or death and triple the risk of cardiovascular events and all-cause mortality,” presenting author Mohammed Hamouda, MD, a postdoctoral fellow at UC San Diego in San Diego, California, told SAVS 2025. “We also see that, in the BEST-CLI trial, that those patients on dialysis had very poor long-term survival, which raises many questions of if we need to treat every single patient on dialysis or revascularize them.”

Mohammed Hamouda presents during SAVS 2025

A total of 1,797 patients were included in the analysis, which categorized patients into three groups according to CKD stage: group A includes non-CKD and CKD stages 1 and 2 patients; group B stages 3 and 4; and group C stage 5 and dialysis-dependent patients. Three-quarters of the patients belonged to group A and 14.7% and 11.5% were in group B and group C, respectively.

Malas and colleagues established that those group C patients had double the risk of amputation with a hazard ratio [HR] of 2.13 (p<0.001), MALE or all-cause mortality (HR, 2.05; p<0.001), and more than triple the risk of all-cause mortality with an HR of 3.40 (p<0.001), compared with group A. In dialysis-dependent patients, endovascular therapy was associated with slightly better survival, but twice the risk of reintervention compared with open surgical bypass, they found.

But, Hamouda elaborated, this National Kidney Foundation staging system of CKD is not designed to investigate surgical outcomes, which then led the research team to carry out a spline analysis in order to establish the significant cutoff at which surgical outcomes in CLTI patients hit statistical significance. “The idea is that we use GFR as a continuous variable, and against it we plot the hazard of MALE or death,” he explained. “We wanted to see where the GFR hits statistical significance, or where is the inflection point at which the hazard of MALE or death becomes statistically significant.”

That then established a GFR of under 30 as statistically positive for increased hazard of MALE or death. “But we wanted to see if there was any confounding by treatment type,” Hamouda continued. Comparing those patients receiving open bypass and endovascular intervention, “we found similar results: as long as the GFR is below 30, there is no difference in the treatment modality when it comes to the hazard of MALE or death,” he added.

Those hazard ratios for eGFR <30 vs. ≥60 were 2.03 (95% confidence interval [CI], 1.68–2.43; p<0.001) and 3.46 (95% CI, 2.80–4.27; p<0.001) for MALE and mortality, respectively.

“One concerning but not surprising point we found during this study was that BEST-CLI was designed to include only patients who have more than two years of expected survival after the procedure, but, with those patients on dialysis in the trial, it doesn’t matter whether they are getting an open bypass or endovascular intervention: as long as they hit the three-year mark, survival was below 50%, which was very sobering.”

Deep vein arterialization: Much remains to be learned but use poised to expand in patients with less severe ischemia

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Bryan Kay
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Deep vein arterialization: Much remains to be learned but use poised to expand in patients with less severe ischemia
Daniel Clair

These remain early days for transcatheter arterialization of the deep veins (TADV) in the setting of patients with severe chronic limb-threatening ischemia (CLTI), says Daniel Clair, MD, one of the principal investigators in key clinical trials of the procedure, but the learning-curve process promises that “we are going to continue to see slow but not insignificant improvement in results” with the technique.

“Even within all of the PROMISE trials, you’re talking about only 250 patients that have been assessed, published and looked at carefully,” says the professor and chair of the Department of Vascular Surgery at Vanderbilt University Medical Center in Nashville, Tennessee. “There is still a lot to learn.”

Late last year, Clair presented two-year outcomes from the prospective, multicenter, single-arm PROMISE II trial of the LimFlow system (Inari Medical) for TADV in so-called no-option CLTI patients at the 2024 edition of Vascular Interventional Advances (VIVA) in Las Vegas (Nov. 3–6), demonstrating sustained limb salvage and wound healing.

All patients enrolled in the trial had Rutherford class 5/6 disease, with a total of 105 CLTI patients undergoing the procedure between 2018 and 2022. At VIVA, Clair reported a limb salvage rate of 65% and improvement in Rutherford classification: 65.8% of patients had class 4 or below and 54.3% had class 0. Wounds were completely healed/healing in 82% of patients and the mean pain score was 1.2 out of 10. When combined with the PROMISE I trial, the two-year limb salvage rate was 68%, with no differences observed based on age, sex, race, baseline Rutherford classification, diabetes or dialysis, Clair had added.

Those type of data are likely to be built upon, with the future portending wider use of TADV, Clair reflects in a recent interview with Vascular Specialist.

“What is likely is that you are going to see an expansion in the use of this technology in patients who perhaps are not as far down the path of ischemia as we have seen,” he explains. “I also think that there will likely be some complementary role in terms of arterial revascularization in people who have very bad distal disease.”

The data show that 25–30% continue to lose their limbs even when TADV is used, so opportunities to enhance benefits from the procedure require exploration, Clair continues. “The use of deep vein arterialization with vascular growth factors to enhance angiogenesis in the foot might be ideal. Right now, we are trying to understand how to optimize the venous flow in the foot to enhance, expedite and speed up the arterialization and delivery of oxygen to the tissues in the foot so we don’t lose the forefoot or toes, but we get them this delivery of oxygenated blood so they can heal the wounds that they have. Part of what we’re doing is trying to look at the angiographic and duplex data from PROMISE I and II patients to see if we can identify who are the patients who did really well and the patients who did not do well, and can we identify differences between them.”

Clair is clear on this direction of travel. The patient population who informed the clinical trials typify the necessity of the procedure, he says. “In the past, essentially everyone I have enrolled in these trials is a patient who likely would have had an amputation, and I can say that because I have watched them worsen before enrolling them having tried other measures to help get them through. In the PROMISE trials, we carried this out in what I call the sickest of this group of patients, because they had to be externally validated as having no option; they had to be more than a month out from any previous angiogram or attempted intervention; and they had to have a wound on their foot in order to allow them to qualify. One of the critical issues now is, while that was what the trial was, in the community this technology is being used more in patients who don’t have good options, but who get an angiogram, can’t have percutaneous intervention, and the next day they are going for this venous arterialization.”

In his own practice, Clair has seen previous non-believers in the technology start to embrace it and make referrals. His previous involvement in angiogenesis trials underscore how sick the PROMISE patients are, he says: in those, patients who had rest pain, severe claudication, and no foot wound could be enrolled. “[PROMISE trial participants] are patients who have not been studied in any previous trial because, frankly, they are sicker than any company was willing to look at, particularly in interventional trials.”

Some form of forefoot amputation is not unusual in the first two to three months after TADV, nor is an increase in pain in the first month, PROMISE data reveal. “It’s unusual for these patients to keep everything because they have such severe disease in the foot by the time they presented for treatment with this therapy,” Clair points out. “Intriguingly, in PROMISE I, with every patient who kept their limb, if you made it three months with their limb on, they were going to keep their limb for the long term. In PROMISE II, there were very few patients who lost their limb beyond that first three-to-four-month period. If you get a good venous arterialization, and you see a response through six to 10 weeks, these people are likely going to keep their limb.”

Meanwhile, PROMISE III will take another extended look at the same group of patients “in a little more real-world applications,” Clair adds. “So many of these patients have bilateral limb ischemia, so we included patients in whom you could do the procedure on both sides. We did not mandate an independent review committee; we did not mandate a 30-day waiting period between a previous angiogram or attempted intervention and moving on to venous arterialization.”

InspireMD and NAMSA to partner on CGUARDIANS II pivotal clinical trial

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Jocelyn Hudson
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InspireMD and NAMSA to partner on CGUARDIANS II pivotal clinical trial

InspireMD and North American Science Associates (NAMSA) today announced that, pursuant to a previously announced strategic outsourcing partnership, the companies are working together to conduct the CGUARDIANS II pivotal study of InspireMD’s CGuard Prime 80cm carotid stent system for use in transcarotid artery revascularisation (TCAR) procedures.

Marvin Slosman, chief executive officer of InspireMD, commented: “With more than 30,000 TCAR procedures performed in the US each year, TCAR is a rapidly growing procedure that represents a significant potential expansion of our addressable market and the lynchpin of our effort to serve the broadest patient population by supporting both CAS [carotid artery stenting] and TCAR carotid stenting procedures. We are very pleased to be working with NAMSA and leveraging their vascular clinical and regulatory expertise to execute this important study as efficiently as possible.”

Adam Saltman, NAMSA’s chief medical officer, added: “The CGUARDIANS II study is a well-designed pivotal study that will evaluate the safety and effectiveness of the TCAR procedure as performed with the novel CGuard Prime stent platform with an FDA [US Food and Drug Administration]-authorised embolic protection device. CGUARDIANS II is an excellent example of how NAMSA and our clinical leaders collaborate and provide support by leveraging our more-than-four-decades of investigative experience in carotid disease in general, and carotid artery stenting in particular, most recently through a TCAR approach. We look forward to continuing our work with the InspireMD team and their advisors in this and other investigations of novel therapies.”

On 9 December 2024, InspireMD announced that the first patient had been enrolled into the CGUARDIANS II clinical study.

A press release notes that CGUARDIANS II is a prospective, multicentre, single-arm pivotal study that aims to enrol a minimum of 50 evaluable patients. The objective of this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with an FDA-cleared TCAR neuro-protection system in patients at high risk for adverse events from carotid endarterectomy.

Akura Medical enrols first patient in QUADRA-PE study

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Bryan Kay
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Akura Medical enrols first patient in QUADRA-PE study

Akura Medical has announced today the first patient enrolment in the QUADRA-PE study evaluating the Katana thrombectomy system in patients with acute pulmonary embolism (PE). The initial procedure was successfully performed by Samuel Horr, director of cardiovascular research at TriStar Centennial Medical Center in Nashville, USA.

“TriStar Centennial is thrilled to be a part of research trials that hold the potential to deliver better care to patients,” commented Horr. “With this trial, the hope is to provide physicians with continuous, real-time pulmonary artery pressure readings throughout the entire procedure to streamline the removal of the blood clot.”

“One of the biggest challenges in thrombectomy procedures for PE is determining when you’ve successfully removed the thrombus entirely, as incomplete removal can may lead to suboptimal outcomes,” said Sanjum Sethi (Columbia University Medical Center, New York, USA) co-principal investigator for the QUADRA-PE trial. “The Katana System’s display of real-time pressure data represents a significant advancement, providing physicians with clinically useful insights during the procedure.”

A recent press release shared by the company has stated that the Katana system includes:

  • A bidirectional, low-profile sheath designed to facilitate smoother navigation in complex vasculature and enable contrast injection without requiring catheter exchanges.
  • High velocity saline jets that are engineered to effectively break up clots independent of morphology and prevent catheter clogging for procedural efficiency.
  • Sensors that provide real-time pulmonary artery pressure data to provide insights into procedure progress.
  • The Sentinel console, which displays clot engagement and blood loss to inform the physician and to potentially minimise uncertainty.

“Pulmonary embolisms can be life-threatening and demand swift and effective intervention. Meaningful strides have been made in the thrombectomy landscape, but challenges remain in navigating complex vasculature and simplifying decision making,” said Ann Gage (TriStar Centennial Medical Center, Nashville, USA), co-principal investigator for the QUADRA-PE trial. “I am incredibly excited to be involved in this study as it represents a significant milestone in the forward trajectory of pulmonary embolism treatment.”

The QUADRA-PE study is a multicentre, international trial designed to enrol up to 118 patients with clinically significant acute PE, at up to 26 sites globally. The primary effectiveness endpoint is the reduction in right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure as assessed by CT angiography. The primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours post-procedure.

ROADSTER 3 provides key evidence that ‘goes beyond registry data’ on TCAR-related stroke rates

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ROADSTER 3 provides key evidence that ‘goes beyond registry data’ on TCAR-related stroke rates
Meghan Dermody

Thirty-day results from the ROADSTER 3 study have demonstrated that transcarotid artery revascularization (TCAR) is a safe and effective approach in patients who are deemed to be standard risk for experiencing adverse events related to carotid endarterectomy (CEA). These findings were presented at the 2024 Vascular InterVentional Advances (VIVA) conference (Nov. 3–6) in Las Vegas by Meghan Dermody, MD, chief in the Division of Vascular Surgery at Penn Medicine Lancaster General Health, in Lancaster, Pennsylvania. Recently speaking to Vascular Specialist, she emphasized the importance of being able to “quote stroke rates that go beyond registry data” for this patient population.

“Since we are unable to conduct an adequately powered randomized controlled trial to study TCAR against other modalities to treat severe carotid stenosis, and especially without a TCAR arm in the forthcoming CREST-2 trial, it is imperative that we study TCAR in a standard-risk population—ideally in a prospective fashion,” Dermody said. “ROADSTER 3 is an FDA [Food and Drug Administration]-required, post-approval study, but it allowed us the opportunity to acquire data from across the USA with multiple generations of surgeons performing the procedure.”

Touted by Silk Road Medical (Boston Scientific) as the first-ever prospective, multicenter trial evaluating the safety and effectiveness of TCAR using the company’s Enroute transcarotid stent system (TSS) in conjunction with its Enroute transcarotid neuroprotection system (NPS) for the treatment of carotid stenosis in standard surgical risk patients, ROADSTER 3 enrolled a total of 344 patients across 53 US sites for intention-to-treat (ITT) analyses. The single-arm study’s primary endpoint is a composite of major adverse events (stroke, death or myocardial infarction [MI]) through 30 days post-procedure, plus ipsilateral stroke from day 31 to day 365 post-procedure, while incidence of cranial nerve injury (CNI) within 30 days post-procedure is described by the authors as a key secondary endpoint.

In ROADSTER 3’s ITT population, 75.3% of patients were younger than 75 years of age, 42.7% were female, and 16.3% had symptomatic carotid stenosis, with a quarter of these symptomatic patients experiencing a neurologic event within the two weeks preceding their TCAR procedure. Dermody and colleagues report that the mean lesion length was 23.3mm, while 47.4% of patients presented with a Type II or Type III aortic arch, and 17.2% of lesions had severe calcification.

The rate of stroke/death/MI at 30 days in the study’s ITT population was 0.9%—a figure that decreased to 0.6% within per-protocol analyses involving 320 patients. The researchers found that 30-day stroke rates specifically were the sole contributor to these numbers, with no deaths or MIs being reported through the 30-day follow-up. They further relay that the incidence of CNI within 30 days was 0.6% in both the ITT and per-protocol analyses, and that all cases in both of these populations were resolved within six months.

According to Silk Road, this constitutes—to date—the lowest reported rate of adverse event outcomes in a population of standard surgical risk patients treated via carotid revascularization. The company also claims that, in line with the previous ROADSTER and ROADSTER 2 registry studies, ROADSTER 3 demonstrates consistently low adverse event rates across all risk levels.

“Given TCAR is less invasive than CEA and has similar stroke rates with less nerve injury risk, if a patient is able to take dual antiplatelet and statin therapy, and their anatomy is amenable, there is no reason why TCAR shouldn’t be your first-choice modality,” Dermody said, outlining how the minimally invasive procedure may fit within existing carotid revascularization paradigms. “But, given the anatomic and physiologic requirements needed for a successful TCAR, naturally, not all patients will be good candidates for this approach.

“Personally, I believe the treatment of carotid stenosis needs to be more focused on the lesion morphology rather than the degree of stenosis alone. The amount of calcification within or around the lesion; the amount of irregularity or ulceration to the atheroma; any thrombus burden within the plaque; arterial wall inflammation; and a slew of other anatomic features, should truly be what we base our shared decision-making on in the future. This requires thorough scrutiny of preoperative imaging, specifically an adequately thin-sliced and well-windowed CT [computed tomography] angiogram.”

Dermody and colleagues also note that symptomatic status did not appear to have a statistically significant bearing on the 30-day incidence of stroke/death/MI, which occurred at a rate of 1% in asymptomatic patients (n=3) versus 0% in symptomatic patients (n=0) in ROADSTER 3’s ITT population, and 0.7% (n=2) versus 0% (n=0) in its per-protocol analysis.

“ROADSTER 3 was not powered to study differences amongst patients based on presenting symptoms, so clinical relevance is difficult to estimate,” Dermody commented. “However, based on multiple previous publications and my own personal experience in practice, the vast majority of patients who present with symptomatic carotid disease are not on best medical therapy at the time of presentation. Adequate management of their risk factors perioperatively is more likely to result in good outcomes, regardless of preoperative symptomatic status.”

Discussing what are likely to be the next key steps in terms of evaluating TCAR, Dermody highlighted the five-year follow-up of these patients—as per a ROADSTER 3 sub-study. In addition, she stated that the future may offer opportunities to study Plavix (clopidogrel) resistance, which is considered a major contributor to post-TCAR stroke, as well as the option to utilize transcarotid flow reversal technology for intracranial neurointerventions.

“There aren’t enough data regarding surveillance of carotid stents, how or when to treat recurrent carotid stenosis within a stent, or long-term outcomes from TCAR yet,” Dermody added. “I look forward to seeing how best medical management compares to CEA and transfemoral carotid stenting in CREST-2.”

Penumbra launches Element vascular access system for VTE

By
Bryan Kay
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0
Penumbra launches Element vascular access system for VTE
Element vascular access system

Penumbra recently announced the launch of its Element vascular access system. This is the first laser-cut hypotube sheath designed for venous thromboembolism (VTE), the company shares in a press release.

Penumbra notes that Element is compatible with the Lightning Flash 2.0 mechanical thrombectomy system for the removal of venous thrombus and the treatment of pulmonary embolism (PE).

“The flexibility and torqueability of the Lightning Flash 2.0 catheter paired with the foundational support of the Element sheath has allowed us excellent angiographic and clinical success,” said Raj Kakarla (Javon Bea Hospital, Rockford, USA). “Penumbra’s continuous advancements provide a comprehensive portfolio for physicians to treat a wider range of patients and improve patient outcomes.”

Penumbra details that Element features the HemoLock valve system, which is designed to ensure haemostasis through dual-valve engineering. “Equipped with a rotating haemostatic valve and a removable cross-cut valve, the system provides physicians with precise control during procedures,” a press release reads.

The company adds that the Element laser-cut hypotube design is engineered to maintain stepwise support throughout the vasculature to enhance performance across challenging anatomies; the atraumatic tip design is crafted to help enable smooth delivery and trackability; and the proximal segment is purposefully engineered to deliver foundational support, while optimised polymer transitions help maintain sheath access without the application of proximal hydrophilic coatings.

SVS calls for comments on Vascular Surgery MIPS Value Pathway

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Marlén Gomez
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0
SVS calls for comments on Vascular Surgery MIPS Value Pathway

The Society for Vascular Surgery (SVS) announced that the Vascular Surgery MIPS Value Pathway (MVP) was posted for public comment by the Centers for Medicare & Medicaid Services (CMS). Developed by the SVS Quality and Performance Measure Committee (QPMC), the pathway is designed to reflect the care of vascular patients across all practice types and locations while minimizing the burden of data submission.

The Vascular Surgery MVP is the first step toward creating specialty-specific quality metrics that improve vascular care. While awaiting CMS approval, the QPMC continued to develop additional measures for potential use in other CMS payment programs.

“This is a significant milestone in our ongoing efforts to improve the quality of care for vascular patients while meeting CMS reporting requirements,” said Dennis Gable, MD, chair of the SVS Quality Council. “The proposed MVP design offers non-burdensome quality metrics that elevate care for multiple vascular procedures.”

MVPs, or MIPS Value Pathways, are part of the Merit-based Incentive Payment System. They focus on measures and activities tied to specific specialties or medical conditions. Compared to traditional MIPS, MVPs require fewer but more targeted measures, easing the reporting burden for physicians. As part of the 2025 Medicare Physician Fee Schedule Final Rule, CMS has committed to transitioning entirely to MVP reporting by 2028. This shift is a cornerstone of CMS’ move toward value-based care models.

The SVS has engaged in productive discussions with CMS during the MVP development phase and will continue to work with the agency to finalize and maintain the pathway.

“There arise certain times when a medical specialty must unify and act to bring voice and change,” said Kenneth M. Slaw, PhD, SVS executive director. “This is such a time for members of the SVS to support our vascular surgery MVP and lead the way in developing vascular measures that CMS adopts.”

The public comment period for the Vascular Surgery MVP was open from Dec. 11, 2024, to Jan. 24, 2025. The SVS encouraged members and stakeholders to contribute comments. Visit vascular.org/MVP.

Past SAVC Award recipients reflect on impact

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Marlén Gomez
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Past SAVC Award recipients reflect on impact
Past Presentation Award winner Olga Bakayev (center)

With nomination deadlines now past, Section on Ambulatory Vascular Care (SAVC) award season is upon us, and past recipients of the Society for Vascular Surgery (SVS) awards reflect on how the recognition has shaped their careers and advanced vascular care in their communities.

This year marks the inaugural awards cycle for SAVC, which was formed in 2024 by merging the Section on Outpatient and Office Vascular Care (SOOVC) and the Community Practice Section (CPS).

Enrico Ascher, MD, a previous recipient of the Excellence in Community Practice Award, said the recognition highlighted his dedication to building the first vascular institute in Brooklyn, New York. “I can’t tell you how proud and humbled I am by this very special recognition,” Ascher said.

Chong Li, MD, who received the Research Seed Grant from the former SOOVC, credited the award with enabling him to pursue groundbreaking research.

“I am honored and thankful for having received the SOOVC Research Grant to realize my proposal of finding the adequate and safe dosage of heparin during outpatient arterial and venous interventions,” Li said.

Olga Bakayev, MD, a recipient of the Presentation Award, described the recognition as a reflection of her team’s dedication to advancing knowledge in vascular care.

The 2025 award recipients will be announced at the 2025 Vascular Annual Meeting (VAM), scheduled for June 4–7, in New Orleans. For more information about the SAVC awards or to apply, visit vascular.org/SAVC.

US ARC uncovers ‘dramatic’ decrease in use of prophylactic spinal drains at same time as spinal cord ischemia steeply declines

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Bryan Kay
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0
US ARC uncovers ‘dramatic’ decrease in use of prophylactic spinal drains at same time as spinal cord ischemia steeply declines
Angela Sickels presents during SAVS 2025

Despite a “dramatic” decrease in the use of prophylactic cerebrospinal fluid drains (CSFDs) for the prevention of spinal cord ischemia (SCI) in patients undergoing fenestrated and branched endovascular aortic repair (F/BEVAR), the rate of SCI has tracked a similarly dramatic decrease, according to the senior author of a new analysis of U.S. Aortic Research Consortium (ARC) data from 2011–2024.

Adam Beck, MD, the Holt A. McDowell Jr., MD, endowed chair of vascular surgery at the University of Alabama at Birmingham (UAB), described the data as likely practice-changing for many specialists who carry out complex repairs of thoracoabdominal aortic aneurysms (TAAAs) ahead of their presentation at the 2025 annual meeting of the Southern Association for Vascular Surgery (SAVS) in St. Thomas, the U.S. Virgin Islands (Jan. 22–25).

The retrospective analysis of the ARC registry—which encompasses 10 major medical centers with individual investigational device exemption (IDE) studies for complex aortic repairs—included 2,585 patients undergoing elective F/BEVAR. Eras of repair were divided into early (2011–2013), mid (2014–2021) and late (2022–2024) based on the publication of influential papers which changed ARC practices. Patient cohorts were separated by prophylactic (n=949), therapeutic (n=27) and no CSFD (n=1609) use. A composite variable consisting of any SCI, major CSFD complication or intracerebral hemorrhage was designated as the primary outcome.

The ARC data showed that 196 patients (7.6%) experienced the primary composite outcome and 160 (6.2%) experienced SCI. Presenting the data, Angela Sickels, MD, an integrated vascular surgery resident at UAB, told SAVS 2025: “The yearly incidence of the primary composite outcome and any SCI gradually declined over time, from a maximum of 25% [for both primary composite and SCI] in 2011 to 2.8% and 2.3%, respectively, in 2023.”

Meanwhile, the use of prophylactic CSFD declined from “being essentially universally done” in 2011 down to just 10.9% in 2023 “without any substantial increase in therapeutic CSFD use, which reached a maximum of just 3.5%,” Sickels said.

In high-risk patients (n=1026), 12.9% (n=132) and 10.6% (n=109) experienced the primary composite outcome or any SCI event, respectively, the data revealed. Rates of the primary composite outcome declined from 38.5% in 2013 to 3% in 2023. Prophylactic CSFD use in high-risk patients—while nearly universal (92.9–100%) until 2016—has also since been on a continuous decline, reaching a minimum of 22.6% in 2023, the research shows. “This subset of patients also saw no increase in therapeutic drain use, reaching a maximum of 5.9%,” Sickels added.

Speaking to Vascular Specialist about the significance of the findings, Beck noted how as experience of endovascular long-segment coverage of TAAAs over the last decade has expanded, discussion and education around SCI prevention protocols, too, have broadened at most large medical centers. “With implementation of defined protocols, the rate of SCI has dropped significantly over the last five or 10 years,” he said.

The ARC data, Beck said, shows a “rapid drop, especially over the last eight years or so, in the rate of SCI. In addition, interestingly people have been using less and less prophylactic spinal drains, and we think that that’s probably because the rate of SCI has dropped with the use of SCI prevention protocols and is almost equivalent to the risk of the placement of spinal drains.”

Beck continues: “Most of the surgeons who have been doing these procedures will have stories about complications associated with the drains, which can be anywhere from 5–10%. Now, the SCI rate is in that 5–10% range, so essentially the risk of SCI is almost equivalent to—or is equivalent to—the risk of putting a drain in, so there is clinical equipoise there.”

One question remains, added Beck. “If you were to randomize patients with an especially high risk of SCI to prophylactic drains or not, whether prophylactic drains would actually prevent SCI—we still do not know the answer to that question.”

Beck believes the education that the ARC research has yielded has led to better outcomes. “There is a learning curve to this and there has been a regression to the mean with how everyone is managing these patients,” he said. “Early on, some of us had well-defined SCI prevention protocols, and some of us were doing things that we thought reduced the risk but didn’t necessarily have a well-formed protocol for it. There has been a lot of conversation around this complication in our monthly ARC meetings and at national/international educational meetings, and I think the dissemination of information and everyone learning from each other has led to this decrease in SCI.”

The ARC researchers are now working on a propensity matched analysis that looks at similar patients with and without prophylactic CSFDs to help evaluate whether the drains help prevent SCI.

“This project was done in preparation for a randomized trial looking at patients with and without prophylactic drains. Given our findings, we are beginning to think that the trial may not be necessary or will be very difficult to complete because of the very low expected effect size of the prophylactic drains. This would necessitate a very large clinical trial, which may not be feasible,” Beck added.

Vascular Verification Program verifies first community hospital 

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Marlén Gomez
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Vascular Verification Program verifies first community hospital 

Intermountain Health St. Mary’s Regional Hospital in Grand Junction Colorado was awarded ACS/SVS Vascular Verification Program (Vascular-VP) designation on Nov. 19, 2024. By achieving this prestigious status, the medical center demonstrated its commitment to delivering high quality treatment for patients receiving vascular surgical and interventional care and to improving outcomes. Intermountain Health St. Mary’s Regional Hospital is the first community hospital to be verified in the ACS/SVS Vascular-VP.  

“This is truly a great honor for St. Mary’s Hospital to be recognized as one of the first nationally verified programs. Kudos to all the doctors, nurses, and staff that worked to ensure its success,” said Bryan Johnson, president of Intermountain St. Mary’s Regional Hospital.

This accomplishment was led by Tej Singh, MD, medical director of vascular surgery. “We’re grateful to Dr. Singh for his instrumental work in building a high-quality vascular program and achieving vascular verification. These efforts include timely patient access and work with the vascular quality initiative registry, national accreditation, care compliance, surgical leadership, and mentoring,” said Ben Smalley, chief operating officer for St. Mary’s Regional Hospital.

Vascular-VP is an ACS Quality Program developed with the SVS and leverages the strengths and expertise of the ACS and SVS to provide an evidence-driven, standardized pathway for instituting and growing a quality improvement and clinical care infrastructure within a center’s vascular program.

Legislation targets stability for physicians amid Medicare cuts

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Marlén Gomez
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0
Legislation targets stability for physicians amid Medicare cuts

Physicians are facing a fifth consecutive year of Medicare payment reductions due to policy adjustments and budget neutrality requirements in the Medicare Physician Fee Schedule. To address the issue, the SVS, in collaboration with congressional leaders and other physician organizations, advocates for a sustainable solution to protect medical practices and ensure patient access to care.

The push for reform has led to the introduction of the Medicare Patient Access and Practice Stabilization Act of 2024 (H.R. 10073). The bipartisan bill proposes a two-part solution: eliminating the scheduled payment cuts and providing an additional adjustment equal to 50% of the Medicare Economic Index (MEI). Together, these measures would deliver a 4.73% positive payment update for physicians in 2025.

The legislation follows months of advocacy, including a “Dear Colleague” letter signed by 233 members of Congress urging action to stabilize physician payment structures. The letter underscores the need for reforms to ensure physicians can deliver high-quality care to Medicare beneficiaries without financial hardship.

With H.R. 10073 now introduced, the SVS is urging its members to take action. Physicians are encouraged to reach out to lawmakers and advocate for two key steps: cosponsoring H.R. 10073, the Medicare Patient Access and Practice Stabilization Act, and pressuring congressional leaders to include the legislation in year-end policy negotiations.

If passed, H.R. 10073 could signal a significant shift in Medicare reimbursement policy, ensuring payment structures align with inflation and the realities of modern practice, providing stability for physicians and patients alike.

SVS members can send alerts to legislators through the SVS Grassroots Advocacy Center or by visiting vascular.org/Grassroots.

Study highlights declining venous stent patency rates after one year

By
Jocelyn Hudson
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0
Study highlights declining venous stent patency rates after one year

A systematic review and meta-analysis of over 1,500 venous stenting procedures—said to be the first study on this topic to date—has highlighted an 18% drop in primary patency rates after one-year follow-up with declining rates beyond 12 months. As a result, researchers highlight the need for surveillance and consideration of reintervention to optimise long-term outcomes.

The study, published as an editor’s choice paper in the European Journal of Vascular and Endovascular Surgery (EJVES), aimed to appraise recent evidence assessing patency outcomes at various time points in patients with superior vena cava, subclavian, and brachiocephalic vein stenosis who had undergone stenting.

As a starting point, Shreya Chawla (Imperial College London, London, UK), Qingwei Zhang (St George’s University Hospital, London, UK), Adam Gwozdz (Imperial College London, London, UK) and colleagues, under the senior authorship of Stephen Black (St Thomas’ Hospital, London, UK), searched PubMed, Scopus, and Cochrane Library databases for studies up to December 2022. The researchers then measured outcomes including technical success rate, and primary, primary-assisted, and secondary patency rates at various time points.

Chawla, Zhang, Gwozdz et al share that they included a total of 39 studies reporting outcomes in 1,539 patients in their meta-analysis.

The authors report that primary patency up to one year after a venous stenting procedure was 81.5%, declining to 63.2% at 12–24 months. Furthermore, they reveal that primary-assisted patency and secondary patency rates at 24 months and beyond were 72.7% and 76.6%, respectively.

The team also conducted subgroup analyses, in which they found no significant difference for pooled secondary patency rates when comparing the malignant and benign subgroups. However, they note that GRADE analysis determined the certainty of evidence for all outcomes to be “very low”.

“Stenting is an effective intervention for benign and malignant stenosis of the superior vena cava, subclavian, and brachiocephalic veins,” Chawla, Zhang, Gwozdz and colleagues conclude. They reiterate that primary patency rates were “good” up to one year but declined after this time point. “Importantly,” the authors continue, “the results suggest that reintervention before in-stent thrombosis significantly increases patency rates.”

Chawla, Zhang, Gwozdz et al note that there is a lack of high-quality evidence related to venous stenting outcomes, which necessitates further research. In particular, they stress that the merits of surveillance and reintervention programmes should be explored in the interest of bettering outcomes. “This review suggests that systematised strategies to monitor and follow up patients may help optimise long-term patency,” they write.

In the discussion of their findings, Chawla, Zhang, Gwozdz and colleagues acknowledge certain limitations of their systematic review and meta-analysis. They note, for example, that the 39 included studies comprised 36 case series and three cohort studies, which they recognise might have affected data quality, and that “significant data” were not reported in the included studies, such as a lack of data on the criteria for reintervention.

Data and device tweaks herald ‘practice-changing’ future for bioabsorbable scaffolds

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Jocelyn Hudson
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0
Data and device tweaks herald ‘practice-changing’ future for bioabsorbable scaffolds
Eric Secemsky presents at LINC 2025
Eric Secemsky presents at LINC 2025

Pending the results of several trials and “iterative changes” to device design, bioabsorbable scaffolds are set to change the treatment paradigm for lower extremity peripheral arterial disease (PAD) within the next decade. So concluded Eric Secemsky (Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA) during a presentation at the Leipzig Interventional Course (LINC 2025; 28–30 January, Leipzig, Germany).

Secemsky was speaking on the future of bioabsorbable scaffolds, providing an overview of the key features of this “ideal” device type for the treatment of below-the-knee (BTK) disease. The first characteristic is drug elution, he noted, which inhibits restenosis and provides drug-modulated healing for sustained patency; second, a scaffold design provides transient support in the vessel and addresses recoil and dissection; and finally, resorbability ensures nothing is left behind.

“The era of bioabsorbable scaffolds has really begun with the Esprit drug-eluting resorbable scaffold (DRS),” Secemsky commented, noting that this Abbott innovation “is what created the market in the USA”. Esprit DRS is the first device of its kind to receive approval from the US Food and Drug Administration (FDA), the presenter shared, highlighting positive data from the prospective, multicentre, randomised LIFE-BTK trial that now has results available out to two years.

Secemsky stressed, however, that the technology is still in its infancy. The Esprit BTK device is “only the first step on a long pathway to solving BTK interventions for both US and non-US patients,” he told the LINC audience.

Here the presenter listed a number of other devices with bioabsorbable properties that are being evaluated in the USA, focusing in particular on the Motiv (Reva Medical) and Magnitude (R3 Vascular) scaffolds.

The Motiv device, Secemsky detailed, is CE mark approved, has been granted FDA breakthrough designation, and is currently being assessed in the recently completed MOTIV BTK randomised controlled trial. Led by Ehrin Armstrong (Adventist Heart and Vascular Institute, St Helena, USA) and Andrej Schmidt (University of Leipzig, Leipzig, Germany), the trial enrolled its target cohort of 292 patients across 35 centres in the USA and Europe and is awaiting completion of follow-up.

“We saw results of their early postmarket trial in the EU looking at 60 limbs, 58 patients, and [the device] demonstrated really impressive patency outcomes through three years,” Secemsky shared. Continuing, the presenter stressed the significance of this result: “It’s hard for a BTK device in vessels that are less than 3.5mm to maintain 88% patency through 36 months.”

Moving on to Magnitude, Secemsky disclosed that he is the co-principal investigator for the US pivotal trial of this device. “[Magnitude] is really as resistant to compression and supportive as a metallic stent, but has unique flexibility to optimally perform in challenging anatomical locations,” Secemsky noted, also pointing out the device’s ability to “maintain its structure in a compromised situation, including in the infrapopliteal space”.

The results of early feasibility study RESOLV I, Secemsky shared, were “very supportive of moving forward to an IDE [investigational device exemption] trial”. In total, he noted that 36 lesions in 35 limbs were treated in this trial with >90% freedom from occlusion or restenosis, which included “really impressive real-world patien t and lesion characteristics”.

“Bioabsorbables have the promise to change clinical practice for infrainguinal arterial disease,” Secemsky posited, drawing his presentation to a close.

The presenter continued, considering timelines: “As iterative changes allow for longer scaffold lengths, larger diameters and consistent tensile strength, the treatment paradigm for lower extremity disease may look much different in the next five to 10 years.

“I think we’ll continue to have these conversations over the years, see more data, and I think we’ll see many of these scaffolds make it to clinical practice.”

Deadline for inaugural SVS visiting professorship to advance young surgeons’ careers nears

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Marlén Gomez
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Deadline for inaugural SVS visiting professorship to advance young surgeons’ careers nears
Ted Gifford

The Society for Vascular Surgery’s (SVS) Young Surgeon Section (YSS) will close applications for its inaugural visiting professorship on Jan. 31. This scholarship program will provide mentorship opportunities, foster professional development and introduce young vascular surgeons to diverse clinical and research environments, ultimately advancing their careers and contributions to the vascular specialty.

Each year, the YSS Award Selection Committee will award one recipient within the first 10 years of their practice a $1,000 travel stipend and a $1,500 honorarium to support their role as a visiting professor.

“We’ve left the topic for this visiting professorship open-ended. We want to hear from you, young vascular surgeons, what you’re currently interested in, said YSS Steering Committee Chair Ted Gifford, MD. “We want to know what work you’re doing to further this forward and how this visiting professorship would impact that work and your career as a young vascular surgeon.”

Chelsea Dorsey

This professorship program was the brainchild of the inaugural YSS chair, Chelsea Dorsey, MD, who will host the first visiting professorship at the University of Chicago.

Applicants must be SVS members and part of the YSS. Early Active Members who have completed a vascular surgery residency or fellowship program are eligible to apply. Candidates should have no more than 10 years of experience as practicing vascular surgeons.

A complete application package includes a filled-out application form, an abstract, a curriculum vitae and copies of slides from a recent talk or presentation. Applications will be evaluated based on professional qualifications, leadership potential, and the proposed scope of the visiting professorship.

“One of the things we strive to focus on in the SVS and the YSS is allowing our young surgeons to connect with other young surgeons and more mid-career and senior surgeons around the country and even worldwide. We feel like a visiting professorship is the perfect opportunity for young surgeons who have a burgeoning in their research or clinical interests to go out and meet other people and share their thoughts and ideas. That spurs further discussions and connections for collaboration down the road.”

For more information on joining the YSS and accessing the application form, visit vascular.org/YSS.

Cagent Vascular initiates the Serranator POINT FORCE observational registry

By
Bryan Kay
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0
Cagent Vascular initiates the Serranator POINT FORCE observational registry
Serranator PTA serration balloon catheter
RECOIL study
Serranator

Cagent Vascular has announced the start of the POINT FORCE registry, a postmarket clinical follow-up study of the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter.

This prospective, multicentre, single-arm study will enrol a minimum of 500 patients at up to 30 centres in the USA. The objective of this study is to evaluate the safety and efficacy, under local standard of care, of serration angioplasty for the treatment of peripheral arterial disease (PAD) throughout the entire leg.

The primary endpoint for this study is device success, defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device with a post-Serranator residual stenosis of ≤30%, as assessed by an independent angiographic corelab. Yale Cardiovascular Research Group in New Haven, USA, will serve as the corelab for this study.

Led by national co-principal investigators (PIs) S Jay Mathews (Manatee Memorial Hospital, Bradenton, USA) and Michael Siah (University of Texas Southwestern [UTSW] Medical Center, Dallas, USA), this registry will build the body of clinical evidence for serration angioplasty. Siah enrolled the first POINT FORCE patient.

“We’re excited to launch the POINT FORCE registry with the initial enrolment here at UTSW,” said Siah. “Serranator is a key part of our ATK [above-the-knee] and BTK [below-the-knee] treatment algorithm, and our team is eager to analyse this large, corelab-adjudicated dataset to capture the results of treating with serranation across a wide spectrum of treatment strategies and clinical presentations.”

“We know from prior corelab-adjudicated studies that Serranator provides an efficacious result for patients, with a very low rate of complication and mitigated recoil,” stated Mathews. “What we endeavor to understand in POINT FORCE is the role serranation can play in routine clinical practice. We anticipate reviewing iliac, fempop, infrapop, and inframalleolar vessel territories, along with AV [arteriovenous] access.”

Brian Walsh, chairman and chief executive officer of Cagent Vascular, added: “Despite having performed over 20,000 procedures, Serranator remains a new and disruptive PAD therapy. We expect POINT FORCE will illuminate the benefits of serranation and help share the impact in all common clinical algorithms. We’re excited to get started and grateful for the support of our PIs and all participating centers.”

Gore announces first commercial implant of Excluder conformable AAA endoprosthesis with Active Control system in Canada

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Bryan Kay
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0
Gore announces first commercial implant of Excluder conformable AAA endoprosthesis with Active Control system in Canada
Gore Excluder

Gore recently announced the first commercial use of its Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis with Active Control system in Canada.

The news coincides with Health Canada approval of the device for the treatment of AAA patients with aortic landing zones as short as 10mm and neck angulation up to 90°.

A press release notes that the device combines “exceptional” conformability with a delivery system fine-tuned for precision, offering physicians a new degree of control and a novel solution for highly angulated aortic necks.

“With the conformability of its nested stent design, angulation control and two-stage deployment, the Gore Excluder conformable AAA device gives us the only option for endovascular repair of difficult angulated anatomy,” remarked Kevin Lee (Royal Columbian Hospital, New Westminster, Canada), who used the device commercially for the first time.

“We can reconstrain. We can reposition. And we can refine angulation,” he continued. “That means more control, more precision and more opportunities to achieve optimal seal.”

“Today was a major milestone for the tools and techniques at our disposal, and it built on the performance we’ve come to rely on over the years using the Gore Excluder device family.”

“That really is a rare recipe for confidence with a new device,” he concluded.

Tracci assumes presidency of Southern Vascular

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Bryan Kay
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0
Tracci assumes presidency of Southern Vascular
Margaret (Megan) Tracci

Margaret (Megan) Tracci, MD, has become the first-ever woman president of the Southern Association for Vascular Surgery (SAVS). The University of Virginia professor of surgery assumed the role at the close of the 2025 SAVS annual meeting in St. Thomas, the U.S. Virgin Islands (Jan. 22–25).

Tracci took over from Alan Lumsden, MD, medical director of Methodist DeBakey Heart and Vascular Center at Houston Methodist.

Mark Farber, MD, chief of the Division of Vascular Surgery at the University of North Carolina at Chapel Hill, is the new president-elect. Dennis Gable, MD, cBaylor Scott & White, T

FDA announces plans to address medical device shortage risks

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Bryan Kay
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0
FDA announces plans to address medical device shortage risks
FDA has issued new guidance for the use of paclitaxel coated devices in peripheral arterial disease

FDAFDAThe Food and Drug Administration (FDA) has issued a statement outlining measures to enhance protections against medical device shortages.

According to Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), supply chain disruptions—often caused by natural disasters, limited production capacities for specialized devices, or manufacturing and quality issues—pose the greatest threat to device availability. Tarver warned that as the global regulatory environment evolves, the USA might risk falling behind in ensuring device availability to protect patients.

On Jan. 10, 2025, new European Union (EU) regulations came into effect, requiring medical device manufacturers to notify authorities about any anticipated supply shortages at least six months in advance. Tarver remarked, “Now, the European Commission and member countries will have access to vital information about medical device shortages that could impact their population. In contrast, there are no mandatory reporting requirements for potential medical device shortages in the U.S. except, as required, during or in advance of a public health emergency.”

To address this gap, the FDA is seeking new statutory authority to amend Section 506J of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)—which was passed in 2020 to address the economic impact of the pandemic—by removing the current limitation that ties device shortage reporting to public health emergencies. The FDA is also advocating for increased funding to support the CDRH Supply Chain Program, which works to identify and mitigate device shortage issues.

“These changes are essential for enabling proactive responses to prevent supply chain disruptions before they impact patient care, and the future of our healthcare system. In recent years, congress has provided resources to support CDRH’s efforts to respond to supply chain disruptions, and while these resources have been helpful, additional funding will be needed to sustain and enhance our abilities to help identify, prevent, and mitigate shortages,” Tarver explained.

Without comparable transparency in the USA, the EU’s new regulations provide critical information to healthcare providers, giving them the opportunity to act in advance to mitigate device shortages. In contrast, Tarver noted that US hospitals and healthcare systems are left “ill-prepared to address shortages, forcing them to rely on unpredictable or ad-hoc solutions.”

Tarver emphasized that safeguarding patients, particularly neonates and children, during medical device shortages is crucial. “When shortages arise, there are few options that may accommodate children—compelling clinicians to adapt adult-sized equipment, which can lead to suboptimal outcomes and increased risks for patient safety,” she said.

In conclusion, Tarver reaffirmed the FDA’s commitment to collaborating with relevant authorities to strengthen the domestic supply chain and address vulnerabilities. “Together, the FDA, healthcare providers, patients, hospitals, and congress can work to ensure that pediatric and other patient populations receive the care they need without interruption,” she said.

SVS gets moving on PAD-related grant

By
Beth Bales
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SVS gets moving on PAD-related grant
Joseph Mills
Joseph Mills

All those steps logged during the SVS Foundation’s exercise challenge in September will help the Foundation—and researchers—take new steps to unlock new treatments for peripheral artery disease (PAD).

The foundation’s Vascular Health Step Challenge, during National PAD Awareness Month, raised money and heightened awareness of the disease process. Foundation members decided to use the funds for a new grant under the Vascular Care for the Underserved (VC4U) program, “intended to support innovative pilot projects that address the unique challenges faced by underserved populations affected by PAD, with an emphasis on improving diagnosis, treatment and patient education.”

Members of both the SVS and the Society for Vascular Nursing (SVN) will be eligible to apply for the $20,000 grant. Details, including the application process and deadlines, are under development and will be announced shortly, once completed.

Foundation Chair Joseph Mills, who directed a previous VC4U pilot project, is excited the program will fund a grant specifically earmarked for PAD and underserved populations. “All vascular surgeons understand the disproportionate effect of PAD on people with poor healthcare access,” he said. “If we can reach and educate people earlier, we can hopefully start with minimally invasive therapy such as medical management, lifestyle modifications and exercise therapy to reduce limb complications and amputation.”

Foundation Executive Board members also released updates on two existing projects: “PAD in west and southwest Philadelphia: Providing education and screening and investigating barriers to care,” from Julia Glaser, MD, and “UMass homeless foot and diabetes screening outreach program,” from Tammy Nguyen, MD.

Glaser, an assistant professor of clinical surgery at Penn Medicine, conducted two health fairs to screen attendees for abdominal aortic aneurysms (AAAs), carotid disease and PAD, as well as for PAD risk factors. She now is undertaking the second part of her grant, to conduct a qualitative study to determine factors that cause patients with chronic limb-threatening ischemia (CLTI) to delay seeking care.

The successful outreach fairs screened approximately 90 patients on various health measures. Patients received the results, guidance on care and encouragement to share the results with a primary care physician.

In the interview study, Glaser is targeting people who needed amputations for vascular disease. Her grant is being extended partially as a result of her maternity leave this year. Study enrollment has been slower than anticipated, “which is actually a good thing—we are doing fewer amputations for vascular disease,” said her colleague, Sarah Harrison Benchimol. Nguyen, from the University of Massachusetts and an assistant professor at UMass Chan Medical School, aims to increase access to comprehensive diabetic foot care in order to prevent, diagnose, and treat diabetes-related foot ulcers among homeless people.

In an update presented earlier this year, Nguyen reported her team has partnered with two community centers— one in a rural area and one in an urban community—to provide comprehensive and multidisciplinary diabetic foot care. For its next event, Nguyen anticipates recruiting pulmonologists and thoracic surgeons as well.

Results from her first event prompted the team to modify outreach site selections to better identify at-risk populations and to serve more homeless participants. The participation number increased by almost 50 % between her first and second events.

Finally, with a goal to ensure follow-up by enrolling eligible patients in a state-sponsored free medical insurance program, the team identified 12 high-risk patients from the two most recent mobile clinics and arranged appropriate follow-up care for them.

Meet the new SVS Executive Board members

By
Beth Bales
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Meet the new SVS Executive Board members

Five prominent vascular surgeons have been named “at-large” members of the SVS Executive Board (EB), which has been newly restructured and expanded to increase diversity of perspective and better meet the Society’s evolving needs.

They are Chelsea Dorsey, MD, Yazan Duwayri, MD, Katherine Gallagher, MD, Vikram Kashyap, MD, and Robert Molnar, MD. All are involved SVS members, leading education or policy initiatives, serving as committee or section members and chairs, and performing other roles.

The expansion is the result of a bylaws referendum in 2023 that received strong support from the membership to change the board’s structure and composition. The new at-large positions expand the Executive Board from nine to 11 members and replace three “designated” positions.

“This completes an initiative begun by the Executive Board in 2019 to examine the governance structure of the SVS and make adjustments to meet the changing and growing needs of our members and the Society,” said SVS President Matthew Eagleton, MD.

An open call for nominations resulted in 45 applications that were reviewed by the SVS Nominating Committee. The committee then presented its recommendations to the Executive Board for consideration and final approval. Considerations included, among others, merit and achievement, qualifications, proficiencies, and gaps in expertise on the EB as identified by the SVS’ Strategic Board of Directors.

Chelsea Dorsey

Dorsey is an associate professor in the Section of Vascular Surgery and Endovascular Therapy at the University of Chicago Medicine. She serves as associate dean for medical student academic advising and advancement at the Pritzker School of Medicine and as vice chair in the Department of Surgery.

Her research interests include workforce diversity in surgery, augmentation of inclusive practices in the surgical environment and optimizing academic resources for diverse learners in the undergraduate medical education space.

Yazan Duwayri

Duwayri is a professor of surgery at Emory University School of Medicine and is co-director of the Emory Aortic Center. He leads his institution’s participation in several aortic device trials as the site principal investigator. Since April, he has been the chief for the Division of Vascular Surgery and Endovascular Therapy at Emory Healthcare.

His current research focus is outcomes and quality improvement in vascular surgery. He has held national leadership positions in the SVS, including as a member of the executive council of the SVS Patient Safety Organization. He also served as medical director of the Southeastern Vascular Study Group (SEVSG), which is dedicated to tracking outcomes and improving the quality of vascular surgical interventions.

Katherine Gallagher

Gallagher is professor of surgery, professor of microbiology and immunology and vice chair of basic and translational science in the Department of Surgery at the University of Michigan. She is an expert in the molecular pathogenesis of wound repair and has contributed substantially to the understanding of epigenetics in immune cells associated with tissue repair, cardiovascular diseases, sepsis and, most recently, COVID-19.

Her research has been supported by multiple grants. In addition to memberships in several associations, Gallagher is a mentor to junior faculty and trainees in medical research and has trained many postdoctoral residents to be the next generation of scientists.

Vikram Kashyap

Kashyap is the endowed chair of the Frederik Meijer Heart and Vascular Institute and the vice president for Cardiovascular Health at Corewell Health in Grand Rapids, Michigan. He formerly worked at the Cleveland Clinic for nearly 20 years, including as chief of the Division of Vascular Surgery and Endovascular Therapy and the co-director of the Vascular Center of the Harrington Heart & Vascular Institute at University Hospitals Cleveland Medical Center, Cleveland, Ohio.

He is principal investigator of several clinical studies of new vascular stents, grafts and prostheses. He leads a national trial on transcarotid artery revascularization (TCAR).

Robert Molnar

Molnar is based in Flint, Michigan, and is a member of the Michigan Vascular Center, one of the oldest private practice vascular surgery groups in the U.S.

Molnar is past chair of the SVS Clinical Practice Section and SVS Subsection of Outpatient and Office Vascular Care (SOOVC), a clinical professor in the Michigan State University Department of Surgery, associate program director of the University of Michigan Health-Sparrow general surgery residency, chair of the Department of Surgery and director of surgical education at McLaren Regional Medical Center, and faculty member of the McLaren vascular fellowship program.

Molnar has been active in clinical research, including being local principal investigator in more than 70 national clinical trials conducted at his facility.

ESVS publishes 2025 vascular trauma guidelines

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Jocelyn Hudson
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ESVS publishes 2025 vascular trauma guidelines

varicose vein managementThe European Society for Vascular Surgery (ESVS) has developed new guidelines for the care of patients with vascular trauma. The 2025 clinical practice guideline document was recently published as an open-access article in press in the European Journal of Vascular and Endovascular Surgery (EJVES).

A writing committee consisting of first author Carl Magnus Wahlgren (Karolinska University Hospital, Stockholm, Sweden) and colleagues from across Europe has outlined a total of 105 recommendations.

The guidelines cover several topics, namely technical skill sets, bleeding control and restoration of perfusion, graft materials, and imaging; management of vascular trauma in the neck, thoracic aorta and thoracic outlet, abdomen, and upper and lower extremities; postoperative considerations after vascular trauma; and paediatric vascular trauma. Unresolved vascular trauma issues and patients’ perspectives are also discussed.

Wahlgren and team state that the guidelines “provide the most comprehensive, up-to-date, evidence-based advice to clinicians on the management of vascular trauma,” whilst acknowledging some limitations affecting their generalisability. “There is a general paucity of high-quality data and literature on vascular trauma management,” they write, noting that this applies to aspects relating to sex and ethnicity, but also conditions of low- and medium-income countries. “These limitations must be kept in mind when managing vascular trauma in different settings and environments.”

Read the full guidelines document here.

New data support role of F/BEVAR for treatment of thoracoabdominal aortic aneurysms

By
Jocelyn Hudson
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New data support role of F/BEVAR for treatment of thoracoabdominal aortic aneurysms
aortic-related mortality
Gustavo Oderich. Photo by Dwight C Andrews/McGovern Medical School at UTHealth Office of Communications

A recent prospective, multicentre cohort study provides insights into early and late aortic-related mortality and rupture after fenestrated and branched endovascular aneurysm repair (F/BEVAR) of thoracoabdominal aortic aneurysms (TAAAs). Researchers claim these are likely to represent the most comprehensive data on the topic for the foreseeable future, citing the unworkable nature of a randomised study.

Gustavo Oderich, Ying Huang (both University of Texas Health Science Center at Houston–McGovern Medical School, Houston, USA) and colleagues, on behalf of the US Aortic Research Consortium (ARC), write in Circulation that F/BEVAR has been used as a minimally invasive alternative to open surgical repair to treat patients with TAAAs.

The authors explain that, despite the widespread use of fenestrated and branched aortic devices worldwide, they are not currently commercially approved by the US Food and Drug Administration (FDA). Access to these devices, they continue, is limited to those centres with ongoing physician-sponsored investigational device exemption (PS-IDE) studies. The researchers detail that the US ARC has been collecting prospective data from these studies since 2018.

The aim of the present study, the authors note, was to evaluate aortic-related mortality and aortic aneurysm rupture after F/BEVAR of TAAAs. In order to do so, the research team analysed patients enrolled in eight prospective, non-randomised, PS-IDE studies between 2005 and 2020 who underwent elective F/BEVAR of asymptomatic intact TAAAs.

The primary endpoints of the study, Oderich, Huang et al detail, were aortic-related mortality, defined as any early mortality (30-day or in-hospital) or late mortality from aortic rupture, dissection, organ or limb malperfusion attributable to aortic disease, complications of reinterventions, or aortic rupture. Secondary endpoints were early major adverse events, TAAA life-altering events—defined as death, permanent spinal cord injury, permanent dialysis, or stroke—all-cause mortality, and secondary interventions.

Oderich, Huang and colleagues share in Circulation that 1,109 patients were analysed in the study, noting that 589 (53.1%) had extent I–III and 520 (46.9%) had extent IV TAAAs. The patients had a median age of 73.4 years and just under one-third were women.

The investigators report that early mortality was 2.7% and that congestive heart failure was associated with early mortality. Furthermore, they reveal that the incidence of early aortic rupture was 0.4% and that the incidence of early major adverse events and TAAA life-altering events was 20.4% and 7.7%, respectively.

Oderich, Huang et al continue that there were 30 late aortic-related mortalities; the five-year cumulative incidence was 3.8%; and older age and extent I–III TAAAs were independently associated with late aortic-related mortality.

Furthermore, the authors report that 14 late aortic ruptures occurred; the five-year cumulative incidence was 2.7%; extent I–III TAAAs were associated with late aortic rupture; five-year all-cause mortality was 45.7%; and five-year cumulative incidence of secondary intervention was 40.3%.

In the conclusion of their findings, Oderich, Huang and colleagues write that aortic-related mortality and aortic rupture are “uncommon” after elective F/BEVAR of asymptomatic intact TAAAs. They add that half of the aortic-related mortalities within the study occurred early, and that most of the late deaths were not aortic related.

Oderich, Huang et al reiterate that five-year all-cause mortality was high—45.7%—mostly due to non-aortic-related causes, “likely reflecting selection of higher-risk subgroups compared with historical reports of [open surgical repair]”.

The final conclusion the authors make is that secondary interventions were needed in one of four patients. They do stress, however, that three-quarters of these were minor procedures.

The authors recognise several limitations of their study, including possible patient selection bias due to a need to adhere to PS-IDE inclusion and exclusion criteria, the frequency of cause of death being unknown, and the reason for aortic rupture and the aortic diameter at the time of rupture not being available for all patients, among others.

Despite these limitations, the authors underline the significance of the present study. “Given a perceived lack of clinical equipoise to justify a randomised controlled trial,” they comment, “these data are likely to be the most reliable and obtainable to validate the role of F/BEVAR for the treatment of TAAA.”

On the clinical implications, Oderich, Huang and colleagues remark: “Rigorous surveillance after F/BEVAR is required because the need for secondary interventions was high among patients undergoing F/BEVAR of TAAAs, and identifying the need for secondary interventions will paradoxically be higher with better surveillance.”

Gore receives CE mark for lower profile Viabahn VBX endoprosthesis

By
Will Date
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0
Gore receives CE mark for lower profile Viabahn VBX endoprosthesis

Gore has announced recent CE mark of a lower profile Viabahn VBX balloon expandable endoprosthesis (VBX stent graft).

Medical Device Regulation (MDR) approval of this innovation builds on a proven device which has become an important tool for treating complex vascular disease, the company says in a press release. In addition to offering the longest balloon expandable stent on the market with its 79mm configuration, and the widest range of stent diameter adjustability, the VBX stent graft now also offers the most 6 Fr compatible configurations, the press release adds.

“We are thankful to Gore for being able to be one of the first implanters of the new lower profile VBX stent graft in Europe,” said Michele Antonello, director of the School of Specialization in Vascular Surgery of the University of Padua (Padua, Italy). “Combined with the device flexibility, its accuracy and trusted performance, the new lower profile will enable me to treat my complex cases with a 6 or 7 Fr device.”

No changes to the stent graft design were made to achieve the lower profile. By focusing on improvements to the delivery system only, the characteristics and performance of the stent graft itself remain unchanged and are joined by the enhanced versatility a lower profile provides, Gore states. Depending on the practice, physicians may be able to use the VBX stent graft with a broader set of patients, experience a lower risk of complications at the access site, find improved procedure efficiency and/or a general improvement in ease of use.

“With the recently published five-year data and being part of the current Gore VBX FORWARD clinical study that aims to investigate the superiority of the VBX stent graft compared with bare metal stents for the treatment of complex iliac occlusive disease, this lower profile innovation provides yet another reason to feel confident in the proven outcomes of the VBX Stent Graft and the broad applicability of its use in my practice,” said Ash Patel, vascular surgeon, Guy’s & St Thomas’ Hospital NHS Foundation Trust, London, UK.

Since its US launch in 2017, more than 500,000 VBX stent grafts have been implanted worldwide. The VBX stent graft is indicated in the EU for the treatment of: De novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation; De novo or restenotic lesions in the visceral arteries; Isolated visceral, iliac and subclavian artery aneurysms; or Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral and pulmonary arteries).

The lower profile device will be rolled out to the European market over the coming months.

“The approval and release of the lower profile VBX stent graft serves as a demonstration of the Gore Medical Products Division’s commitment to continual improvement and lifelong innovation in collaboration with physicians to solve tough challenges where there is a critical patient need,” said Jill Paine, leader of Gore’s peripheral business. “We look forward to supporting our physicians and their patients through the delivery of this exciting innovation to their treatment toolbox.”

One-year SAVVE trial results are ‘most encouraging data ever produced for a bioprosthetic vein valve’

By
Bryan Kay
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0
One-year SAVVE trial results are ‘most encouraging data ever produced for a bioprosthetic vein valve’
Manj Gohel

The one-year data from the SAVVE trial represent the “most encouraging clinical data that have ever been produced for a bioprosthetic deep vein valve” in more than half a century of attempts at developing such a device, according to one leading venous disease specialist.

Manj Gohel, MD, from Cambridge University Hospitals in Cambridge, England, cautiously welcomed what he described as an outstanding set of one-year results for the VenoValve device (enVVeno Medical) but also reflected on patient selection, durability and health economics challenges to come. “There have been efforts to treat deep venous reflux for at least 50 years,” says the Cambridge University Hospitals consultant. “A native valve—a healthy normal valve—is a thing of beauty: it is incredibly flexible, mobile, is not thrombogenic at all, and is also really strong. So that is a tough ask for anything prosthetic. And, for half a century, people have been trying to do this and have generally failed.”

Case selection will pose the greatest challenge, Gohel explains. “Deep reflux is very common. Of all the patients I see, probably a third, if not a half, of them will have deep venous reflux. The potential population is enormous, but we need to be very selective of the people we put through this procedure because it is still going to be experimental, expensive and invasive.” As such, for Gohel, VenoValve implantation is a third-line treatment option after superficial vein procedures and deep venous stenting “for those people who have still not responded.”

Further, Gohel says he will be closely following the durability of the device as longer-term data emerge. “The one-year data are nice, but one year is nothing in the grand scheme of things when it comes to venous disease. The problem is, if you get device failure, then the risk is you might get thrombosis of this prosthesis, and that is effectively a DVT [deep vein thrombosis].”

Gohel says he will also be following the price at which the VenoValve device enters the market in light of health economics considerations. “Venous ulceration is extremely expensive, but even with the very best treatments, the best they do is improve the ulceration rate and reduce recurrence rates by 50%—you don’t cure the problem,” he points out. “Even then, cost effectiveness is only just demonstrated, because the treatments that you are carrying out—dressing the ulcers—cost money, but they are still relatively cheap next to a very expensive procedure. So, you’ve got to get a lot of ulcer healing benefit in order to demonstrate cost effectiveness.”

Ultimately, says Gohel, reducing the level of invasiveness of the procedure will be key. “At the moment, the procedure is an open surgery and has to be performed by a vascular surgeon,” he adds. “A lot of these patients are quite elderly and frail. You may not want to be putting many of them through relatively major surgery, so the percutaneous valve—which I know [enVVeno Medical] are working on—is going to be a really important next step.”

Recent years have brought other efforts to produce innovative technology that treats deep venous reflux, adding to the 50-year canon of vein valve replacement attempts.

“There was one valve called the Sail [flow regulator] valve, that there was a lot of interest in, and that had some first-in-man data, but that has disappeared,” recalled Gohel. “There was the endovenous, percutaneous valve called Blueleaf, which also disappeared. So we don’t want to get too excited, but [Food and Drug Administration] approval is a big thing.”

Researchers develop machine learning models to predict IVC filter complications

By
Jocelyn Hudson
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0
Researchers develop machine learning models to predict IVC filter complications
Ben Li

Researchers in Canada have developed machine learning (ML) models that they claim, “can accurately predict one-year IVC [inferior vena cava] filter complications, performing better than logistic regression”.

Writing in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL), Ben Li (University of Toronto, Toronto, Canada) and colleagues highlight that IVC filter placement is associated with long-term complications and posit that predictive models for filter-related issues “may help guide clinical decision-making”. The authors state that it was their objective to develop ML algorithms that predict one-year IVC filter complications using preoperative data.

Li et al write that they used the Vascular Quality Initiative (VQI) database to identify patients who underwent IVC filter placement between 2013 and 2024. They identified 77 preoperative demographic and clinical features from the index hospitalisation when the filter was placed.

The authors note that the primary outcome of the study was one-year filter-related complications, specifically a composite of filter thrombosis, migration, angulation, fracture, and embolization or fragmentation, vein perforation, new caval or iliac vein thrombosis, new pulmonary embolism, access site thrombosis, or failed retrieval.

Going into more detail regarding their study methods, Li and colleagues share that the data were divided into training (70%) and test (30%) sets, and that six ML models were trained using preoperative features with 10-fold cross-validation. These were Extreme Gradient Boosting, random forest, Naïve Bayes classifier, support vector machine, artificial neural network, and logistic regression. The primary model evaluation metric was area under the receiver operating characteristic curve (AUROC).

The researchers also assessed model robustness, detailing that they used calibration plot and Brier score to do so, and evaluated performance across subgroups based on age, sex, race, ethnicity, rurality, median Area Deprivation Index, planned duration of filter, landing site of filter, and presence of prior IVC filter placement.

Li et al report in JVS-VL that 14,476 patients underwent IVC filter placement over the course of the 11-year study period, of whom 584 (4%) experienced one-year filter-related complications.

“Patients with a primary outcome were younger and more likely to have thrombotic risk factors including thrombophilia, prior venous thromboembolism (VTE), and family history of VTE,” the authors detail.

Furthermore, Li and colleagues reveal that the best prediction model was Extreme Gradient Boosting, achieving an AUROC of 0.93. Comparatively, they continue, logistic regression had an AUROC of 0.63.

The authors state that calibration plot showed “good agreement” between predicted and observed event probabilities with a Brier score of 0.07.

In addition, Li et al report that that top 10 predictors of one-year filter-related complications were, in order, thrombophilia, prior VTE, antiphospholipid antibodies, factor V Leiden mutation, family history of VTE, planned duration of IVC filter (temporary), unable to maintain therapeutic anticoagulation, malignancy, recent or active bleeding, and age. “Model performance remained robust across all subgroups,” the researchers share.

In their conclusion, Li and colleagues posit that the ML algorithms assessed in the present study “have potential to guide patient selection for filter placement, counselling, perioperative management, and follow-up to mitigate filter-related complications and improve outcomes”.

Boston Scientific to acquire IVL developer Bolt Medical

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Boston Scientific to acquire IVL developer Bolt Medical
Boston Scientific's global headquarters in Marlborough, USA
Boston Scientific’s global headquarters in Marlborough, USA

Boston Scientific has announced it has entered into a definitive agreement to acquire Bolt Medical, the developer of an intravascular lithotripsy (IVL) advanced laser-based platform for the treatment of coronary and peripheral artery disease.

“Representing one of the fastest growing medical device segments, intravascular lithotripsy therapy addresses a significant unmet need for patients with complex calcified arterial disease through a minimally invasive approach,” said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. “Bolt Medical is developing a next-generation technology that is highly complementary to our existing portfolio. The addition of this system to our offerings can help us better serve physicians and their patients and provides a platform for future innovation.”

Lithotripsy is a procedure in which a physician breaks up hardened masses such as calcium to help restore blood flow. The Bolt IVL system is designed with a novel application of lithotripsy to fracture calcium by creating acoustic pressure waves inside of a balloon catheter. The system also includes visible, directional emitters for consistent energy delivery in the treatment of the calcified lesions.

Boston Scientific initially developed the concept for the Bolt IVL system which helped establish Bolt Medical in 2019. As a strategic investor in Bolt Medical, Boston Scientific has an equity stake of approximately 26%. As a result, the transaction consists of an upfront payment of approximately US$443 million for the 74% stake not yet owned and up to US$221 million upon achievement of certain regulatory milestones.

Bolt Medical recently announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the Bolt IVL Above the Knee (ATK) and Below the Knee (BTK) systems for the treatment of peripheral artery disease in patients with moderate to severely calcified lesions. The data from both studies will be used to support US Food and Drug Administration (FDA) and CE mark regulatory submissions for the devices. In December 2024, Bolt Medical received FDA approval to commence the global FRACTURE IDE clinical trial in the USA, which is investigating the use of the Bolt IVL coronary system for the treatment of coronary arterial disease with severely calcified lesions.

Boston Scientific anticipates the transaction to be completed in the first half of 2025, subject to customary closing conditions.

Large database study finds no difference in outcomes between three carotid shunting strategies

By
Jocelyn Hudson
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Large database study finds no difference in outcomes between three carotid shunting strategies
Xavier Hommery-Boucher

A new Vascular Quality Initiative (VQI) data analysis, recently published in the European Journal of Vascular and Endovascular Surgery (EJVES), has found no statistically significant differences between three carotid endarterectomy (CEA) shunting strategies regarding in-hospital stroke and death rate, including in patients with contralateral carotid occlusion or recent stroke.

In their editor’s choice paper, Xavier Hommery-Boucher (Centre Hospitalier de l’Université de Montréal [CHUM], Montreal, Canada) and colleagues outline that the study aimed to evaluate in-hospital outcomes after CEA according to shunt usage, particularly in high-risk groups of patients such as those with contralateral carotid occlusion or recent stroke.

Considering the context for their study, the authors underline a lack of data on the topic of carotid shunting. They note that systematic reviews comparing the three shunting strategies have concluded the evidence is too limited to support one over the others, and that there are no randomised data available on the subject.

In their study, Hommery-Boucher et al set out to perform a registry-based analysis. Specifically, they analysed data from CEAs registered in the VQI database between 2012 and 2020, excluding surgeons with fewer than 10 CEAs registered in the database, concomitant procedures, reinterventions, and incomplete data.

The authors note that participating surgeons were divided into three groups based on their rate of shunt use: non-shunters (<5%); selective shunters (5–95%), and routine shunters (>95%). They analysed primary outcomes of in-hospital stroke, death, and stroke and death rate in both symptomatic and asymptomatic patients.

Hommery-Boucher and colleagues share that, in total, 113,202 patients met the study criteria. Of this total, 31,147 were asymptomatic, while a majority of 82,055 were asymptomatic.

Writing in EJVES, the authors report that 12.1% of the 1,645 surgeons included in the study were non-shunters, while 63.6% were selective and the remaining 24.3% were routine shunters. The number of procedures in each group was 10,557, 71,160, and 31,579, respectively.

Hommery-Boucher et al reveal that, in the symptomatic cohort, in-hospital stroke, death, and the combined stroke and death rate were not statistically different among the three groups, based on univariable analysis. Similarly, they note that the asymptomatic group also did not show a statistically significant difference for any of the three primary outcome measures.

The authors go on to state that a multivariable model did not show a statistically significant difference for the primary outcomes between the three shunting cohorts and that, on subgroup analysis, the stroke and death rates were not statistically significantly different for patients with contralateral carotid occlusion and those presenting with a recent stroke.

“This paper adds new data collected from a large registry regarding postoperative outcomes related to shunt use during [CEA],” Hommery-Boucher and colleagues write in EJVES, remarking that the design of the study enabled comparison between three shunting strategies.

The authors summarise that the results of their study “demonstrated that there was a two-fold increase in the percentage of surgeons using the non-shunting strategy between 2012 and 2020, with no significant difference in outcomes compared with the other two strategies”.

In the discussion of their findings, Hommery-Boucher et al recognise some limitations of their research, including those “intrinsic” to the use of a large database like the VQI.

The researchers conclude that, despite its limitations, their study “could not define a preferential shunting strategy,” leading them to advise that the strategy “should be mainly based on a surgeon’s preference and skillset”. They go on to stress that their study has “provided quality data on the impact of a surgeon’s shunting pattern on postoperative stroke and death rate, particularly for the most at-risk groups”.

Study finds adverse outcomes after decreased use of paclitaxel-coated devices

By
Jocelyn Hudson
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0
Study finds adverse outcomes after decreased use of paclitaxel-coated devices
Eric Secemsky

A recent analysis of over 270,000 Medicare fee-for-service beneficiaries has found an increase in adverse outcomes and death after a US Food and Drug Administration (FDA) warning led to decreased use of paclitaxel-coated devices for peripheral revascularisation procedures.

Writing in the Journal of the American College of Cardiology (JACC), a team of researchers from the Richard A and Susan F Smith Center for Outcomes Research at the Beth Israel Deaconess Medical Center (Boston, USA) begin by stating that peripheral revascularisation has faced “intense scrutiny” in the past decade.

The authors—Joseph M Kim and colleagues—first cite the impact of a 2018 meta-analysis associating paclitaxel-coated devices with increased mortality when used for peripheral revascularisation. The paper led the FDA to warn against routine use of such devices. It was not until 2023, the authors add, that the FDA reversed its warning following the publication of several further studies showing no mortality signal.

COVID-19 also impacted peripheral revascularisation, Kim et al continue, noting that the pandemic “complicated peripheral arterial disease (PAD) management by reducing access to patient care”.

To assess the impact of these events, the researchers conducted a study to evaluate trends in femoropopliteal revascularisation from 2016 to 2023 and to analyse safety outcomes during three key time periods: 1) before the paclitaxel safety concern; 2) after the onset of the paclitaxel safety concern; and 3) during and after the COVID-19 pandemic.

Kim and colleagues detail that their study included all Medicare fee-for-service beneficiaries aged ≥66 years who underwent femoropopliteal revascularisation by International Classification of Diseases-10th Revision codes between 1 January 2016 and 31 December 2023.

Regarding statistical analysis, the authors state that they examined trends of femoropopliteal artery revascularisation procedures by quarter year across the eight-year study period. Endovascular revascularisation procedures were stratified by percutaneous transluminal angioplasty (PTA) alone, drug-coated balloon (DCB) alone, bare metal stent (BMS) alone, or drug-eluting stent (DES) alone.

The study’s primary outcome was the composite of major amputation and all-cause mortality.

“During the study period, the number of endovascular revascularisation procedures declined 38.2%; the number of surgical revascularisation procedures declined 59.7%,” Kim et al report in JACC.

The authors share that PTA was the primary method (27.72%) used for endovascular revascularisation before the onset of the paclitaxel-coated device safety concern, followed closely by DCB (24.91%). After the paclitaxel safety concern, the use of DCBs declined to a low of 17.89% by 2019, with a proportional increase in the use of uncoated PTA (34.52%).

In addition, Kim and colleagues write that the proportion of DCB use increased after the onset of COVID-19. “By the time of the FDA’s reversal of its warning against routine use of drug-coated devices in 2023,” the authors continue, “DCB use had reached 23.46%.” They go on to note that the use of uncoated PTA stabilised at a proportion higher than was seen before the safety concern.

Furthermore, Kim et al reveal that revascularisations performed between the paclitaxel safety concern and the COVID-19 pandemic were associated with a higher rate of the primary outcome compared with procedures performed before the paclitaxel safety concern. They note that this was driven by increased risk of all-cause mortality.

“By contrast,” Kim and colleagues report, “there were lower rates of major amputation after the paclitaxel safety concern.”

“The paclitaxel safety concern sparked a rapid shift away from the use of paclitaxel-coated devices and toward the use of uncoated devices, particularly PTA,” the authors write in their discussion. “The use of DCBs has only recently regained some ground since its nadir in 2019, but their use remains remarkably low relative to PTA despite evidence supporting their superior efficacy and the FDA’s reversal of its warning against their routine use.”

Regarding limitations to their study, Kim et al recognise that claims data lack detailed anatomical and procedural information, and that the Medicare population “may not represent the US population at large, including those who are younger, are of minority background, or are privately insured”.

Eric Secemksy, senior author of the study, remarks on the significance of the findings: “This analysis is critical in informing how external events impact patient care. Between device safety concerns and the COVID-19 pandemic, treatment approaches changed dramatically for lower extremity interventions and patient outcomes were negatively impacted. How we approach existential threats to peripheral vascular care will require thought and caution, as informed by these novel data that were generously supported by the SCAI [Society for Cardiovascular Angiography and Interventions] Early Career Research Grant.”

Study reports lack of evidence to support theory that hospital integration improves value of healthcare

By
Bryan Kay
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Study reports lack of evidence to support theory that hospital integration improves value of healthcare

A systematic review of U.S. literature focused on analyzing the effects of mergers and acquisitions on healthcare suggests that there is a lack of evidence to support the theory that integration is an effective strategy for improving the value of care delivery, according to the study authors.

Bhagwan Satiani

“In the last 30 years, consolidation of healthcare systems in the United States has accelerated through mergers and acquisitions,” Bhagwan Satiani, MD, and colleagues write in the Journal of the American College of Surgeons (JACS). “We completed a systematic literature review on integration to determine if its reputation for enhancing the value of healthcare by reducing price and cost/spending and improving overall quality of care is justified.”

The authors found that, in papers published from 1990–2024, neither horizontal integration (joining two or more hospitals) nor vertical integration (the merging of physicians and hospitals) has been found to result in “consistent and significant improvements in price, cost/spending, or quality associated with healthcare delivery.”

The authors screened 1,297 articles and identified 37 that met inclusion criteria. Results from any form of integration were mixed, they reported. Thirteen of 14 studies (93%) about price reported price increases. Thirteen of 16 (81%) about cost/spending showed cost increases or no change. Twenty of 26 studies (77%) about quality showed reductions or no change from integration.

“This finding represents an opportunity for healthcare leaders, including surgeons, to better define value in their efforts to improve quality while balancing the financial stability of the healthcare industry with a focus on benefiting the patient,” Satiani and colleagues conclude.

Satiani, professor of surgery emeritus at The Ohio State University College of Medicine, Columbus, Ohio, and a Vascular Specialist associate editor, writes frequently for this publication on the topics of hospital administration and how healthcare is delivered.

In a column published in the July edition entitled “Beyond private equity: A new sheriff in town,” Satiani explored the entrance of insurance companies into the physician practice acquisition market.

“When hospitals—which have integrated horizontally, vertically and every which way to consolidate and hire thousands of physicians— complain about the insurance companies buying physician practices, we better pay attention,” he wrote.

“Insurers like UnitedHealth Group now employ not only more physicians than the health systems, but they also own data analytic centers, accountable care organizations, office-based labs (OBLs), pharmacy benefit managers, urgent care centers, nursing homes, behavioral and mental health centers, and nursing schools.

“A recent example is the large acquisition of Wisconsin-based ProHealth Care, armed with 800 employees to manage the revenue cycle, information technology and data analytics. The strategy is to build out the back office to support the workers. Amazon-like, isn’t it? A particular concern with insurer-owned physician practices that are dominant in certain markets is their poor record related to passing on any savings to employers and ultimately patients.”

In the article, Satiani pondered what might be ahead “It is possible we may have three or four vertically and horizontally integrated for-profit juggernauts serving the entire healthcare supply chain or a single payor system,” he considered.

“It is like the Wild West and Dodge City right now. Is it possible for physicians to ‘get outta Dodge’ and escape from this scenario? Is it possible that we will see a repeat of the hospital acquisitions of the 1980s and the accompanying financial disaster?”

Novel sirolimus-eluting scaffold system demonstrates ‘potential to address Achilles’ heel’ of currently available endovascular treatment options

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Bryan Kay
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Novel sirolimus-eluting scaffold system demonstrates ‘potential to address Achilles’ heel’ of currently available endovascular treatment options
Rym El Khoury presents during MVSS 2024

Ongoing studies of the Efemoral vascular scaffold system (EVSS)—previously described as a potential new paradigm in the treatment of long occlusive lesions—show that the device continues to show promise, according to investigators.

The latest animal study assessed the subacute response to implantation of the novel, sirolimus-eluting bioresorbable system in 10 arteries of five female mini-swine, finding that it provided effective scaffolding of the treated artery, achieved near-complete reendothelialization within 30 days and “generated only a modest vascular proliferative response.” The data were revealed at the 2024 Midwestern Vascular Surgical Society (MVSS) annual meeting in Chicago (Sept. 12–14). Clinical data from the ongoing first-in-human trial of the device, EFEMORAL I, are due to be presented at the 2025 Charing Cross (CX) International Symposium in London, England (April 23–25). Here, Rym El Khoury, MD, a vascular surgeon at NorthShore-Endeavor Health in Chicago, the first-named author on the latest animal study, takes stock of the progress made with the EVSS (Efemoral Medical) to date.

Can you tell us about the latest animal data presented at MVSS 2024 and how this contrasts with that from MVSS in 2021?

In 2021, we presented an acute animal study of a novel bioresorbable vascular scaffold system. This investigational device consisting of multiple, serial, short, balloon-expandable scaffolds was implanted in a validated large animal model of percutaneous femoropopliteal arterial intervention. The animal’s hindlimb was bent in a physiologic and supra-physiologic position to assess arterial deformation and preservation of arterial lumen diameter after device implantation. We found that the inter-scaffold spaces allowed for unencumbered arterial motion in an environment that exceeded the mechanical requirements of the human superficial femoral and popliteal arteries. We also demonstrated that the copolymer of poly-L-lactic acid (PLLA) scaffold was able to deform with hindlimb extreme flexion. The hypothesis that long segments of human arteries can be effectively treated with this new paradigm was thus tested. In order to address the periprocedural arterial injury and neointimal hyperplasia that hinders durability, we spray-coated this investigational device with a known antineoplastic agent—sirolimus—and implanted it in a similar model. The purpose of this study was to assess the subacute response to its implantation. At 30 days, all treated arteries exhibited modest inflammation, near-complete endothelialization, modest neointimtal reaction, and ubiquitous fibrin. This novel sirolimus-eluting PLLA-based scaffold demonstrates the potential to address the Achilles’ heel of currently available endovascular treatment options.

Can you update us on how the first-in-human trial is progressing?

EFEMORAL I is a multicenter international trial currently enrolling in Australia and New Zealand. To date, 28 patients have been treated with the investigational device, with follow-up data up to three years in the first human subjects. In April 2024, Dr. Andrew Holden, the principal investigator for this first-in-human trial, presented the early results at CX, including the first transcutaneous ultrasound demonstrating device resorption between the first and second year. The clinical data are scheduled to be presented at the next CX meeting in 2025 as Dr. Holden presents EFEMORAL I’s results for the first time.

The device has been adapted for below-the-knee interventions. How is this development progressing?

The Efemoral system presents the advantages of treating long-segment tibial disease with a single device; prolonged drug elution to limit neointimal hyperplasia; disappearing from the artery within the first two years; and promoting positive remodeling. In May 2024, the Food and Drug Administration granted Efemoral a Breakthrough Device designation for the treatment of de novo or restenotic lesions of the infrapopliteal arteries in patients with chronic limb-threatening ischemia (CLTI). Pre-clinical studies assessing drug transfer and vascular response to the tibial device are underway.

Marriage and other things I’m probably doing wrong

By
Malachi Sheahan III
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Marriage and other things I’m probably doing wrong
Malachi Sheahan III

I met my wife, Claudie, at the Harvard Medical School vascular research lab. This was not a romantic environment by most standards (depending, I suppose, on your feelings towards Mike Conte). Many of the researchers were general surgery residents invigorated by this temporary reprieve from the horrors of their (pre-80-hour work week) training programs.

My friend Evan Deutsch pinned a map of Oslo above his desk, letting the other poseurs know who was destined for greatness. But, as the kids say, we were all NPCs (non-player characters) living in Claudie’s story. She would roll in around noon, latte in hand, opining on her self-diagnosed insomnia. I once considered suggesting that she would fall asleep more easily if she simply woke up earlier. It was never my sense, however, that she was seeking enlightenment.

Everyone knew not to book the conference room over lunch, as that was Claudie’s time to spread out the current issue of the Boston Globe and carefully consider the new shoe offerings at Filene’s. My predominant feeling towards Claudie during this time was jealousy. As the clinical fellow, I had minimal time in the lab and needed to focus on boring database research. Claudie, however, had the prize project: a study of the effects of stem cells on intimal hyperplasia. But this was 2003, and we had not learned how to make those pesky stem cells stick to the endothelium. With her research time dwindling, Claudie needed to get a few projects to the finish line. So, as PubMed can attest, our relationship began studying minor amputations and bypasses in transplant patients. Who needs romance?

The prospect of marrying another physician was terrifying. How would this all work? At the time, there weren’t even many women in vascular surgery, never mind married couples. Claudie never seemed hesitant, though. I thought, well, she is incredibly bright and seems always to have a plan; she must have thought this through. Well reader, she had not. Twenty years later, it has been a life of complications. A life of extremes. And, primarily due to my chosen spouse, a life of insane, unforced financial peril. But despite my decades of experience, I am definitively not an expert in physician marriages. My insight is more akin to one of my patients with a 9.5cm aneurysm. I don’t really know what is happening, but it’s probably going to kill me.

Claudie and Malachi Sheahan

A few months ago, my friend and SVS President Matt Eagleton spurred my interest in looking at the data behind surgeon marriages. Matt was preparing a talk on the topic and asked if we had any insight or advice. Matt also made the mistake of asking for a picture of the two of us, not knowing that my wife guards these with the determination of a North Korean press secretary. After reviewing her photo selections, it appears Claudie’s criteria are that she is wearing something she likes, and I look like the cover of The Complete Idiot’s Guide to Looking Like a Doofus.

Surgeons marrying surgeons is a relatively recent occurrence. Halstead’s original residents were required to be single males. Like Catholic priests, they were bonded to their vocation. Marriage between surgeons has become much more common as more women enter the surgical workforce. According to census data, about 25% of physicians are married to another doctor. The divorce rate among these pairings is around 25%, which trails the 35% seen in the general population. A 1997 study of Johns Hopkins graduates found the specialties with the highest rates of divorce were psychiatry (50%!) and surgery (33%).

A 2008 American College of Surgeons (ACS) survey found that surgeons in dual-physician relationships experienced a higher incidence of career and work-home conflicts. This led to more depressive symptoms and a lower mental quality of life.

Among U.S. medical school surgery faculty, 40% of women and 29% of men have an academic physician partner. These couples are generally more productive, with higher numbers of publications and more leadership positions. They are also seen as more stable with longer tenure, likely because leaving would require finding two new opportunities.

On average, female physicians interrupt their careers for 8.5 months for child rearing, while, for men, it is less than four weeks. Unsurprisingly, male physicians have significantly more children than females. Female doctors who marry other physicians report working fewer hours and having more children. The tradeoff appears to be that they earn less money and are more likely to report that their family life substantially limited their professional life. In the end, though, female physicians married to other doctors do not report less success in achieving their career goals.

I have spent a good portion of the last decade studying the effects of burnout on surgeons. At the beginning of our careers, most of us perseverate over life choices such as where to live, what type of employment to seek, and when to have children. I am now convinced that the two most important decisions are your spouse and your work partners. Nail both choices and the rest tend to sort themselves out.

Surgeon-surgeon marriages will continue to grow in popularity as we change the demographics of our workforce. For now, though, the data is relatively limited. So, for the next issue, I have assembled an all-star team of married surgeons to offer advice, guidance and safety tips. Until then, please enjoy your holidays, and thank you for all of the interaction this year (even the haters!).

Malachi Sheahan III, MD, is Vascular Specialist medical editor.

How physician assistants help vascular surgery teams provide ‘continuity of care’

By
Bryan Kay
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How physician assistants help vascular surgery teams provide ‘continuity of care’
Julie Ann Freischlag dials in to Brighton, England

The key role played by physician assistants (PAs) as part of vascular surgery teams in the U.S. came into focus during the Vascular Societies’ Annual Scientific Meeting in Brighton, England.

Julie Ann Freischlag, MD, the former Society for Vascular Surgery (SVS) president and current CEO of Atrium Health Wake Forest Baptist in Winston-Salem, North Carolina, outlined how the integration of PAs had positively impacted vascular practice over the course of the last couple of decades during a President’s Symposium session on multi-professional teams.

Freischlag provided attendees with a rundown of lessons learned during her career—from the point at which PAs were not part of the picture of vascular surgical practice, through the advent of the 80-hour work week limit for residents in training and their subsequent incorporation into the heart of surgical services and research.

For Freischlag, PAs entered the scene while she was practicing at Johns Hopkins in Washington, D.C., where an early PA surgical program was developed and rolled out.

Fast forward 20 years, and now at Wake Forest, she said PAs have helped across a number of fronts, with impacts made across areas such as patient length of stay and the length of time residents spend in the operating room (OR).

At present, Freischlag pointed out, some 3% of PAs work in general surgery, with about 18.7% operating in the surgical subspecialties. “When I moved from Hopkins to UC Davis and I was doing my first case—involving a thoracic outlet—my PA was talking to my really young partner about how to assemble the retractor and how to take care of that patient,” she reflected. “PAs who have worked with me on thoracic outlet can assess and treat and take care of postoperative patients as well as I can.”

She highlighted how she sees much more “continuity of care,” with improvements seen in care coordination and patients’ ability to navigate the healthcare system. “We do simulation in virtual encounters, working through scenarios together, so not only do the patients go through what they do when they get to the hospital but we do all this before they even show up so they are used to many different types of people around the bed, around the OR table,” Freischlag added.

To be able to safely and efficiently perform their roles in vascular surgery teams, PAs must satisfy heavy requirements that include 2,000 hours of supervised clinical practice. Freischlag also zeroed in on another dimension where their impact is felt: in the context of social determinants of health and health equity. She used an example from her own time as a resident to illustrate the PA effect, explaining how, while working at the VA, “we used to double book patients because many didn’t show up and we didn’t understand that it was mainly because of their social determinants.” Now, as PAs help patients navigate often labyrinthine health systems and with their ability to attend, those issues are being better tackled. “PAs, NPs [nurse practitioners], all of us need to know those impediments to care,” Freischlag noted.

Ultimately, she said, how PAs fit into vascular surgery teams might differ but “continuity throughout the perioperative period decreases complications and increases patient satisfaction, and that’s what is so important.”

Vascular trainees better prepared for open aortic practice than commonly reported, new study shows

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Bryan Kay
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Vascular trainees better prepared for open aortic practice than commonly reported, new study shows
Young Kim

Current graduates from both vascular surgery residency and fellowship programs are well prepared for surgical practice in aortic disease whether they are performing open repair or endovascular therapy, contrasting with research indicating that trainees are entering the workforce with inadequate experience of open aortic repair. That is the main finding of a new study set to be presented at the 2025 annual meeting of the Southern Association for Vascular Surgery (SAVS) in St. Thomas, the U.S. Virgin Islands (Jan. 22–25).

The analysis of Accreditation Council for Graduate Medical Education (ACGME) reports from 2013–2023 adds a counterweight to the increasingly accepted wisdom that current vascular fellows are graduating with less than five open abdominal aortic aneurysm (AAA) repairs on their docket when they complete training, according to senior author Young Kim, MD, an assistant professor of surgery at Duke University School of Medicine in Durham, North Carolina.

Crucially, Kim highlighted that trainee experience was robust across the breadth of open aortic cases, not only those which involve aneurysm repair.

“An open aorta is an open aorta, whether it is for occlusive disease or an infected aorta,” he tells Vascular Specialist. “There are a lot of very similar principles between the different types of aortic operations, but the well-cited study quoting the five-open-aortas statistic pertained only to open AAA repairs, and that was back in 2014, and looked at Medicare beneficiaries.”

Young and colleagues found that over the 11-year period of their analysis, the mean aortic case volume among graduating vascular surgery fellows and residents were 118.8 and 130.5, respectively.

The open aortic experience comprised 32.9 cases among fellows, including 17.5 aneurysm repairs and 15.5 operations for aortic occlusive disease, with a <1% decline in open aortic operations.

Endovascular aortic volume among fellows included 85.8 total cases, which increased by 1.5 each year. These included 42.2 endovascular aneurysm repairs (EVARs), 15.8 thoracic EVARs (TEVARs), and 27.8 aortoiliac angioplasty and/or stenting operations.

Among graduating residents, open aortic experience comprised 36.1 cases, including 18.3 aneurysm repairs and 17.7 operations for aortic occlusive disease, with no decline in open aortic operations. Residents’ endovascular aortic case volume included 94.4 total cases, which increased by three annually. These included 46.5 EVARs, 15.8 TEVARs, and 32.1 aortoiliac angioplasty and/or stenting operations.

“Having personally graduated from fellowship three years ago, and speaking with many other co-fellows and fellows in training at the moment, we all know this intrinsically to be not true for ourselves—that we graduate prepared for surgical practice in open AAA repairs,” Kim explains.

“I’m not sure how that speaks to the national trends, but it is hard to hear that as somebody who recently has gone through training, having other people tell me that we are not prepared for surgical practice in open AAA repairs. That was the impetus for taking a look at the data. Specifically, we wanted to look at the ACGME case logs because these are self-reported cases by each of the trainees during their training, so reliable in that regard.”

The types of open repairs included in the analysis ranged from infrarenal, suprarenal, thoracoabdominal and thoracic aneurysms, to aortoiliac bypasses and aortofemoral bypasses or resections for occlusive disease.

“Open aortic case volume for both residents and fellows was somewhere between 30 and 40 by the time of graduation,” Kim says. “That number didn’t really change much over the years, which really speaks to the consistency and reliability of the data for total open aortic case volume, so it’s not as if this data is unreliable.”

Still, as trainees enter practice, Kim adds, “the most important thing is having a supportive senior partner because, though you may have done a number of aortic cases during training, it is really only during the first few aortic cases you do in practice when the training wheels come off.”

The endovascular revolution and open aortic training: ‘It’s not necessarily a crisis but it could become one’

By
Bryan Kay
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The endovascular revolution and open aortic training: ‘It’s not necessarily a crisis but it could become one’
Jean Panneton

Jean Panneton, MD, considers himself what he terms a “blue-collar” vascular surgeon as much as one engaged in academic practice and the necessity of helping contribute to the next generation of vascular surgeons. He operates. And he operates a lot. But he is also a professor of surgery, and a program director in charge of turning out vascular trainees so important to the future of the specialty. For him, the rigors of both silos, brisk practice and academia, coalesce in his everyday working life—and they also underpin the thrust of the message he was trying to send in a recent turn at the lectern as well as in this interview.

“Blue refers to the fact you have to take care of business, take care of patients,” Panneton, a vascular surgeon with Sentara Vascular Specialists and chief of vascular surgery at Eastern Virginia Medical School in Norfolk, Virginia, tells Vascular Specialist. “Because when you work in a non-academic center per se, and non-university hospitals, some of these places are very busy, high volume, so that is where that statement comes from.” When he used the phrase as he delivered the Robert R. Linton Lecture at the 2024 annual meeting of the New England Society for Vascular Surgery (NESVS) in Portland, Maine (Oct. 25–27), he got a few laughs, but a seriousness underpinned it. “The changing landscape of aortic surgery” was the title. The message was twofold: the shift in volume from open surgery to endovascular therapy and the new language and complications that have come with it, alongside the impact this evolution has had on the open surgical skills with which graduating trainees emerge from residency and fellowship.

“With endovascular therapy comes an increased need for reintervention and the concept of new types of complication—endoleaks for example, graft migration too,” he says. “These never existed before. And how has this shift affected training? Nowadays, a lot of the recent graduates are not comfortable with open aortic surgery.”

Nationwide, there is a growing realization of the issue and the need to address it—regionalized aortic care, an aortic fellowship, simulation, trainees rotating to high-volume centers are among the remedies circulating— but Panneton is not sure scalable solutions to remedy the deficit are close. “For now, it’s not necessarily a crisis but it could become one,” he says. “Because when you look at the median age of currently practicing vascular surgeons, and how a lot of them have significant open aortic skills, in the next 10 to 15 years, a lot of those surgeons will end up retiring. It’s crucial that before this wave of vascular surgeons with open aortic skills retire that they transmit the skills to the younger generation. Some of those surgeons do not work in a place where there is a formal ACGME [Accreditation Council for Graduate Medical Education] training program. One way for these skills to be transferred might be for trainees to continue to look, wherever they end up after completing training, at their job as an apprenticeship mode, where junior surgeons can really be tagged to more senior surgeons who can share some of that experience with open aortic surgery to junior partners.” Still, Panneton adds, absent a formal way of measuring knowledge transfer and aortic care skill acquisition outside of the standard structures of ACGME programs and American Board of Surgery (ABS) exams, scalable solutions remain to be developed.

On the other hand, there is the other side of that training deficit, the endovascular revolution, the one for which Panneton had to learn a new language and new way of doing things, and it has tracked his 35-year career. The new language signposted those new complications but, importantly, came along with reduced mortality and morbidity. “One of the exciting things of this move toward endo has definitely been the evolving technology that has gone hand in hand with that shift,” he says. “Over 30 years of implanting endografts, from gen-one devices to the next-gen devices, has been phenomenal. Industry has done a fantastic job of trying to improve devices year after year. We started with simple EVAR [endovascular aneurysm repair], to now being able to do fenestrated or branched repairs for TAAA [thoracoabdominal aortic aneurysm] and endovascular repair of aortic arch pathology as well.”

Complex problems and devices to match brought with them not only issues related to complications but others like repair complexity, high costs and the need for additional devices such as bridging stents. Thus, Panneton says, the necessity of simple solutions and devices endures. He points to in situ laser fenestration, for example, which “can be done in a very simple, effective manner, and those devices have a smaller delivery profile than more complex devices. The operations tend to be quicker, and with less manipulation.” On the topic of in situ fenestration, Panneton’s group has a paper due at the 2025 annual meeting of the Southern Association for Vascular Surgery (SAVS) in St. Thomas, the U.S. Virgin Islands ( Jan. 22–25), in which they look at a 15-year experience of the technique in zone 2 thoracic EVAR (TEVAR). The paper will report “a very, very low stroke rate,” Panneton says. “It’s also very durable.” His first patient received the procedure in August 2009, with that subject representative of quite a few others among the cohort, he adds: an intact fenestration, patent vessel and no fenestration-related complications.

Alongside complexity sit an aging patient population, increasing prevalence of vascular disease, and, therefore, a need for more vascular surgeons. Up come those training questions again: Panneton sees a need for an increase in the number of vascular surgery training programs. While the level has been steadily increasing, he notes, it “is not increasing fast enough. What’s predicted is a deficit in vascular surgeons. There is also a generational shift, with the newer generation not necessarily looking at working as a surgeon in the same way we previous generations looked at it.” Which is to say, work-life balance has taken root, further shaping the face of the workforce and needs of the workplace, Panneton observes. Running in tandem are increased demands on vascular surgeons—the expansion of peripheral arterial disease (PAD) treatment, pulmonary embolism response teams (PERTs), wound care, and, an area previously the preserve of cardiac surgery, the aortic arch. “When a hospital has a TAVR [transaortic valve replacement] program, they cannot exist without vascular surgeons,” he continues. “We get called a few times per week for structural heart. There has been an increase in the demand for vascular surgeons because the work has diversified even more.”

As a result, another evolution plays out. “Vascular surgery is evolving like general surgery,” Panneton reasons. “In the past, general surgeons took care of everything. But now, there are general surgeons who do only trauma, or oncology surgery, or colorectal surgery. We are seeing that start to happen with vascular surgery. Some only do vein procedures, because they tend to be elective, which is a much more controlled thing. Some do wound care or work in a limb salvage clinic. There are some, like me, who you might consider an aortic surgeon, as the majority of my practice is aortic stuff. That is one way for the workforce to deal with the demands of practice in the future.”

Yet, the training imperatives of aortic surgery remain, adds Panneton. “That is the most high-risk and most likely to be the one to require additional training, as opposed to other ‘sub-specialties’ within vascular surgery, which are not quite the same level of complexity and risk.”

How the RevCore and VenaCore thrombectomy catheters combine to broaden treatment approach among advanced deep vein thrombosis patients previously limited to few options

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How the RevCore and VenaCore thrombectomy catheters combine to broaden treatment approach among advanced deep vein thrombosis patients previously limited to few options

This advertorial is sponsored by Inari Medical.

Clot haul from a procedure involving both the RevCore and VenaCore devices
For Joseph M. Liechty, MD, a vascular surgeon with Texas Vascular Associates in Plano, Texas, the emergence of the RevCoreTM and VenaCoreTM devices (Inari Medical) have helped broaden his treatment strategies for advanced venous disease patients in whom options were previously limited. Liechty, who operates in the Dallas-Fort Worth (DFW) metroplex, sees a significant number of patients living with the long-term sequelae of deep vein thrombosis (DVT), especially those with symptoms of post-thrombotic syndrome (PTS).

Here, he describes how he has harnessed the RevCore thrombectomy catheter to tackle in-stent thrombosis and the VenaCore thrombectomy catheter to address challenging venous occlusions, as he builds a venous practice that reaches beyond best medical therapy with a limited suite of interventional tools. These new thrombectomy devices, Liechty explains, have helped him reach a community in need of alternatives with enduring results.

Can you describe how your venous practice has evolved since you started to see patients in the DFW metroplex?

Venous patients make up about 30% of all the cases I do now, with acute referrals coming from emergency departments (EDs) and hospitalists from multiple healthcare systems in the area, and from outpatient clinics dealing with more chronic DVT and symptomatic venous obstructions. When I first came here, I did a lot of ED and intensive care unit talks and I visited primary care, wound care, hematology/oncology and cardiology practices. I did a lot of promotion, case sharing, and awareness work because the technology was so new.

There has been a long-standing paradigm of treating venous disease extremely conservatively that is not easy to change. Something that has been helpful when speaking to colleagues is to have trials and data to show them, as well as case presentations.

In what ways have RevCore and VenaCore grown your practice?

Prior to the introduction of RevCore, there was a certain period in which a thrombectomy needed to be done before the clot in the stent became impossible to remove and would require a new stent to be placed inside the old one. The only real option was to go in with some kind of aspiration tool to remove the thrombus or use thrombolytics; however, neither of these options were consistently effective in cases where the thrombus had been present for perhaps a couple of weeks, and so it was a pressing matter to get the thrombectomy done as soon as possible. With the RevCore device, that sense of urgency has been removed. We have the liberty to go in a little bit later. More importantly, if a patient should present late with a thrombosed stent, we don’t have to say, “There is nothing we can do.”

Additionally, prior to RevCore, if you couldn’t get the clot out when it was fresh, you didn’t really have any other choice than to place another stent. RevCore gave us an option to remove thrombus of varying chronicity from an existing stent and hopefully limit the need to place another.

What has been your experience offering patients treatment with the RevCore and VenaCore devices when previously they couldn’t get an interventional option?

We have had a lot of success. We haven’t had many cases where there has been thrombus that has been resistant to these devices. I have found VenaCore to be especially useful in the common femoral vein, where perhaps there would be concern for having to stent across the infrainguinal ligament, even though this is well-tolerated when I’ve done it.

For clotted stents, the only option was to aspirate whatever could be removed, perform balloon angioplasty, and then possibly place more stents, leading to patients with a couple of layers of stents if they had experienced more than one clotting episode. RevCore allows you to clean out stents, which has decreased my need to re-stent.

What would you tell your peers about building an advanced venous practice?

There are a lot of upsides. We deal with patients who have problems for which they have been told there aren’t any good solutions. In the vascular world, DVT is different because the disease process skews toward a younger population compared to arterial disease. We can improve the quality of life for people who are still trying to work and support a family, for example.

Advanced venous cases require considerable planning in terms of anatomy, thrombus distribution, pre-existing stents and/or filters, and available access points, as well as which devices are available. We have seen very grateful patients for whom previously there wasn’t anything we could do other than offer compression stockings and anticoagulation.

If you are just starting out with these devices, perhaps an ideal patient might be one who has a unilateral problem and no thrombotic history. For more advanced cases, I favor general anesthesia because these cases can take a few hours, and having multiple access sites could be uncomfortable for an awake patient.

Can you break down how RevCore fits into your surveillance of patients who have had a stent placed?

I schedule regular surveillance on all the iliac vein stents I implant—I routinely follow up with these patients at four weeks, three months, nine months and then annually— and occasionally we’ll see stents that appear to be occluding, developing a lining on the inside that narrows the flow lumen.

There is a subset of patients whose stents will eventually go on to occlude and they remain asymptomatic. This is probably because they have managed to develop collaterals that are sufficient during that time. But I also have patients who have a stent that is starting to occlude, and they are beginning to have swelling and pain in their leg. Those are the patients who don’t have collaterals yet, or maybe they are always going to be dependent on their stent. These are the patients on whom I would intervene early. Essentially, my strategy is based more on how the patient feels and how the leg looks rather than whether there is some narrowing on ultrasound. That shouldn’t be the deciding factor.

Case report

A man in his late 60s with a left iliac vein stent and revision two years prior was referred for consultation. The patient discontinued his anticoagulation two months before he was referred for consultation for severe left leg swelling. Duplex ultrasound confirmed a reoccluded left iliac venous stent. The decision was made to intervene with mechanical thrombectomy.

Procedural overview

Access was obtained in the superficial femoral vein and right internal jugular (IJ) vein under ultrasound guidance. A venogram demonstrated significant thrombus in the common femoral vein, profunda and extending into the external iliac vein. A .035” guidewire was inserted into the femoral vein and externalized through the access sheath. A ProtrieveTM sheath (Inari Medical) was inserted over the wire into the right IJ vein and advanced into the inferior vena cava. Next, the Triever20 catheter (Inari Medical) was inserted over the wire and directed to the profunda and common femoral vein. Aspiration with the Triever20 removed acute and sub-acute thrombus. Organized material could not be removed with aspiration. RevCore was then inserted over the wire into the occluded stent. Multiple clockwise and counterclockwise turns in conjunction with scrubbing the element within the stent resulted in successful clearance of nonacute thrombus. VenaCore was then introduced through the Protrieve sheath to clear the common femoral vein. Completion venogram demonstrated brisk cephalad flow. Total procedure time was 90 minutes.

DISCLOSURE: Joseph M. Liechty is a paid consultant of Inari Medical. All views and opinions expressed here by Liechty are his own and do not represent those of Inari Medical.

Indications For Use: The RevCore Thrombectomy Catheter is indicated for (1) The non-surgical removal of thrombi and emboli from blood vessels. (2) Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature. The VenaCore Thrombectomy Catheter is indicated for (1) The non-surgical removal of thrombi and emboli from blood vessels. (2) Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The VenaCore Thrombectomy Catheter is intended for use in the peripheral vasculature. The Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions. Triever Catheters are indicated for (1) The non-surgical removal of emboli and thrombi from blood vessels (2) Injection, infusion, and/ or aspiration of contrast media and other fluids into or from a blood vessel. Triever Catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters are also intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Review complete Instructions for Use, Indications for Use, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. For all non-Inari products, please refer to complete manufacturer Instructions for Use/ Intended Purpose for complete indications for use, contraindications, warnings and precautions. All copyrights and trademarks are property of their respective owners.

Inari Medical 6001 Oak Canyon, Suite 100, Irvine, CA 92618

Vascular Specialist–December 2024

By
Bryan Kay
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Vascular Specialist–December 2024

In this issue:

  • Positive one-year data for new venous valve portends promising future in chronic venous insufficiency treatment
  • Vascular trainees better prepared for open aortic practice than commonly reported, new study shows
  • From the Editor: Malachi Sheahan III, MD, on ‘Marriage and other things I’m probably doing wrong
  • Interview: Jean Panneton, MD, discusses the aortic surgery landscape and the state of training

 

FDA approves Humacyte’s Symvess for vascular trauma

By
Jocelyn Hudson
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FDA approves Humacyte’s Symvess for vascular trauma
Human Acellular Vessel
ATEV
Symvess

Humacyte recently shared that the Food and Drug Administration (FDA) has granted a full approval for the Symvess acellular tissue-engineered vessel.

A press release notes that Symvess is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularisation is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.

“We are very excited and proud to provide patients suffering from arterial injury with a novel treatment option. Symvess has been made possible by our innovative bioengineering science along with the contributions of many patients, healthcare providers and Humacyte team members,” said Laura Niklason, founder and chief executive officer of Humacyte. “Symvess approval in this first indication for arterial injury repair is a milestone for regenerative medicine overall, as well as for Humacyte. The FDA’s full approval of Symvess is a transformational event for the company and our bioengineering technology platform. Even more importantly, we believe Symvess provides a new means of treating patients with devastating arterial injuries, which is a population that has not benefited from substantial innovation in decades. We look forward with great excitement to our upcoming commercial launch of Symvess, and we have recruited and trained a terrific team to execute on our sales and marketing missions.”

“The approval of a vascular conduit that resists infection and remodels into native arteries is an extraordinary technological advancement that will have a huge impact on the quality of trauma care around the world,” said Charles J Fox (University of Maryland Capital Region, Lake Arbor, USA), a clinical investigator in the V005 clinical trial. “Symvess is perfectly sized to treat most injuries, has excellent handling properties, and reduces time necessary to save both life and limbs. The Humacyte team has responsibly and scientifically solved a major clinical problem that I believe will reduce the amputation rate for traumatic vascular injury. They should be congratulated on an accomplishment that will undoubtedly advance our specialty to the next level.”

“I believe that Symvess will revolutionise vascular trauma care and be profoundly beneficial to our patients,” said Rishi Kundi (University of Maryland Medical System, Baltimore, USA). “From my experience so far, Symvess will allow reconstructions that are currently impracticable because of contamination and infection. It will make reconstructions that we now perform with prosthetic or even biologic grafts more successful. I am most excited about the promise that Symvess holds for the long-term experience of our patients. I hope that, with Symvess, the 19-year-old patient with vascular reconstruction after trauma will no longer spend the six decades after their surgery anticipating disaster, but that their chances for reintervention will be no different than if they had autologous conduit.”

A press release details that Symvess is a first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. “While harvesting vein from a trauma patient takes valuable surgical time, Symvess is available off-the-shelf, and does not require further injuring the patient to obtain vascular repair material,” the release notes.

Humacyte’s biologics license application (BLA) included positive results from the V005 pivotal Phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid programme. Symvess was used to repair many types of traumatic injuries including car accidents, gunshot wounds, blast wounds, and industrial accidents. It was utilised by vascular and trauma surgeons in level-one trauma centres throughout the USA and Israel to repair severe limb-threatening and life-threatening injuries, and in frontline hospitals in Ukraine to treat wartime injuries. Results from these studies were published in JAMA Surgery in November 2024. In the civilian and military clinical studies, Symvess was observed to have high rates of patency, or blood flow, and low rates of amputation and infection.

“Finally, we have an innovative technology for battlefield vascular injuries using a tissue-engineered human arterial replacement that can resist infections that are so prevalent in modern combat zones,” added Fox. “Symvess shows promise to reduce amputation rates since an alternative conduit for war injuries is often needed but up until now has not been a good option.”

“The FDA approval of Symvess will make it the preferred conduit for complex vascular injuries, and particularly those at risk for infection,” said Ernest E Moore (Denver Health, Denver, USA), a clinical investigator in the V005 trial. “I look forward to using Symvess in my practice.”

Humacyte shares that the Symvess trauma programme was granted regenerative medicine advanced therapy (RMAT) designation by the FDA in May 2023, a BLA was submitted to the FDA in December 2023, and in February 2024 the FDA granted a priority review. On 9 August 2024, the FDA informed Humacyte that it needed additional time to complete its review of the BLA, although there were no outstanding pre-approval requirements for Symvess as of that date. The FDA completed its review on 19 December, granting full approval.

Merit Medical announces FDA approval of the Wrapsody cell-impermeable endoprosthesis

By
Bryan Kay
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Merit Medical announces FDA approval of the Wrapsody cell-impermeable endoprosthesis
wrapsody first study
Wrapsody endoprosthesis

Merit Medical Systems announced today that the Wrapsody cell-impermeable endoprosthesis has received premarket approval from the US Food and Drug Administration (FDA). With this approval, a press release notes, Merit can begin commercialisation of the device in the USA in 2025.

The company details that Wrapsody is designed to extend long-term vessel patency in dialysis patients. “Preserving vascular access for dialysis patients is critical for them to maintain lifesaving treatment,” said Bart Dolmatch (Palo Alto Medical Foundation, Palo Alto, USA), who is credited as co-inventor of the Wrapsody device, in a Merit press release. “I believe the advancements that the Wrapsody device offers will translate to better outcomes for haemodialysis patients.”

The Wrapsody cell-impermeable endoprosthesis consists of a proprietary covering that features a nitinol stent frame enveloped by an expandable polytetrafluoroethylene (ePTFE) outer layer, an inner-luminal layer of novel “spun” PTFE designed to reduce platelet and fibrin formation, and a middle cell-impermeable layer designed to prevent transgraft tissue migration or accumulation. Merit claims that the nitinol frame provides enhanced radial force, compression resistance, and softened ends to help the device conform to vessels, withstand physiological compression, and reduce stress on vessel walls.

Results from the WRAPSODY WAVE pivotal trial demonstrated that arteriovenous (AV) fistula and AV graft patients receiving treatment with the Wrapsody device for dialysis outflow lesions achieved a target lesion primary patency of 89.8% and 82%, respectively, at six months. The primary patency of the entire access circuit at six months in patients with an AV fistula and AV graft were 72.6% and 68.8%, respectively.

“Historically, interventions for patients who experience a stenosis in their AV fistula or AV graft have not provided sustained clinical benefits and often require multiple reinterventions,” said Mahmood K Razavi (St Joseph Heart and Vascular Center, Orange, USA), co-principal investigator of the WAVE trial. “Results from the WAVE trial have demonstrated that the Wrapsody device is associated with high patency rates and is likely to become the new standard of care.”

“Over the past decade, Merit has worked to ensure that the Wrapsody device helps physicians achieve the best possible outcomes for patients,” said Fred P Lampropoulos, Merit’s chairman and chief executive officer. “We are proud to design and deliver such an innovative solution that has demonstrated the highest efficacy to date.”

Positive one-year data for new venous valve portends promising future in chronic venous insufficiency treatment

By
Bryan Kay
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Positive one-year data for new venous valve portends promising future in chronic venous insufficiency treatment
VenoValve implantation
SAVVE trial principal investigators discuss results showing 98.4% VenoValve device patency, 85% clinically meaningful benefit and an 80% rate of ulcer size reduction at 12 months.

Fresh from delivering positive one-year data from the Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) pivotal trial at the 2024 VEITHsymposium in New York City (Nov. 19–23), site principal investigators Matthew Smeds, MD, and Raghu Motaganahalli, MD, are both ebullient about what the results might mean about the future for patients with chronic venous insufficiency (CVI) and venous ulcerations.

Matthew Smeds

The data show that 85% of patients surgically implanted with a bioprosthetic VenoValve (enVVeno Medical) reached the one-year milestone having achieved a clinically meaningful benefit of a three or more-point improvement in revised Venous Clinical Severity Score (rVCSS); a 7.91 point average improvement in rVCSS; clinically meaningful benefit across all CEAP (Clinical, Etiological, Anatomical and Pathophysiological) classes of patients enrolled (C4b–C6); 97% target vein patency at one year; and significant resolution in venous ulcerations.

“It is the first device we have had to treat deep venous insufficiency in years,” Smeds, a professor of surgery and the former division chief of vascular and endovascular surgery at Saint Louis University in Saint Louis, Missouri, tells Vascular Specialist in an interview in the days after presenting at VEITH 2024. “These patients are typically relegated to compression therapy alone. There are no really great surgical options for this issue.”

Similarly, Motaganahalli describes the novel device as representing a “game-changer” given how previous attempts at developing a surgical option for the CVI patient population failed to take hold. “The procedure does not have a steep learning curve; technically, this is a procedure that can be accomplished by any trained vascular surgeon. It is not technically demanding,” says. “Before, these were technically demanding operations: if you really look at the historical data from internal valvuloplasty or external valvuloplasty, vein valve reconstruction, vein valve transplant—they were effective in a few select centers and a few select hands, but that result was not reproducible at multiple centers.”

Smeds zeroes in on the topline result of 98.4% device patency and considers how there were nine device occlusions over the course of the one-year study. “However, eight of them re-canalized,” he explains. “I had some patients that thrombosed the device. Interestingly, in one of them I sucked out the thrombus via mechanical thrombectomy and then it occluded a few weeks later. I thought that that device was never going to be functional, but, within a month or two, the device recanalized and the patient had decreased reflux below the device and was healing her ulcer.”

Though these thromboses were each marked down as a device “failure,” Smeds continues, the fact eight reopened and many were then functional represented pleasant surprises. “I think you see that in the natural history of people with DVTs [deep vein thromboses] to begin with,” he explains.

Elsewhere among the data, he picks out the trial’s inability to pinpoint a direct relationship between reflux and ulcer healing, and the role of compression therapy compliance as intriguing propositions. “We cannot find a direct one-to-one ratio in terms of if you have a really high decrease in reflux, then you get a really high ulcer healing rate,” Smeds says. “So, there are certainly more complex things going on at a patient-to-patient level with the device as far as who is benefiting from it.

“We also looked at whether there was full compliance for compression therapy—whether that increased or decreased over the length of the trial—and there was a slight decrease in its use, which demonstrates that the device is doing something to aid in the ulcer healing and the symptom improvement, because it wasn’t necessarily due to an increase in compression.”

Raghu Motaganahalli

For Motaganahalli, chief of vascular surgery and program director at Indiana University in Indianapolis, ulceration reduction data were stark. In those who had their ulcers for less than three months, the SAVVE trial demonstrated there was 100% resolution— “complete healing,” he says. “Most of the patients who had an ulcer more than a year or so, even then 60% of them showed full resolution of the ulcer. In terms of the average area of the ulcer—especially in those who had a longer duration of ulcer—those patients had an average ulceration of 20.6cm2 at baseline, and that reduced to 12.3cm2.”

Motaganahalli sees a promising future for the device: “The one-year data tells you that it provides a sustained benefit of symptomatic improvement for patients with CVI. The VenoValve is a safe and effective treatment for patients with CVI due to deep valvular incompetency. It’s not only effective, but effective across the whole spectrum of CEAP classification: for C4b through C5 and C6. The benefits were seen within the first three months and were sustained through the one-year period of observation.”

Motaganahalli also lingered on the significance of the improvement in average rVCSS among the trial cohort: the 7.91 score recorded at 12 months came amid a Food and Drug Administration (FDA) mandate for a more than 3-point advance in rVCSS. “Here, more than 85% of the patients had more than a 3-point improvement,” Motaganahalli notes.

On the eve of the VEITHsymposium, enVVeno Medical announced it had submitted an application with the FDA seeking approval to market the VenoValve based on the one-year data Smeds and Motaganahalli presented. The company is also developing a next-generation, non-surgical transcatheter-based replacement venous valve called enVVe. It is expected to be ready for its own pivotal trial in the middle of 2025.

VenoValve device

Smeds is excited by the portent of what might be to come as development of the devices proceed. The venous system is still “Pandora’s box as far as putting devices and valves in there,” he says. Further, in the SAVVE trial, each patient was implanted with only one replacement valve. Smeds considers the questions of whether more than one device should be fitted in patients to further decrease reflux; whether in patients with duplicate incompetent systems both should receive a VenoValve; and whether the location of the replacement valves should be modified. “There are a lot of unknown questions that will hopefully begin to be answered once this becomes FDA approved,” he adds.

Motaganahalli believes some might query the device cost once it enters the market but sees the potential impact on the heavy cost burden associated with wound care for venous ulcers as a boon. “If you look at the cost of treating ulcerations, several billions of dollars are spent annually,” he says. “With appropriate patient selection, the device can do wonders. We have 2.5 million potential patients with CVI in the U.S., with close to around 40% missing workdays, $3 billion in direct medical costs, $30,000 per patient in terms of the annual cost of ulcer treatment, with the potential for 20–40% of these patients to have a recurrence. This makes the device a very attractive option.”

Novel bioabsorbable perivascular wrap aims to reduce AVF failure

By
Bryan Kay
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Novel bioabsorbable perivascular wrap aims to reduce AVF failure
Ellen Dillavou presents during VEITH 2024

Ellen Dillavou, MD, division chief of vascular surgery at WakeMed Heart Center in Raleigh, North Carolina, primary investigator (PI) for the VenoStent trial, presented new data during the 2024 VEITHsymposium in New York City (Nov. 19–23) about the SelfWrap (VenoStent) bioabsorbable perivascular wrap, outlining how the novel device can, she says, improve arteriovenous fistula (AVF) maturation and patency.

According to data published in the Journal of the American Society of Nephrology (JASN) and American Journal of Kidney Disease (AJKD), annually, 5 million patient lives are put at risk by 60% one-year failure rates of AVFs and arteriovenous grafts (AVGs), as well as 20% one-year failure rates of vein grafts in bypass grafting, she said.

One solution, Dillavou argued, is the SelfWrap device. Receiving its Food and Drug Administration (FDA) Breakthrough Device designation in May 2022, followed by investigational device exemption (IDE) approval in May 2023, this vascular wrap made of bioabsorbable polymers uses an artery-like mechanical support to help veins first “behave” and then “become” like an artery. It also regulates flow—which Dillavou stated will “impart hemodynamic benefits.”

“In every large animal model which tested AVFs, AVGs and bypass grafts over five years and three different centers, the advanced materials approach that ‘arterializes’ veins significantly reduces neointimal hyperplasia,” said Dillivou.

The SelfWrap trial’s objective was to demonstrate feasibility and evaluate the safety and performance of the SelfWrap device by enrolling 20 participants in a single-center, prospective, single-arm study, with follow-up obtained at six months up to 60 months. The primary endpoint was a high patency rate. Three SelfWrap sizes were employed, with selection based on vein size. A total of 13 patents (65%) were given brachiocephalic fistulas (BCFs), two received basilic vein transpositions (BVTs), and five were given radiocephalic fistulas (RCFs).

Dillavou reported that there were no adverse events probably or definitely related to the device through 36 months, as well as no device deficiencies nor adverse device effects.The SelfWrap device had a high maturation rate, she reported. Functional maturation was 95%, compared to the <58% expected, and unassisted maturation was 90% for SelfWrap, compared to 33%. Further, SelfWrap saw 89.5% of catheters removed at nine months, 94% of which were unassisted, compared to ~27% at nine months for untreated AVFs. Dillavou noted that, should the results translate to the ongoing IDE study, they would prove impactful in the space.

When RCTs are essential for novel vascular access device regulation

By
Bryan Kay
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When RCTs are essential for novel vascular access device regulation
Robert Lee presents during VEITH 2024

As part of a 2024 VEITHsymposium (New York City; Nov. 19–23) debate, Robert E Lee, MD, a medical officer recently retired from the Food and Drug Administration (FDA), presented an argument in favor of when the use of randomized controlled trials (RCTs) for the regulation and approval of novel vascular access devices becomes important.

“Randomization,” he stated, “helps assure that participants in both treatment groups are similar in the distribution of prognostic factors. This minimizes bias in statistical comparisons of patient outcomes when looking at both effectiveness and safety.”

“RCTs yield the highest level of evidence to establish causal associations in clinical research,” he said, so that there is no need for statistical sleight of hand with propensity scoring or other complex methodology to understand if a new therapy is more effective.

Venous VQI celebrates decade milestone

By
Jocelyn Hudson
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Venous VQI celebrates decade milestone
Marc Passman at VEITH 2024
Marc Passman presents at VEITH 2024

At the recent VEITHsymposium (Nov. 19–23) in New York City, Marc Passman, MD, reflected on the achievements of the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) venous arm, in collaboration with the American Venous Forum (AVF), since its inception 10 years ago. 

Passman, who is professor of surgery in the Division of Vascular and Endovascular Therapy at the University of Alabama at Birmingham and chair of the VQI Venous Quality Council (VQC), shared that a total of 1,302,849 procedures have been captured by the VQI as a whole as of November 1 2024.

Regarding venous interventions, Passman specified that there are currently three venous modules within the VQI, with varicose vein, inferior vena cava (IVC) filter, and venous stent procedures comprising 70,097, 19,793 and 305 of the November 2024 total, respectively.

Passman first highlighted data from the VQI IVC filter registry. Initiated in 2014, the presenter shared that 50 centers were subscribed to the registry as of November 2024, which is the latest participation datapoint available from the registry. He noted that this has decreased by 16 from a peak in July 2017 of 66 centers subscribed.

Participation in the varicose vein registry shows a similar trend, Passman highlighted. Following its inception in 2015, the number of centers subscribed peaked at 45 in May 2021 ahead of falling by 13 to 32 centres as per the latest figures from November 2024.

The venous stent registry was the most recent of the three venous modules to be established. Passman reported that the number of centres subscribed has been on an upwards trajectory since data capture began in 2020 and currently stands at 10.  Providing an update on this newest of the venous VQI registries, Passman noted that there has been a recent revision of the original data fields. Specifically, he shared that less-needed registry variables have been removed and highlighted efforts to decrease registry data entry burden. Passman also detailed that the development of registry reporting measures is now underway, as well as a drive to increase site recruitment.

Moving on to consider how the three venous VQI registries can be used to encourage best practice, Passman shared that a VQI best practices dashboard has been introduced across the board to summarize each individual center’s results, and provide comparison to national VQI benchmarks.

The next topic on the agenda was research, with Passman stating that a venous VQI research advisory council (RAC), chaired by Nicholas Osborne, MD, of the University of Michigan, was set up in 2020. The presenter noted that submission of venous RAC proposals is increasing, and encouraged centers not enrolled in a venous VQI module but are interested in research projects to connect with a venous VQI registry partner.  Passman highlighted several publications to have emerged from the venous VQI registries over the past 10 years, including on the impact of COVID-19 on the varicose vein and IVC filter registries and on the use of telemedicine for the management of patients with varicose veins, among various other topics.

In his conclusion, Passman summarized what has been achieved over the past 10 years since the first venous VQI registry was initiated. He highlighted progress in several regards, notably the improvement of long-term outcomes through standardization, the availability of evidence-based outcomes analysis, and the use of data to define best clinical practices. In addition, Passman underscored the introduction of site and national benchmarks that have the potential to monitor safety and efficacy, as well as the provision of comparative effectiveness research.

Closing the presentation, Passman gave a glimpse of what the next 10 years of the venous VQI might look like. The presenter alluded to the development of additional venous procedural registries, better integration and coordination between venous modules, the expansion of artificial intelligence (AI) initiatives, electronic medical record (EMR) data extraction and finally cross-module, interactive data analysis for better benchmarking and expanded research opportunities.

Speaking to Vascular Specialist following his VEITHsymposium presentation, Passman commented on the significance of the last 10 years of the venous VQI: “After a decade of efforts through multiple participants, administrative resources, clinical sites, and research initiatives, venous VQI modules are now poised to be a valuable source of standardized data for improved quality of venous care, benchmarking, and investigation both at the local sites and nationally. With future expansion plans and technological improvement on the near horizon, the next 10 years offers improvement in data accrual and analytical power thereby expanding the value of the venous VQI quality mission.”

In search of the ‘holy grail’: New analysis brings aneurysm rupture prediction closer

By
Jocelyn Hudson
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In search of the ‘holy grail’: New analysis brings aneurysm rupture prediction closer
Randy Moore presents during VEITH 2024

A rupture prediction-based algorithm is set to enhance patient selection for abdominal aortic aneurysm (AAA) repair. This is according to Randy Moore, MD, a vascular surgeon at the University of Calgary in Calgary, Canada, who, at the 2024 VEITHsymposium (Nov. 19–23) in New York City reported that the ViTAA system (ViTAA Medical Solutions) can predict rupture risk independent of aneurysm size and post-endovascular aneurysm repair (EVAR) neck behavior.

Before sharing the results of a retrospective analysis of computed tomography (CT) factors determining AAA wall weakness and strength in AAAs, Moore—who is chief medical officer for ViTAA Medical—began his presentation by outlining an unsuccessful case that highlighted for him an unmet need in vascular surgery. Showing a CT scan, the presenter recalled: “Fifteen years ago, this patient died on my operating table. He wasn’t supposed to die; his aneurysm was small, and I was following guidelines.”

Moore noted that cases such as this are not unique. “In fact,” he said, “a number of large database studies with thousands of patients have demonstrated that up to 12% of patients may have a rupture below size threshold.” Despite this, Moore highlighted that there are investigators who are suggesting the size thresholds for repair can safely be increased due to a low overall risk of rupture.

Moore’s explanation for this “confusion” is the “absolute reliance on AAA size to risk stratify.” In his VEITHsymposium presentation, it was Moore’s aim to suggest to the audience that this firm trust in aneurysm size “remains fundamentally flawed.” “We really need to analyze the aortic wall,” he said. “That’s the key.”

Other investigators have tried to analyze the aortic wall using traditional finite element analyses and stress-based indices, Moore shared, before noting that several publications in the engineering space have underscored the deficits of such strategies. “You’re not taking into account the actual intrinsic patient wall characteristics,” the presenter stated. “In other words, the same stress or force applied to two aortas is going to give you two different clinical outcomes based on the tissue characteristics.”

“We took a different tack,” Moore told the VEITHsymposium audience. Over the past decade, the presenter recounted that he and a team of engineers have processed over 200 aortic specimens. The aim has been “to develop technology that precisely takes into account the integral strength of the aortic wall,” Moore shared.

The presenter explained that, based on a cardiac-gated scan that allows a clinician to track the motion of the aortic wall, data are uploaded to the cloud where a combination of algorithms assess the intraluminal thrombus thickness, time-averaged wall shear stress with computational fluid dynamics and a peak strain module, all of which are then combined as an output called a regional aortic weakness (RAW) map.

“These maps allow you for the first time to virtually assess the mechanical properties of the aortic wall, not based on population data but based on the individual patient sitting in front of you in the clinic,” Moore elaborated. “We now have an AAA wall analysis that includes wall tissue strength characteristics irrespective of size.”

On use of the technology so far, Moore reported that it has played a role in analyzing landing zones for EVAR and has demonstrated that implanting a stent into a weak infrarenal aortic neck is more likely to result in a type 1 endoleak. “That’s not a surprise,” Moore commented, “but now we can actually measure that.”

The technology can also be used for surveillance, Moore continued. He explained that this is due to its ability to analyse peak strain post-EVAR and to point out “which endoleaks actually need to be treated, and which can be safely ignored.”

Furthermore, Moore shared that the technology is being used with artificial intelligence (AI) algorithms to predict rapid growth, which he describes as a “surrogate marker for negative outcomes.” These data were shared at the 2023 VEITHsymposium.

The “holy grail,” however, is rupture prediction. Moore detailed that he and his team previously published on the ability to identify the site of aortic rupture, but that the more recent aim had been to complete a study looking at the risk of rupture and the ability to predict rupture using the ViTAA technology. “This was a very difficult study to complete,” the presenter remarked, citing specifically the challenge of finding patients with images prior to rupture.

Moore detailed that he and colleagues retrospectively reviewed 38 patients with rupture and matched them in terms of size, age and demographics to 38 non-ruptured patients before conducting a ViTAA analysis. “We wanted to make sure we included patients who had a range of aneurysm sizes to reflect real-world practice—roughly 4.6cm all the way up to 12cm,” he said.

The team then completed a traditional analysis using finite element and stress-based indices, finding no statistical difference between ruptured and non-ruptured patients. With the ViTAA analysis, however, Moore reported that the team was able to identify a “highly predictive” tool and one that “provides the clinician with an at-a-glance interpretation of aortic wall risk with an accuracy of 92%, a sensitivity for rupture prediction of 100%, specificity of 83% and an area under the curve of 86%.”

“Our AAA wall analysis based on tissue strength and strain allows for patient-specific wall maps that will eventually allow us to more precisely inform patient care,” Moore concluded. “We have a rupture prediction algorithm that will enhance patient selection for repair so that patients like mine 15 years ago will no longer die unnecessarily.”

In Moore’s closing statement, he outlined the longer-term goal of “no longer seeing exclusive reliance on aortic size to determine patient care.”

Data collection ‘absolutely crucial’

In discussion time following Moore’s presentation, Rao Vallabhaneni, MD, a professor of vascular surgery at theUniversity of Liverpool in Liverpool, England, commented on the potential limitations of the 38-patient sample size of the study.

“The difficulty is the great heterogeneity within one person’s aneurysm from different areas of the same aneurysm and between patients,” Vallabhaneni began. “It is such highly heterogenous tissue that I don’t think your sampling is enough to develop a reliable tool.”

While acknowledging Vallabhaneni’s concern, Moore stressed that “the proof is in the pudding”. “With a limited number of 38 ruptured patients, we showed a sensitivity of 100% in terms of rupture prediction,” he reiterated.

However, Moore closed his reply by agreeing with Vallabhaneni that data accumulation is “absolutely critical,” going on to share that he and his team have initiated a series of prospective registries they hope will answer further questions about the technology.

Pioneering Florida limb preservation program laser-focuses on evidence-based, customized care for PAD

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Pioneering Florida limb preservation program laser-focuses on evidence-based, customized care for PAD
Sashi K. Inkollu

This advertorial is sponsored by Tampa General Hospital.

As the prevalence of peripheral arterial disease (PAD) continues to climb across the U.S. and globally, a pioneering limb preservation program in south Florida is sharpening its resolve to provide cutting-edge treatment specifically tailored to individual patient characteristics, furthering efforts aimed at more precision care.

The Limb Preservation-Peripheral Arterial Disease Program team at Tampa General Hospital (TGH) Heart & Vascular Institute (HVI) and the University of South Florida (USF) is laser-focused on what its new director, Sashi K. Inkollu, MD, calls “functional limb preservation,” a concept that not only encompasses technical and surgical case planning but also drills deep into patient-specific risk factors such as those dictated by their anatomy, disease pathology and functional status.

The TGH HVI is part of a tertiary-level, academic institution that serves a patient population who often present with severe and complex problems. As the only academic health system in the area, volume of cases is robust. That presents an ideal opportunity to continue to trailblaze in the tradition of TGH’s chief of vascular surgery, Jean Bismuth, MD, explains Inkollu.

“We get a lot of patients who have already had prior procedures—for instance, a lot of the bypasses we perform are re-do procedures,” he says. “The difference between TGH and a lot of other hospitals is that many of the patients who we see are complex, and, as such, we have a talented group of surgeons and ancillary staff with the skillset and the tools to handle these complex situations.”

The Limb Preservation-Peripheral Arterial Disease Program, the first of its kind in the region, already provides a truly multidisciplinary, integrated and evidence-based approach to the management and care of patients with complex PAD, continues Inkollu. But as Florida’s population continues to grow—and with it the number of people living in the state with vascular disease—patient volume is following suit. “Vascular disease is rampant and growing across the country, and, of course, a lot more goes into taking care of the sorts of complex patients we tend to see,” observes the USF assistant professor of surgery and associate program director of the vascular surgery residency and fellowship. “At the same time, unfortunately not all medical facilities in the state have an organized or outcomes-based approach to take care of these patients who get interventions or surgery. This can be down to the fact that the procedures these patients received were not indicated, or because the wrong decisions were made for their care.”

That TGH-USF evidence-based approach to care includes access to the latest in devices that have the potential to push beyond the current frontiers of PAD treatment.

“We are looking at newer devices that can tackle aggressive disease patterns, such as in the setting of heavily calcified lesions, where arteries simply cannot be traversed with conventional techniques,” says Inkollu. “For example, we recently performed a procedure on a heavily calcified lesion in an elderly lady using a newer crossing catheter. This is a patient who would not otherwise have tolerated a bypass, and we were able to cross this lesion with this device, enabling us to avoid a bigger operation for someone who is an elderly patient with multiple medical conditions.

“We are enrolling in several clinical trials, such as in the use of drug-coated balloons [DCBs] in vascular beds where we currently have less data. We are also involved in comparing different techniques and approaches to the use of stents, as well as intravascular lithotripsy [IVL]. All in all, we are currently either enrolled or in the process of enrolling in trials of these different minimally invasive technologies. We aim to tackle PAD on every front, with the overarching mantra that the answer is not always the same for every patient.”

That customized approach to the patients who present marries the academic with the innovative, which follows a tradition set by TGH chief of staff and USF chair of surgery Murray Shames and furthered by vascular chief Bismuth, whose career in vascular surgery has been defined by a commitment to innovation in the field.

“I feel there is role for every tool,” says Inkollu. “At the same time, you have to really establish which device fits which pathology, and for whom it will be successful in terms of the technique deployed. The advantage of being in a place like TGH is that you have a huge clinical volume, so even though we are enrolling and using these devices—deep vein arterialization, crossing catheters, DCBs—we have enough patient volume to be able to perform a meaningful number of procedures with each of them and, thus, provide a long-term difference in patient management.”

Inkollu spent part of his vascular training working alongside Bismuth in Houston, itself a traditional breeding ground for innovation in vascular disease treatment. He was drawn to reunite with his former partner in part because of the opportunity it presented to break new ground at TGH.

“Dr. Bismuth’s vision is crystal clear and highly impressive: his CV speaks for itself about how he consistently has dedicated his life and career to innovation and making a huge difference in the care of patients and to the field of vascular surgery in general,” says Inkollu.

“I myself want to crystallize the picture of limb preservation as more one of ‘functional limb preservation,’ where we already have a plan from a technical and surgical standpoint, but also have an approach, in the pre- and postoperative setting, of individual risk factor identification and preserving limb function. This means not only medical risk factors, but also lesion or anatomic, with the aim of helping us identify disease and what device actually works for some patients more than others. There is a lot of innovation and research in the aortic field in the use of preoperative assessment and planning for complex aortic cases, as well as in, to some extent, pulmonary embolism care, where there is a role for artificial intelligence [AI] in terms of patient management. But there is very little in the management of PAD.”

Inkollu wants to drive this kind of innovation in PAD care through the TGH Limb Preservation-Peripheral Arterial Disease Program. “If we can use patient scans to identify if someone has calcific occlusions or disease, and—based on their symptom duration and risk-factor-profile—create a predictive pattern of success,” he says, “we can then choose a customized technique that will streamline the care of these patients and, at the same time, conserve resource.”

Ultimately, it’s a vision in keeping with the approach to care across the TGH vascular division, Inkollu finishes. “The biggest thing here is we are building a great program with excellent leaders in Dr.  Bismuth and Dr. Shames, alongside an excellent group of ancillary staff including nurse practitioners and other advanced practice providers who are focused on providing great care for the Tampa Bay area.”

Endothermal ablation significantly outperforms surgery for varicose veins in long-term randomized trial

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Jocelyn Hudson
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Endothermal ablation significantly outperforms surgery for varicose veins in long-term randomized trial
Daniel Carradice

Ten-year data from the randomized HELP trial show that, while both endothermal ablation and conventional surgery are effective treatments for great saphenous varicose veins at 10 years, the former was associated with superior clinical and quality-of-life (QoL) outcomes. These findings have been published in the British Journal of Surgery (BJS).

First author Abduraheem H. Mohamed, senior author Daniel Carradice, MBChB, both from Hull University Teaching Hospitals and Hull York Medical School in Hull, England, and colleagues reported that they obtained data for 206 of a total of 280 patients (73.6%) at 10 years, revealing that both the ablation and surgery groups retained significant QoL improvement compared with pretreatment levels, as assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ), Short Form 36 (SF-36) and EQ-5D, with a p value of less than 0.001.

Microlearning: The non-clinical realties of vascular surgery

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Microlearning: The non-clinical realties of vascular surgery

In residency and fellowships, vascular surgeons learn the techniques and skills to help them diagnose, manage and treat vascular disease.

But there are still important proficiencies to absorb. That is why the SVS has launched a series of seven free microlearning videos on “Adulting in Vascular Surgery.”

They are part of the SVS’ “microlearning videos,” shorts that answer a specific question and highlight important points on certain topics relevant to vascular surgery. It will cover topics such as medical billing, how to educate, social media and malpractice law.

Log in to access the videos at vasculearn.vascular.org.

VAM 2025 abstract submission period opens

By
Marlén Gomez and Beth Bales
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VAM 2025 abstract submission period opens
Jason T. Lee, MD

Vascular surgeon-scientists may submit their research for presentation at the 2025 Vascular Annual Meeting (VAM) in June through Wednesday, Jan. 8, 2025. The submission period opened Nov. 6.

VAM research—both clinical and translational—is considered for presentation in several different forums that appeal to all attendees, from plenary presentations, rapid-fire talks, international and video sessions, poster competitions and more.

In 2024, there was a nearly record-breaking 794 abstracts submitted, with 407 finding space on the meeting’s program.

VAM 2025 will be June 4–7, 2025, returning to New Orleans for the first time in several decades. Educational sessions will run across all four days and there will be ample opportunity for all to participate.

“Our best vascular surgical science is at the heart of the Vascular Annual Meeting,” particularly, the plenary and rapid-fire presentations, said Jason T. Lee, MD, the new chair of the SVS Program Committee, which selects the abstracts in a blinded process. “VAM 2025 is where we will showcase the latest findings that influence care of patients with vascular disease, provide broad education to vascular surgeons and highlight the future of our specialty.”

The SVS Postgraduate Education Committee (PGEC), chaired by Claudie Sheahan, MD, is slated to offer sessions on topics including dialysis challenges, Enhanced Recovery after Surgery (ERAS), complex dissection care, vascular trauma and spinal cord ischemia.

To learn more about the abstract submission process, visit vascular.org/VAM. Guidelines are at vascular.org/VAM25Program.

In focus: Outpatient vascular practice

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Robert Molnar and Anil Hingorani
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In focus: Outpatient vascular practice
Robert Molnar and Anil Hingorani
Robert Molnar and Anil Hingorani
This month, Vascular Specialist launches its newest column, The Outpatient, which seeks to cover issues near and dear to the hearts of vascular surgeons practicing in outpatient settings such as office-based labs (OBLs) and ambulatory surgery centers (ASCs). Here, in the inaugural edition, Robert Molnar, MD, and Anil Hingorani, MD— two key figures behind the creation of the newly launched Society for Vascular Surgery (SVS) Section on Ambulatory Vascular Care (SAVC)— detail the column’s aims and objectives.

Welcome to the first article in a series in­tended to help you and your practice achieve enhanced success in delivering high quality outpatient vascular care. This is also an introduction to SAVC, formed by combining the SVS Community Practice Section (CPS) and the Section on Outpatient and Office Vascular Care (SOOVC). SAVC will leverage the collective knowledge, re­sources and expertise of vascular surgeons providing outpatient care to foster innova­tion, education, research and high quality care. Unifying the CPS and SOOVC will strengthen those vascular surgeons perform­ing outpatient procedures in their ability to network, mentor upcoming vascular sur­geons, and advocate for their practice, their patients and their communities—and, very significantly, for themselves.

It is clear that the majority of invasive vascular procedures has shifted to the outpatient arena. There are more than 1,300 OBLs and nearly 5,000 ASCs in the U.S. Nearly 80% of peripheral vascular intervention (PVI) cases are appropriately provided—and nearly 60% of these cases are currently being performed—in these sites of service. As compared to the hospital outpatient setting, OBLs and ASCs provide significant value to the payer system, as the reimbursement rates are much less than the Hospital Outpatient Prospective Payment System (HOPPS). In addition, patient satisfaction outside of the hospital setting is extremely high. Regardless of the site of service, all vascular surgeons—whether private practice, community practice, academic affiliated/employed—are being significantly harmed by the inadequate reimbursements for providing these needed services. As we have recognized the significant cuts to our reimbursements and the inefficiencies we are forced to accept in the hospital outpatient space, we need to advocate for ourselves, our patients and our communities. As the leaders in the delivery of expert, quality and high value vascular care, we need to leverage our collective strength in advocating for our patients and our communities.

The headwinds have been—and will continue to be—significant for the foreseeable future. However, the pendulum will begin to swing in our favor once the ill-intended consequences of payor and regulator decisions lead to limited access to care, increased costs due to hospital inefficiencies, and patient dissatisfaction. To combat these headwinds, we need to engage with each other, continue to advocate on our behalf, and share common problems and lessons learned with each other.

By bringing the CPS and SOOVC under SAVC, we will continue to promote the community practice surgeon and outpatient vascular care in the OBL and ASC settings. Specifically, we will continue to hold educational sessions at the Vascular Annual Meeting (VAM), webinars, and offer guidance in print within Vascular Specialist. We are striving to enhance all of these offerings, but we need your engagement to move the needle.

One of the projects that we continue to work on is the OBL Handbook, which is meant to help our community to open and maintain their practices by establishing and excelling in providing quality, cost-effective and needed vascular care. We certainly recognize the fluctuating reimbursements in the outpatient site of service and want to capitalize on opportunities to appropriately enhance your revenue streams by networking with those who have led the way in developing effective and highly productive practice developments.

In addition, we continue to recognize leaders in community practice with the SVS Excellence in Community Practice Award, the SAVC Presentation Award and the SAVC Research Seed Grant awards. We continue to promote the goals of the members of our section with representation from the SVS Coding Committee, the SVS/American College of Surgeons (ACS) Vascular Verification Program (Vascular-VP) and the Postgraduate Education Committee. These are just some of the projects that we have and continue to work on to help vascular surgeons across the spectrum of our various vascular surgery practice types. We are currently engaged in ways to enhance practice revenue, given the significant cuts we have experienced for the care we provide. By engaging each and every vascular surgeon, we can promote the advocacy we deserve and share successful practice development tools and opportunities. We aim to appropriately enhance the reimbursements that each of you so significantly deserve to protect your practice and to continue to secure the finances needed to enable your continued success. We hope to enable you to compete on a level playing field through the newly launched vascular branding campaign and provide you with the marketing opportunities and SVS outreach that has been established to boost your recognition.

Therefore, if you are not currently a member, please join your colleagues in SAVC at soovc@vascularsociety.org to leverage our strength in protecting all of our futures. We need engagement, ideas and a forum to share opportunities in order to strengthen your practice.

ANIL HINGORANI is chair of SAVC, having previously held the role of chair of the SOOVC Steering Committee. ROBERT MOLNAR chaired the CPS Steering Committee.

Government Grand Rounds: What happens next? The importance of the lame duck session for vascular surgeons

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Andrew Kenney
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Government Grand Rounds: What happens next? The importance of the lame duck session for vascular surgeons

Post election and with the end of the year on the horizon, a crucial but often overlooked period in the legislative calendar begins: the lame duck congressional session. This period, which occurs between the November elections and the start of the new Congress in January, allows outgoing lawmakers a final opportunity to pass critical legislation. For vascular surgeons, the upcoming lame duck session is particularly significant, as they face a looming 2.8% Medicare reimbursement cut scheduled for Jan. 1, 2025.

Depending on the results of an election, the lame duck session is often a time when Congress acts to “clear the deck” and potentially negotiate agreements on high-priority issues previously marred by the politics of an election year. This creates a unique window for legislative compromise and action, particularly in healthcare. For vascular surgeons, this period is crucial to advocate for changes that directly impact their ability to provide care.

Starting in January 2025, physicians, including vascular surgeons, are set to face a 2.8% cut in Medicare reimburse­ment under the Medicare Physician Fee Schedule (MPFS). For practices already operating under tight financial condi­tions, these cuts could have severe consequences. Reduced reimbursement threatens the financial sustainability of practices, limits the resources available for patient care, and places a strain on vascular surgeons who rely on Medicare payments to continue offering high-quality services.

The timing of these cuts, coupled with rising inflation and increasing costs, makes it difficult for physicians to maintain the same level of care without a corresponding increase in payments. Unfortu­nately, the current payment sys­tem does not adequately adjust for inflation, leaving healthcare providers to bear the brunt of escalating expenses.

Recognizing the urgency, the Society for Vascular Surgery (SVS), alongside the House of Medicine and several congres­sional leaders, is actively advo­cating to prevent these cuts and pushing for possible solutions. The lame duck session rep­resents the last opportunity of the congressional session to secure a temporary fix or, ideally, advance discussions on a permanent solution.

Engaging with SVS advocacy efforts plays a central role in this fight. It is essential for vascular surgeons to stay active in advocacy, communicating directly with their legislators and highlighting the real-world impact of reimbursement cuts.

The lame duck session provides a critical, but short, win­dow to address the 2.8% Medicare reimbursement cut. For vascular surgeons, this period is key to avoiding immediate financial strain and ensuring they can continue providing high quality care.

However, the fight doesn’t end here. While preventing these cuts is the immediate priority, advocacy efforts must also focus on securing a permanent solution that aligns Medicare payment updates with inflation, ensuring long-term stability for physicians and patients alike.

As the 118th Congress wraps up, vascular surgeons must also prepare to pivot to­ward building new relation­ships with the incoming 119th Congress. Establishing these connections early will be es­sential for advancing broader reforms in healthcare policy. By engaging with new and re­turning legislators, the vascular surgery community can ensure that their priorities remain front and center in future leg­islative efforts.

ANDREW KENNEY is a member of the SVS advocacy staff, representing the Society in Washington, D.C.

CPVI course: Learning the latest intricate skills and techniques to treat complex PAD

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Marlén Gomez
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CPVI course: Learning the latest intricate skills and techniques to treat complex PAD
L to r: Daragh Moneley, Alicia Stafford and Amani Politano
L to r: Daragh Moneley, Alicia Stafford and Amani Politano

Vascular Specialist attended the SVS Complex Peripheral Vascular Interventions (CPVI) Skills Course and spoke with participants about the hands-on learning experience designed for vascular surgeons and specialists at all stages of their careers. Over two days (Sept. 28–29), participants learned the latest techniques and innovations for treating periph­eral arterial disease (PAD) through small-group sim­ulations, using cadavers and benchtop models. Here, a small group of attendees share their experiences.

“I want to learn a bit more about distal revascularization, and I wanted to see if this course would be worthwhile for our trainees to attend in the future,” said Daragh Moneley, MD, a training program director from the Royal College of Surgeons in Dublin, Ireland. “The hands-on stations have been excellent, particularly the industry being present and being able to demonstrate their products on actual models. It really shows the intricacies of how to use them or where you might be able to apply them. We’ll definitely encourage our trainees to at­tend, there’s no doubt about that”

Alicia Stafford, MD, a vascular surgeon with Evansville Surgical Associates in Evansville, Indiana, used the course as an opportunity to add new skills to her armamentarium. “I deal with a lot of PAD and advanced diseases in the leg in my region and I felt like this course would be a good place to learn extra skills to help me take care of those patients,” she said. “I’m excited to see if I can institute deep vein ar­terialization, and so, coming to a course that teaches me the newer techniques and innovations that are out there to take care of my patients just makes sense.”

Amani Politano, MD, a vascular surgeon at Oregon Health and Sci­ence University used the course to brush up. “It’s been a while since I graduated from my training program and I thought that this would be a good time to get some new skills and things that I didn’t do when I trained,” he shared, “and also to get a little bit of insight into what’s maybe more cutting edge in the peripheral percutaneous world than what I remember years ago. This has definitely given me a lot more opportunity to practice some tools that I’ve heard about but maybe not done very frequently and then added some tools to my toolbox.”

BIO-OSCAR SOC trial examines standard of care in PAD treatment

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Jocelyn Hudson
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BIO-OSCAR SOC trial examines standard of care in PAD treatment
Koen Deloose
Koen Deloose presents BIO-OSCAR SOC data at PVI 2024

Biotronik today announced that it has concluded the BIO-OSCAR SOC study evaluating the baseline against which to measure the Oscar multifunctional catheter in treating complex peripheral arterial disease (PAD). The outcomes were presented at the Paris Vascular Insights (PVI) course 2024 (12–14 December, Paris, France) by principal investigator Koen Deloose (AZ Sint Blasius Hospital, Dendermonde, Belgium).

BIO-OSCAR SOC is a prospective, multicentre, observational trial assessing the current standard of care, procedural outcomes, complication handling and device use in endovascular treatments for atherosclerotic lesions both above the knee (ATK) and below the knee (BTK).

The study analysed data from 247 patients across 16 European CE-mark territories, aiming to deliver insights into real-world practices for managing PAD.

“BIO-OSCAR SOC is an important step toward understanding the treatment of complex infrainguinal lesions under current standard-of-care practices, and especially how important vessel preparation can be,” Deloose remarked in a press release announcing the results. “With this baseline study, we aim to evaluate [how] the Oscar catheter can streamline procedures by minimising the need for multiple device exchanges, reducing procedural steps, and lowering complications.”

The primary endpoint of BIO-OSCAR SOC was procedural success, defined as a combination of technical success—achieving ≤30% residual stenosis following vessel preparation and prior to the definitive treatment—and the absence of complications such as target-vessel perforation, rupture, acute occlusion, or distal embolisation.

The outcomes, as outlined in the press release, show:

  • 50% procedural success in ATK and 59% in BTK lesions.
  • 94% crossing success in chronic total occlusions (CTO) for ATK and 90% for BTK.
  • 50% bailout stenting rate in ATK cases, highlighting that vessel preparation is often insufficient. Biotronik notes that appropriate vessel preparation may significantly improve short- and long-term outcomes.

The procedural cost related to access, crossing and vessel preparation averages €750, while for complex cases the cost can go up to €1,100.

Biotronik shares that the clinical evidence will be further validated by the BIO-OSCAR FIRST study, which is designed to confirm the safety and clinical performance of the Oscar catheter for dilation of lesions in the femoral, popliteal, and infrapopliteal arteries, including both ATK and BTK lesions.

“This study provides the vascular community with valuable insights into existing procedural success rates and cost-efficiency data,” said Stuart Perks, vice president marketing at Biotronik Vascular Intervention. “BIO-OSCAR SOC is pivotal in validating Oscar’s role in improving the standard of care for PAD and optimising treatment strategies for patients with complex lesions.”

A press release summarises that the BIO-OSCAR SOC study establishes the baseline of standard of care, which will be used to evaluate the outcomes of the BIO-OSCAR FIRST study.

Applications open for 2025 James S.T. Yao Resident Research Award

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Marlén Gomez
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Applications open for 2025 James S.T. Yao Resident Research Award
The SVS Foundation is accepting applications for the 2025 James S.T. Yao Resident Research Award

The SVS Foundation is accepting applications for the 2025 James S.T. Yao Resident Research Award, which supports emerging medical professionals researching vascular disease biology and innovative translational therapies. The application deadline is Jan. 8, 2025.

The recipient will present their research at the 2025 Vascular Annual Meeting (VAM), which takes place in New Orleans ( June 4–7), and will receive a $5,000 prize along with a one-year subscription to the Journal of Vascular Surgery (JVS).

In 2023, the award was renamed to honor the late James S.T. Yao, MD, PhD, a pioneer in vascular surgery and his contributions to the field. The change was made possible through donations from Yao’s family. He passed away in December 2022.

“The Yao Award not only supports young researchers but also highlights the importance of foundational and translational research in vascular disease,” said Kathryn L. Howe, MD, chair of the SVS Basic and Translational Research Committee. “It’s a tremendous opportunity for residents to have their work recognized on a national stage.”

Kevin D. Mangum, MD, PhD, a vascular surgery resident at the University of Michigan, received the 2024 award. Applicants must be general or vascular surgery residents or fellows enrolled in a U.S. or Canadian training program.

VRIC 2025: Consider the Vascular Research Initiatives Conference a path to becoming a surgeon-scientist

By
Beth Bales
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VRIC 2025: Consider the Vascular Research Initiatives Conference a path to becoming a surgeon-scientist
Frank Davis

When Frank Davis, MD, attended the SVS Vascular Research Initiatives Conference (VRIC) for the first time in 2014, he found not only meaningful discussions on research but also a pathway to the life he wanted. And he encourages those interested in research to attend.

The then-medical school student had taken a year off to do research and study basic science in the lab of Alan Daugherty, MD, at the University of Kentucky. Daugherty encouraged Davis to attend VRIC, telling him it wasn’t just basic research and basic biology.

Davis said Gilbert R. Upchurch Jr., MD, an invited speaker that year, “talked about his pathway to being a surgeon-scientist and the top 10 things he learned along the way.” “It was eye-opening,” said Davis. “I saw my interest in vascular surgery and being a surgeon-scientist playing out in front of me.” His mentor Peter Henke, MD, also gave a talk on the road Davis wanted to follow. “I heard two prominent talks that showed me, ‘This can be done.’ It was a good opportunity for me to see people who are the surgeon phenotype of who I wanted to be.”

Abstracts for VRIC 2025 are now being accepted through 6 p.m. Central Standard Time on Nov. 20. The conference itself— which focuses on basic and translational vascular science in an atmosphere that fosters thoughtful discussion on research—will be held all day on April 22, 2025, at the Marriott Baltimore Waterfront in Baltimore, Maryland.

VRIC will be held in conjunction with the American Heart Association’s Vascular Discovery 2025 Scientific Sessions: From Genes to Medicine, in the same location, from April 22–25, 2025.

Davis, a past attendee and presenter who now has his own named lab at the University of Michigan, encourages all those interested in basic science and translational research to attend. “It’s fertile soil for junior researchers to launch their careers,” he said. It lays a “supportive groundwork and provides robust surgeon-scientist mentorship opportunities.”

Visit vascular.org/VRIC25 for more information.

Microbot Medical announces FDA submission for commercialization of Liberty endovascular robotic system

By
Jocelyn Hudson
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Microbot Medical announces FDA submission for commercialization of Liberty endovascular robotic system

Microbot Medical recently announced that it has submitted a 510(k) premarket notification to the Food and Drug Administration (FDA) for its Liberty endovascular robotic system.

A press release details that Liberty is the world’s first single-use, fully disposable robotic system for endovascular procedures. The 510(k) submission follows the successful completion of Microbot Medical’s multicenter, single-arm trial to evaluate the performance and safety of Liberty in human subjects undergoing peripheral vascular interventions.

The company anticipates FDA marketing clearance during the second quarter of 2025, with U.S. commercialization activities expected to commence after the clearance.

Microbot Medical states that Liberty eliminates the need for large and expensive capital equipment and streamlines customers’ access to robotics. With its remote control, Liberty is designed to significantly reduce radiation exposure to physicians and staff, and improve ergonomics, which has the potential to reduce the physical strain on healthcare providers. The company also believes that Liberty has the potential to lower procedure costs, increase procedure efficiency and improve the overall quality of care.

Corner Stitch: How to make the most of your research year(s)—personal growth edition

By
Saranya Sundaram
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Corner Stitch: How to make the most of your research year(s)—personal growth edition
Saranya Sundaram

I’m sure research residents everywhere have heard their fair share of unsolicited advice on this topic. But among all the voices advising me on “how to be productive” or “how to make the most impact on the vascular world,” I was lucky enough to have one mentor who asked me, “Who do I want to be at the end of this year?”

That concept, which I felt myself coming back to over and over again throughout my year out, inspired me to come up with a list of ways a research year can really help you become the person you have strived to be but maybe just didn’t quite have the time to develop. This is by no means a complete list.

Spend time with family, friends, and significant others

This seems like a given, but don’t take it for granted. The generally unfiltered access to your family, friends, and significant others is something you may never get to experience again in your medical career. For me, it meant spending every birthday and holiday with my parents and sibling, maintaining friendships that were on the verge of being forgotten, and getting to know the most incredible person in my life right now. Take every opportunity you can to prioritize your time with people (and pets!) you won’t see regularly when you return to the hospital.

Find something that is just yours

I know, it sounds cheesy, but when we make our lives about other people, we forget what makes us who we are. For one of my friends, she felt most herself when she started writing and performing music. For another friend, it was joining a tennis club and playing tournaments on the weekend. For me, it was getting back into sewing and redesigning clothing. I could spend hours not speaking to anyone and consumed just in sewing a new outfit together or fixing ones that needed altering. Now, when I find myself in a rut or just in need of some personal time, I pick something from my “alterations rack” and lose myself in it. It’s important to have something that grounds and reminds you of yourself when you feel lost or burnt out.

Slow down and process

You now have so much more time to process how you choose to interact with the world and the people in it. I found myself taking extra time to think through decisions, what I wanted out of my relationships with others, and whether the ways in which I responded to problems aligned with how I wanted to present myself. As someone who didn’t take much time off before they started training, I found this year offered me room to “develop myself,” especially how I deal with tough situations—this made returning to clinicals much smoother as it was easier to align myself with my personal goals and values.

Make that major event/travel

Whether it’s a wedding, family planning, or visiting your family in another country, take advantage of the time (and significantly less stressful responsibilities) to follow through with it. For me, it was planning a trip to see my grandparents in India, as I had often been stressed by the uncertainty of when I would see them given their late stage in life. It seems like the straightforward move, but I would absolutely recommend pulling the trigger if you have the means to follow through.

Learn something about the world outside of medicine

Though this may not be high on everyone’s list, it certainly increases your appreciation of life outside of the hospital. For me, I enjoyed attending a few birdwatching events that focused on the wildlife in Charleston. Through some of these Saturday kayaking events, I was able to learn about the dragon boat racing culture that was a huge part of many local lives. I also made it a point to take cooking and local wine classes around my community. It gave me an appreciation of what drives others every day.

Again, this is by no means a complete list. But I welcome others to continue to share these aspects of their personal development as I believe prioritizing personal growth (though a sadly underrated practice) ultimately shapes us to contribute to this field in the best ways we can.

Saranya Sundaram, MD, is a vascular surgery resident at Medical University of South Carolina in Charleston and Vascular Specialist‘s resident/fellow editor.

Artivion granted FDA humanitarian device exemption for the AMDS hybrid prosthesis

By
Bryan Kay
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Artivion granted FDA humanitarian device exemption for the AMDS hybrid prosthesis
Artivion logo

Artivion recently announced that the Food and Drug Administration (FDA) has granted a humanitarian device exemption (HDE) for use of the AMDS hybrid prosthesis (formerly known as the Ascyrus Medical dissection stent) in acute DeBakey type I dissections in the presence of malperfusion.

A press release notes that the AMDS is the world’s first aortic arch remodeling device for use in the treatment of acute DeBakey type I aortic dissections.

An HDE is a marketing application for a product that has been designated a humanitarian use device (HUD). Artivion details that AMDS received both HUD and breakthrough designation, due to its intended benefit for patients in the treatment or diagnosis of a rare disease or condition in which no other comparable options currently exist. The HDE allows for commercial distribution of AMDS in the U.S. prior to anticipated approval of a premarket approval (PMA) application.

Under the HDE, AMDS will be available as a treatment for acute DeBakey type I dissections in the presence of malperfusion, which represent approximately 40% of all acute DeBakey type I dissections in the U.S. The PMA, if approved, is expected to cover all acute DeBakey type I dissections with and without malperfusion, representing an estimated US$150 million annual US market opportunity.

The HDE for AMDS was granted following the availability of full cohort data from the PERSEVERE US investigational device exemption (IDE) trial for AMDS. The trial consisted of 93 participants in the U.S. and met its primary endpoints demonstrating significant reduction of major adverse events (MAEs), including all-cause mortality, stroke, renal failure requiring dialysis, and myocardial infarction at 30 days following AMDS implantation.

More specifically, data showed, from the use of AMDS, a 72% reduction in all-cause mortality and a 54% reduction in primary MAEs, with zero occurrence of distal anastomotic new entry (DANE), when compared to the current standard of care hemiarch procedure. Wilson Szeto, chief of cardiovascular surgery at Perelman School of Medicine at the University of Pennsylvania in Philadelphia recently presented the data from the PERSEVERE US IDE trial as a late-breaking abstract at the Society of Thoracic Surgeons (STS) annual meeting.

The SVS needs your Excellence in Community Practice Award nominations!

By
Marlén Gomez
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The SVS needs your Excellence in Community Practice Award nominations!
Past winners include Daniel McDevitt, Russell Samson, William Shutze and Daniel McGraw

The Society for Vascular Surgery is seeking nominations for its annual Excellence in Community Practice Award.

Formerly known as the Excellence in Community Service Award, the honor is bestowed on a member who has exhibited outstanding leadership within his or her community as a practicing vascular surgeon.

Nominations will be reviewed by the SVS Section on Ambulatory Vascular Care (SAVC)—the SVS Community Practice Section is now folded into this new entity— which will then determine the award recipient.

Past recipient Manish Mehta, MD, a vascular surgeon and director of Vascular Health Partners in Albany, New York, says others should consider applying due to the award’s role in highlighting “the important work that so many community practice vascular surgeons are doing.”

The 2025 nomination period is open, with a deadline to apply for the award of Sunday, Dec. 15.

First patient enrolled in InspireMD’s CGUARDIANS II pivotal study

By
Jocelyn Hudson
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First patient enrolled in InspireMD’s CGUARDIANS II pivotal study
Patrick Muck
Patrick Muck

InspireMD today announced that the first patient has been enrolled in the company’s CGUARDIANS II clinical trial evaluating its CGuard Prime carotid stent system in patients undergoing carotid artery stenting (CAS) via the transcarotid artery revascularisation (TCAR) approach. The patient was enrolled by Patrick Muck at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, USA. Muck serves as both the site principal investigator as well as a co-lead investigator of the CGUARDIANS II study.

CGUARDIANS II is a prospective, multicentre, single-arm pivotal study that aims to enrol a minimum of 50 evaluable patients. The objective of this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with a US Food and Drug Administration (FDA)-cleared TCAR neuroprotection system in patients at high risk for adverse events from carotid endarterectomy.

Marvin Slosman, chief executive officer of InspireMD, commented: “As we approach potential FDA approval of CGuard Prime with a CAS indication in the first half of next year, we are thrilled to have initiated the CGUARDIANS II study that, if successful, will address an ever-expanding TCAR market of roughly 30,000 procedures performed in the USA this year. I would like to thank Dr Muck for helping us achieve this initial and critical enrolment milestone, and I look forward to the efficient execution of this important study as we work to enable the use of CGuard Prime in the broadest application, offering patients and physicians this next-generation stenting platform, which has demonstrated best-in-class clinical outcomes in rigorous clinical studies and with over 60,000 devices sold to date.”

Muck, who is programme director and chief of vascular surgery at Good Samaritan Hospital, stated: “As we begin this study of CGuard Prime in a TCAR setting, we value tremendously the prior data from the C-GUARDIANS PMA [premarket approval], the real-world results of this implant and its potential to advance patient care through these unmatched clinical results. The protective qualities of the MicroNet mesh offer patients the sustainable protection which is so important in both short- and long-term outcomes of this procedure. We look forward to the efficient enrolment of this study, contribution from the team of investigators and working with InspireMD on this important programme.”

Innovation in vascular surgery: Balancing progress with patient safety

By
Jocelyn Hudson
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Innovation in vascular surgery: Balancing progress with patient safety
Matt Thompson speaks during ESVS 2024

A debate at this year’s European Society for Vascular Surgery (ESVS 2024) annual meeting (Sept. 24–27) in Kraków, Poland, centered on innovation in vascular surgery, with experts considering whether it will “change everything.” While Matt Thompson, MBBS, chief executive officer of Endologix, underscored the inherently innovative nature of vascular surgery and the inevitability of technological advancement—he urged specialists to “safely adopt new technologies or become irrelevant”—vascular surgeon Jon Boyle, MBChB, a consultant vascular and endovascular surgeon at Cambridge University Hospitals NHS Foundation Trust in Cambridge, England, championed a more cautious, patient safety-focused approach, highlighting past instances of innovation having caused harm.

In the ongoing endovascular era, Thompson put forward, several innovations—including bioresorbable stents and non-invasive devices—have refined, or are set to refine, longstanding techniques and technologies. Indeed, the presenter said, there is “still room” for endovascular innovation, despite the largely unchanging nature of its fundamental building blocks. However, these innovations will not “change everything” in vascular surgery. Instead, he argued that the next paradigm shift in the field will be defined by technological change that is happening in the wider world. Thompson argued that the pace of technological advancement in society has already led to “enormous” changes in how people live their lives. What do technological advancements in the wider world mean for vascular surgery?

“There’s going to be some technological advance that completely changes our practice,” Thompson posited, listing wearable technology, personalized and regenerative medicine, and artificial intelligence (AI) and machine learning as just three technologies that have practice-changing potential. Thompson had a clear message here: adopt—safely—or be left behind.

‘We’ve got to be careful how we innovate’

Putting forward a counter argument, Boyle stressed the importance of striking a balance between innovation and patient safety. In several instances of innovation, Boyle argued, “we’ve actually got it wrong—we’ve innovated, and patients have come to harm.”

He referenced data from the landmark EVAR-1 trial, noting that patients who were randomized to endovascular aneurysm repair (EVAR) “had far greater numbers of interventions out to 14 years” than the patients who received open repair.

Acknowledging the age of the EVAR-1 data as a weakness of his argument, Boyle moved on to newer EVAR evidence, speaking on results from the VQI VISION study regarding the AFX graft (Endologix). The 2022 data, which illuminate reintervention and rupture rates with an early iteration of the device in the U.S., were published by Goodney et al in the British Medical Journal.

“When we fix an aneurysm, we’re trying to do it to prevent rupture, but the early AFX graft had a near 40% reintervention rate at eight years and a 10% rupture rate at 10 years,” Boyle informed the ESVS audience. In light of these data, Boyle remarked: “We’re fixing aneurysms, but we’re not really fixing them.” The presenter also shared similar findings with regard to fenestrated repair. He commented bluntly that “fenestration means twice the likelihood of being dead at three years,” according to data from Vallabhaneni et al’s UK-COMPASS study, published in 2024 in the European Journal of Vascular and Endovascular Surgery (EJVES).

Boyle presented data on peripheral arterial disease (PAD), citing a growing body of evidence showing that early intervention for claudication leads to worse outcomes. Referencing an Australian study from Golledge et al, published in 2018 in the British Journal of Surgery, the presenter shared that patients with intermittent claudication who were treated early with endovascular intervention had a five-year amputation rate of 6.2% compared to 0.7% for those who received best medical therapy and exercise. “Early intervention for intermittent claudication with new devices led to a significantly higher amputation rate in this patient cohort,” he summarized.

The story is similar with carotid stenting, Boyle said. “We’ve pretty much stopped doing carotid stenting in the UK,” he said. “The reason for that,” he explained, “is that for symptomatic disease, your relative risk of stroke and death following carotid stenting is 1.7 compared to carotid endarterectomy.”

Boyle returned to Endologix, this time focusing on Nellix. “We got our fingers burnt with this device,” the presenter acknowledged. “We all felt at the start this was a device that may change practice,” Boyle remembered. In the end, however, the presenter stressed that “a lot of patients came to harm as a result of being treated with this device.” Concluding, Boyle reiterated his central argument that “we’ve got to get the balance right—we need to innovate, but we need to do it in an environment where we can ensure our patients are safe.”

Track your wRVUs, because no one else does it better

By
Sherazuddin Qureshi, Ryan Meyer, Erica Leith Mitchell, Nicolas Mouawad and Issam Koleilat
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Track your wRVUs, because no one else does it better
Businessman with a wrench in his hands. Technical support and repair. Art collage.
Businessman with a wrench in his hands. Technical support and repair. Art collage.

If you were in the audience at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting, you might have been taken aback by the presentation from UT Health San Antonio and the San Antonio VA Medical Center, presented by Luke D. Perry, DO, and co-authored by Alissa Hart, MD, Reshma D. Brahmbhatt, MD, and Lori D Pounds, MD: “Work for a dollar get reimbursed a dime: An analysis of the dire need for coders trained in vascular billing,” the paper was entitled.

The authors described that only 42% of the cases for three procedure types were coded correctly, with only 67% of work relative value units (wRVUs) captured. This is a tragedy not just for individual compensation, but also division and department financial accounting, and justification for practice growth, i.e., adding surgeons, advance practice providers (APPs), equipment or otherwise. Our administrators don’t really know what we do on a daily basis, nor do they understand the intricacies of our work and operations. Regardless, the wRVU has now become the currency by which we (“they”) measure our work “effort” and productivity, even though wRVUs do not really measure “physician effort,” the work that we do to take care of patients safely, the education we provide, the research we conduct, and the administrative tasks we must complete by day’s end. Our work is also being measured by other surrogates, including the numerical metrics of number of operations, average case length, on-time starts, and average length of stays. So, while you may feel overworked by the end of the week, you may not be working hard enough according to the administrators, because the measured metrics are not above the median.

In a healthcare economy increasingly reliant upon productivity-based compensation models, knowing the minutiae can mean the difference between getting a bonus or not. Each and every wRVU adds up by the year’s end. Consider codes G2211 and the recent inpatient coding changes: a difference of 0.7 wRVUs per patient encounter could mean more than 360 wRVUs at the end of the year if you have 10 relevant encounters per week. That’s just two a day!

Tracking your “work productivity” is particularly critical if you have coders and billers separate from you and your practice, if you have others who code your procedures, and if you just want to know what your wRVUs amount to.

This small group of authors, impressed by the “Work for a dollar get reimbursed a dime” analysis, convened to develop the table provided as a reference for the everyday vascular surgeon. We’ve included the most common procedures that we perform on a daily basis in hopes that we can help our fellow vascular surgeons better account for their daily wRVU earnings. This list will allow you to quickly identify how many wRVUs each procedure carries, and, more importantly, the associated global period associated with a procedure. Did you know that your evaluation and management (E&M) note the day after an inpatient angiogram is a billable encounter? You do now.

The table is based on 2024 Centers for Medicare & Medicaid Services (CMS) numbers, where any and all can look up any procedure at their whim by Current Procedural Terminology (CPT) code. If you just want the wRVU value and the global period, use the first row. The remaining rows are related to reimbursement adjustments based on geographic locations. This table doesn’t even get into the nuances—for instance, adding the diagnostic angiogram codes, if relevant, when you are also doing an intervention, the additional code for brachial plexus decompression during rib resection, modifiers, multiple procedures, etc. It also doesn’t explain the “rules” and allowances of bundled billing versus component billing. But at least it will get you started.

Also captured here is the opportunity cost of your time. So, that challenging open aneurysm repair that takes eight hours is still only about 34 wRVUs. But six or seven vein cases will get you pretty close to that with none of the postoperative headache, and probably less musculoskeletal strain and emotional stress. Not that we’re advocating for patient or case selection based on this; we’re just saying that the next time you get called in to put a stitch in an iliac vein that was traumatized by a laparoscopic port, and you’re done in 30 minutes, be grateful for the quick and easy 26 wRVUs. Knowledge is power. Imagine what you could do with this information. Because, if we don’t know what and how much we do, how can we expect others to know accurately? And, as always, a plug for the Society for Vascular Surgery (SVS) coding course: take your coders, attend yourself. It’s only two days—and an invaluable experience.

Sherazuddin Qureshi, MD, is a clinical assistant professor of surgery at Northwestern Medicine, Ryan Meyer, MD, is a vascular surgeon at RWJBarnabas Health, Erica Leith Mitchell, MD, is a professor of surgery at the University of Tennessee Health Science Center, Nicolas Mouawad, MD, is chief of vascular surgery at McLaren Bay region, and Issam Koleilat, MD, is also vascular surgeon at RWJBarnabas Health.

‘This is just the beginning’: SVS launches patient-facing website in opening salvo of long-term branding campaign

By
Marlén Gomez
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‘This is just the beginning’: SVS launches patient-facing website in opening salvo of long-term branding campaign
William Shutze

The Society for Vascular Surgery (SVS) has launched a new patient-facing website aimed at bridging the information gap between members of the public and their vascular care providers. Your Vascular Health allows patients to navigate the complexities of vascular health with accurate, easy-to-understand resources.

A cornerstone of the broader SVS branding initiative, it is central to efforts aimed at enhancing public awareness of vascular disease and highlighting the critical role vascular surgeons play in managing these conditions.

More than just a digital brochure, the site serves as a comprehensive tool to empower patients and caregivers to make informed decisions about their vascular health. It provides credible, in-depth information on conditions like peripheral arterial disease (PAD), aneurysms, deep vein thrombosis (DVT), and carotid artery disease, among others.

Guided by the latest clinical research and expert recommendations, the platform aims to be the go-to resource, offering support at every stage—whether patients are learning about vascular health for the first time, undergoing testing or managing a condition, according to William Shutze, MD, SVS secretary and a key spokesperson for the campaign.

The branding initiative’s origins predate the pandemic, when the organization rolled out initial toolkits aimed at educating patients and referral sources like primary care doctors.

According to Shutze, the effort intensified in 2023 following an extensive communications retreat designed to refine the SVS’s messaging strategy. “We spent much time honing our understanding of the different target audiences. We then developed messaging that would resonate best with each group, whether patients, referral physicians, healthcare executives, or medical students. That was our blueprint, and we’ve built upon that foundation to arrive at the point we’re at today.”

This blueprint helped build the foundation for the website, the most patient-centric aspect of the campaign. It offers visitors information on various vascular conditions through patient education flyers, treatment options and ways to connect with qualified vascular care providers.

Shutze emphasized the importance of offering actionable insights, stating, “We designed this site to give patients real, tangible information about how they can improve their lifestyle for better vascular health. It’s not just about listing symptoms or treatments. We want to empower patients with the knowledge that they can take control of their condition, whether through lifestyle changes or knowing when and how to seek medical intervention.”

Features aimed at maximizing accessibility for the user include condition-specific information, from which patients can learn about common and complex vascular conditions, their symptoms, risk factors and the latest treatment options.

Lifestyle resources include blog articles that focus on how patients can make daily lifestyle changes—such as diet, exercise and smoking cessation—significantly impacting vascular health. A physician directory functions as a searchable database of board-certified vascular surgeons, complete with biographies and areas of expertise, and helps patients find the right specialist for them. Real-life accounts from patients undergoing vascular treatments are featured, offering inspiration and reassurance for those embarking on their healthcare journeys.

The introduction of Your Vascular Health coincided with the launch of another significant aspect of the SVS’ branding efforts: on Oct. 23, the Society unveiled the findings of a comprehensive consumer survey that sheds light on public perceptions and misconceptions about vascular disease. The survey revealed that 82% of respondents are unfamiliar with the medical specialty that has the most comprehensive training for treating vascular diseases—vascular surgery. The results will help shape ongoing SVS efforts to raise awareness, both on a national scale and within local communities, via a three-year public awareness campaign called “Highway to Health—Fast Track Your Vascular Health,” Shutze explained.

Shutze was at the forefront of this media effort, participating in interviews across TV, radio and other platforms. “We’re hitting the ground running with a six-hour media blitz,” he explained as he prepared to hit the airwaves. “We’ll be discussing the survey results and promoting the new website, ensuring that the public knows about the vast resources available to them.”

While Your Vascular Health marks a milestone in the SVS’s branding campaign, it is only the beginning. Shutze said, underscoring the long-term scope of the effort—much like the continuous branding strategies employed by major corporations. “We’re not treating this as a one-and-done situation,” he said. “For the campaign to be truly effective, we’ll need sustained effort over the coming years. Think about how companies like Coca-Cola never stop branding—they evolve and refresh their message but keep at it. We’re taking the same approach with vascular health.”

Shutze believes that for the initiative to reach its full potential, all SVS members must participate. “Our national efforts are critical, but just as important are the local efforts made by individual surgeons and care providers,” he said. “We’re giving our members the tools to brand themselves and their practices to participate actively in this larger movement.

“This is just the beginning. We’re on a journey to ensure that patients everywhere know how to take charge of their vascular health and that they understand the critical role vascular surgeons play in that journey.”

VASC.AI: Canadian vascular surgery researchers develop vascular-specific bot aimed at aiding education and clinical practice

By
Bryan Kay
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VASC.AI: Canadian vascular surgery researchers develop vascular-specific bot aimed at aiding education and clinical practice
Tiam Feridooni

The advent of large language models such as ChatGPT (Open AI) has left little of the world untouched—and a quintet of University of Toronto vascular surgery researchers are bidding to harness this mode of artificial intelligence (AI) and refine it into a working model that is functionally vascular specific, capable of being used in clinical practice, research and education.

And according to research from the group recently published in the Journal of Vascular Surgery-Vascular Insights (JVS-VI), they are making significant strides just 18 months on from the inception of their work.

Tiam Feridooni, MD, a vascular surgery resident at the institution in Toronto, Canada, and colleagues started to develop the model, named VASC.AI, around the same time as ChatGPT-3 was being launched, initially impressed by the mainstream application’s ability to intelligently answer questions but less so by its logical reasoning. Feridooni and colleagues tested the model on questions from the 5th edition of the Vascular Education and Self-Assessment Program (VESAP5), comparing it to the evolving ChatGPT technology in three iterations: ChatGPT-3.5, -4 and -40. Across 244 text-based multiple-choice questions from six VESAP5 modules, VASC.AI significantly outperformed all three by answering 93.8% of questions correctly at the same time as ChatGPT got progressively better through version -40.

As Feridooni describes, VASC.AI is based on ChatGPT’s interface but is combined with retrieval-augmented generation (RAG), an advanced architecture that integrates specialized vascular surgery data into the model, potentially decreasing the generation of incorrect information and enhancing their educational usefulness. That input of vascular data was no small feat. Feridooni and co needed significant resources. That meant copious man hours, as well as funding. Luckily, they enlisted the help of a keen and engaged coder. Monetary help came via the research grant funding of senior author David Szalay, MD.

VASC.AI’s success is rooted in the database, made up of more than 250,000 abstracts, clinical practice guidelines and clinical trials. “The way it works in layman’s terms is we’ve basically told the model you have to draw your answer from this database of information,” explains Feridooni. “By creating this database, it has access to all of the up-to-date information that a vascular surgeon would need to have access to.” The team also put about six or seven months of labor into making sure the model weighs the database’s constituent content appropriately. “That was a process in itself,” Feridooni recalls. “How do we weigh the abstracts versus the clinical trials versus the clinical guidelines? How do we make sure it is drawing from the right guidelines—for instance, if you asked about renal artery stenting, that it would pick out from the guidelines for peripheral vascular disease.”

Going forward, the research team aims to develop a similar interface for patients. “We want to help patients both pre- and postoperatively,” Feridooni explains. “If someone comes in and they learn they have an aneurysm and need surgery, by the time they have had time to digest the news, they are probably halfway home and probably have questions, and you might not see them again until the day of surgery. This will give patients the chance to ask and get accurate responses.” In the postoperative period, Feridooni says such a model could be deployed to aid triage. For example, if a patient has questions about the look and feel of their wounds, the bot could potentially distinguish between the need to visit the clinic or the emergency department.

Ultimately, the researchers want a standalone, vascular-specific large language model. “Hopefully we can gather enough information to train our own vascular-specific model so that is both faster and cheaper, and more accessible to the vascular world,” Feridooni continues, emphasizing that its fundamentals are applicable to other specialties. He sees utility across education, research and clinical practice, describing the model as “democratizing knowledge,” and even has potential as an “unbiased” arbiter in multidisciplinary discussions over how to treat patients with complex disease, he says. “AI is coming, so why not be the leaders in this rather than let it lead us.”

Service: Giving back

By
Bryan Kay
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Service: Giving back
The EVS and AVF staged day of service in Charleston, South Carolina, as part of the former’s annual meeting program
Pioneering American Venous Forum (AVF) and Eastern Vascular Society (EVS) efforts aimed at breaking down barriers to care and educating patients in economically challenged communities on vascular disease have yielded early gains over the first two events staged this year. The vascular surgeons behind these outreach programs—or days of service—tell Vascular Specialist of their plans for the events going forward, an idea they hope catches on among other societies.

“I’m determined to make these work, I’m not giving up. There is something to this.” Kathleen Ozsvath, MD, is observing the scene at a local community center close to the heart of Charleston, South Carolina, where the EVS and AVF are staging a day of service as part of the former’s annual meeting program currently taking place in town.

Foot traffic has been brisk. Local residents are flowing in to hear short presentations on peripheral vascular health, and how both peripheral arterial disease (PAD) and venous insufficiency develop. Key, the talks are being delivered by nurse practitioners in simple, engaging language. Christina Guarin, NP, from the Department of Surgery at the University of Texas Medical Branch (UTMB) in League City, Texas, is in the middle of one, telling assembled members of the public about the signs and symptoms of PAD and how they can spot potential claudication. Across the room, a vascular surgeon and another nurse practitioner are performing ankle-brachial index (ABI) screenings. The remit is simple: reach local communities where they are and build awareness of vascular disease. Ozsvath—one of the chief architects of the event alongside Misaki Kiguchi, MD, the vascular surgery residency program director at MedStar Washington Hospital Center in Washington, D.C.—is energized. “We plan to do this again at the next AVF in February in Atlanta. I think it’s extremely important for societies to give back in this way,” she tells Vascular Specialist. “We teach our trainees, we teach our young surgeons, we teach one another at these academic meetings, but I think it’s also important that we help and reach out to our patients.”

This is the second such community outreach day those involved have organized this year. The first took place during the AVF’s annual gathering, VENOUS 2024, in Tampa, Florida, in March. The group learned much from that initial foray, Ozsvath observes. The first go round, they involved advanced practice providers (APPs) like nurse practitioners, as well as local doctors to ensure familiar points of contact, in addition to industry partners. Learning from that experience, Ozsvath, Kiguchi and company made sure to enlist industry help at an earlier juncture in a bid to increase foot traffic. It worked. “In Tampa, we had people who went out into the street, walked up to people and knocked on doors,” says Ozsvath, looking back a few weeks after the event. “We did the same thing in Charleston, but had a lot more out there. We also asked several local industry reps to put this out there in advance. The local doctors we included also made sure to advertise it to their patients. We were more aggressive—and pointed—in the appropriate directions.”

The initial idea grew out of a societal equity project to perform a day of service with providers, giving them venous disease education so they could try to treat patients in need, explains Kiguchi. The theory goes that, if primary care providers are not up-to-date on what is available for deep vein thrombosis (DVT), superficial venous disease or pulmonary embolism (PE), then what hope is there for disadvantaged patients. “It then evolved into trying to treat people in underserved communities, where we would do a small day of service at the meetings themselves, bringing everyone together,” she says. “It doesn’t necessarily benefit each of us in terms of practice development because we’re coming from out of town, but what we’re trying to do is allow people in the area to understand what venous disease is and to tell them the resources there are in the community to get evaluated.”

Industry involvement proved fruitful. Jobst provided a tranche of compression stockings to be handed out to those who attended, for instance. Some volunteered their time on the night, fanning out into the surrounding community to help draw residents to attend. Scott Dooney, an area vice president with Advanced Oxygen Therapy, Inc., was one. “I think I walked probably two miles in the community,” he recalls. “I talked to anybody. I went solo, and we all wore scrubs. I had interactions with a guy cleaning his car, I went to the playground and talked to a gathering. I handed out the leaflet for the event and explained what we were trying to accomplish. Simply: ‘If you have diabetes in your family, anybody who has had issues with any type of ulcer on their foot—we’re doing a free screening down here at the community center building, we’re going to have some education and there is something to eat. You can also get screened. Bring your significant other and any family members.’”

Other volunteers, including a group led by local vascular surgeon A. Sharee Wright, MD, a clinical associate professor of surgery at Medical University of South Carolina (MUSC), helped corral a family reunion who had gathered in a local restaurant to the event. Current AVF president Ruth Bush, MD, associate dean for educational affairs at the John Sealy School of Medicine at UTMB, was also part of the team on the ground coaxing in passersby, dressed in scrubs like many of her colleagues as a means of gentle greeting.

The sartorial code was deliberate.

“We didn’t want to appear intimidating,” explains Ozsvath. The language used followed suit. Ultimately, the idea was to blend into the community. To not appear formal. “I personally pride myself very much on speaking to people the way I want to be spoken to and try to explain things in a manner people are going to understand,” continues Ozsvath. “When I speak to patients in an office, I speak to them eye-to-eye so I’m not looking down on them. Those are the things that make people feel better and more comfortable.”

Martin Sylvain, a longtime industry leader in the vascular space and consultant, helped co-ordinate industry involvement. He also took part on the day. “The idea was to make it neighborhood-based so people could access the event with ease, walking a block or two to get there, and to provide food and refreshments. If they were to take place at a medical center where people had to take a bus, for example, people might be less likely to attend,” Sylvain says. “It was a great example of industry partnering with vascular surgery to create awareness for vascular disease at the local level.”

Kiguchi looks at the device company participation through a slightly different lens. Ordinarily, their participation at meetings is through traditional sponsorship opportunities like booths, and breakfast and lunch symposia, she notes. “But there is a push to be more involved in community outreach because that is where the patients are. Think about the fact that you’re educating people who are already at the meeting, at these booths, at these lunch meetings, and you’re kind of educating the people who are already educated. So, there is a movement to educate people who really need the education.”

Kiguchi also highlights the importance of community involvement. “One of the main things we realized from Tampa is that the people in these communities we work in don’t plan. So, right before the events begin, we need people out there corralling people in. And we did that. We went around a couple of hours before, into places like Section 8 housing, and invited people along.”

Come VENOUS 2025 in Atlanta (Feb. 16–19)—scene of the next day of service event—Ozsvath and Kiguchi want to piggyback on local community health events. “Reaching out to communities in the church, communities in volunteer programs—not reinventing the wheel but going to these events—is going to increase foot traffic,” Kiguchi says. Eventually, the organizers hope the idea is adopted by other regional and national meetings, hopefully coalescing around a fixed day or weekend on the calendar for vascular surgery outreach, she adds. From the administrative angle, AVF CEO John Forbes, another of the volunteers present at the EVS day of service, observes the scene and marvels at the big step made from version one in Tampa to 2.0 in Charleston. “The longer-term vision is to scale this even bigger, and provide knowledge to the public that is widespread.”

Venous disease education is a particular focus of the outreach. As Ozsvath tells it, “venous disease is underdiagnosed, undertreated, and it is hard enough to teach providers about venous disease, because it is not something we necessarily learn in medical school.” Hence, the need to go directly to the patients, “especially those who may have less access to care,” she adds, and why the host facilities of the events are in underserved areas.

It’s not just venous disease, Kiguchi says: these events also offer an opportunity to focus in on PAD and highlight how the disease process can manifest. Again, the role of nurses in disseminating the information—just as Guarin did alongside Debbie Williams, RN, clinical lead at Vascular Associates in Albany, New York, in Charleston—comes to the fore. “More so now, the first person people are going to see for venous or arterial disease is the nurse practitioner,” Kiguchi reflects. “We really wanted them to be at the forefront. That is something we learned from the AVF in Tampa. There, I did the presentations along with Ruth [Bush] and Kathleen [Ozsvath], but these APPs are fully capable of evaluating these patients on their own. They are more readily available. Us surgeons get called into the operating room, and we have limited time. It makes the most sense that these providers are able to be the ones who evaluate these patients first. So we thought, if these are the folks that these patients are going to see first anyway, then why shouldn’t they be the ones giving the presentations.”

Running in tandem with the effort to give back amid a vascular disease knowledge vacuum is the ever-present issue of vascular surgery’s identity problem. “If you ask the average person, ‘What is a vascular surgeon?’, they don’t know,” says Ozsvath. “Even a lot of physicians will ask, ‘What do you do again? So you must work on the heart.’ These are the things that we, as a group of professionals, have not done a good job of: get out there to explain to people what it is we do.”

Equally as important, Ozsvath argues, is working across specialty boundaries in a similar way to how the outreach effort operates. “This is also about the other specialties we overlap with: interventional radiology, cardiology, cardiothoracic surgery; there are a lot of people in these specialties who do similar work,” she explains. “For patients, that can get confusing. They might think: ‘Do I go to a radiologist to get my veins done, or do I go to a cardiologist? He’s doing my heart; do I go to them for my veins also?’ What really matters is not so much what your specialty is, but whether or not you have the experience and the knowledge to treat a specific disease entity.”

In this climate, collaboration is key, Ozsvath adds, speaking to Vascular Specialist from the vantage point of a cardiac cath lab. “I did eight cases here today. I love working here. They treat me with open arms, and I work really well with the cardiologists. We share patients. I think that goes a lot further with relationships—and also better with our patients. It’s the same thing with the day of service programs. I tell patients all the time: this is a team sport. We’re in this together. It’s your body. You need to be educated so you can make the best decision for you and I’m here to help.”

Novel measure suggests 20% of elective carotid revascularizations fail to achieve a textbook outcome

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Bryan Kay
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Novel measure suggests 20% of elective carotid revascularizations fail to achieve a textbook outcome
Jesse Columbo speaks during NESVS 2024

One in five patients failed to achieve a textbook outcome after undergoing carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR) or transfemoral carotid artery stenting (TF-CAS), a Vascular Quality Initiative (VQI) analysis that tested a novel, patient-centric textbook outcome metric found.

“Having a non-textbook outcome was prognostic of an inferior five-year survival” among asymptomatic carotid stenosis patients who underwent any of the three carotid revascularization procedures, Jesse Columbo, MD, presenting author of the multi-institutional study, told the 2024 New England Society for Vascular Surgery (NESVS) annual meeting in Portland, Maine (Oct. 25–27). “Hospital transfer, non-home living status and severe comorbidities were predictive of a non-textbook outcome.”

The findings come in the wake of the Centers for Medicare & Medicaid Services (CMS) Medicare coverage expansion for carotid stenting to standard-risk patients, with a physician-patient shared decision-making interaction now required to form part of the preoperative assessment process.

The crucially important carotid revascularization effectiveness measures of stroke, death and myocardial infarction (MI) are, of course, “irrefutably important,” Columbo told NESVS 2024, but—referencing his group’s prior work—he pointed to data showing patients prioritize additional aspects of their perioperative care, and drew further reference to another crucial factor: to obtain reimbursement, the required interaction must involve the personal preferences of beneficiaries.

The novel metric—the work of Columbo, a vascular surgeon at Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, and colleagues from the University of Florida in Gainesville, and the University of Alabama Medical Center in Birmingham—includes stroke, transient ischemic attack (TIA), MI, cranial nerve injury, reperfusion syndrome, return to the operating room (OR), access site complications, death within 30 days, discharge to a facility, and a postoperative length of stay of two days or more.

“The context of a textbook outcome composite adjunct has been championed by several other surgical specialties, most notably surgical oncology,” noted Columbo. “It has been documented as capturing a patient-centric snapshot of the anticipated successful outcome of the surgery. However, to date, vascular surgery has not adopted the use of textbook outcomes in clinical practice.”

Aiming to create such a patient-centered outcome measure to inform shared decision-making conversations surrounding carotid revascularization, the research group established a cohort of elective patients in order to evaluate the likelihood of a textbook outcome. Mining VQI data from 2016–2023 resulted in a patient group further divided into CEA (51,000), TCAR (15,000) and TF-CAS (6,000) cohorts.

Patients had a mean age of 71.6 years, approximately 40% of each cohort was female, and most were White, with those who had a recent MI, on home oxygen and with heart failure important minorities in each cohort, Columbo said. “Notably, 1% of patients who underwent CEA had a history of a prior ipsilateral carotid procedure, compared to 14% of TCAR patients and 22% of TF-CAS patients,” he revealed.

“Across the three cohorts, most patients had a textbook outcome, but a slightly higher percentage of patients who underwent TF-CAS achieved a textbook outcome.”

Stroke and MI were found to be low across the three groups, while return to the OR and access site complications were approximately 2%, while 30-day mortality was low, Columbo pointed out. “Nearly 20% of these asymptomatic patients were discharged on postoperative day two or later.”

Sensitivity analyses showed that the driver of the greater level of textbook outcomes among those treated via TF-CAS—postoperative length of stay—did not endure into days three and four, when the there was no statistically significant difference between the three treatment modalities.

Analysis of five-year survival curve data revealed a rate of 92% among CEA patients who had textbook outcomes versus 86% for those who did not. The data were similar for TCAR and TF-CAS: 91% vs. 85% and 90% vs. 82%, respectively.

“You’ll note that, in each case, the results for patients who underwent elective procedures for asymptomatic carotid stenosis appear roughly similar, and patients who had a textbook outcome had superior survival across the cohorts,” Columbo said.

Columbo acknowledged study limitations, including an inability to quantify the impact of the distinct components of the composite textbook outcome. “A successful textbook outcome after any carotid revascularization in current practice was surprisingly less likely than may have been anticipated, Columbo concluded. “The correlation between textbook outcomes and five-year survival substantiates it as a useful quality measure for patients considering carotid revascularization.”

The novel patient-centric textbook outcome measure at hand may offer value to shared decision-making interactions between physicians and patients as they discuss carotid procedure options in the wake of the CMS coverage expansion, he added.

Bentley announces first-in-human implantation of BeFlared bridging stent

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Bryan Kay
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Bentley announces first-in-human implantation of BeFlared bridging stent
Bentley CEO Sebastian Büchert, vascular surgeon Prof. Stéphan Haulon, with Carmen Panero Delgado, head of R&D at Bentley and project lead Atilla Duyar
BeFlared
L-R: Sebastian Büchert, Stéphan Haulon, Carmen Panero Delgado and Atilla Duyar

Bentley has announced the successful first-in-human implantation of its recently CE-certified BeFlared stent graft system, which the company states is the world’s first dedicated bridging stent for fenestrated endovascular aneurysm repair (FEVAR).

The procedure was performed by Stéphan Haulon, MD, a vascular surgeon at the Hôpital Marie Lannelongue in Paris, France.

In a press release, Bentley detailed that Haulon implanted an aortic endoprosthesis through a small opening in the patient’s femoral artery, with three BeFlared stents then positioned at the fenestrations of the endograft, ensuring an immediate sealing and maintaining blood flow through the visceral arteries to vital organs. In addition, Haulon implanted one regular BeGraft stent at the fourth fenestration. The operation of the 72-year-old patient suffering from a severe aortic aneurysm ended after less than two hours.

“I am happy to report that the BeFlared met all our expectations regarding ease of use during the intervention, duration and matching the requirements of the patient’s anatomy,” Haulon summarized. “The recent certification of the BeFlared marks a milestone in the endovascular treatment of aortic aneurysms as it allows [us] to shorten procedure times and therefore reduce X-ray exposure to patients and operation staff significantly. This ‘two-in-one’ device creates a new standard for bridging stents in FEVAR procedures. The BeFlared is a gamechanger as it makes these interventions safer, faster and enables better outcomes for the patients. It was a pleasure and an honor for me and my team to be part of this development. I dearly thank all Bentley employees involved in the BeFlared project,” added Haulon, a Bentley medical advisors.

The BeFlared will be officially launched at next year’s Leipzig Interventional Course (LINC 2025; Jan. 28–30) in Leipzig, Germany, Bentley stated. It will become commercially available as of Feb. 3, in line with country-specific market regulations.

WAVE trial AVG cohort also benefits at six months with Wrapsody

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Bryan Kay
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WAVE trial AVG cohort also benefits at six months with Wrapsody
Mahmood K. Razavi

Newly released six-month results from single-arm arteriovenous graft (AVG) cohort in the WAVE (Wrapsody arteriovenous access efficacy) trial showed target lesion and access circuit primary patency rates of nearly 82% and 68.8%, respectively.

The latest data on the Wrapsody cell-permeable endoprothesis (Merit Medical) for treatment of stenosis or occlusion within the dialysis access outflow circuit were revealed during the final day of the 2024 VEITHsymposium (Nov. 19–23) in New York City by co-principal investigator Mahmood K. Razavi, MD, an interventional radiologist at St. Joseph Heart and Vascular Center in Orange, California. “In light of the historically low patency rates for AVG patients, the positive results from the AV graft arm of the WAVE trial are very encouraging for physicians who manage these patients,” he said. 

The WAVE trial was designed to evaluate the efficacy and safety of the WRAPSODY endovascular stent graft across two cohorts: up to 244 AV fistula patients randomized 1:1 to either the Wrapsody device or percutaneous transluminal angioplasty, and the AVG cohort. 

The graft arm enrolled 112 patients across 43 international sites.  

Primary efficacy and safety endpoints were assessed by comparing actual rates for the device to performance goals for covered stents (efficacy: 60%; safety: 89%). Efficacy of the Wrapsody device was 81.4%—21.4 percentage points higher than the performance goal (p<0.0001). The proportion of graft patients who were free from an adverse event was higher than the safety performance (95.4% vs. 89.0%, p=0.0162). 

Wrapsody device
Wrapsody stent

“As you well know,” Razavi told VEITH 2024, “these types of numbers are somewhat unusual in this patient population, having this kind of patency.” 

The historical controls were based in three prior stent graft studies, he explained, with patency ranging between 50–71% at six months. 

The proportion of graft patients who were free from an adverse event was higher than the safety performance (95.4% vs. 89%, p=0.0162). 

“The patency results from the WAVE trial are the highest that I have seen to date and are expected to meaningfully improve patients’ quality of life and vascular access survival,” said WAVE trial investigator Leonardo Harduin, MD, a vascular surgeon at University of Rio de Janeiro State in Rio de Janeiro, Brazil. “These results will probably have a positive impact on costs related to the care of these patients.” 

The device is being investigated in the U.S. under a Food and Drug Administration (FDA) investigational device exemption (IDE).

BEST-CLI: Trial results endure in analysis of patients who presented with diabetes

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Bryan Kay
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BEST-CLI: Trial results endure in analysis of patients who presented with diabetes
Cassius Iyad Ochoa Chaar takes to the NESVS 2024 podium

Diabetes affects approximately 70% of patients with chronic limb-threatening ischemia (CLTI) and is associated with more severe presentation, driven mostly by higher rates of wounds and infections, according to a recently presented retrospective analysis of BEST-CLI randomized controlled trial data. Investigators further found that CLTI patients without diabetes presented with more severe ischemia, were more likely to undergo major reinterventions, and that the trial’s seminal finding endures: bypass outperformed endovascular intervention when a single-segment great saphenous vein (SSGSV) graft was used as a conduit.

The data were presented during the 2024 annual meeting of the New England Society for Vascular Surgery (NESVS) in Portland, Maine (Oct. 25–27) by Cassius Iyad Ochoa Chaar, MD, associate professor at Yale School of Medicine in New Haven, Connecticut, on behalf of the BEST-CLI trial investigators.

Of note among baseline characteristics in the cohort of 1,777 patients, those with diabetes were more likely to be younger and significantly more likely to be Hispanic (17.1% vs. 4.7%), Chaar noted. Meanwhile, diabetes patients were more likely to have cardiovascular comorbidities such as hypertension, hyperlipidemia and coronary artery disease (CAD), but those without diabetes were more likely to be smokers and to have chronic obstructive pulmonary disease (COPD). Chaar also pointed out how diabetes patients had a significantly higher rate of previous minor amputation of the index limb at 18.6% vs. 6% for non-diabetes patients.

Procedurally, patients with diabetes had significantly less ischemia than those without, Chaar reported. “So, their ABIs [ankle-brachial indices] were higher—and not just ankle pressure, but their toe pressure was higher as well.” But patients with diabetes had significantly higher WIfI wound and foot infection grades, and, overall, had a higher WIfI stage compared to those without, he added. Meanwhile, there was no difference in the revascularization strategies used between the two patient groups.

In terms of the trial’s primary outcome, Kaplan-Meier analysis showed significantly higher rates of major adverse limb events (MALEs) or all-cause death (53.5% vs. 46.4%), above-ankle amputation of the index limb (17.8% vs. 9.9%), and all-cause death (34.4% vs. 26.0%) in the diabetes group at three years, Chaar revealed. “Interestingly, those curves were flipped when looking at major reinterventions: patients with diabetes had significantly decreased incidence of major reintervention [18.2% vs. 24.3%].”

Under multivariate analysis, the researchers also looked to determine whether WIfI grades compounded the impact of diabetes. “The initial regression showed that diabetes was independently associated with the primary outcome, but when you repeated the model with WIfI, that trend was still there but the significance was lost,” Chaar explained. “However, WIfI was significantly associated with the primary outcome.”

The analysis mirrors the BEST-CLI trial’s overall findings, the investigators found: that is, lower rates of major reintervention, above-ankle amputation, and MALE or all-cause death in patients who underwent bypass with SSGSV compared with endovascular procedures, irrespective of diabetes status. “Patients with diabetes had worse overall outcomes after lower extremity revascularization for CLTI, probably related to more advanced disease on presentation,” Chaar concluded.

Rates of MAE and reintervention following F/BEVAR remain ‘stable,’ Aortic Research Consortium data show

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Bryan Kay
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Rates of MAE and reintervention following F/BEVAR remain ‘stable,’ Aortic Research Consortium data show
Eric Finnesgard presents at NESVS 2024
Latest study out of consortium details trends and outcomes after F/BEVAR procedures carried out over an eight-year period under consortium of 10 physician-sponsored IDEs.

Despite increasing repair extent and complexity, rates of technical failure, adverse events and reintervention remained “stable” following fenestrated and branched endovascular aneurysm repair (F/BEVAR) for abdominal aortic aneurysms (AAAs), a newly presented analysis of U.S. Aortic Research Consortium (ARC) data show. The positive outcomes are “likely secondary to evolutions in minimally invasive techniques and devices,” the ARC investigators report.

The data were presented by first-named author Eric Finnesgard, MD, a vascular surgery resident at UMass Chan Medical School in Worcester, Massachusetts, during the 2024 New England Society for Vascular Surgery (NESVS) annual meeting in Portland, Maine (Oct. 25–27). Finnesgard collected the R. Clement Darling Jr. Award—given for an outstanding original paper from a resident, fellow or medical student—for the work.

The analysis laid out a cumulative 30- day major adverse event (MAE) rate of 10% and a one-year secondary intervention rate of 18%, with adjusted observed-minus-expected cumulative sum used to evaluate outcomes over time. In the case of 30-day MAEs, which occurred in 240 patients, Finnesgard demonstrated a cumulative event rate oscillating around the baseline—reflecting “a stable process that is achieving expected outcomes over time,” he told NESVS 2024. For one-year reinterventions, of which there were 435 performed, the cumulative event rate followed a similar pattern, again reaching expected outcomes over time. Survival at 30 days was 97.3%.

The analysis included 2,377 F/ BEVAR patients—derived from ARC’s 10 prospective, non-randomized, physician-sponsored investigational device exemption (IDE) studies and treated between 2015–2023— with a median follow-up of 2.3 years. Finnesgard detailed how total device components, dissections and the proportion of thoracoabdominal aortic aneurysms (TAAAs) increased across the study period, while technical failure rates and hospital stays remained stable. Fusion imaging, low-profile devices and completely transfemoral repair were increasingly adopted over time, he continued, and there were nonsignificant downward trends in fluoroscopy times, procedure times, radiation dosage and blood loss throughout the study.

Significant determinants of 30-day MAEs included index procedure, technical failure, TAAA, patient age, operative time and baseline renal function. For secondary interventions, significant determinants included index procedure, off-the-shelf device use, technical failure, total target vessels incorporated and prior aortic dissection.

“These data demonstrate trends toward treatment of more complex and extensive aortic disease over the study period,” Finnesgard said, acknowledging study limitations that included the retrospective nature of the analysis and an inability to account for previous operator experience. “These multicenter data demonstrate that, despite an increase in practice complexity, cumulative event rates have actually remained relatively stable.”

Discussant David P. Kuwayama, MD, director of aortic surgery in the Division of Vascular Surgery and Endovascular Therapy at Yale University in New Haven, Connecticut, queried Finnesgard over the nature and outcomes of the reinterventions, as well as the study’s “incredibly low” paraplegia rates. Kuwayama said “the functional question” around reintervention is: “Are the aneurysms actually successfully excluded?”

Finnesgard detailed that 85% of the interventions were performed percutaneously for endoleaks, with type IIIc and Ic the most common, but said he did not have outcome data from these reinterventions on hand, and further acknowledged that “successful aneurysm exclusion” is “a the key metric we need to strive for.” On the paraplegia question, Finnesgard pointed toward practice changes over time—such as a shift toward staged procedures—as significantly helping patients, alongside “big changes to our multimodal protocols for management of spinal cord ischemia” postoperatively.

ARC data guide debate

Meanwhile, the analysis’ senior author, Andres Schanzer, MD, chief of vascular surgery at UMass, made the case for superior outcomes from F/BEVAR over open repair using ARC’s vast dataset during a debate at the 2024 VEITHsymposium in New York City (Nov. 19–23): “While open and endovascular repair are valuable, I believe it is time to stop starting and ending every talk with ‘Open repair is the gold standard,’ because it really no longer is.”

Incorporation of Shockwave E8 Peripheral IVL into the treatment of patients with chronic limb-threatening ischemia

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Incorporation of Shockwave E8 Peripheral IVL into the treatment of patients with chronic limb-threatening ischemia

This advertorial is sponsored by Shockwave Medical.

Anand Prasad, MD, an 18-year veteran of vascular and endovascular medicine with a particular interest in peripheral arterial disease (PAD) in patients with chronic kidney disease (CKD), explores the deliverability of the Shockwave E8 catheter below the knee in patients with advanced disease.

Below-the-knee (BTK) intervention in patients with chronic limb-threatening ischemia (CLTI) represents a challenging area in our field. The length, calcification and smaller size of tibial vessels, coupled with patient comorbidities such as diabetes and CKD, and the consequences of procedural failure, all converge in these patients.1,2 Traditionally, plaque modification with atherectomy devices has been the primary mode to address vessel calcium. Although effective in many cases, atherectomy carries a risk of distal embolization, vessel perforation, and a variable impact on deep and superficial calcium, depending on the specific device used.

Shockwave Medical’s introduction of intravascular lithotripsy (IVL) into the endovascular field has been revolutionary for the treatment of calcium. In my own practice, the use of IVL has provided multiple benefits, including replacing atherectomy for many cases, reducing flow-limiting dissections, and improving vessel preparation prior to adjunctive therapies.

Most recently, our center has used the newest iteration of Shockwave’s IVL family of peripheral catheters extensively: the Shockwave E8 catheter. The Shockwave E8 provides a broad range of IVL sizes, which span utility above and below the knee. Key features include diameters of 2.5–6.0mm, 80mm balloon length with evenly spaced emitters, 150cm working length for distal vessel reach, 400 pulses available at 2Hz (two pulses per second). As many operators use lower-profile access, the smaller balloon sizes, 2.5–4.0mm, are compatible with 5F sheaths. In my experience, the versatility of these Shockwave E8 features can replace the use for Shockwave S4 and Shockwave M5+ catheters in many vessel sizes.

A key challenge with IVL therapy in the BTK circulation has been deliverability. To date, pre-IVL vessel preparation with gentle balloon dilation or use of atherectomy were the primary means to help advance the Shockwave devices. Shockwave E8 has been easier to deliver, despite the longer length relative to the Shockwave S4, in large part due to more extensive (45cm) hydrophilic coating, coupled with a novel tapered tip. These latter features have been particularly helpful to me when treating chronic total occlusions (CTO), as well as distal tibial lesions. The following case highlights many of these capabilities of the Shockwave E8 in CLTI patients.

Case report

Introduction

A 75-year-old female patient with diabetes and end-stage kidney disease (ESKD) presented with progressive right second toe swelling ulceration with gangrene and rest pain (Figure 1). There was extensive osteomyelitis and underlying tissue injury which required a planned amputation of the second toe. We were consulted prior to amputation for angiography, which demonstrated patent inflow vessels but severe BTK tibial disease. The baseline angiogram is shown in Figure 2. There was no inline flow to the foot, with occlusion of the anterior tibial, posterior tibial and peroneal arteries (Figure 2a). There was reconstitution of the peroneal artery, with partial filling of the posterior circulation via the posterior communicating artery. There was reconstitution of the anterior circulation with a visible small dorsalis pedis artery (Figure 2b).

Procedural overview

Given the angiosome of the tissue loss, we elected to pursue opening the anterior tibial CTO. Access with a 5F, 70cm sheath was used from a contralateral femoral approach. Using a 0.014” microcatheter and wire escalation, we were able to cross into the true distal lumen of the distal anterior tibial circulation using a 12-gram tipped guidewire (Figure 3a). A 2.5mm Shockwave E8 was used for multiple treatments along the entire length of the CTO segment (Figures 3b, 3c). Post IVL therapy, angiography showed brisk flow through the anterior tibial and into the distal anterior circulation of the foot (Figures 4a-c). This improvement in circulation allowed for this patient to undergo her planned second toe amputation with primary close (Figure 4d).

Conclusion

The key takeaway points for this case were the deliverability of the Shockwave E8 and the ability to treat longer segments versus the Shockwave S4. In addition, in many cases the Shockwave E8 can serve as the primary or final therapy without the need for additional angioplasty. This catheter continues the evolution of treatment options for patients with BTK disease.

References

  1. Feraresl R, et al. J Cardiovasc Surg. 2018 Oct;59(5):655-664
  2. Mustapha JA, et al. Circ CV interventions. 2016;9e003468

Anand Prasad is a professor of medicine and director of interventional cardiology at UT Health San Antonio and University Health in San Antonio, Texas. He is a paid consultant of Shockwave Medical. The views expressed are those of the author and not necessarily those of Shockwave Medical.

Peripheral Safety Information In the United States: Rx only. Indications for Use—The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature Contraindications—Do not use if unable to pass 0.014” (M5, M5+, S4, E8) or 0.018” (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries. Warnings—Only to be used by physicians who are familiar with interventional vascular procedures—Physicians must be trained prior to use of the device— Use the generator in accordance with recommended settings as stated in the Operator’s Manual. Precautions—use only the recommended balloon inflation medium—Appropriate anticoagulant therapy should be administered by the physician— Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology. Adverse effects–Possible adverse effects consistent with standard angioplasty include–Access site complications – Allergy to contrast or blood thinner– Arterial bypass surgery—Bleeding complications—Death— Fracture of guidewire or device—Hypertension/Hypotension— Infection/sepsis—Placement of a stent—renal failure—Shock/ pulmonary edema—target vessel stenosis or occlusion— Vascular complications. Risks unique to the device and its use—Allergy to catheter material(s)— Device malfunction or failure—Excess heat at target site. Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/IFU. SPL-73445 Rev. A 

Tackling difficult acute limb ischemia cases with an endovascular-first approach using Lightning Bolt 7 computer assisted vacuum thrombectomy

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Tackling difficult acute limb ischemia cases with an endovascular-first approach using Lightning Bolt 7 computer assisted vacuum thrombectomy
Adam Reichard

This advertorial is sponsored by Penumbra, Inc.

Adam Reichard, MD, discusses the use of Lightning Bolt 7® computer-assisted vacuum thrombectomy (CAVTTM) as a first-line option across a wide spectrum of challenging lower extremity acute limb ischemia (ALI) cases, including patients with Rutherford classification IIb ALI.

Two cases stick out for Reichard where he used Lightning Bolt 7 (Penumbra) CAVT as his first-line therapy for patients who require urgent management for lower extremity ALI. Both patients were diagnosed with Rutherford IIb lower extremity acute limb ischemia. And both saw clinical improvement following use of the Lightning Bolt 7 device, notes the vascular surgeon in the TriHealth hospital system based in Cincinnati, Ohio.

For Reichard, the specter of Rutherford IIb cases is a key point of contention. The level of threat to the limb is so great, open surgery would be the traditional approach. Yet, as Reichard has observed in recent years, the landscape has shifted. In these patients, an endovascular-first approach is increasingly the go-to option. For evidence, he points to the STRIDE study, which looked at 30-day outcomes after first-line use of the Indigo and Lightning portfolios in cases of ALI, including Rutherford I, IIa and IIb patients.

“If you’re talking to vascular surgeons who treat this disease pathology, they would agree that it is routine to start with an endovascular approach in someone who has Rutherford I or IIa ischemia, but, when you get into IIb territory, and you know it’s a more threatened limb, then people might be a little more reluctant,” Reichard explains. “However, the STRIDE study did a great job showing that, even in patients with Rutherford IIb ALI, at 30 days you’re going to salvage more limbs and mortality is going to be lower if you start with percutaneous thrombectomy, including computer-assisted vacuum thrombectomy technology, as opposed to open surgery.”

Thirty-day outcomes from STRIDE—a prospective, single-arm observational study carried out at 16 international sites among 119 patients with lower extremity ALI—showed rates of 98.2% for limb salvage, 89.4% for patency, 3.4% for mortality and 4.2% for periprocedural major bleeding.1 This compares to rates of 83.1% (limb salvage),2 78.6% (patency),3 13.2% (mortality),4 and 21% (major bleeding)5 in the setting of open surgery, as recorded in the literature.

During his fellowship years, Reichard watched as endo-first took hold. “When I first started in practice, it wasn’t too long after the Lightning Bolt 7 catheter had been released,” he says. “I got the opportunity to use it in training, as some of my mentors had embraced endovascular-first for lower extremity ALI, and I saw how effective it was. When I went out into practice, I told myself that was going to be my practice pattern when it was appropriate.”

Reichard recalls of those first two patients he treated, both Rutherford IIb: “They
had pain, sensory dysfunction and motor dysfunction, and traditionally we would have taken them to the operating room for a cutdown and open embolectomy or thrombectomy.”

In the first case, a female patient with a prior aortobifemoral graft, Reichard explains, a Lightning Bolt 7 catheter was used in her leg from the common femoral artery down to her foot. “At the end of that case, she had palpable pulses and, a few hours after that, when I went to check on her, she said that her leg and foot felt much better, and it looked much better clinically too,” he says. “That is someone who traditionally probably would have ended up—at least—with a groin incision and a femoral dissection, but probably with a below-the-knee popliteal artery cutdown and dissection.”

The second patient, a male in his 80s with a prior endovascular aneurysm repair (EVAR), underwent a femoral dissection and cutdown to directly access his superficial femoral artery. A Lightning Bolt 7 catheter was similarly used to thrombectomize his leg.

In this case, Reichard acknowledges a possible paradox. “People could argue that if you’re already open, and you already have the femoral vessels exposed, why not just pass a Fogarty balloon embolectomy catheter. However, my issue with that is that you’re sending a balloon catheter blindly down the leg and looking for back bleeding. You do your on-table angiogram at the end of the case to see what your outflow looks like. More often than not, you’re going to end up doing adjunctive endovascular procedures trying to touch that up.”

Reichard argues that, in this case, taking an endovascular-first approach from an open exposure provided visibility on the outflow vessels, ultimately proving to be “more effective and efficient.”

The gravity and complexity of an ALI diagnosis weigh heavily. In-hospital and 30-day mortality rates are up to 9% and 15%, respectively, Reichard points out. Amputation rates can reach 15% at discharge and 25% at 30 days, he continues.

“Something that is most important to consider is that if a patient comes in with ALI, mortality at five years is almost 50%, so obviously there is a lot of morbidity and mortality associated with this issue.”

The safety and effectiveness of endovascular devices mean the shift to endo-first practice patterns like the one adopted by him and his colleagues at TriHealth are increasing, Reichard says. “We know that about 86% of patients with ALI that go for an open embolectomy or thrombectomy end up needing additional endovascular work while you are in the operating room.”

The rapid development of CAVT has led to greater clinical gains as new iterations of the technology have rolled out, Reichard observes. “When the Lightning devices came out, that really mitigated blood loss during procedures. At that point, I think people were a lot less reluctant to use those devices first-line.”

As a vascular surgeon with the skills to pivot to open surgery should the need arise, Reichard says the endo-first approach infrequently leads to the need for bailout procedures. “These devices are so effective at clearing thrombus, even in the tibial vessels, that it has really minimized the need for open surgery for tibial thrombectomies. Also, if a Rutherford IIb lower extremity ALI patient comes in and you are able to de-bulk the majority of that thrombus endovascularly, when we’re still endo, more often than not, we have the option of adjunctive catheter-directed thrombolysis, which we don’t often need to do. Once we’re open, that is taken off the table.”

Lightning Bolt 7 occupies an intriguing position in the shift toward endo-first, Reichard adds. “The fact that the device uses a dual clot detection algorithm—pressure and flow based—is important in these cases, allowing for quicker clot detection and patent flow. What we want in these cases is effective thrombus removal, but we also want to try to mitigate blood loss. This catheter, its algorithm, effectiveness and safety are what makes it more effective in managing these patients.”

References

  1. Maldonado TS, Powell A, Wendorff H, et al. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024;79(3):584–592.e5. doi:10.1016/j.jvs.2023.10.062
  2. Veenstra EB, van der Laan MJ. Zeebregts CJ, et al. A systematic review and meta-analysis of endovascular and surgical revascularization techniques in acute limb ischemia. J Vasc Surg. 2020 Feb;71(2):654–668.e3. doi:10.1016/j.jvs.2019.05.031
  3. Grip O. Wanhainen A, Michaëlsson K, Lindhagen L, Björc M. Open or endovascular revascularization in the treatment of acute lower limb ischemia. Br J Surg. 2018 Nov;105(12):1598–1606. doi:10.1002/bjs.10954
  4. Taha AG, Byrne RM, Avgerinos ED, et al. Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia. J Vasc Surg. 2015 Jan;61(1):147–157. doi:10.1016/j.jvs.2014.06.109
  5. Kolte D, Kennedy KF, Shishehbor MH, et al. Endovascular versus surgical revascularization for acute limb ischemia: a propensity-score matched analysis. Circ Cardiovasc Interv. 2020;13(1):e008150

This interview was sponsored by Penumbra, Inc. Adam Reichard is a consultant for Penumbra.

Procedural and operative techniques and considerations are illustrative examples from physician experience. Physicians’ treatment and technique decisions will vary based on their medical judgment. The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.

Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Summary Statements, please visit www.peninc.info/risk. Please contact your local Penumbra representative for more information.

Vascular Specialist–November 2024

By
Bryan Kay
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Vascular Specialist–November 2024

In this issue:

  • Service: Giving back—The Eastern Vascular Society (EVS) and American Venous Forum (AVF) pioneer vascular days of service in the community
  • Novel measure suggests 20% of elective carotid revascularizations fail to achieve a textbook outcome
  • Guest editorial: Track your wRVUs, because nobody else does it better
  • Brand new column: Vascular Specialist launches its latest comment section addition: The Outpatient

Humacyte clinical results published in JAMA Surgery

By
Jocelyn Hudson
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Humacyte clinical results published in JAMA Surgery
Human Acellular Vessel
ATEV
Acellular tissue engineered vessel

Humacyte today announced the publication of clinical results evaluating the efficacy and safety of the acellular tissue engineered vessel (ATEV) in the repair of extremity civilian and military injuries in JAMA Surgery, an American Medical Association peer-reviewed journal.

The publication describes two clinical studies in which the ATEV demonstrated benefits in terms of patency, limb salvage, and infection resistance compared to synthetic graft benchmarks in the treatment of acute vascular injuries of the extremities.

“The development of a vascular conduit that resists infection and remodels into native arteries is an extraordinary technological advancement that will have a huge impact on the quality of trauma care around the world,” said Charles J Fox (University of Maryland Capital Region, Lake Arbor, USA), a clinical investigator in the Humacyte V005 trauma clinical trial.

He continued: “The ATEV is perfectly sized to treat most injuries, has excellent handling properties, and reduces time necessary to save both life and limbs. Finally, an innovative technology has been developed for battlefield vascular injuries using a tissue engineered human arterial replacement that can resist infections that are so prevalent in modern combat zones. The ATEV shows promise to reduce amputation rates since an alternative conduit for war injuries is often needed but up until now has not been a good option.”

The JAMA Surgery publication described the results of two studies in which the ATEV was evaluated in patients with extremity vascular trauma. The V005 clinical trial was a single-arm study conducted in the USA and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events for whom the standard of care, saphenous vein, was not feasible or available to use as a bypass graft. The V017 single-arm clinical trial evaluated patient outcomes from a humanitarian programme in which patients with wartime injuries were treated in Ukraine.

As single-arm studies, the comparators for the ATEV results were a systematic literature review and meta-analysis of studies conducted with synthetics grafts, providing a current treatment benchmark comparison. In a meta-analysis combining the V005 and V017 trials, the ATEV demonstrated higher patency with a 30-day secondary patency rate of 91.5% for the extremity patients compared to 78.9% historically reported for synthetic grafts. For the secondary comparison of amputation rates, the ATEV demonstrated an improvement with a rate of 4.5% for extremity patients compared to 24.3% historically reported for synthetic grafts. For the secondary comparison of infection, the ATEV demonstrated an improvement with a reduced rate of 0.9% for the extremity patients compared to 8.4% historically reported for synthetic grafts. In summary, researchers concluded that the 30-day outcomes in civilian and military trauma patients indicate superior secondary patency, limb salvage, and resistance to infection of the ATEV conduit compared to synthetic grafts.

“I believe that the ATEV will revolutionise vascular trauma care and be profoundly beneficial to our patients,” said Rishi Kundi (University of Maryland’s R Adams Cowley Shock Trauma Center, Baltimore, USA). “Based on my personal experience so far, the ATEV will allow reconstruction that is currently impracticable because of contamination or infection; moreover, it will make reconstruction that we are now forced to perform with prosthetic or even biologic grafts more successful. I am excited about the promise that the ATEV holds for the long-term experience and outcomes of our patients.”

Also published were longer term follow-up results from the V005 and V017 studies. The ATEV was observed to be mechanically durable and does not appear to dilate or become stenotic over time. Long-term outcomes for secondary patency, limb salvage, freedom from conduit infection, and patient survival were evaluated by Kaplan-Meier analysis. The average follow-up duration for patients receiving the ATEV for extremity trauma is 334.4 days, with a total patient exposure of 61.3 years. These results showcased the potential of the ATEV to retain patency over the longer duration of follow-up. No ATEV infections or patient deaths were reported after month three.

“If approved by the FDA [US Food and Drug Administration], the ATEV will be the preferred conduit for complex extremity vascular injuries, and particularly those at risk for infection,” said Ernest E Moore (Denver Health, Denver, USA), a clinical investigator in the V005 trial. “I look forward to the ATEV being available for use in my practice.”

Evaluation of the safety of the ATEV indicated no safety signals attributable to ATEV mechanical weakness, contamination, or immune rejection. Overall, adverse events (AEs) and serious adverse events (SAEs) were consistent with patients suffering from acute injuries. Adverse events of special interest (AESIs) including thrombosis, rupture, aneurysm, and pseudoaneurysm, occurred at rates that were consistent with reports of other vascular conduits, including autologous vein and synthetic grafts. The meta-analysis combing the V005 and V017 trials showed a 30-day rate of death in ATEV patients of 3.5%, comparable to the 3.4% rate historically reported for synthetic grafts. There were no deaths attributable to the ATEV.

A press release notes that the ATEV is an investigational, first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair, and for use as haemodialysis access. While harvesting vein from a trauma patient requires critical surgical time, the ATEV is designed to be available immediately, off the shelf. A Biologics License Application for the ATEV in a vascular trauma indication is currently under review by the FDA.

Humacyte advises that the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

One-year data from VenoValve US pivotal trial emerges

By
Jocelyn Hudson
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One-year data from VenoValve US pivotal trial emerges
VenoValve implantation

Envveno Medical has announced that it will present one-year data on all patients from the VenoValve US pivotal trial today at the VEITHsymposium (19–23 November, New York, USA). The definitive one-year data support the application submitted earlier this week by Envveno Medical seeking premarket authorisation (PMA) from the US Food and Drug Administration (FDA) to market and sell the VenoValve in the USA.

Among the data being presented at VEITH are:

  • Eighty five percent of the patients in the VenoValve pivotal study that reached the one-year milestone achieved a clinically meaningful benefit of a three or more-point improvement in revised Venous Clinical Severity Score (rVCSS).
  • A 7.91 point average rVCSS improvement among the rVCSS responder cohort.
  • A clinical meaningful benefit was shown across all CEAP diagnostic classes of patients (C4[b], C4[c], C5, C6) enrolled in the study.
  • A 97% target vein patency rate at one year.
  • Haemodynamic data from the study showed a positive correlation between rVCSS improvement and systemic reflux time improvement.

The FDA previously indicated to the company that a three or more-point improvement in rVCSS would be evidence of the VenoValve’s clinically meaningful benefit.

Patients in the VenoValve pivotal study also experienced a median reduction in pain of 75% at one year as measured by Visual Analogue Scale (VAS). Additionally, among patients with venous ulcers (CEAP C6), the median ulcer area was reduced by 87% at 12 months. Patient-reported outcomes in the VenoValve pivotal study also demonstrated improvements in quality of life and disease symptoms (VEINESqol/sym, EQ5D).

The company will also update the pivotal trial safety profile of the VenoValve at VEITH, reporting major adverse events (MAEs) through one year of: one death (unrelated to the VenoValve), zero pulmonary embolisms, 12 target vein thromboses, 10 surgical pocket haematomas, four other bleeds, and seven deep wound infections. Of the patients who experienced an MAE, there was no long-term negative impact on clinical improvement as 94% of the patients who experienced an MAE (not including the unrelated death) also experienced a clinically meaningful benefit (three-point rVCSS improvement) at one year, compared to baseline.

Envveno Medical notes in a press release that the VenoValve is a potential first-in-class surgical replacement venous valve for patients with severe deep venous chronic venous insufficiency (CVI). The company estimates that there are approximately 2.5 million potential new patients each year in the US who could be candidates for the VenoValve. The company adds that it is also developing Envve, a next-generation, transcatheter-based replacement venous valve, that could appeal to an even larger market in terms of both patients and physicians.

PMA application submitted for VenoValve device

By
Bryan Kay
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PMA application submitted for VenoValve device
VenoValve

enVVeno Medical today announced it has submitted an application with the U.S. Food and Drug Administration (FDA) seeking approval to market the VenoValve—a surgical venous valve implant for chronic venous insufficiency—in the USA. Definitive one year data from the application are to be presented on Wednesday at the 51st Annual VEITHsymposium in New York City (19–23 November).

“We are thrilled to get this last step of the PMA review process underway and look forward to further interactions with the FDA,” said Robert Berman, enVVeno Medical’s CEO. “It is difficult to predict precisely how long the PMA process will take, but we expect to learn more and potentially have a decision in the second half of 2025.”

The VenoValve, which has been designated as a breakthrough device by the FDA and is therefore subject to priority review.

The company is also developing a next-generation, non-surgical transcatheter based replacement venous valve called enVVe. It is expected to be ready for its own pivotal trial during the middle of 2025.

Research suggests arm vein is the best alternative bypass conduit to GSV in patients with CLTI

By
Jocelyn Hudson
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Research suggests arm vein is the best alternative bypass conduit to GSV in patients with CLTI
Mohammed Hamouda presents at the WVS annual meeting

A new analysis has found arm vein to be the most suitable alternative conduit to great saphenous vein (GSV) in chronic limb-threatening ischemia (CLTI) patients, particularly in below-knee bypass targets. Prosthetic grafts also represent an adequate option, the researchers add, whilst advising that the use of biological grafts in this setting should be limited.

The research—a retrospective analysis of prospectively collected data from the Vascular Quality Initiative (VQI)—were recently published in the Journal of Vascular Surgery (JVS) following its presentation at the 2024 Western Vascular Society (WVS) annual meeting (Sept. 7–10) in Colorado Springs, Colorado.

First author Mohammed Hamouda, MD, senior author Ann C. Gaffey, MD, both from UC San Diego in San Diego, California, and colleagues write in JVS that, while the optimal conduit for infrainguinal bypass is single-segment GSV, this is not aways available in patients with CLTI. Therefore, suitable alternatives conduits are warranted.

Of the options that are available at present—arm vein grafts, prosthetic grafts, and biological grafts—Hamouda et al state that the available contemporary data regarding their durability and limb salvage rates is scarce. As a result, the researchers aimed to investigate the impact of these alternative graft types on postoperative and long-term outcomes of infrainguinal bypass in patients with CLTI.

The investigators share that they queried the VQI database for patients who underwent lower extremity bypass surgery in the last 20 years, with patients stratified into three graft groups: arm vein (cephalic/basilic), prosthetic (Dacron/polytetrafluoroethylene [PTFE]), and biological (cadaveric/homograft/xenograft).

Outlining the methodology used for the study, Hamouda and colleagues write that multivariate logistic regression analyzed postoperative outcomes including 30-day mortality, major adverse cardiovascular events (MACE), graft occlusion, prolonged length of hospital stay, and infection. Furthermore, they detail that Cox regression was used to report the one-year outcomes of mortality, major amputation (above-ankle), and major adverse limb events (MALE)—defined as major amputation, thrombectomy or reintervention.

The authors share that 9,165 infrainguinal procedures from the over 20-year study period. These included 417 arm vein grafts (4.55%), 7,520 prosthetic grafts (82.05%), and 1,228 biological grafts (13.4%).

Hamouda et al report in their results that, compared to arm vein grafts, patients receiving prosthetic grafts had higher odds of infection (adjusted odds ratio [aOR] 2.89, p=0.045) and higher hazard of one-year mortality (aOR 1.51, p=0.035).

On the other hand, the investigators continue, patients receiving biological grafts had higher risk of graft occlusion (aOR 4.55, p=0.04) and infection (aOR 2.78, p=0.046) as well as higher hazard of one-year mortality (aOR 1.53, p=0.04), amputation (aOR 1.72, p=0.019) and amputation or death (aOR 1.52, p=0.005) compared to arm vein grafts.

Finally, the authors note that, after stratifying by bypass configuration, arm vein grafts had the highest overall survival and amputation-free survival among the three alternative conduits in below-knee popliteal and tibial bypass targets.

“In this large multi-institutional study investigating alternative conduits to GSV, arm vein grafts are found to be the most resistant to infections and are associated with the best overall survival and limb salvage outcomes compared to prosthetic grafts and biological grafts, particularly in below-knee distal targets,” Hamouda and colleagues conclude.

The investigators add that, in cases where no GSV is available, both arm vein grafts and prosthetic grafts are “acceptable alternatives”. On the other hand, biological grafts are associated with a higher risk of graft occlusion and lower freedom from major amputation and death. Hamouda et al therefore advise that the use of biological grafts “should be limited to situations when other options are not available or feasible.”

Review with VESAP6

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Review with VESAP6

The sixth edition of the Vascular Education and Self-Assessment Program (VESAP6) is available for both members and nonmembers of the SVS to purchase. The electronic review program offers over 600 review questions and includes detailed discussions and references throughout.

To learn more about VESAP6 and to purchase the resource, visit vascular.org/VESAP.

‘Voices of Vascular’ series celebrates Ochoa for Hispanic History Month

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‘Voices of Vascular’ series celebrates Ochoa for Hispanic History Month
Lyssa Ochoa, MD
Lyssa Ochoa, MD

The SVS Foundation “Voices of Vascular” series is celebrating Lyssa Ochoa, MD, for this year’s Hispanic History Month.

A Mexican American vascular surgeon, Ochoa is dedicated to serving underserved communities. Raised in Mission, Texas, she founded the San Antonio Vascular and Endovascular (SAVE) Clinic to help address healthcare disparities, particularly in areas with high rates of diabetes-related amputations.

Jimenez joins JVS-CIT as DEI editor

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Jimenez joins JVS-CIT as DEI editor

The Journal of Vascular Surgery-Cases, Innovations and Techniques (JVS-CIT) has appointed Juan Carlos Jimenez, MD, as its new associate editor and diversity, equity and inclusion (DEI) officer. Jimenez, who serves as clinical professor of surgery and director of the Gonda Venous Center at the University of California, Los Angeles (UCLA), will oversee about 200 submissions annually in his role as editor, contributing his expertise in vascular surgery and academic publishing.

Jimenez is also the vice chair for justice, equity, diversity, and inclusion at UCLA, a role that will inform his work on the JVS-CIT editorial board.

To learn more about the journal, visit jvscit.org.

SVN hosts virtual roundtable on PAD awareness

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SVN hosts virtual roundtable on PAD awareness

On Tuesday, Sept. 24, The Society for Vascular Nursing (SVN), in collaboration with the PAD Collaborative and the American Association of Wound Care (AAWC), presented a virtual roundtable titled “PAD: What is it? Leg Circulation Disease is More Common Than You Know—Are You at Risk?”

The event was moderated by Natalie S. Evans, MD, a vascular medicine specialist at the University Hospitals Harrington Heart and Vascular Institute in Cleveland.

The event for SVN members explored the risks of peripheral arterial disease (PAD), with discussion emphasizing how location impacts risk factors.

SVN virtual roundtables are designed to foster informal, collaborative discussions on important issues within vascular nursing. A recording of the event will be available to SVN members on the society website.

Members can submit future topic requests by emailing svs@svnnet.org.

Perioperative care in open aortic vascular surgery: join upcoming webinar

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Perioperative care in open aortic vascular surgery: join upcoming webinar

A webinar on “Perioperative Care in Open Aortic Vascular Surgery: Recommendations from ERAS and SVS” was held by the SVS Leadership Development Committee on Oct. 15.

Enhanced Recovery After Surgery (ERAS) is a comprehensive perioperative care pathway that utilizes evidence‐based best practices across specialties to promote early recovery for patients undergoing major surgery. Implementing ERAS protocols has been shown to reduce recovery time, complications and readmissions while improving patient and staff satisfaction.

This webinar reviewed the recommendations for perioperative care in open aortic vascular surgery based on the consensus statement developed by the ERAS Society and the SVS in 2022.

Topics covered during the webinar included why ERAS is needed in vascular surgery; the necessary collaboration of surgery and anesthesia in implementation of successful ERAS pathways; current guidelines; as well as a literature review of ERAS open aortic surgery and guidelines in practice.

Visit vascular.org/ERAS for more details on this webinar.

SVS and APSA convene for quarterly meeting

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SVS and APSA convene for quarterly meeting

The SVS and the American Pediatric Surgical Association (APSA) Pediatric Vascular Surgery Interest Group convened for its quarterly meeting on Tuesday, Oct. 1. The focus of this quarter’s meeting was arterial thrombosis in children.

The panel for the meeting was made up of experts in pediatric surgery, pediatric hematology and vascular surgery: Erica L. Mitchell, MD, Med; Gavin Roach, MD, MS; David H. Rothstein, MD, MS; and Reagan Williams, MD. The speakers covered a brief overview of pathophysiology and delivered case-based presentations covering trauma, catheter-induced arterial injury and compressive syndromes.

Meeting attendees had an opportunity to gain an improved understanding of etiologies of provoked and spontaneous arterial thrombosis in pediatric vascular patients; the treatment strategies for thrombosis, including anticoagulation/lytic therapies, and endovascular approaches and open approaches; and post-treatment management, including anticoagulation, imaging and long-term follow-up.

In 2021, the SVS and APSA joined together to create a collaborative, interdisciplinary task force to address gaps in pediatric vascular care.

SVS launches leadership podcast series

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SVS launches leadership podcast series
Manuel Garcia-Toca
Manuel Garcia-Toca

In collaboration with the Physician Assistant Section, the SVS Leadership Development Committee, is set to launch a leadership development podcast in partnerhsip with Audible Bleeding.

The first episode, scheduled to be recorded this fall, will spotlight the SVS Leadership Development Program (LDP) and feature insights from committee Chair Manuel Garcia- Toca, MD, and SVS Executive Director Kenneth M. Slaw, PhD.

The podcast series will initially consist of three episodes per year.

“Leadership in vascular surgery is not just about managing a team; it’s about developing the skills to inspire and elevate everyone involved in patient care. The LDP is designed to provide those essential skills,” said Garcia-Toca.

To learn more, visit vascular.org/LDP.

Class of 2024–25: VQI announces third annual set of Fellowship in Training Program awardees

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Class of 2024–25: VQI announces third annual set of Fellowship in Training Program awardees
Brandon Gaston, FIT fellow, Mitri Khoury, FIT scholar, and Nikolaos Zacharias, FIT mentor
Brandon Gaston, FIT fellow, Mitri Khoury, FIT scholar, and Nikolaos Zacharias, FIT mentor

The Vascular Quality Initiative (VQI) Patient Safety Organization’s Fellowship in Train­ing (FIT) Program has announced its third class of FIT participants for 2024–25 along­side the new FIT scholars.

VQI FIT began in January 2022 and is de­signed to introduce residents and fellows in vascular surgery and other cardiovascular-re­lated training programs to the SVS’ Vascu­lar Quality Initiative (VQI). It aims to foster an understanding of quality processes and metrics through mentorship in the VQI, in collaboration with the Association of Pro­gram Directors in Vascular Surgery (APDVS), American College of Cardiology (ACC) and Society for Vascular Medicine.

Participants and mentors use clinical performance data from the VQI registries to enable trainees to learn about quality improvement in healthcare. Each trainee works on projects involving either health services and outcomes research or quality improvement, all designed to improve patient health outcomes.

Adam Johnson, MD, chair of the VQI FIT Committee, looks beyond these current proj­ects and into the future. “What really excites me are the people in the program that we’re investing in, giving them skills they need to have a successful next project,” he said. These skills will help “build who they are as innovators and changemakers and help them become the next generation of leaders in vas­cular surgery.”

The 2024–25 FIT participants, (mentors), centers, and projects are:

Quality Projects

  • Lisa Vi (mentor Miranda Witheford), Uni­versity Health Network, Toronto, Canada; studying the impact of homelessness on vascular surgery
  • Chinmayee Pottie, (Matthew Corrierre), The Ohio State University, Columbus; how distance to a high-volume center, in­surance and primary care provider affect patients with severe late-stage aortic and peripheral arterial disease
  • Lindsey A. Olivere, (Michael Madigan), University of Pittsburgh Medical Center (UPMC); working on an institutional quality improvement project to establish a post-amputation care pathway in order to centralize and improve care delivery to amputees
  • Gabrielle Rieth (Matthew Corriere), The Ohio State University; utilizing throm­boelastography (TEG) to correct coagu­lopathy and improve patient outcomes in vascular surgery
  • Vinay Bhushan Lakki, (Abhishek Singh), Creighton University Medical Center, Omaha, Nebraska; implementing stan­dardized patient selection criteria for ca­rotid artery stenting
  • Ioannis Tsouknidas, (Robert Meisner), Lankenau Medical Center, Wynnewood, Pennsylvania; studying limb preserva­tion, including indications, techniques and results
  • Falen Demsas, (Nikolaos Zacharias), Mas­sachusetts General Hospital, Boston; ex­amining how to implement cul­turally competent surgical care practices to reduce disparities in surgical outcomes among un­derserved populations
  • Brandon Gaston, (Nikolaos Zacharias), Massachusetts General Hospital; performing a retro­spective head-to-head com­parison of frailty calculators for predicting outcomes, length of stay and post-surgery readmission

Research Projects

  • Guillermo Polanco Serra, (Pouya Ente­zami), Henry Ford Health, Detroit; eval­uating the effectiveness of novel endovas­cular treatments to hemodialysis salvage
  • Michael Chaney, ( Jason Ryan), Western Michigan University, Kalamazoo; eval­uating the association between Global Limb Anatomic Staging System (GLASS) scoring, and amputation-free survival and wound healing after isolated proximal en­dovascular intervention
  • Lara Lopes, (Ashley Vavra), Northwest­ern Memorial Hospital, Chicago; examin­ing the correlation between residence in limited food-access or low-income areas and outcomes following revascularization for PAD
  • Karan Chawla, (Matthew Blecha), Loyola Medical Center, Maywood, Illinois; exam­ining variation in thoracoabdominal aor­tic aneurysm repair (TAAA) and carotid interventions across institutions
  • Lorela Weise, (Matthew Blecha), Loyola University; examining the thoracic endo­vascular aortic repair (TEVAR)-complex aortic dataset to determine the efficacy of petticoat placement and its association with 30-day mortality
  • Angela Danielle Sickels, (Adam Beck), University of Alabama Medi­cal Center, Birmingham; evaluating the optimal threshold diameter in women’s elective AAAs
  • Menna Hegazi (Nii-Kabu Ka­butey), University of California, Irvine; evaluating the presence and clinical significance of vari­ous disparities in dialysis access
  • Isaac Naazie (Linda Harris), Buffalo Gen­eral Medical Center, New York; investigating the comparative effectiveness of treatment modalities, identifying predictors of adverse outcomes in vascular surgery
  • Irina Kanzafarova, (Michael Stoner) Uni­versity of Rochester, New York; studying outcomes of infrainguinal bypass surgery with simultaneous distal outflow endovas­cular intervention versus standard infrain­guinal bypass surgery
  • Justin Jay Bader, (Cassius Iyad Ochoa Chaar), Yale New Haven Hospital, Con­necticut; using patient databases and known predictive risk factors to design and build a model to predict the risk of post-contrast acute kidney injury depend­ing on volume of contrast given
  • Camila Guetter, (Marc Schermerhorn), Beth Israel Deaconess Medical Center, Boston; investigating the relationship be­tween diabetes mellitus and antidiabetic medications with changes in aneurysmal sac size post-endovascular aneurysm re­pair (EVAR) for AAA
  • Guarang Joshi, (Marc Schermerhorn), Thomas Jefferson University, Philadelphia; identifying the ideal off-the-shelf graft for promoting the best outcomes in endovas­cular repair for ruptured AAA

In addition, past participants also received the Jack. L. Cronenwett Quality Improve­ment Scholarship Awards to continue re­search and/or work more closely with VQI/ PSO staff and committees. The scholarship is named for Dr. Jack L. Cronenwett, the VQI registry’s co-founder, vascular surgeon and educator. He is professor of surgery emeritus at Dartmouth-Hitchcock Medical Center, was professor of the Dartmouth Center for Health Care Policy and Clinical Practice for nearly 34 years and is chief medical officer for Fivos, VQI’s data management partner.

Scholars named

Five vascular trainees have been selected as FIT Scholars for 2024–25. The safety pro­gram is part of the VQI. They are:

  • Christine Kariya (Danny Bertges), Uni­versity of Connecticut, Farmington; im­plementing patient-reported outcomes (PRO) for better understanding of out­comes in endovascular treatment of PAD and venous care in women with varicose veins, particularly in underserved popu­lations
  • Mitri Khoury (Nikolaos Zacharias), Uni­versity of Arizona, Tuscon; refining the PSO definition of “medically unfit” using registry information and major adverse outcomes to help determine treatment plans
  • Christopher Chow (Arash Bornack), University of Miami, Florida; evaluating outcomes of carotid artery stenting in pa­tients with uncommon conditions such as variant aortic arch anatomy or patients with primary carotid artery dissection
  • Mikayla Lowenkamp (Michael Madigan), UPMC; smoking cessation and medical management in vascular diseases, in­cluding developing educational materials and integrating tobacco specialists into outpatient clinics
  • Saranya Sundaram (Thomas Brothers), Medical University of South Carolina; tracking carotid endarterectomies and outcomes after new quality improvement measures were implemented, including data on the ease of use of the measure at the six- and 12-month marks
  • Amanda Filiberto (Adam Beck), Univer­sity of Alabama at Birmingham; study­ing data and outcomes to ascertain if the VQI’s definition of acute kidney injury after surgery should be changed to align with the updated national definition

Learn more about the FIT Program and its participants at vqi.org.

Vascular Research Initiatives Conference abstracts due

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Vascular Research Initiatives Conference abstracts due

Abstracts for the 2025 Vascular Research Initiatives Conference (VRIC) are being accepted through Nov. 20.

VRIC, which is held in Baltimore, Maryland, this year, emphasizes the exchange of basic and translational vascular science that stimulates thoughtful discussion and motivates participants to discover solutions to important problems affecting vascular patients. It brings together vascular surgeons, vascular biologists and physicians with an interest in vascular problems, vascular surgery and research trainees.

The conference will be held on Tuesday, April 22, in conjunction with the American Heart Association’s Vascular Discovery 2025 Scientific Sessions: From Genes to Medicine.

Abstract submissions will be accepted through the Vascular Discovery abstract portal. To submit an abstract to VRIC, individuals will need to create a free account with the American Heart Association, or sign into their previously existing account. There is a non-refundable fee to submit an abstract to VRIC and/or Vascular Discovery. The fee allows researchers to submit one abstract to one or both meetings.

Any trainees who submit an abstract for VRIC will be automatically considered for the 2025 VRIC Trainee Award. Visit vascular.org/VRIC25 to learn more.

Regional societies see presidential changing of the guards

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Regional societies see presidential changing of the guards

Brajesh K. Lal, MD, assumed the Eastern Vascular Society (EVS) presidency during the 2024 EVS annual meeting. He took over from Kathleen Ozsvath, MD.

Patrick Muck, MD, assumed the reins of the Midwestern Vascular Surgical Society (MVSS) at the conclusion of the 2024 MVSS annual meeting, succeeding Bernadette Aulivola, MD,.

Ahmed Abou-Zamzam Jr., MD, has taken over as the 2024–25 president of the Western Vascular Society (WVS) following the conclusion of the society’s 2024 annual meeting. He was passed the presidential gavel by Roy Fujitani, MD.

During the EVS annual meeting, meanwhile, members of the society, staged a successful day of service in the heart of the downtown Charleston community.

Several senior society members and advanced practice providers were joined by representatives of industry partners on the evening of Friday, Sept. 20, at a community center where they performed screenings for peripheral arterial disease (PAD), handed out free compression stockings as part of an effort to address awareness of venous disease, and sought to educate local residents on the signs and symptoms of both venous and arterial conditions.

The event was held in conjunction with the American Venous Forum (AVF) and the Medical University of South Carolina.

SVS unveils latest round of members to become Distinguished Fellows

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SVS unveils latest round of members to become Distinguished Fellows
SVS President Matthew Eagleton, MD

The Society for Vascular Surgery (SVS) has welcomed 11 surgeons to its ranks of Distinguished Fellows. The new fellows have distinguished themselves by making sustained and substantial contributions to the Society, said current SVS President Matthew Eagleton, MD, himself a fellow. “Becoming a Distinguished Fellow is an honor based on longstanding efforts in research, service, and/or educa­tion,” Eagleton said. “Applicants typically have broad recog­nition of their excellence and competence and significant service to the SVS.”

The 2024 group of honorees are listed as follows: Rana Afi­fi, MD, University of Texas Health Science Center at Hous­ton, Texas; Jayer Chung, MD, Baylor College of Medicine, Houston; Gert de Borst, MD, University Medical Center, Utrecht, the Netherlands; Chelsea Dorsey, MD, University of Chicago Medical Center; Sukgu Han, MD, University of Southern California in Los Angeles; Karen J. Ho, MD, Northwestern Medicine Feinberg School of Medicine in Chicago; Shang Loh, MD, University of Pennsylvania, Perelman School of Medicine, in Philadelphia; Nicolas Mouawad, MD, McLaren Bay Heart and Vascular in Bay City, Michigan; Elina Quiroga, MD, University of Washington in Seattle; Bjoern Suckow, MD, of Dart­mouth Hitchcock Medical Center, Lebanon, New Hampshire; and Gabriela Velazquez, MD, Wake Forest University School of Medicine, Winston-Salem, North Car­olina.

Active, International and Se­nior SVS members may sub­mit applications to become a Distinguished Fellow, denot­ed as DFSVS after a surgeon’s name, by March 1 of every year.

CEA ‘remains useful and relevant’ in era of improving medical therapy

By
Jamie Bell
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CEA ‘remains useful and relevant’ in era of improving medical therapy

Findings from a retrospective analysis delivered at the recent European Society for Vascular Surgery (ESVS) annual meeting (Sept. 24–27) in Kraków, Poland, provide evidence that—for symptomatic carotid artery stenosis patients—endarterectomy “remains a useful and relevant intervention in the era of improving medical therapy.”

Presenter Sashini Iddawela, MBBS, from University College London Hospital NHS Trust in London, England, noted that urgent carotid endarterectomy (CEA) is currently the first-line recommendation for symptomatic, significant carotid stenosis. There is also speculation that symptomatic stenosis could be substantially reduced thanks to today’s advances in optimal medical therapy (OMT) and anti-major cardiovascular event (MACE) medications.

Iddawela and her colleague Daryll Baker, BMBCh, a consultant vascular surgeon at Royal Free London NHS Foundation Trust, undertook a study in an effort to determine whether or not patients undergoing CEA were already on OMT prior to their index admission. They performed a retrospective analysis of 124 patients receiving urgent CEA following development of a stroke or transient ischemic attack between 2021 and 2023. Overall, 36 patients (29%) were on a combination of an antiplatelet, antihypertensive and statin during their index presentation. According to the researchers, there was no significant difference between the proportion of patients on antiplatelets, antihypertensives or statins pre- versus post-CEA. However, patients with ischemic heart disease, diabetes or hypertension were observed as being significantly more likely to be on OMT.

This led to the conclusion that patients undergoing CEA are generally multimorbid and more likely to be on risk-modifying therapy at their index presentation. Thus, the researchers state that CEA should still be considered a useful intervention in these patients.

The top 10 most popular Vascular Specialist stories of October 2024

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The top 10 most popular Vascular Specialist stories of October 2024

In October, the most read stories from Vascular Specialist included a new leadership announcement from the American College of Surgeons (ACS); study results examining a potential link between strenuous physical activity and increased venous thromboembolism (VTE) risk in men; the publication of a new ebook to enhance vascular surgery education from The Association of Program Directors in Vascular Surgery (APDVS), and several more.

  1. APDVS launches vascular surgery curriculum e-book for medical students

The Association of Program Directors in Vascular Surgery (APDVS) has released a new ebook designed to enhance vascular surgery education for medical students. According to developers, the aim of The APDVS Medical Student Curriculum is to broaden the medical student’s clerkship curriculum, in line with the APDVS’s goal to provide a solid foundation in vascular sur­gery pathology and treatment.

  1. Smoking: BEST-CLI trial points to protective effect against MALE in those undergoing open bypass over endovascular intervention

An analysis of the BEST-CLI randomized controlled trial (RCT) found that smokers with chronic limb-threatening ischemia (CLTI) should be preferentially treated with open bypass over endovascular intervention.

  1. The CLTI conundrum: My spirited journey through the CLTI saga

Omid Jazaeri writes about what he refers to as “The CLTI conundrum”, exploring his weekly experience with “misadventures” in chronic limb threatening ischemia (CLTI)

  1. The Shockwave E8 experience: Featuring the new Shockwave peripheral IVL workhorse

Paul J. Foley III, MD, a vascular surgeon and director of the non-invasive vascular lab at Doylestown Hospital in Doylestown, Pennsylvania, and adjunct associate professor of surgery at the University of Pennsylvania in Philadelphia, discusses the virtues of the new Shockwave E8 IVL catheter.

This advertorial is sponsored by Shockwave Medical.

  1. Research suggests potential link between strenuous physical activity and increased VTE risk in men

Published in the Journal of Thrombosis and Thrombolysis, new research with a follow-up of 27 years has found an association between high levels of physical activity (PA) and an elevated risk of venous thromboembolism (VTE).

  1. A team sport: A prescription for the future of vascular surgery

Outgoing Eastern Vascular Society (EVS) President Kathleen Ozsvath, MD, used her presidential swansong to address the needs of those practicing the specialty moving forward, combining themes of family, collaboration, and diversity, equity and inclusion.

  1. VenaCore device offers long-awaited interventional solution for challenging venous occlusions

Managing venous obstruction and the associated symptoms at its initial onset remains a challenge for interventionalists. However, as Steven D. Abramowitz, MD, chair and director of vascular surgery for MedStar Health in Washington, D.C., says, a new technology—the VenaCore™ thrombectomy catheter (Inari Medical)—might be able to “change the care algorithm” for patients burdened by the long-term complications of venous obstruction.

This advertorial is sponsored by Inari Medical.

  1. Bioprosthetic venous valve imparts sustained clinical improvement at one year regardless of CEAP category

A new paper that drills into the impact of a novel bioprosthetic venous valve replacement by CEAP (Clinical, Etiological, Anatomical and Pathophysiological) classification shows sustained clinical improvement regardless of grading, with patients classed as C4b exhibiting greater resolution of symptoms and quicker ulcer healing within the first three months after implantation than those with more advanced disease.

  1. CEA: The importance of doctor-patient conversations about quitting smoking for better stroke outcomes in setting of asymptomatic stenosis

A new analysis that shows current smokers who undergo carotid endarterectomy (CEA) for asymptomatic carotid stenosis are at increased risk of long-term stroke and death compared to former or never smokers helps reinforce the importance of physicians talking to patients about quitting their smoking habit.

  1. Former SVS president named ACS president-elect

The American College of Surgeons (ACS) elected Anton N. Sidawy, MD, as president-elect during the ACS annual business meeting on Oct. 22. He served as president of the Society for Vascular Surgery (SVS) in 2010.

Endologix announces 36-month results of DETOUR2 study

By
Jocelyn Hudson
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Endologix announces 36-month results of DETOUR2 study
Sean Lyden presents at VIVA 2024
Sean Lyden presents at VIVA 2024

Endologix has announced the final 36-month results from the DETOUR2 study—a prospective, single-arm, international, multicentre clinical evaluation of the novel Detour system for fully percutaneous femoropopliteal bypass procedures. 

A press release details that the findings highlight the durable efficacy of the Detour system, which is comparable to open bypass with a synthetic graft. Additionally, the low rates of complications and deep vein thrombosis (DVT) demonstrate the favourable safety profile of this novel technique.

Endologix notes that the Detour system offers a unique approach to treating complex peripheral arterial disease (PAD), enabling physicians to percutaneously bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein to restore blood flow to the leg. The Detour system is comprised of the Endocross device and Torus stent grafts.

The 36-month results from the study were presented during a late-breaking clinical trials session at VIVA 2024 (3–6 November, Las Vegas, USA) by one of the study’s principal investigators, Sean Lyden (Cleveland Clinic, Cleveland, USA). “These extended results from the DETOUR2 study help continue to demonstrate using the Detour system is comparable to surgical bypass but without requiring general anaesthesia, which can come with additional complications and longer length of stay,” said Lyden.

“The 36-month data from the DETOUR2 study underscore the potential of the Detour system to significantly impact the treatment paradigm for long segment SFA disease,” said Matt Thompson, president and chief executive officer of Endologix. “We are confident in the Detour system’s ability to offer a less invasive, effective alternative for patients with challenging femoropopliteal lesions. As we move forward, our focus remains on ensuring optimal patient outcomes through rigorous training, ongoing data collection, and the PTAB-1 postmarket study to further validate these results in real-world settings.”

The DETOUR2 study enrolled 202 patients at 32 sites, and 200 patients were treated with the Detour system. The mean lesion length was 32.7cm, 96% were chronic total occlusions (CTO), and 70% were severely calcified.

The results presented highlight:

  • Freedom from clinically driven target lesion revascularisation was 66.8% through three years.
  • Primary patency was 58.2% through 36 months.
  • Clinical success, defined as improvement in at least one Rutherford category at 36 months, was 96.7%.
  • Freedom from symptomatic DVT was 95.9% at 36 months.
  • Freedom from major lower limb amputation was 98.5% at 36 months.
  • Average length of hospital stay was 1.1 days.

New analysis shows patients treated with Penumbra’s CAVT technology for PE utilize fewer hospital resources

By
Jocelyn Hudson
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New analysis shows patients treated with Penumbra’s CAVT technology for PE utilize fewer hospital resources
Parag Patel presents at VIVA 2024
Parag Patel presents at VIVA 2024

Penumbra has announced new data that demonstrate patients with intermediate-risk pulmonary embolism (PE) treated with Penumbra’s computer-assisted vacuum thrombectomy (CAVT) technology have a shorter length of hospital stay, shorter post-procedure length of stay and fewer complications when compared to other treatment options. Additionally, in-hospital mortality was low with CAVT, with no significant difference between treatment options. The late-breaking study was presented at VIVA 2024 (3–6 November, Las Vegas, USA).

“This first-of-a-kind analysis demonstrates that patients treated with CAVT utilised fewer hospital resources,” said Parag Patel (Froedtert Hospital, Milwaukee, USA), who presented the data. “These findings, as well as recent studies which show CAVT’s positive impact on patient outcomes, strongly showcase the significant benefits of CAVT over other treatment options for PE. We will continue to see the growing adoption of CAVT as a frontline therapy given the notable beneficial impact on patients and the overall health system.”

The retrospective study utilized the Vizient Clinical Data Base to identify 2,060 adult inpatients with intermediate-risk PE. This rigorous 1:1 propensity score-matched analysis included resource use and health outcomes among patients in the USA treated with Penumbra’s Lightning Flash or Lightning 12 technology compared to patients in the USA treated with anticoagulation, catheter-directed thrombolysis or other mechanical thrombectomy devices.

When compared to other modalities studied, the data showed that CAVT resulted in 25–35% shorter total hospital length of stay, 25–30% higher average rate of patients discharged home, and two to three times fewer average composite complications.

In the study, CAVT was associated with improvement in contribution margin relative to anticoagulation alone. An example given was that if 10% more patients are treated with CAVT, hospitals could see up to a 75% gain in profitable contribution margin, representing thousands of US dollars more per patient compared to treatment with anticoagulation alone. These data were presented separately in a symposium during VIVA 2024.

Shockwave Javelin peripheral IVL catheter meets prespecified efficacy and safety performance goals in feasibility and IDE studies

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Jocelyn Hudson
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Shockwave Javelin peripheral IVL catheter meets prespecified efficacy and safety performance goals in feasibility and IDE studies
Shockwave Javelin peripheral IVL catheter

Shockwave Medical, part of Johnson & Johnson MedTech, has announced the first clinical outcomes associated with the Shockwave Javelin peripheral intravascular lithotripsy (IVL) catheter, a novel, non-balloon-based lithotripsy platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral arterial disease (PAD).

A press release notes that the 30-day results met both prespecified performance goals while showing a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters. The results, which helped support US Food and Drug Administration (FDA) clearance of the technology last month, were presented as a late breaker at VIVA 2024 (3–6 November, Las Vegas, USA).

“The outcomes were exactly what we have come to expect from IVL studies—a strong safety profile with the low final residual stenosis that physicians would hope to achieve,” said JD Corl (The Christ Hospital, Cincinnati, USA), principal investigator of the FORWARD PAD study. “These initial data are promising and pave the way for a new approach to the application of Shockwave IVL in our peripheral practices. With technologies now suited to safely address both crossable and uncrossable lesions, IVL has a unique opportunity to play an increasingly important role in optimising outcomes for a wider set of patients with PAD.”

Corl reported at VIVA that the Shockwave Javelin peripheral IVL catheter met both prespecified safety and effectiveness endpoints, with a major adverse event rate of 1.1% at 30 days, and a technical acute procedural success rate of 99%. Additionally, at final angiography, angiographic complications were restricted to a single case of dissection with no reported perforations, abrupt vessel closure, distal embolisation or no-reflow.

The feasibility and investigational device exemption (IDE) studies of the Shockwave Javelin IVL catheter, MINI S and FORWARD PAD, respectively, were prospective, multicentre, single-arm, angiographic core-lab adjudicated studies with similar inclusion and exclusion criteria. The studies enrolled 90 patients with 103 heavily calcified, stenotic peripheral arterial lesions. The average lesion length was 77mm, and just under half of the target lesions were located below the knee, and over a third were chronic total occlusions.

“Recognising the risks that patients with difficult-to-cross lesions are exposed to with other treatment modalities, we’re extremely optimistic about the role that Shockwave Javelin could play in offering an effective alternative crossing and treatment tool with a strong safety profile,” said Nick West, chief medical officer at Shockwave Medical. “We look forward to learning more about the performance of the Shockwave Javelin IVL catheter as we add to the ongoing trial follow-up data with a limited market release of the device in the coming months.”

Bolt Medical announces completion of RESTORE ATK and RESTORE BTK pivotal studies investigating Bolt IVL system

By
Jocelyn Hudson
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Bolt Medical announces completion of RESTORE ATK and RESTORE BTK pivotal studies investigating Bolt IVL system
Thomas Zeller presents at VIVA 2024
Thomas Zeller presents at VIVA 2024

Bolt Medical has announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the company’s Bolt intravascular lithotripsy (IVL) above-the-knee (ATK) and below-the-knee (BTK) systems for the treatment of peripheral arterial disease (PAD) in patients with moderate to severe calcified lesions.

Thomas Zeller (University Heart Centre Freiburg-Bad Krozingen, Bad Krozingen, Germany) presented the data from both studies in a late-breaking clinical trials session at VIVA 2024 (3–6 November, Las Vegas, USA).

RESTORE ATK enrolled 95 patients in the prospective, single-arm trial designed to assess the safety and efficacy of the Bolt IVL system in the superficial femoral and popliteal arteries. The study was led by principal investigator Marianne Brodmann (Medical University of Graz, Graz, Austria).

The primary safety endpoint of the trial was freedom from major adverse events (MAE) within 30 days following the index procedure. The primary efficacy endpoint was procedural success, defined as residual diameter stenosis <50%. Through 30 days, there were no reports of MAE including severe dissection, perforation, or unplanned target limb major amputation and no clinically driven target lesion revascularisation supporting the achievement of both the primary safety and efficacy endpoints in the trial.

RESTORE BTK is a prospective, single-arm trial designed to assess the safety and efficacy of the Bolt IVL system in 20 enrolled patients with moderate to severe calcified infrapopliteal arteries. The study was conducted at three centres across Europe and led by principal investigator Michael Lichtenberg (Arnsberg Clinic, Arnsberg, Germany).

The primary safety endpoint of the trial was freedom from MAE within 30 days following the index procedure. The primary efficacy endpoint was procedural success, defined as acute reduction in percent diameter stenosis of the target lesion. Through 30 days, there were no reports of MAE including severe dissection, perforation, or unplanned target limb major amputation and no clinically driven target lesion revascularisation supporting the achievement of both the primary safety and efficacy endpoints in the trial.

“The patients treated in the RESTORE BTK trial presented challenges to traditional IVL therapy. The improved deliverability and crossability of the Bolt IVL catheter accessed complex lesions with ease. Moreover, the visible emitters on the Bolt IVL catheter provided me with the ability to directly focus acoustic energy on areas of persistent calcification,” said Lichtenberg in a Bolt Medical press release.

“The Bolt team is proud to accomplish these major clinical milestones with the completion of both the RESTORE ATK and RESTORE BTK pivotal trial,” said Keegan Harper, chief executive officer of Bolt Medical. “Bolt IVL is positioned to expand the peripheral market and advance patient care as the company plans regulatory submissions for both peripheral devices in the near future.”

Bolt Medical notes that the data presented at VIVA 2024 will be used to support US Food and Drug Administration (FDA) and CE mark regulatory submissions.

Two-year LIFE-BTK data show sustained benefits of drug-eluting resorbable scaffold for below-the-knee arteries

By
Jocelyn Hudson
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Two-year LIFE-BTK data show sustained benefits of drug-eluting resorbable scaffold for below-the-knee arteries
Brian DeRubertis presents at VIVA 2024
Brian DeRubertis presents at VIVA 2024

Presented today, late-breaking data from the second year of the LIFE-BTK clinical trial demonstrate the long-term effectiveness of the US Food and Drug Administration (FDA)-approved Esprit BTK everolimus-eluting resorbable scaffold system (Abbott Vascular) in patients with the most severe form of below-the-knee (BTK) peripheral arterial disease (PAD). The data show that the Esprit BTK offers sustained benefits over balloon angioplasty with fewer repeat procedures at two years.

The LIFE-BTK trial evaluated the Esprit BTK in more than 260 patients worldwide with BTK PAD, comparing treatment with the Abbott device to balloon angioplasty—the current standard of care. Following the presentation of one-year results at TCT 2023 (23–26 October, San Francisco, USA), two-year results were revealed during a late-breaking data session at VIVA 2024 (3–6 November, Las Vegas, USA).

“PAD is a dangerous condition that is complex to treat, with limited approved treatment options,” said Brian DeRubertis (New York Presbyterian–Weill Cornell Medical Center, New York, USA), presenter and one of the principal investigators for the trial, in a press release announcing the results. “Abbott’s Esprit BTK system offers a new option for treating people with the most severe forms of PAD, helping to heal blood flow and potentially salvage limbs.”

Results after two years of the LIFE-BTK clinical trial showed that 90.3% of patients in the Esprit BTK arm did not require a reintervention at 24 months. The trial also showed sustained efficacy at 24 months.

Furthermore, compared to balloon angioplasty, patients treated with Esprit BTK had significantly greater freedom from chronic limb-threatening ischaemia (CLTI), at 61.5% vs. 32.8%.

Additionally, at one year, the trial’s powered secondary endpoints revealed that Esprit BTK had a higher rate of reducing vessel re-narrowing (35.2% improvement) compared to balloon angioplasty.

Alongside the announcement of these results, Abbott also shared that it has launched the Esprit BTK post-approval study (PAS) to assess the continued safety and effectiveness of Esprit BTK in treating CLTI patients in a real-world setting. The first patient was enrolled by Bernardino L Rocha (SSM Health Heart & Vascular Care, Oklahoma City, USA).

First patient enrolled in study of integrated laser atherectomy and IVL catheter

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First patient enrolled in study of integrated laser atherectomy and IVL catheter

Royal Philips has announced enrolment of the first patient in the US THOR IDE clinical trial, which will study an innovative combined laser atherectomy and intravascular lithotripsy (IVL) catheter.

Procedures that previously required the use of two different devices can now be performed in a single procedure using a single device, simplifying workflows and procedures and potentially reducing the risk and improving outcomes for patients who might otherwise face multiple complex interventions, Philips says in a press release.

The Cardiovascular Institute of the South in Louisiana recently completed the first case using the new laser catheter. The care team there successfully treated a 78-year-old male with peripheral vascular disease using the Philips device.

“Developing and driving clinical evidence is crucial to improving care and guiding the adoption of new technologies like the Philips laser atherectomy and lithotripsy system,” said Craig Walker and McCall Walker (both Cardiovascular Institute of the South, Louisiana, USA). “This trial will provide essential data to demonstrate how this combined approach can optimise procedural efficiency and patient outcomes in treating challenging calcified lesions.”

The goal of this pivotal study is to evaluate the safety and efficacy of using this unique laser device, integrating laser atherectomy and IVL in a single device to treat complex, calcified lesions in a single procedure for patients with peripheral artery disease (PAD), restoring blood flow to their legs.

The prospective, single-arm, multicentre study will enrol up to 155 patients at up to 30 sites in the USA. Conducted under an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), it will assess the system’s safety and effectiveness in achieving procedural success with a low rate of complications.

The study’s primary endpoints include freedom from major adverse events (MAEs) such as mortality, unplanned amputations, and clinically driven target lesion revascularisation (CD-TLR) within 30 days (about four and a half weeks) of the procedure, as well as achieving less than or equal to 50% residual stenosis post-procedure. Patients will be followed for 12 months.

“This innovative approach to vessel preparation could improve patient outcomes while minimising the need for multiple therapies and interventions. That makes this an exciting innovation milestone as we enroll the first patient in this important US clinical trial,” said Elizabeth Genovese (University of Pennsylvania, Philadelphia, USA), co-principal investigator of the THOR trial at the Penn Advanced Limb Preservation Hospital. “Integrating atherectomy and intravascular lithotripsy into a single device has the potential to revolutionise the treatment of patients with complex femoropopliteal lesions associated with moderate to severe calcifications.”

Stacy Beske, business leader, Philips Image Guided Therapy Devices, added: “A result of Philips’ extensive in-house innovation and development capabilities, our combined laser atherectomy and intravascular lithotripsy device reflects our commitment to providing physicians with the tools they need to tackle complex vascular challenges more efficiently and effectively, potentially transforming treatment paradigms for peripheral artery disease.  Philips is dedicated to clinically validating its innovations through rigorous trials and does so in collaboration with strong clinical partners.”

The Philips laser atherectomy and intravascular lithotripsy system is currently investigational and not yet commercially available anywhere in the world, including the USA.

FDA grants R3 Vascular IDE approval for ELITE-BTK pivotal trial of Magnitude drug-eluting bioresorbable scaffold

By
Jocelyn Hudson
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FDA grants R3 Vascular IDE approval for ELITE-BTK pivotal trial of Magnitude drug-eluting bioresorbable scaffold
R3 Vascular
Eric Secemsky is lead investigator for the ELITE-BTK pivotal trial

R3 Vascular today announced that the Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of the next-generation Magnitude drug-eluting bioresorbable scaffold for below-the-knee (BTK) peripheral arterial disease (PAD). 

“We are pleased to have FDA approval for our ELITE-BTK pivotal trial, thus allowing enrolment to begin for our next-generation Magnitude scaffold. This will enable R3 Vascular to follow-up on our positive first-in-human RESOLV1 study data, which demonstrated excellent and promising results with 96% patency by DUS [Duplex ultrasound scanning] at six months,” said Christopher M Owens, president and chief executive officer of R3 Vascular. “Initiation of this trial will begin in Q1 2025 and will be conducted at up to 60 global clinical sites with 264 subjects, and upon favourable conclusion will allow the company to complete and pursue a PMA [premarket approval] application for Magnitude with the FDA.”

R3 Vascular notes that Magnitude is a next-generation bioresorbable scaffold with the potential to address one of the greatest needs for patients suffering from chronic limb-threatening ischaemia (CLTI) due to below-the-knee PAD.

“R3 Vascular’s novel bioresorbable scaffolds are made from a unique, ultra-high molecular weight polylactic acid polymer. This polymer, combined with the company’s scaffold design and proprietary processing technology allow the sirolimus-coated scaffolds to be thinner, stronger, and more flexible even at larger diameters and longer lengths,” a company press release reads. “R3 Vascular scaffolds are specifically engineered to ensure that they gradually and predictably absorb into the tissue, leaving nothing behind and enabling a more naturally functioning vessel.”

Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA), lead investigator for the ELITE-BTK pivotal trial, said in the press release: “This is a much-anticipated trial given the advancements and advantages of this next-generation technology, which has the potential to transform the field of peripheral interventions. We look forward to evaluating the impact of Magnitude on patient outcomes and its ability to meet this growing clinical need.”

In May of 2024 R3 Vascular announced the closing of its US$87 million Series B financing round to support the ELITE-BTK IDE pivotal trial as well as additional research and development, global regulatory submissions, scale up of manufacturing processes, and initial commercialisation.   

TCT 2024: Drug-eluting resorbable scaffold proves cost effective at one year in LIFE-BTK analysis

By
Jocelyn Hudson
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TCT 2024: Drug-eluting resorbable scaffold proves cost effective at one year in LIFE-BTK analysis
Sahil Parikh presents at TCT 2024
Sahil Parikh presents at TCT 2024

A retrospective economic analysis of the LIFE-BTK trial has demonstrated the one-year cost-effectiveness of an everolimus-eluting resorbable scaffold over angioplasty for the treatment of infrapopliteal artery disease, with investigators predicting more significant results in the longer term.

Sharing this finding at TCT 2024 (27–30 October, Washington, DC, USA), LIFE-BTK co-principal investigator Sahil Parikh (Columbia University Irving Medical Center, New York, USA) highlighted a “significant difference” in terms of one-year cost-effectiveness in favour of the Esprit BTK resorbable scaffold (Abbott Vascular) over angioplasty using a “relatively modest” willingness-to-pay threshold.

These data come one year after the presentation and simultaneous publication of first results from the LIFE-BTK trial, which enrolled 261 patients globally at 50 sites. The headline finding, Parikh summarised, was that 74.5% of the Esprit BTK group achieved a composite endpoint of limb salvage and primary patency versus 43.7% of the angioplasty group.

With these data in hand, the LIFE-BTK leading investigators—namely Parikh, Ramon Varcoe (Prince of Wales Hospital and University of New South Wales, Sydney, Australia) and Brian DeRubertis (New York Presbyterian–Weill Cornell Medical Center, New York, USA)—set out to perform a cost-effectiveness analysis.

The investigators considered the costs of index procedure and follow-up visits (inpatient, outpatient and office), as well as the incremental cost-effectiveness ratio (ICER)—defined as the difference in total costs divided by the difference in primary endpoint failure or clinically driven target lesion revascularisation (CD-TLR).

At TCT 2024, Parikh shared that index costs were not statistically significant between the Esprit BTK and angioplasty groups, and that follow-up costs were similarly well matched. “The total difference in costs was modest,” he said, citing a gap of less than US$2,000 between the two groups.

The presenter continued that, “using the most conservative delta between the two groups in terms of the primary efficacy endpoint at 365 days, not inclusive of the treatment window”, the Esprit BTK scaffold costs an additional US$7,086 per primary efficacy endpoint avoided.

This led Parikh to report that the Esprit BTK scaffold achieves a 64% probability of cost-effectiveness at a US$10,000 willingness-to-pay threshold compared to angioplasty. As a result of this, he averred: “The use of Esprit BTK at one year alone is likely to be cost effective.”

The presenter went on to note that that Esprit BTK scaffold costs an additional US$22,163 per CD-TLR avoided.

Parikh summarised that the Esprit BTK scaffold shows proven benefit in delaying the need for repeat revascularisation in patients with below-the-knee (BTK) disease and that cost-effectiveness is “likely to increase over time if the reduction of TLR remains consistent over time”.

Additionally, the presenter stressed that the Esprit BTK scaffold is the only US Food and Drug Administration-approved option for patients with chronic limb-threatening ischaemia (CLTI) and infrapopliteal artery disease.

Looking ahead, Parikh highlighted the upcoming presentation of two-year LIFE-BTK results, which DeRubertis is set to announce this week at VIVA 2024 (3–6 November, Las Vegas, USA).

CMS grants transitional pass-through payment for Medtronic’s Symplicity Spyral and Recor’s Paradise renal denervation systems

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Jocelyn Hudson
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CMS grants transitional pass-through payment for Medtronic’s Symplicity Spyral and Recor’s Paradise renal denervation systems

The Centers for Medicare and Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for Medtronic’s Symplicity Spyral renal denervation (RDN) catheter and Recor Medical’s Paradise ultrasound RDN (uRDN) system, according to press releases from the two companies.

TPT payment, which will be effective for up to three years beginning 1 January 2025, aims to support patient access to new and innovative technology.

Symplicity Spyral

Approved by the US Food and Drug Administration (FDA) in November 2023, Medtronic‘s Symplicity Spyral RDN system is a minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure.

“Receiving TPT approval for our RDN catheter is an important milestone for the Symplicity blood pressure procedure, as it will enable greater patient access to a breakthrough treatment by reducing cost barriers for healthcare systems,” said Jason Weidman, senior vice president and president of the coronary and renal denervation business within the cardiovascular portfolio at Medtronic, in a company press release. “Very few technologies achieve this qualification, and the core goals of fostering innovation and increasing access mirror Medtronic’s desire to continue bringing Symplicity to even more patients suffering from uncontrolled high blood pressure. We look forward to continuing to work with CMS to establish coverage and expand patient access.”

Supporting TPT approval is the Medtronic SPYRAL HTN Global clinical programme, which the company claims is the most comprehensive clinical programme studying RDN in the presence and absence of medication, and in patients with both high and lower baseline cardiovascular risk.

Medtronic advises that the Symplicity Spyral RDN system is approved for commercial use in more than 75 countries around the world and is backed by experience in more than 25,000 patients treated globally with the Symplicity blood pressure procedure. The Symplicity Spyral RDN system is limited for investigational use in Japan.

Paradise

A press release from Recor Medical and its parent company, Otsuka Medical Devices, notes that the Paradise uRDN system is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.

The release details that, in approving the TPT, CMS created a distinct device category and code (C1736: Catheter Renal Denervation, Ultrasound) for uRDN in recognition of the differentiated technology and procedure with the Paradise uRDN system.

“TPT for ultrasound renal denervation increases access to a proven device-based hypertension treatment option to patients who have been unable to achieve blood pressure control with lifestyle changes and medications alone,” said Lara Barghout, president and chief executive officer of Recor Medical, in the company’s press release. “The granting of TPT highlights the safety and efficacy of this breakthrough device, which together demonstrated that the Paradise uRDN system met the newness and significant clinical improvement criteria. By creating a distinct device category, CMS have also recognised that the Paradise uRDN system is a highly differentiated technology and that there are significant differences in comparison to other technologies available in the marketplace. This is a major step forward in the reimbursement available for the Paradise uRDN system, creating additional financial support for hospitals and physicians to provide this novel and effective therapy to their uncontrolled hypertension patients.”

Recor Medical advises that the FDA approved the Paradise uRDN system for the treatment of hypertension on 7 November 2023.

Education and representation at core of inclusivity efforts for DEI committee

By
Marlén Gomez
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Education and representation at core of inclusivity efforts for DEI committee
Photo by Dwight C. Andrews/The University of Texas Medical School at Houston Office of Communications Dr. Rana Afifi - Cardiothorasic and Vascular Surgery Surgery
Rana Afifi

The SVS Diversity, Equity and Inclusion (DEI) Committee continues to make strides in advancing inclusivity within the organization, with several projects underway to address both ongoing challenges and new opportunities.

The DEI Committee has seen considerable progress since its inception, following the transition from a task force to a standing committee, says Chair Rana Afifi, MD, who outlined upcoming initiatives, emphasizing the importance of education and representation in fostering an inclusive environment.

Afifi noted that the committee’s work is now informed by a comprehensive report that evaluates SVS progress in DEI efforts. The report highlights positive strides, but also underscores areas where work remains, she said.

One key area of focus is enhancing inclusivity within the committee itself. Afifi explained that certain demographics remain underrepresented.

One of the committee’s upcoming initiatives is an educational campaign designed to broaden understanding of DEI issues, not only in terms of race and ethnicity, but also factors like neurodiversity, ageism, and other social and structural determinants of health. The campaign will feature 20 microlearning modules, based on storytelling and practical, everyday scenarios.

“Education is key,” Afifi emphasized. “A lot of the sensitivity and resistance around DEI comes from misinformation and a lack of understanding.”

The first of these modules is expected to be piloted within the next two months, with full rollout anticipated within the year. Afifi expressed hope that these educational materials will facilitate more open and constructive conversations around DEI, moving away from the tense or sensitive nature that can often surround such discussions.

“The goal is not just to improve awareness but to make DEI an integral part of daily practice and patient care within the vascular surgery community,” Afifi said.

In addition to educational outreach, the DEI Committee is preparing for its third annual DEI Summit, scheduled for December. Although not yet open to the public, the summit aims to engage a broad range of vascular societies, both regional and international, in a unified effort to address DEI challenges. Afifi emphasized the importance of collaboration, noting that the committee is working closely with other SVS committees—such as the Vascular Annual Meeting (VAM) Committee—to ensure that DEI principles are integrated across various organizational efforts. “We are working in collaboration with other committees to ensure that DEI is not just a checklist but has actual impact and results,” Afifi said.

The committee has been actively involved in supporting SVS members who are working on DEI-related projects, offering guidance and assistance in publishing articles and developing educational resources.

One of the key challenges identified is improving racial and ethnic diversity within SVS membership. While the organization has seen a slight increase in diversity, Afifi acknowledged that this progress is not enough

“We need to be intentional about increasing diversity within the SVS, especially in leadership roles,” said Afifi. The committee has been working closely with the Appointments and Nominations committees to ensure that diverse candidates are considered for leadership positions, but more needs to be done to encourage members from underrepresented groups to apply.

“We can’t improve representation if we don’t have people applying for these roles,” Afifi pointed out. The committee is actively reaching out to affinity societies and exploring ways to remove barriers that may be preventing members from pursuing leadership opportunities.

As chair, Afifi has set several goals for her term, with education and increased representation at the forefront. She hopes that the new educational campaign will help dispel misconceptions about DEI and make it a more approachable topic within the SVS.

“I’m not naive enough to think we can solve everything, but I do hope we can move the needle and make some real progress,” said Afifi.

The committee is also focused on fostering collaboration between the various SVS sections, seeking ways to ensure that all are included in DEI discussions, possibly by appointing permanent liaisons from underrepresented groups.

The clash between mission and revenue for not-for-profit, tax-exempt hospitals

By
Bhagwan Satiani
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The clash between mission and revenue for not-for-profit, tax-exempt hospitals
Bhagwan Satiani

Hospitals represent one of the largest industries in the U.S., with revenues greater than $1.4 trillion. The American Hospital Association reports that there are 5,200 nonfederal, short-term general, and other special hospitals in the country, of which 3,000 are non-for-profits (NFPs), 1,300 for-profits (FPs), and about 1,000 state and local government organizations. About 60% of community hospitals are NFP entities and managed by a community board.

People use 501(c)(3) and NFP terms interchangeably, which they are not. The former are recognized by the Internal Revenue Service (IRS), a federal agency, as being tax-exempt because of their charitable programs under the tax code. Section 501(c)(3) of the code authorizes tax exemption for NFP organizations pursuing charitable, religious, educational or scientific missions. An NFP is usually organized as a corporation and designated as such by the state. NFP status does not automatically confer tax exemption.

Though not that many NFPs do not do so, but FPs must run lean, efficient organizations since they are also focused on providing a return on investment. Because they are tax-exempt, NFPs pay no tax on net income, state and local corporate income taxes, local property taxes, and sales tax on their purchases. These are taxable events for FPs. NFPs do not have shareholders and do not pay dividends, whereas FPs may do so. NFPs contend that they do generate taxable revenue through the likes of payroll taxes and taxes from non-patient care.

IRS

There are regulations common to all hospitals, but some apply only to 501(c)(3) and NFP hospitals. The IRS requires hospitals to report and describe “community benefits” as a percentage of hospital expenses. The tax benefits for NFPs in relation to providing community benefits hinge on an “open medical staff and ER [emergency room], regardless of ability to pay; community board of directors; caring for all patients covered by Medicare and Medicaid or ability to pay; and using surplus funds to maintain facilities, equipment and patient care, [and] advance medical training, research and education.”1

The IRS also requires all hospitals to file Schedule H of Form 990 and, though not required, to self-report compliance with “community benefits” activities every three years. However, there are no specific rules or definition of community benefit activities.

Should NFPs be required to provide community benefits in proportion to their tax-exemption benefits? This view recently gained favor after a study concluded that NFP hospitals do not provide more free care than other types of hospitals, and sometimes even less care than FP or government hospitals.2

How much benefit to hospitals is there?

A recent report suggested that 2,927 U.S. NFP hospitals received $37.4 billion in total tax benefits in 2021. These included “federal income tax ($11.5 billion; 31%), sales tax ($9.1 billion; 24%), property tax ($7.8 billion; 21%), state income tax ($3.7 billion; 10%), charitable contributions ($3.2 billion; 8%), bond financing ($2.1 billion; 6%), and federal unemployment tax ($200 million; <1%).”3 In 2020, a Senate committee reported that benefits averaged $9.4 million per hospital. Although some of the numbers may be flawed, the committee concluded that many of the largest NFP hospitals spend less than 2% of their total revenue on charity care. The Lown Institute Hospitals Index reported that 80% of NFP hospitals spent less on “financial assistance and community investment than the estimated value of their tax breaks.”4

The American Hospital Association declared that hospitals spent 15.5% of their total annual expenses in 2020 as benefits to the community, of which 6.9% was due to financial assistance and unreimbursed Medicaid and other programs.

Clearly, NFP and tax-exempt hospitals provide valuable and necessary services to the public, including funding critical research and revenue-losing inpatient programs such as behavioral health, nephrology, burns, pulmonology, and infectious diseases—often in inner city or rural communities where FP hospitals may not exist. Operating margins for NFPs have hovered between 1 and 3%.

Although hospital margins have been hit over the past few years, management consultants Kaufman Hall reported that, for the previous 12 months, hospital operating margins increased significantly. In April 2024, they went from <1% to 4.3% the previous month. This was primarily due to increasing volumes but also higher prices.

Compensation

Besides proportional community benefits, excessive compensation provided to senior NFP hospital executives is a major source of criticism. This is because the public accepts large sums for FP companies beholden to investors and shareholders, while the expectation for NFPs is the opposite.

On average, NFP hospital CEOs earn about $700,000, exceeding by $300,000 the salaries of university presidents. The Senate report stated that “in 2021, the most recent year for which data is available for all of the 16 hospital chains, those companies’ CEOs averaged more than $8 million in compensation and collectively made over $140 million.”

Excessive compensation for NFP hospital board members is also a concern. As an ex-officio board member at a large health system for four years in the early 1990s, little or no compensation was offered, even though we dedicated many hours before, during and after each board or sub-committee meeting. Most board members are productive citizens and own important businesses or have often high-paying jobs. Compensation for NFP board members has now become commonplace. The percentage of hospital boards offering cash compensation has doubled from 13% in 2018 to 27% in 2022, compared to only a 3% increase from 2014 to 2018. However, trustee compensation has sometimes been negatively associated with NFP hospital charity care provision. Even though board members, trustees and other insiders have a fiduciary responsibility towards the NFP entity, and are not permitted to benefit themselves or other insiders, my own experience is that, in many ways, they benefit from their presence and contacts.5

For-profit activities

Health systems are always looking for new revenue to subsidize losing service lines, new construction, ambulatory centers, administrative hiring, modern technology, litigation and the cost of new regulations. However, analysis of IRS data by Kaiser Health Network showed that NFP health systems “held more than $283 billion in stocks, hedge funds, private equity, venture funds and other investment assets in 2019.” Only 7% of their total investments were principally related to their nonprofit missions. The biggest concern is the substantial mergers and acquisitions of hospitals and physician groups by health systems and private equity investors.

Suggestions

There are several common-sense suggestions advanced by healthcare and legal experts. Congress needs to define exactly what constitutes community benefits to justify a hospital claiming NFP status. The Affordable Care Act required NFP hospitals to conduct community health needs assessments in their geographic area, which included seeking input from low-income, underserved areas. However, Congress did not take the next step and require hospitals to address these concerns. In addition, there are no precise and reasonable standards for what constitutes financial assistance to qualify under community benefits.

The IRS Form 990 listing filed by NFP hospitals lists, among other details, the community benefits they provide. This form is confusing and unclear, leading to partial and inexact data. For instance, hospitals often classify unreimbursed care for some patients as a bad debt expense, because many poor patients do not complete hospitals’ financial assistance processes. This form needs to be revised based on clarification of community benefits and standards for financial assistance. Form 990 could also report forgone federal, state and local taxes, as well as savings associated with using tax-exempt bonds, in the interests of complete transparency.

NFP hospitals are vital to healthcare delivery in the U.S. Tightening some regulations, clarification by Congress, and the recruitment of board members with a diversity of views and backgrounds6 will result in increased transparency and provide assurance to taxpayers that their hard-earned taxes are being used for the benefit of their communities.

References

  1. https://www.gao.gov/products/gao-23-106777
  2. Bai G, Zare H, Eisenberg MD, Polsky D, Anderson GF. Analysis suggests government and nonprofit hospitals’ charity care is not aligned with their favorable tax treatment. Health Aff (Millwood). 2021;40(4):629–636
  3. Plummer E, Socal MP, Bai G. Estimation of tax benefit of US nonprofit hospitals. JAMA. Published online September 26, 2024. doi:10.1001/jama.2024.13413
  4. https://lownhospitalsindex.org/hospital-fair-share-spending-2024/#system-deficit
  5. https://www.sanders.senate.gov/wp-content/uploads/Executive-Charity-HELP-Committee-Majority-Staff-Report-Final.pdf
  6. Satiani B, Prakash S. https://hospital-medical-management.imedpub.com/articles/%20it-is-time-for-more-physician-and-nursing-representation-on-hospital-boards-in-the-us.php?aid=9753

Bhagwan Satiani, MD, is an associate editor for Vascular Specialist. He is not an attorney.

Invisible ties: The unique journey that landed one medical student on vascular surgery rotation

By
Bailey Richardson
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Invisible ties: The unique journey that landed one medical student on vascular surgery rotation
Bailey Richardson
In the latest Corner Stitch column, medical student Bailey Richardson recounts the deeply personal life events that led to her unique journey into vascular surgery.

Despite requesting transplant for my third-year surgery rotation as a medical student, I got placed on vascular surgery. I remember sitting with my mama, debating if I should try to switch. Ultimately, I left it alone, letting fate decide. Fast forward to my second week on service, I heard the residents discuss a patient in the emergency department with a ruptured abdominal aortic aneurysm (AAA). Quickly, one of the MS4s and I searched the board, trying to figure out who it could be, in the hopes of getting to follow the case into the operating room (OR). When I saw my mentor’s name on the screen, my heart stopped; I felt empty. I rushed to the bay, only to find him in his neatly pressed blue-and-white stripped pajamas, smiling, and telling me that he was going to be “alright.” Despite developing a non-intervenable endoleak weeks after his life-saving operation, I will forever cherish the extra time I spent with him and his family prior to sending him home in his last days.

Meanwhile, in the midst of my mentor’s hospital stay, my grandmother was admitted for surgical treatment of her symptomatic AAA. Though her initial fenestrated endovascular aneurysm repair (FEVAR) was successful, her course was riddled with postoperative pseudoaneurysms requiring multiple take-backs. Frequent intubations, combined with her severe cardiopulmonary disease (COPD) and other comorbidities, ultimately resulted in a two-month stay in the cardiovascular intensive care unit (CVICU).

Those days were long, and, honestly, my own personal hell. I knew just enough in medicine at the time to understand her poor prognosis. Deep down, I knew that this was not the vascular team’s fault in any way, shape or form. Her outcomes were a perfect storm of poor overall health and, frankly, bad luck. She was the first person I watched die.

For a long time after losing both my mentor and grandmother, on a service that had piqued my interest, I was terrified to go near the team. I didn’t want to be looked at as the “poor medical student” who was involved with two recent deaths. Things improved as time went on, and my heart slowly shifted. I stopped looking at what I had lost and focused on what I had gained: insight and perspective. It wasn’t until my fourth year, on vascular surgery again, that I realized the invisible ties that had been there all along, pulling me to the field where I belong.

The patient population in vascular surgery is very special. They often have multiple comorbidities, requiring physicians to be technically advanced in both surgery and medicine. Growing up in a two-redlight town in rural South Carolina, I can easily relate to the stubborn and misunderstood population.

By pursuing this field, I will fulfill deep-rooted goals that I had not realized until my fourth year of medical school: patient continuity, medical complexity and innovation. I am blessed that, one day, I will get to see aspects of both my mentor and grandmother in my patients, thus reminding me of the magnitude of my duty as a future vascular surgeon.

Bailey Richardson is a fourth-year medical student at the Medical University of South Carolina in Charleston.

Endoscopic vein harvest under the microscope

By
Bryan Kay
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Endoscopic vein harvest under the microscope
Conflicting results open fresh debate around effect of vein harvesting technique on long-term patency of lower extremity bypass grafts.

Two separate analyses that looked at the impact made by the method used to harvest great saphenous vein (GSV) on the long-term patency of lower extremity arterial bypasses demonstrated markedly different results over the issue of whether open harvest was superior to the endoscopic approach.

One, a collaborative effort between the University of Iowa in Iowa City and Henry Ford Hospital in Detroit, was drawn from Vascular Quality Initiative (VQI) data and showed that a lower postoperative wound complication rate when performing endoscopic harvest of GSV over the open approach came at the expense of worse long-term patency outcomes. The other, from a research team at Wright State University in Dayton, Ohio, probed an institutional experience, reporting no significant difference in patency rates between the two techniques. Both sets of results were delivered at the 2024 Midwestern Vascular Surgical Society (MVSS) annual meeting in Chicago (Sept. 12–14).

The former, delivered by Mohamad Chahrour, MD, a vascular surgery resident at the University of Iowa and previously a general surgery resident at Henry Ford, won the John R. Pfeifer Best Venous Paper Award.

The use of endoscopic vein harvest for lower extremity bypass remains a contentious issue in vascular surgery over possible damage caused to the harvested GSV, with open harvest the preferred method in the absence of robust evidence favoring either technique.

Superiority of open approach?
Mohamad Chahrour

Amid this ongoing debate, Chahrour and colleagues sought to compare outcomes between the two approaches and determine whether there has been any improvement in endoscopic harvest outcomes over time.

They plumbed VQI lower extremity infrainguinal bypass registry data from 2011–2023, propensity matching 7,929 open harvest patients to 2,643 subjects who underwent endoscopic harvest.

Short-term outcome data revealed open harvest was associated with an increased rate of surgical site infection and higher length of stay, procedure time and estimated blood loss.

However, Chahrour told MVSS 2024, open harvest was superior in terms of both primary and secondary patency: At one-year follow-up, the primary patency rate was 71% for open vs. 65% for endoscopic harvest; secondary patency 90% vs. 85%; and major adverse limb events (MALE) 25% vs. 30%.

“We performed a subgroup analysis in which we looked at the outcomes based on the outflow target,” Chahrour said. “Endoscopic harvest was again associated with worse outcomes regardless of the target vessel, with almost 25–50% increased odds of loss of primary patency at one year.”

On the other hand, the analysis revealed that endoscopic harvest outcomes improved over time. Primary patency went from 59% in 2011, gradually increasing to reach 70% in 2020. “This could be due to advanced technologies in the new endoscopes or due to experience accumulated by the vein harvesters,” Chahrour said.

“When we compared outcomes based on technique by years, we saw that open was superior in the first half and became equivalent in the second half. We started with a 13% difference in patency in 2011 and, in 2020, we saw a difference of 3%, which was non-statistically significant. However, it is important to note that this comparison is between unmatched and unadjusted samples and that those findings should be analyzed with caution.”

Concluding, Chahrour said the study demonstrated endoscopic harvest’s association with improved short-term outcomes but “open vein harvest was associated with improved long-term outcomes, both with increased patency and increased limb salvage,” he said, adding: “Endoscopic vein harvest is improving with new technologies and more experience. We believe a repeat outcomes analysis will be needed to reflect those advances in the future.”

Conversely, no significant differences?
Justin Robbins

The analysis of Wright State University’s institutional experience, meanwhile, showed conflicting results. Presenting the data, Justin Robbins, MD, Wright State University’s chief general surgery resident, pointed toward endoscopic GSV harvesting’s mid- 1990s roots and now widespread use in coronary artery bypass grafting (CABG).

Studies exploring its applicability in lower extremity bypass grafting have so far produced mixed results, with some showing decreased patency and others reporting no change, Robbins said.

He highlighted a 2021 Journal of Vascular Surgery meta-analysis—which contained 12 comparative studies—that found “a significant decrease” in patency rates with endoscopic harvest.

“Of note, the last study that was conducted was in 2019, from a single center, and they found no difference in patency rates among the two groups [open and endoscopic], and they attributed this significantly to provider experience with endoscopic harvest,” Robbins said.

The Wright State University researchers sought to catalogue their institutional experience with endoscopic harvest and its impact on patency in light of their retention of a highly experienced vein harvester as part of their vascular surgery team.

The retrospective study encompassed 340 chronic limb-threatening ischemia [CLTI] patients undergoing infrainguinal bypass with GSV from 2013–2023—111 through open harvesting of the vein and 229 endoscopically. The experienced harvester, a physician assistant (PA) who spent two decades in cardiothoracic (CT) surgery, where the PA performed endoscopic harvesting for coronary bypasses, has been a part of the Wright State vascular team for seven years.

Robbins and colleagues found no difference in need for arterial surgery within one or five years, as well as no difference in need for amputation. “However, there was a significant difference in incision breakdown, 12% [for endoscopic harvest] vs. 21%; surgical site infection, 25% vs. 71%; and procedure duration, which was shorter by half an hour at least for endoscopic harvest.”

When looking at patency rates, Robbins said there was no difference between open and endoscopic harvest for primary, primary-assisted or secondary patency.

“We feel that, with experienced providers, endoscopic harvest can be a safe option for great saphenous vein harvest for lower extremity arterial bypass,” Robbins concluded. “However, it is unrealistic to believe that every vascular program can hire someone with 20 years endoscopic harvest experience.

“It’s important to collaborate with CT surgery groups in your institutions if this is something you want to do, because those providers are going to need the experience with short-segment harvest, where they can make those errors. With some of the previous CT surgery studies, they have shown that less experienced providers more likely injure at the junction of the ostium when they’re doing endoscopic harvest. In our group, we saw no effect on patency up to five years and decreased wound complications.”

Contradictory findings come under scrutiny

Jill Colglazier, MD, program director of the vascular surgery integrated residency at the Mayo Clinic in Rochester, Minnesota, who was a moderator of the MVSS session in which the Wright State paper was presented, asked Robbins if he was able to explain the apparent contradictions between the two studies.

Robbins said he had noted during Chahrour’s presentation the previous day that, “when [the University of Iowa-Henry Ford group] looked at [the VQI registry] patency rates, they also noted, as the years went on, that patency rate difference decreased, and they feel that could have been a possible correlation.”

At Wright State, on the other hand, the vascular surgery group used the same provider for each of their cases of endoscopic vein harvest for lower extremity bypass.

Alexander D. Shepard, MD, one of the University of Iowa-Henry Ford paper authors and a Henry Ford Health vascular surgeon, opined that the Wright State study was “a good example of what happens with increased operator experience,” but said he maintained a skepticism of endoscopic harvest. “I think it’s getting better and better, but my concern is with the marginal vein,” he added.

For his part, under questioning after presenting the VQI data, Chahrour tackled the issue of a vein harvester’s experience level. “Because the VQI doesn’t allow for that variable, how do you think you can mitigate that bias, since I think that is probably the number one determinant of the outcome?” he was asked by one attendee.

“For CABGs, there were two trials in the New England Journal of Medicine [NEJM] around 2009 that showed superior outcomes with open [harvest]; the only difference was in the REGROUP trial [looking at open vein harvesting for CABG] of 2019 [in which] they only allowed the experienced harvesters,” answered Chahrour. “So, the first take-home message from that was, if we are going to adopt an endoscopic vein harvest method, then we have to get the PAs to harvest the veins because they are more experienced.”

VAM 2025 abstract submission period set to open Nov. 6

By
Beth Bales
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VAM 2025 abstract submission period set to open Nov. 6
Jason Lee

Vascular surgeon-scientists may submit their research for presentation at the 2025 Vascular Annual Meeting (VAM) in June starting from Nov. 6 through Wednesday, Jan. 8, 2025. 

VAM research—both clinical and translational—is considered for presentation in several different forums that appeal to all attendees, from plenary presentations, rapid-fire talks, international and video sessions, poster competitions and more.

In 2024, there was a nearly record-breaking 794 abstracts submitted, with 407 finding space on the meeting’s program.

VAM 2025 will be June 4–7, 2025, returning to New Orleans  for the first time in several decades. Educational sessions will run across all four days and there will be ample opportunity for all to participate.

“Our best vascular surgical science is at the heart of the Vascular Annual Meeting,” particularly, the plenary and rapid-fire presentations, said Jason T. Lee, MD, the new chair of the SVS Program Committee, which selects the abstracts in a blinded process “VAM25 is where we will showcase the latest findings that influence care of patients with vascular disease, provide broad education to vascular surgeons and highlight the future of our specialty.”

The SVS Postgraduate Education Committee (PGEC), chaired by Claudie Sheahan, MD, is slated to offer sessions on topics including dialysis challenges, Enhanced Recovery after Vascular Surgery (ERAS), complex dissection care, vascular trauma and spinal cord ischemia.

Former SVS president named ACS president-elect

By
Marlén Gomez
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Former SVS president named ACS president-elect
Anton N. Sidawy

The American College of Surgeons (ACS) elected Anton N. Sidawy, MD, as president-elect during the ACS annual business meeting on Oct. 22. He served as president of the Society for Vascular Surgery (SVS) in 2010.

Sidawy is currently the Lewis B. Saltz chair and professor of surgery at The George Washington University School of Medicine and Health Sciences in Washington, D.C.

Sidawy’s career spans several decades and includes 180 peer-reviewed articles, 60 book chapters, and numerous national and international presentations.

He served as editor-in-chief of the Journal of Vascular Surgery (JVS), launching two additional titles: the Journal of Vascular Surgery-Venous and Lymphatic Disorders (JVS-VL) in 2013 and the Journal of Vascular Surgery-Cases, Innovations and Techniques (JVS-CIT) in 2015.

In addition to his editorial work, Sidawy has authored three influential textbooks, including Basic Science of Vascular Disease (1997), Diabetic Foot, Lower Extremity Arterial Disease, and Limb Salvage (2006), and the 9th and 10th editions of Rutherford’s Vascular Surgery and Endovascular Therapy, released in 2018 and 2022, respectively.

Sidawy has been an ACS fellow since 1987 and has played a key role in shaping the future of surgery. He has served on both the ACS Board of Governors (2001–2007) and the Board of Regents (2015–2024), including a term as chair of the Board of Regents from 2021–2022. Notably, he led a joint effort by the ACS and the SVS to establish the Vascular Verification Program (Vascular-VP).

In his upcoming term as president of the ACS, Sidawy envisions focusing on the well-being of fellows, the quality of surgical care, and improving the practice environment for surgeons. He remains deeply committed to the ACS’s mission to “heal all with skill and trust,” a vision he will continue to champion in his new role.

Surmodics announces early results from PROWL registry of Pounce thrombectomy system

By
Jocelyn Hudson
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Surmodics announces early results from PROWL registry of Pounce thrombectomy system

Surmodics has announced that early results of a subset of 60 real-world acute, subacute, and chronic limb ischaemia patients from its PROWL registry study were presented by Dean Ferrera (Powers Health, Munster, USA) at TCT 2024 (27–30 October, Washington, DC, USA).

PROWL is an open-label, retrospective, multicentre US registry of the Surmodics Pounce thrombectomy platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.

A press release details that the registry is collecting real-world efficacy and safety outcomes data for endovascular interventions using the fully mechanical, non-aspiration-based Pounce platform for up to 500 patients at up to 30 sites.

The core lab-adjudicated study is enrolling all patients treated with the Pounce platform, including those with shortened life expectancy, history of cancer or COVID-19, and those with prior interventions to the target limb.

Ferrera, on behalf of the PROWL investigators including national co-principal investigators Sean Lyden (Cleveland Clinic, Cleveland, USA) and Joseph Campbell (OhioHealth, Columbus, USA) presented results from the infrainguinal PROWL subset.

All patients in the 60-patient subset analysis were treated with the Pounce thrombectomy system, indicated for use in peripheral arteries 3.5–6mm in diameter. The analysis examined patients with symptomatic native, infrainguinal vessels, followed through 30 days.

Surmodics reports that procedural success, defined as restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment (patient level success), was 90%; nearly all (96.8%) patients experienced final post-procedural TIPI (thrombo-aspiration in peripheral ischaemia) 2–3 blood flow restoration; and technical success, defined as restoration of blood flow to the target lesion(s) with <50% residual obstruction without the need to initiate catheter-directed therapies or to proceed to open surgery or other endovascular thrombectomy devices (lesion-level success), was 80.8%.

Furthermore, the company shares that 49 of the 60 patients (81.7%) received no further thromboemboli removal treatment within 30 days post Pounce system use and that product use was well tolerated, with only one patient (1.7%) experiencing device-related adverse events.

Surmodics notes that previous studies of aspiration thrombectomy for symptomatic limb ischaemia excluded patients with symptom duration greater than 14 days or patients whose thrombi or emboli were not fresh. In the 60-patient PROWL cohort, however, 60% of patients presented with acute (≤14 days) limb ischaemia, 16.7% with subacute (15–28 days) limb ischaemia, and nearly one in four (23.3%) presented with chronic (>28 days) limb ischaemia. Forty patients (66.7%) in the 60-patient cohort avoided an intensive care unit (ICU) admission, while 49 (81.7%) were discharged home.

“Although patients with limb ischaemia often seek care acutely, many patients present after experiencing symptoms for several days or weeks,” said Campbell. “As a result, operators are often challenged to remove clots of mixed morphology and chronicity, which may impact procedural success rates both with thrombolytic and primary aspiration strategies. These early PROWL results suggest that the Pounce thrombectomy system is effective as a standalone solution for removing acute-to-chronic clot in real-world clinical settings without use of adjunctive thrombolytics, aspiration devices, or surgery.”

He added: “In terms of healthcare resource utilisation, the high rate of ICU avoidance and discharge home in this very ill population is encouraging. We’re eagerly awaiting further results from this highly promising registry study.”

The Japanese concept of ikigai and how mentorship might help specialty amid challenges of vascular surgery workforce shortage

By
Bryan Kay
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The Japanese concept of ikigai and how mentorship might help specialty amid challenges of vascular surgery workforce shortage
Roy M. Fujitani during WVS 2024

The Japanese concept of ikigai, or an individual’s reason for being, underpinned the message behind a fresh call for mentorship in vascular surgery and how mentoring could aid efforts to plug a shortage in the specialty’s workforce.

Roy M. Fujitani, MD, chief of vascular and endovascular surgery at the University of California, Irvine, in Orange, California, made the plea to gathered colleagues in his Western Vascular Society (WVS) presidential address during the 2024 WVS annual meeting in Colorado Springs, Colorado (Sept 7–10).

Integrating the core spheres of ikigai— made up of what a person is good at, what they love doing, what the world needs, and what they can be paid for—with mentorship creates a “meaningful framework for personal and professional development,” he told attendees.

Those spheres combine to create passion (a person’s strengths plus love), mission (love plus need), vocation (need plus remuneration) and profession (remuneration plus strengths), he said. If an individual doesn’t combine all four spheres, they may not achieve “full fulfillment,” said Fujitani, who grew up in the rural area of Ahualoa in Hawaii, the grandchild of Japanese immigrants.

He laid out the scale of the challenge to vascular surgery from the predicted workforce shortage through 2030 and beyond: “According to some estimates, the current number of vascular surgeons may not meet the current demand for vascular surgery services over the next decade, with estimates reaching 35–45%.”

Along with the demands of an aging population, the rise of chronic disease, and an aging vascular workforce, Fujitani pointed to training and recruitment concerns: a restricted number of fellowship programs and the breadth of choices available to medical students—some which are perceived as having better work-life balance and financial rewards, he said. “Without intervention, the gap between the supply of vascular surgeons and the demand for services may widen by 2030 and beyond.”

This is where mentorship and the concept of ikigai might have a dual role to play, Fujitani explained. “Early and persistent mentorship is a critical element in the safeguarding of vascular surgery,” he said.

Across the spheres, the experienced surgeon can support and provide advice to mentees as they pursue what they love doing and identify their strengths, and spur skill development by providing opportunity as they discover what they are good at, Fujitani continued. In terms of what the world needs, mentors can help guide purposeful careers that not only fulfill personal ambitions but also contribute to society, as well as support mentees as they navigate career choices that align with their skills and financial and personal fulfillment.

“I fully encourage you to actively participate in first gaining your ikigai yorokobi, activities that bring you intrinsic fulfillment and happiness, and then foster strong mentorship with our young mentees, identifying the very brightest, the very best, to safeguard the future of our vascular surgery specialty.”

TCT 2024: PEERLESS trial finds large-bore mechanical thrombectomy superior for intermediate-risk PE

By
Jocelyn Hudson
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TCT 2024: PEERLESS trial finds large-bore mechanical thrombectomy superior for intermediate-risk PE
Wissam A Jaber presents at TCT 2024
Wissam A Jaber presents at TCT 2024

Findings from the first international randomised controlled trial (RCT) to compare patient outcomes following treatment with large-bore mechanical thrombectomy (LBMT) versus catheter-directed thrombolysis (CDT) for intermediate-risk pulmonary embolism (PE) found that LBMT is superior with respect to the hierarchically-tested aggregated outcome of all-cause mortality, intracranial haemorrhage, major bleeding, clinical deterioration and/or escalation to bailout therapy, and postprocedural intensive care unit (ICU) admission and length of stay.

Findings were reported today at TCT 2024 (27–30 October, Washington, DC, USA) the annual scientific symposium of the Cardiovascular Research Foundation (CRF). Results were also published simultaneously in Circulation.

Over the last decade, catheter-based interventions for intermediate- and high-risk PE, including catheter-directed thrombolysis (CDT) and large-bore mechanical thrombectomy (LBMT), have been adopted to avoid the bleeding risks of systemic thrombolysis. Observational studies of CDT and LBMT have separately reported positive outcomes but there are no prior RCTs directly comparing these two interventional strategies.

From February 2022 to February 2024, a total of 550 haemodynamically stable adults with acute PE, right ventricular dysfunction and at least one additional clinical risk factor for adverse outcomes who did not have absolute contraindications to thrombolytics were randomised in a 1:1 allocation to LBMT with the FlowTriever device (Inari Medical; n=274) or CDT (n=276). The trial was conducted at 57 sites in the USA, Germany and Switzerland. Follow-up was performed at 24-hours, discharge (or after seven days), and at 30-days.

The primary endpoint was a hierarchal win ratio of five outcomes including all-cause mortality, intracranial haemorrhage, major bleeding per International Society on Thrombosis and Haemostasi (ISTH) definition, clinical deterioration and/or escalation to bailout therapy, and postprocedural ICU admission and length of stay. These five outcomes were assessed at discharge or seven days post procedure, whichever came sooner. The primary endpoint favoured LBMT over CDT with a corresponding win ratio of 5.01 (95% confidence interval [CI]: 3.68–6.97, p<0.001).

Among the individual components of these, the rates of all-cause mortality, intracranial haemorrhage, and major bleeding were similar between groups. Less than half of LBMT patients were admitted to the ICU following the procedure compared with nearly all CDT patients (41.6% vs. 98.6%; p<0.001). Although this occurred infrequently, there was also a lower rate of clinical deterioration and/or escalation to bailout therapy with LBMT (1.8%) compared with CDT (5.4%, p=0.038).

At 24 hours, LBMT patients also showed greater improvement in several symptom scores. In addition, the total hospital stay was shorter with LBMT compared to CDT (4.5±2.8 vs.  5.3±3.9 overnights; p=0.002) and fewer LBMT patients were readmitted to the hospital within 30 days (3.2% vs. 7.9%; p=0.03). All-cause mortality within 30 days was similar between both groups (0.4% vs. 0.8%; p=0.62).

“The PEERLESS results represent the most robust evidence comparing two methods of intervention for pulmonary embolism to date,” said Wissam A Jaber (Emory University Hospital, Atlanta, USA). “LBMT was shown to be superior to CDT driven by significantly lower rates of clinical deterioration or escalation of therapy and ICU admission. LBMT was also associated with faster clinical and haemodynamic improvement at 24 hours, significantly shorter hospital stays, and fewer readmissions through 30 days.”

TCT 2024: One-year data from SIRONA trial show similar results for sirolimus versus paclitaxel DCB

By
Jocelyn Hudson
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TCT 2024: One-year data from SIRONA trial show similar results for sirolimus versus paclitaxel DCB
Ulf Teichgräber presents at TCT 2024
SIRONA
Ulf Teichgräber presents at TCT 2024

Data from the prospective, multicentre, investigator-initiated SIRONA randomised clinical trial demonstrated MagicTouch (Concept Medical) sirolimus-coated balloons to be noninferior compared to paclitaxel-coated balloons with regards to the primary safety and efficacy endpoints in patients with femoropopliteal artery disease. Findings were reported today at TCT 2024 (27–30 October, Washington, DC, USA).

Researchers aimed to determine if sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty. From April 2021 to September 2022, a total of 482 participants with Rutherford category 2–4 femoropopliteal artery disease were enrolled at 25 clinical sites in Germany and Austria. Patients were randomised 1:1 to receive angioplasty with either a sirolimus-coated balloon or a paclitaxel-coated balloon. Patient characteristics were similar between both groups.

The mean lesion length was 84 ± 61 mm. A total of 34% of the lesions were totally occluded and 29% were calcified according to Peripheral Arterial Calcium Scoring System (PACSS) grade four. Bailout stents were implanted in 22.8% of the sirolimus group and 20.3% of the paclitaxel group lesions (2.5% (95% confidence interval [CI]: -4.9% to 9.8%).

The rate of the primary efficacy endpoint of primary patency at 12 months was 73.8% in the sirolimus drug-coated ballon (DCB) group compared with 75.0% in the paclitaxel DCB group (-1.2% (-9.7% to 7.4%, p=0.022, non-inferiority). The rate of the composite primary safety outcome at 12 months of clinically driven target vessel revascularisation (cdTVR), major amputation, or death was 9.4% in the sirolimus DCB versus 7.3% in the paclitaxel DCB (2.1% (95% CI: -3.2% to 7.5%, p=0.003, non-inferiority). Functional outcomes were similar between the two groups.

“This head-to-head comparison of sirolimus-coated balloons with paclitaxel-coated balloons during angioplasty of the femoropopliteal artery shows comparable results between the two study groups,” said Ulf Teichgräber (University Hospital Jena, Jena, Germany). “Understanding the safety and efficacy of these two types of balloons, especially compared to one another, can help provide the best patient care possible.”

NESVS 2024: Simons becomes first woman president of New England Society for Vascular Surgery

By
Bryan Kay
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NESVS 2024: Simons becomes first woman president of New England Society for Vascular Surgery
Robert A. Cambria and Jessica P. Simons during NESVS 2024

Jessica P. Simons, MD, has become the 2024–25 president of the New England Society for Vascular Surgery (NESVS). She is the first woman to serve as NESVS president since the society was formed in 1973.

She assumed the role at the 2024 NESVS annual meeting held in Portland, Maine (Oct. 25–27), taking the reins from 2023–24 President Robert A. Cambria, MD.

Simons is a professor of surgery at UMass Chan Medical School in Worcester, Massachusetts, and the institution’s integrated vascular surgery residency program director.

Cambria is the medical director of vascular care at Northern Light Health/Eastern Maine Medical Center in Bangor, Maine.

TCT 2024: PATCH study reports initial positive results for sutureless vascular closure system

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TCT 2024: PATCH study reports initial positive results for sutureless vascular closure system
William Gray
William Gray

Vivasure Medical has announced initial positive results from its US IDE PATCH pivotal study evaluating the safety and efficacy of the Vivasure PerQseal closure device system. Results were presented at TCT 2024 (27–30 October, Washington, DC, USA)

PerQseal is the a sutureless, fully absorbable synthetic implement for large-bore vessel punctures, and is an alternative to the use of suture- or collagen-based closure devices.

It is used for large hole arterial access and is needed for a variety of procedures including transcatheter aortic valve implantation (TAVI) and numerous other large hole cardiovascular procedures. The goal of the device is to reduce vascular complications while simplifying the closure.

Vivasure’s US IDE PATCH clinical study, a multicentre, single-arm, pivotal study, enrolled over 145 patients across 17 US and European investigational sites and evaluated the safety and efficacy of PerQseal when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22F sheaths (arteriotomies up to 26Fr) in subjects undergoing percutaneous catheter-based interventional procedures.

Data presented at TCT show a 0.8% Valve Academic Research Consortium 3 (VARC-3) major complication rate at discharge in 124 patients included in the study’s primary intention-to-treat analysis. Times to haemostasis following percutaneous procedures were a median time of zero minutes.

“Complications from large hole vascular closure remain vexing, impacting patients and requiring additional time and resources. As interventionalists, we need new technologies to improve both outcomes and procedural efficiency,” said William Gray (Main Line Health, Philadelphia, USA), principal investigator of the PATCH study. “The PATCH study results presented today show real promise for the PerQseal technology and positions it to meaningfully improve patient care.”

Thrombolex begins enrolment in RAPID-PE study of Bashir catheter

By
Jocelyn Hudson
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Thrombolex begins enrolment in RAPID-PE study of Bashir catheter
Bashir endovascular catheter
PE
Bashir endovascular catheter

Thrombolex has announced the enrolment of the first two patients in the RAPID-PE study using the Bashir endovascular catheter for the treatment of acute pulmonary embolism (PE). The patients were enrolled by Ayman Iskander (St Joseph’s Health Hospital, Syracuse, USA).

RAPID-PE is a single-arm, multicentre, postmarket study evaluating the safety and effectiveness of on-the-table pharmacomechanical lysis (PML) without post-procedural thrombolytic infusion using the new 0.035” guidewire-compatible Bashir endovascular catheter. “This next-generation platform technology is engineered for optimal resolution of thrombus in the treatment of PE. Patients with acute intermediate-risk PE are treated with four 1mg pulse sprays of r-tPA [recombinant tissue plasminogen activator] into each pulmonary artery without subsequent r-tPA infusion,” a press release reads. “The first two patients treated were discharged from the hospital in good health less than 24 hours post procedure.”

Iskander commented: “It was exciting to see a dramatic improvement in haemodynamics on the table in both patients with very short treatment times (one bilateral; 38 minutes and one unilateral; 16 minutes) in the cath lab. This approach may eliminate the need for an ICU [intensive care unit] stay, which could be a boon to the overburdened health systems.”

Wissam Jaber (Emory University, Atlanta, USA), co-national principal investigator of the RAPID-PE study, commented: “We are pleased to see the enrolment of the first two patients in the RAPID-PE study and are very encouraged by the clinical response with this novel PML approach. We believe this protocol will be as effective as traditional PE therapies and potentially safer, due to the ultra-low dose of lytics used. This is a logical next step in improving upon the excellent clinical results from the original RESCUE study.”

The RESCUE study enrolled 109 patients with intermediate-risk PE at 18 US hospitals and “showed unsurpassed effectiveness and safety in this patient population,” according to Thrombolex. The data from a related single-centre study from Temple University Hospital, the RESCUE-II study, that uses the on-the-table protocol will be presented at TCT (27–30 October, Washington DC, USA).

Who harmed who?

By
Jonathan Cardella and Jean Bismuth
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Who harmed who?
Jonathan Cardella and Jean Bismuth

In his address at the 2024 Vascular Annual Meeting (VAM), Society for Vascular Surgery Immediate Past President Joseph Mills, MD, eloquently stated—and please excuse the paraphrase Dr. Mills—that we as a specialty need to come together and become cohesive, as opposed to divided. Give three vascular surgeons a clinical problem and it is assured you will receive five opinions. Over the last few years, we have seen very public mudslinging directed at vascular surgeons who have chosen private practice careers. The falsehood projected that our private practice colleagues are avaricious and not patient-focused is simply a distortion of reality. There are unscrupulous people everywhere, even in our ivory towers! Currency in private practice is hard cash, while, in our precious hospitals, it’s simply called work relative value units (wRVUs), or hospital Bitcoin. We don’t really know its value, hospitals can’t explain it to us, and in our everchanging field, there are some procedures without wRVUs assigned to them.

Former Polish president Lech Walesa spurred the concept of Solidarność, or solidarity, through the trade union of the same name. Although we’re not necessarily suggesting that we unionize and incite a national strike, the reality is we would benefit from a little more solidarity in our specialty. We are in the ballpark of 3,000 vascular surgeons in the U.S., for a population of nearly 350 million. Although we lack the prowess of Einstein, the math simply doesn’t make sense. There is simply no way we could manage all who need vascular care in this country. Then why are we so preoccupied with the noise of what the interventional cardiologist, nephrologist and radiologist are doing? Were we appointed to police vascular care? The reality is that there are plenty of those interventionalists who do respectable work, so why not embrace that? We need to be the strongest we can be, and that entails leading vascular care from all perspectives. Let us be the standard bearer and fight for things that really matter.

Administrative harm is defined as the adverse consequences of administrative decisions within a healthcare enterprise that affect patient care, professional practice and organizational efficiencies.¹ Colloquially stated, these are the things that hospital decision-makers decree that make our patients’ lives and our lives incredibly difficult: operating room (OR) time cuts, equipment and device decisions, compensation changes, etc. Any of us who practice within the walls of a large conglomerate, even part-time, are affected dramatically by administrative harm. We should all address this as a unifying challenge.

Most of our current hot-button topics are just different ways to look at a problem, depending on how your lens is tinted. We feel administrative harm is not like these other issues. Administrative decisions affect us all, usually unfavorably. When was the last time you heard the administration say: “Dr. Bismuth, we feel you are working too hard. You need a pay raise and an extra two weeks’ vacation, and we won’t take no for an answer”? Are we really training our residents and fellows for the realities of vascular practice in the U.S.? Do they understand administrative harm? Is there an understanding that the more hospital Bitcoin we are asked to mine, the more that places a premium on time and can affect education? Do they realize that there is a national push to “defund vascular surgery”? The truth is that the Centers for Medicare & Medicaid Services (CMS) has slowly been mounting a frontal assault on reimbursements, and we are naïve to think that this doesn’t impact those of us salaried in hospital-based systems. Our specialty depends not only on the academicians—rapidly becoming an enigma who seem to now just produce confounding Vascular Quality Initiative (VQI) analyses— but also on our private and community practitioners, who are delivering the lion’s share of vascular care nationwide, and doing it well.

However, in the face of these local and national administrative harms, our small and highly skilled specialty has chosen instead to debate issues that, by their very nature, are divisive among our own ranks. Atherectomy, office-based lab (OBL) use, cardiology, the concept of an independent board, the list goes on. So, who is harming who? Are the threats facing our specialty existential, or are they internal? Have we leveraged ourselves in such a way that reveals our true value to hospitals? A specialty that fills the coffers of healthcare systems while enabling complex surgery in other realms: we are the proverbial “firefighters,” always available to help sick patients and keep colleagues out of medicolegal peril. In the words of Navy SEAL Jocko Willink, it is indispensable that we take “extreme ownership” of our destiny. This means taking responsibility for everything that impacts our mission, including mistakes, failures, successes and challenges that will affect our abilities to perform the mission in the current and future environment. We should embrace sisu, the extraordinary and indomitable Finnish spirit to never quit and go beyond all limitations, especially in the face of extreme adversity.

Where do we go from here? With a specialty as small as ours, is this time for a unionized approach? Is there a minimum pay we should all receive for the multitude of hats we wear in a health system? SVS President-elect Keith Calligaro, MD, and others have attempted to lend transparency to this via the Pharify compensation survey, but is this enough? Even salary may be a hot-button topic, as it can create a have-and-have-not scenario. Instead, we should address the administrative harm happening locally, regionally and nationally. This is our biggest threat. We could call 20 vascular surgeons around the country at any hour for clinical advice, and they would happily answer the phone. It’s time for us to lean on each other in our non-clinical struggles. To share our experiences and triumphs and display solidarity in an effort to unite us. Perhaps eliminating our greatest existential threat will bring us back on the same page. We have a rare opportunity and obligation to unify and protect our specialty, for ourselves and those who follow.

It seems there is more to digest here than breakfast at Denny’s, so let’s break it down. Clinically, educationally and administratively, we all face significant challenges. We have had great victories and even failures in these realms. Somewhere in this country, someone is fixing your endoleak or maybe re-opening your bypass, but there is also someone enjoying time with loved ones having survived a ruptured aneurysm. We share in these victories and defeats, yet our righteous indignation regarding many of the topics outlined above only fulfills our need for a zero-sum game, where there are winners and losers. This only harms us. This division has made us more susceptible to the one threat we all share: administrative harm. The more divided we become, the easier we are to ignore. So, the next time you post, comment, malign or fall on the proverbial sword, ask yourself who harmed who? Let our next headline in the New York Times be “Vascular surgery, a David and Goliath story defining the standard for vascular care among all providers.” Instead of a haughty quest for a nebulous vascular superiority (that may not exist), we call for unity. Together we need to fight our common battles while attracting more candidates to join our ranks.

Reference

  1. Burden M, Astik G, Auerbach A, et al. Identifying and measuring administrative harms experienced by hospitalists and administrative leaders. JAMA Intern Med. 2024 Sep 1;184(9):1014–1023

Jonathan Cardella, MD, is an associate professor of surgery at Yale School of Medicine in New Haven, Connecticut. Jean Bismuth, MD, is chief of vascular surgery at University of South Florida (USF) Health/Tampa General Hospital in Tampa.

SVS launches Highway to Health campaign to help people maintain vascular health at every age

By
Jocelyn Hudson
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SVS launches Highway to Health campaign to help people maintain vascular health at every age

According to a new national survey released by the Society for Vascular Surgery (SVS), nearly one in three Americans at the highest risk for developing vascular diseases have not heard of any of the most common conditions, like peripheral arterial disease (PAD) and carotid artery disease. An SVS press release notes that this comes at a time when by 2030 more than 100 million people in the USA will be reaching an age associated with a high risk of vascular diseases, meaning more people than ever before may require care from a specialist yet a critical gap exists.

To address this gap, the SVS is launching a three-year patient education campaign, Highway to Health, to empower Americans to learn their SVS Strong Vessel Score and start a conversation with their doctor to see if a vascular surgeon could be a good addition to their overall care team.

“Surgery is only part of the story for vascular surgeons—a significant amount of the care we provide is dedicated to prevention, screening, and ongoing medication management of vascular diseases,” Matthew Eagleton (Massachusetts General Hospital, Boston, USA), SVS president, says in the press release. “We encourage the millions of people in the USA who are at the highest risk for vascular disease to talk with their doctor and ask if seeing a vascular surgeon is right for them.”

To increase awareness of vascular health and vascular disease prevention, SVS released the Highway to Health patient education toolkit which includes videos, checklists and interactive elements and can be found at YourVascularHealth.org.

“Maintaining vascular health at every age supports overall health, quality of life, and longevity, yet more than seven in 10 doctors haven’t talked to their patients over the age of 50 about their risk for vascular disease, or their Strong Vessel Score,” the press release details, sharing one of the findings of the SVS Consumer Survey.

The release continues: “The SVS Strong Vessel Score offers patients a way to share information with their doctor about risk factors and family history to help benchmark and start a conversation about their vascular health.”

William Shutze (Texas Vascular Associates, Plano, USA), SVS secretary, comments: “My guiding mission as a vascular surgeon is to improve the quality of life for my patients with the highest quality, expert care. You see vascular surgeons in lots of different settings from the ER trauma centre to helping patients prevent vascular disease at every age. We are on the front lines of treating patients with a wide array of vascular conditions, from prevention and screening to medical management and surgery—we are here to care of patients across the continuum.”

About the survey

The SVS fielded a survey among a general population that included 1,000 responses from a nationally representative sample over the age of 18 to gather insight into the awareness and perception of vascular disease and vascular health. The confidence level for the survey is 95% with a margin of error of ±3.1.

Key survey highlights

  • Nearly one in three (29%) Americans have not heard of any of the most common vascular diseases, like PAD, carotid artery disease, or abdominal aortic aneurysm.
  • More than one in three (36%) of current tobacco users and more than half (56%) of former tobacco users have never had their provider talk to them about their vascular disease risk.
  • More than eight in 10 (85%) people are not familiar with the role of vascular surgeons.
  • Less than half (46%) of people would opt to see a vascular surgeon for symptoms related to their blood vessels, such as leg swelling or pain or difficulty walking.

ABRE subanalysis highlights obesity ‘paradox’ in post-venous stenting outcomes

By
Jocelyn Hudson
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ABRE subanalysis highlights obesity ‘paradox’ in post-venous stenting outcomes
Abre
Abre

Results from a subset analysis of the ABRE study have shown that patients in three out of the six World Health Organisation (WHO) body mass index (BMI) groups—‘pre-obesity’, ‘obesity class I’ and ‘obesity class II’—trended towards higher 36-month patency rates compared with the ‘normal weight’ group.

Erin Murphy (Atrium Health Sanger Heart and Vascular Institute, Charlotte, USA) shared this finding at the 2024 American Vein and Lymphatic Society (AVLS) annual congress (10–13 October, Chicago, USA), noting that further research on the topic is needed.

The ABRE study was designed to evaluate the safety and efficacy of the Abre venous self-expanding stent system (Medtronic) in patients with symptomatic iliofemoral venous outflow obstruction. A total of 200 patients with an average age of 51.5 years, average BMI of 29.5 and 66.5% of whom were female, were enrolled across 24 global study sites and followed for 36 months.

In her presentation at AVLS 2024—which earned the first-place Best in Show award at the meeting—Murphy detailed that the ABRE subanalysis sought to assess the impact of BMI on post-iliac vein stenting outcomes. Historically, she noted, obesity has been viewed as a potential hindrance to venous stenting, with expectations of poorer patient outcomes due to higher comorbidity risks.

For the subanalysis, patients were categorised by the six WHO BMI groups: ‘underweight’ (four patients; 2%), ‘normal weight’ (55 patients; 27%), ‘pre-obesity’ (50 patients; 25%), ‘obesity class I’ (51 patients; 26%), ‘obesity class II’ (22 patients; 11%), and ‘obesity class III’ (18 patients; 9%).

Murphy reported at AVLS 2024 that, with regard to revised venous clinical severity score (rVCSS) outcomes, the ‘pre-obesity’, ‘obesity class I’, ‘obesity class II’, and ‘obesity class III’ groups showed increasingly higher baseline scores compared to ‘underweight’ and ‘normal weight’ patients. After six months, the presenter added, improvement in rVCSS was constant across all BMI groups except for ‘underweight’.

Murphy also shared quality-of-life (QoL) results. The presenter detailed that, as BMI increases, the baseline VEINES-QoL scores worsen and that improvement in VEINES-QoL at six months is constant across all BMI groups except for ‘underweight’. BMI was not found to be a factor in VEINES-QoL change from baseline to six months, she continued.

Regarding primary patency, Murphy relayed that the ‘pre-obesity’, ‘obesity class I’, and ‘obesity class II’ groups “paradoxically” trended towards higher patency rates at month 36 compared to the ‘normal weight’ group. However, the presenter stressed that the 95% confidence intervals overlapped for all three groups and that the subgroups are small.

Finally, Murphy added that the ‘obesity class III’ group (BMI >40) had the lowest 36-month patency—which she said indicates potential higher risk in this group independent of disease cohort—and that there was no significant difference in underlying disease cohort across the BMI categories.

CEA: The importance of doctor-patient conversations about quitting smoking for better stroke outcomes in setting of asymptomatic stenosis

By
Bryan Kay
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CEA: The importance of doctor-patient conversations about quitting smoking for better stroke outcomes in setting of asymptomatic stenosis
Hassan Chamseddine during MVSS 2024

A new analysis that shows current smokers who undergo carotid endarterectomy (CEA) for asymptomatic carotid stenosis are at increased risk of long-term stroke and death compared to former or never smokers helps reinforce the importance of physicians talking to patients about quitting their smoking habit.

That was one of the key messages from the authors behind study findings showing a stroke rate among current smokers that was nearly twice as great as their former-smoker—defined as those who quit at least 30 days prior to surgery—and never-smoker counterparts. The data were reported at the 2024 Midwestern Vascular Surgical Society (MVSS) annual meeting in Chicago (Sept. 12–14). In an interview with Vascular Specialist, presenting author Hassan Chamseddine, MD, a research fellow at Henry Ford Health in Detroit, Michigan, describes the rationale behind digging into the Vascular Quality Initiative (VQI) in order to try to uncover evidence around the benefit from smoking cessation amid questions over CEA use among the patient population at hand.

“Currently, the Society for Vascular Surgery [SVS] recommends an endarterectomy for patients with an asymptomatic carotid stenosis if their stenosis is greater than 70%,” he explains.

“The evidence for the benefit of endarterectomy in this population comes from landmark trials—ACAS and ACST-1—but those trials are very old, and they are currently under increased scrutiny because the medical therapy arm back then does not reflect contemporary medical management. More recent studies—including the SPACE-2 trial—did not show any difference between CEA and best medical therapy in this population. And, all over the country, there is some doubt over the benefit, or necessity, of endarterectomy in asymptomatic patients.”

The research team—led by senior author Loay Kabbani, MD, vice chair of surgery for research and program director of the vascular surgery fellowship at the same institution—looked at all members of the patient population undergoing CEA from 2013–2023 logged in the VQI. Of the 77,664 included, 24% were current, 51% former and 25% never smokers.

The data showed the three groups had similar rates of perioperative complications, but, at 18-month follow-up, former smokers exhibited strokes comparable to never smokers—and both were “significantly lower” than current smokers (0.8%, 0.9% and 1.5%, respectively), Chamseddine points out.

In terms of major adverse cardiac events (MACE)—a combination of stroke, myocardial infarction and death—quitting smoking at least 30 days prior reduced MACE risk among former smokers when compared to current smokers, “but not by as much as those who never smoked,” adds Chamseddine.

Kabbani says the results help highlight a dual purpose. “Number one, this shows the benefit of smoking cessation for the patient, but [number two] also for the physician: If I’m a physician and I’m seeing a patient with asymptomatic disease that has significant stenosis, and there is a question mark about the benefit of the operation, if we want the patient to have the best long-term outcome, we really need to convince them to stop smoking before the operation. They do better in the long run in multiple settings, including decreased myocardial infarction and death.”

Kabbani underscores the importance of physician efforts around the subject of cessation: “Time and time again, we see that if a physician talks to a patient about quitting smoking, they have twice as much chance of stopping.”

ABS seeks vascular surgeon nominations for council position

By
Marlén Gomez
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ABS seeks vascular surgeon nominations for council position

The American Board of Surgery (ABS) is accepting nominations for vascular surgeons to serve on its council for a six-year term, beginning on July 1, 2025.

SVS members interested in this role should have experience as program directors or in private practice. The ABS encourages candidates with expertise in emerging areas such as artificial intelligence (AI), simulation applications, outcome research methodologies and big data.

The deadline for submissions is Tuesday, Nov. 12, at 4:30 p.m., Eastern Time. To apply, SVS members should complete the ABS council candidate/nominee form and notify the SVS for consideration of a Society endorsement by visiting vascular.org/ABSnominations.

For questions or more information, contact Tania Rosha at trosha@absurgery.org.

SVS launches VascuLEARN

By
Marlén Gomez
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SVS launches VascuLEARN

The Society for Vascular Surgery (SVS) online learning management system (LMS), now known as SVS VascuLEARN. The platform was formerly called SVS OnDemand. VascuLEARN hosts hours of educational content for vascular surgeons, trainees and allied health professionals.

After logging in with SVS credentials, users will see a slew of content that is available to them, including a list of microlearning videos that range in topic, as well as coding and reimbursement resources and past webinars from the SVS.

Additionally, those who attended the Vascular Annual Meeting (VAM), Vascular Quality Initiative (VQI) annual meeting and/ or the Society for Vascular Nursing (SVN) Annual Conference in the years 2022, 2023 and/or 2024 can view session recordings through the LMS.

To access VascuLEARN, visit vasculearn.vascular.org and login using SVS credentials. VascuLEARN is available to all SVS members, with limited content being available to nonmembers as well.

Hybrid aortic arch: ‘We believe there is still a role for a versatile multiple-branched arch option’

By
Bryan Kay
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Hybrid aortic arch: ‘We believe there is still a role for a versatile multiple-branched arch option’

Mid-term results from an analysis of a series of hybrid aortic arch reconstructions utilizing overlapping single thoracic branch endoprostheses in a dual-branch configuration showed the technique to be safe and versatile.

Delivered at the 2024 Western Vascular Society (WVS) annual meeting in Colorado Springs, Colorado (Sept. 7–10), the paper was the winner of the WVS Rapid Fire Competition.

Presenter Evan R. Brownie, MD, a vascular surgeon at Intermountain Health in Murray, Utah, characterized use of the procedure following the commercial launch and subsequent widespread use of the Gore Tag thoracic branch endoprosthesis (TBE). Despite this, Brownie said, “we believe there is still a role for a versatile multiple-branched arch option.”

Brownie and colleagues performed their first 49 TBE deployments in 44 patients from October 2022 to December 2023, five of which involved the dual-TBE configuration in question. Median follow-up was six months, and up to 12 months.

“All of these patients had at least one prior sternotomy with an existing ascending aortic stent graft, some sort of systolic heart failure and one of the five patients had a prior recurrent laryngeal nerve injury at the time of their index procedure, henceforth why—even though we do an equal number of zone 0 deployments off a single branch—we are trying to minimize risk for this patient population and the discrepancies that can be seen with a single branch perfusing all of the great vessels,” he explained.

Three of the five underwent a dual brachiocephalic configuration with a left carotid-to-subclavian transposition through a left cervical incision, Brownie said. The other two had a left-common-carotid-to-right-common-carotid transposition, he added, explaining that “we do a separate arteriotomy in the right carotid artery to maintain cerebral perfusion throughout the case.”

For the endovascular portion of the procedure, he continued, “we obtained bilateral percutaneous femoral and bilateral percutaneous arm access. We do a zone 2 thoracic branch stent graft, put in an oversized Viabahn (Gore) stent graft in position, then extend proximally with our zone 0 stent graft and deploy it. So, we are gaining the overlap seal between the devices, as well as the parallel seal zone, just to maintain perfusion to the subclavian limb.”

Procedures were typically staged, Brownie said, with the transposition performed two days prior to the endovascular repair. Following transposition, there were no strokes, cranial nerve injuries or early thrombosis, he told WVS 2024. Similarly, following endovascular repair, there were no cases of spinal cord, renal or bowel ischemia.

Furthermore, one patient was returned to the operating room for an access site complication, one had a stroke, and there were no type I or II endoleaks, nor gutter leaks. Sixty percent of these patients have already demonstrated sac regression, Brownie added.

“An appropriate trial design and regulatory application could bridge the gap until we have a dedicated arch graft available,” he concluded. “And, of course, this will largely be dependent on compensation and reimbursement for such procedures.”

Female patients found to be at increased risk from adverse outcomes after an ALI diagnosis

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Bryan Kay
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Female patients found to be at increased risk from adverse outcomes after an ALI diagnosis
Mikayla Lowenkamp

Results from a new study highlighting that female patients are at increased risk of adverse outcomes after acute limb ischemia (ALI) lend weight to the possibility of underdiagnosis and management of vascular disease among women, the authors behind the research report.

Investigators from the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania, found that females who presented with ALI were less likely to have had prior vascular interventions, less frequently on a preoperative statin or antiplatelet agent and more likely to be hypercoagulable. They had a higher rate of mortality after revascularization except when medically optimized, and female patients also had “notably higher amputation rates following endovascular interventions,” the UPMC research team found.

The results were delivered by Mikayla Lowenkamp, MD, a vascular surgery resident at UPMC, during a session dedicated to diversity, equity and inclusion (DEI) at the 2024 Eastern Vascular Society (EVS) annual meeting in Charleston, South Carolina (Sept. 19–22).

Lowenkamp set the scene for the study by pointing to the “underrepresentation of female patients” in key trials and a resultant “lack of sex-based guidelines regarding the evaluation, diagnosis and management” of vascular disease in women. “As a result, recent literature has found a difference in amputation and mortality rates following acute limb ischemia,” she said.

Lowenkamp and colleagues looked to identify sex-specific predictors of major amputation and mortality, as well as sex-specific differences in the presentation, management and outcomes in patients undergoing revascularization for ALI in a retrospective cohort study of cases from a multihospital system. All patients who underwent a revascularization procedure for ALI from 2016–2023 were included, with 548 meeting inclusion criteria. Female patients were older and made up 46% of the cohort. They were less likely to have a history of cardiovascular disease, specifically lower rates of coronary artery disease (CAD), Lowenkamp told EVS 2024.

Study data demonstrated that females report earlier after symptom onset and were more likely to go to the operating room within 24 hours in comparison to their male counterparts, despite no differences in Rutherford ALI classification on presentation.

There were no differences in either the initial surgical approach—endovascular vs. open—or in terms of endovascular strategy. But female patients were less likely to undergo thrombolysis or bypass. After intervention, female patients were less frequently discharged on an antiplatelet, and experienced an increased rate of mortality on both univariable and multivariable analyses. Increasing age, a cancer history and an advanced Rutherford classification were all predictors of an increased mortality risk, Lowenkamp added.

On subgroup analysis, the association between women and mortality did not differ except in the context of preoperative optimal medical therapy (OMT): “In female patients on optimal medical care, mortality risk after revascularization was equivalent to males,” she said. “In female patients not on OMT, their mortality risk was significantly increased in comparison to males.”

Furthermore, there were no differences in overall amputation rates between the sexes on univariable analysis, and sex was not a predictor of amputation on multivariable analysis, Lowenkamp continued. “And the association between females and amputation did not differ among the subgroups, except in patients who received an endovascular-first approach; they were 2.6 times as likely to undergo a major amputation.”

Concluding, Lowenkamp emphasized the data showing a higher rate of long-term morality alongside a higher rate of amputation following endovascular intervention, commenting that “one can speculate that may be due to smaller vessel size, differences in chronicity or distribution of the disease.”

Posing a question from the meeting floor, Alan M. Dietzek, MD, the chief of vascular surgery at Nuvance Health in Danbury, Connecticut, said the take-home message from the study results seemed to be women not being on OMT, and asked Lowenkamp whether, given the totality of the data, this prompted a preference for an endovascular or open surgical approach.

Lowenkamp said her takeaway was more centered on a need to ensure that female patients are medically optimized should they require a vascular intervention.

Study details aspects of early care improvements after publication of SVS appropriate use criteria for claudication

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Bryan Kay
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Study details aspects of early care improvements after publication of SVS appropriate use criteria for claudication
Andrea Alonso

An observational study of intermittent claudication (IC) practice patterns before and after publication of the Society for Vascular Surgery (SVS) appropriate use criteria (AUC) for IC management points to a series of areas where care has improved, alongside aspects still in need of attention, according to the authors.

The researchers noted improvements in optimal medical therapy (OMT), particularly in the postoperative setting, and patient selection, as well as a decrease in complex aortoiliac and infrapopliteal peripheral vascular interventions (PVIs). However, they reported no changes in medical optimization or bypass practices, and an increase in endovascular common femoral artery (CFA) and infrapopliteal disease interventions, “suggesting that there may be further improvement in this area.”

The data, drawn from the Vascular Quality Initiative (VQI), were presented during the 2024 Eastern Vascular Society annual meeting in Charleston, South Carolina (Sept. 19–22) by Andrea Alonso, MD, a general surgery resident at Boston Medical Center, on behalf of a research team led by Jeffrey Siracuse, MD, an attending vascular surgeon at Boston Medical Center and professor of surgery and radiology at Boston University.

The SVS AUC, published in the Journal of Vascular Surgery (JVS) in April 2022, came amid a significant increase in the number of interventions for claudication over the past couple of decades, despite medical therapy being the first-line treatment for the less advanced form of peripheral arterial disease (PAD).

The research team defined the pre- AUC period as January 2018–December 2019, with the period after the AUC’s publication in JVS set as May 2022– December 2023. The period in between was excluded for matters related to the COVID-19 pandemic.

All patients with claudication who underwent an intervention in the VQI PVI, and suprainguinal and infrainguinal bypass registries were included in the analysis. Alonso informed EVS 2024 that the investigators tried to adhere to as many of the SVS AUC principles as possible, pointing out the exception of exercise therapy, which is not available as part of the VQI. The team primarily looked at complex aortoiliac and femoropopliteal lesions, as well as isolated infrapopliteal lesions.

“When we looked at PVI demographics, we saw that, post-AUC, there was a significant increase in severe disease as an indication for interventions, and that there was a significant increase in optimal medical therapy [OMT] use following the AUC [publication] in the postoperative period,” Alonso told EVS 2024 attendees. “However, we noted that there was no significant change in current smoking or preoperative medical therapy.”

Among significant comorbidities in the patient population, Alonso pointed to an increased number of interventions in patients with coronary artery disease (CAD), but a significant decrease in those on dialysis.

Homing in on interventions in specific anatomic segments, Alonso and colleagues saw that there was a significant decrease in the number of endovascular interventions for complex aortoiliac and femoropopliteal disease, but a notable increase in endovascular treatment for disease in the CFA and isolated infrapopliteal disease.

“With suprainguinal bypass, we didn’t see any significant changes in the use of extra-anatomic revascularization, and, in the infrainguinal bypass registry, we did not see any changes in bypasses, specifically those using prosthetic conduit,” she said.

“An important limitation of this study is that, as it was observational, we were unable to conclude if the changes seen were due to the guidelines or other external factors, and we were unable to evaluate exercise therapy.”

The SVS AUC for IC was the work of a multidisciplinary team of experts who evaluated several unique scenarios for disease in the aortoiliac, CFA and femoropopliteal regions, Alonso pointed out. They looked at several variables, including exercise therapy, OMT use, smoking, medical risk, degree of lifestyle-limiting disease, walking distance, lesion location, endovascular interventions and the type of bypass used.

“The key principles of the AUC are that the first-line treatment [for patients with claudication] is a combination of exercise therapy, medical therapy and smoking cessation, and that interventions may have a benefit if a patient has undergone conservative management and has severe lifestyle-limiting disease, and more short distance walking,” Alonso observed.

As published in JVS, those key AUC principles for the management of IC—by anatomic segment—are as follows: “invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance; in the CFA, open common femoral endarterectomy will provide greater net benefit than endovascular intervention; in the infrapopliteal segment, invasive intervention is of unclear benefit and could be harmful.”

Additionally, Alonso noted from the AUC that, in the aortoiliac region, patients who may have a benefit from invasive interventions for claudication could undergo endovascular treatment primarily, but also inline bypasses in certain scenarios.

Discussion afterward raised the specter of payment and reimbursement. Rabih Chaer, MD, chief of vascular surgery at the University of Pittsburgh in Pittsburgh, Pennsylvania, suggested that guidelines themselves “are not going to change practice patterns, unless this perhaps impacts reimbursements and insurance providers.” He asked Alonso whether she thought this scenario would eventually play out. Alonso agreed that changes in practice would have to come through reimbursement channels, adding that, “to a point, AUCs do affect payment.” According to the AUC for IC paper published in JVS, the Centers for Medicare & Medicaid Services and other payors have taken notice of AUC, primarily for their role in reducing overuse.

Endospan completes enrolment of primary arm in TRIOMPHE IDE clinical study

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Jocelyn Hudson
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Endospan completes enrolment of primary arm in TRIOMPHE IDE clinical study
Nexus stent graft system
Nexus stent graft system (Endospan)

Endospan today announced the completion of enrolment for the primary arm of its TRIOMPHE investigational device exemption (IDE) clinical study investigating the Nexus aortic arch stent graft. The study is evaluating the safety and efficacy of the device for the treatment of aortic arch disease.

A company press release details that the Nexus aortic arch stent graft is a bi-modular off-the-shelf device designed to provide a minimally invasive solution for patients with aortic arch disease. The TRIOMPHE IDE study is a three-arm non-randomised study conducted at 30 aortic centres across the USA and one centre in New Zealand, enrolling patients with a variety of aortic arch pathologies.

“We are thrilled to announce the completion of enrolment for the primary arm of this important clinical study,” said Kevin Mayberry, chief executive officer of Endospan. “The Nexus aortic arch stent graft has the potential to significantly improve outcomes for patients with aortic arch disease. We are committed to bringing this innovative technology, which is already a proven platform in Europe, to the USA as quickly as possible.”

Brad Leshnower (Emory School of Medicine, Atlanta, USA), who is the cardiac national principal investigator of the study, added: “We are excited to be part of this groundbreaking study. While the early results from the TRIOMPHE study presented at STS this year suggest that the Nexus system can be used safely to treat aortic arch disease in a high-risk surgical cohort with a low rate of stroke, we anxiously await the results from the full cohort.”

Ross Milner (UChicago Medicine, Chicago, USA), who is the vascular national principal investigator, commented: “The Nexus device has the potential to revolutionise the treatment of aortic arch disease by offering a less invasive alternative to open surgery. We are eager to see the results of this study regarding midterm durability and patient outcomes.”

The company states that it plans to monitor the patients’ safety and efficacy for one year prior to submitting for US Food and Drug Administration (FDA) approval.

CVRx announces new CPT Category I codes for Barostim baroreflex activation therapy

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Bryan Kay
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CVRx announces new CPT Category I codes for Barostim baroreflex activation therapy
The Barostim device

CVRx, the company behind the Barostim baroreflex activation therapy system, recently announced that the American Medical Association (AMA) has accepted new Current Procedural Terminology (CPT) Category I codes for the device, which treats the symptoms of heart failure.

The decision to accept the application for Category I codes for Barostim therapy will help further facilitate reimbursement for healthcare providers performing the procedure and enable broader patient access, according to CVRx.

The company credited the lead taken by the Society for Vascular Surgery (SVS), and the support of the American College of Cardiology (ACC) and others, in the application effort. The codes are expected to be implemented on January 1, 2026. In the interim, U.S. hospitals and physicians performing Barostim procedures should continue to utilize the existing Category III codes, CVRx added.

Barostim therapy—an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery and designed to restore balance to the autonomic nervous system, thereby reducing the symptoms of heart failure—is the first medical technology approved by Food and Drug Administration (FDA) that uses neuromodulation to improve the symptoms of heart failure.

The procedure is FDA-approved for use in heart failure patients in the U.S. and has also received CE Mark for heart failure and resistant hypertension in the European Economic Area.

SVS member picks up prestigious American Heart Association accolade for scientific work

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Bryan Kay
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SVS member picks up prestigious American Heart Association accolade for scientific work
Katherine Gallagher

A prominent surgeon-scientist and Society for Vascular Surgery (SVS) member is the 2024 recipient of the American Heart Association (AHA) Joseph A. Vita Award, which recognizes published work that has had a transformative impact on basic, translational or clinical cardiovascular research.

Through the Gallagher Lab, Katherine Gallagher, MD, and her team of researchers have become a fixture in the translational vascular science space, producing a prodigious output of research and publications.

Her lab, based at the University of Michigan in Ann Arbor, has also produced several SVS Foundation James S.T. Yao Resident Research Award recipients in recent years, including the most recent: University of Michigan integrated vascular surgery resident, Kevin D. Mangum, MD.

Gallagher spoke of her honor at receiving the landmark award, telling Vascular Specialist her interest in translational research was embedded early on.

“I’ve always had an interest in immunology and how immune cells influence the vascular system—both a healthy system and one with disease—and have always been interested in looking at it from a more a translational research standpoint,” says the University of Michigan professor of surgery, microbiology and immunology. “In the last 10–12 years, there has been a lot more interest in the immune system and the role that it plays in vascular diseases, as well as the development of various immune therapies. I’ve had an interest in how we can try to manipulate these immune cells, which are very inflammatory in vascular disease, and then try to reverse this inflammation.”

Gallagher arrived at Michigan as a junior scientist 15 years ago, starting her lab with just one other team member. It has since grown to include between 15–20 colleagues, with its research interest morphing from tissue regeneration and metabolic disease to, now, a full spectrum of cardiovascular diseases, including aneurysmal, atherosclerotic and COVID-19-related impacts on vascular disease.

She is particularly proud of her lab’s success in shepherding the next generation of vascular surgeon-scientists. “We have had lot of success with mentees, getting NIH [National Institutes of Health] grants, SVS Foundation funding, AHA awards, and so on,” Gallagher says. “That’s the part I find most exciting: the next generation and trying to get them thinking about science and translational therapies.”

She highlighted the importance of translational vascular science to the future of vascular surgery as a specialty. “A lot of the therapies we are going to see coming down the pipeline in the next 20 years are going to be immune and cell-based therapies. Unless vascular surgeons are involved at the forefront of research, then there is less bench-bedside translation, which hurts vascular patients. So, it is really important for vascular surgeons to be involved in translational research in order to allow our patients to benefit from the latest, greatest, innovative treatments.”

To that end, her lab’s focus has now turned toward how immune cells interact with other structural cells in blood vessels and pathological processes, with the aim of developing nanomedicine therapies to target those interactions, she added.

Novel RCT framework set to improve design and reporting of endovascular infrainguinal lower-limb interventions for PAD

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Jocelyn Hudson
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Novel RCT framework set to improve design and reporting of endovascular infrainguinal lower-limb interventions for PAD
Ewa M Zywicka

Pilot testing has shown that a new framework—dubbed Endo-STAR—can be used to describe and standardise endovascular interventions for peripheral arterial disease (PAD) within a randomised controlled trial (RCT) protocol and monitor adherence to the protocol over the course of a trial. Ewa M Zywicka (University of Bristol Medical School, Bristol, UK) shared this conclusion during the Prize Session at the recent European Society for Vascular Surgery (ESVS) annual meeting (24–27 September, Kraków, Poland).

Zywicka began by noting that rigorous evaluation of novel lower-limb endovascular interventions is “critically important” to ensure adoption of effective technologies and rejection of those that are ineffective or harmful.

The presenter continued that poor reporting of RCTs limits the evaluation of technologies for lower-limb endovascular interventions, highlighting a recent study in which more than half of RCTs did not adequately describe interventions, and almost 80% did not report any form of standardisation.

The aim of Zywicka and colleagues’ present study, therefore, was to develop a specific framework for describing and standardising endovascular lower-limb interventions within clinical trials.

Zywicka explained to the ESVS audience that the Endo-STAR framework was developed using qualitative research methodology and the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. The presenter added that trial reports and associated protocols identified in a recent systematic review of endovascular infrainguinal lower-limb RCTs for PAD provided the data for developing the preliminary framework.

Going into more detail about the research methods used, Zywicka detailed that a framework approach to thematic analysis of qualitative data was employed to code and categorise text into steps and components of endovascular infrainguinal interventions.

Subsequently, focus groups were conducted with key international stakeholders such as clinical practitioners—namely vascular surgeons, interventional radiologists, angiologists and cardiologists—trialists, industry representatives and journal editors to refine the framework and consider clarity and feasibility issues. Zywicka noted that the framework was updated based on this feedback, and a consensus between stakeholders was reached via a modified Delphi-style questionnaire.

Finally, Zywicka shared, the framework was refined through cognitive interviews with trialists to test the real-world feasibility of using the Endo-STAR framework in contemporary endovascular RCTs. An online version of the Endo-STAR framework was developed to facilitate implementation and dissemination.

At ESVS, Zywicka informed attendees that the preliminary framework was developed after including data from 112 RCTs evaluating endovascular infrainguinal interventions for PAD.

Zywicka relayed that 24 key stakeholders participated in three focus groups, contributing to the refinement of the framework, and all 24 participants took part in the consensus questionnaire. After the first round of the questionnaire, the presenter continued, an agreement above 85% was reached for each framework section. Ten trialists involved in contemporary endovascular trials took part in pilottesting the framework.

Ultimately, Zywicka reported, the Endo-STAR framework was structured into six main sections: 1) expertise of the professional delivering the intervention, 2) setting/location of the intervention, 3) anaesthesia provided for the intervention, 4) imaging used at the time of the intervention, 5) intervention components: access, crossing the lesion, treating the lesion (including specific steps and details related to all currently available endovascular devices) and closure of the artery, and 6) pharmacological interventions.

In discussion time following Zywicka’s talk, jury member Jon Boyle (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) asked how the framework might help in terms of monitoring long-term outcomes of endovascular interventions, to which the presenter responded: “What we are aiming to achieve with this framework is to know what has been done in a trial […] we expect that actually being able to know and clearly describe what was done in a trial can be used to easily compare trials and even potentially compare results in the long term as well.”

The Shockwave E8 experience: Featuring the new Shockwave peripheral IVL workhorse

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BIBA Publishing
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The Shockwave E8 experience: Featuring the new Shockwave peripheral IVL workhorse
Paul J. Foley III

This advertorial is sponsored by Shockwave Medical.

Paul J. Foley III, MD, a vascular surgeon and director of the non-invasive vascular lab at Doylestown Hospital in Doylestown, Pennsylvania, and adjunct associate professor of surgery at the University of Pennsylvania in Philadelphia, discusses the virtues of the new Shockwave E8 IVL catheter.

Endovascular interventions for chronic limb-threatening ischemia (CLTI) are technically demanding endeavors. Multi-level arterial disease, long-length lesions and other complex plaque characteristics are frequently encountered when treating these patients.1,2

Calcium modification with intravascular lithotripsy (IVL) has emerged as a useful tool to combat the challenges of calcified lesions with the goal of maximizing luminal gain to achieve improved endovascular outcomes, both radiographically and clinically.³ Balanced lithotripsy pulse delivery across longer-length lesions, as well as effectively treating calcified disease across multiple arterial beds, can be laborious considering the number of available pulses and the length of the IVL catheter relative to the extent of disease.

To address this, the Shockwave IVL peripheral portfolio has now been enhanced with the addition of the Shockwave E8 catheter. The Shockwave E8 contains eight emitters across an 80mm-length balloon platform with treatment diameters ranging from 2.5–6mm and the ability to deliver up to 400 pulses. A working length of 150cm now provides an extended reach for more distal disease. The Shockwave E8 catheter allows for expanded application of IVL in treating a wide range of infrainguinal disease. Longer-length lesions involving the superficial femoral (SFA) and popliteal arteries or disease involving multiple tibial arteries that may have previously required a very selective pulse delivery approach can now be more broadly treated with the Shockwave E8.

Case report

The following case highlights the versatility of the Shockwave E8 IVL catheter to treat long-length lesions in two tibial arteries.

History

A 78-year-old man who resides in Uzbekistan presented to the office with CLTI of the left lower extremity manifested by a non-healing gangrenous left toe ulcer and associated rest pain (Figure 1). He was initially evaluated by providers in his home country and had a recent arteriogram in Uzbekistan demonstrating severe multi-level arterial disease in the left lower extremity, but no intervention was performed. The patient’s son, who lives in the U.S., brought him to the office for vascular surgery evaluation. The patient’s past medical history is notable for hypertension, hypercholesterolemia and a heavy smoking history. On physical examination, he had a palpable left femoral pulse but non-palpable pedal pulses in the left foot.

Preoperative ankle brachial index (ABI) of the left lower extremity was severely reduced at 0.31 and the left toe pressure was zero. He was taken to the operating room for a left lower extremity arteriogram and endovascular intervention.

Arteriogram, left lower extremity

An arteriogram of the left lower extremity was performed via antegrade left common femoral artery access based on preoperative review of the lower extremity arteriogram from Uzbekistan. Scattered non-calcified plaque with moderate to high-grade stenoses were identified in the proximal and mid superficial femoral artery. Diffuse severe calcified tibial artery disease was identified. There was a long segment stenosis of the proximal and mid posterior tibial artery coupled with a more distal occlusion. The proximal peroneal artery was calcified and occluded with distal reconstitution identified. There was complete occlusion of the anterior tibial artery (Figure 2).

Shockwave E8 3mm x 80mm to the posterior tibial artery

The posterior tibial artery was successfully crossed first. The long-length posterior tibial artery disease was treated with a Shockwave E8 3.0mm x 80mm IVL catheter, with no pre-dilatation required. A total of 200 pulses were delivered along the length of the posterior tibial artery (Figure 3).

Shockwave E8 3mm x 80mm to the peroneal artery

Following this, the peroneal artery occlusion was successfully crossed. The long-length peroneal artery disease was treated with the same Shockwave E8 3mm x 80mm IVL catheter also with no pre-dilatation required. The remaining 200 pulses were delivered across the length of the peroneal artery disease (Figure 3).

Left SFA intervention

To ensure adequate inline blood flow to the tibial vessels, the SFA disease was treated with drug-coated balloon angioplasty, followed by self-expanding stent placement.

Post-intervention arteriogram

An excellent technical result was achieved. The SFA was widely patent with no significant residual stenosis. The posterior tibial and peroneal arteries were widely patent with brisk flow and no residual stenosis. Significantly improved flow was identified to the foot (Figure 4).

Post-intervention follow-up

The patient had an uneventful postoperative recovery. His post-intervention lower extremity arterial studies demonstrated a significant improvement in both the ABI and toe-brachial index (TBI). At his one-month postoperative visit, he had completely healed the toe ulcer without any further intervention (Figure 5).

References

  1. Fitzgerald PJ et al. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation, 1992
  2. Rocha-Singh KJ et al. Peripheral arterial calcification: Prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv, 2014
  3. Armstrong E. VIVA Late Breaking Clinical Trial, 2022

Paul J. Foley III is a paid consultant of Shockwave Medical.

Peripheral Important Safety Information In the United States: Rx only. Indications for Use—The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature Contraindications—Do not use if unable to pass 0.014” (M5, M5+, S4, E8) or 0.018” (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries. Warnings—Only to be used by physicians who are familiar with interventional vascular procedures—Physicians must be trained prior to use of the device— Use the generator in accordance with recommended settings as stated in the Operator’s Manual. Precautions—use only the recommended balloon inflation medium—Appropriate anticoagulant therapy should be administered by the physician—Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology. Adverse effects—Possible adverse effects consistent with standard angioplasty include—Access site complications— Allergy to contrast or blood thinner. Arterial bypass surgery—Bleeding complications—Death— Fracture of guidewire or device—Hypertension/Hypotension— Infection/sepsis—Placement of a stent—renal failure—Shock/ pulmonary edema—target vessel stenosis or occlusion— Vascular complications. Risks unique to the device and its use—Allergy to catheter material(s)—Device malfunction or failure—Excess heat at target site. Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/IFU. SPL-73151 Rev. A

Pounce Thrombectomy Platform use in acute limb ischemia: Vascular surgeons weigh in

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BIBA Publishing
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Pounce Thrombectomy Platform use in acute limb ischemia: Vascular surgeons weigh in
Pounce system

This advertorial is sponsored by Surmodics.

Interventions for acute limb ischemia (ALI) represent up to 16% of the case volume for vascular surgeons and cost healthcare systems $26,000–$29,000 per patient in hospitalization costs.¹ While revascularization may be achieved via open or endovascular approaches, guidelines recommend selection of the technique that will provide the most rapid restoration of arterial flow with the least risk to the patient.²

Endovascular treatment to remove clots and restore blood flow is now a common alternative to surgery for revascularization in ALI.³ In recent years, percutaneous thrombectomy has become a viable option for vascular surgeons seeking single-session revascularization without the risks associated with thrombolytics4 or the need for costly intensive care unit (ICU) or hospital admissions.

Until recently, the mainstays of percutaneous thrombectomy for ALI have been pharmacomechanical or aspiration devices. In 2021, Surmodics introduced the PounceTM Thrombectomy System, a purely mechanical solution that relies on a dual-basket technology to capture and remove chronic or acute emboli or thrombi without aspiration, lytics or capital equipment.

A 2023 retrospective study5 of 44 consecutive patients treated for lower extremity limb ischemia with suspected thrombus using the Pounce system demonstrated 83% technical success, defined in the study as effective removal of thrombus from the peripheral arterial segments where the system was used.

Notably, unlike previous studies of percutaneous thrombectomy devices in ALI, the study population included patients with subacute (15–30 days of symptoms; 16% of patients) and chronic (>30 days; 43% of patients) limb ischemia in addition to ALI (≤14 days; 41% of patients). In just one of 44 cases, thrombolysis was used to resolve thrombus secondary to treatment with the Pounce system. Procedural success, defined in the study as restoration of pulsatile flow to the foot and resolution of ischemic pain, was 95%.

Moving on from aspiration

Vince Weaver

Vascular surgeon Vince Weaver, MD (consultant to Surmodics), from the Vascular Specialty Center in Baton Rouge, Louisiana, uses percutaneous thrombectomy for most of his ALI cases. Today, the Pounce system is his go-to device.

“I’ve had access to just about all the arterial thrombectomy devices and have whittled them down,” he says. “Our practice still has the Angiojet pharmacomechanical system [Boston Scientific], but I really don’t use it anymore due to the use of tPA [tissue plasminogen activator] and [the] device’s systemic effects [e.g., renal impairment].”6

As for aspiration, Weaver used the Indigo aspiration system (Penumbra) and QuickClear thrombectomy system (Philips) as his primary percutaneous devices until about two years ago, when he started using the Pounce system. “The limitation I found with suction thrombectomy is that you could go in and take out a lot of fresh clot, but when you take your post-thrombectomy angiograms, you see that there’s a lot of residual thrombus and organized stuff remaining. With the Pounce system, after one, maybe two passes, I’ve been able to remove, if not all, at least a significant amount of that more organized thrombus. I’ve been getting much more robust thrombectomy with the device, and my success rate has been much higher for the right patient.”

Lucas Ferrer Cardona

Lucas Ferrer Cardona, MD (consultant to Surmodics), a vascular surgeon with the Dell Seton Medical Center at the University of Texas Hospital in Austin, has gravitated toward use of the Pounce system for similar reasons.

“The most significant benefit of the Pounce system over aspiration is that it’s effective in treating both acute and chronic clot,” he says. “Aspiration works great for fresh thrombus, but thrombus is usually not homogeneous.”

Efficiency and time management

Ferrer Cardona finds it efficient to be able to treat a range of heterogeneous clots with the PounceTM platform.

“For us, time management is critical. Elective procedures are 60% to 80% of our practice. We schedule these weeks in advance,” he says. “But patients with ALI or ALI and CLI [critical limb ischemia] can’t wait. They present at all times, and you have to treat them in a very time-sensitive manner because the outcomes are worse with delays. So, those two realities have to somehow coexist. That requires time management and efficiency.”

It takes him about 45 minutes to “treat what I’m going to treat with the Pounce system,” he says. “Let’s say I have an emergent patient come with rest pain; if, based on my experience, I feel confident I can get that patient in and out in a timely manner and bring in my other, scheduled patient— and my staff knows that and my cath lab manager knows that—then my flexibility to treat all patients and not have to put some things off and triage some patients increases significantly. Whatever makes that easier, more effective, and more predictable is going to benefit patients and the hospital. You’re using less human capital, you’re using less space, you’re using less time that can be used for treating additional patients.”

A new option for distal embolization

Vascular surgeons have also found significant benefit in using the Pounce platform as a bailout device for distal embolization during planned percutaneous lower-limb interventions. The PounceTM LP (Low-Profile ) Thrombectomy System, introduced in 2024, is intended for use in 2–4mm peripheral arteries, making it suitable for tibial occlusions. The original Pounce system is intended for use in 3.5–6mm arteries.

Christopher Leville

“Embolizing plaque is terrible, and we really have had limited options to get that embolus out,” says Christopher Leville, MD (consultant to Surmodics), a vascular surgeon with the CentraCare-St. Cloud Hospital in St. Cloud, Minnesota. “We used to try to use Export catheters [Medtronic] or other devices, or even a SpiderFX filter [Medtronic] or other devices, but everything was suboptimal. In these situations, you can use the Pounce LP system very quickly, without major setup. You just open the package, get out the embolus, and a major problem is often resolved within minutes without surgical cutdown or another procedure with tPA.”

Leville believes the Pounce platform’s mechanism of action is particularly suited for this application. “What I like about the Pounce platform is that it behaves more like a Fogarty balloon. You start distal to the thrombus and withdraw back, just as you would with a Fogarty. In situations where you’re concerned about distal embolization, it can make more sense to use a Pounce platform. We do Fogarty procedures without wire access all the time—you just thread the catheter down the leg, inflate the balloon, and withdraw the clot. The Pounce platform behaves very much like that. That’s why I use it. The last thing I want to do is to have to convert a case from percutaneous to open surgical or overnight tPA in the intensive care unit if that’s not what we had planned. The Pounce platform gives me a third option.”

References

  1. Gupta R, Siada SS, Bronsert M, Al-Musawi MH, Nehler MR, Jeniann AY. High rates of recurrent revascularization in acute limb ischemia–a national surgical quality improvement program study. Ann Vasc Surg. 2022;87:334–342
  2. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017;69(11):e71–126
  3. Lind B, Morcos O, Ferral H, et al. Endovascular strategies in the management of acute limb ischemia. Vasc Specialist Int. 2019;35(1):4
  4. Ebben HP, Jongkind V, Wisselink W, Hoksbergen AW, Yeung KK. Catheter directed thrombolysis protocols for peripheral arterial occlusions: a systematic review. Eur J Vasc Endovasc Surg. 2019;57(5):667–675
  5. Gray BH, Wheibe E, Dicks AB, Low ML, Tingen JS. Pounce thrombectomy system to treat acute and chronic peripheral arterial occlusions. Ann Vasc Surg. 2023;96:104-114
  6. Acosta S, Karonen E, Eek F, Butt T. Short-term complications and outcomes in Pharmaco-mechanical thrombolysis first and catheter-directed thrombolysis first in patients with acute lower limb ischemia. Ann Vasc Surg. 2023;94:253–262

Case reports

Removal of acute and organized SFA thrombus

Vince Weaver highlights a case in which the thrombus in the left superficial femoral artery (SFA) is tackled.

Patient presentation and diagnostics: A 45-year-old man with a history of embolic and thrombotic events presented with left leg pain of one-week duration. The initial angiogram (Figure 1) showed new arterial thrombus in the mid to distal left SFA.

Thrombectomy: The Pounce system basket wire was deployed distal to the thrombus and the funnel catheter deployed proximal to the thrombus. The baskets were withdrawn into the funnel catheter and the system was removed, completing the first device pass. Balloon angioplasty was also performed to clear residual disease. The final angiogram showed full restoration of SFA flow (Figure 2).

Post-procedure outcome: The patient was discharged the next day. The Pounce system aided in the removal of acute and organized thrombus in one pass.

Removal of organized infrapopliteal arterial thrombus

Lucas Ferrer Cardona presents a case of complete thrombus in below-the-knee arteries.

Patient presentation and diagnostics: A male patient presented with immediate onset of numbness, pain and decreased function in his lower left leg. The initial angiogram showed complete thrombosis of the left popliteal, tibioperoneal trunk (TPT) and tibial arteries (Figure 1).

Thrombectomy: Two Pounce system passes removed organized thrombus from the popliteal artery, but distal flow continued to be hampered by an occlusion in the proximal anterior tibial (AT) artery. One pass with the Pounce LP System resulted in complete removal and resolution of the thrombus burden with improved flow through the AT to the plantar arch (Figure 2).

Post-procedure outcome: The patient was discharged after two days. The combination of Pounce and Pounce LP systems allowed for complete removal of organized thrombus from below-the-knee vessels without the need for thrombolytics or surgical intervention.

Removal of brachial and ulnar artery thrombus

Christopher Leville demonstrates the use of Pounce LP in the upper extremity.

Patient presentation and diagnostics: A man in his late 60s presented with a cold left hand symptomatic for 24 hours. An initial ultrasound showed a partial occlusion of the left ulnar artery (Figure 1) and complete occlusion of the patient’s left brachial artery. The patient was not a candidate for tPA and open surgical thrombectomy was not deemed appropriate.

Thrombectomy: Two Pounce system passes in the mid and distal brachial artery, respectively, were followed by one Pounce LP system pass in the ulnar artery. Final angiograms showed complete resolution of the ulnar artery (Figure 2) and a patent brachial artery, with no embolization to the patient’s hand.

Post-procedure outcome: The patient was discharged the day after the intervention, with instructions to maintain his warfarin regimen for three months. At one-month follow-up, the patient’s brachial and ulnar arteries continued to show patency and good flow.

A version of this article first appeared in Endovascular Today.

Caution: Federal (U.S.) law restricts the Pounce™ Thrombectomy System and Pounce™ LP Thrombectomy System to sale by or on the order of a physician. Please refer to each product’s Instructions for Use for indications, contraindications, warnings and precautions. SURMODICS, POUNCE, and SURMODICS and POUNCE logos are trademarks of Surmodics, Inc., and/or its affiliates. Third-party trademarks are the property of their respective owners.

Pulse IVL system US pivotal trial enrolls first patient

By
Bryan Kay
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0
Pulse IVL system US pivotal trial enrolls first patient
Pulse console

Amplitude Vascular Systems (AVS) recently announced that it has enrolled the first patient in its U.S. pivotal trial for pulsatile intravascular lithotripsy (IVL) therapy.

A press release notes that the POWER PAD II clinical study will evaluate the safety and efficacy of AVS’s Pulse IVL system for the treatment of patients with moderate to severely calcified peripheral arterial disease (PAD). Nicolas W. Shammas, MD, an interventional cardiologist, conducted the first case at UnityPoint Trinity Medical Center in Bettendorf, Iowa.

AVS received an investigational device exemption (IDE) from the Food and Drug Administration (FDA) in June 2024 to begin POWER PAD II. The trial will enroll up to 120 patients who will be followed for up to six months at as many as 20 facilities.

“We found the device to be very deliverable and incredibly efficient at effectively modifying calcium and ultimately restoring blood flow to our patients’ vascular system,” said Shammas, who is also president and director of the Midwest Cardiovascular Research Foundation.

Vascular Specialist–October 2024

By
Bryan Kay
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0
Vascular Specialist–October 2024

In this issue:

  • Endoscopic vein harvest under the microscope
  • Study details aspects of early care improvements after publication of SVS appropriate use criteria for claudication
  • Guest editorial: Jonathan Cardella, MD, and Jean Bismuth, MD, on: “Who harmed who?”
  • Bhagwan Satiani, MD, on: “The not-for-profit hospital clash between mission and revenue”

 

‘Investing in the people of vascular surgery’

By
Bryan Kay
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0
‘Investing in the people of vascular surgery’
Bernadette Aulivola

Outgoing Midwestern Vascular Surgical Society (MVSS) President Bernadette Aulivola, MD, underscored the importance of “investing in the people of vascular surgery—those learning about it and those progressing through their careers”—for the future of the specialty.

At the heart of this investment is mentorship, and, crucially, mentoring early on the training trajectory, she told the 2024 MVSS annual meeting in Chicago (Sept. 12–14).

“We know if we engage medical students early that they have a higher likelihood of applying to surgical residency if they see that [mentorship] early, because the pipeline is super early,” said the division director of vascular surgery and endovascular therapy at Loyola University in Maywood, Illinois.

“One study that took a look at general surgery residents found that about two thirds identified certain qualities within their mentors that made them choose that mentor’s specialty. This is based on the skills and achievements of that mentor, but also that the mentor talked about what they do passionately. So, we should talk about what we do.”

Aulivola also pointed to research showing the overlapping factors that impact a medical student’s decision, such as in the process of experiential learning, or “getting their hands on stuff.” Mentorship played an important role this environment in addition to mentorship alone, she said.

She highlighted one more study that looked at a simulation skills course and the impact it had on the strength of student interest in procedural specialties and vascular surgery. That interest increased throughout the eight-week course—“and that was a durable result,” Aulivola said. Ninety percent who took part attributed their interest to the technical portion and 70% linked it to the mentorship happening while they performed the simulation-based skills, she added.

Contego Medical’s Neuroguard IEP system receives US FDA approval for carotid revascularisation

By
Jocelyn Hudson
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0
Contego Medical’s Neuroguard IEP system receives US FDA approval for carotid revascularisation

Contego Medical today announced the US Food and Drug Administration’s (FDA) premarket approval (PMA) of the Neuroguard IEP system for carotid revascularisation. 

The company shares in a press release that clinical studies of the Neuroguard IEP system, including the PERFORMANCE I trial and PERFORMANCE II investigational device exemption (IDE) trial, have consistently recorded unprecedented low event rates—zero major strokes, zero neurologic deaths, and zero stent thrombosis at 30 days and one year.

William Gray, system chief of the Division of Cardiovascular Diseases at Main Line Health (Wynnewood, USA) and co-national principal investigator of the PERFORMANCE II trial, said in the press release: “FDA approval confirms the results of the clinical studies. The innovative Neuroguard IEP system performs exceptionally well with the lowest one-year stroke rates ever shown for any type of carotid revascularisation, thereby establishing a new standard of care for meaningfully reducing the risk of procedural and long-term stroke among patients with carotid artery disease.”

The Neuroguard IEP system utilises Contego Medical’s Integrated Embolic Protection (IEP) technology, featuring a 40-micron filter integrated on a 6 French delivery catheter. The size of the integrated filter can be adjusted by the operator to custom fit each patient’s unique anatomy, and the pores on the filter are three to four times smaller than those on traditional filters, the company claims, improving protection against stroke and cognitive impairment. According to Conteo Medical, the newest generation closed cell stent is highly conformable and shows remarkable short- and long-term durability, with no thromboses, no clinically driven target lesion revascularisation, and very low restenosis rates at one year.

“This FDA approval is a huge step forward for Contego and for patient care. The Neuroguard IEP system transforms how we approach patients with carotid artery disease by addressing the specific threats of microembolisation while simultaneously reducing procedural steps, ensuring patients receive the highest level of protection throughout the procedure,” said Ravish Sachar, Contego Medical’s chief executive officer and founder. “The ongoing PERFORMANCE III trial is evaluating the Neuroguard IEP system with a next-generation direct transcarotid access and protection system, TCAR-IEP,  to demonstrate advanced stroke protection regardless of vascular approach.”

In 2023, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage decision significantly expanding coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting performed with FDA-approved carotid stents and embolic protection devices. Contego Medical states that this decision and FDA approval of the Neuroguard IEP system positions the company for ongoing growth.

VenaCore device offers long-awaited interventional solution for challenging venous occlusions

By
BIBA Publishing
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0
VenaCore device offers long-awaited interventional solution for challenging venous occlusions
Steven D. Abramowitz

This advertorial is sponsored by Inari Medical.

Despite the recent growth in mechanical thrombectomy devices for acute deep vein thrombosis (DVT), interventional options for wall adherent venous obstruction are extremely limited. Residual venous obstruction after medical or interventional therapy for the treatment of acute DVT is associated with an increased incidence of post-thrombotic syndrome (PTS).1,2 Managing venous obstruction and the associated symptoms at its initial onset remains a challenge for interventionalists. However, as Steven D. Abramowitz, MD, chair and director of vascular surgery for MedStar Health in Washington, D.C., says, a new technology—the VenaCore™ thrombectomy catheter (Inari Medical)—might be able to “change the care algorithm” for patients burdened by the long-term complications of venous obstruction.

“A revolutionary technology like VenaCore addresses a previously unmet procedural need and allows operators to remove venous occlusions from within the vein lumen,” he explains. “As an endovascular tool, it has enough engagement with venous obstruction to remove adherent clot from the vein wall, as well as force to grab post-thrombotic scar tissue. The unique design of the device allows for effective treatment of acute and chronic pathology without harming the vein wall. VenaCore is the first FDA [Food and Drug Administration]- approved device that is designed to address challenging venous occlusions in a wide variety of patients.”

The ClotTriever® (Inari) Outcomes (CLOUT) registry demonstrated that mechanical thrombectomy using the ClotTriever system can have similar procedural success regardless of newly diagnosed DVT chronicity.2 However, removing refractory wall-adherent material can still be challenging. Balloon maceration or other adjuvant techniques can be of limited success. When used with the ClotTriever system, VenaCore can target focal treatment areas of underlying venous obstruction that may reduce the severity of associated complications.

Residual venous outflow obstruction is not only associated with a higher future risk of DVT and pulmonary embolism (PE), but also has a significant impact on a patient’s Villalta score, as well as their venous disease-related disability and quality-of-life outcomes. The pain associated with PTS can be “pretty severe, and lifestyle-limiting,” Abramowitz states, citing venous claudication, ulceration and trophic skin changes as notable symptoms.

“While I utilize VenaCore to improve outcomes in acutely presenting patients, the other patients who benefit from VenaCore-assisted thrombectomy are symptomatic patients who have venous occlusions that are challenging to treat”, says Abramowitz. Many DVT patients are relegated to compression therapy once symptoms begin. For those eligible for iliofemoral stent placement, femoropopliteal inflow disease can limit the likelihood of long-term stent durability and patency.

According to Abramowitz, many PTS patients with poor inflow suffer from poor long-term stent patency outcomes. Balloon venoplasty has therefore represented the most frequent intervention for primary and secondary-assisted patency, but this approach itself is associated with an incredibly “high rate of recurrence” and “very short-lived results.”

“We were doing these procedures with great frequency, with little or no return,” he recalls. “That’s because, as much as you want to balloon the scar tissue ‘out of the way’ in the femoropopliteal segment, all you’re doing is shifting something that’s solid to the side—and it bounces back. It’s not like arterial disease, which can remodel around a treated segment. Venous disease and post-thrombotic scar do not positively remodel.”

Such a lack of interventional options and physicians’ subsequent inclination towards more conservative management has created a huge array of patients who, historically, have disengaged from their vascular specialists and had minimal contact with healthcare beyond that initial recommendation. In Abramowitz’s view, the situation has created a “really unique physician-patient interaction”—both in terms of treatment opportunities and re-education. The VenaCore device represents a leading solution that may ameliorate things for interventionists treating patients with a history of venous disease.

He highlights three distinct patient groups who can now be addressed and for whom the device may open doors: those with prior iliofemoral or femoropopliteal DVT treated with anticoagulation alone with persistent symptoms; those whose stents failed as a result of poor inflow; and those in whom stents would otherwise have been contraindicated due to poor inflow, which can now be restored to allow for iliofemoral stenting.

“VenaCore on its own, and in conjunction with RevCore™ [Inari], truly disrupts all of our current care algorithms when it comes to venous occlusions that are difficult to treat,” Abramowitz says, alluding to the disconcerting fact that many providers have historically been reticent to offer intervention, or even follow-up management in the outpatient setting. “It was essentially seeing somebody every three to six months when you had nothing to offer them. VenaCore not only disrupts the interventional algorithm, but also the care algorithm for these patients, revitalizing and reengaging those patients who’ve been told there are no options.”

VenaCore case report 1

A man in his late 40s was diagnosed with an extensive iliofemoral DVT while traveling five months prior to outpatient consultation with severe symptoms, despite anticoagulation therapy. Mechanical thrombectomy with ClotTriever, despite adjuvant manoeuvres, was only partially successful at removing highly-wall adherent thrombus. VenaCore was used to mobilize additional material within the vein for a technically optimal result.

VenaCore case report 2

A woman in her early 60s who has had PTS for many years presented to the office with hemosiderosis and atrophic blanche. An ultrasound in the femoral vein showed a post-thrombotic scar related to a prior femoropopliteal DVT. The patient was brought in for intervention with VenaCore and underwent a successful procedure with no complications.

References

  1. Iding AFJ et al. Residual venous obstruction as an indicator of clinical outcomes following deep vein thrombosis: A management study. Thromb Haemost. 2023 Aug
  2. Dexter D et al. Safety and effectiveness of mechanical thrombectomy from the fully enrolled multicenter, prospective CLOUT registry. JSCAI. 2023 March

Disclosure: Steven D. Abramowitz is a paid consultant of Inari Medical. All views and opinions expressed here by Abramowitz are his own and do not represent those of Inari Medical.

Indications For Use: The ClotTriever Thrombectomy System in indicated for the (1) non-surgical removal of thrombi and emboli from blood vessels (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature, including deep vein thrombosis (DVT). The VenaCore Thrombectomy Catheter is indicated for (1) The non-surgical removal of thrombi and emboli from blood vessels. (2) Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The VenaCore Thrombectomy Catheter is intended for use in the peripheral vasculature. The RevCore Thrombectomy Catheter is indicated for (1) The non-surgical removal of thrombi and emboli from blood vessels. (2) Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Refer to Indications for Use for complete Indications for Use, contraindications, warnings and precautions. For Indications for Use of non-Inari products, please refer to the manufacturer. All copyrights and trademarks are property of their respective owners.

Laser atherectomy redefined: Breakthrough 355nm technology opens next frontier in treatment

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BIBA Publishing
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0
Laser atherectomy redefined: Breakthrough 355nm technology opens next frontier in treatment

In this supplement, sponsored by AngioDynamics:

  • The storied history behind the Auryon Atherectomy System
  • What micro-CT reveals about the effectiveness of the Auryon laser on medial arterial calcification
  • A mainstay device: Deploying the Auryon laser catheter above and below the knee to treat a diverse array of plaque morphology
  • Combining atherectomy with simultaneous thrombectomy

Research suggests potential link between strenuous physical activity and increased VTE risk in men

By
Éva Malpass
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0
Research suggests potential link between strenuous physical activity and increased VTE risk in men

VTEPublished in the Journal of Thrombosis and Thrombolysis, new research with a follow-up of 27 years has found an association between high levels of physical activity (PA) and an elevated risk of venous thromboembolism (VTE).

The research, led by Per Wändell (Karolinska Institutet, Huddinge, Sweden) and colleagues, was drawn from the Uppsala Longitudinal Study of Adult Men (ULSAM). Their team followed a cohort of 2,294 patients in Uppsala, Sweden who were initially examined at age 50, with data on their PA levels collected over four follow-up periods at ages 60, 70, and 77. After a median follow-up time of 33 years, 186 cases of first-time VTE were recorded, with a total of 68,263 person-years at risk.

Wändell and his team defined activity levels by grade 1–4:

  1. Mainly sedentary behaviour (reading, watching television)
  2. Walking or cycling (for pleasure walking, cycling)
  3. Recreational sports or heavy gardening for at least 3 hours every week
  4. Regularly engage in hard physical training (hard training or participation in competitive sports, regularly and several times a week

Results from the study showed that men with the highest levels of physical activity—defined by the authors as engaging in regular strenuous exercise—had a more than doubled risk of developing VTE (adjusted hazard ratio [HR] of 2.22; 95% confidence interval [CI] 1.05–4.67) compared to those who reported the lowest PA levels. The findings suggest that, while moderate exercise has well-documented health benefits, there may be a point at which intense physical activity could increase VTE risk.

Using Cox regression analysis, Wändell et al adjusted for cardiovascular risk factors such as blood pressure, cholesterol levels, body mass index, diabetes, and smoking. Despite these adjustments, the elevated risk remained significant in the highest PA group.

In their subsequent commentary, the authors write that VTE is the third most common type of cardiovascular disease in Sweden, with a marked increased risk with age. Although low levels of exercise are associated with higher cardiovascular disease and VTE risk, there have been documented cases of cardiovascular events occurring after strenuous exercise, such as sudden cardiac death in long-distance running.

In men, the increased risk of VTE is may be due to that exercise sessions including long and vigorous extreme exertion is associated with an imbalance between pro-thrombotic and fibrinolytic factors, thus causing hypercoagulability together with a weakened fibrinolysis. Other possible explanations include a more pronounced effect on platelet function during strenuous exercise, or dehydration which increases blood viscosity, therefore causing a higher clotting probability, the authors explain.

The study authors acknowledge limitations of their study, including the relatively small sample size and the use of self-reported physical activity data, which may have led to misclassification of activity levels. They state that their variables do not provide absolute predictors of VTE due to the potential for unaccounted factors, yet they contend that their lengthy follow-up period and careful patient examination bolster their results.

The researchers emphasise that clinicians should be aware of the possible risk of VTE in patients engaging in high levels of strenuous exercise on a regular basis, as to not delay diagnosis and treatment. Further, for individuals taking part in marathons or ultra competitions, they add that spreading awareness of the early signs of VTE is crucial.

Bioprosthetic venous valve imparts sustained clinical improvement at one year regardless of CEAP category

By
Bryan Kay
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0
Bioprosthetic venous valve imparts sustained clinical improvement at one year regardless of CEAP category
Raghu Motaganahalli

A new paper that drills into the impact of a novel bioprosthetic venous valve replacement by CEAP (Clinical, Etiological, Anatomical and Pathophysiological) classification shows sustained clinical improvement regardless of grading, with patients classed as C4b exhibiting greater resolution of symptoms and quicker ulcer healing within the first three months after implantation than those with more advanced disease.

The findings emerged during the 2024 Midwestern Vascular Surgical Society (MVSS) annual meeting in Chicago (Sept. 12–14) in the latest analysis of the SAVVE (Surgical Antireflux Venous Valve Endoprosthesis) multicenter pivotal trial assessing the safety and efficacy of the VenoValve (enVVeno Medical) in patients with chronic venous insufficiency.

The fully enrolled trial—made up of 75 patients across 21 sites in the U.S.—measures disease in CEAP categories C4b, C4c, C5 and C6. The paper presented at MVSS 2024 sought to elucidate how the valve affects disease severity, pain levels, quality of life and ulcer healing at the point of enrollment out to 12-month follow-up.

C6 patients comprised 50% of the study population. “What was interesting to see here was that 70% of the patients who were enrolled in the study had a nonhealing ulcer for more than a year or so,” Raghu Motaganahalli, MD, a SAVVE trial principal investigator who is chief of vascular surgery and program director at Indiana University in Indianapolis, told MVSS 2024. He reported primary and secondary patency rates for the valve of 87% and 96%, respectively, adding that there were four reinterventions and no procedural-related deaths or device-related infections. Benefits from device implantation in terms of venous reflux time were seen after three months and significantly decreased, he added.

In terms of clinical improvement by CEAP classification, Motaganahalli reported improvements in revised Venous Clinical Severity Score (rVCSS) across CEAP categories at three- and six-month follow-up. Compared to the baseline, he said there was an overall 9-point gain in rVCSS at 12-month follow-up after valve implantation. Visual Analogue Score (VAS) for pain assessment improved by almost 50% at one year, Motaganahalli continued, and quality of life, as measured by the VEINES-QOL/Sym instrument, also “significantly improved” across the CEAP spectrum.

Motaganahalli also noted a decrease in the use and need for compression stockings in tandem with the increase in patient quality of life. Meanwhile, ulcer area was reduced from 18.16cm2 at baseline to 3cm2. “It was also interesting to see that if a patient has an ulcer for less than three months, they have a 100% resolution of the ulceration over time,” Motaganahalli added.

Concluding, he said: “For patients with chronic venous insufficiency, the VenoValve was a novel treatment option. It has shown improvement by rVCSS, we have seen a reduction in pain as evidenced by VAS, ulcers heal, limb swelling is improved by the VEINES-QOL/Sym score, and all improvements are shown within the first three months of the clinical period.”

During discussion, Motaganahalli highlighted how the paper helps draw attention to optimal intervention points. “By the time you transition from a C4b, or a C4c, to a C6 category, you have a lot of damage in those patients,” he said. “That is exactly the purpose of this paper: to see where to intervene and when to intervene. In fact, the C4b category patients had more resolution of their symptoms. Ulcers heal much more quickly in that group of patients—they were the ones to improve within the three-month window—as opposed to much more advanced disease.”

InspireMD receives IDE approval from FDA for CGUARDIANS II pivotal trial

By
Bryan Kay
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0
InspireMD receives IDE approval from FDA for CGUARDIANS II pivotal trial

InspireMD has announced that the Food and Drug Administration (FDA) approval of the company’s investigational device exemption (IDE) application to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm carotid stent system during transcarotid artery revascularization (TCAR) procedures.

In February 2024, InspireMD announced that professor of surgery and radiology Patrick Geraghty, MD, from Washington University School of Medicine in St. Louis, and program director and chief of vascular surgery Patrick Muck, MD, from Good Samaritan Hospital in Cincinnati, Ohio, have agreed to act as lead investigators for the trial.

Smoking: BEST-CLI trial points to protective effect against MALE in those undergoing open bypass over endovascular intervention

By
Bryan Kay
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0
Smoking: BEST-CLI trial points to protective effect against MALE in those undergoing open bypass over endovascular intervention
OLYMPUS DIGITAL CAMERA
Rohini Patel

An analysis of the BEST-CLI randomized controlled trial (RCT) found that smokers with chronic limb-threatening ischemia (CLTI) should be preferentially treated with open bypass over endovascular intervention.

Researchers from the University of California San Diego (UCSD) looked at BEST-CLI patients stratified into two groups related to smoking status—current smokers and non-smokers (a combination of never smokers and former smokers)—and discovered the paradox of the smokers’ effect: current smokers among those who underwent a bypass and those who received an endovascular procedure had better overall survival than non-smokers. However, the UCSD study revealed that the current smokers who got a bypass “had this protective effect against major adverse limb events (MALE) and we didn’t see that in the endovascular group,” presenting author Rohini Patel, MD, a general surgery resident at UCSD, tells Vascular Specialist after delivering results from the analysis at the 2024 Western Vascular Society (WVS) annual meeting in Colorado Springs, Colorado (Sept. 7–10).

Having previously looked at smoking in peripheral arterial disease (PAD) patients through the lens of the Vascular Quality Initiative (VQI) and finding that former smokers and never smokers had similar outcomes to one another, and that current smokers had worse outcomes than former smokers, the research team increasingly leant on the theory that, if they could get smokers to quit their habit, then they could have similar outcomes to people who never smoked.

“Our theory was that in patients who could have either an endovascular approach or an open approach—which is not every patient, but in the ones who could—that maybe we should really be doing an open approach in them first, because it tends to protect, at least in BEST-CLI, against major adverse limb events,” Patel explains.

The perennial mission to instigate smoking cessation, either though pharmacotherapy, counseling or regular physician interaction on the topic, remains important, Patel says, but “the reality is that a lot of these patients are going to continue smoking, so the thought is, knowing that information, what can we do? Is there something we can do that would maybe be better? That’s where our analysis has led us—to an open bypass as maybe a preferential treatment in these patients if they are still going to continue smoking.”

Looking ahead, Patel says BEST-CLI is laden with more nuanced data on smoking than the VQI, suggesting the trial might help yield further evidence around pack years and the extent of former smokers’ habits. Determining the optimal interval for smoking cessation is another potential area of future study, she adds.

Andrew Barleben

Andrew Barleben, MD, an associate professor of vascular and endovascular surgery at UCSD and senior author of the analysis, points to the unique vantage point brought by vascular surgery to this patient population.

“This helps us know a little bit more that vascular surgery provides a unique capability to do both open or endovascular surgery on these patients,” he says, “and that it emboldens our practitioners who help with care for these patients on the interventional side. To this end, they can—hopefully—easily get a venous ultrasound to see if there is an available vein for these patients, who may have difficulty quitting smoking or may intermittently quit smoking, and achieve better outcomes than if they just underwent endovascular intervention.”

A team sport: A prescription for the future of vascular surgery

By
Bryan Kay
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0
A team sport: A prescription for the future of vascular surgery
Kathleen Ozsvath

Outgoing Eastern Vascular Society (EVS) President Kathleen Ozsvath, MD, used her presidential swansong to address the needs of those practicing the specialty moving forward, combining themes of family, collaboration, and diversity, equity and inclusion.

Ozsvath, who serves as chief of surgery at Samaritan Hospital in Troy, New York, set the tone by invoking elements of her own story and career journey: a family history that includes highly successful immigrant parents; a feeling early in life of not fitting in; and an odyssey into vascular surgery that, at first blush, was discouraged by those who would be her mentors.

In her EVS 2024 presidential address “Vascular surgery: An EVS team sport and family affair combined with finding your superpower,” Ozsvath provided a prescription for change in a specialty increasingly made up of a more diverse workforce and facing a rising tide of vascular disease.

Ozsvath is the child of Hungarian parents: her father, Istvan, was a celebrated theoretical mathematician, and her mother, Zsuzsanna, a professor of literature and the history of ideas, and a Holocaust survivor.

Ozsvath told those gathered for the address, which took place during the 2024 EVS annual meeting in Charleston, South Carolina (Sept. 19–22), how she found elements of her own experience in a book she recently finished reading that was authored by the first-ever Native American woman surgeon: In it, “the concept of not fitting in during her younger teenage years, and also coming from a family whose very existence was almost eradicated,” spoke to her about belonging to a family in the filial sense but also to “groups of families,” like the EVS.

Ozsvath urged the next generation of vascular surgeons—both trainees and medical students—to pursue their dreams and to ignore any naysayers who may be attempting to discourage them. At the outset of her journey in medicine in Dallas, Texas, she described how she faced down her own version of discouragement. “As a medical student, I was told I couldn’t be a surgeon because I’m a female,” she said. “Of course, I smiled, said, ‘Thank you, sir,’ and went to New York.”

Ozsvath cast an eye over a profession in transition but with challenges to be tackled. “The patriarchal system of learning in surgical training still exists today; we carry forward with our forefathers upon us. However, the conversation now is becoming very loud and very clear: that we need change, to embrace our differences and the differences of our patients, and to create better training programs and better academic societies like this one, and to create better work environments.”

The specialty faces dual concerns around gender and racial equity issues, both within the workforce and in the patient population, as, now, publications and research in these areas gather apace, Ozsvath noted.

“Our patients need a nurturing environment to feel safe and share,” she said. “We need to understand and better embrace their cultural differences to be their doctors. It is our responsibility to translate, and speak in the language that our patients understand, these daunting procedures that we have to offer. Learning from one another about our differences will make us better people, better doctors, better humans and, more important, better family members.”

Medinol announces first-in-human implantation of drug-eluting peripheral stent in Australia

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Bryan Kay
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Medinol announces first-in-human implantation of drug-eluting peripheral stent in Australia

Medinol has announced the successful first-in-human implantation of the ChampioNIR drug-eluting peripheral stent by Gerard S. Goh, MD, head of interventional radiology, and Thodur Vasudevan, MBBS, a vascular surgeon, both from the Alfred Hospital in Melbourne, Australia.

The ChampioNIR drug-eluting peripheral stent poses a transformational technology designed to improve patient outcomes and procedural success. In a first-of-its-kind hybrid mechanical design, radial support is provided by the metallic component of the stent, whereas longitudinal structure is provided by a bioresorbable polymeric mesh providing unsurpassed flexibility and long-term durability in even the most challenging anatomies.

Furthermore, a unique drug-elution paradigm releases drug from the entire cylindrical area of the stent, drastically reducing diffusion distances and allowing, for the first time, therapeutic dosing of a large peripheral vessel with a limus drug for an extended period of time.

“We were impressed with ChampioNIR’s deliverability and its straightforward deployment”, said Goh. “The frictionless deployment mechanism made the precise positioning of the stent very straightforward.”

The CHAMPIONSHIP study will enrol a total of 30 patients across seven sites in Australia and the U.S. Sahil Parikh, MD, an intervention al cardiologist at Columbia University Irving Medical Center in New York City and principal investigator of the CHAMPIONSHIP study commented: “The ChampioNIR stent represents a breakthrough in treatment for superficial femoral artery [SFA] lesions. I am excited to see this device come to life after years of development.”

Carotid intervention linked to improved survival versus medical management in symptomatic patients 

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Carotid intervention linked to improved survival versus medical management in symptomatic patients 
Manar Khashram (left) and Eric T.A. Lim

New study data suggest that the interventional treatment of symptomatic carotid artery disease may result in an improved rate of age-adjusted overall survival compared to medical management. However, the same study—presented at this year’s European Society for Vascular Surgery (ESVS) annual meeting (Sept. 24–27) in Kraków, Poland—also indicates a relatively low future ipsilateral stroke risk among patients who were not offered carotid intervention, highlighting medical management’s importance as a standalone strategy in patients deemed to be ‘high risk’ if treated via intervention.

Findings from the study in question were delivered by Eric T.A. Lim, MBChB, from the Department of Vascular & Endovascular Surgery at Waikato Hospital, Hamilton, New Zealand, on behalf of Manar Khashram, MBChB, from the same institution, and other investigators, in an abstract presentation at ESVS 2024.

Lim et al‘s prospective, observational study—undertaken in a single vascular tertiary referral center in New Zealand—aimed to assess the outcomes of symptomatic carotid artery stenosis cases that were managed non-operatively. The study was carried out from June 2019 to January 2024.

According to the investigators, patients who underwent carotid intervention had a 0.25 (0.17–0.5) hazard ratio of survival compared to patients managed conservatively—when adjusted for age. The overall survival rates at one and four years were 88% and 57%, respectively, and corresponding ipsilateral stroke-free survival rates at both one and four years were 97% in the medically managed patient group.

Cook Medical creates custom-made aortic device for fenestrated FET procedure

By
Bryan Kay
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Cook Medical creates custom-made aortic device for fenestrated FET procedure
François Dagenais

Cook Medical this week announced that it has created a custom-made device for the frozen elephant trunk (FET) aortic procedure. 

A press release details that, earlier this year, cardiothoracic surgeon François Dagenais, MD, from the Quebec Heart and Lung Institute in Quebec City, Canada, approached Cook Medical. One of his patients had severe complex aortic arch disease. He explained that he needed to perform a FET procedure on the patient but wondered if it could be done with some innovative and different techniques. He asked if Cook could extend to the descending thoracic aorta and include a unique fenestration for the left subclavian artery (LSA).

Cook Medical describes a FET procedure as a hybrid technique that combines surgically replacing the aortic arch while simultaneously stenting the descending thoracic aorta. Patients requiring FET procedures often have complex aortic arch disease. One of the significant benefits of using an FET procedure, the company notes, is that it enables the physician to complete the aortic repair in a single operation instead of multiple operations.  

According to Cook Medical, a FET procedure had never before been performed with a custom-made device that had a fenestration. Adding a fenestration in the aortic graft removed the need for surgical intervention for the LSA vessel, allowing for a smooth endovascular LSA stenting and a streamlined, more minimally invasive procedure. 

“We performed the world’s first procedure using a fenestrated frozen elephant trunk device. This unique case was designed through Cook Medical’s custom-made device program. During FET procedures, the LSA can be challenging to access surgically. Using an endovascular technique to revascularize the LSA through a pre-designed fenestration within the FET graft facilitates the procedure, decreases operative time and minimizes the complication rate of the FET procedure,” Dagenais commented.

He continued: “The development of this unique FET device is an example of collaboration between clinicians and the expertise of Cook Medical in fenestrated graft technology. Many thanks to Cook Medical for your support; one more step forward in our journey of innovation for the best interest of patient care.”

The top 10 most popular Vascular Specialist stories of September 2024

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The top 10 most popular Vascular Specialist stories of September 2024

top 10In September, the most read stories from Vascular Specialist included a change in leadership for the Midwestern Vascular Surgical Society; study results examining new treatment options for chronic limb-threatening ischemia (CLTI) patients; a call for more Spanish-speaking vascular surgeons, and several more. 

1. Muck takes over Midwestern Vascular Surgical Society presidency

Patrick Muck, MD, assumed the reins of the Midwestern Vascular Surgical Society (MVSS) at the conclusion of the 2024 MVSS annual meeting in Chicago (Sept. 12–14).

2. Are we overtreating aortic aneurysms in the elderly?

A large meta-analysis of elective endovascular aneurysm repair (EVAR) outcomes by age showed that three-to-five-year survival is very low in octogenarians, prompting researchers to caution against routine intervention in these patients.

3. The good, the bad and the bloody: Reflections on the road to residency

Blake Murphy, a third-year resident, reflects on her experiences as a resident, stating that “that little thing called The Match feels like a distant fever dream” and that “the memories of Electronic Residency Application Service (ERAS) application anxiety now tinted with the rose-colored glasses of a surgical resident entering her much-needed research years”.

4. Study sheds light on vascular-specific advanced practice provider experience

A survey showed that over 200 U.S. advanced practice providers (APPs) in vascular surgery cited performing at the top of their license as the most important determinant of job satisfaction.

5. Abou-Zamzam assumes Western Vascular Society reins

Ahmed Abou-Zamzam Jr., MD, has taken over the as the 2024–25 president of the Western Vascular Society (WVS).

6. ‘Select CLTI patients may be safely treated in the office-based lab’

Results from a single-center analysis show the outpatient setting met SVS objective performance goals.

7. VQI analysis of CLTI practice following BEST-CLI finds no pick up in bypass rate

A Vascular Quality Initiative (VQI) analysis of evolving practice in the wake of the BEST-CLI trial demonstrated no increase in the rate of surgical bypass in the year afterwards.

8. Our patients need more Spanish-speaking vascular surgeons: An argument for medical Spanish in residency

Since there are more than 40 million Spanish speakers in the United States, training more bilingual physicians could potentially improve equitable care in Latino communities, according to an article published on July 18, 2023, by the Association of American Medical Colleges (AAMC).

9. SVS announces merger creating Section on Ambulatory Vascular Care

 The Society for Vascular Surgery (SVS) announced the merger of its Section on Outpatient and Office Vascular Care (SOOVC) and the Community Practice Section (CPS), marking the creation of the new Section on Ambulatory Vascular Care (SAVC), which is set to launch in early fall.

10. Who’s covering second? Rogue hospital human resource departments

In the September issue of Vascular Specialist, editor Arthur E. Palamara examined what he referred to as “rogue hospital human resource departments”.

Surmodics receives FDA 510(k) clearance for Pounce XL thrombectomy system

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Bryan Kay
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Surmodics receives FDA 510(k) clearance for Pounce XL thrombectomy system

Pounce LPSurmodics has announced that it has received Food and Drug Administration (FDA) 510(k) clearance for its Pounce XL thrombectomy system.

The Pounce system is indicated for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10mm in diameter, making it suitable for iliac, femoral and other arteries within this range. The Pounce XL thrombectomy system increases the size range of the Pounce platform, which also includes the thrombectomy system, indicated for 3.5–6mm peripheral arteries, and the Pounce Low Profile (LP) thrombectomy system, indicated for 2–4mm peripheral arteries. The Pounce thrombectomy system and Pounce LP thrombectomy system were introduced in 2021 and 2024, respectively.

Surmodics expects to initiate limited market release for the Pounce XL thrombectomy system in the first half of 2025, with commercialization planned following the completion of the limited market release.

Novel AI-assisted DVT diagnostic pathway aims to ‘democratize’ point-of-care ultrasound

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Jocelyn Hudson
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Novel AI-assisted DVT diagnostic pathway aims to ‘democratize’ point-of-care ultrasound
Efthymios (Makis) Avgerinos

A new deep vein thrombosis (DVT) diagnostic pathway incorporating non-expert artificial intelligence (AI)-guided compression ultrasound could reduce workload and costs for healthcare systems while providing a quicker diagnosis and improving patient care.

Efthymios (Makis) Avgerinos, MD, of Athens, Greece, shared this key conclusion from a pilot study of the ThinkSono guidance system (ThinkSono) at the 2024 European Society for Vascular Surgery (ESVS) annual meeting (Sept. 24–27) in Kraków, Poland.

“The diagnosis of DVT in a tertiary setting is part of a complicated clinical pathway including clinical probability scoring, D-dimer testing and a full duplex scan, often leading to long waiting times,” Avgerinos—who is co-director of the Clinic of Vascular and Endovascular Surgery at Athens Medical Group and visiting professor of vascular surgery at the University of Athens in Greece—told Venous News ahead of the ESVS meeting. He added that the need to have trained radiologists or sonographers available 24/7 incurs high costs and represents a “suboptimal use of resources”.

The ThinkSono system, Avgerinos explained, is based on the point-of-care ultrasound concept and eliminates the need for an expert operator and the absolute need to perform a standard duplex. “It is an AI-based software that you can install on your cell phone or tablet and will guide a non-expert on how to perform a compression ultrasound using a wireless probe,” he continued.

In their pilot study of the ThinkSono system, Avgerinos and colleagues set out to evaluate its clinical utilisation in real-world practice—having previously demonstrated its ability to generate valid images—hoping to show that the system could spare the need for standard venous duplex.

The researchers prospectively enrolled 53 patients who were suspected to have a DVT. These patients underwent a ThinkSono scan, performed by a nurse or resident in the emergency room, with the resulting images then reviewed remotely by the on-call radiologist. D-dimer testing was also performed as a safety measure.

Avgerinos shared that all 53 scans generated were of appropriate quality to be read by the radiologist. “This is a great milestone for an AI technology in the hands of non-experts,” he told Venous News, going on to reveal that 89% of the scans were negative for DVT. The team managed to discharge one-third of the patients without performing any standard duplex scan, which Avgerinos commented represents significant cost and time savings.

Six out of eight suspected DVTs were confirmed on standard duplex to be real, with the ThinkSono technology not missing a diagnosis. “Interestingly enough,” Avgerinos added, “all positive D-dimer testing patients who had a negative ThinkSono scan were also eventually negative, indicating D-dimer has a very low specificity and is not really a powerful testing method to rule in DVT.”

ThinkSono software

Avgerinos continued that it took on average six and a half minutes in total for scan and review. The median length of time between scan and review was 30 minutes, although there was a wide variation in this figure. According to Avgerinos, this “reflects unoptimized hospital logistics—mainly the availability of the qualified clinician to review the data”. He clarified that the expert clinicians who took part in the pilot study were volunteers who had various other clinical lab duties, going on to suggest that careful resource planning or the use of dedicated reviewers could help to maximize the efficiency of the AI-assisted pathway.

Avgerinos summarized: “Our study demonstrated that in DVT diagnostic workflow, using AI and remote expert review could safely decrease the need for a full duplex ultrasound and even D-dimer testing for a significant proportion of the patients who are suspected to have a DVT in the emergency room.”

Looking ahead, he noted that a large trial is needed to validate the results of this pilot study, and that clinical commercialization will soon launch in the UK and Germany, while a Food and Drug Administration (FDA) trial is underway in the U.S.

Finally, Avgerinos considered the wider application of this technology. While the pilot study focused on tertiary centers, he hinted at its potential future use in community hospitals and ambulatory centers. “Not a lot of hospitals have radiologists who can perform standard duplex scans 24/7,” he said. “With this technology, patients would not need to travel to the reference centers. A nurse at the community hospital, a nurse at the GP’s office or at the ambulatory centre could perform the scan and an expert could review it remotely from the main hospital. The application eventually expands to any remote or rural underserved area, essentially democratizing ultrasound—anybody can do it, anywhere.”

SVS president champions continuity, collaboration and unified future

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SVS president champions continuity, collaboration and unified future
Matthew Eagleton, MD

As Matthew Eagleton, MD, continues with the duties of president of the Society for Vascular Surgery (SVS), his vision for the organization extends well beyond his year-long term. Eagleton brought a wealth of experience to the position, not only from his current role as system chief of vascular and endovascular surgery for Mass Gener­al Brigham and co-director of the Fireman Vascular Center at Massachusetts General Hospital, but also from his years of dedica­tion to advancing vascular care and educa­tion. However, his approach to leadership emphasizes continuity, collaboration and a commitment to long-term goals that surpass the influence of any single president.

Reflecting on his journey, Eagleton traces his passion for vascular surgery back to his roots in upstate New York, where he grew up in a small farming community near Rochester. Influenced by his father, a retail pharmacist, and his mother, a high school science teacher, Eagleton’s early exposure to medicine laid the foundation for his future career. After receiving his medical degree and completing his general surgery residen­cy at the University of Rochester, he further specialized in vascular surgery at the Univer­sity of Michigan. This journey through these institutions and his advanced training at the Cleveland Clinic, where he became a leader in the field, is one he credits in shaping his perspective on surgery and leadership.

Throughout his career, Eagleton has been guided by numerous mentors, from Seymour Schwartz, MD, who sparked his interest in surgery, to vascular surgery pi­oneers like James DeWeese, MD, Richard Green, MD, and Ken Ouriel, MD. These influences not only guided his professional path but also instilled in him the importance of mentorship, collaboration and long-term planning—principles that now inform his leadership at the SVS.

One of the key messages Eagleton empha­sizes is that the role of SVS president cannot be viewed as an isolated position of power. Instead, it is part of a larger, ongoing effort that requires the collective wisdom and con­tributions of the entire SVS Executive Board, the SVS Strategic Board of Directors and the membership.

“Each president has the opportunity to champion specific issues that can provide immediate improvement in our ability to provide quality vascular care,” said Eagleton. “In addition, we have invested in a number of projects, as part of our long-term strate­gic plan defined by the Strategic Board of Directors, that we must not lose focus on as they will have a tremendous impact on the future of vascular care globally.”

Eagleton is acutely aware of the challenges that come with leader­ship transitions and the poten­tial for disruption in long-term initiatives. He stresses the im­portance of continuity within SVS leadership, ensuring that the Society’s core objectives— improving patient care and serving its membership—remain steadfast despite changes in administration. This commitment to continuity is re­flected in the way the SVS Executive Board (EB) operates, providing critical guidance to the president on key decisions, helping to maintain focus on the Society’s mission and ensuring that the SVS remains aligned with the needs of its diverse membership.

“Anytime there is a major issue, it’s not the president alone who makes decisions about what we’re doing,” Eagleton explains. “The EB functions critically, providing guidance on how we should react, what we should invest in and what to avoid. It’s im­portant that we have diverse voic­es within the Executive Board so that we can understand the many different facets and interests of the SVS.”

This emphasis on diversity and collaboration within the leadership team is essential to Eagleton’s vision of a more unified Society. He recog­nizes that the SVS represents a wide range of vascular surgeons, from those in private practice to those in academic set­tings, and that the Society must find ways to bring these different groups together. As Joseph Mills, MD, highlighted in his 2024 SVS presidential address, unity is key to de­termining the future of the specialty, and it is a message he intends to continue to cham­pion throughout his presidency. In addition to fostering unity, Eagleton is focused on en­suring that the SVS plays a larger role in the global political dynamics of vascular care. He sees the SVS as a crucial voice in advo­cating for the specialty. A major part of this effort will involve an education campaign to help the world better understand what vascular surgeons offer.

As Eagleton embarks on his year as SVS president, his vision is clear: leadership is not about short-term gains or individual achievements but about guiding the Soci­ety toward a future where vascular surgery is better understood, more unified and more impactful. Through collaboration, continui­ty, and a commitment to the long-term goals of the SVS, Eagleton hopes to leave a lasting legacy that benefits both the Society and the patients it serves.

“Our vision is longer than my 12-month term. We need to focus on this goal, and it’s up to all of us in leadership to ensure that SVS stays on track to achieve it,” said Eagleton.

APDVS launches vascular surgery curriculum e-book for medical students

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Marlén Gomez
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APDVS launches vascular surgery curriculum e-book for medical students

The Association of Program Directors in Vascular Surgery (APDVS) has released a new ebook designed to enhance vascular surgery education for medical students. According to developers, the aim of The APDVS Medical Student Curriculum is to broaden the medical student’s clerkship curriculum, in line with the APDVS’s goal to provide a solid foundation in vascular sur­gery pathology and treatment.

“Unfortunately, the notion that assessment drives educa­tion holds true. Vascular surgery has very limited represen­tation on the surgery shelf and Step exams and so finding the motivation to study vascular topics can be tough. For students on vascular surgery rotations, intrinsic motivation plays an equal if not larger role than extrinsic motivation. We created a resource that makes intrinsically motivated vascular surgery studying accessible, level-appropriate and interesting,” said Ezra Schwartz, MD, co-editor and lead developer of the project.

The ebook covers key domains of vascular surgery, of­fering both the fundamentals and opportunities for deeper dives. Originally published in January 2023, the APDVS Med­ical Student Curriculum project was years in the making. The idea was born from research spearheaded by Chelsea Dorsey, MD, of the University of Chicago, where she did a national needs assessment to understand the curriculum for medical students.

The results revealed that neither the American College of Surgeons (ACS) nor the Society for Vascular Surgery (SVS) provided curriculum recommendations for medical students rotating on a vascular surgery service, resulting in a gap in education geared towards medical students with minimal knowledge of vascular services.

Two studies by Dorsey et al are particularly relevant to the goals of the ebook: “Vascular surgery curriculum for medical students: A national targeted needs assessment” and “The value of a vascular surgery curriculum for clinical medical students: Results of a national survey of nonvascular educators.”

“[These articles] demonstrate the need to have a standard­ized curriculum and use the Delphi method to determine the topics that we should prioritize,” said Schwartz.

Critical contributors have supported the ebook’s devel­opment, including Sharif Ellozy, MD, director of the New York Presbyterian Hospital (Columbia and Cornell Campus); Adam Johnson, MD, of Duke Health, the Audible Bleeding Vas­cular Surgery Exam Prep project and the SVS Resident Stu-dent Outreach Committee (RSOC). Additionally, Schwartz credits his thesis mentor, Traci Wolbrink, MD, of Boston Children’s Hospital, founder of the modular online learning platform OPENPediatrics.

The ebook includes supplementary materials, such as slide decks, pre- and post-reading questions and teaching cases developed by the APDVS in addition to highlighting highly relevant outside content such as Audible Bleeding podcast ep­isodes. One advantage of publishing an ebook is the ease of releasing updates, with the title set to continue to create and share additional slide decks, questions and podcast episodes, the developers said.

“We strive to present each chapter in the preferred modal­ities for every learner type. This means sharing the informa­tion in a traditional textbook style, a PowerPoint presenta­tion, a podcast, etc. We want students to be able to learn the material on their way to the hospital if they’re biking or on public transportation,” summarized Schwartz.

“We want to cover all learning styles because everyone learns differently, and time is a limited resource in the life of a medical student. We want to make sure that people can learn vascular surgery in the way they prefer.”

There are three main points developers hope to convey to the vascular community: that the ebook is comprehensive, utilitarian and concise.

“As vascular surgery continues to evolve and differentiate itself from general surgery, the surgical curricula at many medical schools can leave students poorly equipped to have meaningful discussions about complex issues in vascular surgery,” said Mark Basilious, a fourth-year medical student at Weill Cornell Medical College in New York City and co-ed­itor of the ebook. “This resource is an effort to democratize knowledge in this niche field and make it accessible to train­ees everywhere. We are deeply grateful for the enormous contributions of our student and trainee authors, and we extend our heartfelt thanks to our expert senior authors for volunteering their time to review the product as it rolls out.”

Drayson Campbell, a fourth-year medical student at the Ohio State University College of Medicine, feels the oppor­tunity to contribute to a practical, convenient and accessible resource for medical students like himself has been incredibly fulfilling. Based on his experience, transitioning from stan­dardized pre-clinical curricula to caring for vascular surgery patients has presented a steep learning curve.

“Numerous challenges exist in navigating the complex practice guidelines written for trainees and attending vascu­lar surgeons, and these are amplified by the gap in medical education. The ability to contribute to a resource written for medical students in their clinical years to facilitate the next generation’s transition has been a satisfying way to give back to the community that has given me so much,” said Campbell.

To learn more about the needs assessment research, visit vascular.org/APDVS-ebook.

Government Grand Rounds: A call to action for the 119th Congress

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Andrew Kenney
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Government Grand Rounds: A call to action for the 119th Congress

A foundational element for effective advocacy is understanding the profound impact that legislative decisions have on the practice of medicine and the health of our patients. The retirement announcements of several key members of Congress from the “Doc Caucus” present both a challenge and an opportunity as we approach the 119th Congress.

The Doc Caucus, a group of Republican physician-legislators, brought firsthand experience to Capitol Hill. This group has also established a mechanism for lawmakers to directly educate their peers on the real-life impact of health-related policies. The Doc Caucus has been a vital voice in Congress, ensuring that the perspectives of healthcare providers are considered in legislative decisions. These physician-legislators understood the unique challenges of balancing patient care with the regulatory and financial constraints imposed by federal policies. The Doc Caucus has been at the forefront of efforts to address the unsustainable Medicare payment system, advocating for reforms that ensure fair reimbursement for physicians while maintaining access to care for seniors.

With the retirement of several of these influential members, there is a risk that the voice of physicians in Congress could be diminished. However, this is not a time for retreat—it is a call to action. As we look ahead to the 119th Congress, it is imperative that the Society for Vascular Surgery (SVS) and the broader medical community remain actively engaged in the legislative process. We must ensure that the needs and concerns of our profession continue to be heard. We must build relationships with new members of Congress, particularly those who may not have a healthcare background. It is essential to educate them on the challenges we face and the impact of their decisions on patient care. Our input is crucial to crafting policies that support both physicians and patients.

We also need to become more aggressive in identifying and supporting candidates with health-related backgrounds. As we look toward the January 2025 start of the 119th Congress, we must mobilize members to be active participants in the political process. Whether through letter-writing campaigns, or visits to Capitol Hill, every effort counts. Collective action can drive significant change.

The departure of crucial Doc Caucus members may initially be viewed as a challenge to overcome, but it also opens the door for new opportunities. By staying engaged, informed, and active, we can continue to advocate for the policies that protect patients and the profession. Let us recommit to our role as advocates for vascular surgery and the broader medical community. The future of healthcare depends on our continued involvement and leadership.

Andrew Kenney is a member of the SVS advocacy staff, representing the Society in Washington, D.C.

The CLTI conundrum: My spirited journey through the CLTI saga

By
Omid Jazaeri
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The CLTI conundrum: My spirited journey through the CLTI saga
Omid Jazaeri

Welcome to the CLTI Chronicles, a saga of mystery, medi­cine and misadventures in limb salvage unfolding weekly in my office, where the drama of threatened limbs rivals any Latin telenovela. My clinic has become a crossroads for the second opinion seek­ers, the exclusive club of the limb-threatened, each bearing the mysterious mark of CLTI—critical or chronic limb-threatening ischemia, who can say?—a definition that looms like a shadow and is as elusive as a politician’s promise.

Imagine this: A parade of patients, each with a medical history reading like a travelogue through the land of “100% successful interventions.” They’ve journeyed through the valleys of endovascular treatments, scaled the mountains of open surgeries, and been guided by a motley crew of vascular magicians and interventionalist du jour. Yet, here they are, in my office, still sporting their troublesome limbs like unwelcome souvenirs from a trip gone wrong. After a forensic dive into their histories, imaging and procedures, the twist emerges—the majority did not have CLTI as their opening act.

But wait, there’s more to this plot. It seems there’s a CLTI epidemic sweeping the nation, and it’s not just confined to the realms of vascular journals or my office; it’s trending on social media as well. You’ve seen the angiograms, those before-and-after images where you can’t help but wonder: “Really? Was that truly CLTI?” It’s a diagnosis in vogue and it appears my community has become the unofficial epicenter of CLTI, defying statistical probabilities where CLTI represents 10% of patients with peripheral arterial disease (PAD). But beneath the surface lies a narrative steeped in gravity: amputation risk as high at 40% in six months and an all-cause mortality rate of 70% in five years that overshadow colorectal cancer, breast cancer, stroke and coronary artery disease. CLTI is not just a hashtag; it’s a killer outshining the darkest plots of a Stephen King novel.

Then came that moment of reckoning. A patient asked me an innocent question: “What is CLTI?” I was dumbstruck, my mind a vortex of nothingness. Eventually, I managed to mutter something about the looming threat of limb loss, avoiding the gory details of wounds, arterial blockages, and the like. That encounter sparked in me a quest through the vascular literature and the abundance of expert forums including SVSConnect, searching for that Holy Grail: a definition of CLTI. A definition that would be as easy to recite as ordering an iced latte at Starbucks. What I uncovered was a labyrinth of conflicting viewpoints, a chaotic battleground of Current Procedural Terminology (CPT) codes and ambulatory surgery centers, along with squabbles over interventional integrity, all leaving me still craving that elusive clarity. By the end, I found myself more tangled than a season finale of the Bachelorette.

In the world of vascular disease, we have a lexicon to define just about everything, except, it seems, for CLTI. It’s like trying to nail jelly to the wall. Guideline-directed therapies? Sure, we’ve got those—a veritable buffet of evidence-based options, from interventional routines, to limb salvage approach, to cardiovascular risk reduction. But where’s the meat of the matter? My commentary is not about the mechanics of arterial repair (stents, balloons and atherectomies), but about the missing clarity in the definition, a gap leading to fragmented and variable care for our characters in distress, turning CLTI recommendations into a kind of medical choose-your-own-adventure.

The backstory takes us to the 1980s European effort to define not just questionable fashion but this elusive antagonist, focusing on rest pain, tissue loss and hemodynamic parameters. But like all great plots, it’s riddled with twists— subsequent studies showed a broader spectrum of patients with ulcers and normal hemodynamics who benefited from early interventions, despite the initial definitions of CLTI. Fast-forward through decades of academic adventures and classification crusades—from TASC-I followed by TASC-II to the University of Texas classification to PEDIS to the SVS Lower Extremity Threatened Limb Classification better known as WIfI (Wound, ischemia and foot infection)— each a chapter in the never-ending saga of CLTI. Yet, despite all these classifications, the true essence of CLTI remains as elusive.

Then, in a sudden plot twist, 65 years after Fontaine first attempted to classify this process, enter the GLASS investigators, the latest heroes in our tale, attempting to demystify CLTI with a blend of PAD, rest pain, tissue loss present for greater than two weeks, and a sprinkle of hemodynamic intrigue including ABIs, toe pressures and transcutaneous oxygen measurements. But wait, there’s more! Embedded within CLTI are definitions within definitions layering our CLTI mystery novel—PAD, rest pain, gangrene and ulcer, each a sub-plot within the grand narrative of CLTI. Does one have PAD based on anatomy, hemodynamics or symptoms? Many patients with PAD are sedentary (obesity, shortness of breath, lumbar disc disease, diabetic neuropathy, frailty) and do not experience symptoms. What if the patient describes burning, tingling or numbness, is that considered rest pain?

In the latest chapter of the ongoing saga that is CLTI, definitions have taken a dark turn, becoming less about medical precision and more about wielding the grim reaper’s scythe over the heads of our protagonists. It’s as if some Dickensian villain has whispered into the collective ear of the vulnerable, “Beware, an amputation awaits those with rest pain,” turning a choice into a tale of certain dread.

Now enters our reluctant hero, the every-patient, who earns his living from his motor skills and finds himself at a crossroads. Offered the devil’s bargain: a “low-risk” procedure pitched with the same persuasive charm as Clark Stanley, aka the Rattlesnake King, versus the foreboding loss of a limb—a phantom limb, haunting his future. The narrative escalates, becoming a weapon that doesn’t just threaten physical loss but launches a calculated strike at the patient’s dignity and self-worth. The looming threat of amputation casting a long shadow in the corridors of his mind is compounded by the barking of the black dog of depression causing our character to turn to a form of self-flagellation.

“Well, if my leg’s going to be tossed out like bad leftovers, why not call the shots on my way down,” he suggests as the cigarette smoke swirls like the fog in a San Francisco sunrise. Unfortunately, following a “100% successful procedure” and now post amputation, he is only a shadow of his former self—a poignant reminder that our medical decisions are not just clinical; they’re deeply personal. We forget and overlook the human element in return for technical success and financial gain.

The tale of CLTI cannot be told without the pioneers who in the early- to mid-20th century outlined the early principles of vascular occlusive disease and oversaw both clinical and experimental techniques in revascularization. We tip our hats to the trailblazers—Carrel, Leriche, Jaboulay, Kunlin, DeBakey, Dotter and Grüntzig—who, with the verve of pioneers and the audacity of explorers, sketched the early maps of vascular wilderness. Yet, here we are, nearly a century later still caught in the whirlwind of defining and redefining CLTI. Despite the cash tsunami funneled into research and development, we’re somewhat akin to hamsters on a wheel—spirited but spinning in place.

We’ve also now ventured into new territories, from infrapopliteal to inframalleolar, with the same zeal and optimism as a toddler’s first steps—eager, if not a tad wobbly. Over the last century, through the thick tome of literature, with acronyms that could double as the latest tech start-ups, we’ve showcased our unwavering commitment to tackling PAD and limb salvage. But the gold standard? It’s still Kunlin’s single-segment GSV bypass from 1948—vintage, classic, yet undefeated.

And so, I lament, perched upon decades of innovation and introspection: “Have we truly advanced in our quest against CLTI, or are we just marching to the nostalgic rhythm of past triumphs?”

Our final chapter calls for unity—a rallying cry for a collaborative, evidence-based definition of CLTI that stands the test of time and scrutiny. A definition that’s not a mere classification of the severity of a disease process but a clear and concise answer to the question, “What is CLTI?” We can all conclude that CLTI is not localized and segmental, as our interventions suggest. The complexity of CLTI, influenced by a kaleidoscope of patient factors, poses a formidable challenge and we should start to look to the future where advanced molecular, genomic and imaging techniques is what helps define CLTI. After all, rest pain, multi-level occlusions, wounds and hemodynamic derangements are simply downstream consequences of CLTI and we should get away from the circularity of using these constructs to define CLTI.

Perhaps the answer lies in simplicity—a return to the basics, where critical limb threat encompasses not just a focus on what can be intervened upon anatomically, but a larger story about the human element: the people attached to the limbs, their stories, their risk factors and paths through the intricate world of vascular health.

Omid Jazaeri, MD, is a medical director of vascular services at AdventHealth in Denver, Colorado.

SVS encourages participation in compensation survey

By
Kristin Spencer
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SVS encourages participation in compensation survey
The survey, which launched at the 2023 Vascular Annual Meeting (VAM), has already seen significant participation from members

The Society for Vascular Surgery (SVS) is encouraging members to participate in the 2024 Compensation Survey, a key initiative designed to provide vascular surgeons with tailored insights into compensation, productivity and practice data. This effort, conducted in collaboration with Phairify—a web-based data collection and visualization platform—aims to help SVS members make informed career decisions by offering exclusive access to detailed information that is specific to their specialty and practice situations.

The survey, which launched at the 2023 Vascular Annual Meeting (VAM), has already seen significant participation from members, with 22% completing the survey by the end of 2023—exceeding the initial 20% target.

As 2024 progresses, the SVS is urging both new participants and those who took part last year to update their data to ensure the most accurate and up-to-date information is available.

The survey, designed with busy physicians in mind, takes approximately 15 minutes to complete. It is fully anonymous, allowing participants to provide information without concerns about privacy. The survey covers a wide range of topics, including compensation, call frequency, productivity, bonuses, benefits and practice settings, among others.

Members can use this data to compare their financial situation with their peers across various demographics, such as geographic location, gender, race, age and practice type (academic vs. private practice).The platform’s focus on privacy and security ensures that all data is de-personalized and inaccessible to any external agencies.

Participation in the survey also unlocks additional benefits for SVS members. Upon completing the survey, members gain access to comprehensive benchmarking data, allowing them to review their compensation and productivity relative to peers. The initiative was developed in response to ongoing requests from SVS members for more transparency and data-driven insights into vascular surgery compensation. The SVS Financial Compensation Task Force, responsible for overseeing the work, worked closely with Phairify from January 2023 through May 2023 to design the survey.

The survey is open to all SVS Active and Early Active members residing in the U.S. Participation is free, and the data is completely anonymous. Once a sufficient number of responses (a minimum of 10) are collected for a given data field, participants gain immediate access to the compensation benchmark data.

Visit vascular.org/Compensation.

SVS empowers surgeons with patient-reported outcomes toolkits

By
Marlén Gomez
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SVS empowers surgeons with patient-reported outcomes toolkits
Ashley Vavra, MD, MS, Surgery Vascularsurgery

The Society for Vascular Surgery (SVS) Quality Improvement Committee has developed toolkits aimed at enhancing patient care and outcomes by integrating patient-reported outcomes (PROs) into clinical practice. These resources are set to transform how healthcare professionals interact with and understand their patient experiences and health statuses.

“Patient-reported outcomes are invaluable in understanding the full scope of our patients’ well-being and the effectiveness of our interventions,” said Ashley Vavra, MD, chair of the SVS Quality Improvement Committee. “These toolkits provide vascular surgeons with the necessary resources to incorporate patient perspectives directly into their care plans, ensuring a more holistic approach.”

PROs are essential metrics that allow healthcare providers to assess medical interventions’ effectiveness by capturing patients’ firsthand accounts of their health and experiences. This approach offers a direct, unbiased insight into patient perspectives, free from the influence of clinicians or other intermediaries.Two primary categories of stand out: satisfaction scores and health-related quality of life (HRQOL). The toolkits include resources on survey administration, data collection and an inventory of existing PROs.

For more information on the toolkits, visit vascular.org/Quality.

SVS disseminates educational needs assessment survey to members

By
Marlén Gomez
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0
SVS disseminates educational needs assessment survey to members

The Society for Vascular Surgery (SVS) has called om members to detail their educational and professional development needs in order that it can seek to better support vascular surgery careers.

The Society recently sent an educational needs assessment surgery to members and other vascular surgery constituents, which will continue into early October. The survey is aimed at helping the SVS to map out future education priorities.

“This is one of the three key surveys that the SVS Executive Board weighs in on and approves the SVS to send out,” said SVS Education Council Chair Kellie Brown, MD.

The first assessment survey was sent out in 2021 and received 767 responses. The usable sample was 585, the number SVS hopes to exceed this time around. The 2021 assessment produced data that showed the need for more coding and reimbursement resources.

The SVS is encouraging all vascular surgery specialists to participate in the needs assessment in order to map out educational needs for the next three years. Those who complete the assessment will be entered into a draw to win one of 10 Amazon gift cards (ranging from $100–$200 in value). Email education@vascularsociety.org.

Are we overtreating aortic aneurysms in the elderly?

By
Jocelyn Hudson
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Are we overtreating aortic aneurysms in the elderly?
First author Sebastian Vaughan-Burleigh

A large meta-analysis of elective endovascular aneurysm repair (EVAR) outcomes by age has shown that three-to-five-year survival is very low in octogenarians, prompting researchers to caution against routine intervention in these patients.

Sebastian Vaughan-Burleigh, BMBCh, Dominic P.J. Howard, DPhil, and colleagues from the Department of Vascular Surgery at Oxford University Hospitals NHS Trust in Oxford, England, write in the Journal of Endovascular Therapy (JEVT) that elective repair for abdominal aortic aneurysm (AAA)—a condition known to increase in prevalence with age—is commonly performed in octogenarians. However, while previous trials have confirmed elective EVAR to be an effective intervention for AAA, the authors note that the data are limited for elderly patients due to them often being excluded from randomised trials.

To evaluate the safety and outcomes of elective EVAR in elderly patients, the researchers performed a systematic review and meta-analysis of studies reporting risk of complications and death in relation to age. They included observational studies and, if outcome rates or raw data were provided, interventional arms of randomized trials.

Howard et al identified 38 eligible studies from 9,060 citations, including eight national and five international registries, 25 retrospective studies, and their own prospective cohort. The analysis included 208,997 non-octogenarians and 84,589 octogenarians in total.

The authors report in JEVT that 30-day mortality post-elective EVAR—the study’s primary outcome—was higher in octogenarians than in younger patients.

Senior author Dominic PJ Howard

In addition, they write that linear regression demonstrated a 0.83% increase in 30-day mortality for every 10-year age increase above 60 years old.

Another key finding from the study was that mortality for octogenarians increased “significantly” during follow-up, with Howard and colleagues sharing figures of 11.35%, 22.8%, 32%, 47.53%, and 51.08% at one-through-five-year follow-up, respectively.

Finally, the authors reveal that 30-day complication rates after elective EVAR were higher in octogenarians than in younger patients.

“We have performed the largest meta-analysis of elective EVAR outcomes stratified by age to date,” Howard and colleagues state, going on to summarize that, while octogenarians experience “higher but acceptable” perioperative morbidity and mortality compared to younger patients, three-to-five-year survival is “very low” in older patients.

The authors recognize that there are certain limitations to their study, including the “increasingly infrequent” reporting of mortality data beyond 30 days, the “inconsistent” reporting of data outside mortality across studies.

Despite these limitations, Howard et al stress that many patients in the study came from registries, which they note are “generally considered most representative of underlying populations”.

Based on their findings, the authors conclude: “Our findings challenge the notion of routine intervention in elderly patients, and support very careful selection for elective EVAR.”

They continue that many octogenarians with ‘peri-threshold’ AAAs, i.e. those less than 6cm in diameter, “may derive no benefit from EVAR” due to limited three-to-five-year survival and the low risk of aneurysm rupture that is associated with conservative management. “An adjusted threshold for intervention in octogenarians may be warranted,” they assert.

Eastern Vascular Society presidency transfers from Ozsvath to Lal

By
Bryan Kay
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Eastern Vascular Society presidency transfers from Ozsvath to Lal
Brajesh K. Lal

Brajesh K. Lal, MD, assumed the Eastern Vascular Society (EVS) presidency during the 2024 EVS annual meeting in Charleston, South Carolina (Sept. 19–22).

The professor of surgery at the University of Maryland School of Medicine in Baltimore took over from Kathleen Ozsvath, MD, a vascular surgeon at St. Peters Health Partners in Albany, New York.

Benjamin Jackson, MD, chief of vascular and endovascular surgery at Lehigh Valley Health Network in Allentown, Pennsylvania, is now EVS president-elect.

Elsewhere on the EVS Executive Council, Ageliki Vouyouka, MD, a professor of surgery at Mount Sinai in New York City, took over as secretary and Misaki Kiguchi, MD, an associate professor of surgery in the Department of Surgery at MedStar Georgetown University Hospital in Washington, D.C., became a councilor-at-large.

The EVS held a successful day of service during the Charleston gathering. Several society members and advanced practice providers spent the evening of Friday, Sept. 20, at a downtown community center performing screenings for peripheral arterial disease (PAD) and educating local residents on both venous and arterial disease.

Boston Scientific completes acquisition of Silk Road Medical

By
Bryan Kay
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Boston Scientific completes acquisition of Silk Road Medical

Boston Scientific announced the close of its acquisition of Silk Road Medical, the company behind transcarotid artery revascularization (TCAR).

“The integration of the TCAR platform into our portfolio means we can offer a treatment option for patients suffering from carotid artery disease that can reduce the risk of stroke and lead to improved patient outcomes,” said Cat Jennings, president of vascular peripheral interventions at Boston Scientific.

Boston Scientific revealed on June 18 that it had entered into a definitive agreement to acquire Silk Road.

SVS announces merger creating Section on Ambulatory Vascular Care

By
Marlén Gomez
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0
SVS announces merger creating Section on Ambulatory Vascular Care
The SVS has merged SOOVC with the Community Practice Section

The Society for Vascular Surgery (SVS) announced the merger of its Section on Outpatient and Office Vascular Care (SOOVC) and the Community Practice Section (CPS), marking the creation of the new Section on Ambulatory Vascular Care (SAVC), which is set to launch in early fall. In a bid to advance outpatient vascular care, the SVS established SOOVC in 2019 and, then, in 2021, the CPS.

The decision to merge these two sections comes as the traditional boundaries of vascular care continue to blur as the vascular surgical specialty evolves.

According to SVS leadership, increasing overlap between community practices, outpatient labs, vein clinics and other outpatient settings has highlighted the need for a more unified approach.

Recognizing this, Anil Hingorani, MD, of Total Vascular Care in New York, and Robert Molnar, MD, of Michigan Vascular Center, in collaboration with SVS staff, proposed the merger to bring together resources and expertise under one umbrella. Hingorani previously held the role of chair of the SOOVC Steering Committee, while Molnar chaired the CPS Steering Committee.

SAVC will encompass a broad range of outpatient vascular care settings, including community practices, office-based labs (OBLs), ambulatory surgery centers (ASCs) and hospital-affiliated outpatient facilities.

With this new section, the SVS aims to enhance its efforts in education, advocacy, quality, ethics, research and overall member value within the burgeoning landscape of outpatient vascular care.

“All current members of the CPS and SOOVC will automatically become members of the new section,” said Hingorani, who will serve as the chair of the SAVC. “We are excited about the contributions this section will make to the field of vascular care.”

Hingorani will be joined on SAVC by Geetha Jeyabalan, MD, of MedStar Health and Vascular Institute in Annapolis, Maryland, who will perform the role of vice chair.

The merger’s call for volunteers to join the SAVC Steering Committee closed in August. Members interested in leadership roles will find opportunities to shape the direction of the new section as it begins to take shape.

They are encouraged to keep an eye out for upcoming SVS communications for more information and to stay updated on SAVC’s progress, including within the pages of Vascular Specialist.

Awards update

Under their current section names, nominations are now open for the 2024–25 SVS awards. The Excellence in Community Practice Award will retain its name, continuing to honor outstanding contributions in this area.

Starting in 2025, the awards previously associated with SOOVC will be rebranded under the new SAVC. This includes the SOOVC Presentation Award and the Research Seed Grant, which will carry the new SAVC acronym moving forward.

SVS members are encouraged to apply for the current awards, and nominations are due by Tuesday, Oct. 15.

For more information and to submit your nominations for any of the awards, visit vascular.org/Awards.

Abou-Zamzam assumes Western Vascular Society reins

By
Bryan Kay
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0
Abou-Zamzam assumes Western Vascular Society reins
Ahmed Abou-Zamzam Jr.

Ahmed Abou-Zamzam Jr., MD, has taken over the as the 2024–25 president of the Western Vascular Society (WVS).

The professor of surgery at Loma Linda University Health in Loma Linda, California, assumed the WVS reins following the conclusion of the society’s 2024 annual meeting held in Colorado Springs, Colorado (Sept. 7–10).

He was passed the presidential gavel by outgoing 2023–24 WVS President Roy Fujitani, MD, chief of the Division of Vascular & Endovascular Surgery at the University of California, Irvine School of Medicine in Orange.

David Rigberg, MD, vascular surgery program director at the University of California, Los Angeles (UCLA), became president-elect.

Wrapsody WAVE trial demonstrates superior patency versus standard of care in AV fistula patients

By
Bryan Kay
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0
Wrapsody WAVE trial demonstrates superior patency versus standard of care in AV fistula patients
Wrapsody endoprosthesis

Merit Medical has today announced positive six-month findings from the randomized arteriovenous (AV) fistula arm of its Wrapsody arteriovenous access efficacy (WAVE) pivotal trial. The data were shown at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (Sept. 14–18) in Lisbon, Portugal, during a FIRST@CIRSE presentation.

Wrapsody is a cell-impermeable endoprosthesis which is intended to extend long-term vessel patency in dialysis patients.

The AV fistula arm of the WAVE trial enrolled 245 patients at 43 sites. Patients were randomized 1:1 to Wrapsody or percutaneous transluminal angioplasty (PTA).

Merit shares in a press release that target lesion primary patency in patients treated with Wrapsody was 27 percentage points higher than patients in the PTA cohort (89.8% vs. 62.8%, p<0.0001). The proportion of patients who experienced an adverse event was similar between cohorts.

“The superiority of the six-month efficacy data is compelling and provides clinicians the chance to evaluate how WRAPSODY can help us prolong the vascular access of our patients. Wrapsody should be the new standard of care for these patients,” said Mahmood K. Razavi, an interventional radiologist at St. Joseph Heart and Vascular Center in Orange, California, co-principal investigator of the WAVE trial.

“Meeting with colleagues at CIRSE to discuss the AV fistula arm of the WAVE study was the first of what we hope to be many productive discussions,” said Robert G. Jones, MD, an interventional radiologist at Queen Elizabeth Hospital Birmingham in Birmingham, England, co-principal investigator of the WAVE study. “The potential for Wrapsody to help us safely extend vascular access for our patients is a vital component of care.”

“The data release of positive findings from the randomized AV fistula arm of the WAVE study marks a major milestone for Merit,” said Fred P Lampropoulos, Merit’s chairman and chief executive officer (CEO). “This is an important next step in our continued efforts to seek ways to improve care for patients requiring hemodialysis treatment.”

Merit advises that the Wrapsody cell-impermeable endoprosthesis is not approved or available for commercial distribution in the U.S. and may not be approved or available for sale or use in other countries. In the USA, the device is being used under an investigational device exemption (IDE) from the Food and Drug Administration (FDA). Findings from the WAVE study expand on results from the first-in-human study (WRAPSODY FIRST) and support the premarket approval (PMA) application to the FDA for commercial use in the U.S. The device is available in Brazil and in the European Union.

Philips announces FDA approval for enhanced LumiGuide guidewire, marks 1000th patient treated with 3D guidance technology

By
Jocelyn Hudson
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0
Philips announces FDA approval for enhanced LumiGuide guidewire, marks 1000th patient treated with 3D guidance technology
Philips LumiGuide
Philips LumiGuide

Royal Philips today announced the introduction of the 160cm Food and Drug Administration (FDA)-approved version of its LumiGuide endovascular navigation wire. This enhanced LumiGuide guidewire, which utilises the company’s Fiber Optic RealShape (FORS) technology, was used for the first time on a patient by Carlos Timaran (UT Southwestern Medical Center, Dallas, USA). He used the technology during a complex aortic aneurysm repair operation, marking the 1000th patient treated milestone using FORS since its first clinical use in 2020.

A press release notes that the introduction of a longer FORS-enabled LumiGuide navigation wire enables US clinicians to visualize a broader range of catheters and expands usage of this technology to patients in the U.S. treated in centers equipped with LumiGuide.

“The new enhanced Philips LumiGuide navigation guidewire represents a significant leap forward in endovascular surgery, offering unprecedented 3D visualization and precision during complex procedures,” said Timaran. “As the first to use this guidewire for a complex aortic repair, I experienced firsthand its potential to revolutionize how we approach minimally invasive vascular interventions. The patient who underwent this groundbreaking procedure is doing well, further validating the efficacy of this innovative technology.”

Philips shares that LumiGuide—powered by the company’s FORS technology—allows clinicians to see their guidewires and catheters in 3D and color as they manipulate them inside the patient’s body, from any angle, in real-time, and with minimal radiation. The company adds that its FORS technology simplifies navigation in tortuous vessels.

Using this advanced technology, research published in the Journal of Vascular Surgery and from Philips shows that complex cases such as aortic repair procedures can be done 37% faster and use 70% less X-ray imaging during the process.

Providing greater reach and enhanced catheter loading possibilities than the company’s existing 120cm (47 inch) guidewire, Philips claims that its new 160cm (63 inch) LumiGuide wire enables US physicians to experience 3D device guidance with more catheters than before, enabling use of the technology for more patients and procedures.

“LumiGuide unlocks the colour visualization of wires, catheters, and patient anatomies in 3D from any angle, including simultaneous angles to generate ‘virtual biplane’ images. Combined with device navigation viewed from angles physically unachievable using conventional C-arm systems, it has already been shown to improve workflows, reduce procedure times, and decrease patient and staff radiation dose,” said Atul Gupta, chief medical officer for diagnosis and treatment at Philips and a practicing interventional radiologist.

Philips advises that LumiGuide integrates seamlessly into the company’s image-guided therapy system, Azurion, allowing its use alongside preoperative cross-sectional imaging.

Our patients need more Spanish-speaking vascular surgeons: An argument for medical Spanish in residency

By
Melissa D'Andrea
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0
Our patients need more Spanish-speaking vascular surgeons: An argument for medical Spanish in residency
Melissa D’Andrea

Since there are more than 40 million Spanish speakers in the United States, training more bilingual physicians could potentially improve equitable care in Latino communities, according to an article published on July 18, 2023, by the Association of American Medical Colleges (AAMC).¹

To provide better care to Spanish-speaking patients, there is a call for medical schools and residencies to recruit and retain more Hispanic, Latino and multilingual doctors, and to provide medical Spanish language training and proficiency testing to medical students and physicians to enhance their ability to communicate with and relate to their patients.

Patients without language-concordant healthcare providers are more likely to experience miscommunication and adverse events, are less likely to comply with medications and medical advice, and are less likely to come to follow-up appointments, according to a case study published in February 2023.²

Moreover, only 2% of physicians speak Spanish, according to AAMC diversity facts and figures from 2019, which is a very low number compared to the demand that exists among Spanish-speaking patients in the U.S. According to a more specific poll conducted by the Society for Vascular Surgery (SVS) that was published in 2012, only 3.7% of vascular surgeons are Hispanic. It is unknown how many speak Spanish.³

So, how can we address this issue as a specialty? By implementing Spanish-language competency programs—especially in training regions with large Spanish-speaking populations during the course of surgical training—we could significantly improve patient care.

The goal of medical Spanish proficiency classes is not to create perfect Spanish interpreters or bilingual fluency geniuses, but to have enough Spanish knowledge to get your point across to a patient in basic medical terms in order to gain patient trust. The classes can be implemented for those trainees practicing in areas where most of the patient population speaks Spanish and has limited English proficiency, and ideally students enrolled have at least intermediate Spanish skills and an interest in working in the Hispanic-Latino community.

Medical schools with higher Spanish-speaking populated cities such as Texas Tech University Health Sciences Center in El Paso, Texas, and Loyola University Chicago Stritch School of Medicine in Chicago, where I went to medical school, teach medical Spanish as a part of the pre-clerkship curriculum for students. However, few residency programs offer medical Spanish courses, most likely due to pre-existing, busy service obligations.

Here in Tucson where I am a resident, one hour from the U.S.-Mexico border, there is a large Spanish-speaking and Sonoran Mexican population. At the University of Arizona College of Medicine-Tucson, there is a weekly medical Spanish class for advanced speakers to learn medical terminology offered through the Diversity Equity and Inclusion Department that takes place every Thursday. The course is to be completed over a two-year period. This schedule is ideal for the first couple of years of surgical residency when residents are doing more floor work, intensive care unit (ICU), and night shifts so that attendance can be optimized prior to busy operative senior years. The classes are built such that if you miss the first Thursday of the month class (for Main campus), you can still make it to the third Thursday class (for South campus). This allows flexibility in the schedule.

Then, there is an ALTA Language Services exam at the end of the year to show competency. If graduates attain >80% proficiency on the oral exam, they receive a badge confirming they can speak with patients in Spanish and even consent them for procedures without the need for an interpreter. This can potentially allow for more efficiency, better patient-physician relationships and fewer miscommunications.

As a fellow champion of the argument for increased medical Spanish training, I plan to develop a booklet that can be carried around in providers’ white coats or in a phone app. These will contain key medical and surgical terminology in Spanish to help describe common pathology and interventions relevant to vascular surgery, so those trainees who don’t have access to classes can utilize this platform to make connections with their Spanish-speaking patients more feasible.

Please reach out to be involved in this future project via LinkedIn or Twitter (@MelissaDAndrea4).

References

  1. https://www.aamc.org/news/united-states-needs-more-spanish-speaking-physicians
  2. Lopez Vera A, Thomas K, Trinh C, Nausheen F. A case study of the impact of language concordance on patient care, satisfaction, and comfort with sharing sensitive information during medical care. J Immigr Minor Health. 2023 Dec;25(6):1261–1269.
  3. Woo K, Kalata EA, Hingorani AP. Society for Vascular Surgery Diversity, Equity and Inclusion Committee. Diversity in vascular surgery. J Vasc Surg. 2012; 56: 1710–1716

Melissa D’Andrea is a fourth-year integrated vascular surgery resident at the University of Arizona-Tuscon.

VQI analysis of CLTI practice following BEST-CLI finds no pick up in bypass rate

By
Bryan Kay
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0
VQI analysis of CLTI practice following BEST-CLI finds no pick up in bypass rate
Marc Schermerhorn

A Vascular Quality Initiative (VQI) analysis of evolving practice in the wake of the BEST-CLI trial demonstrated no increase in the rate of surgical bypass in the year afterwards.

More analysis needs to be done comparing the data pre- and post-publication of BEST-CLI in the New England Journal of Medicine (NEJM) in November 2022, explains lead author Marc Schermerhorn, MD, “but I still think it’s surprising that there has been essentially no increase whatsoever about a year later. There wasn’t really a trend.”

Among 29,000 patients, overall use of bypass was 15%, the chief of vascular surgery at Beth Israel Deaconess Medical Center in Boston continues. “When we compared the time period before the publication and the time period afterwards, it really didn’t change: it went from 14% to 15%; in men it went from 16% to 14%; and women from 11% to 16%—but none of those are anything close to anything significant.”

Broken down by segment, there was still no change, Schermerhorn added of the data, which will be presented at the New England Society for Vascular Surgery (NESVS) annual meeting in Portland, Maine (Oct. 25–27).

BEST-CLI demonstrated that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective revascularization strategy for patients with chronic limb-threatening ischemia (CLTI) who are deemed to be suitable for either an open or endovascular approach.

Speaking with Vascular Specialist ahead of the NESVS meeting, Schermerhorn points to several possibilities to explain why the needle hasn’t shifted.

“It always takes time after new data comes out for it to diffuse out broadly,” he says. “I suspect that that’s the main thing. Sometimes practice doesn’t change until a guideline comes out.” As chair of the Society for Vascular Surgery (SVS) Document Oversight Committee, he points out an update of the CLTI guidelines is in the works. “That will certainly incorporate [the BEST-CLI trail data],” Schermerhorn adds, explaining that that too remains more than a year down the road owing to the guideline development process. “We will re-evaluate this after that to see if there is a change after the guidelines are published … I think we need to get the word out to more people, to the New England community, to the SVS and internationally—that people with a good single-segment saphenous vein should at least be considered for bypass more so that they were in the past.”

Schermerhorn acknowledges that there may be differing interpretations of the BEST-CLI results between specialties to a certain extent but says even among vascular surgeons there may be a hesitancy to do more bypasses. “People have gotten so used to doing peripheral interventions, and their volume of bypass grafts have gone way down,” he explains. “It’s possible that surgeons are less comfortable with bypass than they used to be, or that they’re more fearful of the potential complications and feel that the patients are too frail for bypass. And that may well be the case for many patients.”

The Harvard University professor of surgery also concedes that the BASIL-2 trial results, though based on a slightly different patient population, may be “holding things back.” As a result, he believes those data should likewise be “considered differently” and underscores his belief that bypasses should nevertheless be performed more often. “[BEST-CLI] certainly changed my practice and that of our group,” says Schermerhorn. “We always check to see if someone has got saphenous vein before we do an angio, which is something we started doing when we participated in the trial. We hadn’t done that previously. We’re much more likely now in a patient with extensive multi-level disease—and significant ischemia and significant foot lesions—to recommend bypass.”

He finishes by referencing an analysis conducted by a partner that looked at graduating vascular surgery trainees’ facility with infrapopliteal bypasses. “It showed that when they graduate, they have done very, very few during their training period—I think the average is well below 10,” Schermerhorn says. “The last time we looked at that was probably eight or 10 years ago. It’s an area where people are not being trained adequately because we have made such a switch to peripheral intervention.”

SVS task force assesses progress made, remaining gaps in optimal board certification for vascular surgery

By
Kenneth M. Slaw
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SVS task force assesses progress made, remaining gaps in optimal board certification for vascular surgery
Kenneth M. Slaw
SVS Executive Director Kenneth M. Slaw, PhD, examines the key forces and factors shaping vascular surgery and how they may interact to create different environments.

The Society for Vascular Surgery (SVS) Strategic Board of Directors (SBOD), at its January 2024 meeting, reached a consensus to form and launch a special task force appointed by Immediate Past President Joseph Mills, MD, to assess the significant progress made by vascular surgery as an independent medical specialty over the past two decades and looking forward, analyze and identify strategic gaps, if any, that must be addressed for vascular surgery to reach its “optimal state.”

The process began before there were talks of the recent submission to the American Board of Medical Specialties (ABMS) of the planned American Board of Cardiovascular Medicine (ABCVM). The goal of this task force—called the SVS Task Force on Free-Standing or Federated Board Certification—is to help the vascular surgery community fully understand the implications to individual diplomats, trainees and our organizations regarding forming an independent board versus maintaining the status quo. “While many have a visceral reaction to what they think would be preferable, the SVS will make a well-informed decision after genuinely understanding all the ramifications,” said Michael Dalsing, MD, task force chair.

A membership call for action resulted in 30 volunteers for the task force. The SVS Executive Board (EB) approved the appointees and overarching objective of the task force: to examine the two primary existing models of board certification, free-standing or federated, and complete an objective, concise analysis of their strengths and weaknesses, which may provide an optimal path forward.

The composition of the task force intentionally provides a representative cross-section of the SVS membership from practice type to time in practice, as well as including those who support the formation of an independent board and those who lean against its formation. Michael Dalsing, MD, serves as chair of the task force and members include the following: James Black, MD; Karan Chawla, MD; R. Clement Darling III, MD; Alan Dietzek, MD; Dennis Gable, MD; Elizabeth Genovese, MD; Tom Huber, MD; Vikram Kashyap, MD; Elina Quiroga, MD; Matthew Sideman, MD; Natalie Sridharan, MD; and Gabriela Velazquez, MD. Matthew Eagleton, MD, SVS president; Keith Calligaro, MD, president-elect; Linda Harris, MD, vice-president; and Joseph Mills, MD, immediate past president, are ex-officio members.

The task force has conducted five Zoom calls and most recently held a meeting on July 25 at SVS Headquarters. The foundation for the task force’s work was identifying key guiding research questions solicited from the SVS EB, the SBOD and task force members, which helped with discovery and discussion during each call/meeting. Questions focused on the following areas: the role, function and relationships of key organizations involved in Vascular Board Certification; characteristics and differences in free-standing models within the ABMS and federated models within the American Board of Surgery (ABS)/ABMS: an opportunity analysis; detailed review of the ABS and the Vascular Surgery Board (VSB); financial variables and cost considerations; training/workforce impacts; and branding the specialty and board certification.

To answer these questions, interviews were conducted with the executive staff and leadership of the ABS, VSB, the Accreditation Council for Graduate Medical Education (ACGME), ABMS, the American Board of Thoracic Surgery (ABTS) and the American Board of Colon and Rectal Surgery (ABCRS). At the in-person meeting on July 25, a panel of representatives from the organizations interviewed was convened for a two-hour Q&A session. Follow-up questions based on the interviews were asked of the participants. The task force members also engaged in a “scenario planning” exercise to examine key forces and factors shaping vascular surgery and how they may interact to create different environments, as well as an analysis of how to best prepare for those conditions.

The task force will finish its analysis in September and prepare a final summary report for review by the SVS EB in November. Upon review, the SVS will share an executive summary with members for comment. SVS leadership will present the final report to the SBOD at the January 2025 meeting. The SVS EB will then process the feedback from the SBOD.

Muck takes over Midwestern Vascular Surgical Society presidency

By
Bryan Kay
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Muck takes over Midwestern Vascular Surgical Society presidency
(c)Shane Gamble
Patrick Muck

Patrick Muck, MD, assumed the reins of the Midwestern Vascular Surgical Society (MVSS) at the conclusion of the 2024 MVSS annual meeting in Chicago (Sept. 12–14).

The chief of vascular surgery at Good Samaritan Hospital in Cincinnati, Ohio, took over from Bernadette Aulivola, MD, professor and chief of the Division of Vascular Surgery and Endovascular Therapy at Loyola University in Chicago, to become the 2024–25 MVSS president.

Ross Milner, MD, chief of the Section of Vascular Surgery and Endovascular Therapy at Chicago Medicine, has slotted in as president-elect.

The society’s 2025 annual meeting will take place in Cincinnati (Sept. 18–20).

 

Pilot study looks at undiagnosed vascular disease in homeless

By
Bryan Kay
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Pilot study looks at undiagnosed vascular disease in homeless
Ian Malnis during a clinic

A pilot study in Canadian capital Ottawa aimed at uncovering the extent of undiagnosed vascular disease among the city’s homeless population detected a subset who may be in need of treatment for venous disease.

The work was carried out by a team from The Ottawa Hospital Division of Vascular Surgery. The group’s findings were presented at the 2024 annual meeting of the Canadian Society for Vascular Surgery (CSVS) being held in St. John’s, Newfoundland and Labrador (Sept. 13–14) by Ian Malnis, MD, a vascular surgery resident at the institution. The pilot is set to give way to a survey-based study aimed at establishing what are the barriers to obtaining wound care from vascular-trained providers.

The study grew out of Ottawa inner-city health authority’s review of the area’s growing homeless population, with the hospital identifying that they did not see a great deal of this demographic unless members presented with a big vascular problem.

“Ottawa inner city health has been operating there for a long,” explained Malnis. “They run a clinic downtown in Ottawa. Their mandate is for people with no fixed address or who are housing insecure. We partnered with them to run a monthly clinic there just to see what kinds of wounds they were seeing and whether or not those wounds were related to vascular disease or other traumatic injuries or infections that aren’t related to perfusion.”

Malnis, previously a nurse in Vancouver, has previous experience working with the homeless in the Canadian west coast city where there is a greater homeless problem. Among their findings while conducting the monthly clinics, Malnis and colleagues found that the nurse practitioners who assess patients reported a vascular knowledge gap.

“They said ‘We’d really benefit from having some extra education targeted specifically at how to refer, when to refer, how to properly assess people that we think have vascular disease,’” Malnis said. That led to afternoon classes, with more referrals from the downtown area now landing with the hospital’s vascular surgery division. “The nurse practitioners are accurately diagnosing people as not being in vascular disease. Most of the people that we saw who had any vascular problem was for venous disease. I think we saw one person with an arterial problem, and it was CLTI [chronic limb-threatening ischemia].”

Argon Medical announces launch of peripheral venous thrombectomy system

By
Bryan Kay
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Argon Medical announces launch of peripheral venous thrombectomy system
Cleaner Vac thrombectomy system
Cleaner Vac thrombectomy system

Argon Medical has today announced the launch of the Cleaner Vac thrombectomy system for the removal of blood clot from the peripheral venous vasculature.

The Cleaner Vac thrombectomy system is a disposable, large-bore aspiration system designed to quickly and effectively remove blood clot, also known as thrombus, from vessels with restricted blood flow. In a recent press release, the company states that the device enables physicians to manually control powered aspiration, enabling procedures with precise clot removal that may minimize vessel damage and reduce blood loss.

“Removing thrombus from the venous anatomy can be very challenging depending on the patient’s condition. Interventionalists need a simple and intuitive tool that allows them to easily navigate through the vasculature to the treatment area and control the removal of any obstructive thrombus. The streamlined design of the Cleaner Vac enables easy assembly, quick navigation, and efficient treatment, making it a welcomed treatment option for patients with this disease state.” said Fakhir Elmasri, MD, an interventional radiologist at Lakeland Vascular Institute in Lakeland, Florida. Elmasri was the first physician in the U.S. to treat a patient with the Cleaner Vac system.

The Cleaner Vac thrombectomy system is currently available in the U.S.

Former SVS president named chair of AAMC board of directors

By
Marlén Gomez
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0
Former SVS president named chair of AAMC board of directors
Julie A. Freischlag

The Association of American Medical Colleges (AAMC) has elected Julie A. Freischlag, MD, as chair of its 2024–25 board of directors. Her term will commence on Nov. 12 and extend through the conclusion of the AAMC’s “Learn Serve Lead” annual meeting in November 2025.

Freischlag, a prominent vascular surgeon and healthcare leader, currently serves as chief academic officer and executive vice president of Advocate Health, chief executive officer and academic officer of Atrium Health Wake Forest Baptist and executive vice president for health affairs at Wake Forest University. She is also the previous dean of Wake Forest University School of Medicine.

Throughout her career, Freischlag has broken new ground in academic medicine. She was the first female surgeon-in-chief at The Johns Hopkins Hospital and the first female chief of vascular surgery at the University of California in Los Angeles (UCLA). Her previous roles include vice chancellor for Human Health Sciences and dean of the School of Medicine at UC Davis.

Beyond her administrative and academic roles, Freischlag is an accomplished vascular surgeon specializing in thoracic outlet syndrome (TOS). She is a past president of the American College of Surgeons and was elected to the National Academy of Medicine in 2015. In 2021, she was inducted into the Academy of Master Surgeon Educators.

As a member of the Society for Vascular Surgery (SVS), Freischlag has made significant contributions to the field. She served as 2013-2014 SVS president and received the 2023 SVS Lifetime Achievement Award, the Society’s highest honor. Freischlag also holds the distinction of being the sixth woman in the U.S. to receive board certification in vascular surgery.

“It is an honor to lead the AAMC at such a pivotal time in healthcare. I look forward to working alongside my colleagues to advance academic medicine and ensure that we continue to educate the next generation of physicians and healthcare professionals,” said Freischlag.

Freischlag earned her medical degree from Rush Medical College and completed her residency at Ronald Reagan UCLA Medical Center. Her election as chair of the AAMC Board of Directors adds another significant chapter to a career marked by leadership, innovation and service.

New OBL column to launch in October issue

By
Bryan Kay
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New OBL column to launch in October issue
Anil Hingorani

Vascular Specialist is launching a new column in the October issue of the newspaper dedicated to issues important to—and involving—the office-based lab (OBL) setting.

Entitled “The Outpatient,” it will run bimonthly (or six times per year) and be edited by Anil Hingorani, MD, who was chair of the SVS Section on Outpatient and Office Vascular Care (SOOVC) until it was recently merged with the Community Practice Section (CPS) to form the new Section on Ambulatory Vascular Care (SAVC), which he will also chair.

Hingorani, a clinical professor of surgery at NYU Langone Hospital-Brooklyn and a vascular surgeon at the Vascular Institute of New York, also in Brooklyn, will write the maiden column.

‘Select CLTI patients may be safely treated in the office-based lab’

By
Bryan Kay
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‘Select CLTI patients may be safely treated in the office-based lab’
Moira McGevna
Results from a single-center analysis show the outpatient setting met SVS objective performance goals.

A retrospective study of endovascular interventions performed for chronic limb-threatening ischemia (CLTI) in an office-based lab (OBL) associated with a large New York City medical center across seven years determined that carefully selected patients may be treated safely in the outpatient setting.

Researchers from NYU Langone Medical Center report that 44.8% of the 230 patients included in the study required ipsilateral reintervention, with 30.4% warranting inpatient reintervention; and 20.4% required ipsilateral amputation, with 9.1% undergoing major amputation. All-cause mortality was 16.5% at three-year follow-up. This is set against Society for Vascular Surgery (SVS) objective performance goals for revascularization carried out for CLTI of 55% freedom from reintervention, 84% limb salvage and 80% survival at one year.

The data, from September 2016–February 2023, are to be presented at the 2024 annual meeting of the Eastern Vascular Society (EVS) in Charleston, South Carolina (Sept. 19–22), by Moira McGevna, a medical student at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, who worked on the project during a research year at NYU under the senior authorship of Thomas Maldonado, MD, NYU Langone professor of surgery.

Thomas Maldonado

Acknowledging the controversy that often surrounds the role of the OBL in the treatment of vascular disease, Maldonado notes in an interview with Vascular Specialist ahead of EVS 2024, “we found that despite not being adjoined or adjacent to a hospital, the OBL plays an important role, even in patients with critical limb ischemia [or CLTI].”

The tendency with CLTI patients, often bearing the risk of limb loss, is to treat them “in-house,” he says. “When we looked at our experience of 230 patients over seven years who had a minimum of one year of follow up—we had a mean follow up of 3.1 years—in these patients we found really very favorable outcomes with respect to major amputation, for instance, of only 9.1%. This compares very favorably to the SVS performance goals, which suggest limb salvage at 84, 85%.”

The key, Maldonado says, is in patient selection. “I think what we’re taking from this is that the OBL has a role to play even in patients who have more advanced comorbidities, with higher risk of limb loss, and may be an appropriate place to treat these patients, understanding that we only have a 9.1% risk of major amputation in this cohort. We feel that the OBL may be an appropriate setting in select patients with critical limb ischemia. Like anything we do in vascular surgery, patient selection and good judgment are paramount. Despite the OBL being a setting that is not in the context of a hospital with all its support, I still believe it has an important role, even with patients with critical limb ischemia who have higher comorbidities.”

To this end, the analysis showed that patients who underwent amputation were more likely to have diabetes (79.2% vs. 58.2%). “When we looked at comorbidities, diabetic patients in particular were more likely to have amputation after out patient endovascular procedures for CLTI—not particularly surprising for this higher-risk cohort of patients is at increased susceptibility to infection, wound complications, etc.,” says Maldonado.

“But again, that speaks to proper patient selection and understanding that these patients need to be vetted and properly worked up to make sure that their comorbidities have been optimized and well managed before attempting something like this in the outpatient setting.”

Future research directions will look at cost implications of OBL use for CLTI patients, Maldonado continues. “Anytime you use the hospital infrastructure for taking care of these sick patients, there is an associated cost. Future studies should examine the health economics associated with caring for a patient with critical limb ischemia in the inpatient versus outpatient setting.

“Our present study has shown that over 70% of these patients do not require inpatient reinterventions. We can keep them out of the hospital and that may be beneficial, not just for the patient but it also may be economic from a cost-savings standpoint.”

Maldonado also points toward likely gains in terms of patient quality of life and overall satisfaction.

“There’s no doubt that patients coming into the hospital, often resulting in an overnight stay or longer, can result in decreased patient satisfaction and negatively impact their quality of life,” he adds.

Vascular Specialist–September 2024

By
Bryan Kay
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Vascular Specialist–September 2024

In this issue: 

  • ‘Select CLTI patients may be safely treated in the office-based lab’: Single-center analysis finds outpatient setting met SVS objective performance goals
  • MVSS: Study sheds light on vascular-specific advanced practice provider experience
  • The CLTI conundrum: My spirited journey through the CLTI saga
  • SVS announces merger that creates the new Section on Ambulatory Vascular Care
  • APDVS launches vascular surgery curriculum e-book for medical students

Shockwave Medical expands US peripheral IVL portfolio with enhanced catheter

By
Bryan Kay
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Shockwave Medical expands US peripheral IVL portfolio with enhanced catheter
Shockwave E8 peripheral IVL catheter

Shockwave Medical, part of Johnson & Johnson MedTech, has announced the full U.S. launch of its Shockwave E8 peripheral intravascular lithotripsy (IVL) catheter, following clearance by the Food and Drug Administration (FDA).

A company press release details that the Shockwave E8 catheter is designed to optimize the treatment of patients with calcified femoropopliteal and below-the-knee peripheral arterial disease (PAD), including patients with complex chronic limb-threatening ischemia (CLTI).

“Shockwave’s newest peripheral catheter offers significant improvements that will help physicians refine their treatment algorithm and better support challenging patients with heavily calcified disease,” said Venita Chandra, MD, vascular surgeon and clinical associate professor in the Division of Vascular Surgery at Stanford Health Care in Stanford, California. “The catheter’s ability to treat long lesions and its extended reach enable safe and effective treatment of some of our most difficult-to-treat patients, including those with CLTI, a complicated and severe disease state with a high mortality rate.”

The top 10 most popular Vascular Specialist stories of August 2024

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The top 10 most popular Vascular Specialist stories of August 2024

In August, the most read stories from Vascular Specialist included a research letter addressing ‘alarmingly high’ mortality rates in chronic limb-threatening ischemia (CLTI) patients; a new book published due to the SVS History Work Group’s recent project; new funding for the development of MRI techniques for peripheral arterial disease (PAD) care, and several more. 

  1. SVS History Work Group’s landmark project culminates in new book

The 2024 Vascular Annual Meeting (VAM) saw the culmination of a decade-long project by the Society for Vascular Surgery’s (SVS) History Project Work Group. The release of the book, Legends Leaders Pioneers: Surgeons Who Built Vascular Surgery, marks a significant milestone in documenting the history and evolution of vascular surgery.

  1. SCOREPAD seeks to address ‘alarmingly high’ mortality in CLTI patients with underlying coronary disease

A new research letter underscores the need to improve long-term survival following lower extremity revascularization for chronic limb-threatening ischemia (CLTI), setting out a randomized controlled trial to examine the impact of coronary artery ischemia testing in these patients.

  1. ‘Choosing the right devices for the right patients’: Surgeon-scientist secures NIH funding to develop MRI technique for precision PAD care

Michael Conte, MD, recently used his 2024 Veith Lecture to call on young vascular surgeons on the peripheral arterial disease (PAD) frontlines to drive the space forward amid a great unmet need.

  1. SVS urges revisions for independent cardiology certification board

The Society for Vascular Surgery (SVS) has expressed conditional support for cardiology establishing an independent certification board but objects to provisions in the current American Board of Cardiovascular Medicine (ABCVM) proposal as they conflict significantly with the mission and requirements of the Vascular Surgery Board (VSB), which already issues a primary certificate issued by the American Board of Medical Specialties (ABMS).

  1. Physician-modified endografts ‘safe and effective’ for thoracoabdominal and complex AAA repair

Researchers have reported a 94% technical success rate among other key findings from a recent international, multicentre, single-arm cohort study of physician-modified endografts (PMEGs) for thoracoabdominal and complex abdominal aortic aneurysm (AAA) repair.

  1. Silk Road celebrates milestone of 100,000 TCAR procedures

Silk Road Medical has announced the milestone of more than 100,000 transcarotid artery revascularisation (TCAR) procedures having been performed to date.

  1. Survey of off-label treatment of complex repair pinpoints factors behind underreported outcomes data

The potential for cost and time to be key factors in low levels of outcomes data reporting emerged during a national survey of the off-label use of approved endovascular devices for complex aortic aneurysm repair.

  1. New ESC guidelines combine peripheral arterial and aortic diseases for first time, emphasising interconnectivity of whole arterial system

The European Society of Cardiology (ESC) has today published its 2024 guidelines for the management of peripheral arterial and aortic diseases (PAAD), evaluating these vascular conditions together as part of the same cardiovascular system.

  1. Inari Medical updates ClotTriever XL IFU amid FDA recall notice

The Food and Drug Administration (FDA) has issued a Class I recall—the most serious type—for Inari Medical‘s ClotTriever XL, 30mm device due to reports of patient injury, and death from device entrapment and pulmonary emboli (PE).

  1. Societies seek consensus on NIVL management amid ‘paucity of rigorous data’

The diagnosis and management of non-thrombotic iliac vein lesions (NIVL) is the focus of a newly published set of consensus statements from the Vascular Interventional Advances (VIVA) Foundation, the American Venous Forum (AVF), and the American Vein and Lymphatic Society (AVLS).

SVS president convenes 2024 Executive Board retreat

By
Kenneth M. Slaw
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SVS president convenes 2024 Executive Board retreat
Matthew Eagleton

The Society for Vascular Surgery (SVS) Executive Board (EB) gathered at its headquarters in Rosemont, Illinois, this summer, tackling over 40 strategic, policy and governance issues as it set the course for the year ahead.

“The annual EB Retreat is a critical meeting,” said SVS President Matthew Eagleton, MD. “The SVS strategic plan and program portfolio are expansive, and this retreat allows the EB to establish focused priorities for the next 11 months, define desired outcomes and ensure that governance structures and resources are aligned to achieve those priorities.”

The retreat’s discussions centered on the long-term health, vitality and trajectory of vascular surgery as a specialty. Key focus areas included the SVS branding campaign, the society’s response to the proposed new American Board of Medical Specialties (ABMS) American Board of Cardiovascular Medicine (ABCVM) and the ongoing work of the Vascular Certification Board (VCB) Task Force.

“The next six to 12 months could bring significant changes for vascular surgery, and we need to be prepared for multiple scenarios,” said Eagleton.

The EB outlined specific measures of success for its branding initiatives and developed key messaging for each target audience in preparation for a major launch in September-October. With the ABMS expected to decide on the proposed ABCVM as early as October, the EB also prepared responses for various potential outcomes. The VCB Task Force met in person the day before the retreat and also considered the potential impacts of a new ABCVM.

“The outcome of the ABMS decision will almost certainly influence discussions and decisions about the optimal structure of the Vascular Surgery Board (VSB),” said Michael Dalsing, MD, task force chair.

The VCB Task Force will deliver its final report in November, and a presentation to the SVS Strategic Board is scheduled for January.

Additional priority initiatives and decisions discussed during the retreat included:

  • SVS Advocacy Leadership Conference: Preparations are underway for the inaugural conference and Hill visit in Washington, D.C., in September 2025
  • SVS education needs assessment: The board agreed to design the following needs assessment, focusing on early-and mid-career vascular surgeons, to guide the launch of a comprehensive support approach for these groups
  • SVS Gala transition: The board approved transitioning the SVS Gala at the Vascular Annual Meeting (VAM) to a milestone event celebrating SVS anniversary years, with more informal events in between
  • PMEGs best practices paper: At the Food and Drug Administration’s request, the SVS was approved to develop a “best practices” paper on physician-modified endografts (PMEGs)
  • Young Surgeon Section: The board approved the Young Surgeon Section as a full-standing section of SVS
  • Section mergers: The board approved merging the Section on Outpatient and Office Vascular Care (SOOVC) with the Community Practice Section to form the new Section on Ambulatory Vascular Care (SAVC)
  • Senior Members Provisional Section: A new provisional section for senior members was approved
  • APP Section: The Advanced Practice Providers (APP) Steering Committee was approved to design and launch a new APP Section within the SVS. This will be merged with the currently existing Physician Assistant Section
  • Inter-society relations: The board approved SVS’ support of vascular society milestone events, provided that inter-society relations are in good standing
  • SVS EB at-large members: Plans for the nomination and selection of five at-large members of the SVS Executive Board were approved
  • DEI Committee priorities: The top priorities of the Diversity, Equity and Inclusion (DEI) Committee for the coming year were accepted
  • SVS HQ space assessment: The board agreed to assess future headquarters space needs, considering changes in work culture post-COVID-19

“The health and vitality of our specialty and members will be front and center during my year as president,” said Eagleton. “SVS has strong leadership on the Executive Board, the Strategic Board of Directors and throughout the staff structure. We are ready to meet the challenges and opportunities ahead.”

Study sheds light on vascular-specific advanced practice provider experience

By
Jocelyn Hudson
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Study sheds light on vascular-specific advanced practice provider experience
Saideep Bose, MD

In a recently conducted survey, over 200 U.S. advanced practice providers (APPs) in vascular surgery cited performing at the top of their license as the most important determinant of job satisfaction. This and other key findings are set to be presented at the Midwestern Vascular Surgical Society (MVSS) annual meeting (Sept. 12–14) in Chicago.

The research—conducted by author Saideep Bose, MD, and colleagues—investigated scope of practice, workplace satisfaction and burnout among vascular-specific APPs who practice in the U.S.

Bose, a vascular surgeon and assistant professor at Saint Louis University in Missouri, told Vascular Specialist ahead of his MVSS presentation that there is a “strong contingent” of APPs in vascular practice. “The main issue is that we don’t know how people in these APP positions feel about their careers or their jobs and if they feel like they are being utilized effectively or just being asked to do tasks that no one else wants to do,” he said, highlighting the genesis for the research.

In order to illuminate the experience of vascular-specific APPs, the researchers conducted a survey of 50 questions. The main component was the Mini Z survey—a validated questionnaire that was created by the Institute of Professional Worklife to look specifically at clinical burnout.

Bose shared that, of the 280 survey respondents, 47% were nurse practitioners, 31% were physician assistants and 21% were registered nurses.

One of the key questions on the survey probed the predictors of a joyful workplace. “Interestingly, there were only two things that were strongly predictive of a joyful workplace,” Bose revealed, “the ability for an APP to practice at the top of their license and a shorter shift length”.

Another question considered factors that predict being comfortable in taking care of vascular patients. “Again, the number one thing was practicing at the top of the license,” Bose reported, also citing number of years practicing as an APP taking care of vascular patients and being a member of the Society for Vascular Surgery (SVS) Physician Assistant Section or the Society for Vascular Nursing (SVN).

Bose et al subsequently investigated the defining factors of practicing at the top of one’s license, which they identified as seeing new patients in the outpatient clinic, a salaried pay structure and working with specific physicians. On the latter, Bose shared: “In my personal experience, I have seen that, because oftentimes a physician will have a particular specialty—for example aortic work or peripheral work—a physician nurse practitioner or a physician assistant who works specifically with them will become a master of that specialty as well. I think everyone benefits when there’s that pairing with specific physicians.”

Bose commented that the significance of these findings comes from the fact that “some of these are factors that we can change”. He elaborated: “We can make sure our APPs are paired with a particular physician, we can make sure they see new patients and we can make sure that they are salaried.”

On some of the key strengths of the survey, Bose highlighted that this is “one of the largest surveys that asks APPs about their experiences, their feelings and their work patterns”. What’s more, he noted that no studies to date have looked at vascular-specific APPs.

He did, however, recognize the limitations associated with this being a survey, including recall bias. “People that have very strong opinions one way or the other are more likely to respond to a survey,” he remarked.

Overall, he described the survey as a “good overview” of APPs’ experience, stressing that the next step should be to study this more systematically—to “really go into the programs where APPs are happy and ones where they are unhappy and try to tease out factors that explain that”.

“Our ultimate goal is not just to explain what’s going on, but to try to figure out management factors, practice factors that we can implement to increase the job satisfaction of these APPs.”

Being a vascular nurse: Notes from SVN president ahead of Vascular Nurses Week

By
Kristin Spencer
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Being a vascular nurse: Notes from SVN president ahead of Vascular Nurses Week
Karen Bauer

In recognition of Vascular Nurses Week (Sept. 8-14), Vascular Specialist spoke with Society for Vascular Nursing (SVN) President Karen Bauer, DNP. Bauer is a clinical assistant professor, lead vascular and wound surgery advanced practice provider (APP) and director of Vascular and Wound Services at the Univer­sity of Toledo Physicians.

What does being a vascular nurse mean to you?

I am honored to be among such a diverse group of high-quality clinicians. Vascular nursing allows so many touchpoints with patients and provides oppor­tunities to not only manage their vascular diseases, but to impact their lifestyles and overall happiness and well-being. As a vascular nurse/advanced practice nurse (APN), I get to engage with such a broad range of other professionals and, while vascular nursing can be mastered, there is always more to learn. I love the challenge!

Why do you think it is important that Vascular Nurses Week is celebrated?

Vascular nurses are crucial mem­bers of healthcare teams across so many different roles, which unfor­tunately is something that is often overlooked. We are positioned per­fectly to positively affect the health and well-being of our patients and our teams, and that deserves some recognition. To recognize vascu­lar nurses is to recognize great patient care.

How long have you been in the vascular field?

My first love was wound care, which integrates organically with the vascu­lar field. I have been doing wound care for over 16 years, discovered my pas­sion for limb salvage about eight years ago, and expanded my knowledge and skill set in vascular surgery about five years ago.

Why are you passionate about vascular care?

Small victories make for big wins in our field. I love the challenge and joy of figuring out how to meet my patients where they are and help them better under­stand both their disease process and how to prevent additional disease or other sequelae of it. The sheer happiness and pride I get to see on the faces of patients when they close a wound, or have improved leg pain, or successfully navigate new diets and exercises regimens, is endlessly fulfilling.

Tell us about a specific patient story that stands out when you think of a favorite vascular nursing memory.

All patients are special to me, but one patient that stands out was an older gentleman with a severe dia­betic foot ulcer and concurrent peripheral arterial dis­ease (PAD) who was told he would end in amputation after his initial emergent debridement/revasculariza­tion. I love a good challenge. He trusted our team, and while it took almost a year total of countless visits, diagnostics and sur­geries, his ulcer closed, and he was able to dance at his granddaughter’s wedding. What was most striking throughout our journey together, still, was his willingness to be vul­nerable and share with us his life stories as well as his family, who al­ways attended visits with him. He is my constant reminder that our patients are human first and deserve our undivided attention.

During Vascular Nurses Week, SVN invites Society for Vascular Surgery (SVS) members to give the gift of membership to their nurses and nurse practitioners. SVN membership offers valuable benefits, including a journal subscription, educational resources and leadership opportunities. Learn more at svnnet.org/page/VascularNursesWeek.

Lightning Bolt 7 technology sets the pace for clot removal

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BIBA Publishing
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0
Lightning Bolt 7 technology sets the pace for clot removal

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Jean Bismuth, MD, the University of South Florida Health and Tampa General Hospital chief of vascular surgery, talks to Vascular Specialist about the evolving nature of vascular surgery through the prism of acute limb ischemia (ALI) and how clinical care guidelines lag behind the rapidly developing endovascular technology, now available to treat the condition.

Discussing the role of Penumbra’s  Lightning BoltTM 7 aspiration thrombectomy system, Bismuth points to data from the STRIDE study to underscore advances in patient outcomes.

“Today, what we have on the market is a game-changer,” he notes. “We started with some smaller catheters and then went to Lightning 7, which gives a little bit better aspiration technology—finally going to Bolt, which is really a game-changer because, in a shorter period of time, we can aspirate the same amount of clot and get the legs reperfused faster.”

This video is sponsored by Penumbra, Inc.

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SVS Vascular Quality Initiative launches Carotid Care Quality Champion program

By
Jocelyn Hudson
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SVS Vascular Quality Initiative launches Carotid Care Quality Champion program
Jens Eldrup-Jorgensen

The Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) clinical registry today announced the Carotid Care Quality Champion recognition program.

The program honors healthcare organizations across the USA dedicated to improving the safety and effectiveness of vascular care through participation in the VQI’s carotid artery stenting and carotid endarterectomy registries.

Today, select facilities across the country have been recognized as Carotid Care Quality Champions. These organizations engage the SVS VQI infrastructure to monitor the quality of care for their vascular patients and help them comply with the latest societal and governmental guidelines, including the change in carotid artery stenting coverage reflected in the Centers for Medicare and Medicaid Services’ (CMS) recent national coverage decision (NCD) 20.7.

As part of the CMS NCD 20.7 reimbursement modifications, the organization requires centres to establish a quality monitoring program and maintain institutional and physician standards. Registry participation provides a robust and user-friendly approach to CMS compliance. A press release notes that the SVS VQI carotid artery stent registry is the gold standard for developing a carotid quality assurance program, with registry participation enabling centres to ensure the safety of their patients and adhere to the CMS coverage decision.

“We are proud to launch the Carotid Care Quality Champion program to honor organisations across the country that are demonstrating their commitment to exceptional patient care by maintaining a robust quality program,” says Jens Eldrup-Jorgensen (Maine Medical Center, Portland, Maine), SVS Patient Safety Organization (PSO) medical director. “By harnessing the power of data with benchmarked reports from over 900 centers, these centers have access to the best resources available for quality assurance and focused quality improvement efforts.”

Since the SVS VQI’s inception, clinical data gathered from participating centers has dramatically impacted patient care, leading to scientific discoveries that have changed the way in which care is delivered. Participating centers include academic medical centers, teaching hospitals, community hospitals and office-based labs.

A press release details that VQI participation offers centers the ability to:

  • Track provider and centre performance and compare to national benchmarks
  • Identify areas for quality improvement, including patient outcomes and length of stay
  • Participate in a robust quality improvement program, with access to quality improvement toolkits, quality charters, webinars and one-on-one mentoring for members
  • Network with other participating centers to review outcomes data, foster collaboration and spark further clinical innovation

To learn more, visit https://www.vqi.org.

Stepping up for vascular health: Challenge commences

By
Marlén Gomez
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Stepping up for vascular health: Challenge commences
Past SVS President Peter Gloviczki steps up for PAD

The 2024 SVS Foundation’s Vascular Health Step Challenge kicked off Sept. 1 with over 400 registrants committed to walking 60 miles throughout September in honor of Peripheral Arterial Disease (PAD) Awareness Month. With over 60,000 miles of blood vessels in the human body, walking is a common prescription that vascular surgeons give their patients to decrease their risk of PAD or to manage their symptoms.

SVS members and people from across the world have signed up to support the third annual iteration of the challenge. Registrants have come from places as far flung as India, Mexico, Vietnam and Brazil as part of the global commitment to vascular health.

The mission of the SVS Foundation is to optimize the vascular health and well-being of patients and the public through support of research on circulatory disease. Recently, the foundation announced that funds raised from the challenge will support a new Vascular Care for the Underserved (VC4U) grant for SVS and Society for Vascular Nursing (SVN) members.

It isn’t too late for walkers who still want to sign up: registration will remain open through the end of September. Donations toward individual walkers, teams and the general campaign will be accepted throughout September as well. Visit vascular.org/Step2024 for more details

Koya Medical announces full results from TEAYS study of Dayspring device

By
Jocelyn Hudson
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Koya Medical announces full results from TEAYS study of Dayspring device
Thomas Maldonado
Maldonado
Senior author Thomas Maldonado

Koya Medical recently announced that full results from the TEAYS clinical study have been published in the Journal of Vascular Surgery (JVS).

The data highlight superior efficacy and improved quality of life for patients suffering from lower extremity lymphoedema with Dayspring, a novel non-pneumatic compression device (NPCD), compared to advanced pneumatic compression devices (APCDs).

Dayspring met the study’s primary and secondary outcome measures and showed a broad range of superior clinical benefits for patients using the device compared to using an APCD, a press release reports. These results are consistent with prior studies’ findings associated with Dayspring for the treatment of lymphoedema.

“The introduction of Dayspring represents a clinically differentiated and therapeutically distinct advancement in the treatment of lower extremity lymphoedema,” said Michael Barfield (University of Tennessee Health Science Center, Nashville, USA), lead investigator. “Patients participating in the TEAYS study expressed a strong preference for the Dayspring treatment over advanced pneumatic compression devices. The ability for patients to remain mobile while receiving effective treatment is a game-changer in improving adherence and overall quality of life.”

Key findings from the TEAYS study include:

  • Efficacy: Patients using Dayspring experienced a mean limb volume reduction of 369.9mL, significantly greater than the 83.1mL reduction observed in the APCD treatment arm.
  • Quality of life: Significant improvements were noted in the overall Lymphedema Quality of Life Questionnaire (LYMQOL) scores for Dayspring users, with a mean improvement of 1.01 compared to 0.17 for APCD users. Key functional sub-scores such as symptoms, appearance, and function also favored Dayspring.
  • Adherence: Dayspring users demonstrated an adherence rate of 81%, significantly higher than the 56% adherence observed in the APCD group.
  • Safety: No device-related adverse events were reported for either treatment, highlighting the safety of Dayspring.

The TEAYS (Treatment effectiveness of a non-pneumatic compression device versus an advanced pneumatic compression device for lower extremity lymphoedema swelling) study is Koya Medical’s eighth clinical study evaluating Dayspring for the treatment of lymphoedema since its US Food and Drug Administration (FDA) clearance in 2021. The TEAYS study was a prospective, multicentre, randomised, single-crossover clinical trial conducted across nine sites in the USA. It involved 71 patients with confirmed lower extremity lymphoedema, comparing the treatment effectiveness and patient adherence between Dayspring and APCDs.

VVT Medical receives endorsement letter from AVF on CPT coding guidance for ScleroSafe

By
Bryan Kay
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VVT Medical receives endorsement letter from AVF on CPT coding guidance for ScleroSafe
ScleroSafe
ScleroSafe

VVT Medical recently announced that the American Venous Forum (AVF) has provided an official opinion letter regarding CPT coding guidance for the ScleroSafe percutaneous endovenous ablation procedure. This procedure, which combines mechanical collapse and chemical ablation to treat incompetent varicose veins, is now supported by existing CPT codes 36473 and 36474.

A press release includes the following CPT code descriptors:

  • 36473: Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging guidance and monitoring percutaneous mechanochemical; first vein treated.
  • 36474: Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging guidance and monitoring percutaneous mechanochemical; subsequent vein(s) treated in a single extremity each through separate access sites.

The AVF Health Policy Committee convened on 13 August 2024 to review and discuss the ScleroSafe device. The committee confirmed that the procedures performed using the ScleroSafe device are accurately described by the current CPT codes 36473 and 36474, which cover endovenous ablation therapy of incompetent vein extremities, inclusive of all imaging guidance and monitoring.

View the official letter from the AVF Health Policy Committee here.

ScleroSafe has been cleared by the US Food and Drug Administration (FDA) under the 510(k) process, with its predicate device being Clarivein. The ScleroSafe device utilises mechanical disruption and abrasion of the venous intima, combined with the infusion of a physician-specified sclerosant using the ScleroSafe dual procedure syringe/catheter system. This approach provides a comprehensive solution for treating varicose veins, VVT Medical claims.

“We are delighted with the AVF’s endorsement, which provides clear and accurate coding guidance for physicians utilising ScleroSafe™ in their practice,” said Erez Tetro, chief executive officer of VVT Medical. “This is a significant step forward in our mission to enhance the treatment of varicose veins and ensure that our healthcare partners are well supported in providing high-quality care. This achievement was made possible with the support of our US partner, Methapharm, and our leading key opinion leaders (KOLs), who have been instrumental in guiding this process and ensuring the device’s alignment with current CPT codes.”

Submit session proposals for VAM 2025

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Submit session proposals for VAM 2025

While the 2024 Vascular Annual Meeting (VAM) only wrapped up in June and attendees are still in awe of its education offerings, it is time to start planning for the VAM 2025 program. VAM 2025 will take place in New Orleans, Louisiana, June 4-7, which is two to three weeks earlier than VAM is normally held. The call for educational session proposals opened on July 24 and will close at 3 p.m. Central Time on Wednesday, Aug. 28.

For more information regarding session proposals, visit vascular.org/VAM25Proposals.

SVS Executive Board accelerates strategic priorities

By
Marlén Gomez
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SVS Executive Board accelerates strategic priorities

The SVS Executive Board (EB) convened on July 25 under the leadership of SVS President Matthew Eagleton, MD, to accelerate the implementation of key priorities identified earlier this year.

The current board includes Keith Calligaro, MD, as president-elect, Linda Harris, MD, as vice president, William Shutze, MD, as secretary, Tom Forbes, MD, as treasurer, and Joseph Mills, MD, as immediate past president.

The EB’s July meeting followed the Strategic Board’s January review, where the Society’s Strategic Plan and priorities for the coming year were developed. The July session focused on advancing these initiatives to further the Society’s mission in the field of vascular surgery.

SVS calls for nominations

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Kristin Spencer
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SVS calls for nominations

The SVS has called on its members to nominate individuals to fill five at-large positions on the Executive Board (EB) as required following a bylaw referendum passed by the membership in late 2023. This change creates flexibility and greater diversity of perspective in selecting members on the EB to address changing needs and priorities.

The Nominating Committee opened the call this month, with a closing date of September 30. The new at-large members will be named in November and assume their roles in January 2025, coinciding with the Strategic Board of Directors (SBOD) retreat.

The initial terms for these positions are staggered to ensure continuity: one member will serve a four-year term, two will serve three years, and a further two will serve two years.

Subsequent members will serve three-year terms to prevent all five members from rolling off in the same year.

Eligibility criteria for the at-large members include being an SVS member in good standing for at least five years and demonstrating consistent service or contribution to the SVS, SVS Foundation or SVS Patient Safety Organization (PSO) through involvement in committees, subcommittees, section committees, task forces, writers’ groups or editorial groups.

Staff will contact all nominees to confirm their interest and require them to complete a short application. For any questions, email governance@vascularsociety.org.

‘Night at the Museum’

By
Marlén Gomez
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‘Night at the Museum’

The SVS Foundation hosted its annual gala on June 21 at Chicago’s famous Museum of Science and Industry. This was the first of the Foundation galas to take place offsite from the Vascular Annual Meeting (VAM).

“Operation Golden Key” was an attendee favorite event of the evening. SVS Executive Director Kenneth Slaw, PhD, posed as James Bond, working the Gala floor with members of his security detail (aka other SVS staff members) and visiting attendees who had purchased keys to try and unlock his briefcase. The winner of the game unlocked $500 worth of champagne.

The evening included a touching tribute to the late James S.T. Yao, MD, a former SVS president and giant in vascular surgery who supported the SVS Foundation throughout his career. Yao’s family established the SVS Foundation’s James S.T. Yao Resident Research Award in 2024 and attended the Gala.

The night saw nearly $100,000 raised through donations, ticket sales, and both live and silent auctions.

The top prize of note from the silent auction was the 2025 VAM VIP Package which was won by Mel Sharafuddin, MD. The University of Florida/Brigham and Women’s Hospital Vascular Surgery Fishing Trip Weekend was won by Peter Henke, MD.

In transition: SVS Young Surgeons achieve full section status

By
Kristin Spencer
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In transition: SVS Young Surgeons achieve full section status
Edward Gifford, MD

The Society for Vascular Surgery (SVS) Executive Board (EB) unanimously approved the transition of the Young Surgeons Section (YSS) from a pilot section to a full section during their annual retreat held July 26–27. The decision is a reflection of the section’s many accomplish­ments and commitment to its mission.

The SVS implemented membership sections to give dif­ferent subsets of the organization an opportunity to provide added member value and voice in Society initiatives. In 2022, the EB approved the section to begin its pilot phase to rep­resent members within their first 0–10 years of practice, a demographic of membership that has been growing rapidly over the years. The formal mission of the YSS is to foster and accelerate the learning and career development of SVS members within their first decade in clinical practice.

“While the number of ‘young’ vascular surgeons is in­creasing, there is expected to be a surgical shortage of about 30,000 by 2030. The YSS aims to bring forth relevant edu­cation and resources to those millennials and Gen Z-ers who are entering the surgeon workforce. We hope that by offering more relevant resources to this group, we don’t see as many people leaving the specialty or the surgical field,” said Edward Gifford, MD, chair of the YSS.

Gifford recently assumed the section chair position after the 2024 Vascular Annual Meeting (VAM). Prior to VAM, Chelsea Dorsey, MD, served as the section’s inaugural chair, and Gifford served as the vice chair. The two have led a steer­ing committee of 12 young surgeons who have spearheaded initiatives and engaged the section’s membership at large.

The SVS leadership has championed the importance of expanding diversity of perspective and engagement. There is now a YSS representative on the SVS Nominating Com­mittee. This change has given voice to the YSS demographic when it comes to choosing leadership for future SVS posi­tions. Another change that was influenced by the YSS leadership was to give Early Active members of the SVS the opportunity to vote in SVS elec­tions and serve on SVS committees. Both proposed changes were brought to the SVS membership to vote and passed in 2022 and 2023, respectively. The chair of the YSS now sits on the SVS Appointments and Nominations Committee, as well as the Stra­tegic Board of Directors.

“Seeing these changes to the structure of long-standing SVS Committees and the voting membership has motivated me during my years as section chair to keep advocating for this demographic,” said Dorsey. “Being able to make a difference and provide a voice for this growing group of members of our organization is vitally important, in my mind, to the overall health and growth of the SVS.”

Since its inception, the YSS has implemented two work­groups of section members to in order to thrash out different initiatives based on the results of a needs assessment. The career development and research workgroups are composed of 10 YSS members each and have worked to implement two monthly YSS-sponsored journal clubs with the Journal of Vascular Surgery (JVS), help expand the SVS mentor match program to include all SVS members and more. Additionally, members of the YSS currently serve on other committees and workgroups through­out the SVS, including the Communications and Branding Committee, Leadership Development Committee, Education Council and Compensation Study workgroup.

While at VAM, Dorsey announced that a visiting professorship for YSS members will be added as an opportunity for application in 2025, and a schol­arship program is being designed to help mem­bers travel to different conferences. The SVS is expected to emerge with more information on these initiatives in the coming months.

Gifford is excited to see membership growth throughout the section. He also plans to work with SVS leaders to get YSS members on more committees.

“Young vascular surgeons are the future of our specialty and our society. We are so excited about the approval of the section and are committed to providing resources for advocacy, collaboration, mentorship and career development for our peers,” he said. “We want all the young vascular surgeons around the country and the world to know that there is a dedicated group within the SVS to be inclusive of your needs.”

To join the YSS, members within their first 10 years of practice can email communications@vascularsociety.org.

SVS’ inaugural leadership and advocacy conference

By
Marlén Gomez
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SVS’ inaugural leadership and advocacy conference

The Society for Vascular Surgery’s (SVS) Advocacy team is thrilled to an­nounce the inaugural Leadership and Advocacy Conference, set to take place Sept. 14–16, 2025, in Washington, D.C. The event is designed to bring together passionate vascular surgeons nationwide to engage in meaningful dialogue, share insights and collaborate on an advocacy agenda designed to protect and promote the future of vascular surgery.

With its rich history and political significance, Washington, D.C., provides the perfect setting for the SVS’ collective mission to advance vascular health advocacy. From exploring effective leadership qualities to discussing strategies for effective lobbying, every session will be meticulously designed to inspire and empower.

Mark your calendars to participate in this transformative experience that will enhance your leadership skills and amplify your voice in vascular advocacy. Over the course of three days, attendees will have the unique opportunity to participate in a series of dynamic workshops, keynote presentations, and panel discussions. Additionally, attendees can visit Capitol Hill and directly engage with lawmakers and their staff. The conference promises to equip both seasoned advocates and those new to advocacy with the tools and knowledge necessary to serve as a champion for the field of vascular surgery and its patients.

“Surgeon involvement in managing change and solving the challenges of our health care system has never been more important. I am incredibly excited that the SVS is working to position vascular surgeons at the forefront, building knowledge and skills within our ranks, leveraging the expertise we have, and bringing it all to Congress’s doorstep,” said SVS Advocacy & Policy Council Chair Megan Tracci, MD, JD.

Save the date and prepare to participate in an experience that will impact professional journeys and the broader healthcare landscape.

Decoding differences for proper billing and reimbursement

By
Kristin Spencer
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Decoding differences for proper billing and reimbursement

The Society for Vascular Surgery (SVS) has partnered with KarenZupko and Associates (KZA), a consulting and education firm, to create vascular surgery coding resources for SVS members and their coding staff. The resources include on-demand courses for purchase and frequently asked questions (FAQs) and answers.

The on-demand courses will be released each quarter, with the third and latest course released in June. The new course, entitled “Co-Surgeon and Assistant: What’s the Difference?”, helps staff understand the importance of the differentiation between co-surgeons and assistants when it comes to the important area of coding and reimbursement.

In the past, Medicare noted that this type of coding error has resulted in improper billing, leading to a report by the Office of Inspector General recommending payor scrutiny of their use.

Once completed, participants should be able to describe the difference between co-surgery and assistant surgery, list the key documentation necessities and understand the reimbursement differences of co-versus assistant surgeons. The course will provide a detailed explanation of payor rules and documentation imperatives, as well as clinical scenarios.

The two previous on-demand courses covered surgical modifiers in vascular surgery and nonphysician provider (NPP)/ advanced practice provider (APP) billing and coding for vascular surgeons. The remaining courses published later this year will cover the evaluation and management of clinical scenarios for vascular surgeons, and relative value unit compensation and contracting.

The courses provide American Academy of Professional Coders with continuing education credits.

New FAQs are being added to the SVS website on a monthly basis. They are sorted by category and aimed at answering questions and helping to avoid coding errors down the road. Categories range from aneurysms to venous disease and cover every vascular bed and area in between.

Each fall, the SVS hosts an in-person Coding and Reimbursement Workshop now open for registration. To access more information on this workshop and the other coding resources, visit vascular.org/CodingInquiries.

AngioDynamics announces CE mark approval in Europe for the Auryon system

By
Jocelyn Hudson
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AngioDynamics announces CE mark approval in Europe for the Auryon system

AngioDynamics today announced European CE mark approval of the Auryon atherectomy system, designed for the treatment of peripheral arterial disease (PAD), including chronic limb-threatening ischaemia (CLTI) and in-stent restenosis (ISR).

The Auryon atherectomy system uses solid-state laser technology to treat PAD lesions and occlusions. A press release notes that Auryon is the first laser atherectomy system to efficiently treat lesions of any type, length, or location (above and below the knee), with minimal impact on vessel walls.

“The CE mark approval of the Auryon system is a significant milestone that underscores our commitment to bringing safe and effective solutions to healthcare professionals treating peripheral arterial disease,” said Laura Piccinini, AngioDynamics senior vice president and general manager of endovascular therapies and international. “This approval validates the clinical value of the Auryon system and allows us to expand our presence in Europe, as the prevalence of PAD continues to grow across the region. We are committed to supporting physicians with innovative technologies that empower them to deliver the best possible care when treating some of the most challenging cases of this disease.”

AngioDynamics states that the Auryon atherectomy system, which received US Food and Drug Administration (FDA) 510(k) clearance in 2020, has treated over 50,000 patients in the USA. The recent CE mark approval now provides patients with PAD in the European Union access to the Auryon system’s laser platform.

The technology underlying the Auryon atherectomy system has been shown in clinical studies to be effective in treating lesions ranging from soft plaque to severely calcified, a press release reports. The system uses a 355nm wavelength laser platform, enabling the use of short UV laser pulses with targeted biological reactions that are effective in treating PAD while minimising the risk of perforation and preserving the ability to vaporise lesions without thermal ablation.

The press release continues that the Auryon atherectomy system features aspiration and off-set capability in certain catheter sizes, allowing clinicians to address the risk of embolisation and to treat all lesion types, while answering a need for non-surgical intervention options for PAD, including ISR, and CLTI.

Nicolas Shammas and the Midwest Cardiovascular Research Foundation (Davenport, USA) have published a prospective, multicentre, single-arm investigation examining the use of the Auryon laser system in patients with below-the-knee CLTI. The study demonstrated that the Auryon laser system effectively reduced residual stenosis to ≤30% in the majority of patients post-treatment, without any cases of target lesion revascularisation.

The recently published PATHFINDER registry further supports these findings, showing no flow-limiting dissections and significant improvement in ankle-brachial index (ABI), Rutherford classification, and Walking Impairment Questionnaires at both six and 12 months in a real-world clinical setting.

These results add to a growing body of evidence indicating that the Auryon laser system is a safe and effective treatment option for a wide range of complex patients with PAD.

The good, the bad and the bloody: Reflections on the road to residency

By
Blake Murphy
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The good, the bad and the bloody: Reflections on the road to residency
Blake Murphy

As my third year of residency comes to a close, that little thing called The Match feels like a distant fever dream. The memories of Electronic Residency Application Service (ERAS) application anxiety now tinted with the rose-colored glasses of a surgical resident entering her much-needed research years.

Every summer, however, the residency application process starts anew. Like many colleagues, matching into residency was filled with some staggering highs and notable lows. So, for the vascular surgery residents of tomorrow, I encourage you to shoot your shot!

Find your footing and your mentors

As someone batting less than 500 on the day of United States Medical Licensing Examination (USMLE) Step 1, the weak points in my application were well defined. Even with solid clinical grades and an extensive advocacy background, the climb to surgical residency felt like tackling Mount Everest. Thankfully, honest feedback from thoughtful mentors provided invaluable guidance—focused on centering my lived experience. My work as a primary care scribe, data analyst, and advocacy fellow in Washington, DC meaningfully informed my answer to “why medicine” and “why vascular surgery.” As a non-traditional medical student, creating a framework to highlight my unique strengths was crucial for success on the interview trail. And if we’re being honest, my Step 2 CK (clinical knowledge) score improved massively—thanks in large part to dedicated work around test anxiety.

Survive and thrive on the interview trail

The cost of applying to more than 40 programs was dulled by the thrilling prospect of color-coded Excel spreadsheets and enabling email alerts for interview invites. Before the spreadsheets, however, came honest reflection about my priorities in surgical training—mainly the importance of living in an urban environment, exposure to vascular trauma and complex aortic work, and access to dedicated research years. On the interview trail, I clearly communicated how my priorities as a future vascular surgeon-in-training aligned with my programs of interest. After each interview, I took time to digest the experience and updated my rank list in real-time. While momentarily tedious, this practice saved hours, if not days of deliberation in the weeks leading up to rank list certification. Last but certainly not least, I militantly tackled my post-interview follow-up emails—for which my future self is grateful.

Trust the process

Trusting the process is always easier in retrospect. Even during my Halloween COVID-19 wedding in 2020—amidst the first round of interview invites—real uncertainty about my future was front of mind. Looking back, the process of organizing an application, completing interviews and honest self-reflection was just good practice for surgical training. You must trust the knowledge, confidence and purpose you have cultivated. The Match is simply about finding a training program that challenges you to be the best person and vascular surgeon you can be. It should come as no surprise—this looks different for every applicant. Nevertheless, I promise your first open abdominal aortic aneurysm repair, tibial bypass or trauma thoracic endovascular aortic repair (TEVAR) is truly just a blink away.

Blake Murphy, MD, is a an integrated vascular surgery resident at the University of Washington in Seattle.

Study: Social support associated with better PAD health outcomes

By
Jocelyn Hudson
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Study: Social support associated with better PAD health outcomes
social support
L-R: Senior authors Kim G Smolderen and Carlos Mena-Hurtado

Patients with peripheral arterial disease (PAD) reporting lower levels of social support experience worse health outcomes, a new Yale-led study finds.

Social support is thought to bolster cardiovascular health by facilitating health-promoting behaviors and acting as a buffer against the impacts of stress on the heart. A team led by Santiago Callegari, MD, of the Yale University Department of Internal Medicine in New Haven, Connecticut, used questionnaires to assess perceived social support (ENRICHD Social Support Inventory), PAD-specific health status (Peripheral Artery Disease Questionnaire), and general health status (EuroQOL Visual Analog Scale) for 949 patients at baseline and 12 months later.

For the 18.2% of respondents reporting low social support, researchers found scores more than seven points lower on average on both the Peripheral Artery Disease Questionnaire and the EuroQOL Visual Analog Scale, indicating significantly poorer outcomes in PAD-specific and general health metrics. The association between low social support and poorer outcomes remained strong even when adjusting for factors including stress, depression, and socioeconomic status.

The research team says their work highlights the importance of psychosocial factors, like social support and depression, in the treatment of cardiovascular disease. “The focus has been on specific devices to open blockages or do bypasses,” says corresponding author Carlos Mena-Hurtado, MD, associate professor of medicine (cardiology) at Yale. “This study shows that it is time to see patients with PAD in a multidimensional way, such that a multidisciplinary team needs to get involved in their management.”

Who’s covering second? Rogue hospital human resource departments

By
Arthur E. Palamara
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Who’s covering second? Rogue hospital human resource departments
Arthur E. Palamara

While nobody died, the procedure could have gone smoother. The patient, a corpulent man in his late 40s had been on dialysis for half of his life. Two transplanted kidneys failed, and multiple access procedures and his native arteries and veins were beyond salvage. Multiple stents were plastered within his chest, making his upper extremities impenetrable. The superior vena cava was blocked. The left iliac vein had been his lifeline for the past year and now was surrounded with pus. He came in septic. The dialysis catheter in the left groin was removed. He still needed dialysis. Somehow.

An occluded stent lay within the left external iliac vein. The veteran radiologist knew that the stent was not that old and might contain a soft “core.” Ploughing through the fat and musculature above the inguinal ligament, he skillfully aimed a needle at the center of the stent. It gave and he gently maneuvered a variety of wires into the vena cava and met with success! Several inexperienced techs worked with him as he barked orders, colorfully buttressed with a slew of profanity. The tension was high. Several times the wires came close to being pulled out but were saved at the last minute. The poor technician’s hands were uncontrollably shaking. Observing the procedure, I reassured her stating: “He doesn’t bite, just take it one step at a time.”

While the patient would not have immediately died, establishing dialysis access was critical and lifesaving. Working with an inexperienced team did little to bolster the radiologist’s confidence. Although the radiologist was one of the best in his field, he was not immune to the pressure. Extreme tension dissolves even the most placid individual’s restraint. His assistants’ inexperience increased his frustration.

Second base

Using a baseball analogy: it’s the bottom of the ninth, your team is up by one, and the opposing team is at bat. There is one out. The bases are loaded, and a ground ball is hit to the shortstop, who fields the ball cleanly and throws to second for the double play. The second baseman has failed to cover, and the ball lands in right field. Two runners score and the team has lost because of the error.

Who is covering second? That question is central to the frustration and isolation that the radiologist felt in a critical moment when he lacked confidence in his assistants. Success is exclusively up to him, and no help is on the way. What happened to those seasoned techs who had worked with him for years? Those veterans who knew what each wire, catheter and balloon did, and where they could be immediately retrieved: experienced techs could have made the job much easier and certainly less stressful. Some moved on to higher paying jobs during the pandemic when the hospital refused to meet their salary demands. Some retired, some were demoted for discourteous behavior, and some were fired.

Human resource failure

Staffed as they are with non-clinical human resource (HR) employees—who know little to nothing about the positions they fill—they accept candidates who correctly check a number of boxes. Positions are staffed with employees who have agreed to work at a pre-set salary determined by financial officers who know nothing about the demands of highly complex surgical or radiologic procedures. HR personnel, abstracted as they are from real dramas of medical care, are unable to separate the wheat from the chaff. Nor do they manifest a desire to learn.

During the pandemic, HR and administrators complained that they could not retain doctors, nurses and technicians because of outlandish salaries offered by temporary staffing companies. Yet they were happy to pay $120 per hour to a “temp” instead of giving another $10 per hour to excellent, loyal employees with recognized value to the system. As such, many of these core employees left and have not returned. Even worse, HR made no attempt to recognize key employees, nor acknowledge their fundamental contribution to the system.

Regretfully, hospitals’ current culture has been replaced by externally imposed standards of behavior that fail to portray human experience. Emotional temperance has replaced expertise; inexperienced personnel have been given responsibilities far in excess of their capabilities. This is particularly destabilizing in healthcare, and potentially dangerous for the patient. Medical error rates have increased but only the most egregious cases are reported. Moreover, lack of trained staff, while more obvious in the operating room (OR) and radiology suites, is reflected in other ways by increased length of hospital stays, longer OR turnover times, utilization of equipment, limitless diagnostic tests, and, ultimately, outrageous costs. Retention of key individuals is paramount to achieve excellent outcomes.

HR departments have to accept the lion’s share of the blame. While adopting the DEI (diversity, equity and inclusion) philosophy is beneficial and desirable, it only works with meritocracy. Partially trained individuals eventually realize that they lack expertise and retreat from accepting responsibility, only to become resentful when confronted with a crisis. If they have the will and the stamina, they ultimately acquire the experience and enjoy the satisfaction that accompanies achievement. Unfortunately, promotions are not based on expertise, an attribute administrators fail to appreciate. Even an occasional—but rare—word of praise will suffice.

Creating effective groups

HR departments and most hospitals have yet to acknowledge the importance of creating “effective groups,” a concept that is vitally important in healthcare. From heart transplant groups to interventional radiology to nursing floors, teams are the cornerstone of excellent outcomes.

It also helps if HR and hospital administrators appreciated that physicians are highly educated, motivated people with the lofty goals of curing people and succeeding professionally. They come laden with idealism and critical thinking skills. They look for the

opportunity to solve problems and refine processes to enhance care. When denied the chance to fulfill their expectations, they become disillusioned and filled with moral outrage. Then they leave.

Some years ago, at the inception of robotic surgery, a small hospital in upstate New York was matched against an Ivy League competitor in Manhattan. The researchers went back five years later to look at the results and found the smaller hospital enjoyed better outcomes than their prominent competitor. The smaller hospital was able to train and retain the same team of surgeons and nurses while the larger, world-renowned hospital suffered numerous defections. The smaller hospital experienced cultural growth, and a sense of pride and shared identity. Their leadership was respected and inspired the team members to achieve superlative results.

That was, of course, before the pandemic, an event to which many hospital systems lay blame for their failures. While partially true, valuable team members who could have been retained were allowed to leave for wont of small increases in salary and lack of recognition of their contribution.

Instead, these professionals were never acknowledged as integral and criticized for their lack of loyalty. HR departments now complain that Gen Z and millennials lack commitment. But also true is that when hiring new physicians and key team members, existing doctors’ recommendations are often ignored. Since administrators have little appreciation of what transpires when dealing with critical medical challenges, their hiring decisions are based on irrelevant factors—often social perception. They, their institutions and the patients would be better served if they spent more time on the front line of medicine to gain an understanding of what is really essential.

Transactive memory

Loyalty to an institution and accomplishing highly complex tasks are accomplished by developing what is known as “transactive memory,” through which collective intelligence is achieved and shared.

Returning to the baseball analogy, the second baseman would instinctively know to cover the “bag,” as the scrub tech instinctively knows to hand over a Crafoord clamp when blood is gushing from the aorta. But creating a staff capable of achieving those goals requires an investment of time, money and patience.

Regretfully, our capitalistic, fragmented, patient-unfriendly, expensive healthcare system seems loathe to make that commitment. Patients are not ignorant; they will respond to and seek excellent care. Ultimately, a healthcare system espousing these virtues will be both medically and financially rewarded. And their employees much happier.

Arthur E. Palamara, MD, is a vascular surgeon practicing in Hollywood, Florida, for 44 years. He is active in county, state and national medical organizations.

New ESC guidelines combine peripheral arterial and aortic diseases for first time, emphasising interconnectivity of whole arterial system

By
Jocelyn Hudson
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New ESC guidelines combine peripheral arterial and aortic diseases for first time, emphasising interconnectivity of whole arterial system

The European Society of Cardiology (ESC) has today published its 2024 guidelines for the management of peripheral arterial and aortic diseases (PAAD), evaluating these vascular conditions together as part of the same cardiovascular system.

The guidelines are aimed at cardiologists, but were coordinated for alignment with guidelines for surgeons by the European Association for Cardio-Thoracic Surgery (EACTS) and endorsed by the European Reference Network on Rare Multisystemic Vascular Diseases (VASCERN) and the European Society of Vascular Medicine (ESVM).

“These updated guidelines have been introduced now due to significant advancements and shifts in our understanding and management of aortic and peripheral arterial diseases (PAD), including new treatment modalities, since the last guidelines were published in 2014 and 2017, respectively,” says ESC guidelines co-chair Jose Fernando Rodriguez Palomares (University Hospital Vall d’Hebron, Barcelona, Spain).

“The decision to integrate these guidelines is based on several key factors. The aorta and peripheral arteries are integral components of the same arterial system. Disorders in one part of this system often have implications for the other,” adds co-chair Lucia Mazzolai (Lausanne University Hospital, Lausanne, Switzerland. “Combining the guidelines provides consistent and standardised recommendations for the management of arterial diseases as a whole. This ensures that patients receive cohesive and coordinated care across different vascular conditions, reducing fragmentation and improving overall treatment outcomes.”

An ESC press release notes that PAAD is estimated to affect around 113 million people aged 40 and over globally, of whom nearly half (43%) are in low- and middle-income countries. The global prevalence is 1.5% and increases with age, affecting 15–20% of those aged 70 years and over and 20–30% of those aged 80 years and older. Prevalence increased by 72% from 1990 to 2019, despite the global population growing only 45%.

The authors say the most important recommendations in the new 2024 guidelines are those addressing the chronic nature of PAAD, the importance of screening, and the necessity of comprehensive treatment strategies—and awareness that this a chronic disease that needs lifetime follow-up.

“A significant proportion of patients are asymptomatic and therefore PAAD screening is crucial, based on age, the presence of cardiovascular risk factors, family history and/or presence of syndromic features. PAAD diagnosis can be easily achieved with a non-interventional vascular test/imaging,” says Rodriguez Palomares. The guidelines highlight that optimal pharmacological treatment (antithrombotic, lipid-lowering, antihypertensive, antidiabetic) and emphasis on exercise and lifestyle changes are mandatory and effective in reducing burden of disease. Patients with PAAD have a very high cardiovascular risk and require optimal management of risk factors such as hypertension, hyperlipidaemia, and diabetes to prevent serious complications.

Finally, the authors emphasise gender aspects and that PAAD comprises chronic diseases requiring continued attention. They conclude: “PAAD is a chronic disease necessitating lifelong follow-up by vascular specialists, cardiologists, and a multidisciplinary team. Women often present with atypical or asymptomatic disease, warranting special attention during screening. Exercise and lifestyle changes are crucial before considering interventional management in chronic PAAD.”

First-in-human study of SonoThrombectomy system completed

By
Bryan Kay
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First-in-human study of SonoThrombectomy system completed
The SonoThrombectomy system catheter

SonoVascular has announced the successful initiation of its first-in-human study (FIH) of the company’s SonoThrombectomy system, an ultrasound-facilitated, thrombolytic-enhanced platform that utilizes multiple mechanisms of action to treat patients with venous thromboembolism (VTE). The catheter-based system combines microbubble-mediated cavitation with low-dose thrombolytic delivery to treat clots with no blood loss. 

The FIH case was completed at the Hospital Dipreca in Santiago, Chile, under the supervision of vascular surgeon Manuel Espíndola, MD, principal investigator (PI) at the site, with the assistance of Albrecht Krämer, MD, also a vascular surgeon and the study PI. The clinical team successfully used SonoThrombectomy to treat deep vein thrombosis (DVT) involving the common and external iliac veins, SonoVascular reported in a press release.

“We were extremely pleased to perform the first clinical case using the SonoThrombectomy system,” said Espíndola. “The Resonator catheter performed exceptionally well, successfully and very quickly removing the thrombus and, most importantly, without the typical blood loss commonly seen in mechanical thrombectomy procedures. The patient was discharged from the hospital within 48 hours and is now at home, asymptomatic and recovering well.”

“The SonoThrombectomy system was effective at reducing thrombus burden while preserving vessel walls due to its unique and gentle approach,” added Krämer. “It is exciting that we achieved such a comprehensive result on the table with a very low dose of thrombolytic.”

Inari Medical updates ClotTriever XL IFU amid FDA recall notice

By
Bryan Kay
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Inari Medical updates ClotTriever XL IFU amid FDA recall notice

The Food and Drug Administration (FDA) has issued a Class I recall—the most serious type—for Inari Medical‘s ClotTriever XL, 30mm device due to reports of patient injury, and death from device entrapment and pulmonary emboli (PE).

The device remains on the market with updated instructions for use (IFU), with all devices and lot numbers with labeled dates prior to Aug. 1 affected. The FDA recall was categorized as a “correction,” addressing a problem with a medical device in the place where it is used or sold rather than removing it from the market.

There have been four reported injuries and six reports of death, the FDA noted. The serious adverse events occurred in patients who had the ClotTriever catheter inserted through the jugular vein; thrombus that is fibrotic, organized and/or adherent; clot formed by tumor cells; and extremely large clot that can’t be removed in pieces.

On July 19, 2024, Inari sent all affected customers an Urgent Medical Device Labeling Correction letter covering IFU updates, recommending that they view the letter and updates, then share it with any relevant personnel and/or device users; share this information with any organization where the ClotTriever XL catheter may have been transferred; and complete the Customer Acknowledgement Reply Form as soon as possible.

The FDA recommended that, based on its review of the reported adverse events, users consider the device to be contraindicated for the removal of fibrous, firmly adherent or calcified material, and be aware that the use of a clot capture device—for example an embolic protection device—”has not yet been demonstrated to be effective in the venous vasculature.”

The FDA noted in the recall that U.S. customers with questions about the recall should contact their local Inari sales representative, Inari Customer Care at 877-923-4747, or its quality department at QA@inarimedical.com.

SCVS issues call for abstracts as deadline approaches for 2025 symposium

By
Bryan Kay
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SCVS issues call for abstracts as deadline approaches for 2025 symposium
SCVS 2025 takes place in Austin, Texas

The Society for Clinical Vascular Surgery (SCVS) has issued a call for abstracts for its 2025 Annual Symposium, with just under two weeks left until the deadline.

Once again, the SCVS will give special consideration to papers deemed “collaboration abstracts”—those which include three or more SCVS members, are original and encourage multi-institutional experiences. Priority will be given to papers not derived from large national databases, the SCVS announced.

Scientific abstract categories cover each of the vascular beds and other topics that include the likes of education and training, imaging, and medical management of vascular disease. Case report submissions include the categories: abdominal aortic, thoracic aortic, peripheral and other, and venous and dialysis. Video submissions fall under “How I Do It” presentations about common vascular procedures that illustrate technique and “Unique, Interesting and Rare Vascular Case Videos.”

SCVS 2025 takes place in Austin, Texas, from March 29–April 2. For full details, visit symposium.scvs.org.

Eastern Vascular Society set to stage day of service during 2024 annual meeting

By
Bryan Kay
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Eastern Vascular Society set to stage day of service during 2024 annual meeting
The EVS is hosting a day of service Sept. 20

The Eastern Vascular Society (EVS) has incorporated a day of service into its 2024 annual meeting, being held in Charleston, South Carolina (Sept. 19–22).

Leading vascular surgeons, alongside nurse practitioners and advanced practice partners, will educate local residents about their peripheral vascular health under an initiative entitled, “From A to V: Completing the Circuit. The Truth About Arteries and Veins.”

The event, which takes place at. St. Julian Devine Community Center in downtown Charleston on Friday, Sept. 20, from 6.30–8.30 p.m., includes a free screening and compression stockings for the members of the public who attend.

A multidisciplinary panel will provide expert advice about both arterial and venous disease, including on the most common signs and symptoms of venous insufficiency. A question-and-answer session will also form part of the event.

Vascular surgeons A. Sharee Wright, MD, from the Medical University of South Carolina (MUSC) in Charleston, Misaki M. Kiguchi, MD, from Medstar Washington Hospital Center in Washington, D.C., and Anil Hingorani, MD, from NYU Langone in New York City, are among the panelists.

The event is taking place in partnership with the American Venous Forum, with collaboration from MUSC.

SVS Foundation’s Step at VAM challenge raises more than $30,000

By
Kristin Spencer
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SVS Foundation’s Step at VAM challenge raises more than $30,000
Step Challenge T-shirt

The recent Vascular Annual Meeting (VAM 2024) was more than a gathering of medical professionals to discuss advancements in vascular health. It featured the Step at VAM challenge, an inspiring event highlighting the importance of physical activity that raised over $30,000 for the SVS Foundation.

Participants collectively walked over 575,000 steps in less than three days, promoting vascular health awareness through their efforts. The event saw enthusiastic participation, with one standout participant: Greg Westin, MD, from the Indiana University School of Medicine, was named VAM’s top walker after covering 24 miles.

Westin expressed gratitude to the challenge organizers and appreciated the convenience of VAM’s walking location, which had a gym available. His room was on the 31st floor, giving him “plenty of stairs to climb!”

The challenge at VAM 2024 was just the beginning. As part of Peripheral Artery Disease (PAD) Awareness Month in September, the SVS Foundation is gearing up for the third annual Vascular Health Step Challenge. This initiative encourages participants to walk 60 miles throughout September, symbolizing the 60,000 miles of blood vessels in the human body. PAD, a chronic disease where plaque builds up in the arteries of the legs, affects more than 10 million people in the U.S. and walking aids in its prevention and treatment.

“Walking is a fundamental human activity that keeps us healthy,” said SVS Foundation Chair Joseph Mills, MD. “It’s great to see this campaign succeed in not only raising PAD awareness but also funds for the SVS Foundation.”

Registration for the 2024 Challenge opened on Aug. 1, and walkers can sign up as individuals or form teams. Everyone who registers will receive a commemorative Step Challenge T-shirt.

This year’s sponsors for the event include presenting sponsor Advanced Oxygen Therapy, Inc. (AOTI), superior sponsor W. L. Gore & Associates (Gore), as well as Abbott and the Society for Vascular Nursing (SVN).

With the success of the Step Challenge at VAM 2024 and the enthusiasm building ahead of the September event, the SVS Foundation continues to lead the charge in promoting positive vascular health. Organizers want everyone who can to join the movement, walk for a cause and contribute to a healthier vascular future.

To register, visit vascular.org/STEP2024.

SVS sets modest dues increase to drive enhanced member benefits

By
Marlén Gomez
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SVS sets modest dues increase to drive enhanced member benefits
SVS President Matthew Eagleton

The Society for Vascular Surgery (SVS) announced an increase in membership dues for 2024 for Active members, a strategic move aimed at enhancing support and resources for its members. This adjustment will bolster professional development opportunities, networking, advocacy and resources tailored to the needs of vascular surgeons and related professionals. Members are encouraged to renew their registration to take full advantage of these benefits.

SVS President Matthew Eagleton, MD, informed members in late July of the increase and noted that a portion of the adjustment will be allocated to support the SVS’ efforts to establish a stronger brand identity for the specialty via a multifaceted public awareness campaign.“In an ever-evolving healthcare landscape, vascular surgery must strengthen its specialty identity and increase our exposure to a variety of public-facing audiences. A robust and recognizable brand not only amplifies the SVS voice in advocating for vascular health but also ensures that members like you receive the recognition and support they deserve,” stated Eagleton.

Members will soon have access to updated materials associated with this campaign, which will provide benefit for both physician practices and their patients, including free downloadable patient care and awareness brochures, media materials and a new patient-centric website. Consensus documents, information on the Medicare Quality Payment Program and the SVS Patient Safety Organization’s Vascular Quality Initiative (PSO VQI) are additional resources that support members in providing top-tier patient care.

An SVS membership also includes the SVS Branding Toolkit, which offers customizable tools to help vascular surgeons communicate their role in vascular care. These tools help facilitate crucial conversations with referral sources and administrators, and emphasize the increasing value of vascular service lines.

The 2024 secretary report, delivered at the Annual Business Meeting (ABM) in June 2024, listed a total membership of 6,635. Of these, 38% are practicing vascular surgeons in the Active Member category, while 11% are early-career vascular surgeons in the Early Active Member category. Candidates-in-training, which include 237 general surgery resident members and 346 medical student members, make up 19%. Fully retired Senior members account for 14% of the membership.

Additionally, 8% of SVS members are International and from more than 50 countries outside the U.S. and Canada. Affiliate members, such as nurses and physician assistants affiliated with vascular surgery, constitute 10% of the membership. The remaining 2% comprises Honorary members and Affiliate members, such as specialty physicians (DPMs) and academic researchers (PhDs).

SVS members have access to peer-reviewed research and surgical techniques through the Journal of Vascular Surgery (JVS) body of titles—subscription free for Active, Trainee, Graduated Candidates and Associate members. Additional member updates are available via the electronic newsletter, Pulse, and the monthly Vascular Specialist newspaper, which inform members about the latest news and developments in the field. SVSConnect, the Society’s online community, provides an exclusive platform for members to engage in discussions, share insights and collaborate with peers worldwide. Members enjoy reduced pricing for key events such as the Vascular Annual Meeting (VAM), the Vascular Research Initiatives Conference (VRIC), the Complex Peripheral Vascular Intervention (CPVI) Skills Course and the Coding & Reimbursement Workshop.

The sixth edition of the Vascular Education and Self-Assessment Program (VESAP6) offers a structured approach to continuous learning and gives members access to the latest educational materials to stay current with evolving medical standards.

The SVS offers mentorship programs, leadership opportunities on councils and committees and scholarships that support members at all stages of their careers, from emerging professionals to seasoned experts. Research grants are available for vascular surgeons, ensuring innovative work continues to thrive.

The SVS professional government affairs staff advocates on behalf of members to influence federal legislative and regulatory processes that directly impact their practices and patients. This advocacy ensures that member voices are heard in decisions affecting their lives, livelihoods and patients, providing essential support and representation. An advocacy conference will take place in 2025, allowing SVS members to participate actively in these efforts.

To learn more about SVS membership, visit vascular.org/MemberBenefits.

‘Choosing the right devices for the right patients’: Surgeon-scientist secures NIH funding to develop MRI technique for precision PAD care

By
Bryan Kay
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0
‘Choosing the right devices for the right patients’: Surgeon-scientist secures NIH funding to develop MRI technique for precision PAD care
Trisha Roy

Michael Conte, MD, recently used his 2024 Veith Lecture to call on young vascular surgeons on the peripheral arterial disease (PAD) frontlines to drive the space forward amid a great unmet need.

The professor and chief of vascular and endovascular surgery at the University of California San Francisco (UCSF) called on those in the vascular surgical specialty to take the lead in confronting the challenges of the global PAD burden and in furthering the science. He laid down the gauntlet. But many are already answering the call. And some have already been chosen.

One of those pressing at the leading edges of the PAD frontier is Trisha Roy, MD. The University of Toronto, Ontario, Canada-trained vascular surgeon-scientist recently received a $3.3 million funding boost from the National Institutes of Health (NIH) to push on with a cutting-edge imaging technique aimed at pinpointing who benefits from an open bypass vs. endovascular intervention, as well as more accurately tailoring device selection.

Now based at Houston Methodist DeBakey Heart & Vascular Center, Roy is deep in the throes of developing a magnetic resonance imaging (MRI)-histology technique to help distinguish plaque morphology in PAD. As she puts it, the method is “unlike anything we have right now.” Establishing how hard or soft a plaque is via computed tomography (CT), X-ray or ultrasound is not possible, Roy explains. That makes figuring out whether an individual patient would be a good or bad candidate for an endovascular intervention on the same basis falls short. “If you have something that is a long, long, long occlusion but is very soft and easy to cross, you can’t tell that apart from a rock-hard dense collagen lesion with CT scans, X-ray or ultrasound right now,” she tells Vascular Specialist. “The only way we can test is by trying—and that is why we do endovascular-first for most of these patients.”

This raises a point of both challenge and excitement for Roy. Or, as Conte referred to it in his Veith Lecture at the 2024 Vascular Annual Meeting in Chicago: “opportunity.”

That endovascular-first approach was challenged by the landmark outcomes reported from the BEST-CLI trial. Key among its findings was that, for many patients with adequate saphenous vein, bypass surgery was a better option, Roy observes. High failure and immediate technical failure rates for endovascular interventions were reported. “The problem is that [bypass] is so much more invasive. So the question that we had with this NIH grant was: is it a matter of bypass being better for PAD patients full stop?”

Or, Roy considers, perhaps there is a way patients can be better selected for endovascular treatment. “We know that the most common mode of failure is the inability to cross a lesion because it’s too hard or too stiff.” Those immediate technical failure rates amount to about 15–20%. “We want to bring that down to 0% by selecting the right patients that you can treat.”

Which is really only the opening gambit in this MRI-histological quest.

“Once you get your wire across, how do you actually open the blood vessel in an effective way?” Roy continues. “We know that PAD plaques are very variable, and depending on what a plaque is made out of, it’s going to be more or less amenable to a certain device. Each of these devices are made for specific types of plaque. So, if you’re talking about something that’s a big nodular chunk of calcium, that’s going to be different from the eggshell calcium around the perimeter, which is different from soft thrombus, and so on.”

This brings to the fore an important biographical detail from Roy’s own trajectory—and how it interplayed with the development of the MRI technique.

She first started to work on the imaging modality as a PhD student in Canada. Back then, about a decade ago, Roy was more or less focused on the mechanical properties of plaques. Upon arriving in the U.S., the plethora of endovascular devices at the disposal of surgeons and interventionalists—unknown north of the border—helped drive exploration of the device-vessel wall-plaque morphology interaction. In essence, without the ability to differentiate different types of plaques, “we’re not able to make informed decisions about who’s going to benefit from what device,” she says. “So that’s why the mainstay, especially for below-the-knee disease, is still balloon angioplasty. And our results are dismal—up to 70% having re-narrowing within just three months.”

Another detail of the U.S. dimension, not available back home sans evidence in support of its use: atherectomy. “I come to the States and it’s used a ton here,” Roy observes. “I can see why—you know balloon angioplasty is not going to work; maybe atherectomy can help in some patients? We don’t know who or what, we say, ‘But let’s give it a try,’ as this is kind of their last chance.”

Cue the contemporary backdrop to atherectomy: overuse, questions of harm and worsening results, and mainstream media scrutiny. “We are looking at that right at the vessel wall level,” Roy points out. “We’re taking the legs of real patients who undergo amputation because we were not able to save their legs, characterizing those plaques, then using orbital atherectomy and comparing that with plain balloon angioplasty. We are making real observations of whether it helps in terms of the vessel wall damage, or are we still doing a lot of dissections? Or does it make any difference at all?”

Into the longer distance, Roy wants to see an outcome whereby a more precision level of care for PAD patients is achieved. “What I envision is that we are using MRI for patients we think need revascularization and individualizing our care based on what the patient’s individual anatomy is,” she explains. “I think that can reduce our failure rate—so, that 20% going down to 0%, but also ultimately making us more successful because we’re choosing the right devices for the right patients.”

The knowledge gleaned from the research thus far has also helped inform new device development. “Right now, we are using coronary devices and applying them to the leg,” says Roy, adding: “They haven’t been very effective.”

Physician-modified endografts ‘safe and effective’ for thoracoabdominal and complex AAA repair

By
Jocelyn Hudson
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Physician-modified endografts ‘safe and effective’ for thoracoabdominal and complex AAA repair
Nikolaos Tsilimparis
Nikolaos Tsilimparis

Researchers have reported a 94% technical success rate among other key findings from a recent international, multicentre, single-arm cohort study of physician-modified endografts (PMEGs) for thoracoabdominal and complex abdominal aortic aneurysm (AAA) repair. The work has been published in the American Heart Association (AHA) journal Circulation.

Nikolaos Tsilimparis (Maximilian University Hospital, Munich, Germany) and colleagues note in their introduction that, despite the widespread use of PMEGs in thoracoabdominal and complex AAAs, “robust” data on their safety and effectiveness in these pathologies are lacking. Generally, they write, previous data are “limited to small, single-centre studies”.

It was the investigators’ aim, therefore, to perform an international, multicentre study analysing the outcomes of PMEGs in elective, symptomatic and ruptured thoracoabdominal and complex AAAs.

In their research article, Tsilimparis et al detail that they defined variables and outcomes according to the Society for Vascular Surgery reporting standards and collected and analysed device modification and procedure details to inform their analysis.

In terms of outcomes, the authors share that efficacy was measured by technical success and safety by major adverse events and 30-day mortality. Additionally, the investigators looked at follow-up outcomes including reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. They performed multivariable analysis with the aim of identifying predictors of technical success, 30-day mortality and major adverse event rates.

Tsilimparis and colleagues state that 1,274 patients from 19 centres were included in the study. The median age of these patients, they detail, was 74 (interquartile range, 68–79) and just over three quarters (75.7%) were men. With relation to pathologies, there were slightly more thoracoabdominal aortic aneurysms than complex AAAs included in the study—54.3% vs. 45.7%, respectively. The majority of patients presented electively (65.5%), while 24.6% had symptomatic aneurysms and 9.9%, ruptured aneurysms.

The authors relay that 83.1% of patients were submitted to a fenestrated repair, 3.6% to a branched repair and the remaining 13.4% to a combination of the two. They note that the majority of patients (85.8%) had three or more target vessels included.

Tsilimparis et al reveal an overall technical success rate of 94%. They specify that this was the exact result for elective cases, with the figure being slightly lower (93.4%) for symptomatic patients and slightly higher (95.1%) for ruptured cases.

In addition, they share that 30-day mortality was 5.8% overall, identifying a lower rate of 4.1% in elective cases and higher rates of 7.6% and 12.7% in symptomatic and ruptured aneurysms, respectively.

Major adverse events occurred in just over a quarter (25.2%) of cases, Tsilimparis and colleagues continue, noting that they occurred in slightly fewer elective cases (23.1%) and slightly more symptomatic (27.8%) and ruptured cases (30.3%) than the average.

Finally, the authors report that freedom from reintervention was 73.8%, 61.8% and 51.4%; primary target vessel patency was 96.9%, 93.6% and 90.3%; and overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6% and 55%/89.1% at one, three and five years. Median follow-up was 21 months.

Tsilimparis and colleagues summarise that PMEGs were a “safe and effective” treatment option for elective, symptomatic and ruptured complex aortic aneurysms in this international, multicentre study. “Long-term data and future prospective studies are needed for more robust and detailed analysis,” they state.

Vascular Specialist–August 2024

By
Bryan Kay
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Vascular Specialist–August 2024

In this issue: 

  • ‘Choosing the right devices for the right patients’: Surgeon-scientist secures NIH funding to develop MRI technique for precision PAD care
  • SVS urges revisions for independent cardiology certification board
  • Guest editorial: Who’s covering second? Rogue hospital human resource departments
  • Vascular heritage: SVS History Work Group’s landmark project culminates in new book

 

SCOREPAD seeks to address ‘alarmingly high’ mortality in CLTI patients with underlying coronary disease

By
Jocelyn Hudson
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0
SCOREPAD seeks to address ‘alarmingly high’ mortality in CLTI patients with underlying coronary disease
CLTI
Dainis Krievins

A new research letter underscores the need to improve long-term survival following lower extremity revascularization for chronic limb-threatening ischemia (CLTI), setting out a randomized controlled trial to examine the impact of coronary artery ischemia testing in these patients.

The letter, authored by Dainis Krievins (Pauls Stradins Clinical University Hospital, Riga, Latvia), Andrejs Erglis (University of Latvia, Riga, Latvia) and HeartFlow’s senior advisor for medical affairs, Christopher K. Zarins, was recently published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

Krievins and colleagues first detail that patients undergoing lower extremity revascularization for CLTI or claudication have “poor” long-term survival due to co-existing coronary artery disease (CAD), which they note is “often asymptomatic, undiagnosed and undertreated.”

Diving into the available data on the topic, Krievins et al highlight an “alarmingly high” mortality rate in these patients that is evident throughout the literature. They state, for example, that the recent BASIL-2 and BEST-CLI randomized controlled trials reported a five-year mortality rate for patients with CLTI that exceeded 50% and was three times higher than the risk of amputation. They also note a 10–12% annual mortality rate following lower extremity revascularization in studies including both patients with CLTI and those with claudication—namely SWEDEPAD, SAFE-PAD and VQI Vision.

The authors point out that the mortality rate in these patients is not only high, but has remained unchanged over the past 40 years, contrasting a “marked decline” in the mortality rate among patients with symptomatic CAD in association with coronary revascularization as a mainstay of treatment. Current annual mortality for patients with CAD is only 1–2%, the researchers point out, as per the ISCHEMIA, FAME 2 and SCOT-HEART trials.

Krievins and colleagues state that guidelines recommend no cardiac testing of patients without cardiac symptoms prior to vascular surgery procedures, despite patients with PAD with combined CAD having “invariably worse outcomes.”

Against this backdrop, Krievins et al detail that they have embarked on a multicenter, randomized clinical trial to determine whether non-invasive diagnosis of silent coronary ischemia together with ischemia-targeted coronary revascularization can improve the outcome of patients following lower extremity revascularization.

The SCOREPAD (Selective coronary revascularization in peripheral artery disease patients after lower extremity revascularization) trial, will enroll up to 600 patients with CLTI or severe claudication and no known CAD after successful open or endovascular lower extremity revascularization, Krievins and colleagues share in EJVES. The patients will be randomized to either coronary computed tomography angiography (CTA) plus computed tomography-derived fractional flow reserve (FFRCT; HeartFlow) with ischemia-targeted coronary revascularization in addition to best medical therapy (BMT) or BMT alone with no elective coronary revascularization, which they note is the current guideline-directed standard of care.

The primary endpoint of the trial is a composite of cardiac death, myocardial infarction (MI) and urgent (unplanned) coronary revascularization during two-year follow-up, the authors detail. Extended followup will continue out to five years.

“Patient enrollment began in February 2024 and more than 80 patients have been randomized so far,” Krievins et al report in EJVES, who go on to say that the trial is seeking to include up to 10 additional sites in Europe and the U.S.

Survey of off-label treatment of complex repair pinpoints factors behind underreported outcomes data

By
Bryan Kay
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Survey of off-label treatment of complex repair pinpoints factors behind underreported outcomes data
Grayson S. Pitcher

The potential for cost and time to be key factors in low levels of outcomes data reporting emerged during a national survey of the off-label use of approved endovascular devices for complex aortic aneurysm repair.

Grayson S. Pitcher, MD, an assistant professor of vascular surgery at the University of Rochester in Rochester, New York, and colleagues conducted targeted sampling to identify vascular surgeons with experience in off-label treatment complex repair, disseminating an electronic survey to 291 individuals that achieved a response rate of 38%.

The researchers found that from an estimated number of elective cases totaling nearly 1,800 per year, the majority—1,307—were performed at medical centers without a Food and Drug Administration (FDA) physician-sponsored investigational device exemption (PS-IDE).

“Estimates of off-label repair are underrepresented in the literature in the U.S.,” Pitcher et al report. “Physician-modified endograft [PMEG] has become the dominant modality. Underreported outcomes data appear to be limited by non-standardized PS-IDE reporting to the FDA, the lack of VQI [Vascular Quality Initiative] participation and prospective institutional data collection, and limitations imposed on publication and presentation.”

Pitcher first presented the survey findings during the 2024 Vascular Annual Meeting (VAM) in Chicago (June 19–22), and they have since been published in the Journal of Vascular Surgery. During VAM 2024, Pitcher reminded delegates of the FDA bar for the off-label use of approved devices: deep knowledge of the product, use based on sound scientific rationale, and use and effects record-keeping. “Unfortunately, the 2013 advisory statement from the SVS was contradictory,” he said, recommending against the performance, presentation and publication of off-label procedures. “This has resulted in a lack of transparency to clinical practice and outcomes data, despite an increase in off-label cases.”

Pitcher told VAM attendees the survey was aimed at not only estimating national volume but better understanding the behaviors of vascular surgeons performing off-label endovascular repairs of complex aortic aneurysms.

Covering a total of 89 institutions in 38 states—including four with Cook Medical device PS-IDEs and 11 other PS-IDEs—the survey showed that 43% of sites perform more than 15 cases per year and that PMEG (63%) was the common and preferred technique, with a market share dominated by Cook, Pitcher reported. “What stands out among this group [of surgeons] is that this is a young group: the majority of respondents were less than 45 years of age, within the first 10 years of practice, and [with] the majority having the technical skills and requisite technical skills having trained at a center with a PS-IDE,” he said.

An exit survey demonstrated that only 29% of respondents always referred to PS-IDE centers “with multiple barriers for referral listed,” Pitcher continued. Only 61% participated in the VQI and 57% maintained an institutional database, he added.

“This study highlights an underrepresented population and the barriers that inhibit referrals to PS-IDE centers,” Pitcher explained. “We felt the best way to visualize this was to use the Dartmouth Atlas hospital referral regions [HRRs] where each outlined area represents a regional healthcare market where patients are referred for major cardiovascular surgery,” he said, pointing to a patchy map of the continental U.S. depicting coverage of PS-IDE centers and those with off-label use. “Even with off-label use in the U.S., only 20% of HRRs are represented.”

Pitcher acknowledged limitations, including recollection bias and the limited number of vascular surgeons surveyed. “There is a need for access to commercially available devices and transparent outcomes, with the majority of respondents in this survey interested in a national collaborative,” he concluded.

Pitcher was asked about a discrepancy between a lower level of those taking part in database collection and a higher number expressing interest in being part of a registry. Pitcher noted that respondents reported that the limitation was cost and time, suggesting the potential of a VQI lite to ease data input.

Societies seek consensus on NIVL management amid ‘paucity of rigorous data’

By
Jocelyn Hudson
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Societies seek consensus on NIVL management amid ‘paucity of rigorous data’
Kush Desai

The diagnosis and management of non-thrombotic iliac vein lesions (NIVL) is the focus of a newly published set of consensus statements from the Vascular Interventional Advances (VIVA) Foundation, the American Venous Forum (AVF), and the American Vein and Lymphatic Society (AVLS).

The report, authored by Kush Desai (Northwestern University Feinberg School of Medicine, Chicago, USA) and colleagues, appears as an open access article in the American Heart Association (AHA) journal Circulation: Cardiovascular Interventions.

Imaging considerations for diagnosis, patient selection and technical considerations for stent placement, and optimal post-procedure medical therapy and surveillance are all covered in the document.

On imaging, Desai et al advise: “In a patient considered for NIVL treatment, an invasive diagnosis with the complementary use of venography and IVUS [intravascular ultrasound] is recommended.” In addition to this, the authors stress the importance of “dynamic” IVUS evaluation of NIVL, which they explain includes breath hold and manoeuvres that increase intra-abdominal pressure.

The writing group further advise that intervention below the thresholds of >50% area reduction or >61% diameter stenosis on IVUS at the NIVL is not recommended, and that use of venography thresholds alone for diagnosis and treatment of NIVL is “less well established”.

Finally in this section, Desai and colleagues state that axial imaging with computed tomography (CT) or magnetic resonance imaging (MRI) “can help confirm the presence of anatomy that may be associated with a clinically significant NIVL”. They stress, however, the importance of clinical evaluation and venography and/or IVUS being central to the final diagnosis and intention to treat.

On the topic of patient selection for NIVL stent placement, the authors recommend that stenting “may be appropriate” in certain circumstances, for example in the presence of either asymmetrical oedema significantly affecting quality of life (QoL), progressive Clinical-Etiology-Anatomy-Pathophysiology (CEAP) class 4 to 6 venous disease, or venous claudication with minimal superficial venous disease, or following previous treatment of underlying superficial venous reflux.

The authors warn, however, that stent placement for NIVL is “inappropriate” in patients with minimal to no symptoms and in asymptomatic patients to prevent possible future venous thromboembolism (VTE) events.

In their final recommendation of this section, Desai et al write that stenting “may have a role” in some cases with QoL-impacting chronic pelvic pain of venous origin in the presence of parauterine veins with or without pelvic venous reflux.

The report also includes four consensus recommendations on technical considerations for stent placement, including firstly that the choice of stent size and length in NIVL “should depend on IVUS for diameter/length measurements with compulsory fluoroscopy for length measurements”.

This section of the report also addresses stent migration, which Desai and colleagues highlight can have “devastating consequences”. As a result, the authors stress that measures to mitigate the possibility of stent migration and complications—including appropriate device diameter and length—are “mandatory”.

Desai and colleagues continue that sizing based on the normal reference vessel is “generally recommended” and that stents for NIVL should be extended into the straight portion of the external iliac vein to limit complications including stent migration.

The authors advise against routine use of anticoagulation or antiplatelet therapy for untreated NIVL, opening their recommendations for optimal medical therapy and surveillance for NIVL patients. They go on to highlight that, in treated patients with NIVL with no evidence of previous VTE, there is “no consensus that anticoagulation or antiplatelet therapy is necessary”.

Furthermore, they recommend that an assessment of thrombotic risk in patients with NIVL should be made and, should anticoagulation or antiplatelet therapy be indicated, the agent, dose and duration “should be tailored accordingly”. The final recommendation the authors make in this section is to encourage routine early and long-term clinical surveillance following stent placement.

Finally, the document outlines future direction in research and education on the topic of NIVL diagnosis and management. “Evidence-based appropriateness of treatment and longitudinal management of patients with NIVL should be supported by long-term prospective trials,” Desai et al write, going on to emphasise that these should include outcomes focusing on patient QOL measures. On appropriateness, they detail that this “emphasises patient selection, intervention technique, and post-procedure optimal medical therapy and surveillance”.

Desai and colleagues underline the fact that future directions in NIVL research should include the establishment of consensus guidelines with multi-societal endorsement, and in NIVL education must incorporate the dissemination of future appropriateness guidelines to providers treating NIVL and to referring practitioners as the standard of care through societal endorsement.

“The challenge of developing consensus documents for the treatment and management of patients with NIVL stems from the paucity of rigorous data supporting a specific treatment strategy,” the authors write in the closing paragraphs of the document. As a result of this, they emphasise that future studies “need to focus on defining who benefits the most from the treatment of NIVL and defining the determinants of treatment success”.

Lastly, Desai et al reiterate the importance of appropriateness of care when it comes to NIVL patients, which they state, “requires accountability, starting with physicians tracking their quality outcomes”.

The full consensus statement can be found here: https://www.ahajournals.org/doi/pdf/10.1161/CIRCINTERVENTIONS.124.014160

SVS urges revisions for independent cardiology certification board

By
Marlén Gomez
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SVS urges revisions for independent cardiology certification board
Dr. Bernadette Aulivola
Bernadette Aulivola

The Society for Vascular Surgery (SVS) has expressed conditional support for cardiology establishing an independent certification board but objects to provisions in the current American Board of Cardiovascular Medicine (ABCVM) proposal as they conflict significantly with the mission and requirements of the Vascular Surgery Board (VSB), which already issues a primary certificate issued by the American Board of Medical Specialties (ABMS).

The proposal requires critical revisions to address the underrepresentation of vascular expertise and training needed to fully care for patients with vascular disease and ensure high standards of care, the Society said.

In a detailed comment letter submitted July 10, the SVS took the lead with other vascular societies to outline concerns and suggested improvements to the ABCVM proposal, which is currently under review by the ABMS Advisory Council. “Not surprisingly, the SVS’ perspective on the strengths and areas for improvement of the ABCVM proposal was echoed by numerous other national and regional vascular surgery societies, who joined us in providing feedback to the ABMS on this proposal. Ultimately, we are all deeply invested in assuring that the care provided to our patients with vascular disease meets the highest of quality standards in order to serve the public to the best of our ability,” said Bernadette Aulivola, MD, a member of the SVS Executive Board and the VSB of the American Board of Surgery (ABS).

The ABMS opened a 90- day comment period April 24 to gather feedback on the proposed ABCVM. If approved, this new board would become a voting member of the ABMS. There is concern in the vascular community that both the public and other providers may become confused or misunderstand the expertise and extensive training of vascular surgeons who have a primary ABMS certificate in vascular. The SVS and co-signatories support the initiative for an independent cardiology board, the Society pointed out, but stressed that the current proposal falls short in several key areas.

Underrepresentation of vascular diseases

The SVS letter highlights the critical expertise and years of experience required to provide high-quality care for patients with vascular diseases such as peripheral arterial disease (PAD), cerebrovascular disease and renovascular disease. With more than 200 million people worldwide suffering from PAD alone, the SVS argues that the proposal does not adequately address the significant health burden posed by these conditions, or the amount of training or case volume to care for patients.

Lack of specific credentialing pathways

The proposed board lacks clear pathways for credentialing in vascular disease, the SVS continued, emphasizing the necessity of detailed training paradigms and requisite case numbers for vascular procedures to ensure consistent expertise among practitioners.

According to Aulivola, “The ABMS requires that its boards ‘create independent, external assessments and conduct comprehensive evaluations of the knowledge, clinical competence, performance and experience, of such candidates through initial and continuing certification.’ The current proposal lacks clarity in both areas, with the suggestion that continuing certification assessments would be delegated to specialty societies rather than being directly overseen by the board itself. This is a significant concern when it comes to assuring that the care of patients with vascular disease meets established standards.”

Quality improvement and practice standards

The proposal does not adequately outline plans for quality improvement programs, the SVS said, underscoring the importance of quality registries, such as the Vascular Quality Initiative (VQI), in improving patient outcomes and maintaining high standards of care. The VQI provides the continuous feedback necessary for vascular providers to verify national benchmark levels, said SVS Secretary William Shutze, MD, an advocate of the proposal.

Potential public confusion

The SVS stressed that the interchangeable use of “cardiovascular medicine” and “cardiology” in the proposal could lead to public confusion over qualifications and areas of expertise, possibly misleading patients regarding the extent of cardiologists’ training in vascular diseases. According to Shutze, cardiology has multiple subspecialties, including but not limited to electrophysiology, heart failure and structural heart, all of which are laser-focused on their domain.

“The nomenclature of the new board elevated them as vascular-proficient providers. That is not the case,” Shutze said. “If the proposal is approved with the current name-granting, this board authority and domain over the vascular space, it will not advance vascular care but diminish it.”

Public safety risks

The proposed certification raises concerns about the impression that all cardiologists can fully manage vascular diseases, but the SVS pointed out that most cardiologists lack comprehensive training in medical, surgical and endovascular treatment for these conditions. “With the comment period closed, we now await the ABMS decision. If approved, we will congratulate them and work with the new board to address the noted deficiencies in vascular education and training. If rejected, we will learn from the process as we consider our Board’s options. Should revisions be requested, we will collaborate with the proposed new board, too,” said Shutze.

According to Aulivola, the SVS has offered to work with ABCVM proponents to enhance their proposal, particularly in areas concerning the care of vascular disease, where significant overlap with care provided by VSB-certified vascular surgeons exists. The aim is to fulfill the ABMS’ mission of improving healthcare quality.

“The SVS is excited to partner with our colleagues in cardiology to develop improved training paradigms and quality improvement initiatives that will allow those interested in contributing to the care of vascular patients to do so with rigor and expertise,” added SVS President Matthew Eagleton, MD.

For more information and to view the full comment letter, visit vascular.org/ CVMComments.

Centerline Biomedical receives FDA 510(k) clearance for new IOPS Viewpoint catheter

By
Jocelyn Hudson
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Centerline Biomedical receives FDA 510(k) clearance for new IOPS Viewpoint catheter
IOPS cart
IOPS cart

Centerline Biomedical recently announced that its Intra-Operative Positioning System (IOPS) Viewpoint catheter has received Food and Drug Administration (FDA) 510(k) clearance. The Viewpoint catheter is the most recent addition to the company’s patented IOPS portfolio.

A press release details that Viewpoint—a low-profile 6-French catheter available in multiple tip shapes and lengths—is designed for precision access to provide three-dimensional (3D) navigation feedback to clinicians.

When Viewpoint catheters are used in combination with the proprietary algorithms of the IOPS software, Centerline Biomedical explains, clinicians can clearly visualize endovascular tools in real-time and reduce their dependency on fluoroscopy systems. The result, according to the company, is state-of-the-art image-guided, real-time navigation designed to revolutionize the way endovascular procedures are performed. This is achieved while reducing exposure to harmful radiation emitted from the X-ray fluoroscopy systems that are typically used to see vessels during these procedures.

The press release continues that, at its core, the IOPS platform is designed to enhance visualization, minimize procedure times, and reduce total radiation exposure for the benefit of both patients and healthcare providers.

“Development of our second-generation portfolio for IOPS has been the top priority for Centerline Biomedical. Viewpoint catheters were developed with input from leading clinicians to best meet their procedure needs,” said Gulam Khan, chief executive officer of Centerline Biomedical. “Our company continues to re-envision the field of endovascular interventions developing technologies designed with the express purpose of improving outcomes for both providers and patients.”

Vascular Therapies completes enrollment in the ACCESS 2 study

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Vascular Therapies completes enrollment in the ACCESS 2 study

Vascular Therapies has today announced completion of enrollment in the ACCESS 2 trial, a Phase III prospective randomized, multicenter clinical study of Sirogen for the surgical creation of arteriovenous (AV) fistula in patients requiring hemodialysis vascular access. 

Vascular Therapies developed its sirolimus formulation (Sirogen) for intraoperative local, perivascular drug delivery. In a post-hoc subgroup analysis from ACCESS, the original US prospective randomized study, Sirogen showed improved fistula maturation and secondary patency when compared to standard of care controls.

The ACCESS 2 Study was designed to validate the post-hoc results from ACCESS and further evaluate the effectiveness of Sirogen to improve outcomes in patients requiring an AV fistula. This multicenter randomized study enrolled 136 patients across 17 centers in the U.S. and the United Kingdom. The primary endpoint of the study is fistula maturation at six months, and results are currently expected to be announced in the second quarter of 2025.

SVS History Work Group’s landmark project culminates in new book

By
Marlén Gomez
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SVS History Work Group’s landmark project culminates in new book
New book on the history of vascular surgery

The 2024 Vascular Annual Meeting (VAM) saw the culmination of a decade-long project by the Society for Vascular Surgery’s (SVS) History Project Work Group. The release of the book, Legends Leaders Pioneers: Surgeons Who Built Vascular Surgery, marks a significant milestone in documenting the history and evolution of vascular surgery.

Authored by the late James S.T. Yao, MD, and Walter J. McCarthy, MD, the title brings together the recollections of over 90 prominent vascular surgeons who were instrumental in shaping the field. Through in-depth video interviews conducted by the SVS History Project Work Group committee, readers are given a unique opportunity to meet these pioneers face-to-face. Each biography in the book is accompanied by a QR code, enabling instant access to the full video interview, providing an immersive historical experience.

The project, initiated by Yao in 2011 and chaired by McCarthy since 2018, captures first-hand accounts of technical advances, new devices, prosthetic materials and the fascinating careers of these surgeons. McCarthy highlighted the project’s significance, stating, “This book is a testament to the incredible journey of vascular surgery. It preserves the voices and experiences of those who have paved the way for future generations. Their stories of innovation, perseverance and dedication are invaluable to both the vascular surgery community and the practicing vascular surgeons as inspiration to those in training or in those contemplating this career.”

Other initiators included Norman M. Rich, MD, Roger Gregory, MD, and Calvin Ernest, MD. Committee members  of the project included Kenneth Cherry, MD, William Baker, MD, Mark Eskandari, MD, Melina Kibbe, MD, Peter Lawrence, MD, Richard Lynn, MD, and William Pearce, MD.

One notable feature of this book involves vascular luminaries Michael DeBakey, MD, Denton Cooley, MD, and Juan Parodi, MD. The work reflects on their mentors, including the likes of Alfred Blalock, MD, and Marie René Leriche, MD, who advanced the understanding of intermittent claudication and lumbar sympathectomy. This book is available through Amazon. The SVS owns the copyright, and royalties from book sales support the organization.

In addition to celebrating this project, the SVS has launched a new history project—the Vascular Surgery History Archive. This initiative was featured in the VAM 2024 video titled “LEGENDS LEADERS PIONEERS: Surgeons Who Built Vascular Surgery.” The archive aims to continue documenting the field’s evolution, and preserving the stories of current and future vascular surgery leaders.

The new archive promises to be a rich resource for surgeons, historians and the public, ensuring that the legacy of vascular surgery’s pioneers is accessible for generations to come.

“It’s an honor to carry on the work of Dr. Yao, Dr. McCarthy, and all the others who did such an outstanding job in the Vascular Surgery History Group. Our goal with the Vascular Surgery History Archive Task Force is to create and curate a digital nexus for the history of the SVS and the specialty of vascular surgery, a central hub on the internet where information in all media is available for anyone interested in these topics. We encourage all members of the society who possess historic artifacts, information or an interest in this project to contact us,” said Craig Miller, MD, co-chair of the SVS History Digital Archives Task Force.

To learn more about the project, visit vascular.org/History.

Silk Road celebrates milestone of 100,000 TCAR procedures

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Silk Road celebrates milestone of 100,000 TCAR procedures

Silk Road Medical has announced the milestone of more than 100,000 transcarotid artery revascularisation (TCAR) procedures having been performed to date.

“A growing number of patients come to us looking for a solution that is minimally invasive and requires less downtime so they can get back to their daily lives,” said Gregg Landis (Northwell Health, New York, USA). “It’s incredible that Silk Road was able to not only address that need by creating the TCAR procedure, but also achieve such widespread adoption in a short period of time. TCAR has transformed the way we approach treating carotid artery disease while consistently delivering positive patient outcomes.”

Silk Road claims in a recent press release that, since its inception, the company has worked diligently to reduce the risk of stroke during treatment of carotid artery disease through innovative technology and minimally invasive techniques.

Silk Road is credited with pioneering the TCAR procedure and building the Enroute transcarotid neuroprotection system (Enroute NPS) that supports the procedure with its patented flow reversal technology.

The company further states in its recent release that, compared to traditional open surgery (carotid endarterectomy [CEA]), TCAR has demonstrated a lower risk of acute heart attack, fewer occurrences of nerve injury, shorter time required to perform the procedure, and a reduced length of stay at the hospital for patients.

“Completing the 100,000th TCAR procedure is the culmination of more than 15 years’ worth of work by members of the Silk Road Medical team and the healthcare providers we work with,” said Chas McKhann, chief executive officer of Silk Road. “As we celebrate this important milestone, we remain excited and motivated to establish TCAR as the standard of care for addressing carotid artery disease.”

CIRSE begins CALCIO trial enrolment for treatment of CLTI with Shockwave IVL system

By
Éva Malpass
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0
CIRSE begins CALCIO trial enrolment for treatment of CLTI with Shockwave IVL system
Shockwave lithotripsy system
Shockwave lithotripsy system

The Cardiovascular and Interventional Society of Europe (CIRSE) have announced that patient enrolment for the CALCIO trial has begun. CALCIO started patient enrolment on 15 July, 2024, with the goal of recruiting 400 chronic limb-threatening ischaemia (CLTI) patients over the next two years.

CALCIO is a prospective, observational cohort study that is collecting real-world data on the use of intravascular lithotripsy (IVL) with the Shockwave Medical IVL system (Shockwave Medical) to disrupt vascular calcifications in patients with CLTI. The study was initiated and is co-chaired by Raman Uberoi (The John Radcliffe Hospital, Oxford, UK), Peter Reimer (Municipal Clinic Karlsruhe, Karlsruhe, Germany) and Christoph Binkert (MRI Bahnhof Oerlikon, Zurich, Switzerland).

Once patient enrolment is complete, an additional two years will be dedicated to the collection of patient follow-up data to ensure the study meets its objectives. Currently, there are several sites enrolled from Germany and the UK. More centres from Germany, the UK, France, Austria, Italy, Greece and Canada are in the recruitment process and are expected to join soon.

Next Research, CIRSE’s contract research organisation (CRO), is the administrator of CALCIO and is managing the study on a day-to-day basis, the press release states. Their team asked the CALCIO initiators and principal investigators to share their thoughts on the study’s significance, their experiences so far, and the importance of generating more clinical evidence. They also encouraged other centres to participate in this research effort.

Binkert shared: “I think CALCIO is an important registry because it collects real-world data on a very severe problem, as patients with CLTI need to get revascularisation and if they have very calcified arteries, this is a big challenge and the current evidence is not sufficient.”

Reimer said: “As interventional radiologists, we should learn to collect outcome data that looks at the long-term prognosis of patients. This is exactly what we will do with the CALCIO study. We’ll look at the amputation rate and wound healing through the use of IVL. That is why we should all try to enrol as many patients as possible in the CALCIO study.”

Joo-Young Chun, principal investigator (St. George’s University Hospital, England, UK), highlighted what makes CALCIO so special:  “I am very excited to be part of the study. What makes CALCIO quite unique is that it takes real-world patients with very wide inclusion criteria and very few exclusion criteria. I am also happy that the outcome measures are clinically focused. We are talking about CLTI patients, so these are patients with the risk of losing their legs, and we are looking at wound healing and also amputation-free survival. We are not necessarily focusing on how the lesion performs with IVL, but on how the patient does. Another exceptional thing about CALCIO is that we are looking at quality of life, which is quite unusual in such studies, and it would be very interesting to see how patients perceive their treatment and how it is affecting their quality of life.”

Raghuram Lakshminarayan (Hull University Teaching Hospital, England, UK) principal investigator, emphasised the significance of addressing calcification: “Calcification is a huge problem for the medical community, especially with peripheral arterial disease. We saw this in the pulmonary system, and we now realise that this is a major issue in peripheral arterial disease, and IVL has come as a new technique in order to try to deal with this problem of calcification in peripheral arteries. CIRSE has set up this unique registry to look at exactly how IVL is going to work over a period of time. There have been a lot of studies, but we want to have a large population to look at over a long period of time for us to get to the bottom of how IVL modifies calcium and the outcomes when we treat these patients. CALCIO is a great registry, and I think you should add every patient with CLTI to this study!”

Thrombolex and Aidoc announce strategic partnership to advance breakthrough PE treatment

By
Jocelyn Hudson
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Thrombolex and Aidoc announce strategic partnership to advance breakthrough PE treatment
Bashir endovascular catheter
PE
Bashir endovascular catheter

Thrombolex and Aidoc have announced a strategic partnership aimed at revolutionising the treatment of acute pulmonary embolism (PE), a press release reports.

This strategic collaboration, the release details, will leverage Aidoc’s artificial intelligence (AI) technology to accelerate patient identification and enrolment for Thrombolex’s single-session RAPID-PE study—a prospective, single arm, multicentre, postmarket clinical registry evaluating the efficacy and safety of the Bashir endovascular catheters in the treatment of acute intermediate-risk PE.

Thrombolex’s Bashir endovascular catheters are engineered to immediately restore blood flow, rapidly resolve blood clots and help reduce complications. Aidoc’s AI capabilities and tailored mobile application will provide local healthcare teams at RAPID-PE trial sites with timely alerts on patients who meet the inclusion criteria.

“Integrating Aidoc’s advanced imaging solutions with our innovative technology will help to improve the diagnosis and treatment process for acute PE,” said Michael Cerminaro, president and chief executive officer of Thrombolex. “This partnership demonstrates our commitment to leveraging cutting-edge technology to enhance patient outcomes, streamline clinical workflows and expedite enrolment in our RAPID-PE study.”

Aidoc’s proprietary technology features dedicated US Food and Drug Administration (FDA)-cleared algorithms for PE, central PE, incidental PE (iPE), and RV/LV ratio. It also alerts care teams to both expected and unexpected PE cases for faster triage and coordination with the right specialists. Recent studies showed the mean hospital length of stay decreased by 36.7% and the annual volume of patients referred for interventional therapies rose by 68% compared to the period before the implementation of Aidoc PE AI.

Wissam Jaber (Emory University, Atlanta, USA), co-national physician investigator for RAPID-PE, said: “Combining Thrombolex’s innovative PML [pharmacomechanical] technology with Aidoc’s advanced AI-powered imaging solutions enhances speed to diagnosis and treatment efficiency for acute PE patients. This collaboration, along with RAPID-PE’s groundbreaking single session investigational protocol, represents a major step forward in improving patient outcomes and advancing the standard of care in our field.”

The RAPID-PE study will utilise a therapy protocol designed as a single session treatment (less than one hour), with no need for an intensive care unit (ICU) stay and a reduced dose of lytics (only 4mg per pulmonary artery).

“We are proud to collaborate with Thrombolex on this groundbreaking clinical study by leveraging our advanced AI technology,” stated Tom Valent, chief business officer, Aidoc. “Thrombolex’s leadership and innovative solutions are setting new standards in patient care, and our collaboration is a testament to the power of combining cutting-edge medical devices with AI-powered solutions for the joint mission of improving patient care.”

The RAPID-PE clinical study is currently qualifying multiple centers across the USA.

CEA and TCAR should be ‘first-line’ interventions for weekend carotid revascularization, researchers advise

By
Jocelyn Hudson
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CEA and TCAR should be ‘first-line’ interventions for weekend carotid revascularization, researchers advise
Mahmoud B Malas
Senior author Mahmoud Malas

Patients who undergo carotid revascularization at the weekend have increased odds of complications and mortality, with transfemoral carotid artery stenting (TFCAS) posing the highest risk and transcarotid artery revascularization (TCAR) the lowest, compared to carotid endarterectomy (CEA). This is one of the key findings of new observational research published online ahead of print in the Journal of Vascular Surgery (JVS).

Lead author Mokhshan Ramachandran, MD, senior author Mahmoud Malas, MD, and colleagues—all from UC San Diego in San Diego, California—state in their research article that outcomes for weekend surgical interventions are known to be associated with higher rates of complications and mortality compared to weekday interventions. The aim of their study was to assess the ‘weekend effect’ for the three available carotid revascularization methods—CEA, TCAR and TFCAS—noting that research on the topic is currently only available regarding CEA.

To do this, the researchers queried the Vascular Quality Initiative (VQI) for patients undergoing CEA, TCAR and TFCAS over a six-year period, from 2016–2022. They employed Chi-square and logistic regression modelling to analyze outcomes including in-hospital stroke, death, myocardial infarction (MI), and 30-day mortality by weekend versus weekday intervention.

Providing more details on their study methods, Ramachandran et al write that they used backward stepwise regression to identify significant confounding variables, and that logistic regression of outcomes was substratified by symptomatic status. Furthermore, they used secondary multivariable analysis to compare outcomes between the three revascularization methods by weekend versus weekday interventions.

Overall, Ramachandran and colleagues analyzed 155,962 procedures in their study, comprising 103,790 CEA, 31,666 TCAR and 20,506 TFCAS. Of these, the authors specify, 1,988 CEA, 246 TCAR and 820 TFCAS received weekend interventions.

In JVS, the authors report that they observed no significant differences for TCAR, and increased odds of in-hospital stroke, death and MI for CEA and TFCAS procedures conducted at weekends.

In addition, Ramachandran et al share that asymptomatic TCAR patients had nearly triple the odds of 30-day mortality, and that odds of in-hospital mortality were nearly tripled for asymptomatic CEA and asymptomatic TFCAS patients.

Finally, they reveal that CEA and TCAR had no significant differences for all outcomes, while TFCAS was associated with increased odds of stroke and death compared to CEA and TCAR.

In the conclusion of their findings, Ramachandran and colleagues summarize that weekend carotid revascularization is associated with increased odds of complications and mortality, adding that asymptomatic weekend patients perform worse in the CEA and TFCAS groups.

“Among the three revascularization methods, TFCAS is associated with the highest odds of perioperative stroke and mortality. As such, our findings suggest that TFCAS procedures should be avoided over the weekend, in favor of CEA or TCAR,” the authors write. They continue that, in patients who are poor candidates for CEA, TCAR offers the lowest morbidity and mortality for weekend procedures.

Sharing the take-home message from their research, Ramachandran et al posit that CEA and TCAR procedures should be the “first-line” interventions for weekend carotid revascularization.

Machine learning-based model could aid in determining EVAR suitability

By
Jocelyn Hudson
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0
Machine learning-based model could aid in determining EVAR suitability
EVAR
Willemina van Veldhuizen

Researchers at the University Medical Center Groningen (Groningen, The Netherlands) and the University of Twente (Enschede, The Netherlands) have developed a prediction model that they claim could assist in the preoperative identification of patients who are unlikely to achieve sufficient endograft apposition after endovascular aneurysm repair (EVAR).

Willemina van Veldhuizen, MD, and colleagues from the University Medical Center Groningen, including members of the Virtual Stenting study group, shared their work in a paper published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

By way of background, the authors first underline an association between challenging infrarenal aortic neck characteristics, such as short apposition (less than 10mm circumferential shortest apposition length) on the first postoperative computed tomography angiography (CTA), and an increased risk of type Ia endoleak after EVAR. It was the study team’s aim to develop a model to predict postoperative shortest apposition length in patients with an abdominal aortic aneurysm (AAA) based on the preoperative shape.

Van Veldhuizen et al note that they developed a statistical shape model to obtain principal component scores, with the dataset comprising 147 patients in total: 93 treated with standard EVAR without complications and 54 treated with EVAR who went on to experience a late type Ia endoleak.

In terms of methods, the authors detail that they obtained the infrarenal shortest apposition length from the first postoperative CTA, which they subsequently binarised between those under 10mm in length and those equal to or longer than 10mm. The researchers then used the principal component scores that were statistically significant between the shortest apposition length groups as input for five classification models, and subsequently determined area under the receiver operating characteristics curve (AUC), accuracy, sensitivity and specificity for each classification model.

Van Veldhuizen and colleagues report in EJVES that, of the 147 patients included in the study, 24 had an infrarenal shortest apposition length of less than 10mm and 123 had a shortest apposition length of 10mm or more.

The authors share that the gradient boosting model resulted in the highest AUC of 0.77 and that, using this model, 114 (78%) patients were correctly classified, with sensitivity (less than 10mm apposition was correctly predicted) and specificity (equal to or longer than 10mm apposition was correctly predicted) at 0.7 and 0.79, respectively.

Van Veldhuizen et al summarize that the model they present can predict the binarised shortest apposition length of an endograft into the infrarenal aortic neck for treatment of an AAA on the first postoperative CTA scan, with an accuracy of 78%. Given that a shortest apposition length of less than 10mm has been associated with higher risks of type Ia endoleak, the researchers posit that their model “could help vascular specialists in the preoperative phase to accurately identify patients who are unlikely to achieve sufficient apposition after EVAR.”

In the discussion of their findings, the authors acknowledge a series of limitations to their study, including the fact that the data they used came from different datasets, which may have created a selection bias.

Looking ahead, van Veldhuizen and colleagues suggest that their model “should be externally validated with a consecutive patient series that includes patients with an early type Ia endoleak before it can be used as a patient-specific virtual stenting tool in clinical practice.”

One-year STRIDE study data show ‘meaningful’ limb salvage, mortality and QoL outcomes

By
Bryan Kay
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0
One-year STRIDE study data show ‘meaningful’ limb salvage, mortality and QoL outcomes
Thomas Maldonado at VAM 2024

One-year outcomes from the STRIDE study of the Indigo aspiration thrombectomy system (Penumbra) for lower-extremity acute limb ischemia (ALI) showed target limb salvage and mortality rates of 88.5% and 12%, respectively.

The data were revealed by Thomas Maldonado, MD, professor of surgery at New York University Langone Medical Center in New York City and national principal investigator of STRIDE, during the 2024 Vascular Annual Meeting (VAM 2024) in Chicago (June 19–22).

The results stand up “very favorably” to historical controls for open surgery from the academic literature showing a target limb salvage rate of 65.4–82% and a mortality rate of 4.9%–42%.

“We see meaningful information both for very good target limb salvage, very low mortality, and the quality of life is significantly improved at one year,” said Maldonado.

PRESERVE II trial shows robust five-year outcomes

By
Bryan Kay
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0
PRESERVE II trial shows robust five-year outcomes
W. Anthony Lee at VAM 2024

Five-year outcomes the PRESERVE II pivotal trial of Cook Medical’s Zenith branch iliac graft (ZBIS) demonstrate “sustained safety and effectiveness” when combined with the iCast (Getinge) covered stent for the treatment of aortoiliac aneurysms and preservation of hypogastric artery perfusion, new data show.

W. Anthony Lee, MD, chief of vascular surgery at Boca Raton Regional Hospital in Boca Raton, Florida, delivered the results during the 2024 Vascular Annual Meeting (VAM 2024) in Chicago (June 19–22). Five-year outcomes were completed among 75% of the 40-patient cohort across 18 U.S. medical centers. Lee reported no aneurysm-related mortality, rupture, type III endoleaks, migrations or device integrity issues. Five-year freedom from all-cause mortality was 88.9%; hypogastric artery primary and secondary patency were 91% and 94%, respectively; and external iliac artery primary patency was at 95%, he told VAM 2024.

Nine patients underwent 15 secondary interventions, six ipsilateral to the ZBIS, Lee said. Freedom from type I and II endoleaks was 97.3% at five years, while aneurysm shrinkage was about 25%, he added.

‘Well, here we are—but right now I wish I wasn’t’: Early-career errors

By
Kristin Spencer
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‘Well, here we are—but right now I wish I wasn’t’: Early-career errors
Chelsea Dorsey

On Friday, June 21, the Society for Vascular Surgery (SVS) Young Surgeons Section (YSS) held their session at the 2024 Vascular Annual Meeting (VAM). The ses­sion began with Chelsea Dorsey, MD, high­lighting the YSS’ achievements from the last year including a publication in the Journal of Vascular Surgery-Vascular Insights, and the announcement of a new traveling professor­ship program.

“I am really excited about the things that we have done, but also for the future,” said Dorsey. Dorsey served as the section’s chair from its inception in 2021 until recently when she rotated off the Steering Commit­tee; Edward Gifford, MD, will now serve as the chair.

Once the opening remarks were made, the education portion of the section kicked off and shifted focus to early-career errors. The session had six speakers who covered their personal errors, three being clinical and the other three being professional scenarios that the speakers encountered.

Megan Parrott, MD, served as the first speaker in the session and went into details on a patient’s case, with her talk on, “What to do when even our best-laid plans go sideways.”

Ravi Ambani, MD, followed Parrott in the speaking order and told the audience about the things he missed while considering his first job post-training, the missteps taken when moving on to his next role, and gave words of wisdom for building a network of trustworthy people to lean on when making those types of career decisions.

Kyongjune Lee, MD, took the podium next to discuss a patient case where some­thing was missed on imaging, but pointed out by an outside surgeon before an oper­ation took place. Lee shared his insight into the importance of listening to outside opin­ions and always giving them consideration, as well as soliciting feedback on treatment plans to ensure every piece of the puzzle is considered before moving forward. Lee also focused on the significance of having trans­parency with patients to help build trust.

“I loved how both the speakers and audi­ence members were open to having a real conversation about some difficult clinical and career scenarios that many of us have or will face as practicing vascular surgeons,” said Dorsey. “It felt like folks latched onto the ‘brave space’ phenomenon described during VAM’s inaugural keynote address. It was fun to be a part of it and I hope we can continue that trend in years to come.”

Elizabeth George, MD, continued the ses­sion by discussing managing pregnan­cy and returning to work early on in a vascular surgery career. George walked the audience through her three pregnancies and highlighted the stark differences that each one had when it came to her career and her personal life, ultimately stressing that being a surgeon and a great mother are not mutually exclusive. George brought forth the idea for the development of guide­lines for surgeons who are expecting regard­ing radiation exposure.

Behzad S. Farivar, MD, came forward to discuss a time when he “zigged when he should have zagged” that focused on a pa­tient case where an endovascular approach was originally taken. Postoperative imaging showed three different issues, but the patient was okay. Farivar spent much of his time discussing treatment op­tions with the audience and asking questions to make the audience criti­cally consider next steps. His conclu­sion encouraged audience members to acknowledge that complications are a part of surgical practice, to learn from every experience, seek assistance and collaboration, understand the strengths and weaknesses of one’s institution and to always have a contingency plan. To reduce errors, Farivar encouraged adopting a holistic view, working toward continuous improvement while encouraging ongoing learning, and to adopt lean surgical procedures.

The final talk was given by Olamide Alabi, MD, and focused on the importance of find­ing the right mentor, and how to manage the relationship so it benefits the mentee. Alabi discussed the ideal mentor/mentee relation­ship, which consists of open dialogue that bring lead to critical thinking and planning, mutual participation and more. Alabi gave personal examples about mentor/mentee relationships that did not benefit her in the way that she needed, and how she managed the relationship to get more out of them.

YSS leadership designed the session with the intention of creating a space for young surgeons to feel comfortable discussing ca­reer mistakes. “We’ve gotten great feedback from attendees and presenters alike. The session seemed to strike the right note for where we want to see the section go in the future,” said Gifford.

SVS Annual Business Meeting showcases 2024 Foundation award recipients

By
Marlén Gomez
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SVS Annual Business Meeting showcases 2024 Foundation award recipients

The Society for Vascular Surgery (SVS) convened its Annual Business Meeting at the Vascular Annual Meeting (VAM) on June 22 in Chicago.

A highlight of the event was the announcement of the 2023–2024 award recipients by the outgoing Foundation Chair Michael C. Dalsing, MD.

The full list of recipients who received accolades during the gathering are as follows:

James S. T. Yao Resident Research Award

Kevin D. Mangum, MD, PhD

Vascular surgery integrated resident

University of Michigan, Ann Arbor

Title: “The STAT3-SETDB2 axis dictates NFKB-mediated inflammation in macrophages during wound repair”

Vascular Research Initiatives Conference Trainee Awards

Shaunak Adkar, MD, PhD

Integrated vascular surgery resident

Stanford University, Stanford, California

Title: “Soluble guanylate cyclase activators as potential novel PAD therapeutics”

Jack Bontekoe, MD

Integrated vascular surgery resident

University of Wisconsin Hospital and Clinics, Madison

Title: “Reduction of abdominal aortic aneurysm rupture by modulating smooth muscle cell phenotype switching”

Nathaniel Parchment, MD

Integrated thoracic surgery resident

University of Michigan, Ann Arbor

Title: “Endothelial mixed lineage leukemia 1 (kmt2a/MLL1) as a central mediator of immunothrombosis during SARS-CoV-2 infection”

Lucas Reckard-Mota, MD

General surgery resident

Beth Israel Deaconess Medical Center/ Harvard Medical School, Boston

Title: “Deciphering prosthetic bypass graft-to-artery anastomosis dynamics at the molecular level: A single-nuclei and spatial transcriptomics analysis”

Student Research Fellowship Awards

Daniel Zikri Aziz

University of Virginia, Charlottesville

Sponsor: Melina R. Kibbe, MD

Title: “Advancements in early detection of abdominal aortic aneurysms via nanomaterial-conjugated contrast agents”

Warren Carter

Yale School of Medicine, New Haven, Connecticut

Title: “Carotid revascularization outcomes of premature carotid atherosclerosis among patients in neighborhoods of differing social disadvantage”

Caryn Dooner

University of Toronto, Toronto, Canada

Title: “Assessing and addressing health literacy in vascular surgery patients”

Alasdair Fletcher

VA Boston Healthcare, Boston

Title: “Comparing indications for and rates of atherectomy for PAD in single-payer VA healthcare system with national trends”

Alejandra Silva Hernandez

University of Washington, Seattle

Title: “A sustainable real vessel-on-a-chip as an observable disease model of intima hyperplasia”

Stuthi Iyer

University of Pittsburgh School of Medicine, Pittsburgh

Title: “The association between frailty and major adverse limb events is mediated by depression after revascularization for chronic limb-threatening ischemia”

Amin Ali Mirzaie

University of Florida, Gainesville

Title: “Assessing prognostic expectations in patients with chronic limb-threatening ischemia”

Vikki Rueda

Northwell Health, New Hyde Park, New York

Title: “The impact of social determinants of health on genetic profiles in diabetic foot ulcers between responders and nonresponders to standard of care”

Andrew William Schwartz

Yale School of Medicine

Title: “The role of Sox6 expression in venous remodeling after arteriovenous fistula creation”

Hana Soraya Shafique

Duke University School of Medicine

Title: “The role of Spp1+ macrophages in peripheral arterial disease”

Garrett Blane Sweatt

Southern Illinois University School of Medicine, Springfield

Title: “Chronic total occlusion length on long-term femoropopliteal segment patency in chronic limb-threatening ischemia: Are the currently accepted cutoffs supported by clinical data?”

Ashley Xu

University of California, San Francisco

Title: “Underlying mechanisms of vascular calcification in peripheral artery disease (PAD)”

To learn more about the awards and the work of the SVS Foundation, visit vascular.org/ FoundationAwards.

SVS Women’s Section delves into vascular trauma treatment intricacies amid ‘paucity of literature’

By
Kristin Spencer
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0
SVS Women’s Section delves into vascular trauma treatment intricacies amid ‘paucity of literature’

“Life over limb”—that was one of the key messages to emerge from the VAM 2024 SVS Women’s Section session that placed a lens over vascular trauma treat­ment. Misty Humphries, MD, associate professor of surgery at University of California Davis in Sacramento, California, who was covering mangled extremities and providing tips from the frontlines of a level-1 trauma center, underscored the point that maintaining life was always paramount.

“I don’t really implement treatment the way a vascular surgeon would—a lot of times I’ll do things as a trauma sur­geon would,” she said. Humphries walked through the defi­nition of a true mangled extremity, with severe damage being caused to at least three of the four: bone, vessels, nerves and/ or soft tissue. Humphries shared her salvage vs. amputation decision tree and discussed the multidisciplinary evaluation that needs to take place before a decision is made. Humphries covered different orthopedic cases and studies that aided in her trauma training and decision-making on whether to amputate an extremity over time. She wrapped up her time at the podium by sharing practices she had adapted over time to help with extremity trauma.

The session, entitled Vascular Trauma: What I Need to Know in the Middle of the Night, was the brainchild of co-moderator Erica L. Mitchell, MD, professor and chief of vascular and endovascular surgery at the University of Ten­nessee Health Science Center in Memphis, Tennessee. “The idea was inspired by the paucity of vascular trauma literature as well as the rising interest of vascular trauma in the medical field,” she explained. “There needs to be vascular surgical engagement in the care of these vascular trauma patients, so I wanted to host a session that could make vascular surgeons more confident in providing that engagement.”

The session brought together a number of leaders in the vascular surgery arena who have extensive experience with vascular trauma cases. Manuel Garcia-Toca, MD, a vascular surgeon at Emory University in Atlanta, Georgia, discussed managing trauma to the head and neck vessels. “The neck has so many vital structures in a really confined space,” he said. “It is challenging when you get a phone call in the middle of the night when there’s a patient with a neck injury. You don’t know if the patient will have to go to the OR [operating room], and that is a tough call to make from the phone.”

A vast majority of the calls will be from blunt injuries to cervical vessels—injuries that, according to Garcia-To­ca, received a lot of awareness in the 90s because people were having strokes as a result. “So, you need to review the CAT scan from home to make the call,” he said, stressing the importance of acting within the first 72 hours to prevent a stroke. Garcia-Toca underlined the importance of estab­lishing vascular trauma protocols at institutions and offered “pearls in the middle of the night”: that most blunt cerebro­vascular injury injuries should be managed by antithrombot­ic therapy, encouraging the use of computed tomography angiography (CTA) to guide therapy unless there are hard signs of a vascular injury.

Elsewhere, Luc Dubois, MD, associate professor in the Di­vision of Vascular Surgery at University of Western Ontario in London, Ontario, Canada, explored abdominal vascular trauma, highlighting endovascular vs. open procedures for abdominal aortic injuries. Sadia Ilyas, MD, a vascular surgeon at MedStar Heart and Vascular Institute in Washington, D.C., covered thoracic vascular injuries, discussing how she catego­rizes traumas into blunt or penetrating traumas, and shared the grading scale from the 2011 SVS Clinical Practice Guide­lines. Ilyas also walked through how to manage patients with blunt aortic trauma and how to conduct surveillance. Andrea Lubitz, MD, assistant professor of surgery in the Division of Vascular and Endovascular Surgery at the Lewis Katz School of Medicine at Temple University Hospital in Philadelphia, spoke on a “rare but complex problem”: IV drug use-associ­ated pseudoaneurysms. She described the nature of IV drug use (IVDU), its management and gave an overview of the current literature.

The session wrapped with a talk from Pedro Teixeira, MD, associate professor of vascular surgery at the University of Texas at Austin Dell Medical School, who discussed the rarity of vascular surgeons seeing trauma patients for follow-ups.

Vascular care is a ‘team sport’ founded on infrastructure, personnel and standards

By
Jamie Bell
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Vascular care is a ‘team sport’ founded on infrastructure, personnel and standards

The E. Stanley Crawford critical issues forum at VAM 2024 in Chicago—which featured the tagline ‘Quality Care Everywhere’—underscored the importance of standards, infrastructure, personnel and verification pro­grams in vascular surgery.

Multiple speakers throughout the session described vas­cular care as a “team sport,” alluding to the need for collab­oration within individual centers. In addition, presenting experiences from one of the first inpatient centers to have utilized the SVS and American College of Surgeons’ (ACS) Vascular Verification Program, R. Clement Darling III, MD, said the program “allows you to feel proud of what we do as vascular surgeons.”

Following an introduction from then SVS President-elect, now President Matthew Eagleton, MD, the session also saw Clifford Ko, MD, discuss ACS quality initiatives and campaigns; Anton N. Sidawy, MD, outline the Vascular Veri­fication Program (Vascular-VP) itself; and William P. Shutze Sr, MD, home in on how the program can be of help to outpatient centers.

Sidawy spoke of the need for vascular surgery to take charge of ensuring standards and handling its own verifica­tion processes, noting that “if we do not define it, someone else will define it for us.”

A salient message delivered by Ko was that centers with the correct standards and personnel—in short, those who “have it all set up”—tend to perform better. However, Si­dawy later alluded to the fact that these criteria are not al­ways met, hinting at disparities between vascular surgery and other specialties.

“Just go to your hospitals and look at two things,” he said. “Look at transplant and trauma, and see how much support they have. We would dream, as vascular surgery programs, of such support. And the reason they have this support is because, in order to be verified, that’s what they need to have—and this is one part of why we really wanted to em­bark on this verification program.”

Ko, speaking as the director of the ACS’ Division of Research and Optimal Patient Care, added: “We often are finding, in all of our care—cancer as well—that, in order to provide the level of care that we want to provide, we need to have those resources, those people there, in order to do the processes and in order to get the outcomes.

“This partnership together with the SVS and the vascu­lar experts is really trying to identify those things to move us forward.”

Corner Stitch: Navigating pregnancy as a vascular surgery trainee

By
Christina L. Cui
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Corner Stitch: Navigating pregnancy as a vascular surgery trainee
Christina Cui
Christina Cui

As a vascular surgery resident, our training emphasizes anticipating and planning for compli­cations. This mindset is undoubtably critical clinically but can be less beneficial in settings outside of hospital confines. It certainly was my first reaction to the positive pregnancy test halfway through my second year of clinical training.

To be clear, the timing didn’t help. I had just started my pediatric surgery rotation, where my waking hours were spent with babies crashing onto extracorporeal membrane oxygenation (ECMO), undergoing exploratory laparoto­mies in the neonatal intensive care unit (ICU), or screeching through during trauma activations. My subsequent months in the surgical ICU presented a fresh set of challenges. I was inundated with a wave of post-partum patients that demonstrated all the ways childbirth would try to kill you. I was thoroughly convinced that one of these worst-case scenarios would become my reality, and I carried out my daily life with a simmering sense of unease.

While I certainly received my fair share of off hand comments and physical struggles, these mental hur­dles proved to be the most taxing experience. With family on the opposite coast and close friends scat­tered throughout the country, my primary goal was to simply get through my pregnancy. And, I somehow only did because the community in the hospital reached out in ways I could never have dreamed of.

Operating room staff would sneak stools behind me for all cases and refused to let me move patients. Our advanced practice providers would stock their mini-fridge with ginger ale and regularly allowed me to raid their personal snack stash. My attendings were willing to cover call shifts when the morning sickness extended far past the morning and felt much stronger than just “sickness.”

My co-residents threw the most incred­ible, well-fed baby shower, complete with themes, a balloon arch, charcuterie and a custom cake. They all pitched in to buy me a stroller, the first thing I let my hus­band assemble. I am especially grateful for the food and designer adult diapers they brought to the hospital.

This generosity extended far beyond just the pregnancy period. I came home from the hospital to flowers, food deliv­ered personally to my home, and even had people come over to cook food with­in my home. I received bags of clothes, extra bassinets and baby swings, all ma­terializing through a support network I previously did not fully appreciate. Even as I reflect on the experience, I am struck by just how invested and kind every individual was. I made it through the nine months in large part because of every single person who took time and energy out of their busy schedule to care for me.

While my narrative is one of gratitude and community support, I am acutely aware that not all share this experi­ence. As a cisgender, heterosexual, Asian female who did not face significant medical complications or the challenges of alternative paths to parenthood, my experience was in many ways very straightforward. I was fortunate to spend the latter part of my pregnancy in my research year, which provided a degree of flexibility many do not have.

There remains a multitude of reasons that better cultural, structural and in­stitutional support is needed for fami­ly-building alongside surgical careers. There has been an incredible influx of literature discussing pregnancy com­plications, leave policies, post-partum support, discrimination, among other topics. These discussions are crucial as they pave the way for a more inclusive and supportive environment for those who come after us.

Christina L. Cui, MD, is an integrated vascular surgery resident at Duke University in Durham, North Carolina.

Government Grand Rounds: The role of stakeholders in legislative and administrative engagement

By
Andrew Kenney
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Government Grand Rounds: The role of stakeholders in legislative and administrative engagement

Stakeholder organizations such as the Society for Vascular Surgery (SVS) play a crucial role in shaping healthcare policies and ensuring that the voices of medical profes­sionals are heard in the legislative and administrative pro­cesses. These organizations utilize several key methods to interact with Congress and the Administration, including Requests for Information (RFIs), comment letters and let­ters of support.

RFIs are formal tools Congress and federal agencies use to gather input on specific issues from stakeholders, including professional organizations, industry experts and the public. When an RFI is issued, it signals that lawmakers or regulators seek detailed information or opinions.

For an organization like the SVS, responding to RFIs is an opportunity to influence policy by providing evidence-based insights and recommendations. These responses typically include data from clinical research, expert opinions and practical insights from medical practice. The SVS can help shape policies that impact vascular surgery and broader healthcare practices by submitting comprehensive and well-supported responses.

The SVS has recently submitted comments to an RFI regarding consolidation in healthcare markets. Highlighting its negative impact on independent practices and patients, the SVS noted that mergers can worsen geographic, logistical and cost barriers, reducing access to vital services for vulnerable populations. The SVS urged the Administration to consider these concerns in policy and enforcement decisions. For more information, visit vascular.org/RFI_Response.

Comment letters are another vital mechanism through which the SVS can influence federal policy, distinct from RFIs in both purpose and timing. RFIs are typically issued at the early stages of policy development to gather broad input and ideas from stakeholders. In contrast, comment letters are solicited during the rulemaking process after a proposed regulation has been drafted. This timing allows organizations like the SVS to respond to specific regulatory proposals with focused feedback.

The SVS leverages its expertise to submit comment letters that critique, support, or suggest modifications to these proposed rules. By focusing on the regulations’ practical implications, the SVS can highlight potential impacts on patient care, medical practice and healthcare costs. These letters provide detailed analysis, often supported by clinical data and professional experience, to substantiate the organization’s position. Participating in this process allows the SVS to ensure that the concerns and perspectives of vascular surgeons are directly considered before final regulations are enacted.

The SVS recently joined a coalition of medical organizations in submitting a formal response to the U.S. Preventive Services Task Force (USPSTF) regarding its draft research plan on Enhanced Risk Assessment for Cardiovascular Disease. The response emphasizes the need for a balanced approach in evaluating both the benefits and potential risks and calls for a research framework that integrates comprehensive data from recent and historical studies to mitigate health disparities and enhance early diagnosis and treatment of cardiovascular diseases. For more information, visit vascular.org/Comment_Letter.

In contrast, letters of support are proactive endorsements of legislative initiatives or regulatory actions. Letters of support are used to endorse specific pieces of legislation, regulatory actions or other governmental initiatives. When a bill that aligns with the SVS’s goals is introduced in Congress, organizations may issue a letter of support to circulate to Congress. These letters articulate why the proposed legislation benefits patient care, public health and the medical community.

Letters of support often highlight the legislation’s practical implications, provide patient testimonials and cite relevant research to bolster the case. By lending its voice, the SVS can help build momentum for legislative initiatives that align with its mission and advocate for policies that improve vascular health.

The SVS joined over 60 other medical organizations in advocating for continued education, training and mental health resources for healthcare professionals by sending a letter of support to the reauthorization of the Dr. Lorna Breen Health Care Provider Protection Act.

For more information, visit vascular.org/Support_ Letter.

ANDREW KENNEY is a member of the SVS advocacy staff, representing the Society in Washington, D.C.

Exploring the effectiveness of Topical Wound Oxygen therapy in diabetic foot and venous leg ulcers: ‘A new, different functionality that penetrates the wound’

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Exploring the effectiveness of Topical Wound Oxygen therapy in diabetic foot and venous leg ulcers: ‘A new, different functionality that penetrates the wound’
TWO 2 device

This advertorial is sponsored by AOTI.

Alisha Oropallo

Until about a decade and a half ago, vascular surgeon Alisha Oropallo, MD, could be counted among the skeptics. Back then, she says, topical wound oxygen therapy for nonhealing vascular wounds did not have much traction in the vascular surgery community. Skepticism was widespread. There was little data be­hind the technology of the time, and ques­tions lingered over its effectiveness.

Then along came a new mechanism of oxygen delivery to the wound bed. Data followed, including results from a random­ized controlled trial (RCT) showing durable healing in chronic diabetic foot ulcer (DFU) wounds.

The key difference maker, says Oropal­lo, who is professor of surgery at Zucker School of Medicine at Hofstra University/ Northwell and director of the Comprehen­sive Wound Healing Center at Northwell Health in New Hyde Park, New York, is the cyclical pressurized oxygen applied directly to sites of wounds by Topical Wound Oxy­gen (TWO2) therapy.

“It wasn’t cyclical before, there wasn’t 100% oxygen, there wasn’t proof that it was actually penetrating the tissues—I think they were just blowing in oxygen from the outside and there wasn’t really a pump mechanism for the most part,” she explains. “It’s new and different multi-modality func­tionality in how it penetrates the wound with oxygen.”

TWO 2 device

For Oropallo, TWO2 use is now routine. With DFU patients who qualify, she starts topical oxygen therapy almost immediate­ly. For patients who she sees with radiation injuries, she almost always refers them for TWO2. And then there are those patients with venous leg ulcers (VLUs), and particu­larly recurrent VLUs.

A real-world outcomes study, conduct­ed on a very co-morbid diabetic popula­tion—similar to the population that Oro­pallo treats—showed that even in the face of dysvascular function, and in many cases dialysis, this technology can help this partic­ular population achieve successful outcomes and expedite healing of these hard-to-heal wounds. As the data in the study—carried out by Jessica Izhakoff Yellin and colleagues, and published in Advances in Wound Care in 2021—demonstrates, the significance of be­ing able to decrease hospitalizations that pre­vent amputations in this group of patients with diabetic foot ulcers is life changing for them, Oropallo points out. It also showed that it was economically beneficial for all concerned when this TWO2 therapy can be implemented, she adds.

Image 1

Oropallo cites a recent VLU case involving a 64-year-old man with a history of multiple deep vein thromboses (DVTs) and Factor V Leiden deficiency. Prior, he had undergone left iliac vein stenting and radiofrequency ablation. The patient had residual deep venous reflux of the femoral vein and re­current leg ulcerations, despite compliance with compression therapy, says Oropallo. “He received adjunctive therapy, such as skin substitutes,” she explains. “TWO2 was applied with subsequent improvement from baseline [image 1] and over four months duration to closure [2 and 3].”

Oropallo says she deploys TWO2 when­ever feasible. “I use it throughout the treat­ment too,” she continues. “Because a lot of times the patients are only given a few weeks of hyperbaric oxygen therapy through insurance and that’s just not enough. So, I use it adjunctively and concomitantly. I don’t find that they’re mutual­ly exclusive. I think that they can both help to enhance the wound healing, at least from a continuous basis.”

Image 2

“Some do very well with TWO2,” she adds. “It also depends upon the mental sta­tus of the patient too, because if the patient is cognitively impaired, that can change the role of how we use TWO2, because they have to administer it themselves.”

Oropallo says the RCT that evaluated the efficacy of TWO2 in the setting of DFUs represented a gamechanger in the level of evidence behind the therapy. Known as the TWO2 Study, led by Robert G. Frykberg, DPM, it demonstrated that at 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal stan­dard of care alone. Oropallo believes a sim­ilar study carried out in the setting of VLUs and published in the vascular literature might eventually lead to topical wound ox­ygen therapy forming part of the guidelines.

Image 3

“The TWO2 Study is one of the stron­gest manuscripts in the literature regarding Wagner grade 1 and 2 DFUs,” she says. “So, I think that pans out really well for vascular surgery in general. If a DFU is a 3 or a 4, then it is more challenging, but the application may still be there—especially concomitantly with an adjunc­tive therapy.

“Probably the bulk of vascular surgeons’ work is in the field of foot ulcers, because that’s where they do a lot of the revascularization. Most of those patients are admitted in the hospi­tal; they’re going to be under the vascular surgery service line; they’re not going to be under podiatry. The podiatrist might be see­ing them ancillary, but the vascular surgeon is really making all the decisions and seeing the patients every day.”

Oropallo contrasts how vascular surgeons face DFU patients with the current VLU treatment landscape.

“Unfortunately, not many patients with venous leg ulcers get admitted too often at the hospital anymore, but they are routinely seen about 80% of the time,” explains Oro­pallo. “There’s not a lot of good literature out there on topical oxygen in VLUs. But for patients with hard-to-heal wounds who have been recurrently coming back to the office, I wrap the wounds and apply TWO2 on those patients who really have some challenging wounds that are difficult to heal.”

Acellular tissue-engineered vessel granted FDA Regenerative Medicine Advanced Therapy designation for advanced PAD

By
Will Date
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Acellular tissue-engineered vessel granted FDA Regenerative Medicine Advanced Therapy designation for advanced PAD

vascular traumavascular traumaHumacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational acellular tissue-engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This RMAT designation was granted at the same time as the FDA cleared a new Investigational New Drug (IND) application for the PAD indication for ATEV, formerly referred to as the human acellular vessel (HAV).

According to Humacyte, this is the third RMAT designation granted by the FDA for Humacyte’s ATEV, in addition to previous RMAT designations for vascular trauma repair and arteriovenous (AV) access in hemodialysis.

Life Seal Vascular awarded NSF SBIR grant to advance sac management technology for EVAR

By
Jocelyn Hudson
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Life Seal Vascular awarded NSF SBIR grant to advance sac management technology for EVAR
Life Seal Concept
Life Seal Vascular
Life Seal concept

Life Seal Vascular recently announced that it has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant. The funding will be used to accelerate the development of the company’s endovascular aneurysm repair (EVAR) technology.

“We are honored to receive this prestigious SBIR grant from the NSF. This funding is a testament to the innovative potential of our technology and our commitment to advancing EVAR care,” said Bob Mitchell, executive chairman of the board at Life Seal Vascular.

He continued: “With this support, we are well positioned to advance the development of our breakthrough aneurysm sealing solutions and make a significant impact on the lives of EVAR patients worldwide.”

Life Seal Vascular notes that the NSF SBIR grant will enable the company to further develop its proprietary aneurysmal sac sealing technology. Designed as an adjunctive therapy to native endografts, Life Seal Vascular’s approach seals the entire aneurysmal sac potentially eliminating endoleaks, reducing reintervention rates and improving clinical outcomes for EVAR patients.

Michel Reijnen

Vascular surgeon Michel Reijnen, MD, from Rijnstate Hospital in Arnhem, The Netherlands, commented on the significance of Life Seal Vascular’s technology, stating: “The advancements being made by Life Seal Vascular are truly remarkable. Their innovative solutions have the potential to revolutionize EVAR, offering patients safer and more effective treatment options. I am excited to see the positive impact this technology will have on the field and on patient care.”

A press release details that the NSF SBIR program is a highly competitive initiative that supports scientific excellence and technological innovation through the investment of federal research funds.

VAM 2024 recordings available now

By
Marlén Gomez
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VAM 2024 recordings available now

Attendees of the 2024 Vascular Annual Meeting (VAM) can now access recordings of the sessions, including poster presentations, lectureships and more. The recordings are available through the SVS mobile app or the online planner, providing a convenient way for participants to catch up on sessions they missed or review their favorite presentations.

To view the recordings, attendees should log in to the platform, click on “Full Schedule,” select the desired session, and click the pop-up. They can then look for the “Video Recording” button next to the moderator’s name. To access the recordings, visit vascular.org/OnlinePlanner.

SVS Foundation board welcomes new members

By
Marlén Gomez
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SVS Foundation board welcomes new members

The Society for Vascular Surgery (SVS) Foundation has appointed new members to its Board of Directors. These individuals will continue the Foundation’s mission of driving advancements and impacting the field of vascular surgery. Peter Henke, MD (pictured), the new Research Council chair, replaces Raul Guzman, MD. Joseph Mills, MD, will assumes the role of Foundation chair, succeeding Michael Dalsing, MD, and Matthew Menard, MD, replaces Ulka Sachdev-Ost, MD.

Henke was the past chief of surgery at the Ann Arbor Veterans Affairs, co-director of the Blue Cross Blue Shield of Michigan Vascular Intervention Collaboration and a past president of the American Venous Forum.

Mills currently serves as the Reid professor and chief of vascular surgery and endovascular therapy at Baylor College of Medicine in Houston. His extensive vascular surgery leadership and academic background have led him to hold the presidency in multiple vascular societies and contribute significantly to vascular surgery literature.

Menard is the vascular and endovascular fellowship program director at Brigham and Women’s Hospital in Boston.

“The SVS Foundation’s commitment to advancing vascular health is unwavering,” Mills said. “I am excited to lead this distinguished board in continuing to make impactful strides in our field. We will focus on driving research, fostering innovation, and improving patient care to meet the challenges of vascular disease.”

Keith Calligaro, MD, the SVS president-elect, will join the board as part of the presidential line. Calligaro is the chief of vascular surgery at Pennsylvania Hospital in Philadelphia.

For more information about the SVS Foundation and its Board of Directors, visit vascular. org/FoundationBoard.

Beyond private equity: A new sheriff in town

By
Bhagwan Satiani
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Beyond private equity: A new sheriff in town
Bhagwan Satiani, MD, explores the entrance of insurance companies into the physician practice acquisition market.

The well-written recent editorial from Mal Sheahan, Vascular Specialist medical editor, explained the case against private equity in medicine, and what is at stake for physicians and patients.

I published a review of private equity about three years ago, hoping that surgeons would exercise caution before they jump into a ”deal.”1 It concluded that, “Fatigued by numerous stressors, physician practices and ASCs [ambulatory surgery centers] are increasingly choosing financial security through partnership with private equity investors as an alternative to hospitals or large group employment. However, careful consideration is needed in partnering with ‘for-profit’ and majority investor-owned private equity firms.” My opinion about private equity in healthcare has changed from being slightly negative to truly negative. However, as we pointed out, the model may work for a small group of physicians planning to retire within a few years. Other than cardiology, the number of private equity acquisitions dropped in 2023. I suspect this is because most physicians are hearing about the downsides from colleagues, and the Department of Justice (DOJ) is hot on the trail over allegations of poor business practices against private equity.

A much larger, and darker, cloud has appeared over our healthcare system, as I warned on these pages. “Over time, some of us may feel they are faced with thralldom and are looking for options,” I wrote. And: “Novel options may include staying in practice but considering non-traditional and even provocative paths.”2 I mentioned private equity and the new sheriff in town that has taken up residence: the publicly-traded insurance companies. This happened quietly and quickly.

When hospitals—which have integrated horizontally, vertically and every which way to consolidate and hire thousands of physicians— complain about the insurance companies buying physician practices, we better pay attention. Insurers like UnitedHealth Group now employ not only more physicians than the health systems, but they also own data analytic centers, accountable care organizations, office-based labs (OBLs), pharmacy benefit managers, urgent care centers, nursing homes, behavioral and mental health centers, and nursing schools. A recent example is the large acquisition of Wisconsin-based ProHealth Care, armed with 800 employees to manage the revenue cycle, information technology and data analytics. The strategy is to build out the back office to support the workers. Amazon-like, isn’t it? A particular concern with insurer-owned physician practices that are dominant in certain markets is their poor record related to passing on any savings to employers and ultimately patients.

You might say that is a corporate takeover? Right. Isn’t it prohibited by law in some states? Right again. They do this because state legislators have looked the other way. The Affordable Care Act (ACA) probably did nothing to discourage corporatization either. In fact, the law may have encouraged it. Insurers told the ACA head honchos back then that they knew how to make the system more efficient, bring down costs and, of course, improve the quality of care.

Let me remind younger members of the Society for Vascular Surgery (SVS) of the origin of the behemoth UnitedHealth Group insurance company. Physicians and others founded the firm in 1974 and incorporated it as Charter Med Incorporated, later morphing into United HealthCare Corporation (UHC). I was too busy with patient care, naïve and cash-poor then and missed the boat on buying shares in the company. In 1992, UHC acquired Columbus, Ohio-based HMO Physicians Health Plan of Ohio for $84 million. An older orthopedic surgeon friend bought shares. Do not ask me what those shares are worth today. The company kept buying up smaller health plans, and now you know the rest of the story, as the late Paul Harvey would say.

United Health Group, the parent group of insurance subsidiary UnitedHealthcare with $372 billion in revenue last year, is the largest insurer and covers about 53 million people. Its Optum subsidiary is now the largest employer of physicians in the U.S., with more than 90,000 employed or affiliated physicians, 40,000 advanced practice clinicians, pharmacy benefit managers, and technology and data analytics. Humana, Aetna, CVS Health and Anthem followed quickly.

Not to be left out, retailers including Walgreens, Walmart and Amazon are joining the physician buyout wave. Amazon purchased primary care company One Medical, which has 815,000 members, for $3.9 billion. Walmart acquired a health technology and a telehealth company, and expanded its Walmart Health centers. In this environment, why should retailers of home appliances such as Best Buy be left behind? TVs are part of healthcare, right? Sick people watch TV too. Fear not. They acquired GreatCall, a home health company, and offered technical support to Atrium Health (hospital at home program).

The latest sector of great concern to surgeons is ASCs. Optum snatched Surgical Care Affiliates (SCA), an owner of ASCs, for a mere $2.3 billion in 2017 to add to their portfolio of more than 300 ASCs and surgical facilities. Another big player in ASCs is Tenet, which, after acquiring/ partnering with established United Surgical Partners, has grown to 500 ASCs and “surgical” hospitals.3 I would not be surprised if they or others are already planning to approach surgeons who currently own about 35% of OBLs.

The American Hospital Association (AHA), representing powerful but alarmed members, has pointed out that from 2019–2023, most physicians were acquired by private equity (65%), physician groups (14%), payors (11%), health systems (8%) and others (4%). This trend has accelerated since then, compelling the AHA to argue against the market power of Optum to the DOJ, and requesting an antitrust investigation. The DOJ has obliged.

Like with the pursuit of private companies, the DOJ has now started looking into massive ownership interests and the conflicts between Optum-owned physicians and competing physicians. The last time the DOJ questioned the UnitedHealth Group about its acquisition of Change Healthcare (recent target of a cyber attack), it took a pass.

This entire wave of acquisitions reminds me and many others to remember the halcyon days, when hospitals went full throttle in the 1980s to hire thousands of primary care physicians. The hospitals lost their shirts. I suspect the loser in the end will be the stockholders of many—but not all—of these public companies that are going outside of their core businesses to catch the wave. What, then, happens to their employed physicians?

There appear to be several objectives to the employment of thousands of physicians: starting with “value-based care” and fixed payments for every service. We are already seeing some of this with physicians sharing profits with insurance companies for Medicare Advantage patients, by taking some financial risk in the care of these patients.

Beside profits, their focus is to aggressively push into the large healthcare markets with a focus on “meeting patients where they are, and utilizing technology and established retail locations to make healthcare as convenient as possible.”4 The impetus comes from the desire to project a “one-stop shopping” façade.

While I agree with almost all of Dr. Sheahan’s commentary in his recent editorial, shifting the blame onto judges— conservative or liberal—is missing the point.

The blame rests, as it often does, with Congress, which finds it convenient to ignore its own responsibilities in providing the federal bureaucracy with ambiguous directions. It is easy to blame a faceless and politicized bureaucracy.

So, what is ahead? It is possible we may have three or four vertically and horizontally integrated for-profit juggernauts serving the entire healthcare supply chain or a single payor system. Erstwhile foes like hospitals and insurers, now gaining the upper hand, may just join hands. Can you imagine the lobbying cash available?

It is like the Wild West and Dodge City right now. Is it possible for physicians to “get outta Dodge” and escape from this scenario? Is it possible that we will see a repeat of the hospital acquisitions of the 1980s and the accompanying financial disaster? CVS Health just purchased Oak Street Health, which employs 600 primary care physicians in 21 states. So far, that deal has been a huge money loser.

Not only that, the DOJ is reportedly investigating CVS for giving out “gift cards, swag and goody bags”!5 An Oregon-based Optum group recently lost 32 physicians within two years. Walgreens lost over $5 billion getting rid of its primary care chain.

We cannot discount that probability. We know there will be versions 3.0 or 4.0 of this familiar tale—and we as physicians will watch from the sidelines as always.

 References

  1. Satiani B, Zigrang TA and Bailey-Wheaton JL. Should surgeons consider partnering with private equity investors? The American Journal of Surgery. https://doi. org/10.1016/j.amjsurg.2020.12.028
  2. Satiani B. The choice between autonomy, true partnership, or the slow drift to thralldom. Vascular Specialist. Feb. 2023
  3. Newitt P. https://www.beckersasc.com/asc-transactions-and-valuation-issues/tenet-enters-new-era-driven-by-uspi-growth.html
  4. Bailey-Wheaton JB. Zigrang TA. Health Capital Topics. Available at https://www. healthcapital.com/hcc/newsletter/03_23/ HTML/CORP/convert_corporate_moves_ in_hc_topics.php
  5. Abelson R. Corporate Giants Buy Up Primary Care Practices at Rapid Pace. New York Times. Available at https://www. doximity.com/articles/365f4e62-b782-4420- b3d8-0a231d61a056

 BHAGWAN SATIANI is an associate editor for Vascular Specialist.

Grasping the nettle: The need to tackle PAD problem head on is huge, says 2024 Veith lecturer

By
Bryan Kay
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Grasping the nettle: The need to tackle PAD problem head on is huge, says 2024 Veith lecturer
Michael Conte, MD

Huge opportunities abound for vascular surgeons to take a leadership role on the frontlines of a developing peripheral arterial disease (PAD) treatment crisis in the U.S., says Michael Conte, MD, who gave the second annual Frank J. Veith Distinguished Lecture at VAM 2024.

Conte, speaking on “The State of PAD Care in the U.S.,” called on vascular surgeons to take a leadership role amid great unmet need among a population who face a significant public problem during the talk in Chicago.

“There are a lot of exciting developments, and vascular surgery really needs to seize the day to lead in the science, lead in the challenges; it’s core to what we do, it’s core to our patient population,” the professor and chief of vascular and endovascular surgery at the University of California San Francisco (UCSF) told Vascular Specialist on the VAM 2024 sidelines.

“I think it’s a really great time for vascular surgeons to get involved, whether that’s in the clinical research, the disparities and access to care issues, amputation prevention programs, or multidisciplinary care.

“There’s a lot there for young vascular surgeons to embrace,” Conte continued. “The service part as well as the research part are significant. So, if you look at what’s happening at the SVS with the VISTA [Vascular Volunteers In Service To All] program [now known as Vascular Care for the Underserved], all the way through to promoting clinical trials in PAD, this is the time—it’s a generational thing.”

With carotid disease now “pretty stable,” as Conte described it, and with the strides made in aortic disease treatment meaning “we’ve solved a lot of stuff” in that domain, he said many roads now lead to PAD, which he labeled “huge” and in need of “a lot of help.”

First comes the opportunity, Conte declared, then the nature of the growing, countrywide public health problem— advancing age, diabetes not abating.

“We need to embrace and promote science-guided, evidence-based practice,” he says. “To do that, we have to continue to try to execute on designing and executing clinical trials using our registries to address important issues of quality of care, and continue to write and update meaningful practice guidelines. It’s a multispecialty space and we should embrace that, not shy away from it. We should just lead.”

During the Veith Lecture, Conte outlined the breadth of the challenges and opportunities at play in PAD treatment. He demonstrated the public health magnitude, the disparities in access to care and health outcomes, and the need to improve available therapies owing to persistent gaps in outcomes.

“What I really want you to take home from this is that in this tremendous field full of opportunities for vascular surgeons at every level, and particularly young vascular surgeons, to embrace and lead,” he implored the VAM 2024 audience.

Conte emphasized the need in the U.S.: “While we were doing really well with cardiovascular mortality, going from the 1980s to the early part of this decade, since 2010 things are going backwards. Cardiovascular mortality rates for both men and women have been back on the rise for the last 10 years, and there is a geographic distribution to this as well.”

After some decades of improvement in overall amputation numbers, those too are rebounding, Conte pointed out. Many are minor “but reflect the growth of diabetic foot disease overlaying with PAD. Those two things in concert have really taken over our practices. We are seeing many, many patients with neuroischemic wounds and diabetes, and a rise in the need for limb amputations.”

Conte turned to disparities in outcomes and the severity of disease, which “is certainly not equally felt by people of all races, colors and creeds.”

He said, “We have a lot of work to do to address the unbalanced proportion of Black and Hispanic patients who are presenting at late stages of disease and are at higher risk for amputation than their White counterparts.”

Economic disparity overlays with racial disparity, he continued. Similar overlays can be demonstrated with food and housing insecurity, Conte said, “highlighting the fact that some of the racial and ethnic disparities are tied into social determinants of health. And until we tackle all of that together, we’re probably not going to be able to make a dent in some of this disparity.”

He pointed to a number of advances in medical therapy for PAD, referencing a change in the approach of the pharmaceutical industry to approach the disease process as an entity in its own right, separate from coronary disease. “Overall, this is a huge change in opportunity but it requires a lot more education and public awareness to transfer this to effective outcomes for patients,” Conte said.

He also addressed access, appropriateness and value issues in vascular care. “It’s difficult to say where we are,” Conte reflected. “Too little care or not enough care? ”The issues within this conundrum must be tackled “head on,” he implored.

In sum, Conte emphasized vascular surgery’s lead role in PAD care delivery, science and innovation—”but multidisciplinary collaboration is fundamental to success.” The SVS should lead by fostering clinical excellence, education, science and building community across all PAD stakeholders, he added.

A calling seeded in childhood: Uniting vascular surgery for the betterment of patient care

By
Bryan Kay
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A calling seeded in childhood: Uniting vascular surgery for the betterment of patient care
Joseph Mills, MD
Joseph Mills, MD

Many attending the 2024 Vascular Annual Meeting (VAM; June 19–22) might have been unaware of the early life of 2023–24 Society for Vascular Surgery (SVS) President Jo­seph Mills, MD. Amongst an intrepid childhood following his father’s career as a dentist, incoming SVS President Matthew Eagleton, MD, noted as he introduced Mills to give the 2024 Presidential Address in Chicago, Mills had spent a portion of his formative years growing up on the Navajo reservation in Arizona. There, an elementary-school-aged Mills was one of only two non-Native American children in his class.

That period of the Baylor School of Medicine in Houston professor and chief of vascular surgery planted a lifelong respect for—and interest in—Native American culture. It also led him down a path of service, following in the footsteps of his father before him, who had landed on the Navajo reservation as part of a public service commitment.

It cast a compelling backdrop to the core message behind Mills’ address in Chicago.

Mills issued a rallying call steeped in classical history and de­cades of collected vascular surgery wisdom with a singular aim: to overcome “unrest” and to drive forward vascular care with a broad approach to diversity.

Mills variously tackled the consolidation of medicine into ev­er-larger for-profit enterprises, the stresses inherent within a body of people such as the SVS, and the strong political position taken by the Society over appropriate care during his term of office.

He cast some of the conundrums facing the specialty thus: “Ten­sion is an everyday consideration in life,” said Mills. “Tension and shear stress in arteries modulate wall thickness and vessel diameter. Tension is a fundamental aspect in each of our lives as well as in society at large.”

Examples include tension between physicians and payors, Mills continued, “tensions between physicians and the healthcare system, and tensions between alternative techniques, societies and special­ties and even within societies.”

He invoked the democratic ideals of the ancient Greeks and how these principles drive collected interests in societies. “The poet and pre-Socratic philosopher Xenophanes stated that justice is a form of ‘tension-in-action,’” he said. “So how do we mitigate tension, particularly within the Society for Vascular Surgery, as we are simply a microcosm of society at large?”

Mills homed in on the necessity of a more diverse SVS Executive Board (EB). The EB, he explained, has expanded to include officers who are either self-nominated or nominated by others and then se­lected by the Nominating Committee and the 37-member Strategic Board of Directors to add diversity of perspective and additional competencies.

But by greater diversity, said Mills, he means more than the obvious markers such as gender and skin color. Diversity is multifactorial and must include diversity of perspective and cog­nitive diversity, he continued. “Alternate perspectives and points of view must be included for a society or group to make the best decisions. As my long-time friend and vascular brother Spence Tay­lor used to say, if you go to see the brown shoe salesman, you are going to get a pair of brown shoes. Or, to paraphrase Atticus Finch in To Kill a Mockingbird, you never really understand a person until you consider it from their point of view and walk in their shoes.”

Mills started his vascular surgery career at Wilford Hall USAF Medical Center in San Antonio, Texas, there beginning the ser­vice-minded approach instilled by his father.

Later in his career, Mills returned to the scene of those early experiences in Arizona, where he helped lead efforts to establish a respected multidisciplinary limb salvage group known as SALSA, or the Southern Arizona Limb Salvage Alliance—a toe and flow model that paved a path for cross-specialty collaboration.

“I would propose that the broad disparities in vascular research and training that have been widely written about are fundamentally due to lack of inclusion and diversity among practitioners and inves­tigators, whether one looks at disparities related to gender, people of different skin colors, or people living in rural environments. In fact, nearly all vascular diseases that have been studied, as well as the majority of device trials, have failed to sufficiently include all members of our society,” he said.

In tandem with the diversity message came a tone pointing to­ward the necessity of collaboration. “In line with building coalitions in a crisis, major efforts are being made to engage other organi­zations when they are in alignment with our goals and objectives to promote our specialty for improving the care of patients with vascular disease,” Mills related.

“We are a small group, far too small to be splintered or fragment­ed,” he said, finishing with a favorite maxim: “If you want to go fast, go alone. If you want to go far go together.”

He added: “It is unquestionable that giant leaps have been made in our field by many individual pioneers and innovators, but the way we reach the goal of optimizing our clinical effectiveness and improving care for all people with vascular disease, is to work to­gether. All major individual accomplishments need to be translated into work that we can all do to provide better care for our patients.”

Vascular Specialist–July 2024

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Vascular Specialist–July 2024

In this issue:  

  • Grasping the nettle—huge opportunity for vascular surgeons to take the lead on the frontlines of peripheral arterial disease (PAD) treatment crisis, says Michael Conte, MD
  • VAM 2024: Highlights from across the recent meeting in Chicago
  • Corner Stitch: Navigating pregnancy as a vascular surgery trainee—better cultural, structural and institutional support is needed, says Christina Cui, MD
  • Early-career errors: SVS Young Surgeons Section (YSS) hold session addressing clinical and professional errors at VAM 2024

The top 10 most popular Vascular Specialist stories of June 2024

By
Éva Malpass
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The top 10 most popular Vascular Specialist stories of June 2024
top 10In June, the most read stories from Vascular Specialist included key reports from the 2024 Vascular Annual Meeting (VAM; June 19–22) covering TEVAR, CEA vs TCAR, PAD and CFA-reintervention, among others; Linda Harris’ placement as SVS vice president; the relationship between patient selection and carotid stenting volume and outcomes, and several more. 
1. Linda Harris elected SVS vice president

The Society for Vascular Surgery (SVS) has announced Linda Harris, MD, as its next vice president, meaning that she enters the presidential line and will become SVS leader in 2026.

2. VAM 2024: Paper exploring stroke rates in arch TEVAR emerges as winner of Poster Competition

The 2024 VAM annual meeting in Chicago showcased emerging talent in vascular surgery through a moderated Poster Competition held over two days of the conference. This event provided a platform for research and recognized excellence among the next generation of vascular surgeons.

3. ‘We are in this together’: SVS president set to issue call for vascular surgery unity amid tensions of modern medicine

SVS President Joseph Mills, MD, is set to issue a rallying call steeped in classical history and decades of collected vascular surgery wisdom in order to bring the specialty together for a common purpose: to overcome “unrest” and to drive forward vascular care.

4. CEA vs TCAR: Surgeons should be familiar with both procedures and ‘collaborate as needed’

When it comes to the ongoing debate of carotid endarterectomy (CEA) versus transcarotid artery revascularization (TCAR) in the treatment of carotid artery stenosis, operators should be comfortable and maintain experience with both of these procedures—and “collaborate as needed.”

That is the ultimate finding of a registry analysis set to be presented later this week at the 2024 VAM annual meeting in Chicago during Plenary Session 1: William J. von Liebig Forum.

5. Young vascular surgeons on the PAD frontier: ‘This is the time to seize the day,’ 2024 Veith Lecturer declares

Huge opportunities abound for vascular surgeons to take a leadership role on the frontlines of a developing peripheral arterial disease (PAD) treatment crisis in the U.S., said Michael Conte, MD, as he gave the second annual Frank J. Veith Distinguished Lecture on the closing day of the 2024 Vascular Annual Meeting.

6. TCAR and endarterectomy both ‘reasonable’ but stenting linked to worse outcomes in kidney disease patients

A study examining outcomes between different carotid revascularization procedures has concluded that transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) both represent a “reasonable choice” in severe chronic kidney disease (CKD) and hemodialysis patients—but transfemoral carotid artery stenting (TF-CAS) appears more likely to result in worse outcomes.

7. VAM 2024: Putting out the fires of intraoperative vascular emergencies

A VAM 2024 Education Session taking place on Wednesday, June 19, examined the most common emergency intraoperative vascular surgery consultations, along with trends in intraoperative vascular surgery consultation over time—the subject area that has seen vascular surgeons referred to as the firefighters of the operating room (OR).

8. Patient selection may explain ‘counterintuitive’ relationship between carotid stenting volume and outcomes in new study

High stroke and death rates relating to carotid stenting in the Pacific Northwest may be driven by the selection of high-risk patients with less than 80% stenosis, and reducing the frequency of stenting in this high-risk group—along with better adherence to guideline-recommended medical management—could improve regional outcomes.

9. New data on TAMBE outcomes in complex aortic aneurysms

The US Food and Drug Administration (FDA)-approved Gore Excluder Thoracoabdominal Branch Endoprosthesis (TAMBE) has been shown to be safe and effective at 30 days for the treatment of patients with complex aortic aneurysms involving the visceral aorta.

10. Endovascular CFA treatment associated with increased rate of long-term CFA-specific reintervention, study finds

A recent study suggests that endovascular treatment of the common femoral artery (CFA) is associated with an increased rate of long-term CFA-specific reintervention, regardless of indication. Nicholas Wells, MA, a medical student at Yale School of Medicine in New Haven, Connecticut, presented this and other key findings from a tertiary care center analysis of open and endovascular treatment of the CFA during yesterday’s William J. von Liebig Forum at VAM 2024.

Sonovein FDA pivotal study treatments completed: Theraclion reaches key milestone on schedule

By
Brian McHugh
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Sonovein FDA pivotal study treatments completed: Theraclion reaches key milestone on schedule
Sonovein
Sonovein

Theraclion, a French MedTech company developing a robotic platform for non-invasive high-intensity focused ultrasound (HIFU) therapy, announces today that treatments in the Food and Drug Administration (FDA) pivotal study for Sonovein, an extracorporeal medical device made to treat varicose veins using HIFU, have concluded, in accordance with the scheduled timeline. 

A total of 70 patients have been treated with Sonovein in the clinical trial across four leading centers in the US and in Europe. 

Principal investigator Steve Elias (Englewood, USA) commented, “I have been involved with many emerging technologies and initial clinical trials. It is very satisfying to have completed the VEINRESET trial treatments using Sonovein. Sonovein is the only extracorporeal, transcutaneous technology capable of treating superficial venous insufficiency. The patient experience and initial results of this trial are extremely promising. I look forward to the final results of the multi-center clinical trial. This has great potential to be an advancement in the management of superficial venous disease.” 

Theraclion’s Chief Medical Officer Michel Nuta added, “We are happy to have completed the always important recruitment phase and to have reached the FDA target for treatment numbers. We will now focus on the study follow-up phase and continue accumulating valuable clinical experience in our top-notch centers.” 

The study results will be released after a 12-month follow-up. 

Following the successful completion of a feasibility study in 2022, the FDA pivotal study was initiated on schedule at the end of 2023. With the conclusion of the treatment phase, a 12-month follow-up period is now beginning, and the study results will be available in the summer of 2025. The market approval application will be submitted to the FDA as soon as the study report becomes available in the second half of 2025, and approval is expected by early 2026 but will depend on the regulatory agency review time. 

Martin Deterre, CEO of Theraclion, concludes, “We are very satisfied to have reached another key milestone on schedule. We look forward to seeing and presenting the results of this strategic study after the follow-up period next year.” 

Humacyte’s ATEV granted FDA Regenerative Medicine Advanced Therapy designation for advanced PAD

By
Jocelyn Hudson
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Humacyte’s ATEV granted FDA Regenerative Medicine Advanced Therapy designation for advanced PAD
Human Acellular Vessel
ATEV
Acellular tissue engineered vessel

Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational acellular tissue engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This RMAT designation was granted at the same time as the FDA cleared a new Investigational New Drug (IND) application for the PAD indication for ATEV, formerly referred to as the human acellular vessel (HAV).

According to Humacyte, this is the third RMAT designation granted by the FDA for Humacyte’s ATEV, in addition to previous RMAT designations for vascular trauma repair and arteriovenous (AV) access in haemodialysis.

“We are very pleased to receive our third RMAT designation from the Food and Drug Administration,” said Cindy Cao, chief regulatory officer at Humacyte. “The RMAT designation we previously received in our lead indication of vascular trauma was very helpful in enhancing our communication with the FDA review team during the filing and review of our BLA [Biologics License Application]. We are excited that this additional designation has been granted in advanced PAD, as we expect that it will further strengthen our communication with the FDA and expedite the development of our ATEV in this important indication.”

A press release notes that Humacyte’s ATEV is designed to be a universally implantable vascular conduit for use in vascular replacement and repair. Importantly, the ATEV has been observed to have a low rate of infection in clinical trials and is designed to be available off-the-shelf and ready whenever surgeons need it, potentially saving valuable time and improving patient outcomes.

The ATEV has been evaluated in two Phase 2 studies in PAD, with patients followed for as long as six years. In addition, The Mayo Clinic in Rochester, USA, is conducting a study in approximately 30 patients with chronic limb-threatening ischaemia (CLTI) under an investigator IND cleared by the FDA. All patients treated with the ATEV for PAD to date have not had autologous vein available for revascularisation, and hence the ATEV may represent an important therapeutic alternative for such patients.

Humacyte advises that the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Walk for PAD awareness this September

By
Kristin Spencer
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Walk for PAD awareness this September
The Society for Vascular Surgery (SVS) Foundation’s 2024 Vascular Health Step Challenge takes place during the month of September

Registration for the Society for Vascular Surgery (SVS) Foundation’s 2024 Vascular Health Step Challenge is now open. The Foundation is hosting the third annual Step Challenge throughout the month of September in honor of Peripheral Arterial Disease (PAD) Awareness Month.

Throughout September, Step Challenge participants are encouraged to walk 60 miles to represent the 60,000 miles of blood vessels in the human body. Registration for the challenge costs $60 per participant. Once registered, participants can download the Charity Footprints mobile application and synch it to their smartphone or watch to monitor their daily step count. A leaderboard is accessible within the application so participants can monitor their progress and their competition.

Proceeds from the Vascular Health Step Challenge will benefit the SVS Foundation’s mission to optimize the vascular health and well-being of patients and the public through support of research that leads to discovery of knowledge and innovative strategies, as well as education and programs, to prevent and treat circulatory disease.  Learn more and register at vascular.org/STEP2024.

Pick up VESAP6

By
Kristin Spencer
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Pick up VESAP6

Those looking for a comprehensive review resource for vascular surgery are encouraged to check out the Society for Vascular Surgery’s (SVS) sixth edition of the Vascular Education and Self-Assessment Program (VESAP6).

This premier digital resource for those preparing for qualifying, certification and recertification examinations is designed to aid professionals in their examination preparation and ongoing education, with over 600 questions covering more than 10 content areas. The product offers up to 102 continuing medical education (CME) credits, with 39.25.

Visit vascular.org/VESAP to purchase.

Smoking cessation remains a ‘ripe target’ for improved medication adherence in carotid disease

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Smoking cessation remains a ‘ripe target’ for improved medication adherence in carotid disease
Randall Bloch presenting at VAM 2024

New data presented at the 2024 Vascular Annual Meeting (VAM) held June 19–22 in Chicago have revealed poor overall rates of medical therapy adherence in moderate asymptomatic carotid stenosis patients—with smoking cessation representing a “ripe target” for improvement moving forward.

“The objectives of this study were to examine adherence to three common tenets of medical therapy among a cohort of patients treated with medical therapy alone, and then to identify shortfalls in therapy to serve as opportunities for improvement,” said Randall Bloch, a research fellow at St Elizabeth’s Medical Center in Boston, presenting these data on behalf of senior author Mark Conrad, chief of vascular surgery at St Elizabeth’s, and colleagues.

Bloch and colleagues’ single-centre, retrospective study involved reviewing consecutive carotid duplex ultrasound scans from 2019–2020. Patients with moderate (50–69%) asymptomatic carotid stenosis—based on Society for Vascular Surgery (SVS) guidelines—were included in the study, while those who underwent upfront surgery “for any reason” were excluded, as were those without available follow-up data.

Patients were assessed for their adherence to optimal medical therapy at the time of the index duplex scan, the first follow-up visit, and at each subsequent follow-up visit until the end of the study, ultimately leading to a median follow-up period of 2.7 years. In the study, optimal medical therapy was defined via three key tenets: abstinence from smoking; use of aspirin or other antiplatelets; and use of statins or other lipid-lowering therapies.

The study, now also published in the Journal of Vascular Surgery, identified a total of 323 duplex ultrasound examinations with moderate asymptomatic carotid stenosis across 255 patients. Bloch reported that 56.1% of these patients were already on all three of the aforementioned aspects of medical therapy at the time of the index duplex, with this rate improving to 68.6% by the end of the follow-up period.

“However,” Bloch continued, “when looking specifically at the 112 patients that were not already on medical therapy, 38.4% were able to achieve adherence to all three tenets of medical therapy by the end of follow-up—and abstinence from smoking was the aspect of medical therapy that was least commonly achieved.”

The presenter went on to highlight the fact that patients with hypertension and those who were not smoking at the outset of the study demonstrated the highest rates of medical therapy adherence. According to Bloch, non-smokers achieving generally better adherence rates was able to be attributed to a rapid, initial uptake in adherence, likely due to “the relative ease of adding additional medications to the regimen, as opposed to the relative difficulty of smoking cessation.” In addition, multivariable analysis revealed that smoking at the time of the index duplex was associated with lower odds of achieving optimal medical therapy adherence.

“In conclusion, adherence to best medical therapy is suboptimal—less than 40% of patients who were not previously on therapy were able to achieve adherence to best medical therapy by the end of follow-up,” Bloch stated. “And, so—despite rapidly evolving medical therapies for cardiovascular risk reduction—smoking cessation remains a ripe target for interventions aimed at adherence to medical therapy.”

Discussions subsequent to Bloch’s presentation saw Kakra Hughes, MD, chief of vascular surgery at Howard University in Washington D.C., note that these data lead him to a slightly different conclusion.

“I don’t quite agree with your conclusion that best medical therapy is not good [in this study], because it’s 80% adherence when you take away smoking cessation—and we all know that smoking cessation is very difficult,” Hughes said. “I’d consider that the adherence to best medical therapy is about 80%, and I’d conclude that it is pretty good.”

Bloch agreed with Hughes to some degree, echoing his point that medication adherence alone was “pretty good,” but went on to assert that smoking cessation was part of the prespecified regimen in the study and is also recommended by the SVS as well as multiple other societal guidelines.

“So, I think it’s important to continuously look at how we’re doing in terms of providing comprehensive care for these patients,” the presenter added.

Another comment came from session moderator Wei Zhou, MD, chief of vascular surgery at the University of Arizona in Tucson, Arizona, who described this as a “really important study”, and suggested that it may have wider implications in other medical areas beyond carotid disease where medication adherence is also poor.

Speaking to Vascular Specialist following VAM 2024, Bloch provided further context regarding his discussion with Hughes, stating: “Given that smoking cessation is such an integral aspect of best medical therapy, my concern is that separating it from the medication regimen may lead to a false sense of success when it comes to stroke and cardiovascular risk reduction. As such, smoking cessation should be a leading priority in the care of these patients.”

SVS raises alarm over healthcare consolidation in comments to FTC, DOJ, HHS

By
Marlén Gomez
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SVS raises alarm over healthcare consolidation in comments to FTC, DOJ, HHS
Margaret Tracci

The Society for Vascular Surgery (SVS) has submitted comments to the Federal Trade Commission (FTC), the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in response to a Request for Information (RFI) concerning the consolidation of healthcare markets.

In its comments, the SVS highlights how the consolidation trend in healthcare exacerbates barriers to patient access, especially for those with vascular diseases. The comments stress that mergers and acquisitions within hospital systems often lead to increased prices and reduced service availability, impacting patient care.

SVS Advocacy Council Chair Margaret Tracci, MD, JD, emphasized the urgency of these concerns, stating, “Our primary concern is ensuring that patients have access to high-quality care. The consolidation in healthcare markets creates significant challenges, particularly for vulnerable populations, by driving up costs and reducing service availability.”

The comments outline several critical concerns regarding the impact of healthcare consolidation. The SVS argues that consolidation often results in higher costs for patients and payors, which can limit access to necessary medical services, particularly for older patients with vascular diseases who are frailer and more reliant on Medicare or Medicaid.

Consolidation threatens the viability of independent or private practices, where many innovative, minimally invasive vascular disease treatments occur in more accessible and cost-effective outpatient settings such as ambulatory surgery centers (ASCs) or office-based labs (OBLs). Tracci pointed out, “The reduction of these accessible and cost-effective service sites due to consolidation is a step backward for patient care.”

The SVS also highlights the role of private equity in driving consolidation. Tracci noted that the influence of private equity in healthcare tends to prioritize financial returns over patient outcomes, thereby compromising the quality and accessibility of care.

The comments note that large healthcare systems may reduce the range of clinical services at various locations based on profitability. The SVS calls for careful consideration of these issues in the administration’s policy development and enforcement actions, and urges any actions to address the negative impacts of consolidation on patients and providers.

The SVS will now await the relevant agencies—including the FTC, DOJ and HHS—to review the feedback and inform their policymaking process. The agencies may use these insights to draft proposals, typically publishing them to solicit further public comments.

“We look forward to collaborating with the FTC, DOJ and HHS to ensure policies that support high-quality care and accessible healthcare services for all patients,” said Tracci.

Incentives and coaching offer promise for improving supervised exercise therapy completion in claudicants

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Incentives and coaching offer promise for improving supervised exercise therapy completion in claudicants
Colin Cleary
Colin Cleary

Study findings were presented during Saturday, June 22’s Plenary Session 7 support current vascular guidelines advocating for effective supervised exercise therapy (SET) prior to offering vascular intervention for patients with intermittent claudication. That is the belief of Colin Cleary, PhD, a fourth-year medical student at the University of Connecticut School of Medicine in Farmington, and his co-authors.

“Current guidelines by the SVS [Society for Vascular Surgery] support the use of effective supervised exercise therapy programming as first-line therapy for all patients with intermittent claudication. These guidelines are supported by primary literature that supports the use of SET before any vascular intervention for symptomatic, flow-limiting arterial disease,” Cleary tells VS@VAM. “However, during this study, we found that patients were motivated much more to complete programming primarily from individualized coaching, and that patients who completed programming were more likely to delay their vascular interventions.”

Published rates of SET program completion range from 5% to 55%. Cleary and colleagues note, for example, a historical completion rate of 54% at their own institution. As such, they sought to identify if targeted patient-supportive interventions—including financial incentives and individualized coaching—can improve completion rates while still maintaining efficacious SET programming. Cleary et al undertook a research effort whereby patients who were diagnosed with intermittent claudication were offered enrollment in a prospective quality improvement protocol for a 12-week SET program at outpatient sites through Hartford HealthCare. Program completion was defined as ≥24 of the 36 offered sessions over 12 weeks.

A three-pronged approach was utilized to improve completion during the study, including financial incentives up to $180, scheduled coaching with advanced practitioner staff, and informational materials on the importance of SET programming and lifestyle modification. Patient-reported improvements in walking symptoms were tracked and analyzed, as were several functional measures of SET programming—including total walking duration and distance, metabolic equivalent of task (METs), ankle-brachial indices (ABIs), and vascular intervention 12 months after completion. In total, 56 patients completed SET programming, while 120 either did not complete SET or declined participation.

Utilizing this approach, Cleary et al increased their SET completion rate to 74.7% over a two-year study period. Compared to pre-SET baseline, patients who completed SET noted less pain, aching, cramps in calves when walking and less difficulty walking one block. Additionally, patients significantly increased their METs, total walking duration and total walking distance from their preSET baseline. And, while the researchers report participant ABIs remaining unchanged from enrollment to completion, they did find that patients who completed SET programming had delayed vascular intervention compared to those who either did not complete SET or declined participation. Cleary highlights a potentially key factor: patients with public insurance had a median out-of-pocket expense of $0 per visit compared to $6 for those with private insurance, which the researchers note could add up to a total of more than $200 across the full program.

They conclude that targeted incentives including cost-coverage vouchers and personalized coaching were able to improve patient completion of a prescribed SET program. Cleary et al add that patients who completed SET programming with incentives demonstrated improvement in reported walking symptoms and objective walking benefits—and that the patients studied had a delayed time to vascular intervention.

Gore announces first commercial implant of Gore Tag thoracic branch endoprosthesis in Canada

By
Bryan Kay
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Gore announces first commercial implant of Gore Tag thoracic branch endoprosthesis in Canada
Gore Tag

Gore has announced the first commercial use of the Gore Tag thoracic branch endoprosthesis (TBE) in Canada.

The news came as Canadian government health authority Health Canada approved the first-of-its-kind endovascular device, which is indicated to treat lesions of the descending thoracic aorta while maintaining flow into the left subclavian artery (LSA) in patients with appropriate anatomy.

Designed for thoracic endovascular aortic repair (TEVAR) procedures, the Gore Tag TBE provides a minimally invasive option in patients requiring aortic treatment into zone 2 across the left subclavian artery.

For surgeons Randy Moore, MD, Kenton Rommens, MD, Scott McClure, MD, Holly Smith, MD, and Eric Herget, MD, of the Calgary Aortic Program team at the University of Calgary in Calgary, Canada, the implantation marked a significant moment for patient care.

“Traditionally, treating aortic arch disease has posed various challenges,” the team remarked in a Gore press release statement. “Now, with a single device that can be used in a single procedure, we possess a powerful solution with the potential to simplify aortic treatment requiring coverage of the left subclavian artery.”

The Gore Tag TBE was the first Food and Drug Administration (FDA)-approved off-the-shelf aortic branch device for treatment of zone 2 lesions evaluated in the U.S. The pivotal trial enrolled 238 patients in zone 2 across multiple aortic pathologies, including aneurysm, dissection, traumatic transections and other isolated lesions. Overall technical success rate was 95.8% across all pathologies, through 30 days the disabling stroke rate was 1.7% and through 12 months the reintervention rate was 2.9%.

For Moore, “the results of this study, which importantly measured both device technical success and the absence of select adverse events in zone 2 subjects, were very encouraging for a variety of patients across aortic pathologies.”

VAM 2024: Paper exploring stroke rates in arch TEVAR emerges as winner of Poster Competition

By
Marlén Gomez
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VAM 2024: Paper exploring stroke rates in arch TEVAR emerges as winner of Poster Competition
Hassan Chamseddine with departing SVS President Joseph Mills

The 2024 Vascular Annual Meeting (VAM) in Chicago showcased emerging talent in vascular surgery through a moderated Poster Competition held over two days of the conference. This event provided a platform for research and recognized excellence among the next generation of vascular surgeons.

Hassan Chamseddine, MD, a research fellow from Henry Ford Hospital in Detroit, Michigan, secured first place for his poster titled “Comparative analysis of stroke rates in arch TEVAR [thoracic endovascular aortic repair]: Total endovascular repair plagued by high stroke rates.” Chamseddine expressed his gratitude to the organizing committee for the award.

“It feels tremendous to be recognized for the research we’ve been doing at Henry Ford Hospital. We hope this project helps move endovascular stent grafting of the aortic arch forward in the future,” he said.

The competition, organized by the Society for Vascular Surgery (SVS) Program Committee, involved a two-round judging process. In the first round, accepted abstracts were divided into topic groups for poster presentations. The 11 winners selected from each group advanced to the final round and presented their posters in a championship round on the final day of VAM in host venue McCormick Place’s Skyline Ballroom.

Jason Lee, MD, one of the competition moderators from Friday, emphasized the importance of the event with how “the poster competition has always been one of the favorite opportunities for people to quickly showcase their research projects. Being able to deliver a message in three minutes is a skill that we want researchers to learn, and providing immediate feedback through a quick question-and-answer session makes it very educational.” Lee will head the VAM Program Committee as chair for VAM 2025 in New Orleans.

The competition on Saturday was moderated by Edith Tzeng, MD, professor of vascular surgery from the University of Pittsburgh Medical Center; Matthew Eagleton, MD, the current SVS president and chief of the Division of Vascular and Endovascular Surgery at Massachusetts General Hospital-Harvard Medical School; Joseph Mills, MD, the immediate past-president of the SVS; and Michael Stoner, MD, professor in the Department of Surgery at the University of Rochester Medical Center.

Lee outlined the competition’s benefits for both presenters and attendees. The combined 180 minutes of presentations allowed attendees to view numerous research projects from future leaders in the field, he said. Lee pointed out that top posters often become highly competitive abstracts for publication.

“For many of the people who have won the poster competition, that was often the first paper they had published, and it’s exciting. It’s often been the younger part of our attendees and trainees, and that allows them to have that experience of seeing a project all the way from inception to presentation to publication,” Lee added. Third and second places were awarded to Chloé Powell, MD, a vascular surgery resident at Michigan Medicine in Ann Arbor, and Arash Fereydooni, MD, a vascular surgery resident at Stanford Health Care in Stanford, California, respectively. Powell was recognized for her work titled “Duplex screening for renal artery stenosis plus selective second trimester angioplasty to reduce maternal morbidity and improve pregnancy outcomes among women with hypertensive disorders of pregnancy.” Fereydooni was recognized for his research, “A standardized, scalable and automated open-source CT [computed tomography] AAA [abdominal aortic aneurysm] diameter measurement tool using deep learning.”

“The SVS Poster Competition and championship highlights the innovative research being conducted in vascular surgery and provides a valuable learning experience for participants. Each topic’s best poster is seen up on the podium, allowing researchers to gain exposure and recognition for their hard work,” said Lee.

Endovascular CFA treatment associated with increased rate of long-term CFA-specific reintervention, study finds

By
Jocelyn Hudson
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Endovascular CFA treatment associated with increased rate of long-term CFA-specific reintervention, study finds
Nicholas Wells

A recent study suggests that endovascular treatment of the common femoral artery (CFA) is associated with an increased rate of long-term CFA-specific reintervention, regardless of indication. Nicholas Wells, a medical student at Yale School of Medicine in New Haven, USA, presented this and other key findings from a tertiary care centre analysis of open and endovascular treatment of the CFA at the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA).

“The CFA is a common site of disease in patients with peripheral arterial disease,” Wells began. He noted that endarterectomy is seen as the gold standard of treatment, with primary patency rates “often surpassing 95% at five years” and evidence of “excellent long-term durability as far out as eight years.”

The objective of the study, Wells shared, was to compare open and endovascular treatment of the CFA with a focus on reinterventions and major adverse limb events.

This was a retrospective study of all revascularisations involving the CFA, including repeated reinterventions, conducted at a single centre between 2013 and 2020. “These procedures were performed by various specialists, including vascular surgeons, interventional radiologists and interventional cardiologists,” Wells detailed, adding that the researchers used standard comparative statistics and stratified their analysis by indication—claudication versus chronic limb-threatening ischemia (CLTI).

The researchers found that, from their database of 1,954 patients, 23% were treated for the CFA at least once and 15% of all individual revascularisations involved the CFA.

“Patients with claudication were more likely to be treated initially with endovascular therapy, at 57%, and those with CLTI were more likely to be treated with open surgery, at 60%,” Wells added.

The presenter reported that approximately one-third of the open surgery group underwent extended CFA endarterectomy involving the external iliac arteries, superficial femoral artery, and profunda femoral arteries, and about one-third underwent a concomitant ipsilateral bypass.

He also noted that approximately half of the patients in the endovascular group underwent concomitant endovascular revascularisation of the distal femoropopliteal region.

In the perioperative period, Wells shared that open surgery was associated with an increased rate of bleeding and wound infection, while endovascular therapy was associated with shorter mean length of hospital stay. Perioperative major amputation and mortality were below 1% in both groups.

“For claudication, endovascular therapy led to an increased rate of CFA-specific reintervention in the long term—35% compared to just 21% of those initially treated with open surgery,” Wells revealed.

“Additionally,” he continued, “15% of those who initially received endovascular treatment required eventual conversion to endarterectomy of the CFA, while only 5% of those who were initially treated with open surgery required a redo open CFA with endarterectomy.”

The researchers observed similar outcomes in the CLTI group, where 33% of initial endovascular recipients required eventual CFA reintervention compared to 21% of those initially treated with open surgery. Conversion to endarterectomy was not found to be significant in this subgroup.

“The take-home message here was that endovascular therapy led to higher rates of CFA reintervention in the long term and that for claudicants, conversion to endarterectomy was more common following endovascular therapy than redo endarterectomy,” the presenter told VAM attendees.

After a median follow-up time of three to four years, major amputation, major adverse limb events and mortality were not found to be different.

Furthermore, major adverse limb events-free survival—which was defined as time to either reintervention to any artery, major amputation or death—was not found to be significantly different between treatment approaches in either subgroup.

Senior author Cassius Iyad Ochoa Chaar, associate professor at Yale School of Medicine, told Vascular News that the anatomy of the CFA is “very peculiar,” and that the extent of the disease treated was not accounted for in this analysis. “Our future work will focus on studying the anatomy of the atherosclerosis affecting the CFA to better understand which lesions are best treated with which strategy of revascularisation,” he commented.

New data on TAMBE outcomes in complex aortic aneurysms revealed

By
Will Date
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New data on TAMBE outcomes in complex aortic aneurysms revealed
Mark A. Farber
Mark A. Farber

The US Food and Drug Administration (FDA)-approved Gore Excluder Thoracoabdominal Branch Endoprosthesis (TAMBE) has been shown to be safe and effective at 30 days for the treatment of patients with complex aortic aneurysms involving the visceral aorta.

This is according to findings of the TAMBE trial, a prospective non-randomised multicentre study investigating the use of the TAMBE device in thoracoabdominal and pararenal aortic patients, enrolled in the USA and Europe. Findings of the trial were presentedat the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA) by Mark A Farber of the University of North Carolina in Chapel Hill, USA.

TAMBE is an implantable branched device designed for use in patients with thoracoabdominal aortic aneurysms (TAAA) and high-surgical risk patients with pararenal aortic aneurysms (PRAAs) of the aorta using an endovascular approach.

The device has four built-in pre-cannulated internal portals to facilitate placement of bridging stent grafts into the visceral arteries perfusing the internal organs within the abdomen. The US FDA granted approval for TAMBE to be used in the treatment of complex aneurysmal disease in January 2024, a move that was heralded by the device’s manufacturer Gore as paving the way for the first off-the-shelf solution in the USA.

Farber presented the first of two arms of the TAMBE trial, which targeted type IV TAAAs and PRAAs, including 102 patients in total. A secondary arm focused on Crawford type I-III aneurysms is continuing enrollment, having recruited 23 patients so far.

Patients enrolled in the primary arm of the trial had an average age of 73, were predominantly male (84%), and presented with significant cardiovascular risk factors including current smoking (42%) and hypertension (92%). Around 40% of patients were treated for PRAA, with around 60% treated for type IV TAAA, with 83% of the TAAA cohort and 72% of the pararenal group had an aneurysm diameter of >5.5cm.

Technical success of the procedure was achieved in all but one patient, Farber detailed, adding that there were no access failures, and 407 of the 408 target vessels were successfully stented. Non-TAMBE components were required to be placed in 19 patients.

Following their procedures, patients had a mean length of hospital stay of 4.9 days, with 89.2% of patients discharged to home. No lesion-related mortality or severe bowel ischemia were reported through 30 days.

Reinterventions were required in 9.4% of patients at 30 days, with one device-related death reported on post-operative day 39, which Farber commented was likely related to superior mesenteric artery (SMA) stent occlusion. Major adverse events occurred in 6.9% of patients, including two with respiratory failure, one disabling stroke, and two patients having developed new onset renal failure requiring dialysis. Two patients developed paraplegia.

The success of the trial was measured against two composite primary endpoints, one including technical success and procedural safety, and the second reinterventions and lesion-related mortality.

“Overall 92% of the subjects were free from procedural safety events, however, the uncomplicated technical safety performance goal, 80%, was not met in the study because of the number of unplanned non-TAMBE devices implanted,” Farber detailed.

Patient selection is likely to have had a significant impact on outcomes, and device applicability may not reflect real-world experience, Farber said, outlining some potential limitations of the study.

“The TAMBE device has been shown to be safe and effective at 30 days at treating patients with complex aneurysms involving the visceral aorta,” said Farber.  “Outcomes demonstrate a high technical success rate, no 30-day mortality, and a low rate of safety events within 30 days of the index procedure.”

However, he cautioned that the procedure is “not without risk”, citing the occurrence of paraplegia, renal failure, and a need for adjuvant stenting to resolve complications both intraoperatively and in follow-up.

“Long term data will help determine where this treatment strategy will fit in the management of patients with TAAA and PRAA,” he said.

Patient selection may explain ‘counterintuitive’ relationship between carotid stenting volume and outcomes in new study

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Patient selection may explain ‘counterintuitive’ relationship between carotid stenting volume and outcomes in new study
Rahul Ghosh presenting at VAM

High stroke and death rates relating to carotid stenting in the Pacific Northwest may be driven by the selection of high-risk patients with less than 80% stenosis, and reducing the frequency of stenting in this high-risk group—along with better adherence to guideline-recommended medical management—could improve regional outcomes.

This was among the key concluding messages delivered by Rahul Ghosh (Texas A&M University, Houston, USA) during one of the 2024 Vascular Annual Meeting (VAM; June 19–22, Chicago, USA) Vascular and Endovascular Surgery Society (VESS) Scientific Sessions as he presented findings from a retrospective review of asymptomatic carotid stenosis patients in the Pacific Northwest region undergoing transcarotid artery revascularisation (TCAR) and transfemoral carotid artery stenting (TF-CAS), within the Vascular Quality Initiative (VQI), from 2016 to 2022. The research was conducted at the University of Washington in Seattle, USA, and led by senior author Sara L Zettervall.

“Education and awareness are critical for improving care,” said Ghosh, a final-year MD/PhD student at Texas A&M University, speaking to Vascular News in light of these findings. “By leveraging registry data to analyze real-world outcomes, surgeons can gain a clearer understanding of how practice patterns affect quality, enabling more informed decisions about when to intervene in asymptomatic patients—particularly those with significant comorbidities.”

Ghosh reported that 1,154 asymptomatic patients across 27 centres underwent carotid stenting in the Pacific Northwest from 2016 to 2022, of which 77% received TCAR and 23% received TF-CAS. The overall stroke/death rates were roughly 3% for both TCAR and TF-CAS, with centre-specific rates ranging from 0–6% for TCAR and 0–17% for TF-CAS. Researchers also found that centres with higher stroke/death rates generally treated fewer patients with >80% stenosis, as well as more patients with high-risk anatomy or physiology.

Following Ghosh’s presentation, Jordan R Stern, associate professor of surgery at Weill Cornell Medical College in New York, USA, commented that another of the study’s findings—that being the fact that all centres with stroke/death rates above 3% ranked among the top half of centres for TCAR and TF-CAS volumes in asymptomatic patients—suggests something of a “counterintuitive relationship” between case volume and stroke risk.

“We know from a myriad of literature […] that higher volume generally leads to better outcomes; what’s your explanation for that?” Stern asked the presenter.

Ghosh conceded that, with this having been an observational study, it is difficult to draw conclusions on any causal relationship, or whether volumes “play into” the high stroke/death rate.

“Of course, patient selection is a big thing,” he added. “The centres with the high stroke and death rates—you could also say they are getting the sicker patients so, maybe, their outcomes are worse [because of that]. Regardless, the association is there, and the important thing is to get the information out there and consider looking more carefully at this high-risk population, and whether an intervention provides a good risk-benefit for them or not.”

TCAR and endarterectomy both ‘reasonable’ but stenting linked to worse outcomes in kidney disease patients

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TCAR and endarterectomy both ‘reasonable’ but stenting linked to worse outcomes in kidney disease patients
Elisa Caron presenting at VAM
Elisa Caron

A study examining outcomes between different carotid revascularisation procedures has concluded that transcarotid artery revascularisation (TCAR) and carotid endarterectomy (CEA) both represent a “reasonable choice” in severe chronic kidney disease (CKD) and haemodialysis patients—but transfemoral carotid artery stenting (TF-CAS) appears more likely to result in worse outcomes.

“And, additionally, the majority of these patients are surviving long enough to benefit from the stroke risk reduction provided by surgery,” said Elisa Caron, research fellow in vascular surgery at Beth Israel Deaconess Medical Center in Boston, USA. At the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA), Caron reported an analysis of Vascular Quality Initiative (VQI) patients with estimated glomerular filtration rate (eGFR) <30ml/min/1.73m2, or on haemodialysis, undergoing TCAR, CEA or TF-CAS between 2016 and 2023.

Presenting on behalf of her co-authors, including senior author Marc L Schermerhorn, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center, Caron relayed data from 13,042 VQI patients with eGFR <30, 2,355 of whom were on haemodialysis.

The majority of outcomes—across both symptomatic and asymptomatic patients—were found to be “fairly similar” between TCAR and CEA, including stroke/death, with both procedures falling within SVS guidelines regarding perioperative stroke and death. However, CEA was linked with a trend towards slightly higher odds of stroke/death/myocardial infarction (MI), as per the analysis’ primary outcome, in addition to higher odds of MI when considered independently. Similar trends continued when the researchers looked specifically at the subgroup of haemodialysis-only patients, according to Caron.

Turning to findings on overall long-term survival, the presenter relayed that TCAR and CEA were once again similar, as survival rates were nearly 80% with both procedures across all asymptomatic patients and only dropped slightly to around 70% in the haemodialysis-only group at five years. She also noted that these trends endured among symptomatic patients, with rates dropping to around 70% across the full eGFR <30 and haemodialysis cohort.

In addition, regarding those who underwent TF-CAS, Caron reported that—prior to statistical weighting—these patients were more likely to be symptomatic, to present with stroke, and to undergo surgery in urgent/emergent settings, compared to TCAR and CEA patients. They also had more baseline comorbidities. But, “even after weighting for symptom status and comorbidities, TF-CAS still underperformed and did not meet SVS guidelines” she continued, with stroke, death and overall long-term survival being among the areas where TF-CAS produced inferior outcomes versus TCAR and CEA, across both asymptomatic and symptomatic patients.

Following Caron’s presentation, session moderator Chelsea Dorsey, MD, associate professor of surgery at UChicago Medicine in Illinois, commented that “these patients are incredibly fragile” and, as such, “the more granular information we have about how to approach them, the better”. Dorsey went on to ask the presenter how she feels these new data may impact people’s clinical practices moving forward.

“I think that patient selection will always play a big role,” Caron responded. “The VQI certainly gives us very granular data but, at the end of the day, it’s not the same as the patient sitting in front of you, and I think that will still have a big impact. That said, I think it’s at least reasonable to consider surgery in these patients—I know some people are hesitant to do so, so this at least provides evidence to support the decision of whether to intervene. But, again, patient selection is still going to be crucial.”

Linda Harris elected SVS vice president

By
Marlén Gomez
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0
Linda Harris elected SVS vice president
Linda Harris

The Society for Vascular Surgery (SVS) has announced Linda Harris, MD, as its next vice president, meaning that she enters the presidential line and will become SVS leader in 2026.

The announcement was made during the SVS Annual Business Meeting, held on June 22 in Chicago as part of the 2024 Vascular Annual Meeting (VAM 2024).

The vice-presidential election process took place online, beginning in early June, and garnered some 867 SVS members who cast a ballot during the voting period.

Harris, a professor of surgery and the program director for the vascular surgery fellowship and residency programs at the University at Buffalo in Buffalo, New York, began her tenure as SVS vice president immediately following the announcement, and will serve in the role through to VAM 2025 in New Orleans, where she will become president-elect.

“I’m honored to have been elected as vice president with the chance to eventually become president of this amazing Society,” said Harris, a former president of the Eastern Vascular Society (EVS), after she was unveiled as the new vice president. “We have so much that we can really do if we work together; the threats that we face are primarily outside threats, and that’s why we need to come together.

“If we are fractured, we won’t succeed. We have so many bright minds and capable people. I want to engage everyone who would like to be involved. Anyone who has ideas, please feel free to reach out. We want to hear what you have to say because you’re part of us and we all have to work together.”

Young vascular surgeons on the PAD frontier: ‘This is the time to seize the day,’ 2024 Veith Lecturer declares

By
Bryan Kay
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0
Young vascular surgeons on the PAD frontier: ‘This is the time to seize the day,’ 2024 Veith Lecturer declares
Michael Conte

Huge opportunities abound for vascular surgeons to take a leadership role on the frontlines of a developing peripheral arterial disease (PAD) treatment crisis in the U.S., said Michael Conte, MD, as he gave the second annual Frank J. Veith Distinguished Lecture on the closing day of the 2024 Vascular Annual Meeting.

Conte spoke on “The State of PAD Care in the U.S.,” taking the opportunity to call on vascular surgeons to take a leadership role amid great unmet need among a population who face a significant public problem.

“There are a lot of exciting developments, and vascular surgery really needs to seize the day to lead in the science, lead in the challenges; it’s core to what we do, it’s core to our patient population,” the professor and chief of vascular and endovascular surgery at the University of California San Francisco (UCSF) explained, speaking to VS@VAM on the sidelines of VAM 2024 ahead of the lecture.

“I think it’s a really great time for vascular surgeons to get involved, whether that’s in the clinical research, the disparities and access to care issues, amputation prevention programs, or multidisciplinary care.

“There’s a lot there for young vascular surgeons to embrace,” Conte continued. “The service part as well as the research part are significant. So, if you look at what’s happening at the SVS with the VISTA [Vascular Volunteers In Service To All] program, all the way through to promoting clinical trials in PAD, this is the time—it’s a generational thing.”

With carotid disease now “pretty stable,” and the strides made in aortic disease treatment meaning “we’ve solved a lot of stuff ” in that domain, he said, many roads now lead to PAD, which he described as a “huge thing that needs a lot of help.”

First comes the opportunity, Conte declared, then the nature of the growing, countrywide public health problem— advancing age, diabetes not abating.

“We need to embrace and promote science-guided, evidence-based practice,” he said. “To do that, we have to continue to try to follow through on designing and executing clinical trials using our registries to address important issues of quality of care, and continue to write and update meaningful practice guidelines. It’s a multispecialty space and we should embrace that, not shy away from it. We should just lead.”

‘Implementation of EPAs marks a paradigm shift in how we prepare vascular surgeons’

By
Marlén Gomez
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0
‘Implementation of EPAs marks a paradigm shift in how we prepare vascular surgeons’
Brigitte Smith
Brigitte Smith

As the landscape of surgical education undergoes rapid evolution, one innovation promises to redefine how future vascular surgeons are trained and certified: Entrustable Professional Activities (EPAs). A group of experts shed light yesterday on their potential to transform surgical training during an afternoon education session.

Described as “the most disruptive innovation in assessment in more than a decade,” Brigitte Smith, MD, from the University of Utah Health, emphasized the pivotal role EPAs have in reshaping competency evaluation. Unlike traditional time-based training, EPAs focus on abilities essential for unsupervised practice, ensuring graduates deliver safe, high-quality patient care across diverse settings.

“The implementation of EPAs marks a paradigm shift in how we prepare vascular surgeons,” said Smith. “These activities not only assess competence but also define the core of our specialty, setting clear benchmarks for performance.”

EPAs delineate specific tasks that trainees must demonstrate proficiency in before being entrusted with independent practice. The American Board of Surgery (ABS) clarifies that EPAs are not the same as competencies. Instead, they complement competencies by providing a practical way to apply the broad concept of competency in daily practice. This approach, already integrated into general surgery, now positions vascular surgery as the next frontier for this competency-based model.

Smith’s presentation outlined the developmental journey of vascular surgery EPAs and provided insights into their implementation process. With the ABS paving the way in general surgery, the adoption of EPAs in vascular surgery signifies a proactive step toward aligning training with contemporary healthcare demands, Smith said.

“EPAs are not just a new assessment tool; they represent a fundamental evolution in how we prepare the next generation of vascular surgeons,” she added.

SOOVC outlines strides made to provide platform for surgeons conducting research in the OBL

By
Marlén Gomez
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0
SOOVC outlines strides made to provide platform for surgeons conducting research in the OBL
Anil Hingorani
Anil Hingorani

The SVS sub-section on Outpatient and Office Vascular Care (SOOVC) Chair Anil Hingorani, MD, used the group’s dedicated VAM 2024 session to focus on the office-based lab (OBL).

“One of the main things we’ve worked on for the last couple of years is research in the OBL space,” he told those in attendance. “We’ve found that few resources are often available for the OBL. We want to give a platform for people already producing work in the OBL space. Maybe you have a database of your lower extremity angioplasties … venous or access cases. Whatever you’re doing, we didn’t find a place where we could present this work.”

Hingorani revealed the availability of the OBL Handbook, with 18 chapters completed last year and four new chapters added since. The handbook is available for purchase at VAM 2024’s SVS Central outside the Exhibit Hall.

The first three presentations were SOOVC Research Seed Grant projects.

Chong Li, MD, a grant recipient from New York University Langone Medical Center, offered insights from a multicenter perspective study on heparin dosing and safety outcomes during outpatient peripheral vascular interventions.

“Our study aims to investigate the safety and efficacy of low-dose heparin (40 units/ kg) versus high-dose heparin (70 units/ kg) in femoral-based angiograms or venograms,” Li explained. “The objective is to demonstrate the safety of a consistent antithrombotic practice with low heparin dosing compared to high dosing during peripheral endovascular interventions in an outpatient setting.”

The study’s first stage involved a retrospective review of data collected by the Vascular Care Group, encompassing seven practices across three states and involving 21 vascular surgeons from 2022–23. Expected to cover 200–300 cases, the study will assess primary endpoints, including ischemic and bleeding complications, and secondary endpoints, including procedural duration and recovery time.

“The evidence for heparin dosages is largely from the coronary literature, much of which is dated from inpatient settings or European countries. This study aims to improve procedural safety outcomes by reducing bleeding and ischemic complications while maintaining safety and efficacy,” said Li.

Margaret Tracci, MD, a professor of surgery at UVA at Charlottesville, Virginia, concluded the session by discussing malpractice protection in OBLs.

Unlike hospitals and ambulatory surgery centers (ASCs), OBLs have notable differences in payment structures and regulatory requirements, she said. These labs have fewer resources, and do not have anesthesia services, operating rooms (ORs), blood banks or intensive care units (ICUs). The equipment and supplies available in OBLs are also more limited compared to more extensive medical facilities.

“Safety and patient selection are fundamental in the OBL setting,” Tracci said. “Key principles include understanding the resources and capabilities of the facility, careful case selection and having a robust plan for potential complications.”

She highlighted several key strategies to avoid complications in the OBL setting, and the cornerstone of which is patient selection. She noted that carefully considering patient characteristics and case or lesion specifics is crucial. She also discussed minimizing risk using minor, safe access points, and employing preventive measures such as embolic protection and intravascular ultrasound (IVUS).

Tracci advised having robust protocols for resuscitation, airway management, vascular salvage and patient transfer. Key equipment, such as thrombectomy catheters and medications, should always be accessible, she said. Establishing hospital privileges and transfer agreements is essential to facilitate smooth and efficient patient transfers when needed, Tracci added.

“Nobody is always both lucky and good, so you will have complications. So how do you avoid both the bad outcomes and the lawsuit? Catch your complications. Check the feet before the patient goes home. Maybe do that really good discharge instruction, telling them what to call for if something’s not quite right at home. Do the phone call,” she said.

Leaders in their field: SVS bestows two awards for lifetime achievement

By
Marlén Gomez
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0
Leaders in their field: SVS bestows two awards for lifetime achievement
Peter Glovicski
Peter Glovicski

A standing ovation, flashing lights and a praiseworthy introduction greeted the recipients of the SVS Lifetime Achievement Award yesterday morning: Peter Gloviczki, MD, and Robert M. Zwolak, MD, took turns to soak in the highest honor a member can receive from the organization.

Greeting them both individually, SVS President Joseph Mills, MD, introduced the two as great leaders of vascular surgery and described the significance of their accomplishments.

“Since its inception in 1998, the SVS Lifetime Achievement Award has celebrated the pinnacle of achievement in our field,” said Mills. “Today, we honor two luminaries who have profoundly advanced vascular surgery and inspired countless colleagues and trainees with their dedication, innovation and leadership.”

Gloviczki has dedicated his career to advancing vascular surgery through clinical practice and academic contributions. His lifetime achievements encompass clinical, scholarly and educational accomplishments, as well as research that has significantly impacted the field. In his acceptance speech, he reflected on his modest beginnings as an immigrant who aspired to be a surgery professor. He expressed his gratitude to everyone who has supported him along his “unique journey,” from a small town in Northeast Hungary near the Ukrainian border to Rochester, Minnesota, at the Mayo Clinic.

“I have been extremely fortunate to have a great family, my father, uncle and brother—they were all physicians. Somewhere in heaven, my parents are smiling down at me right now,” he said, thanking his parents for being his role models growing up and showering him with love and support. He also thanked his professors, colleagues and wife.

Gloviczki has overseen critical advancements in knowledge and practice as the editor-in-chief of the Journal of Vascular Surgery. He has previously served as SVS president and in various executive positions within the Society. Recently, he completed the 5th edition of the Handbook of Venous and Lymphatic Disorders, a landmark resource.

“I would like to dedicate this award to my residents and fellows, as you are the current and future leaders of this distinguished society; you help and inspire me daily to provide the best care to our patients. I am so proud to have shared this with each and every one of you,” said Gloviczki.

Robert Zwolak

Zwolak used his time at the podium to praise the SVS community and call on members to engage now more than ever. He addressed his medical students, residents and fellows in the room, thanking them for choosing vascular surgery as their specialty. “If I could dial the clock back 40 years, would I choose anything different?” he asked the crowd. “Absolutely not.”

Zwolak detailed the numerous complex procedures that vascular surgeons perform daily and highlighted widespread innovation in the field. He emphasized that, with tools like the Vascular Quality Initiative (VQI), “we meticulously follow up, identify evidence-based practices and establish guidelines for these devices.”

Zwolak is renowned for his dedication to advocating for fair payment for vascular care. His research efforts have led to significant advancements in understanding vascular diseases and treatment methodologies. As a principal investigator on numerous studies, Zwolak has authored influential publications and books that have guided practice and policy in vascular surgery. His work with the Centers for Medicare and Medicaid Services (CMS) and various professional societies has led to crucial changes benefiting patients and healthcare providers. Zwolak’s extensive involvement with the SVS includes numerous leadership positions, including a tenure as SVS president.

“Vascular surgery has been the most gratifying career, and I suspect it will be for you as well,” said Zwolak.

Zwolak reminded the crowd how effective political advocacy can be in support of the vascular community in Washington, D.C., referencing the creation of a federal mandate for abdominal aortic aneurysm (AAA) screening and Medicare beneficiaries.

Women’s Section to place a lens over vascular trauma

By
Kristin Spencer
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0
Women’s Section to place a lens over vascular trauma
Erica Leith Mitchell
Erica Leith Mitchell

The SVS Women’s Section will host their VAM 2024 session, “Vascular Trauma: What I Need to Know in the Middle of the Night” at 3:30–5 p.m. on Friday (West Building, Level 1, W184a). The session will feature talks about different vascular trauma types and their guiding principles.

“Vascular trauma is universal and can result in loss of limb or life if not addressed or treated appropriately. When a patient presents with vascular trauma, there are guiding principles for the work up and management of the injury,” said Erica Leith Mitchell, MD, professor and chief of vascular and endovascular surgery at the University of Tennessee Health Science Center in Memphis, Tennessee, one of the session moderators.

Mitchell emphasizes that numerous vascular surgery training programs are not connected to trauma centers, resulting in trainees lacking experience in managing vascular trauma, and how practicing vascular surgeons might not feel assured or skilled in treating these patients. This session aims to provide practical advice for handling vascular trauma and a platform for discussing difficult cases.

Zenith iliac branch graft ‘durable and highly effective’ in PRESERVE II study

By
Jocelyn Hudson
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0
Zenith iliac branch graft ‘durable and highly effective’ in PRESERVE II study

Five-year outcomes from the PRESERVE II study support the safety and effectiveness of the investigational Zenith iliac branch graft (ZBIS, Cook Medical) in combination with the iCast covered stent (Getinge) to preserve internal iliac artery perfusion during endovascular aneurysm repair (EVAR).

W. Anthony Lee, MD, is set to share this key conclusion during Plenary Session 8 (Saturday June 22, 11:15 a.m.–12:30 p.m., West Building, Level 3, Skyline Ballroom).

The PRESERVE II study evaluated the safety and effectiveness of the ZBIS graft with the iCast stent to maintain perfusion of the internal iliac artery during EVAR in patients with insufficient distal landing zone within the common iliac artery. This study was initiated after device integrity issues were observed using an investigational bridging stent in the PRESERVE I study.

This study was a prospective, multicenter, nonrandomized investigation conducted across 18 U.S. sites. Patients were enrolled between 2014 and 2015, with follow-up conducted out to five years.

Forty patients, the majority of whom (38) were male and with a mean age of 67.8 years, were treated. The study’s primary endpoint of sixmonth freedom from patency-related intervention was 100%, 30-day freedom from morbidity was 85%, and six-month branch vessel patency was 100%.

Lee, who is chief of vascular surgery at Boca Raton Regional Hospital in Boca Raton, Florida, will note at VAM 2024 that five-year follow-up was available in 75% of patients with complete imaging in 65%. He will present the findings that freedom from all-cause mortality at five years was 88.9%, there was no aneurysm-related mortality, and five-year freedom from patency-related intervention was 100%.

In addition, Lee will report that a total of nine patients required 15 secondary interventions, with six ipsilateral to the ZBIS, and that the treated iliac aneurysm size was decreased in 27% of patients and unchanged in 73%. There were no ruptures, type III endoleaks, migrations, or device integrity issues.

Early vascular evaluation can ‘significantly supplement’ wound healing and limit resource waste

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Saranya Sundaram presenting at VAM

“Our findings ultimately suggest that vascular evaluation within six weeks of wound appearance can significantly supplement wound healing in wound centers,” said Saranya Sundaram, MD, vascular surgery resident (PGY-3) at the Medical University of South Carolina in Charleston, presenting data from an 80-limb retrospective analysis during Thursday morning’s Plenary Session 3.

Sundaram went on to relay that—based on the study findings—vascular-provider encounters within six weeks of wound appearance may be associated with accelerated time to wound healing; shorter time to wound-healing checkpoints; shorter time to operative intervention; and reduced overall use of wound-clinic resources.

Detailing the backdrop for the present study, the speaker told VAM 2024 that, while some prior data from academic hospital-associated wound care centers have suggested improvements in wound-healing outcomes when wound management is driven by vascular providers, it “remains unclear” whether or not this benefit is derived solely from early vascular provider involvement.

“We studied if simply limiting the time to vascular provider evaluation could benefit wound healing in patients with arterial insufficiency,” Sundaram reported, noting that, in this instance, vascular providers were either board-certified vascular surgeons or advanced practice providers with at least five years of vascular experience.

“We also looked at other measures of resource expenditure to determine if additional benefits could be derived in this potential public health target.”

The presenter stated that she and her colleagues examined patients seen at their institution’s wound center from its initial opening in 2022 through its first year (July 2022–July 2023).

In addition, a sensitivity analysis deemed six weeks to be an “appropriate exposure cutoff ” after wound appearance. Sundaram and colleagues ultimately identified 45 limbs evaluated within six weeks (early-exposure group) and 35 limbs that were not (late/ no-exposure group).

Similar socioeconomic, medication use and comorbidity profiles were observed across both groups—and more patients were appropriately managed on aspirin, statins and insulin after establishing care with a wound center.

“While only 80.6% of late-exposure patients were evaluated by a vascular provider, care was more often supplemented by other surgical subspecialties, such as plastic surgery or orthopedic surgery,” Sundaram said, moving onto the study’s results. “Interestingly, only 51.4% of late-exposure patients had ABI [ankle-brachial index] testing available at initial evaluation.”

She went on to detail that more “classical” arterial-wound distribution was observed among the early-exposure patients, versus a more mixed pattern within the late/no-exposure group, although this difference did not reach statistical significance.

Early-exposure wounds, Sundaram continued, grew to be roughly double the maximum size of their later counterparts (27.1cm2 vs. 11.8cm2), despite wound sizes being similar upon initial evaluation (14.3cm2 vs. 10cm2). Baseline wound and ischemia scores also appeared to be significantly higher in the early-exposure group, although infection scores were comparable, as per initial SVS Wound, Ischemia and foot Infection (WIfI) scores.

In addition, baseline non-invasive testing outcomes were similar between groups, as was the rate of patients who ultimately underwent operative intervention during their wound course.

“Kaplan-Meier analysis suggested faster wound healing may be seen in the early-exposure group—however, this difference did not attain statistical significance,” the speaker said.

“Though, when we accounted for possible confounding factors on Cox regression analysis, we did find that earlier vascular exposure was associated with a nearly 2.5-times faster healing rate. And, on a more granular level, established checkpoints associated with wound closure—such as maximum wound size, a size reduction of greater than 15% in one week, presence of greater than 75% granulation tissue within the wound, and evidence of epithelialization—were all achieved at a much faster pace in the early-exposure group.

“In terms of resource expenditure, earlier vascular exposure limited the average number of wound-center visits and procedures— without transposing the burden to surgical-provider visits; though, these patients were more likely to undergo at least one additional operative intervention than their [late-exposure] counterparts. If intervention was indicated, early-exposure patients underwent these procedures within a much shorter timeframe, among either revascularization or debridement [procedures].”

Vascular Specialist@VAM Conference Edition 3

By
Bryan Kay
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0
Vascular Specialist@VAM Conference Edition 3

In this issue:

  • Chickasaw Nation study exemplifies how diversity can boost patient access to specialized vascular care
  • Young vascular surgeons on the PAD frontier: ‘This is the time to seize the day,’ 2024 Veith Lecturer declares
  • New data on TAMBE outcomes in complex aortic aneurysms
  • Biologic graft proves ‘resilient’ and safe in bypass treatment for CLTI

 

New comparative study shows no differences between HeRO and fAVG

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New comparative study shows no differences between HeRO and fAVG
Theodore H. Yuo

A new contemporary comparative study will be presented during Friday’s Plenary Session 5 (8–9:30 a.m., West Building, Level 3, Skyline Ballroom) by author Theodore H. Yuo, MD, assistant professor at the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania. It will explore the creation of upper extremity arteriovenous (AV) access ipsilateral to central venous lesions, the options that are available in these cases, and how femoral AV grafts (fAVG) and the Hemodialysis Reliable Outflow (HeRO) device are both “valid” options for use in these cases, despite historically poorer outcomes.

Discussing their single-center, retrospective analysis of consecutive use of fAVG and HeRO, Yuo details that their evaluation concerned index AV accesses placed between 2014 and 2023. Cases were identified using the local Vascular Quality Initiative (VQI) database and supplemented by a review of surgeon case logs. Medical history, demographics and operative details were obtained utilizing a combination of VQI data and electronic medical records. Data were analyzed using standard statistical tests, Kaplan-Meier survival estimates, and multivariate Cox proportional hazards (PH) and logistic regressions.

To conduct the study, data for 99 patients were collected (57 HeRO, 42 fAVG), with a median follow-up of 464 days. Between the groups, there were no differences in female sex at birth and being non-White. Yuo et al found that the patients who received the HeRO were older, had higher body mass index (BMI), had fewer previous AV accesses, and were more likely to be diabetic. They also found that the ability to use the AV access for hemodialysis was similar in both groups, and mortality at 30 days occurred more frequently in the fAVG group. They stated that multivariate logistic regression also suggested that fAVG was associated with increased 30-day mortality.

When following up with the study participants one year after undergoing successful hemodialysis, primary, primary-assisted, and secondary patency rates were higher in the fAVG group. Multivariate PH analysis of the study results suggested that primary and primary assisted patency were similar in both groups, while fAVG was associated with improved secondary patency. Finally, the study also showed that graft removal due to infection occurred more frequently in the fAVG group.

The researchers concluded that, in this contemporary series comparing fAVG and HeRO, there were no differences in primary and primary-assisted patency. They did, however, find that there was improved secondary patency among the fAVG patients, as well as the fact that fAVG were associated with higher rates of perioperative mortality and graft infection.

Speaking to VS@VAM about the study, Yuo said: “The HeRO graft and femoral AVG are both reasonable options for ESKD [end-stage kidney disease] patients who are not candidates for standard upper extremity AV access.” He added, “This study evaluating our contemporary experience at UPMC reinforces their relative equivalence, though femoral AVG may have longer secondary patency. HeRO grafts enable extended use of the upper extremity, avoiding use of the lower extremity and the accompanying risks of that anatomic location.”

‘We are in this together’: SVS president set to issue call for vascular surgery unity amid tensions of modern medicine

By
Bryan Kay
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0
‘We are in this together’: SVS president set to issue call for vascular surgery unity amid tensions of modern medicine
Joseph Mills

SVS President Joseph Mills, MD, is set to issue a rallying call steeped in classical history and decades of collected vascular surgery wisdom in order to bring the specialty together for a common purpose: to overcome “unrest” and to drive forward vascular care.

In a presidential address later today (Friday) at the 2024 Vascular Annual Meeting (VAM; June 19–22), Mills will tackle the consolidation of medicine into ever-larger for-profit enterprises, along with the stresses inherent within a body of people such as the SVS. In that way, he will tell his audience, it is no different than wider human society.

Mills’ 2023–24 presidency saw vascular disease enter the mainstream media spotlight in the context of the appropriateness—or inappropriateness—of vascular care. His address tackles the topic as he places the SVS and vascular surgery at the heart of efforts to ensure quality in vascular care.

Mills will invoke the democratic ideals of the ancient Greeks and how these principles drive collected interests in societies.

Mills is currently professor and chief of the Division of Vascular Surgery and Endovascular Therapy in the Michael E. DeBakey Department of Surgery at the Baylor College of Medicine in Houston.

He started his vascular surgery career further west in Texas at Wilford Hall USAF Medical Center in San Antonio. Later in his career, Mills helped lead efforts to establish a respected multidisciplinary limb salvage group known as SALSA, or the Southern Arizona Limb Salvage Alliance—a toe and flow model that paved a path for collaboration.

That same collaborative tone is at the heart of the message contained in his SVS address. “We are a small group, far too small to be splintered or fragmented,” he will say.

Mills says he is looking to drive the conversation forward. “There is currently much unrest among physicians today in medicine,” he tells Vascular Specialist ahead of the address. “What is the root cause of this unrest? How should the SVS address it? My SVS Presidential Address will draw from lessons and insights offered by previous SVS presidents, Greek and Roman philosophers, modern authors—and even rock musicians—to outline the issues and chart a path forward.”

The shift to outpatient care: ‘A good business plan is mandatory’

By
Jocelyn Hudson
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0
The shift to outpatient care: ‘A good business plan is mandatory’
Daniel McDevitt
outpatient
Daniel McDevitt

Daniel McDevitt, MD, spoke during the Community Practice Section at VAM 2024 on potential methods to participate in the shift to the office-based lab (OBL) and ambulatory surgical center (ASC). The president of Peachtree Vascular Specialists in Stockbridge, Georgia, shared his opinion that the OBL currently offers the highest reimbursement for the least investment and underscored the necessity of having a strong business plan ahead of making the move to any outpatient setting.

“We’re in challenging times right now,” McDevitt began, citing a continuing decrease in Centers for Medicare and Medicaid Services (CMS) reimbursement and limited time in the operating room and cath lab due to a “substantial reduction” in most hospitals’ workforce since COVID-19 as two of the main reasons behind this.

“The bottom line is, it’s much more difficult to make a living at the hospital,” McDevitt summarized.

In response to this, the presenter noted that many physicians have gone to employment. He went on to note, however, that positions are limited, and stressed that employed surgeons are often asked to do procedures that do not necessarily align with either their interests or their practice focus.

McDevitt went on to say that independent practice has always been “an escape pod for people [who] are tired of doing what other people have asked them to do” and offers more flexibility in terms of practice goals and lifestyles.

He noted that independent practice can be “financially challenging,” however, due to low reimbursement and escalating overhead costs.

McDevitt then moved on to the benefits and drawbacks of two alternatives: OBLs and ASCs.

With regard to OBLs, the presenter outlined three options: “the first is you can sublet table time or basically rent an OBL, you can purchase an existing OBL, or you can build your own.”

McDevitt noted that subletting an OBL offers an opportunity to “dip your toe in the water” and could provide “a reasonable return” for a relatively low investment.

Purchasing an existing OBL, “may be more realistic now” than it has been in the past due to the financial climate, McDevitt told the VAM audience. However, he stressed the importance of having a strong business plan to make it work.

“Don’t walk into these things without knowing what you’re doing, and always plan for a worse-case scenario,” he advised.

McDevitt then turned to the “most complex” option, which is starting an OBL from scratch.

“I will caution you, you do have to be financially able to withstand the start-up costs,” he said, adding that, “You should already be busy if you’re going to do this.”

In addition, McDevitt highlighted the fact that there would be state regulations to consider.

Moving on to ASCs, the presenter said that “usually the easiest way to go” would be to get staff privileges at an existing ASC.

“You won’t really derive any of the benefits of owning the facility,” he stressed, but emphasized that this option offers “more control over your time” and table access that might not be available at the hospital.

McDevitt said that buying an ASC is also an option but is one that represents “a pretty substantial financial risk” and warned again about having to “conquer” the regulatory side of things.

“Again,” he stressed, “a good business plan is mandatory.”

“In my opinion, the OBL is the highest reimbursement for the least investment right now,” McDevitt shared as his key conclusion. He continued: “Building your own OBL is doable, but buying an existing one may be more efficient for you.”

In terms of ASCs, McDevitt’s main take-home message was that these are “intriguing” for their higher reimbursement for some cases, but underscored the fact that they require a “substantial” investment and that the legal environment is “very challenging.”

Early vascular evaluation can ‘significantly supplement’ wound healing and limit resource waste

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Early vascular evaluation can ‘significantly supplement’ wound healing and limit resource waste
Saranya Sundaram presenting at VAM

“Our findings ultimately suggest that vascular evaluation within six weeks of wound appearance can significantly supplement wound healing in wound centers,” said Saranya Sundaram, MD, vascular surgery resident (PGY-3) at the Medical University of South Carolina in Charleston, presenting data from an 80-limb retrospective analysis during yesterday morning’s Plenary Session 3 at the 2024 Vascular Annual Meeting (VAM; June 19–22).

Sundaram went on to relay that—based on the study findings—vascular-provider encounters within six weeks of wound appearance may be associated with accelerated time to wound healing; shorter time to wound-healing checkpoints; shorter time to operative intervention; and reduced overall use of wound-clinic resources.

Detailing the backdrop for the present study, the speaker told VAM 2024 that, while some prior data from academic hospital-associated wound care centers have suggested improvements in wound-healing outcomes when wound management is driven by vascular providers, it “remains unclear” whether or not this benefit is derived solely from early vascular provider involvement.

“We studied if simply limiting the time to vascular provider evaluation could benefit wound healing in patients with arterial insufficiency,” Sundaram reported, noting that, in this instance, vascular providers were either board-certified vascular surgeons or advanced practice providers with at least five years of vascular experience. “We also looked at other measures of resource expenditure to determine if additional benefits could be derived in this potential public health target.”

The presenter stated that she and her colleagues examined patients seen at their institution’s wound center from its initial opening in 2022 through its first year (July 2022–July 2023). In addition, a sensitivity analysis deemed six weeks to be an “appropriate exposure cutoff” after wound appearance. Sundaram and colleagues ultimately identified 45 limbs evaluated within six weeks (early-exposure group) and 35 limbs that were not (late/no-exposure group). Similar socioeconomic, medication use and comorbidity profiles were observed across both groups—and more patients were appropriately managed on aspirin, statins and insulin after establishing care with a wound center.

“While only 80.6% of late-exposure patients were evaluated by a vascular provider, care was more often supplemented by other surgical subspecialties, such as plastic surgery or orthopedic,” Sundaram said, moving onto the study’s results. “Interestingly, only 51.4% of late-exposure patients had ABI [ankle-brachial index] testing available at initial evaluation.”

She went on to detail that more “classical” arterial-wound distribution was observed among the early-exposure patients, versus a more mixed pattern within the late/no-exposure group, although this difference did not reach statistical significance. Early-exposure wounds, Sundaram continued, grew to be roughly double the maximum size of their later counterparts (27.1cm2 vs. 11.8cm2), despite wound sizes being similar upon initial evaluation (14.3cm2 vs. 10cm2). Baseline wound and ischemia scores also appeared to be significantly higher in the early-exposure group, although infection scores were comparable, as per initial SVS Wound, Ischemia and foot Infection (WIfI) scores. In addition, baseline non-invasive testing outcomes were similar between groups, as was the rate of patients who ultimately underwent operative intervention during their wound course.

“Kaplan-Meier analysis suggested faster wound healing may be seen in the early-exposure group—however, this difference did not attain statistical significance,” the speaker said. “Though, when we accounted for possible confounding factors on Cox regression analysis, we did find that earlier vascular exposure was associated with a nearly 2.5-times faster healing rate. And, on a more granular level, established checkpoints associated with wound closure—such as maximum wound size, a size reduction of greater than 15% in one week, presence of greater than 75% granulation tissue within the wound, and evidence of epithelialization—were all achieved at a much faster pace in the early-exposure group.

“Another interesting finding was that more late-exposure patients had radiographic evidence of osteomyelitis; though, fewer wounds underwent operative debridement in addition to antibiotic therapy. Ultimately, seven of the early-exposure patients and four of the late-exposure patients did require major amputation. However, all early-exposure patients had documented discussion of non-salvageable limbs prior to the decision for amputation.

“In terms of resource expenditure, earlier vascular exposure limited the average number of wound-center visits and procedures—without transposing the burden to surgical-provider visits; though, these patients were more likely to undergo at least one additional operative intervention than their [late-exposure] counterparts. If intervention was indicated, early-exposure patients underwent these procedures within a much shorter timeframe, among either revascularization or debridement [procedures].”

Sundaram noted that its single-center nature and the hospital affiliation of the wound center in question are among the study’s limitations, and these factors may diminish its generalizability to community models.

“We believe that early specialty referral and evaluation for any patient that has a concern for arterial disease could represent a simple target among wound centers that both improves long-term outcomes and limits resource waste—ultimately, non-salvageable limbs,” the presenter concluded, also positing that early vascular referral from wound centers should therefore be “prioritized” across patients with any history or evidence of arterial insufficiency.

The Colombian Chapter strategy: ‘We’ve got to get the word out’

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Jocelyn Hudson
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0
The Colombian Chapter strategy: ‘We’ve got to get the word out’
Ana M. Botero at the VAM podium

The International Chapter Forum Educational Session at VAM 2024 saw Ana M. Botero, MD, chief of vascular surgery at Fundación Santa Fe de Bogotá in Bogotá, Colombia, speak on the evolution of the SVS Colombian Chapter.

“We’re people that do lots of work, but we’re not in the game yet,” Botero began, in a section of her talk outlining “the Colombian problem.” The presenter continued: “We don’t know how to value ourselves, so being here [at VAM] brings us a lot of connections and that’s something that I’m pretty grateful for.”

In addition to networking opportunities, the presenter underscored the importance of the SVS on the world stage, highlighting its synonymity with education, publications, journals, conferences, online courses, research and support.

The focus of Botero’s talk then moved from problem to opportunity. “There [are] many surgeons that paved the way,” she said. “Seeing somebody that looks like you, talks like you, and is an amazing surgeon outside of Colombia is very important.”

Botero noted that the Chilean Chapter played a significant role in laying the foundations for the Colombian Chapter. She recalled thinking: “Chileans got into the SVS as the Chilean Chapter, so the idea came right away—why not Colombia?”

Botero shared that, around six years ago, “people started sending emails, asking questions” about how to get people from Colombia into the SVS, which she noted resulted in a “very beautiful” collaboration with the society.

In terms of what to expect from this sort of collaboration, Botero urged members “don’t be shy” and to ask questions.

“SVS is a huge platform, so take it. And for LATAM [Latin America], everything is possible, so let’s do it, let’s take this,” she continued.

In the discussion following Botero’s presentation, one audience member asked how to approach the challenge of ensuring members enjoy the full benefits of SVS membership.

“I think that we’ve got to get the word out,” Botero responded. “People are scared of being here, in these sorts of spaces. The language barrier is something that is pretty important for us, but I think that once you get here and you get to talk and you get to see people who look like you, talk like you and are able to be here without any reservations, well then you get the courage to do it.”

Chickasaw Nation study exemplifies how diversity can boost patient access to specialized vascular care

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Chickasaw Nation study exemplifies how diversity can boost patient access to specialized vascular care
Zoe Davis presenting at VAM

A “feasible and reproducible” intervention bundle characterized by surveys, provider education and patient screening has demonstrated the potential to not only identify gaps in peripheral arterial disease (PAD) primary care practices, but also to help address them. This was a salient concluding message delivered yesterday morning at the Vascular Annual Meeting (VAM; June 19–22) by Zoe Davis, a third-year medical student at the University of Oklahoma (OU) in Tulsa, whose team set out to identify and reduce limb-amputation risks among Oklahoma’s Chickasaw Nation community.

Audience discussions around this research were led by Fernanda Costa Sampaio Silva, MD, a board-certified vascular surgeon and vascular sonographer at the Federal University of Bahia in Salvador, Brazil, who is also part of the SVS’ Diversity, Equity and Inclusion (DEI) Committee.

“Your work is an example of how diversity in vascular teams can improve patient access to specialized care,” Costa Sampaio Silva said. “By assessing primary care practices, a multi-professional vascular team can achieve impacts on early diagnosis and promote standardized PAD management among underserved populations.”

Costa Sampaio Silva also noted that, through the study, vascular teams were able to establish a “bond” with the Chickasaw community—which, in turn, can improve patient trust and adherence to treatment. “So,” she added, “the ‘Caring For Our Feet’ program is a feasible and reproducible strategy that may serve as a model for further implementation in other communities, reducing disparities in access to vascular care.”

Caring For Our Feet

Speaking during yesterday morning’s Plenary Session 3, Davis—presenting on behalf of senior author Kelly Kempe, MD, associate professor of surgery at OU-Tulsa, and colleagues—began by outlining key motivations behind the study.

“A recent, 12-year review of our state’s hospital discharge data found that amputations—including major amputations—are on the rise in Oklahoma,” she said. “First Americans with a diagnosis of diabetes and/or PAD have one of the highest rates of lower-limb amputation.”

The speaker went on to note that, in an effort to combat limb loss and care disparities, multiple published guidelines have advocated multimodal approaches and consistently recommended provider education on PAD, and limb-loss prevention.

“Given this information, our OU-Tulsa multidisciplinary team partnered with the Chickasaw Nation to create a pilot outreach program,” Davis added, relaying that the project has “affectionately” been dubbed “Caring For Our Feet.” Its objective was to conduct a needs assessment of primary care practices, and it also sought to begin building a systems-based strategy for the early detection and prevention of PAD.

Davis and colleagues hypothesized that direct, in-person engagement would lead to a significant increase in awareness of amputation risks. Their study involved conducting four standardized visits with each of the four Chickasaw Nation primary care clinics. Visit number one was completed virtually and involved the distribution of electronic pre-surveys, while visits two and three consisted of in-person sessions centered on provider and patient education, screening, and semi-structured interviews. Their fourth and final visit was performed online and provided a “wrap-up,” feedback, and distribution of post-surveys.

All four Chickasaw Nation practices participated, Davis continued, also reporting an observed practitioner completion rate of 88% across their pre- and post-surveys. She stated that field notes indicated high receptivity and inquiry among participants based on lectures and discussions—and, overall, 27 out of 28 survey measures (96%) showed improvement, with 21 of these (75%) being statistically significant (p<0.05).

“From pre- to post-survey, we saw an improvement in clinicians’ self-reported comfort in treating, diagnosing and educating patients at risk for limb-loss due to chronic disease,” the presenter said. Prior to concluding, Davis also reported that—across the 20 high-risk patients recruited and identified by the clinics—screening revealed that 40% left with a new diagnosis of PAD.

“To summarize,” she said, “this early-needs assessment shows that there are practice gaps that, if addressed, could improve the prevention and, importantly, early management of patients who may be at risk for limb-loss. We believe this is a viable strategy for the creation of a patient-to-provider-to-specialist network, given the high practitioner engagement on our surveys, our survey measures showing improvement after our intervention, and our ability to newly diagnose PAD in patients identified by the clinic.”

Future directions

Providing an early window into where this research may lead, Davis then relayed that she and her colleagues are “in the process” of performing ongoing qualitative and quantitative analyses—as well as attempting to replicate the strategy with additional clinics. She added: “Our future plans are currently to expand this program more broadly across Oklahoma, to reach more people who may be at risk for limb-loss in their future, as well as—potentially, if successful—nationwide.”

When asked by Costa Sampaio Silva how the team may ‘upscale’ these strategies to state-wide or even national levels, Davis reported that feedback and direct engagement with the Chickasaw Nation community were a “very important” aspect of the present project. According to Davis, these efforts ensured OU-Tulsa multidisciplinary teams were providing appropriate, implementable materials for the local community’s practice—and the same factors are likely to be vital in any attempts to scale the project up moving forward.

“As far as scaling up this project [goes], and making it accessible to more Oklahomans, we are interested in contacting additional clinic sites within other tribal nations, as well as continuing to get feedback from providers who are participating in the program to ensure that we’re delivering content that is relevant to them and, most importantly, usable for them in their practice,” Davis added.

Fernanda Costa Sampaio Silva (above) in discussion with Zoe Davis at VAM

Karith Foster presents vision on how to transform diversity at VAM 2024

By
Marlén Gomez
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Karith Foster presents vision on how to transform diversity at VAM 2024
Karith Foster
Karith Foster

“True diversity is a good and powerful thing that should be celebrated. It’s not mandatory quotas; it’s intentional inclusion,” said Karith Foster, chief executive of Inversity Solutions, as she addressed the audience at the inaugural Keynote Speaker Series at VAM 2024.

Foster aims to create an effort that enrolls people, not repels them. In her talk, “Finishing the Journey to Inclusivity Through Belonging, Intention and Respect,” she challenged conventional approaches to diversity, equity, and inclusion (DEI) initiatives. She advocated for a paradigm shift towards true inclusivity through belonging, intention, and respect.

Foster’s keynote captivated attendees with her candid reflections on the shortcomings of current DEI strategies. She emphasized that many efforts are reactive rather than proactive, failing to achieve sustainable impact beyond initial training sessions.

“Burnout, confusion, overwhelm, exhaustion is real,” Foster acknowledged. “People are exhausted by how we’ve been addressing diversity. Whether you’re painted as the victim or villain, it’s robbing all of us of our agency and defeating the purpose of unity.”

Foster’s message was central to the need for organizations to move beyond tokenism and surface-level diversity metrics. She critiqued the prevalent approach in which diversity efforts, though well-intentioned, often result in short-lived benefits that fail to foster genuine change.

“When DEI is overwhelming, it can do more harm than good,” Foster cautioned, drawing attention to instances where flawed implementation led to legal and reputational repercussions for companies like Starbucks and FedEx.

Foster’s career trajectory, including her role as a national media figure addressing race relations, provided a backdrop for her deep dive into the complexities of achieving true inclusivity. She stressed the importance of acknowledging imperfections and fostering environments where individuals feel safe learning and growing.

“We’re not perfect. We will misspeak. We will put our foot in our mouths. We may freeze up when something makes us uncomfortable or over-explain, making things worse. We’re not all psychic all the time. We are all doing the best we can with the tools we have. But that doesn’t mean we become lackadaisical, or we stop trying. It means we make an effort to do and be better.”

Addressing the audience’s skepticism towards DEI discussions, Foster referenced studies that show widespread disillusionment despite substantial investments. She challenged the audience to redefine diversity beyond quotas and superficial differences, advocating for an inclusive culture that values diverse perspectives and encourages open dialogue.

Throughout her keynote, Foster emphasized the role of leadership in fostering environments conducive to inclusivity. She highlighted the significance of psychological safety, where individuals feel empowered to speak up without fear of retribution, fostering a culture of trust and mutual respect.

“Inversity is about never forgetting the statistics I shared earlier about how close we are genetically to one another,” Foster said of her vision of inclusivity that transcends visible differences. She called for a collective shift in consciousness, where biases are acknowledged and addressed to pave the way for healthier relationships and more equitable workplaces.

Foster’s call for “incremental Inversity“1%” urged small but meaningful steps towards a more inclusive future. Her blend of personal anecdotes and empirical insights left a lasting impression, challenging attendees to reconsider their roles in shaping inclusive organizational cultures.

During the forum, Foster emphasized leadership’s critical role in addressing workplace bias. She asserted, “Leadership must help empower employees, and employees must be empowered to address an issue when it comes up immediately rather than letting it sit and fester.” Foster underscored the pervasive nature of unconscious bias, stating, “Unconscious bias is real; it’spervasive and not going anywhere any time soon. So, we have to learn to deal.”

She outlined a proactive approach to managing these biases by “identifying and recognizing to minimize, mitigate and move forward with as little disruption as possible.” Highlighting the issue’s complexity, Foster noted that “over 100+ unconscious and implicit biases have been identified,” making it clear that addressing them requires continuous effort and attention.

As Foster concluded her address, she left attendees with a call to action, encouraging them to integrate the principles of INVERSITY into their daily practices. Her message of empathy, humility and continuous learning echoed through the conference halls, sparking conversations on how to transform diversity initiatives from compliance-driven tasks into catalysts for genuine cultural change. As organizations navigate the complexities of a globalized workforce, Foster’s insights offer a roadmap toward a more equitable future.

Vascular community embraces learning from past operating room experiences in ‘My Worst Cases’

By
Marlén Gomez
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Vascular community embraces learning from past operating room experiences in ‘My Worst Cases’
William Robinson
William Robinson

Transparency was at the forefront of a My Worst Cases session at VAM yesterday afternoon. Moderator William Robinson, MD, professor and chief in the Division of Vascular Surgery at Southern Illinois University School of Medicine in Springfield, Illinois, set the tone for the session, emphasizing the importance of shared learning experiences.

“The audience wants an opportunity to engage, ask questions, make comments and we’re going to provide that today,” remarked Robinson in his opening remarks. Afterward, VS@VAM caught up with medical student attendees of various backgrounds who shared their reflections on what they heard from the panel of vascular surgeons.

“A lot of cases presented were fantastic because they showed that even in situations where a procedure didn’t go as planned, you know, the surgeons that were presenting were professionally composed and, in many cases, admitted to their faults of being too aggressive with treatment and how they always try to work in the best intention and protection of the patient,” said Alan Nagarajan, from the Baylor College of Medicine, Houston, Texas.

“Much of this is technically their worst cases, as in their worst moments. I think coming up there and showing that bravery of just showing all of the steps and what went wrong, and thinking about the steps where they could have done something different, and leaving it up to the audience to discuss some other options. I think it showed how innovative this field can be,” said Nikitah Gidh from Baylor College of Medicine.

“This is my first time at VAM, and to see experienced doctors humbly admit their difficult cases, it reassures us because, when you’re stepping out, it gives you confidence that things can go bad. It’s bound to happen to anyone,” said Benjamin George, Pushpagiri Insitute of Medical Science, Pathanamthitta, India.

‘Remarkable’ variation in international vascular care calls for better adherence to evidence-based practice

By
Éva Malpass
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‘Remarkable’ variation in international vascular care calls for better adherence to evidence-based practice
Maarit Venermo
Maarit Venermo

“All vascular surgeons have access to the same randomized trials and guidelines, which should harmonize international treatment patterns, but this is not always the case,” says Maarit Venermo, MD, PhD, University Hospital and University of Helsinki, Finland, giving VS@VAM a sneak peek of her upcoming John Homans Lecture this morning (Thursday, June 20, 9:30–10:00 a.m. in the West Building, Level 3, Skyline Ballroom).

At present, Venermo shares, there is “remarkable” international variation in vascular surgery services which are seen through indications for treatment, patient demographics, sex distribution and treatment profiles.

“For example, the proportion of asymptomatic patients in carotid surgery varies between 0–80%, and the proportion of women from 12–40%. In abdominal aortic aneurysm surgery, the proportion of small aneurysms [<55mm aneurysms] vary from less than 10% to almost 30%.”

The reasons for these geographical differences are many, she says, due to prevalence of vascular diseases, risk factors and life expectancy.

However, in following evidence-based practice, vascular care “should” be harmonized internationally. Yet, as Venermo makes clear, this is not always the case.

“Despite the 10-year results from the Asymptomatic Carotid Surgery Trial 1 [ACST1] showing that patients with a life expectancy less than five years do not benefit from carotid surgery—and younger patients with tight stenosis do—the treatment of asymptomatic stenosis has remained the same in a majority of the countries before and after the publication.”

However, if data have not largely influenced vascular care, Venermo explains, reimbursement has been “a force” for change. “In countries that have a fee-for-service reimbursement system, the proportion of asymptomatic carotid patients and patients with small aneurysms who undergo surgery is higher, compared to countries with a public health system,” she says.

“Ultimately, all of the current evidence has been evaluated carefully in the guidelines, and the recommendations have been built on the basis of evidence.”

Navigating clinical guidelines discrepancies between SVS, ESVS patients

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Marlén Gomez
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0
Navigating clinical guidelines discrepancies between SVS, ESVS patients
Ronald Dalman
Ronald Dalman

Clinical guidelines from the Society for Vascular Surgery (SVS) and the European Society for Vascular Surgery (ESVS) are pivotal in directing practitioners’ management of complex vascular conditions.

However, the development and release of these guidelines have not been synchronized, resulting in differences and gaps in recommendations. VAM 2024 attendees were presented with this sentiment during a Wednesday postgraduate session focused on the discrepancies between the clinical guidelines of two societies.

Ronald L. Dalman, MD, from Stanford University in Stanford, California, and Jonathon R. Boyle, MBChB, from the University of Cambridge, England, introduced the session, which examined the real-world implications of these discrepancies.

Dalman remarked, “Understanding why these disparities exist is crucial for improving patient outcomes. This initiative aims to ensure that vascular specialists worldwide can deliver care based on a comprehensive understanding of global recommendations, ultimately promoting better patient care.”

Key topics included the management of aortic graft infection, asymptomatic carotid stenosis, intermittent claudication and incompetent perforators in venous disease.

Contributions from specialists highlighted how scientific evidence, cultural nuances, societal variations and potential personal biases among guideline authors contribute to these differences.

Overcoming barriers and finding solutions for diabetes-related amputations among underserved populations

By
Marlén Gomez
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Overcoming barriers and finding solutions for diabetes-related amputations among underserved populations
Joseph Mills
Joseph Mills

Diabetes-related lower extremity amputations (LEA) disproportionately impact racial minorities and low-income groups. The Vascular Volunteers in Service to All (VISTA) assessment tool identified significant barriers to effective care from a patient’s perspective, including financial constraints, systemic issues, time and access limitations, knowledge gaps, and cultural and provider-related factors.

The Plenary Three paper—”VISTA: Targeting diabetes-related lower extremity amputations among underrepresented communities through a patient-centered multidisciplinary approach”—will see presenting author Paulette Torres Ruiz, MD, a clinical researcher at Baylor College of Medicine in Houston, deliver recent findings and future directions of the VISTA project. It is being held today (8:53–9:04 a.m. in the West Building, Level 3, Skyline Ballroom).

The paper will provide insights into designing a community-based awareness campaign to improve outpatient care accessibility and implement an internal systemic algorithm to promote limb salvage.

“Diabetes-related lower extremity amputations (LEAs) remain a devastating consequence for many individuals, particularly those from racial minorities and low-income backgrounds,” said Torres Ruiz. “Our study aimed to understand the factors contributing to these outcomes and how the VISTA assessment tool could help mitigate this issue.”

The paper will take an in-depth look at the VISTA assessment tool’s impact on non-traumatic amputations in a regional, urban and underserved community. Over the course of a year, 101 consecutive patients with diabetic foot ulceration or infection were enrolled in the study. The results were sobering: 63 LEAs were recorded, including 34 minor amputations, eight transmetatarsal amputations (TMA) and 21 below-the-knee amputations (BKA). Notably, 45 LEAs occurred at baseline admission, and 18 occurred during extended follow-up after discharge.

Torres Ruiz highlighted the primary barriers identified through the VISTA assessment tool, including financial constraints, systemic issues, time and access limitations, knowledge gaps and cultural and provider-related factors. “Our patients reported 83% dissatisfaction with diabetic foot care,” she noted. “Over half were uninsured, and a mere 50.5% had been treated at a wound care specialty clinic.”

The study’s findings underscored the necessity of a multidisciplinary approach, dubbed the Toe and Flow model, to reducing lower limb amputations due to diabetic foot ulcers or infections in marginalized and low-income minority groups. “By addressing these barriers and enhancing patient education, we can significantly improve limb salvage rates,” said Torres Ruiz.

SVS President Joseph Mills, MD, senior author, highlighted the importance of community-based interventions. “We need to focus on creating awareness campaigns to improve outpatient care accessibility,” said Mills. “Implementing an internal systemic algorithm to promote limb salvage is also crucial.”

A significant increase in major amputations, particularly below the knee, was observed during the three-month follow-up period. High Wound ischemia foot infection (WIfI) scores were predictive of increased risk of limb loss during the study.

“Our goal is to implement these findings into practical solutions that can be replicated in other underserved communities. The community-based awareness campaign is just the beginning,” said Mills.

The findings from the VISTA assessment tool and the proposed Toe and Flow model are intended to reduce the burden of diabetic lower extremity amputations in underserved communities.

“We have the data and the strategies,” said Torres Ruiz. “Now it’s time to act and make a tangible difference in the lives of those most affected by this condition.”

SVN wraps conference with joint PA section programming

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Kristin Spencer
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SVN wraps conference with joint PA section programming

The society for vascular nursing (SVN) is in the midst of its 42nd Annual Conference at McCormick Place, West. The conference kicked off Wednesday morning with the Presidential Welcome from Kristen Alix, MS, ANPBC, AGACNP, CVN, and was followed by the keynote address, “Disrupting DEI in a disruptive environment,” delivered by Katie Boston Leary, PhD, MBA, MHA, RN, NEA-BC.

The conference’s education sessions continue to follow four different tracks: Breaking News in Vascular Care and Thoracic Aneurysms; Thinning it Out: Perioperative Considerations and Wound Care Basics, Stroke and Reaching your Vascular Summit; and Upgrades in PAD and Limb Salvage Care.

Alix stated that the education for this year’s program is “unmatched,” with a clinically diverse faculty from all over the U.S. and Canada.

“The conference has grown so much since I became a member and being more involved this year as SVN president has been a true highlight. I can’t wait to see what education and opportunities are brought forth in the years to come,” said Alix. The official SVN meeting program will wrap up today with a closing ceremony that includes “Best Of ” awards.

The available education for SVN attendees won’t end after the four tracks are covered. The SVN conference takes place alongside the VAM 2024. The two meetings have collaborated to offer an immersive program that will merge SVN with the SVS Physician Assistant’s (PA) Section.

The program, built for Advanced Practice Providers (APPs), kicked off on Wednesday evening with the return of Vascular Jeopardy, which first debuted at VAM 2023 in National Harbor, Maryland. The game involved vascular nurses, APPs and PAs facing off in a jeopardy-style format answering questions about different cases and treatment of vascular patients.

The immersive program will resume this afternoon with a lunch coinciding with Vascular Team Talks that will be moderated by Suzanna Fitzpatrick, DNP, ACNP-BC, FNP-BC, immediately followed by an hour-long diagnostics session with Kate Carrato, from Advent Health. The remaining time will consist of a hands-on simulation program covering wound care and compressions, closures, vascular ultrasound and sclerotherapy. The last half hour of education will be spent covering Organizational Change by APP Impact, led by Alix, Matthew Smeds, MD, and Holly Grunebach, PA-C, MSPH. The evening will wrap up with a happy hour for all attendees.

The idea of the immersive APP program was generated for VAM 2023. “We realized that if we are working together on cases, it only makes sense for us to learn together at our annual meetings,” said SVS PA Section Chair Holly Grunebach, PA-C, MSPH. “Learning together helps us to develop skills as a team which then translates to more fluidity when it comes to patient care, which is something we all want.”

Sex-based analysis finds BEST-CLI data generalizable to female patients

By
Éva Malpass
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0
Sex-based analysis finds BEST-CLI data generalizable to female patients
Katharine McGingle

A new secondary analysis of sex disparities in the best endovascular versus best surgical therapy in patients with critical limb ischemia (BEST-CLI) trial data has found that improved major adverse limb event (MALE)-free survival via open surgical bypass with single segment greater saphenous vein (SSGSV) available, is generalizable to female patients.

Ahead of delivering the analysis during today’s Plenary Session 3 (Thursday, June 20, 8–9:30 a.m., in the West Building, Level 3, Skyline Ballroom), Katharine L. McGinigle, MD, associate professor at the University of North Carolina at Chapel Hill, North Carolina, tells VS@VAM of the sex-based, biologic differences in atherosclerosis development which have led to variances in revascularization procedures offered to females.

“In retrospective studies, females have inferior short- and long-term outcomes after intralingual revascularization compared to males. Few randomized controlled trials report sex-stratified results, but this is important to do in order to understand what results can actually be expected in females,” McGinigle explains.

“Despite clear biologic differences, the efficacy of new medications, endovascular devices and other outcomes are rarely tested in females specifically.

“This is much like the common but flawed assumption that non-Hispanic White males are the default standard and that results are generalizable to other populations,” McGingle added.

Looking at the BEST-CLI data, McGinigle and colleagues identify that, regardless of revascularization modality, females had better amputation-free survival at one year when compared to male patients.

However, improved MALE-free survival with surgical bypass in female patients suggests a surgery-first approach should be considered primarily, regardless of conduit availability, she adds.

Vascular community has a role to play in ensuring safety of aortic devices

By
Bryan Kay
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0
Vascular community has a role to play in ensuring safety of aortic devices
Ronald Fairman
Ronald Fairman

Physician-sponsored Investigational Device Exemption (IDE) trials have an important role to play in the continued development and refinement of aortic endovascular devices, attendees of a panel session on aortic device regulation heard yesterday.

The session, taking place Wednesday lunchtime, set out the various Food and Drug Administration (FDA)-mandated pathways that a device must follow before it can enter the market, as well as looking at the involvement of vascular surgeons in this process. Speakers from the FDA outlined the agency’s priorities in ensuring the safety of devices that are approved for use, while balancing the need to encourage innovation.

Considerable innovation has resulted from physician-sponsored IDEs focused on treating patients with complex aortic aneurysms. “There have been substantive learnings that have really contributed tremendously to the development of future clinical studies, to device design modifications and really have helped the endovascular aortic space move forward for many years,” Ronald Fairman, MD, FDA’s Vascular and Endovascular Devices (VEDT) medical officer, and a former SVS president, said during his presentation examining the role of physician-sponsored IDEs.

Fairman outlined the similarities and differences between corporate and physician-initiated IDEs, including the circumstances in which the FDA may recommend the submission of an IDE, citing the example of the use of physicianmodified devices or where a commercial device is routinely being used for a new indication.

“It is important to acknowledge, the FDA does not regulate the practice of medicine,” said Fairman. “If you are modifying a device to save someone’s life, the FDA does not get involved in that. You do not need a investigator-sponsored IDE for that.

“On the other hand, if you are modifying a commercial aortic device or using a commercial device for a new indication and you are doing it routinely, and you are collecting safety and efficacy data to see if it works, we would continue to recommend a sponsored-investigator IDE.”

Gustavo Oderich, MD, professor of surgery and chair of vascular and endovascular surgery at the University of Texas Health Science Center at Houston, shared his considerable experience in physician-sponsored IDEs, and outlined several important developments to have emerged from this setting, in particular in the development of fenestrated-branched endovascular technologies.

“Physician-sponsored IDEs provide a safe venue for continued access, innovation and refinement of endovascular techniques,” Oderich said, setting out several scenarios in which these trials add value. “These often represent the highest level of data for the specialty, and even after a device is approved new iterations will continue to be needed.”

FDA medical officer Robert Craig, DO, outlined the agency’s approach to postmarket data collection and underscored the importance of vascular surgeons participating in the postmarket clinical studies that FDA requires for aortic endografts as a condition of premarket approval (PMA) application.

To conclude the session, moderator and FDA VEDT medical officer Robert E. Lee, MD, outlined the regulatory requirements for medical device event reporting. He underscored the importance of vascular surgeons voluntarily reporting the adverse medical device events encountered in practice using the FDA MedWatch system

Attendees welcomed to ‘more inclusive, more innovative, and more educational’ VAM

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Jocelyn Hudson
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Attendees welcomed to ‘more inclusive, more innovative, and more educational’ VAM
Joseph Mills
Joseph Mills

“I urge each one of you to seize this unique opportunity to not only enhance your patient care but also elevate your careers,” SVS President Joseph Mills, MD, advised VAM 2024 attendees during yesterday’s Opening Ceremony.

Mills welcomed delegates to the SVS’ home city of Chicago, stressing that VAM “is not just a series of lectures and presentations, but a platform for inspiration, growth and progress.”

SVS Program Committee Chair Andres Schanzer, MD, also took to the podium, underlining some highlights of this year’s agenda, including Karith Foster’s keynote on “Finishing the journey to inclusivity through belonging, intention and respect” (see p. 15).

Both Schanzer and Postgraduate Committee Chair William Robinson, MD, are due to step down from their roles after VAM 2024. Schanzer personally thanked Robinson for his contribution to the annual meeting, remarking: “VAM today does not look or feel like the VAM in past years—it’s more inclusive, it’s more innovative, and it’s more educational—and much of that positive change has been a direct result of Dr Robinson’s vision for continued growth and evolution.”

Full smorgasbord of vascular surgery to be showcased during Friday’s International Fast Talk Session

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Full smorgasbord of vascular surgery to be showcased during Friday’s International Fast Talk Session
Wei Zhou
Wei Zhou

On Friday morning, June 21 (6:30–7:15 a.m. in the West Building, Level 1), VAM 2024 attendees will have the chance to take in an International Fast Talk scientific session featuring updates on the latest devices, studies and procedural techniques from all over the globe, and across the full gamut of vascular surgery—including venous stenting, aortic remodeling, dialysis access creation, carotid aneurysm management, and much more.

“The abstracts highlighted in this international session are extremely diverse, including multicentered clinical trials, original research and innovative techniques from around the world,” said Wei Zhou, MD, professor of Surgery at the University of Arizona in Tucson, who is among the session’s moderators.

The session will kick off with a presentation on the safety and effectiveness of the single Prostyle (Abbott) vascular pre-close technique in patients undergoing endovascular procedures. Presenting author Rocco Cangiano, MD, vascular surgery resident at the Sapienza University of Rome in Italy, will deliver findings from a single-center, prospective study that indicate the technique’s efficacy and safety in selected vascular accesses.

Additional European perspectives will be highlighted during the session, as Jerome Albertin, vascular surgeon at Polytechnic Notre Dame in Draguignan, France, presents positive 12-month ELLIPSE study results regarding the treatment of femoropopliteal lesions using the Jetstream atherectomy device and Ranger drugcoated balloon (both Boston Scientific).

And, later, maintaining the thread of endovascular topics, Pasqualino Sirignano, MD, associate professor of vascular surgery at the Sapienza University of Rome, will present insights from SAFEEVAR—a Delphi questionnaire-based study that sought to elucidate the attitude of Italian vascular surgeons towards the use of standard endovascular aneurysm repair (EVAR) to treat infrarenal abdominal aortic aneurysms (AAAs) outside the current instructions for use (IFU).

Venous stenting is also on the agenda, with Mahmood Razavi, MD, director of the Clinical Trials and Research Center at St. Joseph Vascular Institute in Orange, California, set to present the VIVID clinical trial and discuss outcomes with the Duo (Vesper Medical/Philips) stent system.

Lixin Wang, MD, deputy director of Zhongshan Hospital affiliated with Fudan University in Shanghai, China, will outline a study that aimed to compare aortic remodeling of the distal aorta after traditional thoracic EVAR (TEVAR) against repair with the Fabulous (Hangzhou Endonom Medtech) stent—a new, two-stage stent system based on the PETTICOAT technique—in type B aortic dissection (TBAD) patients. The session will also see International Achievement Award recipient Chun Che Shih, MD, deputy superintendent of Taipei Wanfang Hospital in Taipei, Taiwan, provide insights from his lifelong work on aortic dissection. Later in the session, TBAD will come into focus again, as Besher Tolaymat, MD, integrated vascular surgery resident at Cooper University Hospital in Camden, New Jersey, delivers findings from a systematic review assessing the available literature on the variability of impulse control management in these cases.

Elsewhere, a potential innovation in hemodialysis access is set to be presented. Hsuan Yu Chen, from China Medical University Hospital in Taichung, Taiwan, will describe the creation of an “artificial aneurysm” over the brachial artery as an alternative to traditional “shuntless” access approaches.

The carotid territory will also feature—initially, with insights from the prospective, multicenter, international Carotid Aneurysm Registry (CAR) on the conservative management of extracranial carotid artery aneurysms by Saskia I. Willemsen, a PhD student at UMC Utrecht in The Netherlands.

Vascular Specialist@VAM Conference Edition 2

By
Bryan Kay
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Vascular Specialist@VAM Conference Edition 2

In this issue:

  • Attendees welcomed to ‘more inclusive, more innovative, and more educational’ VAM
  • Endovascular CFA treatment associated with increased rate of long-term CFA-specific reintervention, study finds
  • Carotid disease: How do CEA, TF-CAS and TCAR compare?
  • Aortic disease: One-year AAA device data emerge

 

Toe and flow session aims to break down barriers to multidisciplinary limb salvage teams

By
Jocelyn Hudson
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Toe and flow session aims to break down barriers to multidisciplinary limb salvage teams
Joseph Mills
Joseph L. Mills

“If you had cancer you would go to a cancer center where you would get a multidisciplinary approach,” SVS President Joseph L. Mills, MD, tells VS@VAM, drawing on this example to highlight the importance of multidisciplinary teams working for amputation prevention in patients with diabetes and peripheral arterial disease (PAD)—something, he says, is currently lacking in many centers.

Mills, who is the chief of the division of vascular surgery and endovascular therapy at Baylor College of Medicine in Houston, Texas, is one of the architects of the “toe and flow” model of multidisciplinary care that seeks to foster greater alignment between specialties in the field of limb salvage—chiefly podiatry and vascular specialists.

This concept is running through an educational session taking place on Thursday (3:30–5:00 p.m) in room W183b, West Building, Level 1, co-moderated by Mills and Lauren Gordon, MD, a vascular Surgery Resident at the University of Toronto (Toronto, Canada), and seeking to address the fragmented approach to limb salvage in many centers. The session will bring together leaders from multiple specialties to highlight algorithms of care, new approaches to assessment, revascularization, wound care and teamwork, to look at how to broaden access to limb salvage care to underserved communities.

A cancer patient can be faced with several treatment options, requiring experts from numerous fields to come together to work up a therapeutic plan, says Mills, returning to his analogy to sum up the current state of treatment for CLTI and diabetic foot care. “That does not routinely happen with the diabetic foot. What more often happens is the patient gets admitted to the hospital, somebody swabs the wound, random care ensues and important things get missed.”

Toe and flow has its roots in Arizona, where, whilst practicing at the University of Arizona, Mills, along with David Armstrong, DPM, now at the University of Southern California, established the Southern Arizona Limb Salvage Alliance—SALSA—to foster a closer relationship between podiatry and vascular surgery clinics, and to harmonize the patient referral, evaluation and treatment pathway.

Outlining how the toe and flow model works in his practice today at the STEP (Save The Extremity Program) at Baylor College of Medicine, Mills says it doesn’t matter which specialist sees the patient first, they will be treated according to the same algorithm. “If they get sent to a podiatrist and it turns out they have had three failed angioplasties and their blood flow is poor, they meet a vascular surgeon that same day. If they get sent to the vascular surgeon and it turns out it is not really a blood flow issue [and that] they need better offloading or better shoes, then they see a podiatrist. The idea is to not penalize the patient because our system is disorganized.”

Of the session at VAM, Mills tells VS@VAM that the patients’ voice will be heard with involvement from patient representatives, “to bring home how this seemingly simple problem can cause a lot of issues for patients in their lives”.

“Most of the doctors in the audience will probably get this, but to hear what happens to patients and how they perceive their care is really, really important, because often in healthcare we look at outcomes from the standpoint of the system or the doctor and we forget about the patient,” he comments.

The session also features presentations unpacking some of the recent data underpinning advances in CLTI and diabetic foot care, and discussion of key components of team development.

“This is a huge issue for our patients and we need to do better,” says Mills of what he hopes attendees will gain from joining the session. “There are barriers everywhere to setting up this type of system, but they can all be overcome. It is not hard to find a toe partner or a flow partner and to really make a difference in your local hospital and in your local practice. The barriers that the system sets up can be overcome by clinicians who think this is a problem and want to help patients get better outcomes.”

Sex-based analysis finds BEST-CLI data generalizable to female patients

By
Éva Malpass
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Sex-based analysis finds BEST-CLI data generalizable to female patients
Katharine McGingle

A new secondary analysis of sex disparities in the best endovascular versus best surgical therapy in patients with critical limb ischemia (BEST-CLI) trial data has found that improved major adverse limb event (MALE)-free survival via open surgical bypass with single segment greater saphenous vein (SSGSV) available, is generalizable to female patients.

Ahead of delivering the analysis during Plenary Session 3 (Thursday, June 20, 8–9:30 a.m., in the West Building, Level 3, Skyline Ballroom), Katharine L. McGinigle, MD, associate professor at the University of North Carolina at Chapel Hill, North Carolina, tells VS@VAM of the sex-based, biologic differences in atherosclerosis development which have led to variances in revascularization procedures offered to females.

“In retrospective studies, females have inferior short- and long-term outcomes after intralingual revascularization compared to males. Few randomized controlled trials report sex-stratified results, but this is important to do in order to understand what results can actually be expected in females,” McGinigle explains.

“Despite clear biologic differences, the efficacy of new medications, endovascular devices and other outcomes are rarely tested in females specifically.

“This is much like the common but flawed assumption that non-Hispanic White males are the default standard and that results are generalizable to other populations,” McGingle added.

Looking at the BEST-CLI data, McGinigle and colleagues identify that, regardless of revascularization modality, females had better amputation-free survival at one year when compared to male patients. However, improved MALE-free survival with surgical bypass in female patients suggests a surgery-first approach should be considered primarily, regardless of conduit availability, she adds.

TCAR and endarterectomy both ‘reasonable’ but stenting linked to worse outcomes in kidney disease patients

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TCAR and endarterectomy both ‘reasonable’ but stenting linked to worse outcomes in kidney disease patients
Elisa Caron
Elisa Caron presenting at VAM

A study examining outcomes between different carotid revascularization procedures has concluded that transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) both represent a “reasonable choice” in severe chronic kidney disease (CKD) and hemodialysis patients—but transfemoral carotid artery stenting (TF-CAS) appears more likely to result in worse outcomes.

“And, additionally, the majority of these patients are surviving long enough to benefit from the stroke risk reduction provided by surgery,” said Elisa Caron, MD, research fellow in vascular surgery at Beth Israel Deaconess Medical Center in Boston, Massachusetts. During yesterday morning’s Plenary Session 2 at the 2024 Vascular Annual Meeting (VAM; June 19–22), Caron reported an analysis of Vascular Quality Initiative (VQI) patients with estimated glomerular filtration rate (eGFR) <30ml/min/1.73m2, or on hemodialysis, undergoing TCAR, CEA or TF-CAS between 2016 and 2023.

Presenting on behalf of her co-authors, including senior author Marc L. Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center, Caron relayed data from 13,042 VQI patients with eGFR <30, 2,355 of whom were on hemodialysis.

The majority of outcomes—across both symptomatic and asymptomatic patients—were found to be “fairly similar” between TCAR and CEA, including stroke/death, with both procedures falling within SVS guidelines regarding perioperative stroke and death. However, CEA was linked with a trend towards slightly higher odds of stroke/death/myocardial infarction (MI), as per the analysis’ primary outcome, in addition to higher odds of MI when considered independently. Similar trends continued when the researchers looked specifically at the subgroup of hemodialysis-only patients, according to Caron.

Turning to findings on overall long-term survival, the presenter relayed that TCAR and CEA were once again similar, as survival rates were nearly 80% with both procedures across all asymptomatic patients and only dropped slightly to around 70% in the hemodialysis-only group at five years. She also noted that these trends endured among symptomatic patients, with rates dropping to around 70% across the full eGFR <30 and hemodialysis cohort.

In addition, regarding those who underwent TF-CAS, Caron reported that—prior to statistical weighting—these patients were more likely to be symptomatic, to present with stroke, and to undergo surgery in urgent/emergent settings, compared to TCAR and CEA patients. They also had more baseline comorbidities. But, “even after weighting for symptom status and comorbidities, TF-CAS still underperformed and did not meet SVS guidelines” she continued, with stroke, death and overall long-term survival being among the areas where TF-CAS produced inferior outcomes versus TCAR and CEA, across both asymptomatic and symptomatic patients.

Following Caron’s presentation, session moderator Chelsea Dorsey, MD, associate professor of surgery at UChicago Medicine in Illinois, commented that “these patients are incredibly fragile” and, as such, “the more granular information we have about how to approach them, the better”. Dorsey went on to ask the presenter how she feels these new data may impact people’s clinical practices moving forward.

“I think that patient selection will always play a big role,” Caron responded. “The VQI certainly gives us very granular data but, at the end of the day, it’s not the same as the patient sitting in front of you, and I think that will still have a big impact. That said, I think it’s at least reasonable to consider surgery in these patients—I know some people are hesitant to do so, so this at least provides evidence to support the decision of whether to intervene. But, again, patient selection is still going to be crucial.”

Patient selection may explain ‘counterintuitive’ relationship between carotid stenting volume and outcomes in new study

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Patient selection may explain ‘counterintuitive’ relationship between carotid stenting volume and outcomes in new study
Rahul Ghosh presenting at VAM

High stroke and death rates relating to carotid stenting in the Pacific Northwest may be driven by the selection of high-risk patients with less than 80% stenosis, and reducing the frequency of stenting in this high-risk group—along with better adherence to guideline-recommended medical management—could improve regional outcomes.

This was among the key concluding messages delivered yesterday by Rahul Ghosh, MS, during one of the 2024 Vascular Annual Meeting (VAM; June 19–22) Vascular and Endovascular Surgery Society (VESS) Scientific Sessions as he presented findings from a retrospective review of asymptomatic carotid stenosis patients in the Pacific Northwest region undergoing transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TF-CAS), within the Vascular Quality Initiative (VQI), from 2016 to 2022. The research was conducted at the University of Washington in Seattle and led by senior author Sara L. Zettervall, MD.

“Education and awareness are critical for improving care,” said Ghosh, a final-year MD/PhD student at Texas A&M University in Houston, speaking to Vascular Specialist in light of these findings. “By leveraging registry data to analyze real-world outcomes, surgeons can gain a clearer understanding of how practice patterns affect quality, enabling more informed decisions about when to intervene in asymptomatic patients—particularly those with significant comorbidities.”

Ghosh reported that 1,154 asymptomatic patients across 27 centers underwent carotid stenting in the Pacific Northwest from 2016 to 2022, of which 77% received TCAR and 23% received TF-CAS. The overall stroke/death rates were roughly 3% for both TCAR and TF-CAS, with center-specific rates ranging from 0–6% for TCAR and 0–17% for TF-CAS. Researchers also found that centers with higher stroke/death rates generally treated fewer patients with >80% stenosis, as well as more patients with high-risk anatomy or physiology.

Following Ghosh’s presentation, Jordan R. Stern, MD, associate professor of surgery at Weill Cornell Medical College in New York, commented that another of the study’s findings—that being the fact that all centers with stroke/death rates above 3% ranked among the top half of centers for TCAR and TF-CAS volumes in asymptomatic patients—suggests something of a “counterintuitive relationship” between case volume and stroke risk.

“We know from a myriad of literature […] that higher volume generally leads to better outcomes; what’s your explanation for that?” Stern asked the presenter.

Ghosh conceded that, with this having been an observational study, it is difficult to draw conclusions on any causal relationship, or whether volumes “play into” the high stroke/death rate.

“Of course, patient selection is a big thing,” he added. “The centers with the high stroke and death rates—you could also say they are getting the sicker patients so, maybe, their outcomes are worse [because of that]. Regardless, the association is there, and the important thing is to get the information out there and consider looking more carefully at this high-risk population, and whether an intervention provides a good risk-benefit for them or not.”

One-year results confirm safety and efficacy results of conformable AAA device in highly angulated necks

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One-year results confirm safety and efficacy results of conformable AAA device in highly angulated necks
Mahmoud Almadani

Results of a sub-study from the pivotal Investigational Device Exemption (IDE) trial assessing Gore’s Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis have shown that the device is safe and effective in hostile angulated neck anatomy, with the results maintained out to one-year.

Mahmoud Almadani, MD, from Maimonides Health in Brooklyn, New York, presented the new data during yesterday’s (Wednesday, June 19) William J. von Liebig Forum.  

The analysis involved 95 patients who were enrolled in the IDE trial, a prospective, multicenter clinical trial conducted at 35 U.S. sites between January 2018 and February 2022. To be included in the high neck angulation sub-study, patients had to have an infrarenal aortic neck angulation of >60˚and ≤90˚with an aortic neck length ≥10mm. 

Gore’s Excluder conformable AAA device first gained Food and Drug Administration (FDA) approval in late 2020, with an expanded indication for patients with aortic neck angulation ≤90° and a minimum length of 10mm approved last month (May 2024). 

The device is comprised of a conformable stent graft with enhanced positioning and optional angulation control. It also includes a mechanism that, after the first stage of deployment, constrains the device to 70% of its full diameter, which is intended to allow for manipulation and angulation of the proximal end of the stent graft. 

“The device was designed for high neck angulation,” Almadani said during his presentation. “Many of you in the audience have experience using this device in a high neck angle situation, and I will present the data to justify its use.” 

Patients enrolled in the study had a mean age of 74 years old, were predominantly White and non-Hispanic, and were predominantly male, Almadani detailed, acknowledging this as one of the limitations of the study, but also that this represents the typical distribution of aortic aneurysm disease expected in this type of study. 

In terms of the anatomic characteristics, Almadani noted that patients had a mean neck angle of 71˚, with a mean aortic neck length of 21mm. The most common comorbidities included hypertension, hypercholesterolemia and tobacco use. 

Technical success–which was defined as a composite of successful access, deployment, removal of delivery catheters, patent and access site closure, and absence of site-reported type I or type III endoleak–was achieved in 97.9% of patients, Almadani reported, with two patients noted to have a type I endoleak at the completion of the procedure. 

Freedom from the primary safety endpoint–a composite of procedural blood loss >1,000mL, death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, and thromboembolic events–was achieved in 97.6% patients.  

The primary effectiveness endpoint–a composite of technical success and freedom from a type I and III endoleak at 12 months, as well as migration of >1cm and sac enlargement >5mm between one and 12 months, AAA rupture and conversion to open repair through 12 months–was recorded in 94.8% of patients for whom data were available at one year. 

“The Conformable IDE demonstrates the safety and effectiveness of the Gore Excluder Conformable device,”  Almadani said in his concluding remarks. “This was also preserved at one year, and we believe this is a new frontier for safely treating high-risk aortic neck patients with an infrarenal sealing AAA device.” 

During discussion that followed Almadani’s presentation, he was asked by session co-moderator Andres Schanzer, MD, on the “sweet spot” for the device, given other treatment options, including fenestrated grafts and endoanchors. 

“I think this device is ideal in a situation where you have an anatomically high-risk patient, with a highly angulated neck, and you want to try to maintain an infrarenal seal zone without having to extend and manipulate the visceral vessels and place parallel stents or suprarenal stents,” Almadani responded. 

Twin global burdens of growing PAD prevalence and vascular workforce shortfall demand action, WFVS session hears

By
Bryan Kay
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Twin global burdens of growing PAD prevalence and vascular workforce shortfall demand action, WFVS session hears
Vincent Rowe

A growing prevalence of peripheral arterial disease (PAD) across the world parallels a deteriorating PAD landscape in the U.S., underscoring a need for more vascular surgeons and risk-factor reduction globally, according to a leading expert in the field.

Vincent Rowe, MD, chief of vascular surgery at the University of California, Los Angeles (UCLA), was speaking during the VAM 2024 World Federation of Vascular Societies (WFVS) Educational Session yesterday morning (Wednesday, June 19), telling the audience, “It is pretty apparent, that in both the U.S. and globally, we are heading down this dark road to the complications that occur with PAD: if we don’t do something soon it could be an issue, not only for the United States, but also globally.”

Risk factors in the U.S. include tobacco use and glucose and blood pressure control, Rowe explained. Across the world, it is a similar picture, he said, adding low physical activity and diet to the list.

He raised the twin specter of diabetes, with “a tsunami” expected across the U.S. in the next 20 to 30 years, especially among some minority patients, running alongside the global PAD burden. “If we look at diabetes globally, you can see it is increasing, both in terms of prevalence and in terms of incidence, and also deaths.”

Rowe referenced a recent publication that laid out the scope: a 72% increase in global prevalence of PAD, with mortality also continuing to rise.

“The authors stated that this pattern represents a major public health challenge that warrants a coordinated and targeted response from governmental and private medical institutions to try to combat this disease, and especially slow the progression medically,” he said.

The global picture of increasing PAD and associated risk factors— body mass index and food consumption levels among them—plays out across gender and among children, Rowe pointed out.

The bottom line is, according to Rowe, “in the U.S., with all these increases in risk factors, that we predict we’re going to need more vascular surgeons. “The current estimate is a 31% shortfall in the next couple of years, he noted, “and unfortunately we’re not very well distributed across the country.”

Currently, some 2,600 counties in the U.S. have no vascular surgery representation, Rowe said. And they’re not all rural: “Almost half of them are considered urban counties,” he added. “If we look at the world, we can see that the population is going to continue to increase, and our distribution of vascular surgeons across the world in certain countries is not very good at all.” Rowe offered some potential remedies aimed at starting to tackle the increasing disease burden and workforce shortfall. “We can try to increase the number of vascular surgeons, but that is going to be a tall order. But we’re going to really need to, especially globally,” he said.

He also raised the idea of international rotations. “Perhaps if we were allowed to take our fellows and residents internationally, that would increase their interest in going back and serving in those countries,” he elaborated, also suggesting paid service programs as another possible avenue.

“Also, maybe loan forgiveness: we forgive loans for people who go and practice in underserved areas—maybe they should forgive them if someone goes and practices for two to three years internationally as well.”

Rowe added one more remedy from his own circle. “One of my friends is from Nigeria, and he does global grand rounds—not to educate the vascular surgeons but to educate all the other practitioners about vascular disease to help them take care of these patients medically.”

Community affairs: Optimizing, protecting and enhancing clinical practice

By
Kristin Spencer
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Community affairs: Optimizing, protecting and enhancing clinical practice
Robert Molnar
Robert Molnar

The SVS Community Practice Section (CPS) has put together an extensive 90-minute program for Thursday afternoon at VAM.

The session, entitled Community Practice Section: Optimizing and Protecting your Clinical Practice, will take place on Thursday, June 20, from 1:30 to 3:00 p.m. (West Building, Level 1). CPS Chair Robert Molnar, MD, and the VAM Postgraduate Education Committee Chair William Robinson III, MD, will moderate. It will consist of six talks from a variety of speakers across community practice in vascular surgery.

The session will cover a wide breadth of relevant topics, including supplemental income opportunities for practices, malpractice protection, retirement and signing a contract. The education portion will wrap with a 25-minute panel discussion where questions will be taken from the audience.

“The CPS session at VAM 2024 was developed to provide actionable opportunities to optimize, protect and enhance your clinical practice. Every vascular surgeon, regardless of practice type, recognizes how difficult it has become to successfully manage the practice while providing expert vascular care to their community. The Community Practice Section has created a robust session to assist in ensuring continued success,” said Molnar.

There will also be a clinical element to the session. Molnar’s talk will be the first of the six and is entitled, “Transfemoral carotid artery stenting (TF-CAS)—is your practice prepared?” His talk will delve into the detail of the November 2023 National Coverage Decision (NCD) on carotid angioplasty and stenting that decided facilities would no longer require approval by the Centers for Medicare and Medicaid Services (CMS) to perform TF-CAS procedures and that TF-CAS would furthermore be reimbursed for standard indications. The NCD suggests that there should be oversight at the hospital level, but there are no enforcement criteria required to ensure these procedures are being performed appropriately by adequately trained interventionalists.

“There is no registry requirement to follow patient outcomes. In addition, the NCD requires a shared decision-making process, but there has not been a verified tool developed to provide for said process,” said Molnar.

“In short, the guardrails that had been in place to ensure TF-CAS was being performed appropriately in the past have been removed and this potentially places our patients with carotid occlusive disease at risk.”

Molnar’s talk will highlight how community practices can be better prepared for TF-CAS procedures as they relate to the ruling—and so patients receive the best possible care.

The last 15 minutes of the session will be spent highlighting the 2024 Excellence in Community Practice Award recipients. Formerly known as the Excellence in Community Service Award, it is an honor the SVS bestows on members who have exhibited outstanding leadership within his or her community as a practicing vascular surgeon. Selection for this award recognizes an individual’s sustained contributions to patients and their community, as well as exemplary professional practice and leadership.

“It is important that community practice vascular surgeons know that they are an integral part of vascular care across the country,” said Molnar, who himself received the award in 2022.

Molnar will be presenting the awards as chair of the CPS to the 2024 recipients: Enrico Ascher, MD; Sachinder Hans, MD; Chistopher LeSar, MD; and Manish Mehta, MD.

Vascular surgery trainees face the future armed similarly with both open and endovascular skills

By
Urmila Kerslake
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Vascular surgery trainees face the future armed similarly with both open and endovascular skills
Libby Weaver and Erin Buchanan
Libby Weaver and Erin Buchanan

The BEST-CLI trial underscores the importance of ensuring trainee competence in open peripheral revascularization as well as endovascular treatment. Indeed, the trial results have called for a reshift in focus to ensure trainees have much needed open skills.

That’s because, for selected patients, “Bypasses are actually very relevant.” So says new, multi-institutional data to be showcased on Friday in Plenary Session 5 (8–9:30 a.m. in the West Building, Level 3, Skyline Ballroom), which reveals that trainees do face the future with parity in their graduating operative autonomy and competency in both approaches. Erin Buchanan, MD, a vascular and endovascular fellow at the University of Virginia, Charlottesville, and presenting author of the study, and Libby Weaver, MD, assistant professor of surgery and assistant program director at the same institution, and senior author, spoke to VS@VAM about why these data matter.

“The utilization of endovascular procedures for peripheral arterial disease [PAD] treatment has significantly increased over the years, but open procedures still have a really important impact in vascular care—bypasses are really very relevant. We’re trying to ensure that all vascular trainees, whether they are integrated, or follow the traditional pathway of general surgery training and vascular fellowship, are appropriately achieving competence both in endovascular and open procedures to achieve the right balance in training and patient care,” Buchanan said.

Their study’s conclusion shows just that. “There is no difference in the graduating level of autonomy and competence of endovascular compared to open peripheral revascularization procedures for vascular surgery trainees.”

The big picture takeaway results and specific numbers that are striking, says Weaver, are “assuming average-case complexity and a typical resident, rater and program; the predicted probability of a graduating resident or fellow being rated as autonomous was 96% for endovascular cases and 97% for open procedures. The predicted probability of a graduating resident or fellow being rated as competent was also similar for these cases at 88% for endovascular and 86% for open procedures. In other words, there’s no difference in predicted autonomy or competence upon graduation between open or endovascular cases when trainees perform average complexity peripheral vascular revascularization.”

Buchanan says: “These data are reassuring because vascular surgeons want to confirm that we’re creating safe surgeons who can capably use all the tools in their toolbox and use the wide breadth of their knowledge to take appropriate care of patients. In the setting of appropriate complexity cases, this dataset supports that trainees are ready to care for those patients, no matter what approach they need to use.”

Weaver pivots to those more complex PAD procedures. “When we looked at the most complex procedures, there was a slightly lower level of predicted competence achieved. In those situations, about 70% of the time we expect graduating residents and fellows to be able to competently perform complex procedures, whether they are open or endovascular, which just means that we should expect that with complex cases; even in independent practice, there’s a degree of ongoing mentorship needed.” Buchanan adds: “It’s also not unexpected that in situations where trainees are going out into practice and doing complex cases, they may need assistance from their senior partners.”

Weaver explains that these data follow hot on the heels of a recently presented dataset of nearly 5,000 assessments of open and endovascular procedures for fellows and residents at the Society for Clinical Vascular Surgery (SCVS) annual meeting in March that also show “in general, across the board, our residents and fellows, while they follow two unique pathways, seem to be equally prepared to do open and endovascular procedures.”

Outlining the need to capture more nuanced information on true competence rather than just case volume, which Buchanan suggests is merely a surrogate marker of competence, the researchers used the operative performance and autonomy ratings for infrainguinal endovascular and open revascularizations from the Society for Improving Professional Learning (SIMPL) application database for all vascular surgery participating institutions from 2018–2023.

The Vascular Surgery Board (VSB) is supporting the use of this app, which will help implement Entrustable Professional Activities (EPA) for all trainees. While the use of the app is not a requirement, Weaver notes that it will likely be used widely, with required EPA implementation anticipated in early Fall. This dataset, along with a pilot study already underway, is, therefore “a preview of the type of information we can get for our trainees and the way that we can give our trainees good assessments and feedback to help them improve their technical skills and measure pre- and post-operative management of patients as well,” she says.

Radiation safety session seeks to address variability and improve access to education

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Radiation safety session seeks to address variability and improve access to education
fluoroscopy
fluoroscopy

“Variability is a source of inferior quality, poor outcomes and harm,” says Anil Hingorani, MD, vascular surgeon at New York University (NYU) Langone in Brooklyn, speaking to VS@VAM ahead of Thursday morning’s VAM 2024 session on the past, present and future of radiation safety. 

The session—which intends to improve access and address variability within radiation safety education—will feature talks on special concerns for staff, women and pediatric patients, and even new technologies that may enable vascular surgery to “move away” from radiation. It takes place from 7–8 a.m. (the West Building, Level 1).

Hingorani, who will moderate alongside Gale Tang, MD, associate professor and chief of vascular surgery at the University of Washington (UW) in Seattle, continues: “Radiation safety has been relegated to the purvey of each hospital—some have vigorous annual certification and exams; at some others they are practically non-existent.

“After looking over to see what some of our colleagues in other fields have established for education and certification in radiation safety for national standards, and examined the variability at our institution, I would suggest we need to establish minimum standards for the sake of our patients, our staff and ourselves. This course focuses on a key set of skills that all vascular practitioners should own.”

The session kicks off with a presentation on the relevance of radiation safety for the practicing vascular surgeon from Fernando L. Joglar, MD, associate professor of surgery at the University of Puerto Rico School of Medicine in San Juan. Subsequent talks include “Maximizing protection from radiation,” given by Melissa L. Kirkwood, MD, professor and chief of the Division of Vascular and Endovascular Surgery at the University of Texas Southwestern Medical Center in Dallas.

Discussing Kirkwood’s talk, Tang notes that the presentation will cover dose-sparing strategies and also review evidence around various pieces of protective gear that operators wear in order to minimize radiation exposure—something that, in her view, is “extremely practical for every trainee and practicing vascular surgeon to learn.”

Special concerns for women patients, staff and pediatric patients regarding radiation safety are next on the agenda, and will be outlined by Agelilki G. Vouyouka, MD, professor of surgery and radiology at Icahn School of Medicine at Mount Sinai in New York. Following this, a presentation from Peter A. Schneider, MD, professor of surgery in the Division of Vascular and Endovascular Surgery at the University of California San Francisco, will center around the As Low As Reasonably Achievable (ALARA) principle, and methods for “maximizing imaging while reducing radiation exposure.”

Fittingly, the final presentation will nudge audiences to consider the future outlook of radiation safety and education, with Andres Schanzer, MD, professor of surgery in the Division of Vascular and Endovascular Surgery at the University of Massachusetts Memorial Medical Center in Worcester, discussing the latest technologies in this space, and a possible “move away” from radiation further down the line.

“Vascular surgery is still undergoing the endovascular revolution,” says Hingorani. “Every couple of weeks, a new technology is being added to our armamentarium, often using fluoroscopy. Similarly to all technology, it is very useful but has to be used properly. This session focuses on using radiation safely to optimize outcomes and imaging.

“It will cover not only the present technology but also developing technology. These upcoming technologies have the potential to reduce radiation exposure, especially in complex cases. In addition, our future is our trainees. To make change, we need to focus on how to train the trainees in these important concepts.”

APP united: Society for Vascular Nursing and SVS PA Section to host immersive program

By
Marlén Gomez
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APP united: Society for Vascular Nursing and SVS PA Section to host immersive program

The Society for Vascular Nursing (SVN) is again hosting its 42nd Annual Conference June 19–20 at McCormick Place alongside VAM 2024. This year’s meeting offers attendees a diverse offering, including an immersive program that will merge with the SVS Physician Assistants (PA) Section.

The program will kick off on Wednesday evening with the return of Vascular Jeopardy, which debuted at VAM 2023. The educational game will involve vascular nurses, PAs and other APPs facing off in a jeopardy-style format answering questions about different cases and treatment of vascular patients.

The SVN program has been approved for 13.1 contact hours.

Analysis will kickstart conversation on F/BEVAR outcomes

By
Brian McHugh
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Analysis will kickstart conversation on F/BEVAR outcomes
Sara Zettervall

New data presented during Friday’s Plenary Session 6 (10–11 a.m. in the West Building, Skyline Ballroom) will shed light on trends in the adoption of fenestrated and branched endovascular aortic repair (F/BEVAR) outside of Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trials, and probe whether there are differences in mortality rates among patients treated inside and outside of the trial setting.

Presenting author Sara Zettervall, MD, an assistant professor of surgery at University of Washington in Seattle, tells VS@VAM that the results of the analysis should kickstart an important conversation about protocols for the use of F/ BEVAR, an approach that is “increasing dramatically” across the country.

Zettervall and colleagues have used Medicare claims data to identify patients undergoing endovascular treatment of the visceral aorta incorporating two or more visceral artery endoprostheses between 2014–2022, identifying cases performed at both IDE and non-IDE sites. The researchers compared the 30-day and three-year mortality rates between procedures performed within both the trial and non-trial locations. Through the analysis, the researchers have sought to quantify the use of F/BEVAR in the United States and to evaluate any association with case volume and mortality at IDE and non-IDE sites.

“We all suspect that physician-modified endografts are happening all over the place, but because published data are limited just from IDE sites, what is really going on in actual practice has not been widely studied,” Zettervall comments, looking ahead to her presentation of the analysis during Friday’s session, in which she will reveal the findings of the study for the first time. “There needs to be a starting point to know how much this is happening and how are these patients doing, because we really don’t have a marker outside of IDE sites at all,” she says.

Turning to the results, Zettervall explains that the analysis points to the fact that most of the sites at which these procedures are being performed are non-IDE centers, albeit that these sites are performing a much lower volume of procedures than those participating in the IDE trials.

“What we see is that there are a lot of these cases being done outside of IDE sites, in fact the majority of them, and it is increasing,” says Zettervall. “I think the most shocking thing is that the majority of folks who are doing this are doing one or two per year per hospital, which is super low volume.”

Through their research, Zettervall and colleagues have identified 7,977 patients treated with F/BEVAR at 551 hospitals during the eight-year period under the focus of the study. Of these, 25% of procedures were performed at 20 hospitals with an IDE.

The researchers have found that the median annual case volume per hospital was significantly higher at IDE sites, while their research also points towards differences in the 30-day and three-year mortality between patients treated inside or outside of IDE sites.

“When we look at the data, what we can see is that the folks who are doing it outside of [an] IDE are having worse perioperative survival, and I think we will need to do more research to understand the drivers of that,” Zettervall tells VS@VAM, adding that this will become increasingly important as devices such as the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE)—the first off-the-shelf endovascular device for the treatment of complex aneurysmal disease involving the visceral aorta to receive FDA approval—gain wider usage.

“This is really the starting point,” says Zettervall of the research, as her team will be looking to release more data from their study in the coming months.

Artificial intelligence: Breakfast session explores opportunities and risks for vascular surgery

By
Will Date
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Artificial intelligence: Breakfast session explores opportunities and risks for vascular surgery

The advent of artificial intelligence (AI) in vascular surgery holds great promise to optimize the delivery of care, with prospective uses including patient selection and procedural planning. Yet, challenges remain.

Many still view AI with suspicion, and important ethical and security questions over its use remain. A session taking place Thursday, June 20 at 7:00 a.m. (West Building, Level 1) will explore these issues, and look at current and future uses of AI in the vascular space. Session moderator Judith Lin, MD, MBA, professor and chief of vascular surgery at Michigan State University College of Human Medicine, East Lansing, Michigan and Javairiah Fatima, MD, an associate professor of surgery at Georgetown University, Washington, D.C., spoke to VS@VAM about opportunities and challenges for AI in vascular, and what attendees can expect from the session.

VS@VAM: What do you see as being the main uses for AI in the vascular field?

JL: AI has the potential to revolutionize healthcare. AI can enhance diagnostic accuracy, improve patient outcomes, and streamline clinical workflows. Specifically in the field of vascular surgery, the main uses of AI include image analysis to identify aneurysms or thrombosis, predictive models of adverse events, decision support to provide evidence-based recommendations, robotic-assisted surgery to enhance precision and dexterity, automated alerts for graft occlusion, natural language processing and large language models to summarize patient history and make recommendations for personalized treatment.

VS@VAM: Is vascular surgery ready for the advent of AI?

JF: AI has been around for a long time in various forms, we are currently enhancing its use in very specific situations to enhance patient care and technological development. So I would say yes, there is acceptance and utilization.

VS@VAM: Are there good examples of how AI is currently used in vascular surgery?

JF: Artificial intelligence is being used to diagnose aortic aneurysms, assist in preoperative planning and in treatment. Similarly, it has played a role in timely detection of peripheral arterial disease (PAD), pulmonary embolisms, and strokes on imaging done for other indications and routing them to the appropriate personnel for timely intervention. The ability of AI to analyze large amounts of data, using deep learning analysis to detect patterns, perform risk stratification and draw conclusions surpasses human capacities and has already proven beneficial to patient treatment and outcomes.

VS@VAM: Will AI replace physician judgement?

JL: No. AI will enhance clinical decision-making. AI-powered decision support tools provide evidence-based recommendations to clinicians during diagnosis and treatment planning. AI is a powerful tool, but it should complement clinical judgement rather than replace it. I think physicians who use AI will replace those who don’t.

VS@VAM: Can we trust AI?

JF: This is a million-dollar question! I think checks and balance are critical to its ethical and unbiased use. It is incumbent on us to develop algorithms with proper testing and careful and cautious implementation with the highest standards in patient safety.

VS@VAM: How can vascular surgeons prepare themselves for more AI in their daily practice?

JL: Vascular surgeons can prepare themselves for more AI in their daily practice by staying informed about AI developments in medicine and surgery, collaborating with data scientists to develop AI models and algorithms, and investigating relevant existing AI tools and applications.

VS@VAM: What should attendees expect to gain from attending the AI session?

JF: The VAM AI session has an excellent line-up of national leaders in the field who are dedicated to development and implementation of AI to optimize patient care. It’s an excellent opportunity for an interactive discussion on the topic.

Pediatric vascular trauma: ‘Collaboration really matters in this space’

By
Jocelyn Hudson
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Pediatric vascular trauma: ‘Collaboration really matters in this space’

The focus of yesterday’s American Pediatric Surgical Association (APSA)-SVS task force’s spring quarterly interest group meeting at VAM 2024 was the “incredibly crucial” topic of pediatric trauma, as described by co-moderator John White, MD. Various speakers shared a series of predominantly case-based talks, with the importance of collaboration emerging as a key take-home message.

White, who is chair of surgery at Advocate Lutheran General Hospital in Park Ridge, Illinois, outlined the gravity of the topic at hand. “We lose 20,000 young lives each year from trauma,” he said, adding that trauma is the leading cause of death of all children over the age of one and exceeds the combined total of all other causes.

Furthermore, he noted that for every death, 40 children require hospitalisation for major injuries and thousands of others are treated in emergency rooms. These factors, he remarked, make this “an extremely important topic.”

The session featured presentations from co-moderator Dawn Coleman, MD, division chief of vascular and endovascular surgery at Duke University in Durham, North Carolina, J. Westley Ohman, MD, associate professor at Washington University in Saint Louis, Missouri, Luigi Pascarella, MD, associate professor at University of North Carolina at Chapel Hill, and Jayer Chung, MD, MS, associate professor at Baylor College of Medicine in Houston, Texas.

Delivering the final presentation of the session was Regan Williams, MD, medical director of trauma services at the Le Bonheur Children’s Hospital in Memphis, Tennessee, who delivered a presentation titled ‘Expanded support of the pediatric vascular trauma patient—the important of care processes and resources’.

“I think the previous speakers have shown that we have an increased number of pediatric vascular trauma patients, mostly related to the increased number of penetrating injuries that are affecting our children, and the vascular surgeons and pediatric surgeons have really been working well collaboratively together to save these children’s lives,” Williams began. “But what happens after you’ve repaired them, how do we get them back to normal life, how do we help them to be functional children and to live a very long, happy life after they’ve had these drastic injuries?”

Part of Williams’s talk focused on child life services, which the presenter noted is a relatively new field. “Child life uses play and developmentally appropriate communication to help inform hospitalised children and their families,” she explained.

“I think the best collaborative model for pediatric vascular injuries is an adult vascular surgeon that has tons of experience in the technical aspects, but really partnering with a pediatric surgeon and a pediatric hospital so we can support the other parts of the child—they’re really important for their long-term outcomes,” Williams said in her conclusion.

Closing out the session, Coleman summarized: “I’m taking away from this whole session that collaboration really matters in this space.”

White and Coleman co-moderated the session alongside Claudie Sheahan, MD, professor of clinical surgery at LSU Health in New Orleans, Louisiana.

Endovascular CFA treatment associated with increased rate of long-term CFA-specific reintervention, study finds

By
Jocelyn Hudson
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Endovascular CFA treatment associated with increased rate of long-term CFA-specific reintervention, study finds
Nicholas Wells

A recent study suggests that endovascular treatment of the common femoral artery (CFA) is associated with an increased rate of long-term CFA-specific reintervention, regardless of indication. Nicholas Wells, MA, a medical student at Yale School of Medicine in New Haven, Connecticut, presented this and other key findings from a tertiary care center analysis of open and endovascular treatment of the CFA during yesterday’s William J. von Liebig Forum at VAM 2024.

“The CFA is a common site of disease in patients with peripheral arterial disease,” Wells began. He noted that endarterectomy is seen as the gold standard of treatment, with primary patency rates “often surpassing 95% at five years” and evidence of “excellent long-term durability as far out as eight years.”

The objective of the study, Wells shared, was to compare open and endovascular treatment of the CFA with a focus on reinterventions and major adverse limb events.

This was a retrospective study of all revascularizations involving the CFA, including repeated reinterventions, conducted at a single center between 2013 and 2020. “These procedures were performed by various specialists, including vascular surgeons, interventional radiologists and interventional cardiologists,” Wells detailed, adding that the researchers used standard comparative statistics and stratified their analysis by indication—claudication versus chronic limb-threatening ischemia (CLTI).

The researchers found that, from their database of 1,954 patients, 23% were treated for the CFA at least once and 15% of all individual revascularizations involved the CFA.

“Patients with claudication were more likely to be treated initially with endovascular therapy, at 57%, and those with CLTI were more likely to be treated with open surgery, at 60%,” Wells added.

The presenter reported that approximately one-third of the open surgery group underwent extended CFA endarterectomy involving the external iliac arteries, superficial femoral artery, and profunda femoral arteries, and about one-third underwent a concomitant ipsilateral bypass.

He also noted that approximately half of the patients in the endovascular group underwent concomitant endovascular revascularization of the distal femoropopliteal region.

In the perioperative period, Wells shared that open surgery was associated with an increased rate of bleeding and wound infection, while endovascular therapy was associated with shorter mean length of hospital stay. Perioperative major amputation and mortality were below 1% in both groups.

“For claudication, endovascular therapy led to an increased rate of CFA-specific reintervention in the long term—35% compared to just 21% of those initially treated with open surgery,” Wells revealed.

“Additionally,” he continued, “15% of those who initially received endovascular treatment required eventual conversion to endarterectomy of the CFA, while only 5% of those who were initially treated with open surgery required a redo open CFA with endarterectomy.”

The researchers observed similar outcomes in the CLTI group, where 33% of initial endovascular recipients required eventual CFA reintervention compared to 21% of those initially treated with open surgery. Conversion to endarterectomy was not found to be significant in this subgroup.

“The take-home message here was that endovascular therapy led to higher rates of CFA reintervention in the long term and that for claudicants, conversion to endarterectomy was more common following endovascular therapy than redo endarterectomy,” the presenter told VAM attendees.

After a median follow-up time of three to four years, major amputation, major adverse limb events and mortality were not found to be different.

Furthermore, major adverse limb events-free survival—which was defined as time to either reintervention to any artery, major amputation or death—was not found to be significantly different between treatment approaches in either subgroup.

Senior author Cassius Iyad Ochoa Chaar, MD, told Vascular Specialist@VAM that the anatomy of the CFA is “very peculiar,” and that the extent of the disease treated was not accounted for in this analysis. “Our future work will focus on studying the anatomy of the atherosclerosis affecting the CFA to better understand which lesions are best treated with which strategy of revascularization,” he commented.

Unmet needs and paradigm shifts: VESS scientific sessions set to plumb the vasculature for advances in practice

By
Éva Malpass
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Unmet needs and paradigm shifts: VESS scientific sessions set to plumb the vasculature for advances in practice
VESS President Misty Humphries

Selected research to be presented during the Wednesday afternoon, June 19, series of Vascular and Endovascular Surgery Society (VESS) Scientific Sessions (from 1:30 p.m. onward in the West Building, Level 1) will highlight areas of unmet need and offer paradigm-shifting analyses concerning thrombectomy for pulmonary embolism (PE), carotid endarterectomy (CEA) and endovascular aneurysm repair (EVAR), among other key domains.

Presenting in this afternoon’s first session, Jin Hyun Joh, MD, from University Hospital at Gangdong in Seoul, South Korea, will deliver a comparison of outcomes between percutaneous atherectomy versus balloon angioplasty and/or stenting in the treatment of femoropopliteal disease based on the Korean Society for Vascular Surgery’s (KSVS) DAMOEUM registry. The nationwide prospective multicenter repository assessed primary patency rate and postprocedural ankle-brachial index (ABI).

“There have been many studies that have reported on interventional treatments of peripheral arterial disease [PAD]; however, most of these are single-arm or company-sponsored studies, and so are not reflective of real-world practice,” Hyun Joh tells VS@VAM. Theirs, he states, will offer “meaningful real-world data,” suggestive of lower rates of occlusion recurrence post-atherectomy, but places emphasis on “careful” patient selection.

Later in this session, resident Tiffany R. Bellomo, MD, from Massachusetts General Hospital in Boston, is set to present multi-institutional retrospective registry data on the clinical and anatomic characteristics of popliteal artery aneurysms (PAAs) associated with limb-threatening and thromboembolic events. As senior author Anahita Dua, MD, also from Massachusetts General Hospital states, this research identifies a “new variable”—thrombus burden—to more accurately identify which patients will have complications, so lesions can be treated before causing an acute event.

“Through this research, we have identified thrombus burden has the biggest impact in terms of predictive value and we have quantified this through ultrasound,” Dua states. “We hope our research will allow for a new paradigm by which popliteal aneurysms can be evaluated to identify threatened patients and save limbs.”

In the following session, among several abstract presentations, resident Paul Rothenberg, MD, from West Virginia University in Morgantown, West Virginia, will deliver data on abdominal aortic aneurysm (AAA) care, discussing the impact of rural residence on the presentation of AAA and the likelihood of being lost to follow-up after endovascular repair.

Speaking to VS@VAM, Rothenberg emphasizes how deadly AAA ruptures are and how preventable they can be with appropriate screening: “Rural populations are often medically underserved and are particularly vulnerable as a result. At our institution, which is located in a highly rural state in Appalachia, our endovascular repair rate for symptomatic and ruptured AAA is nearly double the national rate reported by the VQI [29.2% vs. 15% for symptomatic AAA; 11% vs. 6.1% for ruptured AAA]. Not only are rural patients presenting with ruptured or symptomatic aneurysms, we also found these patients are lost to follow-up. We know that losing EVAR and TEVAR patients to follow-up brings worse outcomes over time, so we want to highlight these results to emphasize that these patients are not being seen over time, which represents a problem that affects rural patients more. That is why we undertook this research.”

In presenting these data, which highlight the need for access to AAA screening and surveillance in rural areas, Rothenberg and his team of researchers hope to increase resources for rural provider education, ultimately to decrease the number of patients that present with a symptomatic or ruptured AAA.

Rounding off this session with a report on long-term outcomes and adaptive changes in collateral visceral circulation following intentional celiac artery embolization (CAE) during complex EVAR/TEVAR, resident Arash Fereydooni, MD, from Stanford University in Stanford, California, outlines how this research has shown that CAE is a “useful adjunct” to extend proximal or distal seal during EVAR/TEVAR; however, mesenteric complications occur in 10–15% of patients over a 90-day postoperative period. He notes that, although CAE may have “less utility to treat complex aortic pathology in the future,” it will nevertheless “remain a technique in the toolbox of the vascular surgeon in emergency circumstances or when new-generation endografts are not readily available.”

Continuing discussion of CAE, medical student Leana Dogbe, from Penn State Hershey College of Medicine in Hershey, Pennsylvania, will later deliver data on African American women’s more frequent presentation with more severe forms of carotid disease, and the effect of their “inadequate care” on clinical outcomes. She tells VS@VAM that representation of this patient population is “lacking” in landmark trials to date, and with the U.S. population’s increasing diversity, these insights must spark “action” to mitigate poor post-surgical outcomes.

Later today, there will feature an analysis of factors which influence general surgery residents to specialize in vascular surgery. Presenting author, resident Christina Cui, MD, from Duke University in Durham, North Carolina, comments that, in the context of the projected shortage of vascular surgeons, their research highlights how “boosting pipelines is crucial to avoid impacts on patient care.”

Toe and flow session aims to break down barriers to multidisciplinary limb salvage teams

By
Will Date
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Toe and flow session aims to break down barriers to multidisciplinary limb salvage teams
Joseph Mills
Joseph Mills

If you had cancer you would go to a cancer center where you would get a multidisciplinary approach,” SVS President Joseph Mills, MD, tells VS@VAM, drawing on this example to highlight the importance of multidisciplinary teams for amputation prevention in patients with diabetes and peripheral arterial disease (PAD)—something, he says, is currently lacking in many centers.

Mills, who is the chief of the Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine in Houston, Texas, is one of the architects of the “toe and flow” model of multidisciplinary care that seeks to foster greater alignment between specialties in the field of limb salvage—chiefly podiatry and vascular specialists.

This concept is running through an Education Session taking place on Thursday, June 20 (3:30–5:00 p.m. in the West Building, Level 1), co-moderated by Mills and Lauren Gordon, MD, a vascular surgery resident at the University of Toronto in Toronto, Canada, and seeks to address the fragmented approach to limb salvage in many centers. The session will bring together leaders from multiple specialties to highlight algorithms of care, new approaches to assessment, revascularization, wound care and teamwork, in order to look at how to broaden access to limb salvage care to underserved communities.

A cancer patient can be faced with several treatment options, requiring experts from numerous fields to come together to work up a therapeutic plan, says Mills, returning to his analogy to sum up the current state of treatment for chronic limb-threatening ischemia (CLTI) and diabetic foot care. “That does not routinely happen with the diabetic foot. What more often happens is the patient gets admitted to the hospital, somebody swabs the wound, random care ensues, and important things get missed.”

Toe and flow has its roots in Arizona, where, whilst practicing at the University of Arizona, Mills, along with David Armstrong, DPM, now at the University of Southern California, established the Southern Arizona Limb Salvage Alliance—SALSA—to foster a closer relationship between podiatry and vascular surgery clinics, and to harmonize the patient referral, evaluation and treatment pathway.

Outlining how the toe and flow model works in his practice today at STEP (Save The Extremity Program) at Baylor College of Medicine, Mills says it doesn’t matter which specialist sees the patient first—they will be treated according to the same algorithm. “If they get sent to a podiatrist and it turns out they have had three failed angioplasties and their blood flow is poor, they meet a vascular surgeon that same day. If they get sent to the vascular surgeon and it turns out it is not really a blood flow issue [and that] they need better offloading or better shoes, then they see a podiatrist. The idea is to not penalize the patient because our system is disorganized.”

Of the session at VAM, Mills tells VS@VAM that the patients’ voice will be heard with involvement from patient representatives, “to bring home how this seemingly simple problem can cause a lot of issues for patients in their lives.”

“Most of the doctors in the audience will probably get this, but to hear what happens to patients and how they perceive their care is really, really important, because often in healthcare we look at outcomes from the standpoint of the system or the doctor, and we forget about the patient,” he comments.

The session also features presentations unpacking some of the recent data underpinning advances in CLTI and diabetic foot care, and discussion of key components of team development. “This is a huge issue for our patients and we need to do better,” says Mills of what he hopes attendees will gain from joining the session. “There are barriers everywhere to setting up this type of system, but they can all be overcome. It is not hard to find a toe partner or a flow partner, and to really make a difference in your local hospital and in your local practice. The barriers that the system sets up can be overcome by clinicians who think this is a problem and want to help patients get better outcomes.”

SVS, AVF bring the latest innovations in venous disease treatment to VAM

By
Brian McHugh
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SVS, AVF bring the latest innovations in venous disease treatment to VAM
VenoValve
VenoValve

During the first day of VAM 2024, the Society for Vascular Surgery (SVS) and American Venous Forum (AVF) have co-sponsored a session on the latest innovations in the delivery of venous disease treatment.

Madhavi Meka, MD, a clinical associate professor at the University of Arizona School of Medicine and vascular surgeon at the Carl T. Hayden VA Medical Center in Phoenix, Arizona, and Faisal Aziz, MD, chief of vascular surgery at the Penn State Health Hershey Medical Center Heart and Vascular Institute in Hershey, Pennsylvania, are moderating a package of presentations (Wednesday, June 19 at 3:15–4:45 p.m. in the West Building, Level 1) focused on recognizing the various patterns of superficial venous reflux and management options, understanding what the most effective treatment for patients with iliac vein disorders is, and increasing knowledge of venous ulcer care and the influence of health inequities.

“Venous disease is more common than peripheral arterial disease [PAD], affecting nearly 30 million people in the U.S. alone,” Meka told VS@VAM. “Twenty-five percent of the global adult population are afflicted with venous reflux disease or a more serious form of venous disease called chronic venous insufficiency. The spectrum of disease ranges from spider veins, telangiectasia, varicose veins, and venous ulcers.”

The initial section focuses on superficial venous disease. Presenting first will be Glenn Jacobowitz, MD, from NYU Health in New York City, who will be discussing thermal ablation options; Karem Harth, MD, from Case Western Reserve University School of Medicine in Cleveland, is up next and will present on non-thermal ablation options; Sherry Scovell, MD, from Massachusetts General Hospital in Danvers, Massachusetts, will finish the superficial venous disease section by discussing sclerotherapy techniques.

The second section focuses on iliac venous stenosis. Arjun Jayaraj, MBBS, from the RANE Center for Venous and Lymphatic Diseases at St. Dominic’s in Jackson, Mississippi, will present on intravascular ultrasound (IVUS) and its importance for deep venous interventions. This will be followed by Misaki Kiguchi, MD, from MedStar Heart and Vascular Institute in Washington, D.C., who will discuss stenting below the inguinal ligament.

The final section of the SVS-AVF session covers venous leg ulcerations (VLUs), starting with William A. Marston, MD, from University of North Carolina at Chapel Hill, North Carolina, who will be presenting on whether deep or superficial interventions should be tackled first.

Meanwhile, Anil Hingorani, MD, from NYU Langone in Brooklyn, New York, will present next on the role of perforator veins and interventions in the context of VLUs.

And finally, the last presentation before the panel discussion will be by Leigh Ann O’Banion, MD, from UCSF Fresno in Fresno, California, who will be discussing health disparities in patients with advanced venous disease.

“Despite advancements in the techniques and procedures, there has been a paucity of literature delineating outcomes, patient satisfaction and improvement in lifestyle,” Meka states.

Elsewhere in venous disease developments, on Friday, June 21’s Plenary Session 5 (8–9:30 a.m in the West Building, Level 3, Skyline Ballroom), Cassius Iyad Ochoa Chaar, MD, from Yale School of Medicine in New Haven, Connecticut, on behalf of co-authors Claire L. Griffin, MD, Eric S. Hager, MD, Matthew R. Smeds, MD, and Marc H. Glickman, MD, will discuss the impact of the VenoValve device (EnVVeno Medical) on venous ulcer healing in patients with deep venous reflux.

The presentation features data from the multicenter Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) trial, which highlights the impact of the VenoValve device after one year of implantation for patients treated for venous ulcers.

The SAVVE trial enrolled patients with deep venous reflux and symptomatic advanced venous disease with a clinical, etiological, anatomical, and pathophysiological (CEAP) score of C4b–C6, despite standard-of-care therapy. Patient characteristics were recorded and the revised venous clinical severity score (rVCSS), wound surface area, venous ulcer healing, and improvement defined by the reduction of the area was assessed at the preoperative baseline and at three months, six months and one year. During Chaar’s VAM presentation, updated data on all patients who have reached one-year follow-up will be presented.

The latest results show the trial includes 75 total patients, 41 of whom were treated for venous ulcers and were the focus of the report.

The patient population was majority male (78%) and White (93%), with a mean age of 64. Most of the venous ulcers (70.7%) had a duration of more than one year, while only five patients (12.2%) had venous ulcers that had a duration of less than one month.

The results demonstrate high ulcer healing and reduction of ulcer surface area in a group of challenging patients, the authors will report.

“VenoValve implantation provides sustainable improvement in venous ulcer healing that continues for a year after surgery in patients who have exhausted all current standard-of-care treatments,” the authors will conclude.

Earlier this year at the Charing Cross (CX) International Symposium in London, England, David Dexter, a vascular surgeon at Sentara Vascular Specialists in Norfolk, Virginia, declared: “The surgical challenges of repairing deep venous reflux have been present for more than a generation. It is worth reflecting on the fact that this new technology has made the majority of patients vastly better.” He was speaking as he presented podium-first efficacy results from the SAVVE trial.

“These patients are the most severe of the severe,” Dexter said. He described that the “vast majority—around 60%—of these patients have active ulcers.”

Data and discussion forefront carotid session at ‘pivotal moment’

By
Jocelyn Hudson
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0
Data and discussion forefront carotid session at ‘pivotal moment’
Pallavi Manvar-Singh

Contemporary management of carotid disease after the Centers for Medicare and Medicaid Services (CMS) carotid artery stenting (CAS) decision memo and prior to CREST-2 results will be the focus of an Education Session at VAM 2024.

In October, CMS released its final decision regarding NCD 20.7 covering CAS. The move was made to expand Medicare coverage for CAS to include patients who have symptomatic carotid stenosis of 50% or greater and asymptomatic carotid stenosis of 70% or greater.

The timing of the decision has been a point of contention, having been made prior to the 2026 expected release date of CREST-2 results. This trial will compare intensive medical management alone to intensive medical management plus revascularization with carotid endarterectomy (CEA) or transfemoral CAS (TF-CAS) in patients with high-grade stenosis.

The VAM 2024 session, set for the afternoon of Friday, June 21, at 1:30 p.m. (West Building, Level 1), will see Pallavi Manvar-Singh, MD, of the Zucker School of Medicine at Hofstra/Northwell Health in Jericho, New York, and Peter Schneider, MD, of the University of California San Francisco in San Francisco, California, moderate eight podium presentations and extensive discussion.

“The management of carotid bifurcation occlusive disease is a core competency for vascular surgeons and vascular surgery continues to be vital to the development of optimized therapy for this disease process,” Manvar-Singh and Schneider told VS@VAM ahead of the Chicago meeting.

They continued: “Vascular surgeons are experts in the disease process, the longitudinal management of these patients, and different methods of carotid repair when it is indicated, whether by CEA or stent.”

The pair further remarked that therapy for both symptomatic and asymptomatic carotid disease “is well studied but remains quite dynamic” and that “updates on important developments will help us predict how the field is evolving.”

“It is a pivotal moment in the evolution of carotid disease management,” they commented. “Any one of these developing issues could substantially shape our future practices. The recent NCD is an endorsement of stent-based therapy by CMS.

“The pressure to reduce treatment and avoid screening for critical asymptomatic stenosis is increasing. The CREST-2 trial is nearly enrolled. TCAR [transcarotid artery revascularization] is nearing 100,000 procedures in the U.S., and most vascular practices have incorporated it as an option for repair.

“The growth of stroke centers will undoubtedly influence our practices, but we don’t yet know how. For all these reasons, an update on carotid disease management is essential to inform our treatment plans.”

Opening the session, Caitlin Hicks, MD, of Johns Hopkins University in Baltimore, Maryland, will deliver a review of the NCD, before Warren J. Gasper, MD, of the University of California San Francisco, shares an update on the CREST-2 trial.

Mark F. Conrad, MD, MS, of Steward Health in Brighton, Massachusetts, is due to speak on asymptomatic disease, after whom Sonya S. Noor, MD, of Gates Vascular Institute in Amherst, New York, will address the question, “Should vascular surgeons be involved in stroke centers?”

After some discussion time, the focus will turn to data. Sean P. Lyden, MD, o the Cleveland Clinic in Cleveland, Ohio, will present new data covering TF-CAS and new technologies since the last NCD, and Gregg S. Landis, MD, of the Zucker School of Medicine at Hofstra/Northwell will outline the totality of data available supporting TCAR.

The final two presentations of the session before another round of discussion will cover technique and training, respectively, from Mazin I. Foteh, MD, of Cardiothoracic and Vascular Surgeons in Dallas, Texas, and Jeffrey Jim, MD, of Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, Minnesota.

VAM 2024: Putting out the fires of intraoperative vascular emergencies

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VAM 2024: Putting out the fires of intraoperative vascular emergencies
Vascular surgeons have become the firefighters of the OR

A 2024 Vascular Annual Meeting (VAM 2024) Education Session taking place on Wednesday, June 19 (3:15–4:45 p.m. in the West Building, Level 1) will examine the most common emergency intraoperative vascular surgery consultations, along with trends in intraoperative vascular surgery consultation over time—the subject area that has seen vascular surgeons referred to as the firefighters of the operating room (OR).

The aim, through nine presentations given by speakers with broad experience in the field, is for attendees to work together to create a framework for emergency intraoperative consultation, with the assistance of expert viewpoints regarding the best options for vascular intervention for common emergency intraoperative consultation.

Moderated by Maen Aboul Hosn, MD, from University of Iowa in Iowa City, Iowa, and Bryan Dieffenbach, MD, from Scripps Health in San Diego, California, the session will begin by looking at common intraoperative emergencies for contemporary vascular surgeons with Andrew J. Soo Hoo, MD, a general surgery resident at Medical College of Georgia in Augusta.

Following on from this and three other presentations given by Rebecca Scully, MD, from Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, Gaurav Sharma, MD, from Kaiser Permanente Foundation Hospital in Santa Clara, California, and moderator Aboul Hosn, the next presentation will be given by Manju Kalra, MBBS, from the Mayo Clinic in Rochester, Minnesota, entitled “How I do it: A senior surgeon’s approach to emergency intraoperative consultation.”

The final presentation of the session, “How’re you going to fix It? Case presentation: Emergent endovascular repair of an internal iliac artery injury during an outpatient lumbar discectomy,” will be given by Tara Zielke, MD, from Indiana University Health in Indianapolis, Indiana.

Speaking to VS@VAM about the session, Aboul Hosn said it “will highlight the role of vascular surgeons in managing catastrophic bleeding events and lay out a framework for the approach to emergency intraoperative consultation by utilizing existing multidisciplinary models, available data and expert opinions.”

Vascular-VP: ‘The blueprint for what a quality vascular program should look like’

By
Bryan Kay
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Vascular-VP: ‘The blueprint for what a quality vascular program should look like’
Matthew Eagleton

Some of the benefits to quality care provision ensuing from participation in the American College of Surgeons (ACS) and SVS Vascular Verification Program (Vascular-VP) could be almost immediate.

This is among the insights set to feature during one of the most hotly-anticipated insertions on the VAM schedule.

SVS President-elect Matthew Eagleton, MD, who has made the program the subject of this year’s E. Stanley Crawford Critical Issues Forum on Wednesday, June 19 (11:15 a.m. in the West Building, Level 3, Skyline Ballroom), was speaking to VS@VAM ahead of the six-surgeon Crawford panel’s dissection of the Vascular-VP and discussion of why it matters to the improvement of quality in vascular care under the title, Quality Care Everywhere.

“I think at individual sites, you will even see the effects at the beginning of the process,” Eagleton says. “In the case of those involved in the inpatient program, the minute they start looking at—and questioning—what they are doing at their own organizations, they might see that there are lot of things that we take for granted, that we just assume may be happening, or in place, that many not be. So, with some of the changes that will need to occur at each location in order to meet verification status, there will be an immediate fix. When will we see that trickle down into measurable data changes that we can use for analysis of patient care, patient safety? That will probably take a couple of years until we see something like that.”

Eagleton’s panel includes five colleagues immersed in the conception and birth of the ACS-SVS Vascular-VP. The contingent includes Clifford Y. Ko, MD, the director of the Division of Research and Optimal Patient Care at the ACS; Anton N. Sidawy, MD, a former SVS president; R. Clement Darling III, MD, another former SVS president; William P. Shutze, MD, current SVS secretary; and Dennis Gable, MD, from Texas Vascular Associates of Dallas and Plano.

“One of the things we always try to achieve in vascular surgery is to provide patients with quality care,” explains Eagleton. “For the public, what does that mean? How do they know a location they can go to receive care is considered a quality location? That’s what this forum is about—highlighting a program that was put together in conjunction with the ACS so that we have a verification program that can provide the blueprint for what a quality program should look like within an organization.”

Ko, who oversees quality programs at the ACS, will introduce how such programs have proven successful, says Eagleton. Sidawy, chair of the Vascular-VP Steering Committee, “has been instrumental in shepherding the relationship between the ACS and the SVS” in establishing a “functional program.”

Darling will discuss the inpatient program, on which he has been a leading figure, while Shutze will dissect efforts put in to get the outpatient version off the ground. Gable, meanwhile, will talk about his personal experience implementing the Vascular-VP on his own vascular surgery service line.

“We are using this as an opportunity to educate our members about these programs, why it may be important to them and how can they get involved in utilizing them best in order to improve the quality at their locations.”

Welcome to VAM 2024!

By
Malachi Sheahan III
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Welcome to VAM 2024!
Malachi Sheahan III

To help us preview some of the sessions of interest I reached out to the chairs of the SVS Program and Postgraduate Education Committees—Andy Schanzer, Jason Lee, Will Robinson, and Claudie Sheahan. I’ll let you guess which one did not respond to my emails. ANYWAY, here are some anticipated highlights:

  • Wednesday at 5 p.m. will feature the first-ever keynote speaker. Karith Foster will present “Finishing the Journey to Inclusivity Through Belonging, Intention and Respect”
  • New hands-on opportunities will be offered with Touchpoint and Crossroads
  • For long-time VAM attendees like me, the educational programming has undergone a transformative change. This year there will be 26 sessions and there is truly something now for all members, regardless of practice type, clinical focus or academic focus. An emphasis on diverse perspectives means there will be over 200 faculty members this year
  • A new audience polling and response system will be in place for Plenary Sessions 3 and 5, along with the My Worst Cases and RPVI sessions. I will be running it for Plenary 5. What could go wrong?
  • The RPVI content will be a certified course under the APCA for certification and recertification
  • The SVSConnect@VAM will be held at Soldier Field in Chicago. We can see the turf where all the legendary Bears quarterbacks played (Trubisky! Cutler! Grossman!!!)
  • In addition to long-term partner VESS, the ESVS, AVF and WFVS will all be participating

Remember to pick up your daily copy of VS@VAM for in-depth previews of the many scientific and social options being offered up this year. There are three issues of the newspapers covering the four days of VAM programming. Finally, a reminder that VAM 2025 will be in New Orleans. Spoiler—you will NOT need to pack a jacket.

Malachi Sheahan III, MD, is Vascular Specialist medical editor.

Vascular Specialist@VAM Conference Edition 1

By
Bryan Kay
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Vascular Specialist@VAM Conference Edition 1

In this issue:

  • The Crawford Forum: Quality in care is this year’s critical issue
  • National Coverage Determination: Data and discussion come at key moment in carotid disease treatment
  • Toe and flow: The virtues of multidisciplinary care
  • Wellness: Radiation safety session aims to address variability

 

Drilling down on the roots of pathologic inflammation and wound healing challenges in diabetic patients

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Jocelyn Hudson
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Drilling down on the roots of pathologic inflammation and wound healing challenges in diabetic patients
This year’s James S. T. Yao Resident Research Award winner looks at novel therapeutic target for non-healing diabetic wounds. Kevin D. Mangum, MD, PhD, speaks to VS@VAM about his paper ahead of presenting the work at the 2024 Vascular Annual Meeting (VAM).

Mangum, who is a vascular surgery integrated resident at the University of Michigan in Ann Arbor, was announced as the winner of the James S. T. Yao Resident Research Award by the SVS Foundation for his paper ‘The STAT3-SETDB2 axis dictates NFKB-mediated inflammation in macrophages during wound repair.”

This award is designed to support emerging medical professionals exploring vascular disease biology and innovative translational therapies. It recognizes unpublished, original scientific work in manuscript form that demonstrates publication quality. The recipient will present his research during the William J. von Liebig Forum, which takes place on the morning of Wednesday, June 19, at 8:10 a.m. (West Building, Level 3, Skyline Ballroom).

Kevin D. Mangum

In the prize-winning paper set to be presented at this year’s Chicago gathering, Mangum sought to determine the transcription mechanisms regulating SETDB2 expression and activity in wound macrophages. “This is important given the critical and dynamic role that SETDB2 plays in regulating inflammatory gene transcription in wound repair,” he and colleagues at the University of Michigan write in their manuscript.

Mangum conducted his research under the mentorship of Katherine Gallagher, MD, vice chair of basic and translational science and professor of surgery in the Section of Vascular Surgery at the University of Michigan. Speaking to VS@VAM ahead of his presentation, Mangum outlined the evolution of his work. “Over the past two years in the Gallagher lab my research has expanded from epigenetic regulation of immune cells in the wound bed to transcriptional alterations in vascular smooth muscle cells in the arterial wall,” he explained. “We’ve been able to dissect specific DNA-protein and protein-protein interactions regulating macrophage phenotype in wound repair and have applied a similar approach to identifying central transcription mechanisms regulating other disease processes like atherosclerosis and hypertension, which will be the central focus of my research investigations after residency.”

Focusing on the specifics of the paper, Mangum continued: “In our manuscript, we build on prior research studying the histone methyltransferase, SETDB2, which is expressed in macrophages and functions to repress inflammation. We’ve shown that macrophages from diabetic patients actually have lower amounts of SETDB2, which is one mechanism underlying pathologic inflammation and worse rates of wound healing in this population. My research really delves into the exact upstream transcription factors controlling SETDB2 expression, as well as those transcriptional regulators binding to SETDB2 protein to further modulate macrophage phenotype.”

In their research manuscript, Mangum and colleagues give further details about the investigation. “We identified that SETDB2 functions with NFKB to regulate the pro-inflammatory transcriptional repertoire in macrophages during wound healing by targeting NFKB-dependent gene regions,” they write, continuing: “We also demonstrate that the transcription factor, STAT3, regulates SETDB2 via two pathways. First, in normal wound macrophages, STAT3 increases SETDB2 expression, which decreases inflammation. In contrast, by a separate mechanism, STAT3 also limits SETDB2 activity by physically binding to and preventing it from trafficking to inflammatory genes.” He explains the importance of this, stating: “Our work identifies a completely novel role for a well-known transcription factor, STAT3, in sequestering SETDB2 from NFkB and its associated gene regions. Strikingly, we found STAT3-SETDB2 binding was increased in diabetic macrophages, thereby leading to increased inflammation. This work has larger implications for transcriptional regulation because it identifies previously unknown functions of critical transcription factors in the regulation of downstream gene expression and cell phenotype.”

“By defining a novel STAT3-SETDB-NFKB axis,” they write in their conclusion, “we have identified several potential targets to treat non-healing diabetic wounds in a cell-specific and time-dependent manner.” For example, Mangum and colleagues state that immunomodulators during early wound healing to increase or activate STAT3 in order to increase SETDB2 expression may be useful. In addition, they write that inhibiting STAT3 relatively later in diabetic wound healing “may prove useful to increase SETDB2 localization to active inflammatory gene regions, thereby inhibiting pathologic inflammation and improving tissue repair.”

In terms of what is next for Mangum in the Gallagher lab, the vascular surgery resident commented that he and the team have “several exciting things” in the pipeline. “We’re mapping the specific protein domains mediating the interactions between SETDB2, STAT3 and NFKB in macrophages in hopes of developing a novel small molecular inhibitor of these interactions that can be used to treat diabetic wound healing in a cell-specific manner.”

Mangum’s “ultimate goal” after completing residency, he told VS@VAM, is “to really understand how additional chromatin modifiers like SETDB2 are functioning in other cell types, specifically in vascular smooth muscle cells, to regulate vascular disease.”

SVS resident and student program boosts interest in vascular surgery amid workforce crisis

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Jocelyn Hudson
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SVS resident and student program boosts interest in vascular surgery amid workforce crisis
Cassius Iyad Ochao Chaar
Cassius Iyad Ochao Chaar

Against the backdrop of a national shortage in the vascular surgery workforce, a recent study has found that the Society for Vascular Surgery (SVS) VAM General Surgery and Medical Student Program “has a positive impact on interest in vascular surgery,” with more than 50% of scholarship recipients matching into the field.

Paula Pinto Rodriguez, MD, a postdoctoral research fellow at the Yale School of Medicine in New Haven, Connecticut, is set to present this finding during the William J. von Liebig Forum (Wednesday, June 19, 8:10–9:45 a.m. in the West Building, Level 3, Skyline Ballroom). Rodriguez will add that the quality of the program and the number of scholarships correlate with vascular surgery Match rates and thus advise that additional investment in similar programs “could help close the gap in the workforce.”

The overarching aim of the study, led by senior author Cassius Iyad Ochoa Chaar, MD, associate professor in surgery at Yale School of Medicine and chair of the SVS Resident and Student Outreach Committee (RSOC), was to increase interest in the vascular surgery specialty. The SVS RSOC developed a dedicated program for general surgery residents and medical students at VAM and invested in a scholarship program to support attendee expenses, with the study’s main objective being to assess the program’s effectiveness, correlating recipient feedback with likelihood of matching into a vascular surgery training program.

Rodriguez, Chaar and colleagues detail in their abstract that records related to the VAM initiative from 2013–2023 were reviewed, focusing on evaluations of the program. They note that the program included a simulation session from 2013–2019.

Going into the specifics of the study methods, the researchers outline that the average Match rate into vascular surgery was used to divide the data into below-average and above-average groups.

Furthermore, they write that survey responses were based on a five-point Likert scale and allowed for comments, with responses divided into high value, strongly favoring the activity, and low value. The data from years of above- and below-average Match rate were compared. The study revealed that the SVS awarded general surgery residents and medical students 1,040 travel scholarships over 10 years.

Rodriguez, Chaar et al found that, overall, applicants had a 43% success rate in receiving a scholarship, with the annual number of applicants increasing, while the number of scholarships and Match success rates significantly decreased over time. In addition, the research team established that the average Match rate into vascular surgery among scholarship recipients was 50.2%, decreasing over time.

Rodriguez, Chaar and colleagues further detail that the survey response rate was 33%. Results from the survey showed that, during above-average Match rate years, evaluations for simulation allotted time and lectures were significantly more likely to be high value compared to below-average years.

In addition, they reveal that simulation content and residency fair consistently had the most favorable evaluations, and that, overall, the program had a consistently positive impact on recipients’ interest in vascular surgery.

Additional findings include the fact that trainees in the above-average group were significantly more likely to provide positive comments, and that several recipients commented on the need for a dedicated space to interact with faculty and mentors, and highlighted simulation as the standout aspect of the program.

“Our study demonstrates the positive impact that the program has on trainees’ interest in vascular surgery and highlights the return on investment to our society. Expanding this program and developing similar ones in other vascular surgery societies is crucial to keep attracting the brightest trainees to our specialty,” Chaar told VS@VAM ahead of the presentation.

Rutherford lecture at world federation session set to feature vascular low frequency disease consortium director

By
Bryan Kay
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Rutherford lecture at world federation session set to feature vascular low frequency disease consortium director
Peter F. Lawrence
Peter F. Lawrence

The director of the Vascular Low Frequency Disease Consortium (VLFDC) is set to be among the headline presenters at this year’s World Federation of Vascular Societies (WFVS) Educational Session on Wednesday, June 19 (7–8 a.m. in the West Building, Level 1). Peter F. Lawrence, MD, also a former SVS president, will deliver the Rutherford Lecture, covering how the WFVS can play a role in helping the VLFDC widen its research efforts.

The WFVS session will feature seven of the member societies from across the globe that make up the federation, and be co-moderated by Palma Shaw, MD, WFVS secretary-general, and Prem Gupta, the current WFVS president.

“The WFVS continues to have consistent representation at VAM, with the European Society for Vascular Surgery [ESVS], the Society for Vascular Surgery [SVS], the Vascular Society of India [VSI], the Japanese Society for Vascular Surgery [JSVS], Vascular Society of Southern Africa [VASSA], the Latin American Association for Vascular Surgery [ALCVA] and the Australian and New Zealand Society for Vascular Surgery [ANZSVS] all taking part this year,” says Shaw.

Lawrence’s lecture will crown the series of presentations covering a number of vascular disease beds and issues facing vascular surgery on a global scale.

With the VLFDC, the WFVS intends to form ties in order to foster “more intense collaboration” going forward, Shaw tells VS@VAM ahead of the VAM 2024 event.

“The VLFDC already reaches out to different parts of the world, but the WFVS makes it more strategic, and in this way we can have representation from all over the federation membership, expanding the opportunities for collaboration and research.”

The WFVS continues to expand its own reach since recalibrating in 2021 and taking on new administrative headquarters at the SVS offices in Chicago. The Federation recently staged a session that placed a focus on leadership challenges at the Charing Cross (CX) International Symposium in London, England, while another WFVS run will take place later this year at the 2024 VEITHsymposium in New York City.

The WFVS’ own annual meeting, slated to be hosted by the serving president’s home society, the VSI, in Jaipur, India, in October, will feature two dedicated WFVS sessions. The VSI-WFVS tandem will play host to the recently established inaugural Roger M. Greenhalgh Lectureship, which will be given by Alan Lumsden, MD, the Walter W Fondren III presidential distinguished chair at Houston Methodist’s DeBakey Heart & Vascular Center in Houston, Texas, and president-elect of the Southern Association for Vascular Surgery (SAVS). Greenhalgh, who passed away in October last year was chairman and founder of the CX Symposium and a world renowned vascular surgeon.

“Overall, we are seeking to bring more consistent representation, more of an international presence to VAM,” Shaw continues. “This allows for more interaction between the member societies around the world, and now allowing for expansion into more research efforts.”

One such WFVS research outreach involves collaboration on rare diseases. The effort is geared toward establishing global guidelines. “This collaboration to develop guidelines for rare diseases is already underway, and, of course, separately, in a similar vein, we are collaborating with the VLFDC.”

Among the other highlights at the WFVS session at VAM, meanwhile, is a presentation from SVS member Vincent L. Rowe, MD, chief of vascular surgery at University of California, Los Angeles (UCLA), in which he will pose the question: “Peripheral arterial disease on the global scale: Are we winning or losing the battle?”

Elsewhere on the program, Syed Mohammed Ali Ahmed, MBBS, from the VSI, will deliver a talk on “Management of lymphedema nostrus verrucosa.”

Dedicated session offers insight on ebbs and flows of SVS, ESVS guidelines

By
Jocelyn Hudson
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Dedicated session offers insight on ebbs and flows of SVS, ESVS guidelines

An education session set to take place in the afternoon of Wednesday, June 19 (3:15–4:45 p.m. in the West Building, Level 1), will examine discrepancies between Society for Vascular Surgery (SVS) and European Society for Vascular Surgery (ESVS) clinical practice guidelines.

The session centers around the fact that, with the exception of the 2019 Global Vascular Guidelines on the management of chronic limb-threatening ischemia (CLTI), the production and release of clinical practice guidelines by the respective journals of the SVS and ESVS are not coordinated or managed between these societies. Furthermore, recommendations between societal guidelines often differ, leave gaps or content areas unaddressed, or unilaterally define new content areas unique to a specific society.

Against this backdrop, the VAM 2024 session has four key aims: to highlight differences between the SVS and ESVS guidelines and how they play out in day-to-day clinical practice; to examine the scientific, cultural, societal and personal reason(s) behind these respective differences; to gain insight into the guideline development processes between the SVS and ESVS; and to consider future publication upgrades between the respective societies to harmonize recommendations or contextualize differences when apparent, in order to enhance understanding and adaptation when appropriate.

Moderating the session will be Firas Mussa, MD, of the University of Texas Health Science Center at Houston, Texas; Ronald Dalman, MD, of Stanford University in Stanford, California; Ian Loftus, MD, of St. George’s University Hospitals NHS Foundation Trust in London, England; and Thomas Forbes, MD, of the University of Toronto, Canada.

Speaking to VS@VAM, Mussa underscores what attendees can expect. “The session is meant to highlight where the SVS and ESVS might agree or disagree on clinical practice patterns. […] Furthermore, it is meant to touch on the drivers of patient care in the U.S. as compared to Europe,” he says.

Dalman notes that “there are a few important differences in guideline recommendations between those outlined by the SVS and the ESVS” and that SVS members and VAM attendees “will be interested to learn the rationale and evidence behind these differences—and make up their own minds regarding how to manage patients with these challenging conditions based on the explanations provided.”

Dalman anticipates the debate-format session will be “lively and highly engaging” and is one VAM attendees “won’t want to miss.”

Loftus remarks that international clinical guidelines are “important tools to guide patient pathways and decision-making for individual patients,” and that each set of guidelines from the SVS and the ESVS “take many months of intense collaboration between key opinion leaders in the field.” He continues, “While [society guidelines] undoubtedly advance the care of patients with vascular disease, there are often differences between individual recommendations made either side of the Atlantic, which stimulate debate and occasional controversy. It is important that guidelines reflect different healthcare systems, disease patterns and expectations of clinicians and patients alike.

“In this exciting session, we will highlight and debate some of the key differences in our important guidelines, and how they have influenced decision-making with real case examples,” Loftus says.

Forbes notes that the editors of the Journal of Vascular Surgery and the European Journal of Vascular and Endovascular Surgery have brought together an international panel to discuss the guidelines. “We’re looking forward to this session and what should be a robust discussion around these clinically relevant practice recommendations, as well as to explore opportunities to harmonize these efforts in the future,” he tells VS@VAM.

The session will cover four guideline topics, namely the management of aortic graft infection, asymptomatic carotid stenosis, intermittent claudication and the management of incompetent perforators in venous disease. Due to speak on the latter, Maarit Venermo, MD, PhD, of Helsinki University Hospital in Helsinki, Finland, highlights that the recommendations on invasive treatment of perforator veins are very different between SVS and ESVS, with the key variance being that the ESVS “is much more conservative when it comes to the invasive treatment of perforators.” These differences will be discussed in this session around a patient case, with Venermo noting that patient cases will feature throughout the session.

Pediatric vascular care in focus: Raising awareness of supportive care processes

By
Marlén Gomez
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Pediatric vascular care in focus: Raising awareness of supportive care processes
Dawn Coleman

In 2021, the Society for Vascular Surgery (SVS) and the American Pediatric Surgical Association (APSA) established a task force dedicated to optimizing pediatric vascular care through a multidisciplinary educational approach. The task force created a Pediatric Vascular Surgery Interest Group, and now, following three previously completed recorded sessions, the task force will host its fourth Pediatric Vascular Surgery Interest Group session at the 2024 Vascular Annual Meeting (VAM 2024) that will tackle pediatric vascular trauma topics.

Scheduled for Wednesday, June 19, this case-based session will cover pediatric vascular trauma’s diagnostic and technical considerations. Session discussions will include diagnostic imaging for children that consider contrast media and radiation exposure, technical aspects of open surgery, as well as growing endovascular options and the management of iatrogenic vascular trauma. Additionally, the session aims to raise awareness among practitioners about supportive care processes and specialized resources needed for pediatric vascular trauma patients and their families, particularly considering social challenges such as domestic and gun violence.

Dawn Coleman, MD, division chief at Duke University in Durham, North Carolina, and SVS co-chair of the task force, highlights the practical benefits of attending, stating, “this session will equip attendees with valuable insights and practical guidance, empowering them to enhance patient outcomes and address pressing issues in pediatric vascular care.”

To facilitate ongoing education and resource sharing, SVS staff on the task force have launched a website featuring recordings of past sessions. These include “Extracorporeal life support: Cannulation strategies, decannulation strategies and long-term follow-up,” “Pediatric vascular trauma” and “Developmental vascular disease.” For more information, visit vascular.org/SVSAPSAtaskforce.

The most recent recording on developmental vascular disease highlighted the task force’s commitment to multidisciplinary discourse on developmental vascular anomalies. Pediatric surgeon and task force member Sandra Tomita, MD, emphasized the importance of a multidisciplinary approach in the management of these anomalies, setting the stage for collaborative case presentations and discussions featuring experts such as Francine Blei, MD, and Dana LeBlanc, MD. Multidisciplinary case presentations and discussions, labeled “How We Do It,” showcased innovative approaches and best practices from institutions nationwide where experts shared insights into their respective areas of expertise.

SVS co-chair John White, MD, chair of surgery at Advocate Lutheran General Hospital in Park Ridge, Illinois, underscores the task force’s dedication to advancing pediatric vascular care: “By identifying key areas for education, guideline development and training, we aim to elevate the standard of care for pediatric vascular patients.”

The task force is also working on a collaborative special issue on pediatric vascular surgery, which will be co-published in the Journal of Vascular Surgery (JVS) and the Journal of Pediatric Surgery. “The special issue co-published in the journals will be a landmark resource, bringing together cutting-edge research and clinical expertise to transform pediatric vascular care,” said Coleman.

“Our partnership allows us to harness vascular and pediatric surgery expertise, ensuring comprehensive and effective care for pediatric patients with vascular conditions. By disseminating our findings through journals, we aim to reach a wider audience, ultimately improving outcomes for children with vascular issues worldwide.”

Pushing the boundaries of vascular care: VQI meeting kicks off at VAM

By
Marlén Gomez
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Pushing the boundaries of vascular care: VQI meeting kicks off at VAM
Jens Eldrup-Jorgensen

The Vascular Quality Initiative (VQI) is hosting its two-day annual conference at the 2024 Vascular Annual Meeting (VAM 2024) from June 18–19, drawing healthcare professionals dedicated to advancing the quality and safety of vascular care.

This event, organized with the assistance of the Society for Vascular Surgery (SVS), aims to foster collaboration and knowledge exchange among medical practitioners.

The VQI has assembled a network of 14 registries, compiling comprehensive data from more than one million vascular procedures conducted across the U.S., Canada and Singapore. This dataset, which tracks patient information from initial hospitalization through one-year follow-up, enables medical centers and providers to benchmark their performance against regional and national standards.

Participants in the VQI receive biannual dashboards and regular performance reports, empowering them to implement effective quality improvement measures. Additionally, biannual regional meetings provide a platform for physicians, nurses, data managers, quality officers and other stakeholders to share insights and best practices in a collaborative environment. The biannual Mid-America meeting will take place during the VQI meeting on Wednesday, June 19, at 5 p.m. Central Time.

Jens Eldrup-Jorgensen, MD, the medical director of the SVS Patient Safety Organization (PSO), emphasized the transformative impact of VQI data on vascular care. “By leveraging comprehensive clinical data, we can enhance the quality of care at both local and national levels, reducing complications and healthcare costs,” he stated. The data support risk stratification, outcomes analysis, quality improvement initiatives and the development of best practices.

A key technological underpinning of the VQI is the Fivos PATHWAYS platform, a secure, cloud-based system that facilitates real-time data collection and long-term outcomes assessment. This technology has been instrumental in helping participating centers improve patient care, driving scientific discoveries and ultimately saving lives.

During the sessions on Tuesday, June 18, VQI will showcase updates and enhancements to its Fivos registry reporting and product offerings. These improvements aim to better integrate electronic medical records (EMR), enhance reporting capabilities and update product features. Fivos has introduced reports covering various procedures, including carotid artery stenting (CAS), carotid endarterectomy (CEA), endovascular aneurysm repair (EVAR), peripheral vascular intervention, thoracic endovascular aortic repair (TEVAR), hemodialysis access, venous, inferior vena cava (IVC) filter and infrainguinal bypass.

The 2023 claims validation process has significantly improved, with reminders sent to all relevant centers. The deadline for completing the validation—including all reconciliation steps and corrections to PATHWAYS data—is July 15.

Also on Wednesday, the conference will delve into 30-day readmissions and their relation to initial index procedures. A recent study analyzed one-month readmission rates to understand their relationship to initial procedures, aiming to identify patterns and potential improvements in patient outcomes.

Conducted from October 2018 to November 2023 with a sample size of 3,443 procedures, the study collected readmission data on 3,395 patients, with 331 readmitted within 30 days. The findings underscore the complexity of readmissions and highlight the need for a nuanced classification system to address patient care post-procedure.

“As VQI and VAM 2024 continue to push the boundaries of vascular care, the collaborative spirit and innovative advancements showcased at this year’s meeting highlight the ongoing dedication to improving patient outcomes and advancing the field of vascular surgery,” said Eldrup-Jorgensen.

To register for the VQI conference, visit vascular.org/VQI24.

VAM 2024: Presidential welcome

By
BIBA Publishing
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VAM 2024: Presidential welcome
Joseph L. Mills

It is with great excitement and anticipation that I welcome you to the Vascular Annual Meeting (VAM), taking place from June 19–22 in the city of Chicago. This year’s meeting promises to be an exceptional convergence of the brightest minds and most dedicated practitioners in vascular surgery.

VAM 2024 is not just another conference—it’s a dynamic gathering where innovation meets expertise. Over four days, we will offer premier educational sessions, groundbreaking research presentations and interactive panel discussions. This year’s program is designed to ignite your curiosity and fuel your passion for excellence in vascular care.

As we look forward to the meeting, we also mark the end of an era for two of our distinguished colleagues. Andres Schanzer, MD, who has been an integral part of the Society for Vascular Surgery (SVS) Program Committee for the past decade and served as the VAM program chair, will be concluding his term. Likewise, William Robinson, MD, who has been a cornerstone of the Postgraduate Education Committee (PGEC), will be finishing his term. Their contributions have been invaluable, and we owe them a debt of gratitude for their dedication and leadership.

One of the highlights of VAM will be the inaugural SVS Keynote Speaker Series, headlined by Karith Foster, the CEO of Inversity Solutions. Her insights will undoubtedly inspire and challenge us to think beyond the conventional boundaries of our field.

Another event not to be missed is the E. Stanley Crawford Critical Issues Forum. For those looking to immerse themselves in the local culture, we’re bringing the spirit of Chicago football to Soldier Field with our second annual SVS Connect@VAM: Building Community.

The SVS section sessions will provide a broad exposure into the latest advancements in our field, offering valuable insights and practical knowledge. These sessions are designed to foster a dynamic and well-informed community of vascular surgeons.

For those in the early stages of their working life, our career fair presents an unparalleled opportunity to explore a wide range of career options across the country. Networking with peers and potential employers can significantly impact your professional journey.

Finally, don’t miss the SVS Foundation Gala. This event includes complimentary round-trip transportation from the Marriott Marquis to the Museum of Science and Industry for an opportunity to relax and celebrate our shared achievements in a grand setting.

If you forgot to cast your electronic ballot for vice president in the SVS officer election, you can do so in person at VAM 2024 until 2 p.m. Central Time on Friday, June 21. Finally, to fully benefit from VAM 2024, I encourage you to stay for all four days. The comprehensive learning opportunities, professional development sessions and networking events are designed to maximize your experience and provide you with the tools you need to excel in your practice.

Welcome to VAM 2024! Let’s make this an unforgettable meeting filled with learning, collaboration and inspiration.

Warm regards,

Joseph L. Mills, MD

SVS president

Boston Scientific announces agreement to acquire Silk Road Medical

By
Éva Malpass
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Boston Scientific announces agreement to acquire Silk Road Medical

Boston Scientific has announced that it has entered into a definitive agreement to acquire Silk Road Medical, a medical device company involved in producing products to be deployed during transcarotid artery revascularisation (TCAR). The purchase price is US$27.50 per share, reflecting an enterprise value of approximately US$1.16 billion.

“The TCAR platform developed by Silk Road Medical is a notable advancement in the field of vascular medicine, which has revolutionised stroke prevention and the treatment of carotid artery disease,” said Cat Jennings, president, vascular, peripheral interventions, at Boston Scientific. “We believe the addition of this clinically differentiated technology to our vascular portfolio demonstrates our continued commitment to provide meaningful innovation for physicians who care for patients with peripheral vascular disease.”

The TCAR system gained US Food and Drug Administration (FDA) approval in 2015 and is supported by several clinical studies demonstrating a reduced risk of stroke and other complications associated with traditional open surgery. The products sold by Silk Road Medical are the only devices commercially available for use during the TCAR procedure.

Boston Scientific expects to complete the transaction in the second half of 2024, subject to customary closing conditions. Silk Road Medical has guided to net revenue of approximately US$194–198 million in 2024, representing 10–12% growth over the prior fiscal year. The impact to Boston Scientific adjusted earnings per share is expected to be immaterial in 2024 and 2025, and accretive thereafter.

Verified vascular! Quality care in vascular disease

By
Bryan Kay
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Verified vascular! Quality care in vascular disease
Matthew Eagleton

The Society for Vascular Surgery (SVS) and American College of Surgeons (ACS) Vascular Verification Program (Vascular-VP) will be a central focus on the opening day of the 2024 Vascular Annual Meeting (VAM) as the topic of the E. Stanley Crawford Critical Issues Forum.

The Crawford Forum, traditionally put together by the SVS president-elect, drills into the existential issues facing vascular surgery, with quality in vascular care being an ever-increasing priority for the SVS. This year’s incoming President Matthew Eagleton, MD, has assembled an experienced cast of speakers under the moniker: Quality Care Everywhere. Following a short introduction from Eagleton, Clifford Y. Ko, MD, the director of the Division of Research and Optimal Patient Care at the ACS, will open the session with an overview of the ACS’ quality initiative, quality campaign, and its collaborations with specialty organizations.

Anton N. Sidawy, MD, a former SVS president and one of the driving forces behind the Vascular- VP, will then outline how the vascular-specific quality program came about. Sidawy will be followed by R. Clement Darling III, MD, another former SVS president, who is set to showcase the inpatient side of the Vascular-VP. William P. Shutze, MD, SVS secretary, will run down the workings of the outpatient version of the program.

Darling’s institution, the Albany Medical Center in Albany, New York, was among the first cohort of centers to gain both inpatient and outpatient Vascular- VP status. Shutze’s center, Baylor Scott & White Heart Hospital in Plano, Texas, was among the first tranche of hospitals verified on the inpatient side.

The Crawford Forum will be rounded out with a subjective analysis of how the Vascular-VP impacts practice from Dennis Gable, MD, from Texas Vascular Associates, which operates in both Dallas and Plano, a Dallas suburb. Gable will present, “Personal experience and the ‘value add’ to a vascular surgery practice and service line from the Vascular-VP,” before the session is opened up to audience participation.

The VAM 2024 program—which will see Joseph L. Mills, MD, deliver his presidential address on Friday morning—is stacked with top-tier education content that is both clinical and non-clinical across four days. The conference received record-breaking submission numbers when it came to abstracts and education sessions, causing great excitement amongst the VAM Program Committee and Postgraduate Education Committee (PGEC) as they organized this year’s agenda.

“There will be 26 education sessions across the first three days of the meeting,” said William Robinson, MD, chair of the PGEC. “We were excited to see a record-breaking 90 proposals submitted for VAM 2024 education sessions. These were submitted last autumn and initiated a process of session selection and development, which continued through this spring. Our committee is very excited about the 2024 education program, which is both cutting-edge and as comprehensive as possible.”

Robinson expressed his excitement over the breadth and depth of content and the expanding faculty for the 2024 meeting. “We have 188 expert faculty in the education program; we placed an emphasis on representing the broad SVS membership when choosing faculty members,” he said.

“As for the sessions, multiple will be interactive with the audience, and some have already solicited case submissions from attendees to feature in the sessions to help drive the discussion. I think these cases and the utilization of interactive formats will bring a variety of unique perspectives to the meeting and hopefully make the audience feel more engaged.”

Robinson is wrapping up his final year as chair of the PGEC at VAM, having been on the committee since 2016. His tenure on the PGEC draws to a close alongside SVS Program Committee Chair Andres Schanzer, MD, who expressed similar enthusiasm to Robinson when it came to VAM 2024 programming.

“This was an exciting year to be a part of the Program Committee, and not just from the scientific session standpoint,” he said.

“With the debut of the inaugural SVS Keynote Speaker Series, SVS Connect@VAM taking place at Soldier Field, and the many increased opportunities to network with colleagues, friends and industry, I am more excited for this year’s SVS VAM than any other we have had in the past.”

Between the plenary, How I Do It video, and Vascular and Endovascular Surgery Society (VESS) sessions, alongside international and poster presentations, more than 50% of the abstract submissions were accepted for VAM 2024, according to Schanzer. Then, of course, will come Mills’ presidential swansong, followed on Friday night by the annual Gala. Schanzer and Robinson both worked with VAM 2024 faculty, the SVS Young Surgeons Section (YSS) and SVS staff to increase promotion of high-impact work that was done by investigators to get more people interested in what the conference is offering.

For the third year in a row, YSS volunteers worked with the chairs to develop the visual VAM campaign, which hosts visual representations of abstracts and invited sessions that will debut at VAM 2024. Weekly videos were posted across SVS social media accounts to give viewers a quick glimpse into clinical education that will be covered at the meeting. “It has been great to see SVS members and other vascular surgery community members interact with the content on social media,” said Schanzer, “I only hope that this is half of the excitement that we are going to see from the attendees at VAM.”

With the meeting set for record-breaking attendance numbers, a larger focus on networking and togetherness, an expanded number of educational sessions with innovative formats, and a broadening of the VAM travel scholarship program, to name a few, Robinson and Schanzer have set a high bar for VAM going forward.

To register, visit vascular.org/VAM24Reg.

VasQ: The next standard-of-care innovation

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BIBA Publishing
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VasQ: The next standard-of-care innovation
Ellen Dillavou

This advertorial is sponsored by Laminate Medical Technologies.

At the 2024 Charing Cross (CX) International Symposium (April 23–25) in London, England, the Vascular Access Masterclass Controversies session delved into the question, “We have new technology, but do we need it?” Among the notable presentations, Ellen Dillavou, MD, division chief of vascular surgery at WakeMed Hospitals in Raleigh, North Carolina, ignited discourse on whether extravascular support should redefine the standard of care in surgical fistula creation. Advocating for the adoption of the VasQ extravascular nitinol support by Laminate Medical, Dillavou underscored its potential to address numerous prevalent challenges in fistula creation, positioning it as a pivotal innovation in dialysis access.

“Sometimes, it is difficult to see a change in the standard of care as it happens,” Dillavou said as she began her presentation, acknowledging the gradual evolution of medical standards and drawing parallels with the transformative impact of guidelines such as those set forth by the Kidney Disease Outcomes Quality Initiative (KDOQI) in the United States. “We can look back in the U.S. and see that the KDOQI guidelines emphasizing fistula use definitely changed the way we practiced. [They] made more fistulas available for standard use, but it came with costs like increased catheter use, more procedures per usable fistula and a decrease in primary patency results.”

Dillavou emphasized the need for enhanced access solutions with fewer interventions, lower infection rates, and faster maturation, highlighting that “the VasQ device can solve a lot of these problems” by mitigating common issues encountered in standard fistulas, such as stenosis and aneurysmal dilation by “keeping the fistula at an optimal angle and offering support to that dissected area of the vein to counteract the shear stress.”

Central to her argument were compelling datasets supporting VasQ’s efficacy. Referencing studies including a randomized controlled trial by Nikolaos Karydis, MD, assistant professor in general and transplant surgery at the University of Patras in Patras, Greece, and research by Robert Shahverdyan, MD, head of vascular access at Asklepios Klinik Barmbek in Hamburg, Germany, Dillavou showcased consistent improvements in maturation rates and primary patency with VasQ utilization. Furthermore, she presented findings from an ongoing study comparing VasQ to conventional methods, indicating superior functionality and patency outcomes with the device and pointed to Shahverdyan’s long-term success using the device as standard of care.

“When [Shahverdyan’s] practice shifted to using VasQ as part of his standard of care, he had a drastic reduction in primary failures and an increase in primary patency at six months,” said Dillavou, who also referred to a study that she had contributed to that compared VasQ to historic controls. “In the U.S., when we contrasted VasQ fistulas to historic controls, we found increased functionality at three and six months, and increased primary patency at all time-points. When we look at the body of literature in historic unsupported fistulas versus VasQ, we see a clear trend towards enhanced patient outcomes when they are externally supported.”

Beyond immediate postoperative benefits, Dillavou emphasized the long-term advantages of VasQ providing permanent structural support. Drawing from retrospective analyses, she illustrated reduced catheter days, decreased infection-related hospitalizations, and diminished incidences of complications such as steal syndrome and aneurysm formation. “This global view shows that patients have fewer catheter days and have fewer infection-related hospitalizations at one year. We also see that two years after creation with an external support device, we are seeing fewer instances of steal, and we’re seeing less aneurysmal formation,” said Dillavou.

Addressing concerns regarding costs, Dillavou highlighted substantial cost savings estimated based on the existing clinical data. The potential for significant healthcare expenditure reduction with VasQ integration has been replicated in multiple countries, such as the United Kingdom, Italy, Germany and the U.S. She also highlighted that VasQ has now reached Asia with Yong Enming, MD, and Zhang Li, MD, both from Tan Tock Seng Hospital in Singapore, underscoring global interest in exploring both the clinical and economic implications of VasQ adoption.

Following Dillavou’s presentation, audience participation was invited, leading to inquiries delving into technical considerations and comparative efficacy, with insights provided by panelists including experienced VasQ users like Shahverdyan and Nicholas Inston, MBBS, a consultant surgeon at University Hospitals Birmingham in Birmingham, England.

Speaking to Vascular Specialist regarding the role that VasQ has to play in the future of arteriovenous fistulas (AVFs), Inston, the session’s moderator, said: “The signal coming from multiple global studies consistently shows that VasQ has better outcomes than those in traditional surgical studies. If we strive to improve the outcomes of AVFs, we need to take these data seriously.”

Shahverdyan also shared his thoughts on the device, saying: “Looking at our experience of over six years with almost 300 VasQ implants—mostly for radiocephalic AVF creation, which historically have shown to fail more commonly—and the existing evidence throughout the globe on the outcomes of VasQ device, it consistently demonstrates significantly better outcomes in dialysis patients with extremely low safety concerns: we have observed zero cases of infection, steal or juxta-anastomotic aneurysms. Hence, it is justified to say that we as caregivers should provide our patients with best possible treatment options and consider the application of the VasQ device as standard of care.”

The discourse surrounding VasQ at the CX Symposium underscores a paradigm shift in dialysis access management, with mounting evidence and key experts heralding its potential role as a transformative standard of care. Of course, skepticism still exists based on the bulk of VasQ’s evidence from observational studies, especially compared to the numerous randomized controlled studies for technologies like drug-coated balloons (DCBs).

In response to comments regarding the level of evidence for VasQ in comparison to DCBs, Dillavou closed out the discussion by stating that “there’s more agreement in the VasQ device than there is for DCBs.” This statement highlights that the strength of the VasQ data has been in the consistent clinical benefit across multiple studies that is not typically observed for many new technologies.

Learn more about VasQ at laminatemedical.com.

CEA vs TCAR: Surgeons should be familiar with both procedures and ‘collaborate as needed’

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CEA vs TCAR: Surgeons should be familiar with both procedures and ‘collaborate as needed’
Andrea Alonso, MD (left) and Jeffrey J. Siracuse, MD

When it comes to the ongoing debate of carotid endarterectomy (CEA) versus transcarotid artery revascularization (TCAR) in the treatment of carotid artery stenosis, operators should be comfortable and maintain experience with both of these procedures—and “collaborate as needed.” That is the ultimate finding of a registry analysis set to be presented later this week at the 2024 Vascular Annual Meeting (VAM; June 19–22) in Chicago during Plenary Session 1: William J. von Liebig Forum (8:10–9:45 a.m. in the West Building, Level 3, Skyline Ballroom).

The analysis in question will be delivered by Andrea Alonso, MD, a research resident at Boston University in Boston, on behalf of lead author Jeffrey J. Siracuse, MD, professor of surgery and radiology at Boston University, and colleagues.

“Our study observed an inverse relationship between the proportion of a procedure—either TCAR or CEA—conducted by a surgeon, and the rate of postoperative stroke, with surgeons performing the lowest proportion having the highest stroke rates,” Alonso told Vascular Specialist. “Our data also suggest that, among surgeons with a more balanced practice, there continues to be a low rate of stroke. To minimize postoperative stroke risk, we conclude that surgeons who offer both types of carotid revascularization procedures maintain a balance. We also suggest collaboration in challenging cases, leveraging the diverse expertise within a practice, to reduce stroke risk.

“We believe that this can be done effectively in the preoperative setting while evaluating challenging cases and with advanced coordination with colleagues to assist in key parts of the operation. This step takes insight from the lead surgeon to recognize the surgical techniques that they may require more assistance with at that stage in their practice, as well as camaraderie within the practice group.”

According to the authors, TCAR adoption among surgeons has been variable—many still perform more traditional CEAs, while others have shifted mostly to TCAR in their practice. Researchers therefore set out to evaluate the association between surgeons’ relative volumes of CEA to TCAR, and perioperative outcomes, via analyses of the Vascular Quality Initiative (VQI) CEA and carotid artery stenting (CAS) registries from 2021–2023.

Across both registries, participating surgeons were categorized in the following CEA/TCAR volume percentage ratios: 0–25/76–100 (majority TCAR); 26–50/51–75 (more TCAR); 51–75/26–50 (more CEA); and 76–100/1–25 (majority CEA). Primary outcome measures for the analysis consisted of rates of perioperative ipsilateral stroke, death, cranial nerve injury (CNI) and return to the operating room (RTOR) for bleeding.

The researchers found that there were 50,189 patients who underwent primary carotid revascularizations (CEA, 64.3%; TCAR, 35.7%), also noting that—on average—CEA patients were younger (71.1 vs. 73.5 years, p<0.001), with less coronary artery disease and diabetes, fewer symptomatic cases, and lower antiplatelet and statin use (all p<0.001). Meanwhile, they observed that TCAR patients had lower rates of end-stage renal disease, smoking and obesity (all p<0.001).

Postoperative stroke after CEA was found to be significantly impacted by relative surgeon volume ratio (p=0.04), with “majority TCAR” surgeons having higher rates of postoperative ipsilateral stroke (odds ratio [OR], 2.12; 95% confidence interval [CI], 1.15–3.9; p=0.02). Alonso, Siracuse and colleagues have also reported that there was a trend indicating a higher stroke rate after TCAR in “majority CEA” surgeons—however, this did not reach statistical significance. In addition, they saw no association between relative volumes and perioperative death, CNI or bleeding-related RTOR for either procedure.

It is based upon these findings that the researchers conclude that relative surgeon ratios of CEA versus TCAR do appear to influence perioperative stroke rates when it comes to CEA, emphasizing the need for surgeons to be familiar with both procedures and utilize collaboration.

VAM 2024: Enhancing clinical practice and patient interaction in CLTI

By
Kristin Spencer
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VAM 2024: Enhancing clinical practice and patient interaction in CLTI
Michael Conte

A key event on informed decision-making in chronic limb-threatening ischemia (CLTI) promises to be a highlight of the 2024 Vascular Annual Meeting (June 19–22). Funded by a grant from the Council of Medical Specialty Societies (CMSS) awarded to the SVS, the event aims to expand physician knowledge and improve clinical confidence in treating CLTI.

The breakfast event, scheduled for 7 a.m. Central Time on Saturday, June 22, will focus on individualizing treatment recommendations for CLTI patients. It will emphasize staging and setting patient expectations to facilitate better decision-making. The session will review the importance of using the Vascular Quality Initiative (VQI) CLTI risk calculator, Wound, Ischemia and foot Infection (WIfI) classification and Global Anatomic Staging System (GLASS) to guide treatment, along with vein mapping and angiography.

“The goal of this session is to equip physicians with the tools and knowledge needed to engage in meaningful, informed conversations with their patients about CLTI,” said Michael Conte, MD, professor and division chief of Vascular and Endovascular Surgery at the University of California, San Francisco. “By focusing on the PLAN (Patient risk, Limb severity, ANatomic complexity of disease) algorithm, we can set expectations and treatment plans to individual patient needs.”

The event aims to provide a practical framework for enhancing clinical practice and patient interactions. Participants will also learn effective communication strategies for engaging with patients. This patient-centered approach aims to improve clinical confidence and effectiveness in treating CLTI. To register, visit vascular.org/informedCLTI.

SVS launches registration for 3rd annual CPVI Skills Course

By
Kristin Spencer
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SVS launches registration for 3rd annual CPVI Skills Course
Participant take part in the annual SVS CPVI Skills Course

The Society for Vascular Surgery (SVS) has officially launched registration for the annual Complex Peripheral Vascular Initiatives (CPVI) Skills Course. The first course launched in 2022 after being put on hold in 2020 and 2021 due to the COVID-19 pandemic. Vascular surgeons at all career levels and other specialists who wish to remain current in the specialty of vascular surgery and endovascular therapy can attend the course to participate in hands-on and didactic learning led by experts in treating peripheral arterial disease (PAD).

With a maximum capacity of 60 registrants, the CPVI Skills Course ensures that anyone who attends will have ample time to learn from the 19 faculty members leading the course. The curriculum will range from deep venous arterialization and pedal access to percutaneous femoropopliteal bypass and will delve into the Global Vascular Guidelines for treating PAD. Past attendees attribute the course curriculum, faculty, and seven-plus hours of hands-on learning to their feeling completely engaged throughout the two days.

While the course is for vascular surgeons at any career level, the SVS has partnered with the Association of Program Directors in Vascular Surgery (APDVS) to give vascular residents and fellows the opportunity to be mentored and coached by expert faculty and future colleagues in both intermediate and advanced techniques that they may not otherwise be exposed to in their programs.

“The best practices for our PAD patients continue to evolve with new research and improving technologies,” said Elizabeth Genovese, MD, a course co-chair. “It is important that vascular surgeons stay current with the latest advancements, given the increasing complexity of our patient population. This course provides an in-depth opportunity to explore these new endovascular techniques with the leaders in the field.” Stephan Henao, MD, will serve alongside Genovese in the co-chair role. Henao and Genovese have been serving on the course faculty since it began in 2022. Last year, they learned under Vikram Kashyap, MD, Patrick Geraghty, MD, and Daniel McDevitt, MD, to prepare for their new roles as co-chairs.

All interested parties are encouraged to register by June 26 to take advantage of early-bird registration prices. Learn more by visiting vascular.org/CPVI24.

‘The forgotten stepchild of vascular surgery’: The quest to push forward basic science research in venous disease

By
Brian McHugh
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‘The forgotten stepchild of vascular surgery’: The quest to push forward basic science research in venous disease
Peter Pappas

The 2024 Venous Symposium (May 8–11) in New York City was highlighted by keynote speaker Peter Pappas, MD, regional medical director and program director of the venous and lymphatic medicine fellowship at the Center for Vein Restoration in Morristown and Union, New Jersey. Pappas spoke about new frontiers in venous and lymphatic disease management while looking at the past, present and future of how disruptive technologies have shaped treatment.

“It is my hope that in the next 20 to 30 minutes, what I’m about to tell you will inspire a new generation of venous clinicians, researchers, and physicians to do better,” Pappas told the audience.

He began his address by speaking about his history as a vascular surgeon. Early on, Pappas said, he was told “we have this field in venous disease in which there is really not a lot of basic science research. It’s the forgotten stepchild of vascular disease and we really want to elevate the quality of the work that’s being done there.

“I knew nothing about it. As I read the current literature, I quickly realized my mentors were correct and that this was a career opportunity,” Pappas continued, explaining how he dedicated his first year to benchwork research and his second year to clinical work.

“I was the first vascular surgeon at that time to get a K08 training grant from the National Institutes of Health [NIH],” he said, “and it opened the door for me for the next 20 years.”

Pappas pointed to the different grants now available, including three types from the American Venous Forum (AVF) for trainees or trained surgeons within the first five years of their careers.

On the current state of benchwork research, Pappas referenced a study conducted in a dermatology lab in Europe that was “the last breakthrough in our understanding of the pathophysiology of venous ulceration,” he explained.

“These investigators determined that macrophages demonstrate different physiologic phenotypes. You have macrophages that regulate tissue destruction (M1 type), and macrophages that regulate tissue repair (M2 type),” Pappas told the audience. “In venous disease, there’s a push towards tissue destruction.” That iron overload from red blood cell extravasation stimulates macrophages to produce tumor necrosis factor alpha (TNFalpha), he explained. This cytokine keeps macrophages in the M1 phenotype, resulting in ongoing tissue destruction .

Pappas speculated that, based on these observations, possible future clinical applications could include the utilization of existing TNF-alpha blockers and/or iron chelators to promote wound healing. However, he added that, thus far, the current utilization of these drugs have been limited to testing in animal models.

“So let’s talk a little bit about disruptive technologies,” Pappas continued. “Mark Meissner [University of Washington School of Medicine, Seattle] and I were talking one day 15 years ago, and he introduced me to the term disruptive technology when discussing the impact the iPhone had on our daily activities.

“I would submit to you that the major disruptive technology in venous disease was the development of the VNUS catheter, which was originally called the Restore catheter. The original intent of this catheter was to restore venous valvular function and not to destroy the vein.

“After testing the feasibility of restoring valve function, it was discovered that the technique resulted in vein closure and the rise of thermal ablative technologies.

“I remember sitting in the audience in the early 1990s when the first clinical data on thermal ablative technologies was presented. I couldn’t believe this actually worked, and I was a late adopter because I wanted to see the data before subjecting patients to this brave new world,” he stated.

“As a result, this changed my perspective on the management of venous disease.”

Moving from catheters to stents, Pappas also touched on Raju and Neglen’s groundbreaking paper on the efficacy of Wallstents in patients who have venous outflow obstruction.

This work laid the foundation for venous stent outcomes, with Pappas telling the audience that “Raju and Neglen’s results are the gold standard to which all future venous stent trials are measured against.”

First post-FDA approval implant of Duo venous stent system announced

By
Brian McHugh
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First post-FDA approval implant of Duo venous stent system announced
Duo Venous Stent System
Duo Venous Stent System

Royal Philips today announced the first implant of the Duo venous stent system, indicated to treat symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI), following premarket approval (PMA) from the Food and Drug Association (FDA).

On June 11, Erin Murphy, MD, a vascular surgeon and director of the Venous and Lymphatic Program at the renowned Atrium Health’s Sanger Heart & Vascular Institute in Charlotte, North Carolina, and an investigator in the VIVID study, successfully used the Duo stent for the first time outside of a clinical trial.

The Duo system is comprised of two stents—Duo Hybrid and Duo Extend—of various sizes. Duo Hybrid has a distinct integrated design that combines multiple zones of differing mechanical properties into a single stent. For long lesions, Duo Extend smoothly overlaps with the Duo Hybrid to extend therapy. These two stents are designed to work together and minimize the risk of stent fracture and corrosion, while providing an option to stent within caudal veins with smaller diameters.

“Duo is the first stent that offers a differential design for the challenges of venous anatomy—a focal area that withstands the forces of compression as well as the flexibility to accommodate curvature of the vessel,” said Kush Desai, MD, an interventional radiologist and associate professor of radiology, surgery and medicine at Northwestern University in Chicago, and also a VIVID study investigator.

The VIVID study is a global, prospective, multi-center, single-arm, non-blinded clinical trial conducted in the U.S. and Poland, evaluating the safety and efficacy of the Duo stent in the treatment of nonmalignant iliofemoral occlusive disease. It enrolled 162 subjects at 30 centers with three patient populations—non-thrombotic iliac vein lesion (NIVL), post-thrombotic syndrome (PTS) and acute deep vein thrombosis (aDVT). The VIVID study is now in 36-month follow-up and, upon FDA PMA approval, transitioned from an investigational device exemption (IDE) study to a post-approval study.

The VIVID study met all of its primary safety and efficacy performance goals. The 12-month effectiveness endpoint for primary patency reached 90.2%, which exceeded the performance target goal of 77.3%. The 12-month primary safety endpoint of 98.7% also exceeded the corresponding performance goal of 89%.

Duo system

In addition, quality of life and venous functional assessments that were performed in the VIVID study—including Clinical-Etiology-Anatomy-Pathophysiology (CEAP), Venous Clinical Severity Score (VCSS), Villalta, EQ-5D-3L and VEINES scores—showed sustained improvements compared to baseline at 12 months.

The VIVID study was the first clinical trial to mandate IVUS use to aid in lesion assessment and stent sizing prior to device implantation. According to prior published research, IVUS supports accurate diagnosis of venous disease and has been shown to change 57% of treatment plans compared to venography alone.

AVS receives IDE approval from FDA for pivotal intravascular lithotripsy study

By
Jocelyn Hudson
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AVS receives IDE approval from FDA for pivotal intravascular lithotripsy study
AVS console
financing
AVS console

Amplitude Vascular Systems (AVS) announced today that it has received an investigational device exemption (IDE) from the Food and Drug Administration (FDA) to begin its pivotal trial for pulsatile intravascular lithotripsy (IVL) therapy.

The POWER-PAD-II clinical study will evaluate the safety and efficacy of AVS’s Pulse IVL system for the treatment of patients with severely calcified peripheral arterial disease (PAD) in the U.S.

POWER-PAD-II will enrol up to 120 patients who will be followed for up to six months. This new trial follows the success of POWER-PAD-I, which was presented by Jon George (Pennsylvania Hospital, Philadelphia) at TCT 2023 (Oct. 23–27) in San Francisco. POWER-PAD-I demonstrated clear benefits to patients with calcific femoropopliteal arteries, including reduced leg pain, increased blood flow and improved ability to walk.

Vascular Specialist–June 2024

By
Bryan Kay
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Vascular Specialist–June 2024

In this issue:  

    • Verified vascular! Quality care in vascular disease will form a central backdrop to this year’s Vascular Annual Meeting (VAM)
    • VAM 2024: Presidential welcome from Joseph L. Mills, MD
    • Corner Stitch: Women in leadership—it matters to trainees too, says Saranya Sundaram, MD
    • Innovation: ‘The forgotten stepchild of vascular surgery’: Pushing forward venous disease

VAM 2024: Changes to carotid stenting landscape in United States set to be discussed

By
Marlén Gomez
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VAM 2024: Changes to carotid stenting landscape in United States set to be discussed
Sean P. Lyden

Sean P. Lyden, MD, chairman of the Department of Vascular Surgery at Cleveland Clinic’s Heart, Vascular and Thoracic Institute in Cleveland, Ohio, will discuss the national coverage determination (NCD) changes passed by the Centers for Medicare & Medicaid Services (CMS) on carotid artery stenting (CAS) during the 2024 Vascular Annual Meeting (VAM).

His presentation—part of the Contemporary Management of Carotid Disease After the Coverage Decision Change and Prior to CREST-2 Results session on Friday, June 21, at 1:30 p.m. (West Building, Level 1)—will address new options and responsibilities for clinicians and health systems in light of these updates.

Lyden will highlight new data covering transfemoral carotid stenting and new technologies since the last NCD. He will emphasize how the updated NCD equates transfemoral CAS and transcarotid artery revascularization (TCAR) with carotid endarterectomy (CEA) for Medicare reimbursement. This change has expanded coverage to include symptomatic patients with 50% or greater stenosis and asymptomatic patients with 70% or greater stenosis.

Last year, Vascular Specialist reported how nearly one-third of the public comments submitted to CMS on the then proposed coverage decision affecting carotid stenting were from SVS members. Of approximately 760 responses, at least 237 were initially identified as being from SVS members. In October, CMS released its final decision regarding NCD 20.7, covering CAS, essentially confirming the coverage expansion outlined in a July proposed decision memo.

From the editor: House of Cards

By
Malachi Sheahan III
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From the editor: House of Cards
Malachi Sheahan III

On Jan. 22, 2024, the American Heart Association (AHA) and the American College of Cardiology (ACC), together with three other major cardiology societies, submitted a proposal for the formation of the American Board of Cardiovascular Medicine. Essentially, the 157-page document requests the transition of cardiology and its sub-specialties from oversight within the American Board of Internal Medicine (ABIM) to an independent entity within the American Board of Medical Specialties (ABMS). The success or failure of the proposal will likely have little effect on the day-to-day practice of cardiology in our country; it does, however, give an excellent insight into the current thinking of the leadership of their major societies and their vision for the future. Unsurprisingly, I do not agree with some aspects of the document, particularly as it relates to cardiologists practicing in the peripheral vascular space.

The Accreditation Council for Graduate Medical Education (ACGME) oversees the accreditation of residency and fellowship programs in the U.S. Its Program Requirements for Graduate Medical Education (7/1/24) define interventional cardiology as “the practice of procedural techniques that improve coronary circulation, alleviate valvular stenosis and regurgitation, and treat other structural heart disease.” No mention of peripheral vascular disease, carotid stenosis or aortic aneurysms. The ACGME understood the assignment. Fittingly, the requirements for interventional cardiology fellowships include detailed descriptions of a variety of ischemic, structural and valvular disorders in which fellows must acquire competence. A minimum of 250 coronary interventions are also mandatory. Faculty members must be available with expertise in hematology, pharmacology, radiation safety and congenital heart disease in adults. There are no guidelines or requirements for training and competence in peripheral vascular disease.

The ABMS, through its 24 member boards, provides certification for a wide variety of medical specialties. The mission of ABMS is to “serve the public and the medical profession by improving the quality of health care through setting professional standards for lifelong certification.” The ABMS defines interventional cardiology as “an area of medicine within the subspecialty of cardiology, which uses specialized imaging and other diagnostic techniques to evaluate blood flow and pressure in the coronary arteries and chambers of the heart, and uses technical procedures and medications to treat abnormalities that impair the function of the cardiovascular system.” So maybe there is the loophole. The “vascular” in “cardiovascular.” Thankfully, though, the board provides blueprints for its exams so we can see the disease states that a certified interventional cardiologist is expected to treat.

In the content outline for the initial certification exam, the broadly defined “evaluation and case selection in noncardiac disease” constitutes just 5% of the total. While this blueprint details a wide range of cardiac pathologies common and rare (Takotsubo syndrome?), there is no mention of claudication, rest pain or aneurysms. Similarly, the open book 10-year Maintenance of Certification exam dedicates just 10% to catheter-based management of noncoronary disease, with the majority concerning structural and valvular heart disease. Cilostazol, the only drug thus far proven to demonstrate consistent benefits in clinical trials in patients with claudication, is specifically tagged with a “low-frequency” designation.

Look, I have no interest in being the main character on #cardiotwitter again. (By the way, why is everyone there named something like @CLTImuscularwarrior? Where are my @DVTdoughboys and @claudicationcouchpotatoes?) Cardiologists don’t have to take my word for what constitutes adequate training in peripheral vascular disease. Their own leading societies, the ACC, AHA and Society for Cardiovascular Angiography and Interventions (SCAI), published an advanced training statement in 2023. They lay out the problem here: “One year of advanced fellowship training focused predominantly on coronary interventions will likely not provide adequate clinical exposure and procedural experience to achieve competency in all other areas of interventional cardiology. Additional fellowship or post-fellowship training will be needed to gain the experience necessary to become a competent, independent expert in most aspects of peripheral vascular or structural heart interventions.”

The statement then describes what they refer to as Level III training in peripheral vascular interventions, most of which they admit must be acquired outside of the traditional interventional cardiology fellowship. The report also lists a variety of vascular conditions, suggesting that physicians can pick and choose to learn them individually, like ordering apps in a Cheesecake Factory. Level III trainees are not expected to be expert in the management of less common vascular conditions and should utilize “information technology or other available methodologies.” Unfortunately, there is no Level IV in this training paradigm so I guess Google it?

What about venous disorders? The document states, “management of venous occlusive disease, compression and reflux should be part of the curriculum.” Spoiler—it is not. In listing the milestones for peripheral vascular interventions, essentially everything outside of a nonselective aortogram is considered an additional competency that extends beyond the core expectations. Taken as a whole, this consensus statement is a step-by-step outline of why it is impossible to become competent in the treatment of peripheral vascular disease within the context of interventional cardiology training. Virtually none of the requirements are covered by the existing residency requirements or testing blueprints. For endovascular aneurysm repair (EVAR), the authors simply note “additional training will likely be required through non-ACGME-accredited advanced fellowships or post-fellowship training through courses, proctoring, or direct mentorship.” A statement that should stoke fear in the hearts of anyone without a significant financial stake in an endograft company. Folks, it is OK just to say hey maybe doctors should not do things they are not trained to do!

It is not really clear to me how cardiologists began working in the peripheral space. The interventional aspect of the field is fairly young. Cardiology joined the ABIM in 1941, but the first coronary angioplasty was performed three decades later. The volume of coronary interventions declined in the U.S. over the first 10 years of the 2000s. Regrettably, this happened at a time when interventional cardiology saw an explosion in their workforce. Between 2008 and 2013, there was an 85% increase in active interventional cardiologists. No other medical or surgical specialty saw an increase of more than 50% during this time. Perhaps this strain between a burgeoning workforce and dwindling case volume pushed more cardiologists to the periphery. This famously caught the attention of the New York Times, which published a 2015 story on cardiologists performing unnecessary extremity interventions.

I trained in the late 1990s and early 2000s and cannot recall many cardiologists interested in peripheral vascular disease. Most treated circulatory disorders with the intention of preventing heart attack and stroke. Any peripheral vascular benefits were ancillary or unmentioned. I will admit that the peripheral vascular space likely became a free-for-all because most vascular surgeons were slow to adopt interventional techniques. To make up for this, however, we have undergone a revolution in training and assessment. Our case requirements, training duration, residency paradigms and exam blueprints have all been completely rewritten to ensure that vascular surgeons achieved documented proficiency in all aspects of peripheral interventions. Vascular surgery is now the sole training pathway to gain competence in the medical, surgical and endovascular treatment of vascular disease.

The ABMS definition states that vascular surgery “encompasses the diagnosis and comprehensive, longitudinal management of disorders of the arterial, venous and lymphatic systems, exclusive of the intracranial and coronary arteries.” The ACGME affirms “vascular surgery is the surgical specialty involving diseases of the arterial, venous and lymphatic circulatory systems, exclusive of those circulatory vessels intrinsic to the heart and intracranial vessels. Specialists in this discipline demonstrate the knowledge, skills and understanding of the medical science relative to the vascular system, as well as mature technical skills and surgical judgment.” Our country’s leading training and certification authorities have delivered a clear and consistent message. So why is the public confused?

One would hope that in the face of this lack of clarity a new American Board of Cardiovascular Medicine would offer clear and specific guidelines for cardiologists who wish to pursue peripheral interventions or nebulous interests such as vascular medicine. Well reader, one would be disappointed. While the new board proposal does make an excellent case that cardiology is a growing and increasingly complex specialty, a great deal of the aims confusingly focus on changing the continuous certification process. Much of it reads like my 12-year-old hired a consulting firm to get out of studying for a science exam. “Hey Dad, it’s time to change the conversation around education and home study. We here at the House of LukeTM are prepared to embrace a new paradigm, one that will credit me for my wealth of real-world experiences and not these meaningless high stakes exams. It is time for continuous learning, not continuous testing.”

Here are some highlights from the proposal: Patients and the public expect their physicians to have the ability to deliver high-quality care and should require that there are standards in place to assure continuous competence (agree). Cardiovascular medicine has a clearly defined scope of practice and standards of competence which have been set by rigorous scientific processes and experts in the specialty (agree to disagree). The rapid acceleration of innovation and advances in cardiovascular medicine since 1941 has transformed the field of cardiovascular medicine and increasingly requires unique skills and training that are markedly different from those in internal medicine to practice effectively (they go on to list a bunch of advances, none of which are related to peripheral vascular disease). Essentially, it seems the proposed board would allow physicians to identify their own knowledge gaps and fulfill continuous certification requirements through CMEs provided by the (coincidentally?) sponsoring societies.

In defining professional competence, the 2020 AHA/ACC Consensus Conference on Professionalism and Ethics states: “To maintain competence, physicians must be committed to lifelong learning and be responsible for maintaining the medical knowledge and clinical and team skills necessary for the provision of quality care. More broadly, the profession must strive to see that all its members are competent and must ensure that appropriate mechanisms are available for physicians to accomplish this goal.” The proposal for a new American Board of Cardiovascular Medicine fails to address this need for cardiologists performing peripheral interventions. Their plan for continuous certification will not only encourage cardiologists to perform outside of their expertise, it will also make it more likely they will not recognize their own deficiencies.

Psychology calls this the Dunning-Kruger effect. The skills that give us competence in a certain domain are the same skills needed to evaluate competence in that same domain. Competence must be achieved from the competent. Individuals who do not achieve competence dramatically overestimate their ability and are unable to use information about the choices and performances of others to form more accurate impressions of their own ability. Physicians who do not obtain the appropriate skills and training suffer a dual burden. They make poor choices and false conclusions, and their lack of competence robs them of the ability to recognize this. They don’t know what they don’t know. Physicians with properly acquired proficiencies and knowledge are more equipped to recognize and learn from their mistakes. They know what they don’t know and, therefore, are able to continue to gain expertise through lifelong learning.

It is a matter of patient safety that we end the public confusion caused by terms like “cardiovascular” and “vascular medicine.” Physicians need to perform within their expertise. The backbone of U.S. training is graduated responsibility within an ACGME-accredited residency followed by ABMS board assessment and lifelong learning. Equivalent experience should only be applied in rare and exceptional cases. It is time to dispel the illusion that the 10 million Americans with peripheral vascular disease should be cared for by physicians who purport to have gained competence through pathways that are unaccredited, unregulated and untested.

Cardiology is an extremely complex field with multiple subspecialties. It likely deserves its own house. Just don’t hide peripheral vascular disease in the basement.

Malachi Sheahan III, MD, is a member of the Vascular Surgery Board (VSB) of the American Board of Surgery. His opinions do not reflect VSB policy or positions. 

The top 10 most popular Vascular Specialist stories of May 2024

By
Éva Malpass
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The top 10 most popular Vascular Specialist stories of May 2024

top 10In April, the most read stories from Vascular Specialist include new data from the C-GUARDIANS pivotal investigational device exemption (IDE) trial presented at the Leipzig Interventional Course (LINC) 2024 (28–31 May, Leipzig, Germany); recently released randomised data show cyanoacrylate glue performs strongly on patient satisfaction; Karith Foster, chief executive of Inversity Solutions, shares her thoughts ahead of headlining the Society for Vascular Surgery (SVS) Keynote Speaker Series at the 2024 Vascular Annual Meeting (VAM 2024), among several more.

1. We are not ‘and vascular’: SVS set to launch ambitious new phase in branding campaign

SVS secretary details the spirit and the cause behind the next phase of the Society’s branding campaign aimed at helping vascular surgery become an instantly recognizable specialty inside and outside of the hospital.

2. ‘Who let a vascular surgeon in the room?’: Leadership in the face of turf battles in vascular disease treatment

Leading vascular surgeons from across the globe contributed pearls of wisdom on how to go about tackling inevitable turf battles from other specialties practicing in the vascular disease space during a leadership challenges session staged by the World Federation of Vascular Societies (WFVS) at the recent 2024 Charing Cross (CX) International Symposium in London, England (April 23–25).

3. ‘What if we could translate the most durable Dacron repair into a minimally invasive approach?’

Charudatta Bavare, MD, a vascular surgeon at the Debakey Heart and Vascular Center at Houston Methodist Hospital in Houston, Texas speaks to Vascular Specialist on robotic surgery as a key part of vascular surgery’s future.

4. The devil we don’t know: The case against private equity in medicine

Editor-in-chief Malachi Sheahan III writes on private equity in vascular surgery: “I believe PE acquisitions are just a symptom of healthcare’s overall problems. Physicians are selling their practices because it is too hard to remain financially solvent on their own. Paperwork, legal requirements, electronic health records and insurance practices have all placed incredible strain on private practitioners.”

5. End of an era: Schanzer and Robinson leave legacy of VAM innovation

As this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) approaches, it marks the end of an era for Andres Schanzer, MD, and William Robinson, MD, who have played integral roles in shaping the event’s trajectory. Schanzer’s leadership as VAM program chair comes to a close after 10 years of being on the SVS Program Committee, with the last three completing his term as program chair.

6. LINC 2024: C-GUARDIANS data represent lowest event rates in published trials of CAS, TCAR and CEA

New data from the C-GUARDIANS pivotal investigational device exemption (IDE) trial support consideration of carotid artery stenting (CAS) with the CGuard embolic prevention stent system (EPS; InspireMD) as a “frontline therapeutic option for appropriate patients being considered for carotid revascularisation”. This is according to lead investigator Chris Metzger (OhioHealth, Columbus, USA), who presented one-year results from the trial at the Leipzig Interventional Course (LINC) 2024 (28–31 May, Leipzig, Germany).

7. New randomised data show cyanoacrylate glue performs strongly on patient satisfaction

Patients undergoing cyanoacrylate glue closure for superficial venous disease reportedv higher periprocedural satisfaction than those who were treated via surgical stripping, data from a pair of randomised controlled trials (RCTs) assessing the VenaSeal system (Medtronic) reveal.

8. JVS-VL papers go under the microscope

On the final day of the 2024 International Vein Congress (April 18–20) in Miami, Florida, presenters focused on venous and lymphatics abstracts set for submission to the Journal of Vascular Surgery-Venous and Lymphatic Disorders (JVS-VL). Each presentation was then critiqued by one of the attending vascular surgeons.

9. ‘I’m a big fan of firsts’: Nationally renowned speaker on DEI set to headline new SVS keynote

Karith Foster, chief executive of Inversity Solutions, is set to headline the inaugural Society for Vascular Surgery (SVS) Keynote Speaker Series at the 2024 Vascular Annual Meeting (VAM 2024).

10. Springtime in the world of vascular training

Christopher Audu, MD, Vascular Specialist resident/fellow editor, shares programs and textbooks that might be helpful to the vascular surgical trainee and interested medical student.

BEST-CLI and the BASIL trials: Motion sees audience move in favor of endovascular therapy over bypass

By
Brian McHugh
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BEST-CLI and the BASIL trials: Motion sees audience move in favor of endovascular therapy over bypass
Michael Conte
pMAC
Michael Conte

During the 2024 Charing Cross (CX) International Symposium in London, England (April 23–25), a Great Debate that pitted four global peripheral arterial disease (PAD) heavyweights against one another yielded an audience vote that went against the motion, “Bypass surgery is better than endovascular surgery,” by 57% to 43%.

The back-and-forth was set against the backdrop of the results of recent landmark chronic limb-threatening ischemia (CLTI) trials, BEST-CLI and BASIL-2, and immediately after the first-time release of the results from BASIL-3, and included a principal investigator from each: Matthew Menard, MD, of BEST-CLI who argued for the motion, and Andrew Bradbury of BASIL-2, who argued against.

Menard set the tone: “A 33% reduction in MALE [major adverse limb event] or death; 65% reduction in major reinterventions; ongoing reductions in total number of major reinterventions, clinical failure, hemodynamic failure, resolution of index CLTI; better prevention; and better impact in women for surgery,” he said. “Essentially all roads lead to Rome: in this case bypass.”

Bradbury pushed back from the other side of the debate aisle.

“Bypass surgery currently has a very small role—in my opinion—in the management of CLTI,” he argued. “Yes, you can cherry-pick patients with the perfect vein and who are going to live forever, but those are kind of unicorns in our practice here in the UK. I think, realistically, the role of bypass surgery will almost certainly shrink in the years ahead.”

Michael Conte, MD, a BEST-CLI triallist, also making the case for surgery, changed tack slightly, beseeching a change in the motion: “My first disclosure is, of course, I want to change the debate question to a more practical one, which is that bypass surgery is better than endovascular surgery in appropriately selected patients with CLTI because I think that debate question is a bit unrealistic.”

The goal in evidence-based care in PAD is to take a look at the world of coronary artery disease treatment. They have a “robust evidence base based on many clinical trials,” Conte noted. Disease complexity is what defines the advantages of coronary artery bypass grafting (CABG) in certain patients over percutaneous coronary intervention (PCI): “The difference here is based around repeat revascularization,” Conte said. “Heart transplant-free survival is not really what they are measuring,” he added, an allusion to debate around the selection of amputation-free survival as the primary endpoint in BASIL-2.

“You can now put BASIL-3 right next to [BASIL]-1 and 2, which shows absolutely no relative risk to reduction in limb-specific events,” Conte added. “And if you look at the anatomic spectrum of disease, the BEST trial had a broad spectrum of disease and showed a better 30–50% reduction depending on which limb event you look at, including BEST cohort 1, which is limited to infrapopliteal disease.”

Ramon Varcoe, MD, from Sydney, Australia, making the case against the motion, pointed to the now well-circulated Kaplan-Meier curve from the BEST-CLI trial suggesting endovascular intervention is inferior to open surgery. “But if you really drill down into this composite endpoint,” he said, “you can see that this is all driven by major reinterventions, and that’s a big problem.”

Why? he pondered. “Because major reinterventions were highly subjective,” Varcoe continued. “It was completely at the discretion of the operator which patients went on from endo to be converted to an open bypass surgery. With that comes a lot of inherent bias. There was no adjudication by callouts; there were no objective criteria brought to this discussion. Individual surgeons for the most part—three quarters of the operators were surgeons—went on to convert patients at their own discretion.”

Some 15% of patients had a technical failure, he continued. “I would put to you that is not best endovascular care,” Varcoe argued. Two thirds of that number went on to bypass conversion within a 30-day period, which “drove the primary endpoint and made the difference favoring surgery.”

Shape Memory Medical announces first patient treated in the AAA-SHAPE randomised controlled pivotal trial

By
Jocelyn Hudson
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Shape Memory Medical announces first patient treated in the AAA-SHAPE randomised controlled pivotal trial
Impede embolisation plug, expanded
AAA-SHAPE
Impede embolisation plug, expanded

Shape Memory Medical recently announced that the first patient has been treated in the AAA-SHAPE pivotal trial.

AAA-SHAPE (Abdominal aortic aneurysm sac healing and prevention of expansion) is a prospective, multicentre, randomised, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill sevice to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).

The patient was treated by Raghu Motaganahalli (Indiana University School of Medicine, Indianapolis, USA).

“We would like to congratulate Dr Motaganahalli and the clinical study team at Indiana University for being the first to enrol a patient in the AAA-SHAPE pivotal trial. This is the first randomised controlled trial comparing EVAR plus sac management with Impede-FX RapidFill to standalone EVAR to evaluate shape memory polymer and its potential to improve sac regression in AAA patients,” said Ted Ruppel, president and chief executive officer of Shape Memory Medical.

AAA-SHAPE will enrol 180 patients with infrarenal AAA across up to 50 sites in the USA, Europe, and New Zealand. Study participants will be randomised 2:1, either to EVAR plus sac management with Impede-FX RapidFill (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.

Impede-FX RapidFill, the investigational device, incorporates Shape Memory Medical’s novel shape memory polymer, a proprietary, porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood. In AAA-SHAPE, Impede-FX RapidFill is intended to fill the aneurysm blood lumen around a commercially available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.

Prior to the AAA-SHAPE pivotal trial, the AAA-SHAPE early feasibility studies enrolled a combined 35 patients in New Zealand and The Netherlands.

“Large studies report that 60% of aneurysms either fail to regress or expand within one year following EVAR, a problem linked to rehospitalisations, secondary interventions, and increased mortality. Moving more patients toward sac regression has the potential for significant benefits,” said Marc Schermerhorn (Beth Israel Deaconess Medical Center, Boston, USA), AAA-SHAPE national principal investigator.

“We are pleased to be the first site to treat a patient within the AAA-SHAPE pivotal trial,” commented Motaganahalli, principal investigator. “The outcomes of this important trial will help determine whether Impede-FX RapidFill, with its unique properties, plays a meaningful role in post-EVAR AAA outcomes.”

Aspirex achieves 78% two-year primary patency rate in P-MAX postmarket observational study

By
Jocelyn Hudson
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Aspirex achieves 78% two-year primary patency rate in P-MAX postmarket observational study
Michael Lichtenberg

At the Leipzig Interventional Course (LINC) 2024 (28–31 May, Leipzig, Germany), Michael Lichtenberg (Arnsberg Vascular Clinic, Arnsberg, Germany) shared for the first time a 24-month update from the P-MAX study of the Aspirex (BD) endovascular thrombectomy system in the treatment of acute venous occlusions. The study’s principal investigator highlighted procedural and technical success rates of 97.5% and a 24-month primary patency rate of 77.9% among other key findings.

P-MAX is a prospective, multicentre, postmarket observational investigation designed to evaluate the outcomes of Aspirex in patients with deep vein thrombosis (DVT) of the pelvis, legs, and the inferior vena cava (IVC).

The study has enrolled patients at nine centres across the European Union, with follow-up already conducted for post-index procedure (discharge) and at one, six and 12 months. At LINC 2024, Lichtenberg shared 24-month follow-up data and noted that 36-month follow-up is also planned.

The presenter noted that patients over the age of 18 with acute thrombotic or thromboembolic occlusion (defined as the onset of pain within 14 days) and who signed a written informed consent form were included in the study. Key exclusion criteria included unsuitability for thrombectomy and known, unhealed, pre-existing mechanical damage to the vessel wall caused by surgical procedures or interventional complications, among other factors.

Lichtenberg shared with the LINC audience that 81 patients were enrolled in the study, consented to treatment, and subsequently treated with Aspirex. The mean age of these patients, he added, was 49.3±17.4 years, with 50.6% and 49.4% of the patients being male and female, respectively.

Regarding follow-up, Lichtenberg detailed that 80 (98.8%) patients completed one-month follow-up, reducing to 78 (96.3%) at six months, 74 (91.4%) at 12 months, and 66 (81.5%) at 24 months.

Lichtenberg provided some details on the medical history of the patients enrolled in the trial, noting that 21/81 (25.9%) were smokers, 5/81 (6.2%) had diabetes mellitus, 29/81 (35.8%) had hypertension, 11/81 (13.6%) were on systemic contraceptives, and 3/81 (3.7%) were undergoing cortisone therapy.

The presenter also detailed the key lesion characteristics of the 81 patients enrolled in the study. The mean target lesion length was 204.9mm, with a majority (70.4%) of the vessels occluded being veins, and the most common thrombus location being the external iliac vein (74.1%).

Procedural success in the P-MAX study was defined as intervention with Aspirex, with or without adjunctive treatment, being sufficient to remove the thrombus; maintain restored blood flow at least 72 hours post-intervention; avoid critical injuries at access site, route of catheter and target site; and be absent of acute distal embolism respective of pulmonary embolism. This was achieved in 79/81 (97.5%) patients.

Technical success was defined as a successful thrombectomy, which was achieved in 79/81 (97.5%) patients.

Primary patency was defined as freedom from reintervention, which was achieved in 79/80 (98.8%) patients at discharge, 75/80 (93.8%) at one month, 70/79 (88.6%) at six months, 62/72 (82.7%) at 12 months, and 53/68 (77.9%) at 24 months.

Safety was defined as serious adverse events (SAE) rate, procedure-related adverse events (AE) rate, and serious adverse device events (SADE) rate at one, six, 12 and 24 months.

Lichtenberg relayed that the SAE rate results were 27/81 (33.3%), 34/81 (42%), 40/80 (50%), and 46/77 (59.7%) at one, six, 12 and 24 months, respectively. The corresponding figures for AE rate were 11/80 (13.8%), 11/79 (13.9%), 11/74 (14.9%), and 11/66 (16.7%) and for SADE rate were 2/80 (2.5%), 2/79 (2.5%), 2.74 (2.7%), and 2/64 (3.1%).

In terms of secondary endpoints, the presenter reported that Venous Clinical Severity Score (VCSS), Venous Disability Score (VDS) and Clinical-Etiology-Anatomic-Pathophysiologic Score (CEAP) all improved from baseline—an improvement that he shared was sustained out to 24-month follow-up.

Speaking to Venous News following his presentation at LINC 2024, Lichtenberg commented: “Based on the very positive data from this study as well as others for mechanical thrombectomy, I suggest we stop thrombolysis therapy. Mechanical thrombectomy for iliofemoral DVT is safe and effective.”

Choosing the right venous stent for the right situation

By
Brian McHugh
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Choosing the right venous stent for the right situation
Patrick Muck
Patrick Muck

Patrick Muck, MD, from Cincinnati, Ohio, provided a state of the venous stent landscape during IVC 2024. The TriHealth vascular surgery program director ran through the key differences between the venous-specific stents currently available and how he goes about selecting which one to deploy in specific scenarios.

Within the last four years, the Venovo (BD), Vici (Boston Scientific), Zilver Vena (Cook), Abre (Medtronic) and Duo (Philips) venous stents have all been approved for use by the Food and Drug Administration (FDA). “I’ve been fortunate enough to use all of the [currently available stents on the market] besides the Duo so far,” Muck told the audience.

Muck outlined a particular scenario during which he deployed the Abre in a patient who had a history of varicose vein surgery decades ago. When the patient saw Muck, multiple issues needed to be addressed, and, discovering a femoral vein occlusion, he placed the Abre stent, with the patient doing well years down the road, Muck reported.

Muck then turned to the Zilver Vena and a post-thrombotic syndrome patient who had an iliofemoral deep vein thrombosis (DVT) during pregnancy: Nine months after giving birth, “I put a 16, 60 Zilver Vena in,” he described, reflecting that, today, he would place a longer one. “What I like about all these stents is the thumb wheel for the Venovo and the Abre, and the pinch-and-pull for the Zilver Vena, which means you can place it precisely where you need to.”

The Duo stent, recently approved by the FDA, has emerged as “very flexible and very strong,” Muck added. “Ultimately, there’s no head-to-head. You have to individualize each patient based on their scenario as well as their IVUS. Then you can decide which stent is best for you.”

When are lymphedema pumps the answer?

By
Brian McHugh
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When are lymphedema pumps the answer?
Brajesh Lal
Brajesh Lal

The importance of activating the calf muscle pump in the treatment of lower extremity lymphedema came to the fore during the 2024 International Vein Congress (IVC) in Miami, Florida (April 18–20).

“There are a whole host of non-proffered approaches you can take,” said Brajesh Lal, MD, from Baltimore, Maryland, giving a presentation focused on when he believes is the best time to use lymphedema pumps and nonsurgical interventions. “Most important and primary are elevation of the limb, exercise if you’re dealing with lower extremity edema, which is what most of us will be dealing with, and activating the calf muscle pump.”

Lal pondered where pumps fit into a treatment paradigm that includes massage, exercise, and compression garments. There are numerous options for pumps on the market, including nonsequential pumps and those that provide both sequential and segmental compression, he said. One of the more recent to be introduced are non-pneumatic pumps. One of the biggest issues with pumps currently is that there are numerous guidelines that all claim to promote best practice, Lal continued, which he said are “limited by a lack of standard descriptions, a standard way of providing their recommendations, and, of course, a limited quality of the evidence available.”

“I want to be very careful separating out where there is evidence and where there isn’t, and where there is opinion,” he said. “All guidelines recommend initial decongestive therapy followed by maintenance decongestive therapy. Though the recommendation was strong, evidence for this approach has not been tested in any highly-quantitative manner.”

All guidelines also recommend elevation, exercise and compression garments, though they vary in how they express their recommendations, Lal explained, referencing the guidelines created by the American Venous Forum (AVF), “which is essentially a strong recommendation based on either moderate, moderate-good, and very good quality data.

“Manual lymphatic draining or massage has been given various grades even when the level of evidence is modest,” Lal said. “Pump-assisted compression, however, generally gets a low-moderate grade recommendation in view of the evidence available.”

There is another new form of lymphedema treatment arriving soon in the form of non-pneumatic compression devices, he added.

Ultimately, Lal said he uses pumps, as an adjunct to elevation, exercise and compression. “I use [them] in patients who have severe edema and very large limb volumes, those who have limited ambulation, and those who cannot apply compression devices when they go into the maintenance phase.”

Tackling inequities in venous care

By
Brian McHugh
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Tackling inequities in venous care
Ulka Sachdev
Ulka Sachdev

During the 2024 American Venous Forum (AVF;March 3–6) in Tampa, Florida, multiple presenters discussed inequities in venous care with a focus on how to get more patients into research, how geographic and demographic factors determine care both pre- and post-COVID-19, and how to identify populations vulnerable to venous disease.

Presenters brought forward addresses dealing with the social disparities in pulmonary embolism (PE) and deep vein thrombosis (DVT) during the COVID-19 pandemic; how race, biological sex and geographic disparities played a role in PEs prior to the COVID-19 pandemic; how to identify populations that are vulnerable to venous disease; a lack of education regarding venous disease for both providers and patients; and finally how to get more patients into research so they understand their diagnoses.

Ulka Sachdev, MD, associate professor of surgery and chief of vascular services at the Magee-Womens Hospital of UPMC in Pittsburgh, Pennsylvania, spoke on the latter topic, and began by referencing a paper published in the New England Journal of Medicine. “The article stated the following: That there have been centuries, actually, of disparate health outcomes in the U.S.,” Sachdev told the audience.

Sachdev argued that, in order to help remove biases in medicine and care, clinical trials in specific geographic locations should have patients that represent the local census data. She specifically mentioned Pittsburgh, where the population “is about 65% White, almost a quarter Black, Asians are about 5%, and the rest is falling under that 5% range or close to it … that means that, if I’m going to be recruiting patients to look at body markers in venous disease … I’m really going to try to at least hit these numbers because this is the city I’m looking at.”

Register for 2024 Vascular Health Step Challenge at VAM

By
Brian McHugh
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Register for 2024 Vascular Health Step Challenge at VAM

Attending a conference such as the Vascular Annual Meeting (VAM) is a great way to increase step count and get blood flowing, which is why the SVS Foundation is bringing back the Vascular Health Step Challenge at VAM 2024 in Chicago. The first Vascular Health Step Challenge at VAM took place last year in National Harbor, Maryland.

The challenge encourages attendees to engage in friendly competition while also drawing attention to step count to ensure attendees are cognizant of how much they are moving throughout the conference. The walker with the highest step count at the conference at the end of the day (at 5 p.m. Central Time) on June 21 will receive a $100 gift card.

“The Vascular Health Step Challenge at VAM is a great way to keep attendees moving throughout the meeting,” said Edith Tzeng, MD, SVS Foundation Development Committee chair. “Conferences provide a great opportunity to get moving, but it can also be easy to remain sedentary if you don’t have far to go between sessions. The Step Challenge at VAM motivates attendees to keep their blood flowing and legs moving throughout the meeting. I’d love to see every attendee participate in the challenge to show that they’re practicing what we preach to our patients every day.”

The Vascular Health Step Challenge at VAM will set the stage for the third annual version of the event, which will take place throughout September, National Vascular Disease Awareness Month. Registrants for the September challenge are encouraged to walk at least 60 miles during the month to represent the 60,000 miles of blood vessels within the human body. Anyone who pays the $60 registration fee for the Vascular Health Step Challenge at VAM will automatically be registered for the September challenge.

Registration opened May 1. Anyone who signs up will receive a commemorative lapel pin at VAM, and a 2024 Step Challenge t-shirt in August. VAM attendees can register at vascular.org/STEP2024.

The role of deep venous arterialization comes under scrutiny

By
Jocelyn Hudson
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0
The role of deep venous arterialization comes under scrutiny
Rober Hinchliffe
Rober Hinchliffe

“Every so often in vascular disease, disruptive technologies come along and the question really is, ‘Is this going to make a big impact on patient care?’” These were the words of CX Executive Board member Robert Hinchliffe, MBChB, clinical professor of vascular surgery at the University of Bristol, England, setting the scene for a series of presentations, discussion, and polling on deep venous arterialization (DVA) at the 2024 Charing Cross (CX) International Symposium in London, England (April 23–25).

Polling both before and after seven podium presentations—including podium firsts from the CLariTI study and PROMISE UK trial, as well as “a word of caution” from CX Executive Board member Thomas Zeller, MD, from Bad Krozingen, Germany—saw the audience vote split on the current evidence base for DVA.

Around half of the audience, down only three percentage points from 51% to 48% before and after the presentations and subsequent discussion, voted that the current evidence suggests DVA should be considered in “no-option” chronic limb-threatening ischemia (CLTI) patients. The remaining half voted that DVA either has insufficient evidence to suggest a role in clinical practice (up from 22% to 25%); should be considered in expanded indications besides no-option patients (up from 14% to 16%); or should be considered in expanded indications besides no-option patients (down from 14% to 11%).

Daniel Clair, MD, from Nashville, Tennessee, introduced the topic of transcatheter arterialization of the deep veins (TADV) with an overview presentation outlining highlights of the PROMISE trials, before Anahita Dua, MD, from Boston, shared new data from the CLariTI study.

Dua, who is the national principal investigator of the CLariTI study, noted that this prospective, single-arm, observational registry was designed to track the clinical progression of CLTI and the incidence of death, amputation, and revascularization attempts over a one-year period. She outlined that 180 per-protocol patients were enrolled at 22 sites across the U.S. The primary endpoint was amputation-free survival at 12 months.

“CLariTI provides an exciting dataset of real-world outcomes,” Dua shared in her conclusion. The presenter revealed that two-thirds of no-option patients received a major amputation or died at 12 months, stressing that there is an “imminent need for new therapies in this understudied population.”

Hany Zayed, MD, from London, then revealed final results from the multicenter PROMISE UK trial. He reported that TADV using the LimFlow system in no-option CLTI patients resulted in a 67% amputation-free survival rate, an 81% limb-salvage rate, and a 100% rate of fully healed or healing wounds at 12 months. This led him to conclude that TADV with the LimFlow system “is safe and effective with 96% technical success in no-option CLTI patients.”

Following these first-time data presentations, Bruno Migliara, MD, from Peschiera del Garda, Italy, Steven Kum, from Singapore, and Uei Pua, MD, also from Singapore, took to the podium to present on the PiPeR DVA technique, new considerations in DVA, and post-DVA management, respectively.

Closing the session, Zeller played “Devil’s advocate” by offering “a word of caution” on DVA. He argued that a primary below-the-knee amputation with appropriate prosthetic supply is a better alternative for many patients. “Amputation is not the end of the story,” he said. “The key question is what gets our patients into daily life with full ambulation sooner, with full quality of life, and I’m of course aiming to preserve the patient’s limb as much as I can, but I have enough patients in my daily practice telling me: ‘Well if I would have known the long history of recurrent revascularization attempts, I would have voted for primary amputation.’”

Why we keep asking you for money

By
Anahita Dua
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0
Why we keep asking you for money
Anahita Dua
Anahita Dua

Money permeates every single aspect of American politics. To run a congressional race in Massachusetts, you need to raise a minimum of $2.5 million. This money directly pays for staff that run your campaign (the compliance guy makes sure your money is appropriately reported to keep you out of jail, the fundraising guy helps you raise money and connect with donors, and general counsel/campaign managers manage your time, advertising and travel.) If your message doesn’t get to voters, you can’t win, and that message reaches voters through campaign money being used to promote it through the media.

So important is fundraising in politics that it is the primary metric used to judge the likelihood a candidate will win. The more they raise, the greater their campaign reach can be, thus increasing their chances of success. Right or wrong, it’s the way American politics currently work, and clearly, those who can donate to a campaign will have the attention of the candidate and their team. They claim it’s not “pay to play” but, obviously, any physician who has ever heard of the Sunshine Act knows that, if you can raise money and donate to a candidate, they may be more likely to take your concerns seriously. Overall, running for office is expensive, particularly for federal elective offices like the Senate or the House of Representatives.

Candidates for these offices must communicate broadly and repeatedly with voters—on television, digital outlets and mail—which are inevitably expensive endeavors. It doesn’t take a genius to understand that, given the importance of money in a campaign, if the Society for Vascular Surgery (SVS) Political Action Committee (PAC) can financially support candidates that have a similar ideology that we SVS members do in terms of Medicare reimbursement cuts, for example, they are more likely to give us their time and act on our behalf in Congress.

A PAC is an aggregator of contributions, raising money from like-minded individuals who believe in the mission of that PAC and the candidates that the PAC is investing in. It is important to note that PACs are also limited in how much they can contribute to an individual candidate—$5,000 per candidate/per election. There are some PACs that are bipartisan, which means they support Republicans and Democrats. In fact, the SVS PAC is bipartisan, as are most other non-political member-serving societies, given that they represent diverse memberships with varying political views. In this model, PACs—such as the SVS PAC—raise money that is then used in direct support of candidates who support issues that are important to those memberships.

The SVS PAC is the only federally registered PAC operating to advance vascular-centric priorities. The SVS PAC is heavily involved in supporting members of Congress to stop recurrent Medicare reimbursement cuts, fortifying the vascular workforce, reducing administrative burdens associated with the practice of medicine, and ensuring patients can receive quality vascular care precisely when and where they need it.

The primary goal of a PAC is to make positive change in Congress, so we want to support candidates who can win. We ask ourselves before every endorsement: is the candidate raising money for their own campaign? Are they running in a district where they can win? And are they running against an opponent they can beat? We know that not every candidate we endorse is going to win, but if we’re helping to set up a candidate to be more viable in the future, or to make some inroads in a district that can be won in another election down the road, then that investment is still one worth making.

Money is a crucial part of American politics and, if we do not have money invested in the game, our political impact is not as significant as it should be. By giving to the PACs or candidates directly, we can help the right people get into political office so that our country can have the right people representing us at the federal level.

The decisions made by members of Congress directly impact our lives and our patients’ lives. We are not physically sitting in those Congressional seats, but we can ensure the right representatives are sitting there to do what we want for the people of the U.S.

UK-COMPASS: Aortas, open surgical skills and gratitude

By
Erica Leith Mitchell
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0
UK-COMPASS: Aortas, open surgical skills and gratitude
Erica Leith Mitchell

As you read this, you are probably wondering why the heck I am writing an editorial on complex aortic aneurysms when you know I am somewhere in the South focused on vascular trauma and limb ischemia. Well, no good deed goes unpunished. Patrick Chong presented the article, “Comparison of open surgery and endovascular techniques for juxtarenal and complex neck aortic aneurysms: The UK complex aneurysm study (UK-COMPASS)—perioperative and midterm outcomes,” to the VASCC Research Group WhatsApp group for comments, and the usual motley crew responded with differing impressions about the utility of the study. I suggested to Malachi Sheahan, medical editor, that he provide a commentary of the article in Vascular Specialist, and, Mal being Mal, suggested that I write the commentary. Thanks, my friend, and vascular bestie. I still love you, but I don’t like you anymore. Herein, I provide my analysis.

Registry data collected

This observational cohort study truly provides a snapshot of the evolving trends in the treatment of juxtarenal and complex neck abdominal aortic aneurysms (AAAs). The study looked at all UK patients undergoing treatment for AAAs between November 2017 and October 2019. Registry data were collected for patients with AAA ≥55mm in maximum transverse diameter and neck <10mm, and/or complex necks unsuitable for on-label standard endovascular aneurysm repair (EVAR). Aneurysms suitable for on-label standard EVAR, physician-modified endografts (PMEG), ruptured AAAs, and thoracic or thoracoabdominal aneurysms (TAAAs) were excluded. Treatment strategies for AAAs observed in the study included open surgical repair (OSR), fenestrated EVAR (FEVAR), combination of standard EVAR with adjuncts (endoluminal screws or parallel stent grafts) and off-label standard EVAR. The latter two cohorts were combined into one category due to low numbers (n=96) in the EVAR plus adjunct group.

Patients were stratified into six differing categories based on aneurysm neck anatomy and operative risk using the adjusted British Aneurysm Repair [BAR] score to calculate risk. Primary and secondary outcomes were compared for three differing anatomic considerations (0–4mm neck juxtarenal AAAs, 5–9 mm short neck AAAs, and ≥10mm neck/complex neck AAAs not suitable for on-label standard EVAR) and stratified for both high (highest quartile BAR score) and standard operative risk. The primary endpoint was death. Secondary endpoints included complications, secondary interventions for complications, and aneurysm-related death (defined as death from aneurysm- related complication or within 30 days of a secondary intervention).

The two primary comparisons of interest for this study were OSR vs. off-label EVAR and OSR vs. FEVAR. This study sought to address concerns that EVAR patients treated outside of instructions for use (IFU) fare poorer in the long term than similar patients undergoing OSR. As the patients were not randomized, propensity score stratification and regression adjustments were calculated to adjust for treatment biases related to patient baseline physiological fitness and aneurysm neck characteristics.

The Hospital Episode Statistics listed 8,994 patients as having undergone AAA repair in the UK during the study period. After exclusion criteria were applied, 1,916 patient datasets were reviewed.

Early outcomes

Nearly 3% of patients died in the peri-operative period. Not surprisingly, perioperative deaths were highest in the OSR group (4.5%), followed by FEVAR (2.2%, odds ratio [OR] 0.25, p≤0.001) and EVAR (1.2%, OR 0.24, p≤0.001). Death rates after OSR were higher for high-surgical-risk juxtarenal and short neck AAA patients (10.9% and 11.1%, respectively). Interestingly, death rate was highest (13.3%) in the high-operative-risk patients undergoing FEVAR for ≥10mm neck/complex AAAs. Perioperative complication rates were extremely high (55.4%) across the board and, again not surprisingly, occurred more frequently in high-risk patients and were highest (81.8%) in the OSR high-risk juxtarenal AAA cohort. Secondary early intervention rate was 7.7% for all comers and overall highest in the OSR group (8.9%), followed by FEVAR group (8.7%) and EVAR group (5.7%). One would not expect reintervention to be higher in the OSR than endovascular groups as they were in this study. Looking at each cohort separately, the early reintervention rate was highest (25%) in the high-operative-risk juxtrarenal AAA after EVAR.

So, some take home points: endovascular treatment of AAA is associated with lower perioperative morbidity and mortality and need for secondary interventions when compared with OSR. This is nothing new. FEVAR was associated with robust early perioperative mortality advantage, except for high-operative-risk ≥10mm neck/complex AAA patients. Treating patients off-label results in a quarter of these patients needing reintervention in the short term.

Midterm outcomes

Late all-cause death (excluding the perioperative deaths) was 17.8%, 24% after EVAR plus or minus adjuncts, 25.4% after FEVAR, and 9.7% after OSR.

Adjusted risk of late death was significantly greater after EVAR (hazard ratio [HR] 2.18, 95% confidence interval [CI] 1.61–2.95; p<0.001) and FEVAR (HR 2.01, 95% CI 1.46–2.77; p<0.001) than after OSR. For the combined study population, as well as for short neck or complex neck AAA treatment, early survival benefit was lost and reversed during follow-up.

The all-cause mortality rate after FEVAR and EVAR was double that of OSR by 3.5 years. Later secondary interventions were more frequent after endovascular AAA repair—FEVAR greater than EVAR—than after OSR.

Some take home points: patients selected for FEVAR and off-label EVAR died at two times the rate of patients undergoing OSR, and thus far there is not a good explanation for this.

So, what does this registry study tell me?

Its empirical evidence is as close to a randomized controlled trial as we can get for now since every patient who underwent AAA repair in the UK was included. Like the U.S., the UK has a varied practice for the treatment of juxtarenal, short neck and complex neck AAAs. In the UK, more than a third of AAA patients received off-label EVAR. Following off-label EVAR, 25% patients required reintervention within 30 days, and aneurysm-related death was 10 times higher compared with FEVAR and OSR for patients with juxtarenal AAAs.

For juxtarenal AAAs there is a robust perioperative mortality advantage to FEVAR over OSR, with equivalent survival up to midterm follow-up. Patients with short neck or complex neck AAAs lose their perioperative survival advantage midterm and have significantly worse survival compared with OSR patients. Higher midterm mortality is not explained by aneurysm-related mortality.

What are the implications of this study?

Avoid off-label use of EVAR when possible, especially in juxtarenal AAAs: it’s a no-brainer. FEVAR works well for 0–4mm neck/juxtarenal AAAs. For good-risk patients with ≥10mm necks/complex AAA necks, OSR is a viable option. Shocking!

I end in saying this: as vascular surgeons, we are obligated to offer our patients the most viable short- and long-term treatment option that they can tolerate. This means offering them OSR when appropriate. I believe the pendulum has swung too far in favor of endovascular treatment, not just for AAA care but also for the management of CLTI and other conditions. As such, I worry that, as a specialty, we are losing the art of open surgery when open surgery is the skillset that differentiates us from our interventional radiology and cardiology colleagues. Open surgical skills are essential to being a competent vascular surgeon. As a specialty, we need to ensure that our trainees, the future of our specialty, are learning and practicing the open surgical skills that they need to thrive and flourish as vascular surgeons. And that brings me back to why I am in the South. I am fortunate to still be practicing and teaching “the art of open surgery.” And for that I am grateful.

Erica Leith Mitchell, MD, is professor and chief of vascular and endovascular surgery at the University of Tennessee Health Science Center in Memphis.

FastWave Medical announces successful 30-day first-in-human data on peripheral IVL technology

By
Éva Malpass
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0
FastWave Medical announces successful 30-day first-in-human data on peripheral IVL technology
FastWave Medical IVL system
FastWave Medical IVL system

FastWave Medical has announced the 30-day results of its first-in-human (FIH) study using the company’s differentiated peripheral intravascular lithotripsy (IVL) technology.

This was a prospective, single-arm study to assess the safety and feasibility of the FastWave IVL system in patients with peripheral arterial disease affecting the superficial femoral artery (SFA) and popliteal artery with moderate to severe calcium. Principal investigators Miguel Montero-Baker (HOPE Vascular & Podiatry Clinic, Houston, USA), and Venkatesh Ramaiah (HonorHealth Vascular Group and Pulse Cardiovascular Institute, Scottsdale, USA), successfully conducted the procedures in collaboration with the hosting investigator, Antonio Muñoa (San Lucas Hospital, Chiapas, Mexico).

Eight patients with moderate to severe calcified occlusions in the superficial femoral artery (SFA) and popliteal arteries were successfully treated, providing encouraging evidence supporting the early safety and feasibility of the FastWave IVL system, the recent press release states.

Of the company’s key procedural findings, they reported 100% procedural success, 0% peri-procedural adverse events, and 5.9% mean residual diameter stenosis post-therapy. Reporting their 30-day results, FastWave also shared that 0% major adverse events were observed, they identified 100% patency, <2.4 peak systolic velocity ratio (PSVR), no revascularisations, walking impairment questionnaire (WIQ) scores showed improved walking distance and speed, and stair-climbing ability, and finally, ankle-brachial index (ABI) improved from baseline 0.56 to 0.89 at 30 days noting enhanced blood flow.

Montero-Baker approved these results, stating: “The overall improvement in the patients treated in the FastWave FIH study is really encouraging and provides compelling evidence supporting the feasibility and safety of the FastWave IVL system for further evaluation in a larger patient population in the USA.”

Ramaiah added: “I am impressed by the performance of the FastWave peripheral IVL catheter—it’s both highly deliverable and easy to use. Achieving a 94% mean residual diameter stenosis reduction at the end of the procedure is equally impressive and the 30-day follow-up results reinforce the initial procedure’s success.”

Scott Nelson, co-founder and CEO of FastWave Medical, shared his excitement: “The procedural data from the initial intervention and the 30-day results reinforce our confidence in the FastWave IVL system’s potential to pave the way for a peripheral pivotal trial in the USA. On behalf of the rest of our team, I’d like to express our sincere gratitude to the principal investigators for their exceptional clinical work and collaboration with the FastWave team in sharing these 30-day data.”

Rethinking failure as a vascular trainee

By
Christopher Audu
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0
Rethinking failure as a vascular trainee
Christopher Audu
technology
Christopher Audu

This month, I wanted to touch on that ubiquitous topic of failure. This often takes the form of not passing tests, or not matching, or failing clinically with poor patient outcomes. It’s hard, emotionally draining and can be difficult to surmount.

I was a preliminary general surgery resident for a year, after not matching the first go round. That was a tough year, with the emotional ups and downs. What’s worse, you don’t know what the next step will be. What if you don’t match again? There is a bias against preliminary residents, who are sometimes thought to be defective. How do you keep alive the dream of becoming a vascular surgeon?

What about when things go wrong with patient care? In my training, I’ve seen patients have poor outcomes following “minor” operations. How does one not internalize this as a personal failure? And if the outcome was truly your fault, how do you emerge stronger from it?

Let’s take the example of tests. What if you’re a poor test taker but love vascular surgery? How do you make sense of this? How do you move forward towards your dream?

I don’t have the answers, but I do know that one constant in life is that those who dare to be great and do amazing things, will face failure. Vascular surgery training is hard, and sometimes unforgiving. Failure, at some point, is inevitable. In many ways, it is necessary for our maturity and progression toward our goals.

It’s fine to be sad, even angry, after failure. This is normal and expected. The harder part is picking yourself up and not wallowing in self pity. Maybe this means talking to family, loved ones, a therapist who is outside of your work, or some other neutral friend. Look for the helpers. They are the ones that care about you.

How do you pick yourself up? There will be people who will criticize and blame with no input or insight that is meaningful. Avoid them. And if you can’t avoid them, ignore them. The easiest thing after failure is to wallow in it and give up. Rather, use it as a catalyst. Aim to be better. Sometimes, that means changing a routine and taking time to listen to loved ones.

Sometimes failure can mean a new direction. If that’s your story, analyze it and, if it comes to that, embrace it. This is very difficult to do, particularly after significant effort has been put in towards a particular goal. At the end of the day, being excellent at what you’re naturally good at will lead to unique expertise.

This is not an exhaustive list of how to think through failure, of course. There are books and mentors out there for that. That said, as trainees at different stages of learning, we must re-frame the notion of failure—and start to see it as normal process toward becoming great at what we do.

SVS approves FY 2024-2025 budget, sets priorities

By
Marlén Gomez
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0
SVS approves FY 2024-2025 budget, sets priorities
Kenneth Slaw

The Society for Vascular Surgery (SVS) has unveiled its strategic plans for fiscal year 2024–2025. On April 2, the SVS Executive Board (EB) and Strategic Board of Directors (SBOD) approved the budget presented by SVS Treasurer Thomas Forbes, MD. The budget culminated efforts by more than 30 SVS committees, task forces and sections, and reflects a strategic alignment with the organization’s top priorities.

At the forefront of the SVS’s agenda is the launch of a comprehensive branding campaign for vascular surgery. With an initial allocation exceeding $1 million, this initiative aims to enhance visibility and deliver focused messaging across various stakeholders, including patients, caregivers, referring doctors, healthcare executives, and medical school faculty and students. A collaboration with the Association of Program Directors in Vascular Surgery (APDVS) underscores SVS’s commitment to fostering a robust network within the medical community.

“One of the most important elements of success in strategy implementation is directly tying priorities to the budget allocation process,” noted SVS Executive Director Kenneth M. Slaw, PhD.

The approved budget includes investments across SVS’ strategic domains. In advocacy, plans are underway to host a biennial LIVE Advocacy Leadership training event in Washington, D.C., alongside continuous advocacy and leadership skill development for SVS members. Education initiatives are set to evolve with enhancements to the Vascular Annual Meeting (VAM), the introduction of new educational forums and the launch of a revamped model for the sixth edition of the Vascular Education and Self-Assessment Program (VESAP6).

Research endeavors will see the inception of two new task forces focused on innovation in vascular surgery and SVS-driven clinical trials. Practice-related investments include convening writing groups to address key topics, such as the economics of vascular practice and refining vascular surgery for pediatric patients.

To reinforce quality assurance measures, the SVS will continue to promote the Vascular Verification Program (VVP), a collaboration with the American College of Surgery (ACS) on a “center of excellence” model, and propose new vascular surgery performance measures for the Centers for Medicare & Medicaid Services (CMS) Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) program.

As part of efforts to strengthen vascular surgery as an independent specialty, the SVS will also undertake a thorough examination of the Board certification model.

Notably, the SVS will establish a new senior section to enhance engagement among senior members and provide tailored education on pertinent topics.

The SVS is poised to lead and inspire advancements in vascular surgery, driving innovation and excellence in patient care.

“A budget tells the story of where an organization is headed, and it looks to be an exciting one for the SVS the next several years,” said Slaw.

APDVS says goodbye to two long-term leaders during spring meeting

By
Kristin Spencer
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0
APDVS says goodbye to two long-term leaders during spring meeting
Coleman, Lee, and Sheahan
Coleman, Lee, and Sheahan

The 2024 Association of Program Directors in Vascular Surgery (APDVS) convened in Chicago April 5–6 for their annual spring meeting, which held the record for the highest-attended in APDVS history.

APDVS 2024 covered important topics for vascular surgery program directors, including the roles for coaching in program director positions, in-person versus virtual interviews for residency, the evolving curricula for vascular surgery trainees, the pros and cons of artificial intelligence and simulation in vascular surgery training, and more. Most of the sessions took place on April 5, culminating on April 6 with the annual business meeting where leadership bade farewell to Jason Lee, MD, as APDVS president, and Malachi Sheahan III, MD, as secretary-treasurer.

“It has been an absolute privilege and honor of mine to serve the APDVS and complete my term as president out of the [COVID-19] pandemic,” said Lee, who spent his term focusing on the educational environment for trainees and empowering program directors.

“Our terms began with an existential threat to our training programs,” commented Sheahan on the COVID-19 pandemic. “Quick coordination with the Vascular Surgery Board allowed for a case number waiver for any trainee unduly affected by the decreased number of elective procedures nationally. It is a testament to our training programs that not one graduate required the waiver. Our program directors also quickly adapted to virtual interviews, and rather than falter, vascular surgery became the fastest growing specialty in the Match in the years after the pandemic.”

Sheahan has been involved with the APDVS for more than 10 years and refers to his four-year term as APDVS secretary-treasurer as the honor of a lifetime.

During the four years of Lee’s leadership, two as president-elect and two as president, the APDVS covered a lot of ground, including the triumphs during the pandemic. Throughout that time, the APDVS studied impact and alternative recruitment issues through the VISIT (Vascular In-Person for Students in the Match Trial) study, developed new programs, increased curricular resources for trainees and program directors, and worked within the COVERS (Coalition for Optimization of Vascular Surgery Trainees and Students) group to improve recruitment in the vascular surgery field.

“I am proud of all we have done in the past four years and look forward to learning more. We need to continue listening to our program directors and trainees to make the specialty even better than it already is,” said Lee, expressing his gratitude for the volunteerism and professionalism that APDVS brings to trainees.

The APDVS meeting concluded on April 6 with Dawn Coleman, MD, taking over as the next president. For more information, visit vascular.org/APDVS.

UK-COMPASS: Aortas, open surgical skills and gratitude

By
Erica Leith Mitchell
-
0
UK-COMPASS: Aortas, open surgical skills and gratitude
Erica Leith Mitchell
Erica Leith Mitchell

As you read this, you are probably wondering why the heck I am writing an editorial on complex aortic aneurysms when you know I am somewhere in the South focused on vascular trauma and limb ischemia. Well, no good deed goes unpunished. Patrick Chong presented the article, “Comparison of open surgery and endovascular techniques for juxtarenal and complex neck aortic aneurysms: The UK complex aneurysm study (UK-COMPASS) —perioperative and midterm outcomes,” to the VASCC Research Group WhatsApp group for comments, and the usual motley crew responded with differing impressions about the utility of the study. I suggested to Malachi Sheahan, medical editor, that he provide a commentary of the article in Vascular Specialist, and, Mal being Mal, suggested that I write the commentary. Thanks, my friend, and vascular bestie. I still love you, but I don’t like you anymore. Herein, I provide my analysis.

Registry data collected

This observational cohort study truly provides a snapshot of the evolving trends in the treatment of juxtarenal and complex neck abdominal aortic aneurysms (AAAs). The study looked at all UK patients undergoing treatment for AAAs between November 2017 and October 2019. Registry data were collected for patients with AAA ≥55mm in maximum transverse diameter and neck <10mm, and/or complex necks unsuitable for on-label standard endovascular aneurysm repair (EVAR). Aneurysms suitable for on-label standard EVAR, physician-modified endografts (PMEG), ruptured AAAs, and thoracic or thoracoabdominal aneurysms (TAAAs) were excluded. Treatment strategies for AAAs observed in the study included open surgical repair (OSR), fenestrated EVAR (FEVAR), combination of standard EVAR with adjuncts (endoluminal screws or parallel stent grafts) and off-label standard EVAR. The latter two cohorts were combined into one category due to low numbers (n=96) in the EVAR plus adjunct group.

Patients were stratified into six differing categories based on aneurysm neck anatomy and operative risk using the adjusted British Aneurysm Repair [BAR] score to calculate risk. Primary and secondary outcomes were compared for three differing anatomic considerations (0–4mm neck juxtarenal AAAs, 5–9 mm short neck AAAs, and ≥10mm neck/complex neck AAAs not suitable for on-label standard EVAR) and stratified for both high (highest quartile BAR score) and standard operative risk. The primary endpoint was death. Secondary endpoints included complications, secondary interventions for complications, and aneurysm-related death (defined as death from aneurysm-related complication or within 30 days of a secondary intervention).

The two primary comparisons of interest for this study were OSR vs. off-label EVAR and OSR vs. FEVAR. This study sought to address concerns that EVAR patients treated outside of instructions for use (IFU) fare poorer in the long term than similar patients undergoing OSR. As the patients were not randomized, propensity score stratification and regression adjustments were calculated to adjust for treatment biases related to patient baseline physiological fitness and aneurysm neck characteristics.

The Hospital Episode Statistics listed 8,994 patients as having undergone AAA repair in the UK during the study period. After exclusion criteria were applied, 1,916 patient datasets were reviewed.

Early outcomes

Nearly 3% of patients died in the peri-operative period. Not surprisingly, perioperative deaths were highest in the OSR group (4.5%), followed by FEVAR (2.2%, odds ratio [OR] 0.25, p≤0.001) and EVAR (1.2%, OR 0.24, p≤0.001). Death rates after OSR were higher for high-surgical-risk juxtarenal and short neck AAA patients (10.9% and 11.1%, respectively). Interestingly, death rate was highest (13.3%) in the high-operative-risk patients undergoing FEVAR for ≥10mm neck/complex AAAs. Perioperative complication rates were extremely high (55.4%) across the board and, again not surprisingly, occurred more frequently in high-risk patients and were highest (81.8%) in the OSR high-risk juxtarenal AAA cohort. Secondary early intervention rate was 7.7% for all comers and overall highest in the OSR group (8.9%), followed by FEVAR group (8.7%) and EVAR group (5.7%). One would not expect reintervention to be higher in the OSR than endovascular groups as they were in this study. Looking at each cohort separately, the early reintervention rate was highest (25%) in the high-operative-risk juxtrarenal AAA after EVAR.

So, some take home points: endovascular treatment of AAA is associated with lower perioperative morbidity and mortality and need for secondary interventions when compared with OSR. This is nothing new. FEVAR was associated with robust early perioperative mortality advantage, except for high-operative-risk ≥10mm neck/complex AAA patients. Treating patients off-label results in a quarter of these patients needing reintervention in the short term.

Midterm outcomes

Late all-cause death (excluding the perioperative deaths) was 17.8%, 24% after EVAR plus or minus adjuncts, 25.4% after FEVAR, and 9.7% after OSR. Adjusted risk of late death was significantly greater after EVAR (hazard ratio [HR] 2.18, 95% confidence interval [CI] 1.61–2.95; p<0.001) and FEVAR (HR 2.01, 95% CI 1.46–2.77; p<0.001) than after OSR. For the combined study population, as well as for short neck or complex neck AAA treatment, early survival benefit was lost and reversed during follow-up. The all-cause mortality rate after FEVAR and EVAR was double that of OSR by 3.5 years. Later secondary interventions were more frequent after endovascular AAA repair—FEVAR greater than EVAR—than after OSR.

Some take home points: patients selected for FEVAR and off-label EVAR died at two times the rate of patients undergoing OSR, and thus far there is not a good explanation for this.

So, what does this registry study tell me?

Its empirical evidence is as close to a randomized controlled trial as we can get for now since every patient who underwent AAA repair in the UK was included. Like the U.S., the UK has a varied practice for the treatment of juxtarenal, short neck and complex neck AAAs. In the UK, more than a third of AAA patients received off-label EVAR. Following off-label EVAR, 25% patients required reintervention within 30 days, and aneurysm-related death was 10 times higher compared with FEVAR and OSR for patients with juxtarenal AAAs.

For juxtarenal AAAs there is a robust perioperative mortality advantage to FEVAR over OSR, with equivalent survival up to midterm follow-up. Patients with short neck or complex neck AAAs lose their perioperative survival advantage midterm and have significantly worse survival compared with OSR patients. Higher midterm mortality is not explained by aneurysm-related mortality.

What are the implications of this study?

Avoid off-label use of EVAR when possible, especially in juxtarenal AAAs: it’s a no-brainer. FEVAR works well for 0–4mm neck/juxtarenal AAAs. For good-risk patients with ≥10mm necks/complex AAA necks, OSR is a viable option. Shocking!

I end in saying this: as vascular surgeons, we are obligated to offer our patients the most viable short- and long-term treatment option that they can tolerate. This means offering them OSR when appropriate. I believe the pendulum has swung too far in favor of endovascular treatment, not just for AAA care but also for the management of CLTI and other conditions. As such, I worry that, as a specialty, we are losing the art of open surgery when open surgery is the skillset that differentiates us from our interventional radiology and cardiology colleagues. Open surgical skills are essential to being a competent vascular surgeon. As a specialty, we need to ensure that our trainees, the future of our specialty, are learning and practicing the open surgical skills that they need to thrive and flourish as vascular surgeons. And that brings me back to why I am in the South. I am fortunate to still be practicing and teaching “the art of open surgery.” And for that I am grateful.

SVS Foundation awards announced

By
Marlén Gomez
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SVS Foundation awards announced
Kevin Mangum

The SVS Foundation has announced recipients for the 2023–2024 awards cycle. The slew of awardees is headed by the winner of the S.T. Yao Resident Research Award winner, Kevin D. Mangum, MD, an integrated vascular resident at the University of Michigan in Ann Arbor.

His paper, “The STAT3-SETDB2 axis dictates NFkB-mediated inflammation in macrophages during wound repair,” will be presented during the William J. von Liebig Forum at the 2024 Vascular Annual Meeting (VAM) in Chicago ( June 19–22).

The Foundation also announced winners of the Vascular Research Initiatives Conference Trainee Awards and the Student Research Fellowship Awards.

SVS Foundation and American College of Surgeons Mentored Clinical Scientist Research Career Development Award (K08) and the Clinical Research Seed Grant recipients will be revealed at a later date.

‘I’m a big fan of firsts’: Nationally renowned speaker on DEI set to headline new SVS keynote

By
Marlén Gomez
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‘I’m a big fan of firsts’: Nationally renowned speaker on DEI set to headline new SVS keynote
Karith Foster
Karith Foster
Karith Foster, chief executive of Inversity Solutions, is set to headline the inaugural Society for Vascular Surgery (SVS) Keynote Speaker Series at the 2024 Vascular Annual Meeting (VAM 2024).

It starts with a title. For Foster, her keynote begins with an ending: “Finishing the journey to inclusivity through belonging, intention and respect.” The address, which falls in line with the meeting’s overall theme of embracing unity, promises to delve into the elements needed to create an inclusive culture in today’s world.

“Let’s shift the focus from what separates and divides us and focus on what we have in common—being truly inclusive but, most importantly, introspective,” Foster tells Vascular Specialist of her intentions for the keynote. “That doesn’t mean that we’re glossing over issues. It doesn’t mean that racism, sexism and all those things don’t exist. They absolutely do, but the only way we’re going to deal with those issues appropriately and effectively is if we’re speaking to one another in a healthy way.”

Foster, an alumna of Stephens College and Oxford University, brings considerable expertise, which is rooted in personal experiences. After transitioning into corporate America, she sensed an opportunity. She wanted to merge her passion with her purpose. This led to the establishment of Inversity Solutions, a consultancy that challenges traditional diversity paradigms.

Now 13 years in under her leadership, the company has a singular focus. “I’m a big fan of firsts,” Foster remarks, acknowledging the significance of her role. “I was inspired to know that the SVS was committed to their journey of diversity, and I’m honored to lend my voice to that cause.”

Foster says she is dedicated to uniting people. Her outlook reflects a diverse background. With a degree in broadcast journalism, she initially pursued a career in mass media, before turning to stand-up comedy. “I’ve always had this desire from the time I was a child to bring people together, and I thought mass media was the way to do it,” she explains. “When I found comedy, it sealed the deal that so much can come out of laughter and that communication of life, which is sometimes hard and painful, but there is catharsis in that.”

Foster says primary diversity, equity and inclusion (DEI) challenges stem from a reactionary rather than anticipatory approach. The upheavals of 2020, from the pandemic to the George Floyd incident, caught many organizations off guard, and revealed a lack of readiness to tackle diversity issues, she continues. To Foster, the turbulent times brought everyone’s attention to entrenched issues, but addressing them took more than placing people in diverse roles without preparing them or providing the funds to support long-term efforts.

Through a blend of humor and insight, Foster advocates for genuine inclusivity, urging organizations to shift their focus from division to commonality. “I love being able to use messaging that unites people, that brings people together and lets people see that the things that we think separate and divide us are surface things in reality,” she says. “This conversation doesn’t have to be an attack, but it also still needs to exist.”

Foster argues that embracing diversity needn’t be daunting, but rather empowering: “This isn’t scary. This is empowering, and it’s exciting, and it’s about also coming into yourself, right? Because that’s where it must start. That’s kind of the idea behind even the word Inversity.”

As she prepares to address the vascular surgery community, she emphasizes the importance of personal connections in the medical field. “As a surgeon, respect and trust are key,” Foster adds. “If those don’t exist, it’s going to affect how comfortable people are when they show up, it’s going to affect how you perform. It’s about personal interactions, relationships and connection, and it doesn’t get more personal than surgery. There has to be acknowledgement of the patient as an individual, just as there needs to be confidence in the physician.”

The inaugural SVS Keynote Speaker Series will take place at 5 p.m., Central Time, Wednesday, June 19, at VAM.

‘What if we could translate the most durable Dacron repair into a minimally invasive approach?’

By
Bryan Kay
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‘What if we could translate the most durable Dacron repair into a minimally invasive approach?’
Screenshot
Charudatta Bavare

Imagine a world in which the enduring Dacron graft, birthed by vascular pioneer Michael DeBakey, MD, some 70 years ago as an open repair for aortic aneurysms, could be performed minimally invasively with the sorts of gains associated with endovascular aneurysm repair (EVAR). A procedure with an extremely magnified view, that affords full control of instruments and blood vessels, and in which the execution of the anastomosis is essentially an extension of the surgeon’s hands inside the abdomen.

That is the pitch from Charudatta Bavare, MD, a vascular surgeon at the Debakey Heart and Vascular Center at Houston Methodist Hospital in Houston, Texas, to his fellow vascular surgeons who remain to be convinced that robotic surgery is a key part of vascular surgery’s future.

Bavare is at the vanguard of efforts—led by his boss, Alan Lumsden, MD, the Walter W. Fondren III Presidential Distinguished Chair at DeBakey Heart & Vascular Center—to build out a vascular robotics program.

To be sure, the Houston team have been busy banging the drum for robotic surgery in vascular of late. At the Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Scottsdale, Arizona, in March, Bavare presented a case of iatrogenic injury of the external iliac artery repaired via robotic-assisted laparoscopic surgery. SCVS 2024 also heard from Petr Stadler, MD, from Na Homolce Hospital in Prague, the Czech Republic, during a forum hosted by Lumsden. Stadler possesses one of the foremost experiences across the globe of using a robotic platform in vascular surgery. Finally, in late March, Houston Methodist hosted its first Robotic Surgery Summit.

Yet, the trouble is, explains Bavare in an interview with Vascular Specialist, vascular surgery in the U.S. is caught in a sort of catch-22. Because there are no certified trainers in the vascular surgery ranks on the robotic platform, an otherwise burgeoning cadre of general surgery-trained vascular fellowship graduates—whose residency included training in robotic surgery—are at a standstill. As things stand, they won’t be able to perform robotic vascular surgical procedures.

But then there is Bavare himself. The Indian-born, U.S.- trained vascular surgeon took that very general surgery-vascular fellowship route into the specialty. Those laparoscopic skills, fine-tuned during a stint post-fellowship at a rural Texas hospital where he performed both general and vascular surgery, helped lead to the moment when Bavare returned to Houston Methodist and, soon afterward, Lumsden started to entertain thoughts vascular surgery could be left behind if it did not buy into robotic-assisted surgery. With encouragement from Lumsden, Bavare embarked on a laborious journey to acquire the certification and credentialing required to be able to perform vascular procedures using a robotic platform. Now, following in the pioneering footsteps of its namesake, the DeBakey Heart and Vascular Center boasts the first-of-its-kind robotic vascular surgery program in the U.S. And Bavare is quickly racking up experience.

“As of today, I have done 49 robotic cases over the past two years,” he says. “A little less than half have been peritoneal dialysis catheter cases, many release of the median arcuate ligament, two splenic artery aneurysms, one renal vein transposition, and recently our first aortobifemoral bypass.

“For the last 10 years, there was no interest in the robot. For the last two years, there has been an incredibly high interest, especially from trainees in general surgery, just like me. Fifteen years ago, I had no exposure, but today every single vascular fellowship candidate who has finished a general surgery residency is fully certified on the robot and fully capable of doing robotic procedures.”

Back on the Dacron graft, Bavare has one more message: “If we can translate the most durable Dacron repair into a minimally invasive approach, that would give the patient the benefit of both [the open and EVAR] worlds.

LINC 2024: C-GUARDIANS data represent lowest event rates in published trials of CAS, TCAR and CEA

By
Jocelyn Hudson
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LINC 2024: C-GUARDIANS data represent lowest event rates in published trials of CAS, TCAR and CEA

New data from the C-GUARDIANS pivotal investigational device exemption (IDE) trial support consideration of carotid artery stenting (CAS) with the CGuard embolic prevention stent system (EPS; InspireMD) as a “frontline therapeutic option for appropriate patients being considered for carotid revascularisation”. This is according to lead investigator Chris Metzger (OhioHealth, Columbus, USA), who presented one-year results from the trial at the Leipzig Interventional Course (LINC) 2024 (28–31 May, Leipzig, Germany).

Metzger detailed that this was a prospective, multicentre, international, single-arm clinical trial comparing the primary endpoint to a performance goal derived from the literature.

The objective was to evaluate the safety an efficacy of the CGuard in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients at high risk for carotid endarterectomy (CEA) undergoing CAS.

Chris Metzger

From July 2021 to June 2023, 316 patients were prospectively enrolled in the study at 24 sites across the USA and Europe.

The primary endpoint of the trial was a composite of: (1) incidence of major adverse events including death (all-cause mortality), any stroke, or myocardial infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure.

Metzger revealed at LINC 2024 that stenting with the CGuard in patients with carotid artery stenosis and at high risk for CEA had a primary endpoint event rate of 1.95%, from procedure through one-year follow-up.

The presenter commented that the data are consistent with previously published European data.

“We are very excited that the one-year carefully adjudicated C-GUARDIANS data confirm the extremely low rates of stoke, death, myocardial infarction, and target vessel revascularisation in this prospective trial of high-CEA-risk patients with obstructive carotid disease, including 25% who were symptomatic,” Metzger stated in an InspireMD press release announcing the results. “These data confirm the potential ‘neuroprotective properties’ of this unique MicroNet technology, offering an outstanding frontline option to consider for each patient with obstructive carotid artery disease.”

PAD guideline update from ACC, AHA and others centers multispecialty care

By
Jocelyn Hudson
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PAD guideline update from ACC, AHA and others centers multispecialty care

New multisociety clinical practice guidelines for the management of lower extremity peripheral arterial disease (PAD) have been published online in the Journal of the American College of Cardiology (JACC). One of the document’s key takeaway messages is that care for patients with PAD—and those with chronic limb-threatening ischemia (CLTI) in particular—is “optimized” when delivered by a multispecialty care team.

The JACC paper is the work of the American College of Cardiology (ACC), the American Heart Association (AHA) and nine other societies including the Society for Vascular Surgery (SVS) and the Society of Interventional Radiology (SIR).

Authored by cardiologist and writing committee chair Heather L Gornik (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA) and colleagues, the 2024 guidance aimed to advise clinicians on the treatment of patients with lower extremity PAD across its multiple clinical presentation subsets—asymptomatic, chronic symptomatic, CLTI, and acute limb ischemia (ALI). The document represents an update to the 2016 AHA/ACC guidelines on PAD.

Among a list of key take-home messages from the guidance, Gornik et al highlight that health disparities in PAD “must be addressed at the individual and population levels,” recommending that interventions be “coordinated between multiple stakeholders across the cardiovascular community and public health infrastructure.”

Recommendations regarding medical therapy are also underlined, with the writing committee advising that rivaroxaban (2.5mg twice daily) combined with low-dose aspirin (91mg) “is effective to prevent major adverse cardiovascular events and major adverse limb events in patients with PAD who are not at increased risk of bleeding.”

Furthermore, structured exercise is labelled a “core component” of care for patients with PAD, and the writing committee states that revascularization—whether endovascular, surgical, or hybrid—“should be used to prevent limb loss in those with chronic limb-threatening ischaemia and can be used to improve QoL [quality of life] and functional status in patients with claudication not responsive to medical therapy and structured exercise.”

The guidelines continue that foot care is “crucial” for patients with PAD across all clinical subsets and that podiatrists and other specialists with expertise in foot care, wound-healing therapies, and foot surgery “are important members of the multispecialty care team.”

Finally, the guidelines mention the PAD National Action Plan, which, the authors write, outlines six strategic goals to improve awareness, detection, and treatment of PAD nationwide. “Implementation of this action plan is recognized as a top advocacy priority by the writing committee,” the JACC paper reads.

We are not ‘and vascular’: SVS set to launch ambitious new phase in branding campaign

By
Bryan Kay
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We are not ‘and vascular’: SVS set to launch ambitious new phase in branding campaign
Screenshot
William Shutze
SVS secretary details the spirit and the cause behind the next phase of the Society’s branding campaign aimed at helping vascular surgery become an instantly recognizable specialty inside and outside of the hospital.

“We are not going to apologize for trying to educate the public and the referring physicians. There is no reason for us to apologize. And we also are not going to be negative to any other specialty. We are simply going to be positive and truthful about who we are and what we do and what we can do for vascular disease patients on their journey.”

Those were the words of William Shutze, MD, who has been given the task of leading the SVS’ ongoing branding campaign as Society secretary, in an interview with Vascular Specialist ahead of the launch of phase two later this year.

Shutze, also chair of the SVS Communications and Branding Committee, was detailing the need for greater public awareness of what a vascular surgeon does, and the comprehensive and longitudinal nature of the care vascular surgeons provide after a patient is diagnosed with a vascular condition.

But it is not just patients and their families the SVS campaign seeks to target. The Society also wants to pierce through into the consciousness of referring physicians, the C-suites of both healthcare systems and insurance payors, and also medical students.

Branding continually emerges as a top member concern or priority, Shutze explains. “Basically, as a specialty we are either not branded or misbranded, depending on how you want to look at it,” he says. “We are pigeon-holed into this concept of surgery.”

Despite past efforts to tackle vascular surgery’s recognition problem, “without a doubt we have fallen short,” Shutze admits.

So now the Society, with support from the SVS Executive Board and the Strategic Board of Directors, has taken steps to up the ante. A substantial seven-figure sum has been committed to the effort, he reveals.

Phase one started last year with a series of retreats aimed at honing in on the details of the problem and how they should be tackled. Phase two will see an interactive patient-facing website go into full development and an advertising and marketing firm help push vascular surgeon voices to the fore of the public square when stories about vascular disease break.

The latter will be a more proactive multimedia effort aimed at making vascular surgeons the go-to vascular content experts in the mainstream media and beyond.

“Are we going to buy a Super Bowl ad? Probably not,” says Shutze. “We want to get the best return on investment that we can. The best way is for us to be out there with press releases, commenting on current stories that are vascular related so that, when a story comes up, this company can help us be front and center, providing that vascular content expert.

“My personal vision is that, in two or three years, we don’t have to do this. When there is a journalist out there, or a healthcare blogger, and they want a vascular content expert, we want them to just go to the SVS. That would be a measure of success: that they are coming to us.”

The vision for the patient-facing SVS microsite is to create a preeminent source of public information on vascular disease. In terms of targeting referring doctors, partnerships are set to be formed with other specialty societies to help foster an understanding of “the values of working with vascular surgery,” Shutze continues.

A later, third phase of the branding campaign will see the C-suites of hospital systems and insurance providers targeted, explains Shutze. “We need to let them know the value of having a vascular surgeon on their team and raising the support of the vascular surgery service line to the highest level they can to maximize the benefits that the service line can bring to their institution.”

Shutze emphasizes the campaign does not seek to claim vascular surgery superiority. Rather, he says, “it is important for patients to understand what their physician is capable of doing for them. Right now they are not necessarily aware of what a vascular surgeon is capable of doing for them and how important that can be to the success of their vascular journey. I believe it is the SVS’ public duty to educate the patients and their families so they have an understanding—that their doctor is comprehensive and longitudinal, and not focused on episodic care.”

Adds Shutze: “We are not ‘and vascular.’ What I mean by that is, when you look at other specialties in this space, they are always ‘something and vascular.’ We are not ‘and vascular.’ We are vascular and that is it.”

The background, training and commitment to vascular disease of vascular surgeons make them “the best positioned to provide that optimal care to these patients,” he says.

Studies highlight need for tailored treatment options for women with peripheral arterial disease

By
Jocelyn Hudson
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0
Studies highlight need for tailored treatment options for women with peripheral arterial disease

New clinical results highlight the need for inclusive approaches and comprehensive examinations of treatment options for peripheral arterial disease (PAD), including endovascular therapy and revascularisation. The data were presented recently at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions (2–4 May, Long Beach, USA).

In one presentation, late-breaking data showed that endovascular therapy results in a one-third reduction in post-procedural complications for women with PAD, while another demonstrated that women and Asian Americans are less likely to undergo endovascular revascularisation for PAD compared to men and other races.

According to a SCAI press release announcing the results from these studies, PAD contributes to 400 amputations performed each day, with additional data highlighting a disproportional impact on underserved communities.

In addition, the release highlights a December 2023 American College of Cardiology (ACC) statement showing that data from up to 20 years ago highlighted racial and sex-specific disparities in treatment for PAD. “This underscores the need for more recent information on how PAD treatment impacts genders and races (medication, lifestyle changes, angioplasty and stent placement, or bypass surgery),” the SCAI press release reads.

“PAD is a prevalent and debilitating disease with serious consequences, especially for advanced cases that may have progressed due to lack of treatment, which is something that many clinicians are seeing in their patients today. Evidence-based data on treatment outcomes for all are critically important for individualised care,” said SCAI president George D Dangas (Icahn School of Medicine at Mount Sinai, New York, USA). “SCAI and its PAD Pulse Alliance partners have worked to close these gaps through the Get a Pulse on PAD campaign, which kicked off this year with resources for physicians and patients.”

At SCAI, one late-breaking presentation showed data supporting the effectiveness and safety of endovascular therapy with stent implantation as an alternative to bypass surgery in both women and men with PAD.

A literature search identified six randomised controlled trials comparing endovascular therapy with stent implantation (bare-metal, drug-eluting, or covered stent) versus bypass surgery with vein or prosthetic material in patients with symptomatic PAD involving the femoropopliteal segment. The primary endpoint was major adverse limb events (MALE), a composite of all-cause death, major amputation, or reintervention of the target limb. Other endpoints included amputation-free survival (AFS), the individual components of MALE, and primary patency. Early complications were defined as a composite of any bleeding, infection, or all-cause death within 30 days of the procedure.

Of 639 patients investigated, 185 (29.0%) were female. Baseline and procedural characteristics were comparable between patients randomised to endovascular therapy versus bypass surgery. At two years, there was no significant difference in the incidence of MALE between endovascular therapy and bypass surgery in women (40.6% vs. 42.1%, p=0.764; hazard ratio [HR] 0.93) and men (39.7% vs 34.4%, p=0.963; HR 0.98). Similarly, there were no differences in amputation-free survival (AFS), individual components of MALE and primary patency between endovascular therapy and bypass surgery regardless of sex. Endovascular therapy compared to bypass surgery was associated with a significantly lower rate of early complications at 30 days (8.7% vs. 25.96%, p=0.002 in women and 5.9% vs. 21.5%, p<0.001 in men) and significantly shorter hospital stay in both women and men (3.7±5.7 vs. 7.2±4.3 days, p<0.001 and 2.8±3.2 vs. 7.4±5.1, p<0.001).

“While the findings of the study are of value considering the scarce data on PAD treatment in women, they are also a strong reminder that we must do better in enrolling women in PAD trials. Women remain underrepresented in PAD trials and concerted efforts are warranted to achieve adequate representation of women to improve our understanding of the disease and its management in both women and men,” said Serdar Farhan (Icahn School of Medicine at Mount Sinai, New York, USA), lead author of the study. “Early diagnosis and guideline-directed medical therapy are key to improving outcomes of any treatment strategy for PAD.”

Another study presented at SCAI showed that women and Asian Americans are less likely to undergo endovascular revascularisation.

In this analysis, Bayesian machine learning-augmented propensity score translational (BAM-PS) statistics with multivariable regression was conducted for the largest US all-payor inpatient dataset, the National Inpatient Sample (NIS), from 2016 to 2020.

Of 148,755,036 adult hospitalisations, there were 17,173,000 (11.54%) with PAD, of whom 680,025 (3.96%) underwent inpatient endovascular revascularisation. Endovascular revascularisation prevalence increased steadily (0.46% to 0.49%, p <0.001). In BAM-PS multivariable regression adjusting for several clinical and demographic variables, female sex (odds ratio [OR] 0.54) and Asian versus Caucasian race (OR 0.66) significantly decreased the odds of endovascular revascularisation. Medicare versus commercial insurance (OR 1.17) significantly increased the odds of endovascular revascularisation (p<0.001). There were no significant differences in endovascular revascularisation mortality and cost when analysed by sex, race, and income (p>0.05 for all).

“Although not surprising, it is frustrating to see women and Asian Americans are less likely to undergo procedures that may prevent amputations or even death,” said Awad Javaid (University of Nevada, Las Vegas, USA), lead author of the study. “The results reinforce the need to change current practice by using a more inclusive and multidisciplinary approach to peripheral arterial disease interventions.”

Lightning Bolt 7 ‘stands alone’ in aspiration thrombectomy for acute limb ischemia

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Lightning Bolt 7 ‘stands alone’ in aspiration thrombectomy for acute limb ischemia
Martyn Knowles

This advertorial is sponsored by Penumbra, Inc.

“Honestly, there’s nothing even close to it for thrombectomy on the arterial side of things,” according to Martyn Knowles, MD, a vascular and endovascular surgeon at University of North Carolina (UNC) Health Care in Raleigh, North Carolina, speaking about the Lightning Bolt 7 aspiration thrombectomy system.

“There’s really no other game in town,” Knowles continues. “Penumbra is leaps and bounds ahead of anybody else. And I think the thing that has made the Bolt work so well is the ability to use saline to modulate the aspiration and break up the friction within the catheter so clots are quicker and easier to remove in my experience.”

Knowles points to three prevailing ways in which computer-assisted vacuum thrombectomy (CAVT)—as enabled by the Lightning Bolt 7 device—has positively impacted acute limb ischemia (ALI) care in his practice. The first of these is the speed at which clot is removed, with algorithms working to optimize suction and clearance of the catheter; the second is a greater ability to ingest more complex clots more easily, allowing for the treatment of more chronic/ subacute cases; and the third is “really good blood-loss mitigation,” he says.

“You’ve got that saline interacting with the catheter,” Knowles explains, “and it augments those three things that I think are most important for successful thrombectomy—and every iteration that Penumbra provides makes that better.”

Shifting towards thrombectomy

“I finished training in 2014 and, at that time, treatments for ALI were really either thrombolysis—and, if that didn’t work, surgery—or just going straight to surgery,” Knowles states. He recalls that there were several devices that offered some hope in ALI patients back then, but that, ultimately, “none of that stuff ever really worked,” citing inconsistent outcomes and some “really frustrating results.”

“As time went on,” he continues, “I ended up using Penumbra’s CAT 6, CAT 5 and CAT 3 [catheters]. I started using them in ALI and I realized that they worked fairly well—and I figured that there was a place for thrombectomy-first in some of these cases.”

Penumbra’s Lightning Bolt 7 system

From 2015 onwards, Knowles employed thrombectomy more and more often, initially utilizing it in “easier” cases but—following device improvements, including CAVT technologies and larger, more optimized catheters—he was able to achieve increasing levels of success. As a result, he has essentially “flipped” his typical ALI approach from thrombolysis-first to endovascular-first, either deploying thrombectomy on its own or alongside surgery.

“I’ve been fairly consistent with that over the last three or four years, and I really like it,” he adds. “I never liked thrombolytics; I had some complications with people who bled, and so I was really happy to switch. And, as time has gone on, the devices have just gotten better and better, and better. To start with, they were pulled out of the ‘neuro’ world and, as they’ve tailored the devices for the peripheral arteries, it really has worked well.”

A hybrid approach

Knowles highlights the fact that using Lightning Bolt 7 does not burn any treatment bridges down the line. If for some reason the thrombectomy is not fully successful, then open surgery can be employed to gain full perfusion, and using Lightning Bolt 7 will make that surgery “much, much easier,” he explains.

With the other treatment options—lytics and surgery—“if you choose those frontline it is more difficult to change your treatment path,” he continues. “This hybrid approach with Lightning Bolt 7 frontline can be helpful in more challenging or complex cases.

“You’re able to go in and deal with long-level occlusions, and multiple vessels, and—a lot of the time—with one device, the Lightning Bolt 7, for everything from proximal tibial vessels, popliteal and SFA [superficial femoral artery], to bypass grafts. You really only need one catheter, so it has made those tougher cases—and that tougher clot—easier and easier for me.”

Asked to provide a message for his peers regarding the system, Knowles advises that the key is “to get in there quickly” and emphasizes the importance of patience in trickier ALI cases. “Coordinated approaches” to removing clot are vital, as is “making sure you have good sheath access,” Knowles adds.

What does the future hold for ALI treatment?

“I think there are two parts to it,” Knowles says. “I think there’s a large number of practicing vascular surgeons who have not given the device a ‘real go’ in ALI cases— they always go straight to [open] surgery or thrombolytics, and they have not really tried the newer devices.

“So, I think, in the next five-to-seven years, what’s going to happen is that more people are going to see that it works and start using it. And I think the move is going to be more and more towards endovascular-first treatments for ALI.

“Secondly, I think the people who are using it are going to be expecting and wanting even more improvements in the devices. Right now, the interesting thing is that we don’t want the arterial devices to be bigger; we’re at a good size.

“Most vascular surgeons want, at maximum, a 7F device, but we want it to work better and we don’t want a lot of blood loss. So, one thing I can possibly see over the next couple of years is a mechanical aspect to the Penumbra device—something that can assist the algorithm, not just in modulating the aspiration and pulling the clot out, but also in terms of how well the device interacts with the vessel wall as well as the lumen of the vessel.”

Knowles sees an increasing number of operators likely getting “more comfortable with [the endovascular-first approach], and realize that it works.” He reiterates the potential for endovascular thrombectomy as an “adjunct” that enables better outcomes than more traditional surgeries.

“It doesn’t need to be a standalone,” Knowles says. “I think the transition from the open era to the [endovascular]-first era is going to happen—it works, and it’s rare that I do an open thrombectomy by itself nowadays,” Knowles concludes. “A lot of the time, if I do a hybrid procedure, I find that it’s much, much more successful with angiography— and sometimes targeted thrombectomy to really optimize things, and get that patient out of trouble.

“That will be the push,” Knowles adds. “I think there’s going to be more and more endovascular-first, and the era of just pure open ALI treatment is probably going to be gone in the next couple of years.”

Martyn Knowles is a consultant for Penumbra, Inc. Procedural and operative techniques and considerations are illustrative examples from physician experience. Physicians’ treatment and technique decisions will vary based on their medical judgment. The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.

Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Summary Statements, please visit www.peninc.info/risk. Please contact your local Penumbra representative for more information.

‘We need to continue to be deliberate’: Dedicated society for women vascular surgeons formed

By
Jocelyn Hudson
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‘We need to continue to be deliberate’: Dedicated society for women vascular surgeons formed
Linda Harris

The inaugural president spoke to Vascular Specialist about the newly formed International Society for Women Vascular Surgeons ahead of this year’s Women’s Vascular Summit (May 3–4) in Chicago, outlining its genesis and goals, as well as some of the highlights of this year’s gathering.

Linda Harris, MD, a professor of surgery and chief of vascular surgery at the University at Buffalo in Buffalo, New York, notes that she created the Women’s Vascular Summit back in 2019 and, more recently, the International Society for Women Vascular Surgeons, for two reasons: to address vascular health and disease in women, and to promote leadership among women vascular surgeons.

Reflecting on her own experience, Harris is clear: “I’ve had some wonderful opportunities, but there have also been a lot of glass ceilings.”

She says that many of the women who came before her—as well as many of her own generation—have experienced these same glass ceilings, and there was a general feeling that “it was time for a change.”

Leadership will be a key focus of the Society and of this year’s Summit, Harris points out.

“I realized early on that I never really did things like self-promote,” she explains, remarking that part of the reason why has to do with how women are brought up and conditioned. Harris continues: “There’s a lot of data showing that you can have a woman who’s more capable and more experienced and really deserves a position more than a man, and he will self-nominate and she’ll say, ‘I don’t think I’m ready.’”

Harris also considers the role of the Society and the Summit as part of a bigger picture, underscoring the importance of diversity in vascular surgery.

“It’s about having different opinions, and that’s not just male/female,” she says, also citing the importance of engaging with leadership roles in national and regional organizations.

“While there is much we can and will accomplish as a new society, it is still critically important for women to engage and maintain leadership roles in our national and regional organizations,” she says.

“We need to pay particular attention to diversity committees and women’s sections, utilizing them to help facilitate intentional appropriate changes within these organizations, allowing for all undderrepresented groups to gain traction: women, underrepresented minorities, community practice.”

Palma Shaw, MD, the vice president of the new Society, says that “the leadership looks forward to productive collaboration with the SVS, which has been very supportive.”

Meanwhile, Harris outlines some of the highlights of this year’s Summit, explaining that the agenda highlights a mixture of talks, some geared towards vascular disease in women and others dealing with leadership and other non-clinical topics. The program also zeros in on updates on a number of trials that are currently underway and how they apply to women.

Harris points out that, often at national and regional meetings, the conclusion is reached that women have different outcomes. At this year’s Summit, the aim is to go much further than this. “What are we doing about it?” Harris asks, underlining one of the key questions that need to be addressed. “Most of the time we end up saying we don’t have enough data, and that’s not good enough anymore.”

Finally, Harris hopes the Society and the Summit partner with international societies and offer virtual attendance to those not able to attend the U.S. meeting.

She also highlights the importance of the Society’s impact extending beyond her premiership. “When I started this, I didn’t want to have it be my society forever. I wanted it to be something that I could transition to others,” Harris adds, noting that a metric of success would be whether the Society is sustained after she steps aside.

Vascular Specialist–May 2024

By
Bryan Kay
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Vascular Specialist–May 2024

In this issue: 

The Thompson Retractor OneFrame System: A ‘complete partner’ for aortic aneurysm procedures

By
BIBA Publishing
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0
The Thompson Retractor OneFrame System: A ‘complete partner’ for aortic aneurysm procedures
Xavier Berard

This advertorial is sponsored by Thompson Retractor.

Aortic aneurysm procedures range from basic to extremely complex. They all have one thing in common: great exposure is essential. The Thompson OneFrame™ Retractor System, available worldwide, offers an exposure solution for the full range of approaches. In this interview, Xavier Berard, MD, PhD, FEBVS, a Board-certified professor of vascular surgery at the University of Bordeaux in Bordeaux, France, shares his experience adopting the system at his practice, why it became his “complete partner” in the operating room, and the innovative surgical approaches it has allowed him to explore.

Can you describe your first experience with the Thompson Retractor OneFrame System?

XB: I did not start my open surgery program with this retractor. I used it during a free trial. There are two ways to become familiar with the retractor—an experienced surgeon with the opportunity to try something new, or a surgeon who has been trained on the Thompson and wants to bring it to their new facility.

I am an experienced surgeon, operating for 15 years, and decided to switch to this new retractor four years ago.

When you make a change like this, it is not always possible to see the new, big advantages in the first few uses of the device, and the free trial process allows you to learn the extent of the benefits that the system offers.

I was convinced to adopt it ultimately by three factors. First, the Quick Angle feature allows for extensive angling of the blades. Second, the simplicity of the system allows you to get familiar with it very quickly. Third, there are many blade options which offer huge versatility for exposures in many different approaches.

For what type of procedures do you use the system?

XB: I don’t take the OneFrame out just for special occasions, it is my partner. Every time I open the abdomen, I use it. This is very important. In aortic aneurysm surgeries we can do a classic bypass.

There is the basic approach for an aortic aneurysm midline surgery. And there are more complex cases, infrarenal abdominal aortic aneurysm (AAA) left retroperitoneal minimally invasive surgery, and a thoracoabdominal approach for a type IV thoraco AAA, for example.

Can you walk through your typical exposure with the OneFrame?

XB: The exposure is a continuous process. I place the retractor. First, during exploration of the abdomen, I have a very basic exposure. Then I start to create more exposure by progressively adding blades. Depending on what I must do, I continuously adapt my exposure. This is important in vascular surgery as we need to do many complex tasks and great exposure facilitates that execution.

Looking over the set of blades in the OneFrame System, you can progressively work from basic exposure to more advanced exposure. When we are ready to do an anastomosis, the surgeon and first assistant are completely hands free. No one has to hold blades.

How does the Thompson Retractor OneFrame System compare to other forms of retraction in the market?

XB: My past retractors were very basic and had low versatility. The frame was very flat and made it difficult to elevate with minimal to extremely basic angling.

The OneFrame offers exceptional angling and multiplanar retraction. In addition to this, the malleable blades in my Thompson set are excellent. They are soft enough to be shaped, but strong enough to maintain the shape you have given them during the procedure. Combined with the Quick Angling feature, you have the perfect combination of what you expect from your retractor.

How has the OneFrame changed your practice?

XB: I started using a very basic exposure, but I saw the capacity for this retractor to do more because of the Quick Angling feature and I was able to innovate and propose a new approach: the minimally invasive left retroperitoneal surgery. Honestly, this is the sole retractor I can use for this approach.

Additionally, Thompson’s educational donation program has worked with the University of Bordeaux in Bordeaux, France.

It is very important to give simulation tools to trainees. It is difficult to simulate open surgery and, in AAA procedures, it is imperative to learn to expose effectively.

If a colleague were to ask you about the OneFrame System, how would you describe it?

XB: First, with the OneFrame System, you can be very inventive in your approach and achieve a smaller incision, potentially leading to the patient having a shorter stay in the hospital. Additionally, it is an excellent system to learn surgery. Educating surgeons is very important.

In my daily practice with fellows, it allows us to be very cautious about every step and develop a consistent, systematic approach to AAA procedures. From a professor’s point of view, the residents are free from holding blades and are more focused on learning the intricacies of the surgery itself. It’s a complete partner. You can easily learn this system and how to obtain the perfect exposure.

*View the OneFrame in person at the 2024 Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) in Chicago (June 19–22), as well as the 2024 European Society for Vascular Surgery (ESVS) Annual Meeting in Kraków, Poland (Sept. 24–27). ThompsonRetractor.com

 

‘Who let a vascular surgeon in the room?’: Leadership in the face of turf battles in vascular disease treatment

By
Bryan Kay
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0
‘Who let a vascular surgeon in the room?’: Leadership in the face of turf battles in vascular disease treatment
Palma Shaw and Manuel Garcia-Toca

Leading vascular surgeons from across the globe contributed pearls of wisdom on how to go about tackling inevitable turf battles from other specialties practicing in the vascular disease space during a leadership challenges session staged by the World Federation of Vascular Societies (WFVS) at the recent 2024 Charing Cross (CX) International Symposium in London, England (April 23–25).

Palma Shaw, MD, WFVS secretary-general, who had organized the session with Manuel Garcia-Toca, MD, chair of the Society for Vascular Surgery (SVS) Leadership Development Committee, captured the tone of the session with a couple of anecdotes depicting how she confronted conflict in the operating room during a previous clinical appointment.

“When I went to Boston University, vascular surgery was not doing the endovascular cases,” Shaw, now professor of surgery at Upstate University in Syracuse, New York, explained. “They were doing the cutdown and radiology would bring the instruments in and do the case. When I showed up, I could do it all by myself. I invited them to participate in my first case and they deliberately didn’t show up. But it all worked out; I was nice, but I never had to invite them again.

“Then I was the first vascular surgeon doing procedures in the cath lab. There was one very gracious, professional gentleman, but then in the control room I would hear snickering, and I would just be doing my case: ‘Who let a vascular surgeon in the room?’—they would be making these kinds of comments. But I was always nice to them, polite with them, I never gave them excuses to use that against me.”

Shaw and Garcia-Toca, an associate professor of surgery at Emory University in Atlanta, assembled a panel of senior surgeons under the auspices of the Global Training Initiative to tackle key challenges put to them by vascular surgery trainees, with the aim of providing soft skills know-how required in practice but often neglected in medical school.

Shaw’s experience emerged during a scenario put forward by European Vascular Surgeons in Training (EVST) member Desiree van den Hondel, MD, a vascular surgery fellow at Rijnstate Hospital in the Netherlands: “Bridging divides—effective approaches to managing interdepartmental turf battles.”

Van den Hondel presented a hypothetical situation in which they are a newly appointed chief of vascular surgery at a high-volume center, where lower extremity procedures are managed by interventional cardiology and radiology. Previously, they were part of a thriving multidisciplinary group and they now want to implement this practice in their present role but are facing resistance. They have the backing of the chief medical officer but the CMO urges caution.

For his part, Pradeep Mistry, MD, a vascular surgeon based in Johannesburg, South Africa, and a vice president of the WFVS, urged inclusivity over exclusivity.

“When we practice vascular medicine, we don’t see ourselves just as vascular surgeons,” he said. “And if you’re offering a service, and if you’re at the point of service where you see your patients at the outpatient clinic, that’s the first place where you encounter your patients. You are not seen as just a technician; we in South Africa are in a country of have and have nots.

“In private practice we have managed to secure I would say 95%-plus of the vascular patients just because we are willing to go that extra mile in being the vascular physicians for the patients.

“We have very few interventional radiologists, and they are not as hard working as vascular surgeons, just by the definition that we had to go through doing general surgery and trauma first. Going through that gives you a bit more resilience in terms of what you need to do.”

Co-moderating with Shaw, Garcia-Toca emphasized the need for negotiating skills. “We are really good at our craft of vascular surgery,” he noted, “but those negotiating skills: we don’t learn them. And we always need to go in with the mentality of win-win for both parties. Separating and excluding people doesn’t work.”

Prem Chand Gupta, MD, the current president of the WFVS, as well as president of the Vascular Society of India, is part of a 15-member multispecialty team in Hyderabad. He, too, banks on an inclusivity message. “When you have a case that is particularly difficult, it might be a good idea to massage egos and call [the other specialties] to help you with that case, and gradually the relationship does build,” he said.

Martin Bjorck, MD, professor emeritus from Uppsala University Hospital in Uppsala, Sweden, outlined a scenario in which he and his team had to tackle a turf battle head on. Some of the radiologists tended to “monopolize the endovascular procedures,” he said, leading the surgeons to take action, with administrative support.

“Fifteen years ago, we had to be decisive, and we stopped writing referral notes to the radiologists. Since then, we now do all of the arterial work ourselves and we have a much better collaboration with our radiologists.

“We ended up taking more than 1,000 procedures from radiology to vascular surgery per year and that needed a change in budget—that was the most difficult part [to achieve]. That was the decisive point, because then we had the budget.”

Bjorck added that if they could have done anything differently, he would have urged that the action be taken more quickly: “We were too patient. There will be conflict sooner or later; better to take it sooner.”

Philippe Kolh, MD, from Centre Hospitalier Universitaire de Liège in Belgium, highlighted the need to have senior members of the hospital administration on board. “The key is to have the head of the hospital with you,” he said, “because you will get conflict.

“Of course you need the training, you need to see where the guidelines are, what they recommend in terms of number of procedures, and in term of skills. But you cannot go alone; you need a plan; if there is a fight, I’d rather take it sooner.”

The top 10 most popular Vascular Specialist stories of April 2024

By
Éva Malpass
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The top 10 most popular Vascular Specialist stories of April 2024

top 10

In April, the most read stories from Vascular Specialist include new research on Chat generative pre-trained transformer (GPT) technology and its application within vascular surgery and training; SVS Vice President candidates are announced; a guest editorial on how open access is changing academic publishing; and ‘promising’ data revealed in study using novel ultrasound-facilitated thrombectomy with microbubbles for treatment of acute deep vein thrombosis (DVT), among several more. 

1. Bad reading: How to claw back negative revenue? 

Five frequently performed vascular surgeries at a prominent New Orleans-based health system between 2019 and 2022 yielded an average yearly decrease in net revenue of -11.5%, lending weight to growing national evidence that lay bare how increasing direct costs are outpacing reimbursements at U.S. hospitals.

2. SVS announces VAM keynote speaker series

Registration for the 2024 Vascular Annual Meeting (VAM 2024) launched on March 20 and promotions teased a new annual VAM fixture: the SVS Keynote Speaker Series. The inaugural address will take place in Chicago on Wednesday, June 19, and will be delivered by Karith Foster.

3. Research provides ‘stepping stone’ for future application of AI in vascular surgery

New research on ChatGPT technology and its Vascular Education and Self-Assessment Program (VESAP) success rate provides insight into the future of artificial intelligence (AI) in vascular surgery training and practice, investigators Michael Amendola, MD, and Quang Le, BS, tell Jocelyn Hudson.

4. SVS announces candidates for 2024–25 vice president

The Society for Vascular Surgery (SVS) has announced Linda Harris, MD, and Palma Shaw, MD, as the candidates for the upcoming election for SVS vice president.

5. New data show single-session Indigo aspiration system without overnight thrombolytics is safe and effective for patients with ALI

During the Society of Interventional Radiology (SIR) 2024 annual meeting (23–28 March, Salt Lake City, USA), newly presented data from a subgroup analysis of the STRIDE study showed that Penumbra’s Indigo aspiration system used in a single session without the need for overnight tissue plasminogen activator (tPA) is safe and effective for patients with lower extremity acute limb ischaemia (ALI).

6. How intersociety collaboration to promote private practice could help vascular surgery amid workforce crisis

Dawn M. Coleman, MD, chief of vascular surgery at the Duke University School of Medicine in Durham, North Carolina, focused on the likely major shortage of vascular surgeons and physicians to illustrate how intersocietal collaboration will help ease this problem during a special session at the 2024 Society for Clinical Vascular Surgery Annual Symposium in Scottsdale, Arizona (March 16–20).

7. Physician-assembled unitary stent graft platform for debranched TAAA repair found safe and effective

Researchers behind a seven-year retrospective analysis of a physician-developed unitary stent graft system for endovascular debranched aortic repair of various thoracoabdominal aortopathies reported a 30-day mortality rate of 3.6%, with an all-cause mortality rate of 23% and an aneurysm-related mortality rate of 3.6% at median follow-up (360 days).

8. Increasing access and decreasing scientific bias: How open access is changing academic publishing

Matthew R. Smeds and Ronald L. Dalman discuss open access publishing and the costs associated with this mode of publication: “While editor-in-chief positions within most scientific journals are academic roles involved with the overall content published within journals and not the monetary aspects of this industry, we thought it important to discuss the different models of publication given their use has real effects on both authors and readers of the manuscripts received and published.”

9. Novel ultrasound-facilitated thrombectomy with microbubbles shows promise in acute porcine model for DVT treatment

Evaluation of the safety and performance of a novel pharmaco-mechanical procedure for acute DVT in two pigs demonstrated a significant reduction in thrombus burden and vessel wall preservation, data from in vivo testing reveals.

10. SVS launches Vascular Board Certification Model Task Force

The Society for Vascular Surgery (SVS) Executive Board has established the Vascular Board Certification Model Task Force to deliver a final report entitled “Free-standing or federated Board certification: An analysis of the optimal path forward for vascular surgery” by the end of 2024.

US FDA approves expanded indication for Gore Excluder conformable device

By
Jocelyn Hudson
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US FDA approves expanded indication for Gore Excluder conformable device
Vascular, Aortic, Abdominal, EXCC, AAA, EVAR, Photo, Product
Gore Excluder conformable AAA endoprothesis

Gore has announced US Food and Drug Administration (FDA) approval of an expanded indication for the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis. The device is now indicated for patients with aortic neck angulation ≤90° and a minimum length of 10mm.

A company press release states that, with the expanded indication, the Gore Excluder conformable AAA device is now the only FDA-approved endovascular device solution indicated for patients with aortic neck angulation up to 90° and neck length of 10mm.

“This is a landmark indication for an EVAR [endovascular aneurysm repair] device, equipping physicians with an on-label solution for more patients with hostile neck anatomy,” said Robert Rhee, national principal investigator of the Gore Excluder conformable AAA endoprosthesis pivotal study and chief of vascular and endovascular surgery at Maimonides Medical Center (New York, USA).

There were 95 patients enrolled in the high neck angulation sub-study. Through one year, patients experienced a low incidence of type I endoleaks and zero type III endoleaks, zero reported aneurysm-related mortality, migrations, ruptures or stent fractures.

“We deliberately studied performance in both highly angulated and short necks, and the results demonstrate that we can safely and effectively treat these patients—providing an improved potential for favourable outcomes despite hostile anatomy,” Rhee added.

The press release continues that the Gore Excluder conformable AAA endoprosthesis with Active Control system—introduced in the USA in 2020—is the first AAA device to feature angulation control, empowering operators with two opportunities to achieve orthogonal placement in the aortic blood flow lumen. According to Gore, this unique degree of control, along with nesting stent rows and individual stent rings, helps maximise the conformability and seal of the device.

This latest announcement is “the culmination of years of deep collaboration with physicians to understand and overcome treatment challenges in highly angulated necks,” according to Gore Aortic business leader Willy Davison.

Moving forward, the Gore Excluder conformable AAA device will also be studied as part of the 10,000-patient Together registry, with up to 10-year follow-up and minimal inclusion and exclusion criteria to align with real-world clinical care practice. Uniquely, prospective imaging will also be collected for most patients.

JVS-VL papers go under the microscope

By
Brian McHugh
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0
JVS-VL papers go under the microscope
Nuttawaut Sermsathanasawadi, MD
Nuttawaut Sermsathanasawadi

On the final day of the 2024 International Vein Congress (April 18–20) in Miami, Florida, Joseph P. Hart, MD, associate professor of surgery and radiology at Medical College of Wisconsin in Milwaukee, Wisconsin, Andrea P. Munive-Gnecco, MD, from Bogotá, Colombia, Luis E. Londoño-Mejía, MD, also from Bogotá, Colombia, Nuttawut Sermsathanasawadi, MD, from Bangkok, Thailand, Juan Cabrera Garcia-Olmedo, MD, from Grenada, Spain, and Suandaram Ravikumar, MD, from Dobbs Ferry, New York, each presented abstracts focusing on venous and lymphatics set for submission to the Journal of Vascular Surgery-Venous and Lymphatic Disorders (JVS-VL). Each presentation was then critiqued by one of the attending vascular surgeons. 

Hart’s study focused on the current outcomes of interventions to treat mixed arterial-venous ulcers. Hart and his team looked at the outcomes of ulcer healing on about 1,100 patients at 24 weeks, and then a second follow-up at one year. 

“Isolated venous ulcer was defined as the presence of a venous ulcer with a normal TBI [toe brachial index], or toe pressure greater than 60,” Hart told the audience via video conference. “Mixed was defined as a venous ulcer in the presence of an abnormal TBI or the toe pressure was less than 60.” 

Hart and his team found that combined arterial-venous and arterial interventions accelerate wound heling times when compared to venous interventions alone. This leads to decreased ulcer recurrence and improved long-term limb-based events in mixed ulcers. 

The second abstract, from Munive-Gnecco and her team, focused on the outcomes of varicectomies in Colombia, a sub-analysis of the Colombian Surgical Outcomes Study (ColSOS). 

“In low- and middle-income countries like Colombia, primary data on surgical procedures is scarce,” Munive-Gnecco told the audience. She and her team looked at nearly 4,000 patients who were over the age of 18 receiving varicectomies, limb amputations, and other vascular procedures in different institutions across the country. 

The study concluded that the secondary data from the current database, which is from 2015, underestimated the real burden in perioperative mortality across patients. It also became apparent that the procedures being looked at in this study are not directly comparable, which means that drawing conclusions based on the crude data may not be conducive to informed public health decisions, the investigators reported. 

“The intricate interplay of factors influencing outcomes in vascular surgery necessitates a nuanced understanding,” Munive-Gnecco stated. “Efforts should be directed towards refining analyses that consider the unique characteristics of each procedure.” 

The third abstract, from Londoño-Mejía and his team, looked at gonadal vein embolization in pelvic congestion syndrome—a Latin-American center experience. 

Londoño-Mejía and his team performed a single-center, retrospective case series study looking at patients who underwent coil embolization between 2019 and 2023. 

Londoño-Mejía began by explaining that, in their research, the prevalence of pelvic congestion syndrome is up 30-40% in patients who suffer from chronic pelvic pain. He also explained that, since this study was done in Colombia, a low- to middle-income country, there is difficulty in access to surgery and challenges in consistent follow-up post-procedure. 

Londoño-Mejía concluded by stating that coil embolization results in successful improvement of patient symptoms, although objective measurements are needed in future research. More robust studies are necessary, including direct comparisons between different techniques, he added. 

The fourth abstract, presented by Sermsathanasawadi, focused on the effectiveness of early cyanoacrylate closure and compression therapy alone in the healing of venous leg ulcers caused by superficial vein reflux in a randomized controlled trial. Sermsathanasawadi’s presentation won a monetary prize along with a JVS plaque. 

Sermsathanasawadi and his team defined the primary outcome for this study as complete re-epithelialization of all ulcers on the leg with no dressing required. Ulcer wound size was evaluated every four weeks until the 24-week mark. 

The study concluded that the rate of ulcer healing at 24 weeks was comparable between compression therapy alone and compression with cyanoacrylate glue; that cyanoacrylate glue had a higher rate of ulcer healing at 50 days than the compression only group; and that continued compression therapy with the early use of cyanoacrylate glue improves healing of venous leg ulcers. 

The fifth abstract, from Garcia-Olmedo and his team, looked at innovations in nitrogen-free pharmaceutical foams for universal sclerotherapy. 

“Historically, foams have been considered statistical collections of bubbles,” Garcia-Olmedo told the audience. “This paradigm leads to the perception that you can interact with one bubble without changing the rest of the arrangement.” 

Garcia-Olmedo and his team used mathematical computer models to see real-time analyses of how the foams act. The foam will, unless each bubble is identically sized, destabilize and combine into progressively larger bubbles. When this happens, the foam can move away from where it was meant to be placed. 

The study determined that it is not possible for the foam bubbles to be identically sized, though ultrasound guided sclerotherapy with foam is still a good treatment option. 

The sixth and final abstract was presented by Ravikumar and focused on a paradigm shift in treating venous leg ulcers. Ravikumar and his team created a compression system, called AeroCare, that looks to solve venous leg ulcer issues. 

The AeroCare device is measurable, adjustable, and can keep consistent pressure over the course of multiple days, he said. This helps to ensure that, for patients who have limited access to healthcare options, the device is effective without too much physician intervention. Patients who received treatment from the AeroCare device were seen once a week until the ulcer had healed completely. 

Device limitations include requiring appropriate training in technique for the application of AeroCare, which can be time consuming, Ravikumar pointed out. Furthermore, it is not adjustable, and there can be some degradation of pressure over time, he added. “Some patients have also reported discomfort, pain, and odor when using the device.” 

Ravikumar stated that patients who used the AeroCare device consistently and correctly all had their leg ulcers heal within seven weeks. He concluded by saying that the AeroCare system provides a potentially more convenient way to treat VLU.

New randomised data show cyanoacrylate glue performs strongly on patient satisfaction

By
Bryan Kay
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0
New randomised data show cyanoacrylate glue performs strongly on patient satisfaction

Patients undergoing cyanoacrylate glue closure for superficial venous disease reported higher periprocedural satisfaction than those who were treated via surgical stripping, data from a pair of randomised controlled trials (RCTs) assessing the VenaSeal system (Medtronic) reveal.

The modality also showed greater improvement in disease-specific quality-of-life compared to surgery or endothermal ablation. However, at 30 days participants in both the glue closure and strip-ping arms were similarly satisfied post-procedurally, the primary investigators told the Charing Cross (CX) International Symposium 2024 (23–25 April, London, UK) in the first-time release of results from the Spectrum Program trials.

Similarly, principal investigators Kathleen Gibson (Bellevue, United States) and Manj Gohel (Cambridge, United Kingdom) reported that in the RCT comparing the VenaSeal system to endothermal ablation, similar patient satisfaction was demonstrated between the two procedures. The results emerged yesterday afternoon in a Superficial Venous Controversies session at CX 2024.

The peri- and postprocedural primary endpoints were measured using the novel Venous Treatment Satisfaction Questionnaire (VenousTSQ) tool, Gohel said. Data from the RCTs also showed that VenaSeal performed similarly to both surgical stripping and endothermal ablation in terms of elimination of truncal reflux, the third primary endpoint. Results from the secondary endpoint measure of modified Aberdeen Varicose Vein Questionnaire (AVVQ) at 30 days showed trends in favour of the VenaSeal system compared to both surgical stripping and endothermal ablation.

Meanwhile, six-month effectiveness data showed that VenaSeal was non-inferior to surgical stripping, with similar anatomic closure rates (97.9% vs. 92.9%; p=0.00041). The equivalent measure was not tested between VenaSeal and endothermal ablation in the second RCT, but the trial investigators reported similar effectiveness in each arm.

The VenaSeal versus surgical stripping study included 88 patients, with 46 treated with the former and 42 the latter. In the second trial, VenaSeal (82) and endothermal ablation (81) combined for a total of 163 participants. All patients were Clinical, Etiological, Anatomical and Pathophysiological (CEAP) classification 2–5.

“This is an innovative study design, incorporating all of the usual elements we have seen in other trials, including quality of life measures and closure rates, but also includes new outcomes measures that are very patient focused on how they feel about their procedure and their outcomes,” Gibson said. “We are interested to see going forward whether we see any differences when we follow them out further.

“Participants were satisfied with their treatment. The VenaSeal patients—and all of the patients in general—had good quality-of-life improvements at 30 days. The VenaSeal patients had similar elimination of truncal reflux and closure rates compared to what are the worldwide gold standard. There was a low incidence of adverse events, and very similar to what we see in published literature. We did not find any new adverse events that had not been previously reported.”

Despite VenaSeal not meeting all of the patient-specific primary endpoints, “it is notable that there were tends towards advantages with VenaSeal and it performed comparably with our standards of care,” Gibson added.

The Spectrum Programme also contains a third single-arm study set to measure VenaSeal’s impact on venous leg ulcers (VLUs) in patients with C6 disease. It will measure time to ulcer healing through 12 months.

“This is a series of three studies, all with traditional outcome measures—a very robust safety assessment—but then with additional focus on patient satisfaction,” said Gohel. “The patients were similar, although there were some subtle differences.”

CMS considers new approaches to quality payment program with MVPs

By
Marlén Gomez
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CMS considers new approaches to quality payment program with MVPs

The Centers for Medicare & Medicaid Services (CMS) are exploring strategies to enhance the Quality Payment Program (QPP), underscoring an effort to boost healthcare quality and efficiency. Launched on Jan. 1, 2017, the QPP was designed to inspire clinicians to deliver superior, patient-centered care while mitigating payments for those who fail to meet performance standards.

Within the QPP framework, there are two primary payment tracks: the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs).

While MIPS assesses clinicians across various categories, APMs offer customized payment structures aimed at incentivizing high-quality care. MIPS encompasses three reporting tracks, with traditional MIPS requiring clinicians to select quality measures and improvement activities for reporting, alongside complete promoting interoperability measures and cost performance data. Conversely, the Alternative Payment Model Performance Pathway (APP) simplifies reporting and scoring for MIPS APM participants. Additionally, MIPS Value Pathways (MVPs) zero in on specific specialties or medical conditions, offering a more comprehensive evaluation of care quality.

The Executive Board of CMS gave the green light to two MVP applications focusing on improving care for patients with symptomatic extracranial carotid artery disease and asymptomatic abdominal aortic aneurysms. Submitted to CMS on March 20, these applications await review, with CMS poised to seek public feedback before potentially incorporating them into the 2026 Proposed Rule.

CMS officials emphasize the potential of MVPs to refine the QPP, providing clinicians with more meaningful measures and activities. The committee overseeing QPP enhancements is developing two additional MVP applications, targeting chronic limb-threatening ischemia and hemodialysis access.

SVS membership empowers surgeons in and out of the OR

By
Kristin Spencer
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SVS membership empowers surgeons in and out of the OR
Ageliki Vouyouka

The SVS emphasizes the role vascular surgeons play in advancing treatments for vascular diseases, offering a range of benefits through its membership to support these professionals inside and outside the operating room (OR).

“SVS membership equips members with the tools they need to succeed,” said Membership Committee Chair Ageliki Vouyouka, MD. “By joining our Society, the physicians become members of a worldwide community of specialists in vascular disease. This community allows productive interactions among the members regarding the science, advancements, clinical guidelines, regulations, certifications and quality; creates opportunities to make voices heard; provides support at multiple platforms to address the many challenges of our specialty; and shapes the future of vascular surgery.”

Advocacy is a cornerstone of SVS membership, providing tools and resources for members to advocate for patient and practice needs. These include printable guides for patient education and discussions with hospital administrators to ensure effective and safe management of vascular patients. On a larger scale, the SVS maintains a Political Action Committee (PAC) and coalition to represent the interests of the vascular surgery community in Washington, D.C.

Membership includes a subscription to the Journal of Vascular Surgery (JVS). Education and networking opportunities are also prioritized, with discounts on education products and meetings such as the Vascular Annual Meeting (VAM) and the Vascular Education and Self-Assessment Program (VESAP). An exclusive online member community facilitates discussions and experience exchange among peers on new techniques and challenging cases.

End of an era: Schanzer and Robinson leave legacy of VAM innovation

By
Marlén Gomez
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End of an era: Schanzer and Robinson leave legacy of VAM innovation
Andres Schanzer, MD and William Robinson, MD
Andres Schanzer, MD and William Robinson, MD

As this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) approaches, it marks the end of an era for Andres Schanzer, MD, and William Robinson, MD, who have played integral roles in shaping the event’s trajectory. Schanzer’s leadership as VAM program chair comes to a close after 10 years of being on the SVS Program Committee, with the last three completing his term as program chair.

Under his guidance, the VAM program experienced significant growth, with a record-breaking number of abstract and educational submissions. He emphasized the importance of adapting to meet the evolving needs of vascular surgeons, leading to expanded educational sessions and collaborations with partner programs such as the European Society for Vascular Surgery (ESVS) and the American Venous Forum (AVF).

“Probably the most exciting part of that time has been seeing the quality of the meeting—and its many diverse offerings—continue to expand to meet the needs of the broad vascular surgery membership,” said Schanzer.

In addition to enhancing educational content, Schanzer prioritized facilitating connections and collaboration among attendees. He emphasized the importance of networking opportunities and interactive sessions, as well as redesigning the meeting format to encourage participant engagement and discourse. Schanzer also pointed to the importance of making VAM more representative of diversity, equity and inclusion (DEI). He spearheaded various initiatives to achieve this, including encouraging diverse submissions, increasing representation in sessions, and limiting the number of presentations per person to promote equity.

Initiatives like the simultaneous presentation and publication in the Journal of Vascular Surgery (JVS) and the visual abstract program have increased the impact of scientific research, providing researchers with greater visibility and more opportunities for dissemination. The joint JVS-VAM submission deadline, falling April 15, involves accepted manuscripts being formatted and released in print alongside social media and web promotions while they are presented at VAM. This is the second year of this initiative.

Schanzer underscored the shift from presenting scientific content to facilitating networking and interaction among attendees. Initiatives such as morning sessions with no concurrent content and conversational settings were designed to create an environment conducive to collaboration.

“We started the SVS Connect@VAM event last year, a program on the Wednesday night of VAM, which instills a family-friendly, carnival-style event where people can bring their partners, their children, their friends, and it’s been fun to see the membership embrace that,” he said. “This year, for the first time, we’re having a keynote speaker, and the whole concept behind that is to bring in someone who can bring a different lens than a vascular surgeon would on an important topic.”

Looking ahead, Schanzer expressed excitement about VAM’s future under new leadership. Jason Lee, MD, will be the new chair.

“I think it’s a big responsibility to be entrusted with guiding the direction of the meeting, and I’ve taken that responsibility seriously. I’m honored and humbled to have done it. I feel confident that we’ve brought it from a place where it was functioning at a high level to even a higher level, and I know Dr. Lee and his leadership will continue to move that ball forward. Change is good and Dr. Lee will bring a fresh perspective and a new energy to the meeting,” said Schanzer.

He found reward in collaborating with the SVS leadership team and witnessing the meeting’s improvement each year. Schanzer looked forward to continuing his involvement in SVS activities, remaining committed to advancing the organization’s mission.

Meanwhile, William Robinson, MD, who has served on the Postgraduate Education Committee (PGEC) for nine years, including as chair for the last three, shared insights on the evolution of educational programming at VAM. Robinson spearheaded a shift in the way the programming was conceptualized and executed at VAM, transitioning from a committee-centric approach to a more inclusive and rigorous process, where formal proposals were solicited from the membership-at-large, internal groups and external organizations, and then blindly graded and chosen by the PGEC.

“We’ve been so encouraged by an increasing amount of SVS member engagement and internal and external organization engagement throughout those three years,” said Robinson. “We went from, I believe, 33 proposals for educational sessions in the first year to more than 90 for VAM 2024.”

A key aspect of Robinson’s legacy was the emphasis on collaboration and inclusivity in session development. The PGEC developed and moderated the sessions in collaboration with those who proposed them. In addition, by limiting the number of speaking and moderating roles for any one individual, the PGEC promoted a diverse array of speakers and moderators, as well as fostered a culture of continuity and engagement within the educational programming. Around 200 speakers and moderators are slated this year.

Robinson also highlighted the committee’s efforts to enhance the delivery and format of educational sessions. The committee introduced shorter, more interactive formats to increase attendee engagement and accommodate diverse learning styles.

Looking ahead, Robinson expressed gratitude for the opportunity to learn much from his PGEC colleagues and confidence in the emerging leadership’s ability to build upon the foundation laid during his tenure. He emphasized the importance of continued innovation and adaptability in responding to the evolving needs of vascular surgeons and other healthcare professionals. Claudie Sheahan, MD, will replace Robinson as PGEC chair.

“We read about factionalization within vascular surgery, but my experience on the PGEC and VAM creation has been one where I’ve seen a lot of collaboration, fairness and camaraderie,” said Robinson. “Working with all of he talented and dedicated PGEC members and VAM participants over the years has been a tremendous honor and deeply rewarding, and it leaves me very confident of the way VAM can continue to grow in the future.”

Vascular surgery Entrustable Professional Activities available to view

By
Bryan Kay
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Vascular surgery Entrustable Professional Activities available to view
Brigitte Smith
Brigitte Smith, MD

The American Board of Surgery (ABS) has unveiled the 15 proposed core Entrustable Professional Activities (EPAs) that will be evaluated in vascular surgery residents.

They are: cerebrovascular disease; dialysis access; traumatic/iatrogenic vascular injury; peripheral artery aneurysms; claudication; chronic limb-threatening ischemia; acute limb ischemia; amputation; chronic venous disease; acute thromboembolic venous disease; asymptomatic aortoiliac aneurysm; symptomatic/ ruptured aortoiliac aneurysm; chronic mesenteric ischemia; acute mesenteric ischemia; and type-B aortic dissection.

Some three years of work have gone into creating the EPAs for vascular surgery. The work was a collaboration between the Vascular Surgery Board (VSB) of the ABS, the Association of Program Directors in Vascular Surgery (APDVS) and the ABS itself. A vascular surgery EPA pilot is set to launched this month.

EPAs are a slightly different version of the Norwegian concept of “entrustment” as a “core way of thinking about when a healthcare professional is ready to be unsupervised,” explained Brigitte Smith, MD, chair of the VSB EPA Committee and a VSB director, explained in an interview with Vascular Specialist last year.

Smith presented on EPAs at the APDVS spring meeting in Rosemont, Illinois (April 5–6) ahead of the launch of the pilot. The vascular surgery EPAs are currently in a review process and expected to be implemented in October.

The ability of ChatGPT to further patient education and aid surgeons

By
Bryan Kay
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The ability of ChatGPT to further patient education and aid surgeons
Daniel Bertges, MD
Daniel Bertges, MD

ChatGPT 4.0 was able to provide a mean accuracy rating of 4.4 on a Likert scale of 5 (1=very poor; 5=excellent) across 15 patient-level questions designed to assess the ability of the artificial intelligence (AI)-driven large language model to provide accurate information on abdominal aortic aneurysms (AAAs).

When tested on physician-level information—questions focused on the five domains of the Society for Vascular Surgery (SVS) AAA practice guidelines— the AI tool returned an accuracy rating of 4.3.

When queried on four questions related to AAA rupture risk, ChatGPT performed only “fairly,” scoring a mean of 3.4.

The data were presented by Daniel Bertges, MD, vascular surgery program director at the University of Vermont, Burlington, during the 2024 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Scottsdale, Arizona (March 16–20).

In order to perform the testing, a subset of the SVS practice guidelines on AAA were fashioned into 37 questions as Bertges and colleagues sought to query ChatGPT on the physician level. Four additional questions were specifically designed to query for the annual risk of rupture at varying diameters. Ten Board-certified vascular surgeons and one fellow independently graded the accuracy of responses using the Likert scale.

Bertges pointed out one patient-level question posed of ChatGPT in particular: “What should I ask my doctor about my AAA?” The bot returned a score of 4.8, providing such suggested prompts as, “Should I see a specialist, such as a vascular surgeon or a cardiologist?”

“ChatGPT 4.0 provided accurate responses to a variety of patient-level questions regarding AAA,” Bertges told SCVS 2024. “The responses seem well aligned with SVS practice guidelines, except for inaccuracies in quoting the risk of AAA rupture.

“The emergence of generative AI bots presents an opportunity for study of potential applications in patient education and to determine their ability to augment the knowledge base of vascular surgeons.”

Statewide performance metric ‘profoundly’ increases rate of EVAR surveillance

By
Bryan Kay
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Statewide performance metric ‘profoundly’ increases rate of EVAR surveillance
Frank Davis, MD

A statewide collaborative between 35 hospital systems and a large insurance provider showed that the implementation of a performance metric linked with financial reimbursement designed to improve postoperative surveillance of patients who underwent endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) showed a marked improvement in rates of one-year follow-up over a four-and-a-half- year period, according to a new study.

The multi-institutional analysis determined that the average rate of EVAR surveillance imaging in 2017 was just 27.1% but climbed to 70.8% in 2021.

The data were among a tranche of findings from a database established in a collaborative with Blue Cross Blue Shield of Michigan that collects information on all vascular procedures performed within the state. The results—which also looked at contemporary EVAR surveillance trends in Michigan and the impact of surveillance on one-year morbidity and mortality—were revealed by Frank Davis, MD, an assistant professor of vascular surgery at Michigan Medicine in Ann Arbor during SCVS 2024.

“EVAR surveillance imaging is important in order to detect the long-term durability of EVARs, as it is able to increase the number of reinterventions, but we also show that it decreases one-year mortality independent of patient risk factors,” Davis said. “In addition, we show that the implementation of a statewide performance metric can profoundly increase the rate of EVAR postoperative surveillance.”

Springtime in the world of vascular training

By
Christopher Audu
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Springtime in the world of vascular training
Christopher Audu
technology
Christopher Audu

In places across the country, it’s spring. March Madness is ending, flowers are sprouting, gardens are being planted, and trees are budding. In the vascular trainee world, there is frantic preparation for the end of another academic year and the start of a new one.

There are new residents preparing to come into the workforce (congrats on the Match!) and, soon, there’ll be a new crop of fellows, too (May 1, here we come!). Add to the mix the new attendings fresh out of training who are trying to soak up all the knowledge they can before graduating.

In this month’s column, I wanted to touch on some programs and textbooks that might be helpful to the vascular surgical trainee and interested medical student. This is not exhaustive by any means.

The first resource is The Vascular Surgery Review Book by Dr. Thomas Creeden, who is a graduating integrated resident at the University of Massachusetts in Worcester. I’ve heard this book described as a “first aid” for vascular surgery. It comes highly recommended as a great title to have and annotate while studying for in-service exams and Boards. Written by a current trainee in the trenches of train- ing, it’s a high-yield review.

The next resource comes from across the pond. It’s an online and paperback book, titled All You Need to Know About Vascular Surgery. Written by vascular surgical trainees and attendings (consultants, as they’re referred to in England), this book aims to bring home basic concepts of vascular surgery, diagnoses and treatment paradigms to a general audience of health professions.

This includes—but is not limited to—medical students, nurses, general practitioners and junior surgical trainees. The best part is that it’s free, online. Published by the Vascular Society of Great Britain & Ireland, it is another great re- source for sub-interns and the incoming interns.

Last is a resource for graduating fellows and residents. The Advanced Vascular Surgical Skills & Simulation Assessment Program is a unique program geared specifically to the graduating trainee. Drs. O.W. Brown and Mark Mattos, two seasoned vascular surgeons, have put together an incredible course that seeks to help the trainee answer one question: “Are you ready for practice?” The curriculum consists of simulations of various common vascular surgeries that you should be able to perform independently on graduation. It’s a combination of open and endovascular simulation, and the proc- tors are senior attendings, some of whom are department chairs, at various institutions across the country. Taking place in January every year, it’s a great way to find out areas to focus on clinically in the ensuing six months before graduation. In addition, since it consists of primarily senior trainees, it’s a great place to network for jobs. I did it this year, and truly enjoyed learning how I can become an even more skilled surgeon—I have been working on items pointed out to me during the event. Look out for the invite to apply. It’s funded for travel.

In the meantime, here’s to a productive spring 2024!

Christopher Audu, MD, is the Vascular Specialist resident/ fellow editor.

Abbott’s Esprit BTK scaffold system given US FDA approval for CLTI treatment

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Abbott’s Esprit BTK scaffold system given US FDA approval for CLTI treatment

Abbott has announced that the US Food and Drug Administration (FDA) has approved the Esprit BTK everolimus-eluting resorbable scaffold system (Esprit BTK system), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).

The Esprit BTK System is designed to keep arteries open and deliver a drug (everolimus) to support vessel healing prior to completely dissolving.

Until today, there were no stents or drug-coated balloons approved for use below the knee in the USA. The standard of care has been balloon angioplasty, which relies on a small balloon delivered via a catheter to the blockage to compress it against the arterial wall, opening the vessel and restoring blood flow. However, blockages treated only with balloon angioplasty have poor short- and long-term results, and in many instances the vessels become blocked again, requiring additional treatment.

The Esprit BTK system is a first-of-its-kind dissolvable stent and is comprised of material similar to dissolving sutures. The device is implanted during a catheter-based minimally invasive procedure via a small incision in the leg. Once the blockage is open, the Esprit BTK scaffold helps heal the vessel and provides support for approximately three years until the vessel is strong enough to remain open on its own.

“The FDA approval of Abbott’s Esprit BTK System marks a significant milestone in our fight against peripheral artery disease below the knee and should usher in a new era of improved outcomes for people worldwide,” said Sahil A Parikh, (Columbia University Irving Medical Center, New York, USA) and one of the principal investigators of the LIFE-BTK trial. “By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy.”

The LIFE-BTK trial, which evaluated Abbott’s Esprit BTK system, was presented in October 2023 as a late-breaking clinical trial at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference (23–26 October, San Francisco, USA) and simultaneously published in the New England Journal of Medicine. The results of the trial demonstrated that the Esprit BTK System reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current standard of care.

“At Abbott, we’ve recognized the significant burden of disease and limited treatment options available for people living with the most severe form of peripheral arterial disease (PAD). That’s why we’re revolutionising treatments with resorbable scaffold technology below the knee,” said Julie Tyler, senior vice president of Abbott’s vascular business. “Our resorbable program is focused on meeting unmet needs in the peripheral anatomy to help people live better and fuller lives.”

Interim analysis provides early window into real-world Alto stent graft outcomes

By
Jocelyn Hudson
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Interim analysis provides early window into real-world Alto stent graft outcomes
alto stent graft
Sean Lyden presents an interim analysis from JAGUAR at CX 2024

In a podium-first presentation on the final day of the 2024 Charing Cross (CX) International Symposium (23–25 April, London, UK), Sean Lyden (Cleveland Clinic, Cleveland, USA) disclosed an interim analysis from the JAGUAR trial and, in doing so, gave delegates an early window into potential real-world outcomes with the Alto stent graft (Endologix). 

Lyden initially noted that the device in question has been designed to treat a wide range of abdominal aortic aneurysm (AAA) cases via endovascular aneurysm repair (EVAR), even in some of the most difficult anatomical features in these patients. He also described JAGUAR as a postmarket, prospective, multicentre randomised controlled trial (RCT), intending to enrol a total of 450 patients (300=Alto, 150=comparator) across 60 US and European sites, with planned follow-up out to five years. 

As of February 2024, the study had enrolled 272 (180=Alto, 92=comparator) of its target of 450 patients, with 28 sites having already been activated. According to Lyden, enrolment is expected to be complete by Q2 2025, while investigators estimate five-year data being available in 2030. 

Regarding relevant events through 30 days in JAGUAR—as per an interim analysis of the study’s findings to date—Lyden relayed a slightly higher rate of complications in the comparator group versus the Alto group. However, the Alto group patients have experienced a slightly greater rate of Type Ib and II endoleaks at 30 days, he added, also noting no conversions, occlusions or ruptures in either group. 

Moving on to relevant one-year events, Lyden said there has been a slightly higher rate of total secondary interventions with Alto, while there was a marginally increased presence of Type II endoleaks in the comparator compared to the Alto group. Another observation he reported was the fact that the Type Ib endoleaks in the Alto group at 30 days were no longer present at one year. 

Prior to concluding, Lyden informed the CX audience that there was very little increase in sac diameter sizes at six months, and one year, across both groups, and that there were no reports of neck dilatation noted for any patients in the trial at the time of this interim analysis. 

In summary, the presenter stated that anticipated core-lab analyses at one year will provide information on aneurysm-related complications and robust neck dilatation data on Alto, when comparing Alto with other commercially available devices. He also noted that JAGUAR will provide insights on quality, long-term, level-one evidence, and its results “will shape optimal treatment strategies” and shed light on enhancing patient outcomes. 

Questions linger: BASIL-3 does not find for drug-eluting technologies for CLTI

By
Jocelyn Hudson
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Questions linger: BASIL-3 does not find for drug-eluting technologies for CLTI

In the UK National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA)-funded BASIL-3 randomised controlled trial (RCT), neither drug-coated balloon (DCB) angioplasty with or without bare metal stent nor drug-eluting stent (DES), when used in the femoropopliteal segment, conferred a hypothesised clinical benefit over femoropopliteal plain balloon angioplasty with or without bare metal stent.

In addition, it was found that DCB with or without bare metal stent is unlikely to be cost-effective at the UK National Health Service (NHS) National Institute for Health and Care Excellence (NICE) willing-to-pay threshold. DES, on the other hand, is potentially cost-effective at this threshold.

Andrew Bradbury (Birmingham, United Kingdom) and the BASIL-3 team of triallists shared this and other key findings on Tuesday afternoon, addressing the question of which endovascular strategy is best in the femoropopliteal segment. The investigators presented—for the very first time—the results of this long-awaited, only completed, fully publicly funded RCT in the space.

“This was a pragmatic, ‘real-world’ UK trial whose outcomes are likely to be a realistic representation of what can be reasonably achieved across the NHS,” Bradbury shared during the session.

Following an introduction to the trial from Bradbury, Lewis Meecham (Cardiff, Wales) shared evidence for paclitaxel DCB and DES in chronic limb-threatening ischaemia (CLTI) before BASIL-3; Matthew Popplewell (Birmingham, United Kingdom) put the trial into context, speaking specifically about the BASIL Prospective Cohort Study (PCS); and Gareth Bate (Birmingham, United Kingdom) and Jack Hall (Birmingham, United Kingdom) shared BASIL-3 clinical and statistical methodology, respectively.

Against this backdrop, Catherine Moakes (Birmingham, United Kingdom) reported clinical results of the BASIL-3 trial.

Between 29 January 2016 and 26 August 2021, the trial enrolled 481 patients, with 160 randomised to plain balloon angioplasty with or without bare metal stent, 161 to DCB with or without bare metal stent, and 160 to DES.

In the intention-to-treat analysis, Moakes revealed that 54 (34%) patients in the plain balloon angioplasty group met the primary endpoint of amputation-free survival (AFS), defined as the time to major (above-the-ankle) amputation of the index limb or death from any cause, compared to 64 (40%) in the DCB arm and 66 (42%) in the DES arm.

In a per-protocol analysis of only adherent participants, Moakes reported that 49/140 (35%) patients in the plain balloon angioplasty group met the AFS endpoint, compared to 48/122 (39%) in the DCB group and 47/118 (40%) in the DES group.

The research group also shared health economic outcomes. In a cost-utility analysis, Jesse Kigozi (Birmingham, United Kingdom) outlined that DCB angioplasty with or without bare metal stent when compared to plain balloon angioplasty with or without bare metal stent was less costly by £-250.71 and less effective by -0.007 quality-adjusted life years (QALYs).

Kigozi then shared health economic results comparing the DES group versus plain balloon angioplasty. In the cost-utility analysis, the differences observed in the costs and outcomes between DES and plain balloon angioplasty with or without bare metal stent[1]first strategies were minimal, he reported.

However, Kigozi added that DES was the dominant strategy because, when compared to plain balloon angioplasty with or without bare metal stent, DES was less costly by £-724 and resulted in additional 0.048 QALY.

Kigozi summarised that there were minimal incremental differences in costs and outcomes in terms of QALYs out to two years and amputation-free life years out to seven years when the DCB with or without bare metal stent or the DES-first revascularisation strategies were compared to the plain balloon angioplasty with or without bare metal stent-first strategy in the cost-utility and cost-effectiveness analysis.

Kigozi said that, while there is uncertainty overall, the results show DCB is unlikely to be cost-effective when compared to plain balloon angioplasty, while DES is potentially cost-effective when compared to plain balloon angioplasty. He added that these findings were generally consistent over different scenarios and analyses and across different patient subgroups.

Finally, Bradbury summed up the main findings and underscored limitations, take-home messages, and further research.

He stressed that the trial’s power exceeds 90%, with more than the 291 required primary outcomes observed. Bradbury added that follow-up was long and better than anticipated, with only seven patients withdrawing prior to the primary endpoint. Cause of death was available for all deceased patients, he continued, adding also that most (35) UK vascular units randomised patients.

Bradbury also outlined some potential limitations of the trial, highlighting among these the effects of the “Katsanos pause”— referring to the fallout from the controversial 2018 meta-analysis on paclitaxel-coated devices—and the effects of COVID-19.

Discussion following the presentations included examination of the choice of AFS as the primary endpoint.

William Gray (Philadelphia, United States) asked, for example, why AFS was chosen versus another endpoint like major amputation “given the dominance of death” in this patient population.

Bradbury responded that there was a lot of support in the UK for AFS. “I’m not saying it’s the only endpoint, but it’s the one that we’ve chosen, and it runs through all three BASIL trials rightly or wrongly,” he said. “In BASIL-1 and BASIL-2, we have actually found that the biggest difference between the two groups is mortality and not amputation rate.”

Michael Conte (San Francisco, United States) added that there have now been three BASIL trials, but not one has shown a difference in limb outcomes. “While I recognise that AFS is a critical endpoint, I think the way in which you’ve powered it doesn’t take into account that death is a noise and the outcome in the limb is what you’re actually looking to differentiate.”

CX co-chair Andrew Holden (Auckland, New Zealand), who co-moderated the session, asked Bradbury what should be taken away from these trial results in 2024. “We would like to have had a more clear-cut result,” he admitted. “Maybe over the next few days, weeks, months, as we digest it, as the publications come out and as we present more data, people will begin to think about what it means for their practice, in their country, in their healthcare system.”

Prosthetic valve implantation shows “vast” improvements in deep chronic venous insufficiency

By
Éva Malpass
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Prosthetic valve implantation shows “vast” improvements in deep chronic venous insufficiency
David Dexter
chronic venous insufficiency
David Dexter

“The surgical challenges of repairing deep venous reflux have been present for more than a generation. It is worth reflecting on the fact that this new technology has made the majority of patients vastly better,” were the words of principal investigator David Dexter (Norfolk, United States) who presented podium-first efficacy results from the Surgical Anti-reflux Venous Valve Endoprosthesis (SAAVE) trial at the Charing Cross (CX) International Symposium 2024 (23–25 April, London, UK).

The trial evaluated the long-term efficacy of the VenoValve (EnVVeno Medical), a surgically implanted replacement venous valve for patients with deep chronic venous insufficiency (CVI). “These patients are the most severe of the severe,” Dexter detailed of their patient demographic, noting the trials’ inclusion of patients with Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classifications between 4b and 6. He described that the “vast majority—around 60%—of these patients have active ulcers, and 70% of these ulcers had been active for at least a year”.

Dexter told delegates that a total of 69 patients were enrolled, 97% who had a successful valve implantation, leaving two patients with veins that were “too small or diseased” and so were reported as technical failures. The researchers then split the cohort into two subgroups defined by clinical improvement of revised Venous Clinical Severity Score (rVCSS) by ≥1, and clinically meaningful benefit with a rVCSS improvement of ≥3.

At 11-month follow-up, 65 (94%) patients showed clinical improvement of ≥1 and 50 (72%) presented clinically meaningful benefit of ≥3. “When we separated these two groups out,” Dexter said, “in the 50 patients who were meaningfully significant we saw a significant rVCSS drop, but the patients who weren’t meaningful didn’t get worse,” Dexter noted.

“The data presented shows that, for patients experiencing a clinical meaningful benefit rVCSS improvement of ≥3 points, the overall average rVCSS improvement was 8.46 points, including 9.29 points for patients at the two-year milestone, 8.08 points for patients at the one-year milestone, and 8.71 points for patients at the six-month milestone. All rVCSS evaluations were based on the patient’s most recent clinical visit, compared to baseline, for a weighted average of 11 months following VenoValve implantation for the clinically meaningful benefit patient cohort.”

Recording rVCSS and pain (Visual Analogue Scale [VAS]) scores at six, 12 and 24 months, Dexter stated that scores improved through each stage of follow up. rCVSS showed a 8.71-, 8.08-, and 9.29-point improvement, and average VAS score was recorded as 1.78, 2.05 and 2, respectively, in all patients. At 12-month follow up, quality-of-life and venous symptoms were also reported, VEINES-QoL and VEINES-Sym scores showing a 33% and 39% improvement.

“Overall, the VenoValve is a safe and effective surgery for the treatment of symptomatic patients with deep CVI,” Dexter said, concluding his presentation. Then, during panel questions, session moderator Manj Gohel (Cambridge, United Kingdom) highlighted the technical failure during valve implantation and whether this may lower efficacy in women with small veins.

“Clinically, on table, the vast majority of failures occurred preoperatively, and this was not based on gender. It’s really based on preexisting post-thrombotic syndrome that we didn’t identify on duplex,” Dexter responded.

Closing out the session, Gohel thanked Dexter and commented: “People have been trying to do this for decades. In terms of clinical data, this is as good as we’ve got with implanted valves, this research is very exciting.” Dexter stated that, although the VenoValve is currently investigational only, they hope with US Food and Drug Administration (FDA) evaluation of their endpoints, the device can be commercially-implanted soon.

Penumbra announces FDA clearance of Lightning Flash 2 for the treatment of PE

By
Éva Malpass
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Penumbra announces FDA clearance of Lightning Flash 2 for the treatment of PE

Penumbra has announced the US Food and Drug Administration (FDA) clearance and launch of Lightning Flash 2, the next generation computer assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary embolism (PE), a press release states.

Lightning Flash 2 features advanced Lightning Flash algorithms, designed for increased speed and sensitivity to thrombus and blood flow. These new features combined with Penumbra’s novel catheter technology allow physicians to better navigate the body’s complex anatomy and deliver high power for clot removal with possible minimal blood loss.

“Based on what we’ve seen in the initial launch, Lightning Flash 2 has significantly improved procedure time by shortening the aspiration time. It has also shown reductions in blood removed during aspiration. These advantages can improve patient safety, provide better outcomes for the patients, and streamline efficiency for physicians treating the patients,” said James F Benenati, chief medical officer at Penumbra. “As adoption of thrombectomy becomes more widespread, Lightning Flash 2 will provide physicians with the confidence that CAVT is a valuable frontline option.”

With streamlined audio-visual feedback, Lightning Flash 2 enables physicians to have a better understanding of what is occurring at the tip of the catheter during a procedure, the press release details. This enhanced feedback loop results in a more intuitive thrombus removal experience for the physician.

“Lightning Flash 2 now combines an optimally sized catheter with the latest algorithm technology designed to more efficiently remove blood clots while maintaining a high level of safety,” said Adam Elsesser, president and chief executive officer of Penumbra. “Our ongoing innovation around CAVT underscores our commitment to advancing patient care so that more patients suffering from these complicated conditions can benefit from this advanced therapy.”

Lightning Flash 2 is part of Penumbra’s Indigo system with Lightning portfolio. The company’s Lightning products are the only computer assisted mechanical thrombectomy systems currently available in the US and early clinical data has demonstrated improvement in patient clinical outcomes and quality of life.

CX united: Vascular world set to converge with challenging cases

By
Bryan Kay
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CX united: Vascular world set to converge with challenging cases
Palma Shaw

The World Federation of Vascular Societies (WFVS) is bringing the vascular world together at CX 2024 to chew over both challenging cases and leadership challenges.

The pair of sessions is part of the legacy left by Professor Roger M. Greenhalgh, the late CX Symposium chair, and his dedication to concepts such as the Hurting Leg and the Worrying Foot.

First up on Thursday from 1:30 p.m. to 3:20 p.m. (BST), Palma Shaw, MD, a professor if surgery at Upstate Medical University in Syracuse, New York, the WFVS secretary-general, and Prem Chand Gupta, MD, from Hyderabad, India, its president, will moderate a string of surgeons from across the global vascular biosphere as they present their experiences with challenging cases.

The session grew out of the WFVS Global Training Initiative and its commitment to help trainees around the world to plug gaps in their training.

Experienced surgeons will present on such topics as “Angulated aortic neck: Sliding through a reverse slider technique,” by Pranati Swain (Delhi Cantt, India) representing the Vascular Society of India, and “Pseudo aneurysm from right coronary button with previous ascending stent graft,” by Thodur Vasudevan (Hamilton, New Zealand), representing the Australian & New Zealand Society for Vascular Surgery (ANZSVS). All member societies of WFVS will be represented.

“At the Global Training Initiative, we thought we could meet the needs of trainees around the world on things they were missing in their training,” said Shaw. “We’d been meeting for a while to discuss these things and Roger joined us because he was very committed to this.

“We have 11 cases of five minutes each then a further five for discussion.”

The Challenging Cases session will be followed at 3:20 p.m. to 3:50 p.m. by a Leadership Challenges session, moderated by Shaw and Manual Garcia-Toca, MD, a vascular surgeon at Emory University in Atlanta, the chair of the Society for Vascular Surgery (SVS) Leadership Development Committee.

“At the Global Training Initiative, we realized that in addition to the need for access to different clinical scenarios and the hard knowledge of vascular surgery, there is a need for soft skills— all the things nobody teaches you during training that you need to survive,” continued Shaw.

“You can be a great surgeon but if you come in and don’t read the room right, you can make the wrong comments. These are things nobody teaches you, that some people are just better at than others.”

The Leadership Challenges session aims to address these areas and will see two female speakers deliver talks. “Navigating the waters: Strategies for launching a new clinical program in vascular surgery” will be given by Vaiva Dabravolskaite (Bern, Switzerland), and “Bridging divides: Effective approaches to managing interdepartmental turf battles” will be presented by Desiree van den Hondel (Renkum, Netherlands) before a senior panel discusses how they would manage these scenarios.

“With the first one, the idea is to assess, ‘How would you approach that, and what challenges would you anticipate, how would you develop your team and how would you pitch this to the leadership?’” said Shaw.

In the case of the latter talk, the overlapping specialties that treat vascular disease is the focal point. “This really has a lot to do with the fact interventional radiology, interventional cardiology and vascular surgery have a lot of overlap—and even neurointerventional,” added Shaw. “Everywhere politics is local. In a large private hospital, it is different than in a big academic center. Perhaps in The Netherlands it is different than in the U.S. These are things that are important because more and more people, mid-career, are getting their MBAs, and we are finding that we need these skills to help deal with problems and challenges with administration to protect our own vested interests.”

Paclitaxel controversy: Yes, device restrictions did cause harm

By
Éva Malpass
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Paclitaxel controversy: Yes, device restrictions did cause harm
Eric Secemsky
paclitaxel
Eric Secemsky presents at CX 2024

“Unfortunately, we are doing worse for our patients today,” were the sobering thoughts of Eric Secemsky (Boston, United States) during a late-breaking presentation in this morning’s Peripheral Arterial Controversies programme. Among several presentations on paclitaxel safety, he reported that: yes, the meta-analysis and regulatory body restrictions on paclitaxel-coated devices did cause harm through the relegation of patients to the “less durable” conventional device treatment, increasing the incidence of adverse events post-revascularisation.

In a session focused on reaching resolution on the paclitaxel controversy, early presentations given by Thomas Zeller (Bad Krozingen, Germany) and Peter Schneider (San Francisco, United States)—concerning paclitaxel-coated balloon safety in femoropopliteal occlusive disease and paclitaxel mortality across randomised controlled trials—established the “lack” of paclitaxel-coated device mortality risk in the most recent available data.

Secemsky, who presented next, gave a brief timeline of the rise and fall of paclitaxel-coated devices showing their sharp decline in use following the Konstantinos Katsanos (Patras, Greece) et al meta-analysis which reported an increased mortality risk, and the subsequent regulatory restrictions. Previously, paclitaxel devices—driven by drug-coated balloons (DCB)—were the preferred treatment for femoropopliteal intervention for peripheral arterial disease (PAD) in the United States.

Using both Medicare data and the IQVIA: Medical Device Supply Audit database, Secemsky and colleagues looked at paclitaxel device use in US hospitals between Q3 2013 and Q3 2023. He reported that, following the pivotal Katsanos et al meta-analysis, DCB and drug-eluting stent (DES) use did not recover to pre-meta-analysis levels until Q3 2023—a period of four and a half years—showing the close “parallel” trajectory between device use and emerging data, Secemsky said. The speaker also highlighted the “shrunken” downward trend in the overall femoropopliteal procedural counts in the US following the controversy, despite PAD-related amputations remaining “stable” in the same period.

Then, Secemsky and colleagues followed 275,009 Medicare beneficiaries who underwent femoropopliteal intervention, comparing the risk of major amputation and death in the period prior to and following the paclitaxel controversy. Risk of amputation or death was reported in 40.4% and 43.2% of patients in the pre- and post-paclitaxel period, respectively. Secemsky also reported a 43.9% risk of major amputation and death in the post-COVID-19 period, establishing that risks following femoropopliteal intervention were “not driven by COVID-19 alone”, he said.

“Global restrictions on paclitaxel device use relegated thousands of patients to conventional device treatment,” said Secemsky. “The use of a less durable treatment increases the possibility of more frequent repeat interventions, the associated risks of re-intervention and the economic burden of performing these procedures.”

Although the meta-analysis and regulatory body restrictions on paclitaxel devices caused harm, Secemsky—flipping the coin—stated that it “also did good” by reiterating the need for better clinical trial practices and complete study participant follow up.

“The paclitaxel controversy not only instigated interest in non-paclitaxel therapies such as sirolimus-based treatments, but it also demonstrated that the vascular community could quickly band together to address a dispute, and particularly displayed the collaborative nature of US Food and Drug Administration (FDA) who ensured regulatory concerns were addressed,” Secemsky finalised. “These lessons can help guide the vascular community through the next controversy and to further develop evidence to shape clinical practice.”

The discussion was then opened to the FDA and UK Medicines and Healthcare products Regulatory Agency (MHRA) to provide a conclusive perspective on the matter. Representing the FDA, Ariel Ash-Shakoor (Washington, United States) began by tracing the course of the regulatory bodies’ communication to present day. Ash-Shakoor stated that, based on the “totality of available evidence” the FDA has determined that the data do not support an excess mortality risk for paclitaxel-coated devices. However, current FDA guidance when using paclitaxel-coated devices includes, but is not limited to, routine monitoring and optimal medical therapy.

Ash-Shakoor noted that lessons can be learned from the paclitaxel mortality controversy, including the importance of long-term follow up, pre-specified plans concerning missing data, and proactive patient monitoring to ensure “complete” reporting.

Providing the perspective of the MHRA, Alexander McLaren (London, United Kingdom) confirmed that no increased risk in mortality with paclitaxel-coated devices has been observed in their review of available randomised controlled trial data.

“Looking back with a critical eye to our own management of the long-running complex topic, I do feel the MHRA response was swift and decisive with the establishment and advice that we received by the expert advisory group,” McLaren stated. In his view, as “quality, robust data were slow to emerge”, delays in decision-making were inevitable. However, taking what has been learnt forward, McLaren said that the MHRA intends on improving pre-market clinical investigation and ensuring studies are “sufficiently powered and supported” to collect real-world follow-up data.

SVS launches Vascular Board Certification Model Task Force

By
Marlén Gomez
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SVS launches Vascular Board Certification Model Task Force
Michael Dalsing

The Society for Vascular Surgery (SVS) Executive Board has established the Vascular Board Certification Model Task Force to deliver a final report entitled “Free-standing or federated Board certification: An analysis of the optimal path forward for vascular surgery” by the end of 2024.

The task force will engage in months of intensive research and exploration, culminating in a thorough analysis and eventual presentation of its findings in the final report. An interim report is slated for completion by late July, and it is anticipated that it will be presented at the January 2025 Strategic Board of Directors meeting.

The SVS Executive Board acknowledges the substantial response received from its members volunteering to serve on the task force, totaling over 30 submissions. The selection process for task force members proved challenging as the Executive Board aimed to ensure the representation of diverse perspectives within the composition. The task force members are led by Chair Michael Dalsing, MD.

SVS announces candidates for 2024–25 vice president

By
Kristin Spencer
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SVS announces candidates for 2024–25 vice president
Linda Harris and Palma Shaw

The Society for Vascular Surgery (SVS) has announced Linda Harris, MD, and Palma Shaw, MD, as the candidates for the upcoming election for SVS vice president.

“This is an exciting year,” said SVS Nominating Committee Chair Ronald Dalman, MD, who served as 2021 SVS president. “Both Drs. Harris and Shaw have exemplified exceptional leadership with both depth and breadth throughout the SVS, and it is wonderful to see them rise to become the top two candidates for vice president.”

Along with various other SVS-centric contributions, Harris currently chairs the SVS Education Council, and Shaw chairs the SVS Industry Relations Advisory Committee.

The selection of Harris and Shaw will create a milestone election for the SVS as whichever candidate is elected will become the second woman to serve as SVS president, the first being Julie Freischlag in 2014.

The SVS will hold a virtual Town Hall on Wednesday, May 1, at 7 p.m. Central Time, to allow SVS members a chance to ask the candidates questions about their vision for the future of the SVS. All members are invited and encouraged to attend to help inform their voting decisions. Numerous other opportunities to share information about the candidates are also planned.

Online voting will open for Early Active, Active and Senior SVS members in good standing on Monday, June 3, and will remain open until Thursday, June 20, at 2 p.m. Central Time during the 2024 Vascular Annual Meeting (VAM). This is the first election allowing Early Active SVS members the opportunity to vote after the result of the 2023 bylaws change.

To learn more about the candidates, please visit vascular.org/2024SVSVP.

Latest iteration of SVS program seeks to help foster development of resilient leaders

By
Marlén Gomez
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Latest iteration of SVS program seeks to help foster development of resilient leaders
Manuel Garcia-Toca
Manuel Garcia-Toca

As the Society for Vascular Surgery (SVS) prepares to launch its fifth cohort of the Leadership Development Program (LDP), anticipation is high among aspiring leaders in vascular surgery. This seven-month-long program has become a cornerstone for over 100 members of the SVS, offering a comprehensive curriculum designed to cultivate leadership skills tailored to the field’s challenges.

Manuel Garcia-Toca, MD, a longstanding advocate for leadership development within vascular surgery, shares his insights as the current chair of the LDP committee.

“It’s not a matter of ‘if,’ it’s about ‘when’ leadership opportunities occur in your career,’” he emphasized.

In response to feedback and evolving needs, enhancements were made to the LDP format and structure that aimed to foster increased interaction among faculty and cohort members, facilitate collaborative problem-solving and practical application of acquired skills concerning case study projects. Key modifications to the LDP include a reduction in the number of webinars, with more emphasis placed on faculty-led online discussion groups. Additionally, cohort members now have the option to access session recordings on demand, enabling them to tailor their engagement according to their individual schedules and priorities.

A highlight of the LDP is the opportunity for past participants to apply for the Leadership Mastery Grant to further their leadership journey beyond the program. Garcia-Toca explained that the grants grew out of a desire to support graduates in continuing their growth as leaders within the specialty.

The grant selection process concluded in March; four recipients will receive $3,000 each. These recipients will serve as mentors, enriching the learning experience for future participants.

The interactive discussions and case analyses led by faculty members or past Mastery Grant recipients are central to the LDP experience, said Garcia-Toca. He underscored the value of these sessions, noting the exchange of ideas and perspectives among participants.

“By equipping participants with essential leadership skills and fostering a culture of collaboration and innovation, the LDP plays a pivotal role in advancing the specialty of vascular surgery. We want vascular surgery to be at the forefront of leadership roles within hospital C-suites and in different societies,” said Garcia-Toca.

Faisal Aziz, MD, an LDP faculty member, highlighted the importance of vascular surgeons mastering leadership skills.

“By doing so, we can enhance our patient care and shape the future of healthcare while adeptly navigating the evolving healthcare landscape to meet the diverse needs of our communities and patients,” he said.

Reflecting on his experience, Aziz added: “Whether in community or academic practices, I have always been surprised to discover common ground among these settings. It’s remarkable to realize that vascular surgeons nationwide encounter similar challenges and have developed various solutions to address them. Learning from others’ experiences has been invaluable to me.”

Mohamed Zayed, MD, a member of the first cohort, stated his appreciation for the course, highlighting the value of engaging with fellow vascular surgeons with similar perspectives. Zayed emphasized the significance of honing professional skills, including developing organizational currency, conflict resolution techniques and identifying supportive allies within the professional realm. He noted the importance of fostering alliances and driving transformative change, accentuating the need for leadership from the top and the middle. These concepts resonated with Zayed, who acknowledged that his leadership journey was at its beginning, recognizing the infancy of his learning process.

“We spend a lot of time in the operating room learning how to operate, how to take care of patients, how to be very detail-oriented, but we don’t spend much time understanding organizational politics and organizational structure,” said Zayed. “Through the LDP, we learn how to manage and structure projects in a way that is going to be fruitful for not just a few, but for many, and then also how to address key concepts in the workplace like diversity and inclusion, and how to be able to manage time appropriately.”

“This made me hungry to learn more about these topics,” he added.

Zayed received the mastery grant to participate in the second cohort and continue his leadership journey. In May 2023, Zayed completed an MBA at the Olin Business School at Washington University in St. Louis. He asserts that he will continue his leadership training and is engaged in coaching sessions on a regular basis.

“Once you start down this path, you realize there’s an endless capacity to learn and grow there. You continue to develop this process over time,” said Zayed.

Michael Lieb, DO, a participant of the first cohort, was seven years into his career when he initially enrolled in the LDP to advance his professional trajectory. He reflected on a shift in his mindset upon joining the program, explaining his focus transitioned from individual career progression and personal success to the collective success of the group and, ultimately, to the program’s success.

Lieb underscored that individuals can contribute to the program’s goals regardless of their positions or titles. He highlighted that the program fosters a mindset where individuals recognize that effective leadership can come from various organizational levels, not exclusively from senior roles.

“You don’t have to be the head of something to be a role model. Maintaining personal standards without compromise can attract others to seek guidance, even in areas where one may not hold a leadership role.

“While I may not be officially in charge of a particular program or department, people recognize the values I uphold and trust my willingness to assist them. This aspect of leading from within the organization is crucial and often paves the way for new opportunities,” said Lieb.

Since completion of the LDP, Lieb has advanced in his leadership journey, with roles that include lead physician of his vascular group, medical director of both the non-invasive vascular lab and the Vein Center at Virtua Health in Hainesport, as well as vice-chairman of surgery at Virtua Mt. Holly Hospital.

“Once you start down this pathway, these opportunities for leadership and mentorship find you, more so than you seeking them out,” said Lieb.

Leadership Mastery Grant winners announced

The Leadership Mastery Grant selection process saw the following names revealed as this year’s award recipients: Xzabia Caliste, MD (Albany Medical Healthcare System); Maria Castello Ramirez, MD (Penn State Hershey Medical Center); Fernando Joglar, MD (University of Puerto Rico); and Payam Salehi, MD (Tufts Medicine).

Beyond financial assistance, these recipients will also be supporting the current cohort of the LDP as mentors and co-faculty.

The power of grassroots and grasstops advocacy

By
Mounir Haurani
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The power of grassroots and grasstops advocacy
Mounir Haurani

The progress in congress can seem overwhelmingly slow, especially considering the 118th Congress has only passed 27 pieces of legislation while holding over 700 votes. However, rather than being overcome with a sense of discouragement, this is when we should be increasing our persistent efforts to work with our legislators. Some may adopt a mindset of resignation and stop striving for change, but it’s crucial that we continue our efforts without pause during this time. There are several tools that the SVS Advocacy Council uses to organize our collective efforts, such as sending emails to legislators; however, these efforts are driven by membership participation. So, how can we work with Congress to advocate for our patients and practices?

There are several ways that SVS members can participate in these efforts, often referred to as “grassroots” and “grasstops” advocacy.

Grassroots advocacy is the route that is most accessible to the broader population. Think of it like a petition with hundreds or even thousands of signatures. The sheer volume of messages from constituents—the people lawmakers represent—creates pressure to act. The SVS has simplified this process through the VoterVoice page on the SVS website. As issues that are important to our patients and peers arise, VoterVoice simplifies our voice with congressional members. While the perception may be that these letters fall on deaf ears, the message is easily amplified with minimal effort by the membership. When engaging in grassroots efforts, the quantity of communications is key to getting the attention of congressional staf fand legislators. While this approach may seem impersonal, it is still effective when the SVS membership participates widely.

Grasstops efforts can occur when these same constituents develop a strong relationship with their representative offices. Imagine a direct line to the people who make the decisions. That’s the power of grasstops advocacy. This approach focuses on building relationships with those who hold positions of influence, such as business leaders, community influencers, and especially lawmakers’ staff.

These influential figures can become valuable resources for advocacy efforts. For instance, a group might enlist the help of respected community leaders to champion their cause or educate a lawmaker on a specific issue. Think of the program REACH 535, which helps connect advocates with key influencers on Capitol Hill. This connection is similar to the work of the SVS Political Action Committee (PAC). Investing time, energy and, in some cases, campaign contributions to develop strong relationships with lawmakers is one of the best ways to enact change at the federal level.

The key difference between these two approaches lies in their origin. Grassroots is bottom-up, mobilizing the masses, while grasstops is top-down, leveraging existing connections. However, the most effective advocacy often utilizes both strategies.

Lawmakers pay close attention to constituent feedback. While a grasstops connection can educate a lawmaker on the intricacies of an issue, a strong grassroots movement can demonstrate the public’s passionate support and urge the lawmaker to act. The SVS Advocacy Council and SVS staff need continued engagement from the membership to make these efforts effective.

Both grassroots and grasstops advocacy are essential tools for influencing policymakers. By understanding the strengths of each approach, advocates can create a powerful and effective strategy for driving positive change.

Mounir Haurani, MD, is vice-chair of the SVS Government Relations Committee.

Research provides ‘stepping stone’ for future application of AI in vascular surgery

By
Brian McHugh
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Research provides ‘stepping stone’ for future application of AI in vascular surgery
Quan Le, Michael Amendola
Quang Le, Michael Amendola

New research on Chat generative pre-trained transformer (GPT) technology and its Vascular Education and Self-Assessment Program (VESAP) success rate provides insight into the future of artificial intelligence (AI) in vascular surgery training and practice, investigators Michael Amendola, MD, and Quang Le, BS, tell Jocelyn Hudson.

Le, a medical student at the University of Virginia School of Medicine in Charlottesville, Virginia, and first author of the research, explained that the project began with a petition to the Society for Vascular Surgery (SVS) Self-Assessment Committee, which granted access to the fourth edition of VESAP (VESAP4) in April 2023.

Subsequently, VESAP4 materials—namely 385 non-imaging questions, separated into 10 domains of vascular surgery knowledge—were submitted to the GPT-3.5-Turbo (GPT 3.5) large language model. Two independent reviewers examined AI-generated responses for accuracy and content, and compared them to provided key answers. Application programming interface (API) requests were triplicated to evaluate consistency.

The research, recently delivered as a moderated poster presentation at the Southern Association for Vascular Surgery (SAVS) annual meeting ( Jan. 24–27) in Scottsdale, Arizona, showed that GPT 3.5 provided the correct answer to 49.4% of questions, and that 77.8% of correct responses were similar across all three queries.

Le reported that GPT 3.5 performed best in questions on radiation safety, achieving a 54.4% correct rate, while it performed worst in questions on dialysis access, answering only 39% of questions correctly.

Of the incorrectly answered questions, Le noted that the most common cause of inaccuracy was retrieval of false information or failure to retrieve important facts.

The team conducted further research, due to be presented as a poster at the 2024 Vascular Annual Meeting (VAM; June 19–22) in Chicago, which found that while GPT 3.5 had an accuracy rate of about 48%, the corresponding figure for a later iteration of the model, GPT 4, was about 63%. However, the researchers also found that consistency was limited, with GPT 3.5 only consistent 55% of the time across three query attempts. GPT 4 was consistent in 90% of answers.

“Unfortunately, we found that industry updates have had conflicting effects,” Le added. He shared that, while accuracy rates remained stable in the time between the releases of these two models—June 2023 and November 2023—consistency increased to 65% in GPT 3.5 but dropped to 79% in GPT 4 in this period.

Amendola, professor of surgery at Virginia Commonwealth University School of Medicine and chief of the Division of Vascular Surgery at Central Virginia VA Health Care System in Richmond, Virginia, as well as senior author of the research, highlighted a key takeaway from the project: “The interesting finding in this is that [ChatGPT] was not as good as we thought it ought to be.”

Challenges

This comment laid the foundations for a wider discussion on the future of AI—an umbrella term covering a variety of different technologies, from large language models like ChatGPT to machine learning algorithms—in vascular surgery. Both Amendola and Le highlighted various challenges that need to be addressed at this early stage of development before wider implementation into training and practice can be successful.

“A lot of this technology is experimental right now,” Le pointed out, noting that its application is currently highly varied by institution and by country.

Both Le and Amendola underline regulatory issues as one limitation. “Integration of these tools—AI and more specifically large language models—continues to pose significant challenges due to the legislative consideration as well as integration into existing health systems and health record systems,” said Le, with Amendola adding that privacy and Health Insurance Portability and Accountability Act (HIPPA) concerns are “limiting the infiltration of a lot of these models at large healthcare systems.”

Perhaps the biggest drawback at present, though, according to Le, is the tendency for models such as the one used in the aforementioned research to “hallucinate.” He explained: “Our large language models sometimes make up information in a way that might be harmful when used in a clinical setting.”

Amendola also highlighted the impact of early-iteration AI on vascular training, stressing that educational institutions are grappling with how to effectively handle the use of AI among students. “Can you generate your own AI-based position paper or personal statement for an application?” he asked, highlighting a key question at the center of this conundrum.

Data are also an issue. Le pointed out that large language models are influenced by training data, which “may harbor hidden bias.” In addition, he noted that predictive machine learning modeling needs large amounts of clean data, which often are not available. “Unfortunately,” he stressed, “data capture during clinical care tends to be of low quality, for various reasons, with lots of missing or poorly documented information, which reduces the strength of such predictive modeling.”

Opportunities

Overall, however, both researchers expressed cautious optimism about the potential of AI technology in the vascular surgery landscape of the future. “While our study has been about understanding the limitation of these new large language models, it’s only a stepping stone towards the innovative application of these tools,” Le said, putting his and Amendola’s research into context.

Machine learning offers a significant opportunity to individualize care, Le noted. He added that AI in general could improve the efficiency of vascular practice and education, citing the rapid drafting of medical documentation and the distillation of historical medical data as examples. Large language models, Le continued, could build realistic clinical situation simulations for training purposes.

“We’re using this technology now in a lot of other parts of our lives, and eventually it will become part and parcel of what we see at the bedside and within our practice,” Amendola posited.

Alongside this potential, though, Amendola was keen to stress the need for safety measures. “I think there’s a lot of promise and opportunity, but there needs to be a lot of policy, and we’re going to have to put some guardrails on what exactly some of these models are able to look at.”

Commenting finally on adoption of AI at the physician level, Le emphasized the generally user-friendly nature of most current popular large language models, and that learning curves will become shorter as time goes on. “Overall, I think as these technologies develop, the barrier to entry and the learning curve will continue to decrease,” he commented.

“It will be an aid,” Amendola said as a closing remark, citing as one of his key messages the fact it is not a question of if but when with the adoption of AI, urging colleagues to embrace this new set of technologies. “One of the best quotes I’ve heard about AI is that AI will not replace doctors or surgeons, but the surgeon or the doctor who doesn’t use AI will be replaced.”

Physician-assembled unitary stent graft platform for debranched TAAA repair found safe and effective

By
Brian McHugh
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Physician-assembled unitary stent graft platform for debranched TAAA repair found safe and effective
Naiem Nassiri
Naiem Nassiri

Researchers behind a seven-year retrospective analysis of a physician-developed unitary stent graft system for endovascular debranched aortic repair of various thoracoabdominal aortopathies reported a 30-day mortality rate of 3.6%, with an all-cause mortality rate of 23% and an aneurysm-related mortality rate of 3.6% at median follow-up (360 days).

The data were reported by Naiem Nassiri, MD, a vascular surgeon at the Yale University School of Medicine, Yale New Haven Hospital, in New Haven, Connecticut, during SCVS 2024.

The study included 139 consecutive patients at prohibitive risk for open surgery who underwent endovascular debranched aortic repair for the treatment of dissecting and non-dissecting thoracoabdominal aortic aneurysms (TAAAs). It took place at three sites in the U.S., two under the auspices of investigational device exemptions (IDEs) and one pre-submission IDE.

The patient population contained 34% who were smokers, had high rates of congestive heart failure, and a number with chronic kidney disease. Nassiri said that about 18% had prior repairs, and the types of aneurysms included shortneck infrarenal aneurysms (1.4%), type I Crawford TAAA (1.4%), type II (6.5%), type III (4.3%), type IV (71.2%), type V (2.2%), and chronic dissections (12.9%).

“We had 100% technical success on 539 target vessels,” Nassiri told the audience. “Primary and secondary patency rates were 94.4% and 99%.”

The 30-day mortality rate saw five deaths, with major adverse events including respiratory failure, myocardial infarction, renal failure, bowel ischemia, stroke and paraplegia.

“The unitary stent graft is based on the Medtronic Endurant platform, and it was designed to divide aortic flow into a visceral limb and an infrarenal limb,” Nassiri explained.

“Given it’s not a modular-based design, the unitary stent graft system offers safe and effective, reproducible and, importantly, an off-the-shelf option for endovascular debranch aortic repair for various thoracoabdominal aortopathies,” he said. “This includes failed prior repairs of all sorts. It has been our experience that it has been applicable anatomically in 100% of patients.”

How intersociety collaboration to promote private practice could help vascular surgery amid workforce crisis

By
Brian McHugh
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How intersociety collaboration to promote private practice could help vascular surgery amid workforce crisis
Dawn M. Coleman

Dawn M. Coleman, MD, chief of vascular surgery at the Duke University School of Medicine in Durham, North Carolina, focused on the likely major shortage of vascular surgeons and physicians to illustrate how intersocietal collaboration will help ease this problem during a special session at the 2024 Society for Clinical Vascular Surgery Annual Symposium in Scottsdale, Arizona (March 16–20).

“I think there are three big benefits to intersocietal collaboration,” said Coleman, representing an Association of Program Directors in Vascular Surgery (APDVS) perspective during the breakout focused on private practice and collaboration across societies. “One, it helps our workforce. Two, it helps our workforce. And three, it helps our workforce.”

Not only does collaboration help ease the gaps in coverage that patients currently deal with, but it also relieves some issues that will hit the healthcare system in the near future, she explained. “There is a projected physician shortage by 2034 that could be anywhere from 37,000 to 124,000 doctors—dependent on how things are modeled,” Coleman told the audience.

Some of the biggest factors around this potential doctor shortage is “an aging workforce and a lot of the burnout that physicians across the board are feeling,” she stated.

The data Coleman referenced illustrate a real problem for the future that will most likely affect those in rural and urban populations, where vascular surgeons are few and far between. She said that, with the population expected to grow 10% by 2034, population growth will likely surpass physician capacity.

“By population density, we see pretty egregious disparities in urban and rural settings,” Coleman said. “We can’t ignore those data.”

Coleman mentioned some high-level policy changes, including the Consolidated Appropriations Act, the Conrad State 30 program, and the Resident Physician Shortage Reduction Act.

“The Consolidated Appropriations Act created 1,000 new Medicare-supported GME [Graduate Medical Eduction] positions for rural hospitals specifically in 2021. The Conrad State 30 and Physician Reauthorization Act passed in 2021 are allowing us to extend J1 visa holders,” Coleman explained. “Finally, the Resident Physician Shortage Reduction Act passed. That’s going to essentially increase the number of training programs by 14,000 over seven years.”

While those are all great steps in the process of filling coverage gaps, there is still a lot of work to do, Coleman continued. Having more physicians on the frontlines will certainly help, although those physicians need to be spread across the country instead of being focused in high-density areas, she said.

“When we think about volume, [we are] not just addressing disparities in patient access to care,” Coleman expanded. “By recruiting and training more vascular surgeons, it helps us to potentially uniquely position vascular surgeons in underserved spaces. We’ve got just over 3,000 vascular surgeons serving 214 million people. There are 2,600 counties that don’t have one. That leaves 96 million U.S. patients without service.”

With so many patients currently without service, and the likelihood of the population continuing to rise, the potential benefits of intersocietal collaboration are numerous, Coleman added. “I think it’s important that we continue to expand community independent vascular surgeon fellowships and expand exposure of our learners at all levels,” Coleman said in her closing remarks. “We have got to do better at optimizing local and regional networking and partnerships.”

Bad reading: How to claw back negative revenue?

By
Bryan Kay
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Bad reading: How to claw back negative revenue?
Clayton Brinster

Five frequently performed vascular surgeries at a prominent New Orleans-based health system between 2019 and 2022 yielded an average yearly decrease in net revenue of -11.5%, lending weight to growing national evidence that lay bare how increasing direct costs are outpacing reimbursements at U.S. hospitals.

Data from Oschner Health were presented at the 2024 Society for Clinical Vascular Surgery (SCVS) Annual Symposium in Scottsdale, Arizona (March 16–20), with presenting author Clayton Brinster, MD, highlighting that “the significantly lower, concomitant increase in reimbursement demonstrates an ominous trend of eroding hospital revenue for vascular surgery.”

The analysis out of New Orleans comes amid escalating healthcare costs in the U.S. in the wake of the global pandemic—now nearly $5 trillion per year, or about 20% of gross domestic product (GDP). Brinster pointed to data showing that by 2022, more than 50% of U.S. hospitals were operating on a negative margin. Despite signs of some gains early last year, the former Oschner Aortic Center senior staff vascular surgeon, now co-director at the UChicago Medicine Center for Aortic Diseases, set a bleak backdrop to data pulled from his old institution’s balance sheet.

“In 2024, after the withdrawal of government emergency funds [following the COVID-19 pandemic], the future remains uncertain and unstable for hospitals and health systems,” he said.

Why? He ran through some of the reasons. Inflation. Increasing costs, particularly related to a nursing workforce shortage leading to “astronomical agency labor” costs. Increased expenses per patient during the 2019–2022 study period. Hospital expenses “were no less dramatic,” Brinster said, explaining: “When we compare hospital expense growth compared to Medicare reimbursement, we see that cumulative hospital expense increase was more than twice the cumulative increase in Medicare reimbursement per patient between 2019 and 2022.”

Which leads to the focus of the Oschner analysis: the impact on the financial performance of vascular surgery. Brinster and colleagues sought to examine the evolving costs, reimbursement and net revenue trends associated with the five most common vascular surgeries at the institution over the four-year period of study: arteriovenous fistula creation, arteriovenous graft placement, carotid endarterectomy, endovascular aortic repair, and lower extremity angiogram with percutaneous transluminal angioplasty and/or stent. Direct hospital costs and reimbursement perencounter were examined, along with overall reimbursement patterns and insurance payor mix.

They found an average annual increase in direct cost of 31% per case between 2019 and 2022. Likewise, Brinster et al pinpointed an annual increase in reimbursement per case of more than 20% across the same period. “The differential in increased direct cost/case versus a more modest increase in reimbursement/case yielded an average yearly decrease in net revenue of -11.5%,” he reported at SCVS 2024.

Drilling deeper into specific data on all payors for inpatient cases only, the numbers showed that reimbursement lagged behind directs costs by 12%, Brinster explained. “And when we examined Medicare patients only, that number was even greater at 20%.” Meanwhile, the equivalent figures for outpatient cases demonstrated that reimbursement was lagging behind direct costs per case by 25% for all payors and 33% per case for Medicare-covered patients. Insurance payor mix did not change over the study period, with Medicare comprising 71% of all payors. “Why does this matter to vascular surgery? Hospital administrators determine the value of our services by something called contribution to indirect [CTI], or profit margin,” said Brinster. “Eroding margins for vascular surgery could jeopardize our standing within our respective health systems, and will reduce our resources and compensation allocation going forward.”

As he looked ahead, Brinster highlighted the need for action from Washington, D.C. “What can be done in the future? To ensure hospitals have the capability for high-quality, high-acuity care, large-scale governmental support will be required. Congress will have to enact policies that support the healthcare workforce.”

In the questions that followed his presentation of the data, the potential role for the office-based lab (OBL) to alleviate the situation emerged, with session moderator Jason Lee, MD, chief of vascular surgery at Stanford Medicine, asking Brinster whether the onus should fall on the profession to increase cost-effectiveness and efficiency and “therefore raise our value to the hospital system.”

Brinster acknowledged how the OBL is a “hot topic” amid concerns not just around financing but also necessity of procedures. The morality of the necessity of procedures is “a completely different argument” that will require standards to be determined and held up, he answered. “The shift to the OBL will be one of the critical factors to recoup better reimbursement, at least as reimbursement patterns stand now,” Brinster added.

Study details link between increased functional status and improved survival in prosthesis-fitted amputees

By
Bryan Kay
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Study details link between increased functional status and improved survival in prosthesis-fitted amputees
Screenshot
William Shutze

Increasing functional status in vascular patients fitted with a prosthesis after amputation was incrementally associated with improved survival, a retrospective analysis of a 10-year experience at a Dallas-based practice showed.

The team at Baylor Scott & White The Heart Hospital-Plano established that as lower extremity amputees referred for an artificial limb progressed through Medicare Functional Classification Levels—known as K-levels—the probability of survival increased.

At the low end, K0 status means a patient has no functional ability with a prosthesis; conversely, K4 status can mean athletic-level ability. Since the Dallas study involved vascular patients, all 123 referred for a prosthesis who were included were K1 to K3 level, explained lead researcher William Shutze, MD, a vascular surgeon with the Texas Vascular Associates practice group. “As patients went from K1 to K2 and up from K2 to K3, that survival curve was sequentially higher statistically,” he told Vascular Specialist. “Our hypothesis initially was that obtaining a prosthetic will improve your survival, but a higher functional level with that prosthetic will even further improve your survival.”

The latest data were presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting held in Scottsdale, Arizona (Jan. 24–27) and are under review for publication in the Journal of Vascular Surgery.

Shutze and colleagues have previously demonstrated that prosthetic referral was an independent predictor of long-term survival among patients who had undergone lower-extremity amputation, finding factors associated with decreased survival were increasing age, higher American Society of Anesthesiologists (ASA) class, Black race, and body mass index (BMI). Prosthesis-referred patients were approximately 50% less likely to experience mortality, they reported in 2021.

With these findings in mind and the latest results from their study of functional status, Shutze said he is now settling on new questions. “Should we really now be taking our patients, after they get their prosthesis, and providing them with more physical therapy to get them to a higher functional level?” he asked. “Should we be encouraging them to get from K1 to K2 or K2 to K3?” K1 status involves a prosthesis-fitted amputee who is able to move around the home on level surfaces; the K2 level involves patients who can ambulate more in the community with the assistance of a wheelchair; and K3 patients have a level of functional independence whereby they can move around in their artificial limb whenever they choose to use it.

“If we could show patients this data and use it to motivate them, to actually see an improvement in their status, then track that person and compare their survival, that would be phenomenal,” Shutze continued.

He now plans to assemble enough partners at other centers in a multi-institutional study to produce more patients who undergo a change in functional status.

But the data out of Dallas are translational right now, Shutze said. “If people really believe the findings, we can start getting more patients into prosthetics and then we can continue to work with them afterward to get them to a higher functional level.”

Prosthetists are important partners in this endeavor, he added. “We know their main focus is on getting these patients a functional limb, but we want to get them as functional as possible with that functional limb.”

All of that said, Shutze lamented his practice’s prosthetic referral rate: it was just 36%. “Even though we are a group that is focused on prosthetics for our vascular patients who lose a limb, our successful referral was less than half. I think that’s a symptom of the barriers in the process of getting a patient from the operating room into the prosthetics office,” he said. “I’d encourage people around the country to look at their own referral rates and see if they are satisfied with those. The literature shows the referral rate at one center was 80%. I think that is a reasonable goal.”

Greenhalgh legacy set to continue at CX 2024

By
Will Date
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Greenhalgh legacy set to continue at CX 2024
The late Roger M. Greenhalgh

Though the 2024 edition of the Charing Cross (CX) International Symposium (April 23–25) in London, England, marks a new era, it will be tinged with sadness as the first without its visionary founding chairman Roger M. Greenhalgh, MD.

Professor Greenhalgh, renowned internationally for his surgical skill and unparalleled contribution to vascular education and research, died in October 2023 at the age of 82. At the time of his death Professor Greenhalgh was emeritus professor of surgery at Imperial College in London and head of its Vascular Surgery Research Group.

Through a long and distinguished career, he was a staunch advocate of the use of rigorous evidence to address grey areas in vascular disease management and led more than a dozen trials in the field of aneurysm management including the UK Small Aneurysm Trial (UKSAT) and the UK Endovascular Aneurysm Repair (EVAR 1 and 2) trials, authoring more than 300 papers in all areas of vascular surgery.

His commitment to peer-to-peer education saw, aged 37, Professor Greenhalgh found the CX series of international symposia and annual books in 1978. This began as a small, focused symposium at the Charing Cross Hospital, with between 100 and 200 attendees, covering topics including smoking and arterial disease. Over the next 45 years, he stood at the helm as it grew to become the leading event in the vascular education calendar.

Professor Greenhalgh played a pivotal role in the creation of the European Society for Vascular Surgery (ESVS), which was launched at CX in 1987, and was instrumental in the development of surgical training and standards across Europe through the Union Européenne des Médecins Spécialistes (UEMS).

Throughout the years notable pioneers such as Michael DeBakey, Denton Cooley, Jesse Thompson, John Mannick, John Bergan, Jimmy Yao, Ted Diethrich, Juan Parodi and Frank Veith have graced the CX podium. Tom Fogarty spoke of his catheter and Andreas Grüntzig spoke of angioplasty in the 1980s. Julio Palmaz gave news of endovascular aneurysm repair (EVAR) at CX 1990.

In 2024, CX brings together thousands of attendees of multiple disciplines from across the globe to share new evidence and techniques to improve the care of patients with vascular disease in the mould set by Professor Greenhalgh, championing the highest quality education, innovation and evidence.

This legacy will be carried forward by new CX co-chairs Dittmar Böckler (Heidelberg, Germany), Andrew Holden (Auckland, New Zealand) and Erin Murphy (Charlotte, United States). Professor Greenhalgh personally nominated the trio to carry the baton and honor the style of education established over the event’s 45-year history.

“It is an honour and a privilege to carry on his legacy and vision with colleagues, friends of Roger and his son Stephen. I will never forget his credo: ‘…to discover and promote new talents and bring medical education and CX to the next level, year by year. It’s all about controversies and especially consensus in academic medicine, but also in life…’,” Böckler says.

“With the passing of Professor Roger Greenhalgh, we have lost a pioneer, an inspiration, a mentor and an icon of vascular surgery,” adds Holden. “Roger’s passion for education, evidence-based and patient-focused care as well as the value of an inclusive, multidisciplinary approach has greatly influenced many of our careers.”

“Working alongside Roger was an opportunity to witness gracious leadership, which was both a rewarding and humbling experience. I will deeply miss our chances to converse and collaborate,” comments Murphy. “I am [honored] to have been a part of his journey. His legacy will endure through the knowledge he imparted and the educational framework he established, which will continue to enrich global education for years to come.”

Increasing access and decreasing scientific bias: How open access is changing academic publishing

By
Matthew R. Smeds
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Increasing access and decreasing scientific bias: How open access is changing academic publishing
Matthew R. Smeds and Ronald L. Dalman

There has been much talk recently on open access publishing and the costs associated with this mode of publication. While editor-in-chief positions within most scientific journals are academic roles involved with the overall content published within journals and not the monetary aspects of this industry, we thought it important to discuss the different models of publication given their use has real effects on both authors and readers of the manuscripts received and published.

Publishing companies are businesses. In traditional publishing models, publishers make money off subscriptions that are paid by individuals who subscribe to the journal or by societies, institutions, libraries or companies that provide the subscription to their members. While publishing is “free” for the authors, the authors give up copyright for the publication to the journal and only those with access to the journal via subscriptions can view the information within the manuscript. This potentially creates a biased system in which larger or well-funded institutions have nearly unlimited access to published science while those in smaller institutions or those not affiliated with academic groups have decreased ease of accessibility. At the same time, a not insignificant portion of scientific output is supported by grants from federal or public funding sources. If these data are released via traditional models of publishing, the results of this federally funded research may not be accessible by all who “paid” for it with their taxes!

Open access models of publishing attempt to correct this bias and loss of author intellectual property by making research openly available to everyone to read/access by removing subscription fees or paywalls for article use. Authors retain copyright, and the publisher in turn makes money from article publishing charges (APC) for each specific manuscript published. In addition to leveling the playing field for academic researchers’ access to scientific data, articles published open access have demonstrated increased readership, downloads and citations.1-3 Journals may be fully open access or hybrid models that provide both subscription and open access options for authors. In both journal types, there is an established editorial leadership structure with editorial boards and peer-review selection of articles published. This differs from so-called “predatory” journals which have sprung up with the creation of open-access publishing that lack significant adjudication and are purely “pay-for-publish.”

In 2018, a group of funding organizations announced the cOAlition S initiative (Plan S), which included the main goal of mandating all scholarly publications funded by grants provided by national, regional and international research councils or funding bodies be published open access by 2021.4 This plan had initial support of the European Commission and the European Research Council, but the United States Office of Science and Technology Policy (OSTP) declined to join the initiative. Subsequently, in 2022, the OSTP issued a mandate to make all federally funded research freely available with a deadline of Dec. 31, 2025, for federal departments and agencies to update their policies.5 At that time, results of funded research will be accessible via open access.

Despite the obvious advantages, challenges remain to full adoption of the open access model. In open access, APCs become the responsibility of authors and/or their institutions rather than subscribers or libraries. In Europe, due to the adaptation of Plan S, APC responsibility has shifted primarily to institutions. In North America, negotiation of “transformative agreements” between institutions and publishers is pursuing a similar goal, albeit through a less standardized process. Authors supported by these institutional agreements, such as faculty at the University of California system and many others, have their APCs subsidized in part or in whole by their employer. As more institutions negotiate similar agreements with major publishing houses, a more equitable balance is being achieved between access to new knowledge and the expense of compiling and reporting it.

The value that experienced publishers bring to the compilation and verification of new knowledge is substantial, enhancing the rigor and reproducibility of biomedical research and, hopefully, improving access and outcomes for all. As publishing models evolve, all stakeholders in academic publishing (authors, professional societies, funders, academic institutions and publishers) need to adopt sustainable business practices that recognize and reward academic excellence. In some cases, research funding organizations should cover APC expenses as part of the overall cost of conducting and publicizing research, as the National Institutes of Health and National Science Foundation already do. In others, sponsoring institutions should account for the cost of publishing peer-reviewed research results in a manner analogous to how they underwrite expenses required to create new knowledge, in the form of research space and similar infrastructure investments. Expectations regarding faculty research productivity should include underwriting for reasonably anticipatable publishing expenses.

For non-affiliated authors reporting self-funded research, open access APCs unfortunately add to the expense and complexity of reporting results, potentially stifling innovation and advancement of patient care. At the Journal of Vascular Surgery portfolio of journals, we are committed to helping all authors find the most efficacious and impactful pathway to publication of deserving science, including the provision of APC waivers when available and appropriate, as new funding models continue to evolve. Ultimately, the transition to open access promises to advance the interests of all stakeholders in academic publishing, including the public and the patients we serve. As authors and fellow members of the Society for Vascular Surgery, we appreciate your patience and forbearance as we navigate this transition together.

References

  1. Patel RB, Vaduganathan M, Mosarla RC, Venkateswaran RV, Bhatt DL, Bonow RO. Open access publishing and subsequent citations among articles in major cardiovascular journals. Am J Med. 2019 Sep;132(9):1103–1105.
  2. Alkhawtani RHM, Kwee TC, Kwee RM. Citation advantage for open access articles in European radiology. Eur Radiol. 2020 Jan;30(1):482– 486.
  3. Davis PM, Lewenstein BV, Simon DH, Booth JG, Connolly MJ. Open access publishing, article downloads, and citations: Randomized controlled trial. BMJ. 2008 Jul 31;337:a568.
  4. https://www.coalition-s.org/, accessed March 25, 2024.
  5. https://www.whitehouse.gov/ostp/news-updates/2022/08/25/ostp-issues-guidance-to-make-federally-funded-research-freely-available-without-delay/, accessed March 25, 2024.

Matthew R. Smeds, MD, is the editor-in-chief of the Journal of Vascular Surgery-Cases, Innovations and Techniques. Ronald L. Dalman, MD, is the executive editor of the Journal of Vascular Surgery portfolio of journals.

Vascular Specialist–April 2024

By
Bryan Kay
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Vascular Specialist–April 2024

In this issue:

  • Bad reading: Worrying new data demonstrate a consistent shortfall of more than a fifth in net revenues over a four-year period for a quintet of commonly performed vascular procedures
  • Endovascular showdown: Stage is set for BASIL-3 first-time data release
  • Guest editorial: How open access is changing academic publishing
  • ChatGPT: Research provides ‘stepping stone’ for future application of AI in vascular surgery

 

The top 10 most popular Vascular Specialist stories of March 2024

By
Éva Malpass
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The top 10 most popular Vascular Specialist stories of March 2024

top 10In March, the most read stories from Vascular Specialist include a new analysis which suggests of a ‘lack of reach’ of vascular voices within news coverage of vascular disease; a vascular surgery resident reflects on their experience of match day; and Jean Bismuth, MD, takes over presidential duties at the Society for Clinical Vascular Surgery (SCVS) president during the organization’s 51st Annual Symposium in Scottsdale, Arizona, amid many more stories.

1. New data underscore physician experience levels required to derive benefit from transfemoral carotid artery stenting

Data from a new study that maps out the levels at which ad­verse postoperative events decrease following transfemoral carotid artery stenting (TfCAS) based on depth of physician experience with the procedure represent an “absolute mini­mum threshold of learning,” the lead author Marc Schermerhorn, MD, chief of vascular surgery at Beth Israel Deaconess Medical Center in Boston says.

2. The devil we don’t know: The case against private equity in medicine

Malachi Sheahan III—the chief medical editor of Vascular Specialist—write on private equity in vascular surgery. “I believe PE acquisitions are just a symptom of healthcare’s overall problems. Physicians are selling their practices because it is too hard to remain financially solvent on their own. Paperwork, legal requirements, electronic health records and insurance practices have all placed incredible strain on private practitioners.” Read more.

3. Multi-society PAD Pulse Alliance aims to highlight importance of patient education

Marlén Gomez comments on Society for Vascular Surgery (SVS) initiatives as part of the multispecialty PAD Pulse Alliance and the Get a Pulse on PAD public awareness campaign. The campaign is aimed at educating and raising awareness of the risk factors and potential symptoms of peripheral arterial disease (PAD) among Americans. As the campaign gathers steam, the SVS is focused on closing the health equity gap with the aim of equipping patients with essential tools for early detection and treatment, she writes.

4. New analysis points to lack of vascular surgical voices in news coverage of vascular disease

A new study set to be aired at the 2024 Society for Clinical Vascular Surgery (SCVS) annual meeting (March 16–20) in Scottsdale, Arizona, sheds a statistical spotlight on the state of the specialty’s reach into the mainstream consciousness.

5. Non-pneumatic compression device performed better than advanced pneumatic compression for lower extremity lymphedema

A new study presented during the 2024 American Venous Forum (AVF) in Tampa, Florida (March 3–6), that compared a novel non-pneumatic compression device with an advanced pneumatic compression modality in the treatment of lower extremity lymphedema demonstrated “statistically significant disruption” in limb volume that favored the former.

6. Endologix initiates postmarket study of the Detour system

Endologix has announced the initiation of the Percutaneous transmural arterial bypass (PTAB)1 postmarket study. This study marks the beginning of a comprehensive postmarket study aimed at evaluating the real-world performance of the Detour system in patients undergoing treatment for long complex superficial femoral artery (SFA) disease.

7. Vascular surgery resident reflects on Match Day experience

Integrated vascular surgery resident Eric Smith, MD, tells Vascular Specialist how he handled the lead up to Match Day. For medical students hoping to specialize in vascular surgery, the eagerly anticipated Match Day (March 15) marks a pivotal career moment. Organized by the National Resident Matching Program (NRMP), it is the culmination of years of hard work, education and clinical experience.

8. SCVS 2024: Bismuth becomes 2024–25 Society for Clinical Vascular Surgery president

Jean Bismuth, MD, took over as Society for Clinical Vascular Surgery (SCVS) president during the organization’s 51st Annual Symposium in Scottsdale, Arizona (March 16–20). The new University of South Florida chief of vascular surgery followed M. Ashraf Mansour, MD, academic chair in the Department of Surgery at Spectrum Health Medical Group in Grand Rapids, Michigan.

9. Personalized, precision medicine is key to the future of aortic repair

Bijan Modarai, MD, London, UK, set out and addressed this conundrum at the 27th European Vascular Course (EVC; 3–5 March, Maastricht, The Netherlands). He argued that a lack of evidence for predicting longevity—a key factor in deciding whether a patient should undergo aortic aneurysm repair—necessitates a future move towards precision medicine and personalised treatment to avoid operating on patients unnecessarily.

10. First patient enrolled in IDE study of Aquedeon Medical’s Duett vascular graft system

Aquedeon Medical has announced the initiation of an investigational device exemption (IDE) clinical trial to study the Duett vascular graft system. A press release reveals that, this February, the first enrolled patient underwent open surgical aortic arch reconstruction at the University of Pennsylvania Presbyterian Medical Center (Philadelphia, USA). During the surgery, the Duett vascular graft system was successfully deployed to connect the native left common carotid artery to the surgical graft.

FlowTriever device found to dramatically improve breathing among intermediate-risk acute pulmonary embolism patients

By
Brian McHugh
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0
FlowTriever device found to dramatically improve breathing among intermediate-risk acute pulmonary embolism patients
Zachary AbuRahma
Zachary AbuRahma

SCVS 2024 saw Zachary AbuRahma, DO, an assistant professor of vascular surgery at West Virginia University and the Charleston Area Medical Center in Charleston, West Virginia, presented data from a single-center experience focused on the use of the FlowTriever device (Inari Medical) in catheter-directed mechanical thrombectomies for submassive pulmonary embolism (PE) patients. The study, which involved cases performed between January 2019 and June 2023, established safety and effectiveness, with 94% of patients moved to room air post-procedure after 0% were on room air pre-procedure. 

“Pulmonary embolism is the third leading cause in cardiovascular mortality behind CAD [coronary artery disease] and stroke, with over 100,000 deaths per year,” AbuRahma said. “According to the CDC [US Center for Disease Control], 25% of patients present sudden death as the first symptom and 10–30% of these patients will die within one month of diagnosis.” 

AbuRahma and colleagues determined that, with so few single-center studies that show the clinical benefits of endovascular intervention using mechanical suction thrombectomy for pulmonary embolism (PE) being published, they would analyze both the initial experience and clinical outcomes in the treatment of PE using the FlowTriever. 

AbuRahma told the audience that the study “described the clinical features, findings and outcomes of patients with sudden massive PE undergoing catheter directed mechanical thrombectomy.” 

“It was a retrospective study of 50 consenting patients with intermediate to high-risk PE. They received [a] catheter-direct thrombectomy using the Inari device,” AbuRahma stated. “Clinical success was defined by improvement in internal pulmonary pressures and oxygen therapy.” 

The patient population had a mean age of 68 years old, with a male-to-female ratio of 1 to 1. All patients had a right ventricular strain and either required oxygen therapy or an increase in oxygen therapy from baseline.  

Of those patients, AbuRahma said that about 12% of the patients in the study were active COVID-19 patients, about 18% of the patients had stage III chronic kidney disease, and about 72% had a hypothyroid disorder. 

The results of the study concluded that, among the 50 patients at a mean follow-up time of eight months, there was significant improvement in fraction of inspired oxygen (FiO2) noted from the mean pre-procedural 40.6% to 28.3% 24 hours after the procedure. Some 94% of patients moved to room air post-procedure after 0% were on room air pre-procedure. In a later follow-up, 94.4% of patients were improved from baseline for oxygenation, 89% improved for physical activity, and 97% improved for beathing status. 

AbuRahma and his team use the Modified Medical Research Council Dyspnea Score (mMRC). Using mMRC, 93% of patients reported a pre-op score of 4, which means that the patients reported being too breathless to leave the house. During a later follow-up, 70% of patients reported scores of 0 or 1, which means they experienced no breathlessness during normal activity or shortness of breath when hurrying. All patients showed improvement using the mMRC score. 

In conclusion, AbuRahma and his team determined that the FlowTriever device is both safe and effective for patients with submassive acute pulmonary embolism.  “Most patients perioperatively and at eight-month follow-up were back to baseline clinically with regard to activity level, O2 needs and breathing,” he added. 

Novel ultrasound-facilitated thrombectomy with microbubbles shows promise in acute porcine model for DVT treatment

By
Brian McHugh
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Novel ultrasound-facilitated thrombectomy with microbubbles shows promise in acute porcine model for DVT treatment
William Marston
William Marston

Evaluation of the safety and performance of a novel pharmaco-mechanical procedure for acute deep vein thrombosis (DVT) in two pigs demonstrated a significant reduction in thrombus burden and vessel wall preservation, data from in vivo testing reveals.

The SonoThrombectomy system (SonoVascular, Inc.) was tested on swine with thrombi in their iliac veins, with the study focused on establishing how the system—composed of an ultrasound catheter that delivers microbubbles to induce microbubble-mediated sonothrombolysis (MMS) alongside a mechanical thrombus retriever and aspiration sheath—would work in treating DVT without vessel trauma, blood loss, or a prolonged ICU stay.

Results were presented during the 2024 American Venous Forum (March 3–6) in Tampa, Florida, by William A. Marston, MD, professor of vascular surgery at the University of North Carolina Hospitals in Chapel Hill, North Carolina.

Safety was evaluated by a gross examination of the treated vessels following necropsy of the animals to identify intimal injury or disruption.

“We’ve all used ultrasound before,” Marston told the audience, “but this is a new method of using ultrasound, and the key is that it adds the function of microbubbles. These microbubbles are excited by the ultrasound waves to produce specific effects within the clot that you are addressing. This is a sub-megahertz frequency ultrasound catheter.”

Both pigs had fluoroscopies performed to evaluate the iliofemoral venous segments before and after thrombus creation. Complete vessel occlusion was achieved in all veins with a mean diameter of 11.0mm ±0.9mm and a mean clot length of 10.9cm ±1.0cm.

The thrombus was then crossed with a .018 wire and treatment was performed through SonoVascular’s 12F sheath with MMS.

“The procedure is a two-stage effort,” Marston said. “First, the sheath is inserted via the femoral common vein to the thrombus, which allows crossing with an open-ended guidewire. We then cross the thrombus, and pass the ultrasound catheter up and down to break up the clot with MMS and tPA [tissue plasminogen activator]. Second, retrieval is conducted using an associated basket. With this protocol, we advanced the ultrasound catheter one centimeter every 45 seconds. I think we can do it faster than that.”

Total time for the procedure averaged 17 minutes, with nearly complete clot treatment achieved, Marston said, concluding that the in vivo testing showed that the SonoThrombectomy System significantly reduced thrombus burden while preserving vessel walls. “This is a novel combination of ultrasound, microbubbles, and tPA, which we think will lead to the ability to do single-session sonothrombolysis,” he added. “We’re planning to move to in-human [testing]  by the end of this year.”

Johnson & Johnson to acquire Shockwave Medical

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Johnson & Johnson to acquire Shockwave Medical

Johnson & Johnson is to acquire Shockwave Medical, it has been announced today.

Under the terms of the transaction, Johnson & Johnson will acquire all outstanding shares of Shockwave for US$335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired. The transaction was approved by both companies’ boards of directors.

The acquisition of Shockwave further extends Johnson & Johnson MedTech’s position in cardiovascular intervention and accelerates its shift into higher-growth markets, Johnson & Johnson said in a press release. The acquisition will expand Johnson & Johnson’s medtech cardiovascular portfolio into coronary artery disease (CAD) and peripheral artery disease (PAD).

The transaction follows Johnson & Johnson MedTech’s acquisitions of Abiomed, a leader in heart recovery, and more recently Laminar, an innovator in left atrial appendage elimination for patients with non-valvular atrial fibrillation (AF). These

Shockwave is a provider of intravascular lithotripsy (IVL) technology for the treatment of calcified CAD and PAD. IVL is a minimally invasive, catheter-based treatment for calcified arterial lesions, which can reduce blood flow and cause pain or heart attack. IVL

In addition to its IVL platform, Shockwave also recently acquired Neovasc, developer of the the Reducer system, a novel product focused on symptom relief of refractory angina. The Reducer system is currently undergoing clinical studies in the USA and is CE marked in the European Union and the United Kingdom.

Joaquin Duato, chairman and chief executive Officer of Johnson & Johnson, said: “With our focus on innovative medicine and medtech, Johnson & Johnson has a long history of tackling cardiovascular disease—the leading cause of death globally. The acquisition of Shockwave and its leading IVL technology provides a unique opportunity to accelerate our impact in cardiovascular intervention and drive greater value for patients, shareholders and health systems.”

Tim Schmid, executive vice president and worldwide chairman of Johnson & Johnson MedTech, said: “Shockwave offers a truly differentiated opportunity to further enhance our leadership position in medtech, expand into additional high-growth segments, and ultimately transform the future of cardiovascular treatment. Shockwave’s IVL technology for treating CAD and PAD, and its strong pipeline, are in a class of their own. We look forward to bringing Shockwave’s solutions into Johnson & Johnson MedTech and the hands of more physicians around the world.”

“Shockwave has transformed the treatment of complex calcified arterial disease through the pioneering development of intravascular lithotripsy, and it is our mission to make this remarkable technology available to patients worldwide,” said Doug Godshall, president and CEO of Shockwave. “As part of a larger, more diverse organisation, with broad expertise and a core focus on improving patient outcomes, we are confident we will be able to further solidify IVL as the global standard of care for patients.

“I am deeply grateful to our team members and colleagues whose efforts have made today’s milestone possible; their accomplishments and passion have been extraordinary. I could not think of a better partner and home than Johnson & Johnson as the Shockwave team prepares to write its next exciting chapter.”

New data show single-session Indigo aspiration system without overnight thrombolytics is safe and effective for patients with ALI

By
Jocelyn Hudson
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New data show single-session Indigo aspiration system without overnight thrombolytics is safe and effective for patients with ALI
Indigo aspiration system
Indigo aspiration system

During the Society of Interventional Radiology (SIR) 2024 annual meeting (23–28 March, Salt Lake City, USA), newly presented data from a subgroup analysis of the STRIDE study showed that Penumbra’s Indigo aspiration system used in a single session without the need for overnight tissue plasminogen activator (tPA) is safe and effective for patients with lower extremity acute limb ischaemia (ALI). 

“Although the use of tPA following aspiration thrombectomy with [the] Indigo system was not limited during the STRIDE study, the majority of patients did not receive it and still experienced excellent outcomes,” said STRIDE investigator Jayer Chung (Baylor College of Medicine, Houston, USA).

“These findings demonstrate that the use of aspiration mechanical thrombectomy, without overnight tPA, yields high procedural success, low complication rates, and high target limb salvage rates in [lower extremity] ALI.”

A press release details that, although widely used, there are many complications associated with tPA and other clot-busting drugs. In the case of the overnight lytic group, tPA was also associated with an increased need for intensive care unit (ICU) monitoring as shown by the higher median length of ICU stay among those patients.

“The high risk of associated major bleeding is a notable limitation of thrombolytics as an intervention across many disease states, and [lower extremity] ALI is no exception,” said Thomas Maldonado (New York University of Langone Health, New York, USA), national principal investigator of the STRIDE study. “The data show that aspiration mechanical thrombectomy is a safe and effective minimally invasive procedure, which may offer an option to eliminate thrombolytic use for some patients.”

STRIDE is an international, prospective, single-arm, multicentre, observational study of patients with lower extremity ALI and using the Indigo aspiration system as a frontline intervention. The latest findings include:

  • No significant differences were detected between patients who received overnight tPA and those who did not for target limb salvage rate at 30 days, patency at 30 days and 30-day mortality.
  • ICU resource utilisation was significantly lower in single-session Indigo patients.

Penumbra notes that ALI is associated with a high risk of amputation and death. Studies have shown that ALI patients treated with catheter-directed thrombolysis often risk further vascular complications, such as major bleeding.

SVS announces VAM keynote speaker series

By
Kristin Spencer
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SVS announces VAM keynote speaker series
Andres Schanzer

Registration for the 2024 Vascular Annual Meeting (VAM 2024) launched on March 20 and promotions teased a new annual VAM fixture: the SVS Keynote Speaker Series. The inaugural address will take place in Chicago on Wednesday, June 19, and will be delivered by Karith Foster.

Foster is a diversity engagement specialist and creator of the INVERSITY methodology. Through her programs, she aims to create a seismic shift in diversity and culture in academic institutions, organizations and corporations across America. As a speaker, humorist, TV and radio personality, author, entrepreneur, wife and mother, Karith asserts her role as a positive force of change with her sense of duty and service.

Each year, the keynote address will have a theme, with the 2024 theme to be announced later this month. The theme of the address will correlate with the main idea for the conference.

“As the premier educational event in vascular surgery, a keynote address feels like something we have been missing,” said VAM 2024 Program Committee chair Andres Schanzer, MD. “I am excited to see this series kickoff in Chicago and to continue growing after my time as Program Committee chair is complete.”

Schanzer will rotate off of the Program Committee after VAM 2024, which will conclude his four-year term.

The inaugural keynote address for VAM will take place at 5 p.m. Central Time and will be immediately followed by the second annual SVS Connect@VAM: Building Community, a family-friendly event. Visit vascular.org/VAM to learn more.

Study hints at long-term cost-effectiveness of CDT and PMT over oral anticoagulation for moderate and severe PTS

By
Brian McHugh
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0
Study hints at long-term cost-effectiveness of CDT and PMT over oral anticoagulation for moderate and severe PTS
Anna Pouncey
Anna Pouncey feature
Anna Pouncey

During a presentation at the 2024 European Vascular Course (EVC; March 3–5) in Maastricht, The Netherlands, Anna Pouncey, MD, a clinical research fellow for vascular surgery at Imperial College London in London, England, presented findings from a study on the cost-effectiveness of early thrombus removal for acute iliofemoral deep vein thrombosis (DVT). 

The objective of the study was to look at early clot removal using endovascular intervention, which aims to reduce post-thrombotic syndrome (PTS) following iliofemoral DVT. The presenter noted that this technique has the possibility to reduce long-term morbidity, though it incurs a higher cost initially. The study examined the cost-effectiveness of pharmacochemical thrombectomy (PMT) and catheter-directed thrombolysis (CDT) in comparison with oral anticoagulation for acute iliofemoral DVT in the United Kingdom. 

Pouncey opened her presentation by explaining what cost-effectiveness meant in the study. “Our healthcare resources are finite,” she said. “So, if you spend a load of money on a treatment that doesn’t work, you are essentially going to harm patients and harm the healthcare system…Instead, you want to cause a health-gain, and you want this to be at an acceptable cost.” 

The effect of treatment on patients was measured using quality-adjusted life years (QALYs), which are a measure of how valuable the patient’s quality of life is adjusted for how long they’re living. “We can then use this to calculate something called an ICER, which is an incremental cost effectiveness ratio,” Pouncey told the audience. DVT “is a really significant health-economic burden. So, 50%, roughly, of patients with an iliofemoral DVT will go on to develop [PTS]. This is a chronic, debilitating, and really expensive condition.” 

Pouncey then went on to describe how she and her team went about their study.  

“The first step when you perform a cost-effectiveness analysis, is you need to know what you’re looking at,” she said. “You need to know the patient population that you’re looking at.” 

Pouncey and her team used a front-end decision tree to model possible patient outcomes in the acute setting. She explained that, “these are things like death, pulmonary embolism and bleeding from the treatment. Then once a patient, if they survived, got through to the chronic health state, we used something called a Markov model to model transitions between PTS states over time.” 

The study defined cost based on the United Kingdom’s National Health Service national tariff workbook, and used micro-costing for the procedures based on clinical practice at Guy’s and St Thomas’ Hospital, London. 

“We added up the early cost of intervention, and if you look at oral coagulation, it’s considerably cheaper than CDT and PMT. That is because of the cost of stenting, equipment, and increased hospital stay,” Pouncey stated. 

However, after performing a base case analysis, the results were interesting.  

“What we actually found is that both CDT and PMT were dominant over oral coagulation. What that means, is that they were both more effective and, over the lifetime, less costly,” Pouncey explained. 

“In conclusion, CDT and PMT may be cost effective over [oral anticoagulation],” Pouncey told the audience. “This is because of a reduction in the long-term costs of moderate and severe PTS, will offset the early treatment costs. However, there is still significant uncertainty, and we need to continually update our analyses, taking into advancement in procedural techniques and change to clinical practice.” 

Getinge and Cook Medical enter US commercial distribution agreement for iCast covered stent

By
Bryan Kay
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Getinge and Cook Medical enter US commercial distribution agreement for iCast covered stent
iCast covered stent

Getinge and Cook Medical today announced an exclusive sales and distribution agreement for the iCast covered stent system, which recently received Food and Drug Administration (FDA) premarket approval for the treatment of symptomatic iliac arterial occlusive disease.  

Cook Medical will assume sales, marketing and distribution rights for the product in the U.S. over the coming months. The iCast covered stent system will continue to be manufactured by Atrium Medical Corporation, which is part of Getinge.

“This agreement with Cook Medical ensures that the iCast covered stent system will reach the optimum number of patients who will benefit from it in the U.S.,” said Patricia Fitch, president of Getinge in North America.

“iCast has five-year data aligned with our commitment to long-term clinical evidence and predictable results for [peripheral arterial disease] therapies,” said Mark Breedlove, senior vice president of Cook Medical’s vascular division.

Cook and Getinge continue to collaborate in other areas, also partnering to complete the PRESERVE-Zenith branch endovascular graft-iliac bifurcation investigational device exemption (IDE) study with five-year follow-up. The purpose of this study was to evaluate the safety and effectiveness of the Zenith device in combination with the iCast covered stent in patients requiring treatment of aortoiliac and iliac aneurysms.  

First-in-human study of Pounce thrombectomy system in acute iliofemoral DVT demonstrates 12-month PTS rate of 18%

By
Brian McHugh
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0
First-in-human study of Pounce thrombectomy system in acute iliofemoral DVT demonstrates 12-month PTS rate of 18%
Stephen A Black
Stephen Black

Twelve-month outcomes from the Pounce venous thrombectomy system (Vetex Medical) first-in-human study evaluating its use in the treatment of acute iliofemoral deep vein thrombosis (DVT) recently published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL) demonstrated an overall post-thrombotic syndrome (PTS) rate of 18.2%.

The nonrandomized, prospective, multicenter study, sponsored by Vetex Medical, included 19 patients with acute DVT who received treatment with the Pounce system, which combines basket-rotational thrombectomy and is designed to minimise the need for thrombolytics or repeat procedures. It was led by first author Stephen Black (London, UK) and colleagues, and followed patients out to 12 months post-procedure.

The primary performance endpoint of the study was procedural success, with secondary endpoints including patient quality-of-life measurements using the Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire (VEINES QOL/Sym), the venous disease severity assessment using the Villalta scale and the Venous Clinical Severity Score (VCCS), and calf measurements taken at baseline, 24 hours and one-month post-procedure.

The study resulted in complete (seven of 19 patients) or near-complete (12 of 19 patients) thrombus removal. No major bleeding or device-related adverse events were recorded. Only three were given thrombolytics.

PTS (Villalta Scale >4) was found in 17 of 19 patients at baseline. That number reduced to 4 of 13 patients available for follow-up six months out, and two of 11 available after 12 months. The median VCSS decreased to 4 after one month from a baseline of 8.5. That is similar to the changes at six months (2) and 12 months (2). “None of the 11 patients available for Villalta assessment at 12 months developed moderate or severe PTS (Villalta score >9),” the authors note. “Of the two patients who had PTS at 12 months, one had been stented and one had not.”

Median VEINES QOL/Sym scores improved from baseline (57) to one month (96) post-procedure, and remained high at both six-month and 12-month follow-up. Median calf circumference decreased from 39cm at baseline to 36cm 24 hours after the procedure and was 34.5cm at one month.

The authors concluded that the study, while small, indicated the Pounce system is ready for use, with a need for larger studies in the future to confirm the results.

Endovascular showdown: CX 2024 sets the stage for BASIL-3 first-time data presentations

By
Jocelyn Hudson
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Endovascular showdown: CX 2024 sets the stage for BASIL-3 first-time data presentations
The BASIL triallists at CX 2023
BASIL-3
The BASIL triallists at CX 2023

At the Charing Cross (CX) Symposium 2024 (23–25 April, London, UK), Andrew Bradbury (University of Birmingham, Birmingham, UK) and the BASIL-3 team of triallists will address the pressing question of which endovascular strategy wins in the disputed femoropopliteal segment. The investigators will be presenting—for the very first time—the results of this long-awaited, only completed, fully publicly funded randomised controlled trial (RCT) in the space.

The BASIL-3 team will reveal clinical and cost-effectiveness data comparing three alternative femoropopliteal endovascular revascularisation strategies—plain balloon angioplasty with or without bail-out bare metal stent, drug-coated balloon with or without bail-out bare metal stent, and drug-eluting stent— for the management of severe limb ischaemia (chronic limb-threatening ischaemia [CLTI]).

“They’re actually very different technologies,” Bradbury points out to Vascular News ahead of CX 2024. “So, when we set up BASIL-3, we thought it was very important to have a three-arm trial so that we could compare these three different endovascular strategies. And, we’ve been able to do that; we’ve recruited to target, observed more than the required number of primary endpoints and that gives us at least 90% power. We have very complete, virtually 100%, follow-up data on the primary outcome, which is amputation-free survival. So, we think they’re good-quality data.”

“It’s a very controversial area,” Bradbury opines, making the BASIL-3 first-time data presentations an apt centrepiece for this year’s controversies-focused meeting.

“Although these drug devices have been in practice for probably 15 years now and certainly the last 10 years, it’s been a rocky road for them,” Bradbury explains, citing the paclitaxel mortality debate sparked by the 2018 meta-analysis from Katsanos et al as some important context to the trial. The publication directly affected the progress of BASIL-3, halting proceedings for many months.

“There were concerns around what appeared to be excess mortality across a wide range of industry-funded trials at two and five years, and it’s taken a long-time to resolve that,” Bradbury remarks, providing a brief summary of the six-year saga that a separate session at CX 2024 will address in detail. He references recent reversals of paclitaxel safety warnings by both the US Food and Drug Administration (FDA) and subsequently the UK Medicines and Healthcare products Regulatory Agency (MHRA) that have, “to a great extent”, put any concerns “in the rearview mirror”.

Some of the data being presented at CX 2024 will illuminate the cost effectiveness of the three strategies being compared. Bradbury underlines the “very complicated” nature of health economics and details what the investigators have looked for in BASIL-3. “There’s a close relationship between number of days spent in hospital an overall cost,” he says. “So, if you have a procedure that’s more expensive but reduces the length of the index admission and also subsequent readmissions—because a lot of these patients come back into hospital—that saving, in days in hospital and further interventions, could easily wipe out even quite a large excess of increased cost from the procedure, which in this case being three endovascular strategies would be the device costs.”

Bradbury also considers the global landscape of endovascular care. He underlines variation and unpredictability in endovascular practice across the world, highlighting a need for concrete data in the field.

“Sometimes what you hear at meetings is not really what happens day to day in various vascular centres,” Bradbury points out. The BEST-CLI study, for example, published in the New England Journal of Medicine in 2022, showed a benefit of vein bypass over endovascular in cohort one. “But if you look at the data,” he says, “only half of the patients who were put into the endovascular group actually received a drug device.” This, Bradbury points out, is much lower than might be expected for USA-based practice.

In BASIL-2, on the other hand, which was presented at CX 2023 and simultaneously published in The Lancet, around a third of the patients in the endovascular group had a drug device. “That’s higher than I expected,” he comments.

“It’s really interesting to look at what is custom and practice at the moment in different countries and I think it’s quite difficult to know what that it,” Bradbury highlights.

New data set to aid endovascular decision making

“We think you’ll find the data that we present on clinical effectiveness and also cost-effectiveness very interesting, whatever your views at the moment on the role of these drug devices in the management of CLTI,” Bradbury remarks of the forthcoming presentations. “We very much hope that these new Level 1 data will be of great interest to the Charing Cross audience and help people make decisions in their everyday practice.”

The BASIL-3 podium first is set to take place at 16:10 on Tuesday 23 April as part of the peripheral arterial controversies programme’s inaugural Roger M Greenhalgh late-breaking trials session.

FDA Breakthrough Device designation granted for DynamX BTK for use in CLTI treatment below the knee

By
Bryan Kay
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FDA Breakthrough Device designation granted for DynamX BTK for use in CLTI treatment below the knee
Elixir Medical’s DynamX

Elixir Medical has announced Breakthrough Device designation by the Food and Drug Administration (FDA) for its novel DynamX BTK System, an implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI).

The DynamX bioadaptor platform is a metallic device designed to support vessels during the healing phase, after which it unlocks and “uncages” them while providing dynamic support to restore function and maintain an open lumen, according to a company press release. The DynamX BTK System for the treatment of BTK vessels impacted by CLTI broadens the use of the technology beyond the treatment of coronary artery disease, the press release stated.

“The bioadaptor platform was developed to transform treatment of coronary and peripheral artery disease [PAD],” said Motasim Sirhan, Elixir Medical CEO. “We appreciate the FDA recognition of our innovation for treating the CLTI population with BTK disease and its potential impact on the patients suffering from vascular disease.”

The DynamX BTK System is not available for sale in the U.S.

Personalized, precision medicine is key to the future of aortic repair

By
Jocelyn Hudson
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0
Personalized, precision medicine is key to the future of aortic repair
Bijan Modarai

Predicting longevity in patients who may be candidates for aortic repair is challenging. This, coupled with a high and unchanging long-term postoperative mortality rate, begs the question: are patients living long enough to benefit from aortic repair?

Bijan Modarai (King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, London, UK) set out and addressed this conundrum at the 27th European Vascular Course (EVC; 3–5 March, Maastricht, The Netherlands). He argued that a lack of evidence for predicting longevity—a key factor in deciding whether a patient should undergo aortic aneurysm repair—necessitates a future move towards precision medicine and personalised treatment to avoid operating on patients unnecessarily.

“Our assessment of patients has got better, but we still get surprised,” was Modarai’s opening message, sharing with the EVC audience three cases to illustrate his point that predicting longevity remains challenging and uncertain.

Despite showing two examples of aortic patients living longer than anticipated, Modarai highlighted that the totality of the data shows the opposite trend—a high long-term mortality rate. “When you go out to three to five years, there is a significant mortality rate associated with patients who have had an aneurysm repair,” he said, highlighting a 30–50% all-cause mortality rate at five years. “It’s evident that fixing the aneurysm is only one part of what we need to do for our patients.”

Against this backdrop, Modarai then turned his attention to cardiovascular risk factors and malignant transformation, specifically aortic stiffness and aneurysm sac biology, and how both could be managed better.

Regarding aortic stiffness, Modarai outlined some research on the topic: “When you place a stiff stent into the aorta, you change its compliance immediately. That has ramifications for perfusion of organs, particularly for the heart, and there is quite good evidence to show that pulse wave velocity—an indication of increased aortic stiffness—is a cardiovascular risk marker.” He then showed data illustrating that patients with high pulse wave velocity have poor cardiovascular outcomes. “Is that having an impact on our patients after endovascular aneurysm repair?” he asked. While there are currently few data on the topic, Modarai believes this is a “rich area for research”.

The presenter also spoke on whether radiation influences malignant transformation, referring in this part of his talk to the late results of the EVAR trial. “When you get out to beyond eight years,” he said, “there is a signal for higher malignancy rate in the EVAR [endovascular aneurysm repair] group compared to the open group.” He also shared the outcomes of some exploratory work showing fourfold higher numbers of dicentric chromosomes in EVAR patients compared to those in a control group. “Dicentric chromosomes are a marker of genomic instability, caused by radiation damage, and may be a reason why there are more malignancies in this group, but there’s more we need to understand,” he said.

This led Modarai to make one of the key points of his talk. “The guidelines tell us you’ve got to predict longevity in patients when you decide which way to go, but I’m not sure there’s a lot of evidence or robust risk scoring to allow that,” he said.

With risk scoring not available, Modarai outlined how he and his team approach things now. “We’ve made our multidisciplinary meeting structure a lot more inclusive in the past five years,” he said, noting that it now includes a POPS (perioperative medicine for older people having surgery) team. He referred to two colleagues who run this service at Guy’s and St Thomas’ and have “transformed perioperative assessment and treatment of our patients”. He explained that they see just about all of the aortic patients at the hospital prior to surgery and report on what they think about frailty and other health factors. “They’re rolling out this service across the UK now with an NIHR [National Institute for Health and Care Research]-funded trial to find out what difference it makes,” Modarai informed the EVC audience.

Despite initiatives such as this, Modarai stressed that “we’ve still got a long way to go in predicting longevity”.

Moving in the right direction

“We need to have a precision approach to how we manage these patients,” Modarai emphasised. “There’s a lot of heterogeneity in the aortic group that we deal with and there is a lack of predictability. It’s all about developing these precision measures and personalised treatment of each patient using multimodal data.”

In terms of progress, Modarai believes “we’re starting to move in that direction”. He referenced a paper showing the use of advanced artificial intelligence (AI)-powered neural multi-task logistic regression techniques to perform patient-specific estimation of survival after elective aneurysm treatment. “These kinds of algorithms are more likely to capture complex, non-linear discrepancies between patients and I’m sure that in the next five years this is the direction that we’ll be moving in,” he said.

He also stressed the importance of AI in the future of precision medicine, opining that “we need to get on this wave early”.

“We’re still operating on too many patients with aortic aneurysms, I’m convinced of that,” Modarai said in his concluding remarks. “And when you put in a certain number of stent grafts and the enthusiasm plateaus, I think you’re more likely to admit that.”

Modarai also advised colleagues to “beware of endovascular heroics in patients who aren’t durable”.

The importance of multidisciplinary working was another of Modarai’s take-home messages. “I think medical collaboration and having an open mind about hearing from our medical colleagues is important,” he commented.

Sharing a forward-looking statement on what’s next for the treatment of aortic patients, Modarai opined: “I think a precision-medicine approach will be the future.”

Bentley, Cook Medical enter US distribution agreement for BeBack device

By
Bryan Kay
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0
Bentley, Cook Medical enter US distribution agreement for BeBack device
BeBack crossing catheter

Cook Medical and Bentley today announced a distribution agreement for the BeBack crossing catheter in the U.S., with Cook assuming commercial responsibilities for the Bentley product in the coming months.

The BeBack device is designed for steering through chronic total occlusions (CTO) and provides targeted re-entry options in the peripheral vasculature.

“Thanks to this collaboration with Cook, we will now have a better commercial footprint in the U.S. with even more opportunities to treat patients with debilitating arterial and venous disease,” said Martijn Nugteren, director of sales and marketing at Bentley.

SCVS 2024: Bismuth becomes 2024–25 Society for Clinical Vascular Surgery president

By
Bryan Kay
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0
SCVS 2024: Bismuth becomes 2024–25 Society for Clinical Vascular Surgery president
Dr. Jean Bismuth
Jean Bismuth

Jean Bismuth, MD, took over as Society for Clinical Vascular Surgery (SCVS) president during the organization’s 51st Annual Symposium in Scottsdale, Arizona (March 16–20).

The new University of South Florida chief of vascular surgery followed M. Ashraf Mansour, MD, academic chair in the Department of Surgery at Spectrum Health Medical Group in Grand Rapids, Michigan.

Vincent Rowe, MD, chief of vascular surgery at the University of California, Los Angeles (UCLA), is the new SCVS president elect. Peter Faries, MD, the chief of vascular surgery at Mount Sinai in New York, moves up to become vice president. Palma Shaw, MD, professor of surgery at Upstate Medical University in Syracuse, New York, is now SCVS recorder.

Meanwhile, Malachi Sheahan III, MD, is the program chair for the 52nd Annual Symposium, set to be held in Austin, Texas, from March 29–April 2 next year.

Hans-Henning Eckstein: 1955–2024

By
Jocelyn Hudson
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Hans-Henning Eckstein: 1955–2024
Hans-Henning Eckstein

Hans-Henning Eckstein, the vascular surgeon who played a leading role in the SPACE and SPACE 2 randomised controlled trials on the treatment of carotid stenosis and founder of the Munich Vascular Conference (MAC), died on 24 February at the age of 68. Colleagues have paid tribute to an “excellent doctor, outstanding researcher and university professor” as well as a “bridge-builder between vascular surgery and neurology”.

Eckstein had been chair and professor of the Department of Vascular and Endovascular Surgery at the University Hospital Rechts der Isar of the Technical University of Munich (Munich, Germany) and was widely recognised for advancing research and knowledge in the field of vascular surgery. He was awarded an honorary doctorate from the Medical Faculty of the University of Larissa (Larissa, Greece) in 2017 and, since 2019, had also been a visiting professor at the Medical School of Pittsburgh (Pittsburgh, USA) and Stanford University (Stanford, USA).

After studying medicine at Ruprecht-Karls University Heidelberg (Heidelberg, Germany), Eckstein completed his PhD in 1986 and two years later acquired his postdoctoral teaching qualification in Heidelberg.

From 1999 until 2003, Eckstein was medical director of the Clinic for Vascular Surgery at Ludwigsburg Hospital (Ludwigsburg, Germany). In 2004, he became director of the Department of Vascular Surgery at the University Hospital “Rechts der Isar” of the Technical University of Munich and five years later was appointed the first holder of the newly created chair for vascular and endovascular surgery at the university—a role he held until his retirement in 2023.

A statement on the Technical University of Munich’s website mourning the loss of Eckstein reflects on his impact at the institution: “Prof Eckstein made the clinic known far beyond the borders of Munich and developed it into a leading centre and attraction for patients with vascular diseases.”

Eckstein played a leading role in research including randomised controlled trials on symptomatic and asymptomatic carotid stenosis, which—a statement on the European Stroke Organisation (ESO) website reads—made him “well-known” in vascular neurology. He was co-chair of the steering committee of SPACE and SPACE 2, representing vascular surgery in both multicentre trials.

Furthermore, Eckstein was heavily involved in the creation of international guidelines in his field, including the German S3 guideline for the diagnosis, therapy, and follow-up care of patients with carotid stenosis and the ESO guideline for carotid stenosis.

Eckstein’s involvement in professional organisations included his 2009–2010 presidency of the German Society of Vascular Surgery and Vascular Medicine (DGG), and his editorship of the journal Gefässchirurgie (Vascular Surgery).

Eckstein was also involved in vascular education and founded the Munich Vascular Conference (MAC). The 12th iteration of this event took place in December 2023 and received international attention.

Several colleagues have paid tribute to Eckstein and highlighted his legacy in the fields of vascular surgery and neurology. “We are deeply saddened by the death of Prof Eckstein,” a statement on the Technical University of Munich’s website reads. “With Prof Eckstein we are losing an extremely committed colleague and excellent doctor, outstanding researcher and university professor.”

Eckstein is also remembered in a statement on the ESO website, with Werner Hacke, senior professor of neurology at Ruprecht-Karls University of Heidelberg, and Peter Ringleb, academic researcher at the University Hospital Heidelberg (Heidelberg, Germany) stating: “In Hans-Henning Eckstein we have lost an extremely dedicated colleague and excellent physician, an outstanding researcher, university lecturer, bridge-builder between vascular surgery and neurology, and a friend.”

First patient enrolled in IDE study of Aquedeon Medical’s Duett vascular graft system

By
Jocelyn Hudson
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0
First patient enrolled in IDE study of Aquedeon Medical’s Duett vascular graft system
Duett vascular graft system

Aquedeon Medical has announced the initiation of an investigational device exemption (IDE) clinical trial to study the Duett vascular graft system.

A press release reveals that, this February, the first enrolled patient underwent open surgical aortic arch reconstruction at the University of Pennsylvania Presbyterian Medical Center (Philadelphia, USA). During the surgery, the Duett vascular graft system was successfully deployed to connect the native left common carotid artery to the surgical graft.

Aortic arch surgical reconstruction involves removal of the diseased aortic segment and replacement with a synthetic (e.g. polyester) surgical aortic vascular graft. Typically, the three vessels, which provide blood flow to the brain and the left arm, are resected from the diseased aortic arch and reattached to the surgical aortic graft with a series of hand sewn, circumferential surgical anastomoses by suturing. A sutured surgical anastomosis can take upwards of 15 minutes per vessel to complete, while Aquedeon Medical claims that its Duett vascular graft system may enable surgeons to connect vessels in substantially less time.

“This procedure is done under hypothermic circulatory arrest (HCA), in which the body temperature of the patient is brought down from 37°C to 28°C with the heart stopped and the body supported with a cardiopulmonary bypass machine. During this period of HCA, the brain and the lower body are subjected to temporary periods of decrease blood flow, and therefore, the longer the patient is subjected to HCA, the greater the risk for neurological complications” said Wilson Szeto, chief of Cardiovascular Surgery at Penn Presbyterian Medical Center and professor of Surgery at the University of Pennsylvania, who is serving as the principal investigator for the clinical trial. He added: “I’m very excited about this technology. Suturing vessels by hand adds time to the procedure, as these vessels are often deep within the thoracic cavity and difficult to access. The Duett enables us to significantly reduce the surgical time associated with creating an anastomosis.”

“The patented Duett vascular graft system has been developed in collaboration with leading cardiothoracic surgeons and the device is aimed at helping to address the complexities and intricacies of thoracic aortic surgeries. Reducing anastomosis time is one major step in addressing this long and complex procedure,” said Tom Palermo, chief operations officer and general manager of Aquedeon Medical. “This is a significant milestone for our team, and we look forward to continued patient enrollment and use of the device at our other clinical sites.”

Florida IDE trial data support use of physician-modified F/BEVAR over open conversion to treat failed EVAR

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BIBA Publishing
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Florida IDE trial data support use of physician-modified F/BEVAR over open conversion to treat failed EVAR
Dean Arnaoutakis

This advertorial is sponsored by Tampa General Hospital. 

As Dean Arnaoutakis, MD, describes it, failed endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) because of poor proximal fixation of the implanted endograft is a small but increasing problem. So much so, he estimates that they likely account for about a third of his current practice at Tampa General Hospital (TGH). 

As things stand, there is a paucity of options available to vascular surgeons tackling this type of failed EVAR, known as a type Ia endoleak.

With the traditional rescue option for this largely elderly, co-morbid population—open conversion of the compromised endograft—often dire, Arnaoutakis and colleagues in the TGH Aortic Disease Program have emerged among the leading specialists in Florida and nationally in the push to offer alternative methods of fixing failed EVARs.

“The gold standard of EVAR explant is a maximally invasive operation and, unfortunately, most of the patients we see with a failed EVAR are in their 70s and 80s with a number of medical issues, and their ability to tolerate the procedure is rather limited in terms of their subsequent quality of life and independence afterwards,” says the TGH Aortic Disease Program medical director and associate professor of surgery at the University of South Florida (USF).

Physician-modified endograft

“With the advent of our physician-modified endograft [PMEG] program at our institution, under the auspices of our physician-sponsored investigational device exemption [IDE] trial, we have shifted our treatment approach for these patients such that, in the majority of them, if candidates anatomically, we are attempting to salvage their endografts with a PMEG to obtain more proximal seal.”

Recently presented data show the extent to which PMEGs, or physician-modified fenestrated or branched EVAR (F/BEVAR), have moved the needle at TGH.

Arnaoutakis and colleagues compared patients who underwent repair for a failed EVAR from 2015–2023 into two groups: those who received a PMEG IDE (35 patients) and those who had an open conversion (41).

What they found was illuminating. Average hospital length of stay among PMEG recipients was less than half that of open explant patients; similarly, 30-day mortality was 0% vs. 15% and postoperative complications 23% vs. 73% in favor of patients undergoing PMEG. The patients, drawn from a prospective database of consecutively treated aortic patients, were mostly male with an average age of 75 and typical comorbidities associated with the complex aortic patient population. The data were reported at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27), by Trung Nguyen, DO, a vascular surgery resident at the USF Health Morsani College of Medicine.

The TGH practice pattern curve shows that over the last 10 years, the number of EVAR explants the TGH team have completed has steadily declined, with the PMEG program taking over since its onset, notes Arnaoutakis. “The outcomes between the two are dramatically different in terms of perioperative and 30-day mortality, and major complication rates. It’s significantly better in the PMEG group than in the open explant group, which is obviously a good thing.” That said, Arnaoutakis concedes that open explant will always have a role as some patients have prohibitive anatomy or underlying aortic infection.

The complex pathology of the patient group presenting with failed EVARs with poor proximal seal means that very few medical centers in Florida are equipped with the expertise and infrastructure to provide the care they require, explains Arnaoutakis.

A similar story plays out for advanced care teams like that at TGH who, when confronted with the problem of patients increasingly presenting with such complexity, are faced with few Food and Drug Administration (FDA)-cleared options with which to treat them. The recent FDA-approved Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE) device might be one avenue, Arnaoutakis says. The Cook Medical Zenith Fenestrated+ (ZFEN+) endovascular graft, whose pivotal IDE trial recently began enrolling at U.S. study sites that include TGH, however, does not permit inclusion of patients with a prior EVAR in place—similar to the TAMBE device while it was still under clinical trial, he adds.

“We need better solutions from industry in the future to help us address what is going to be a growing problem of the type I endoleak across the paravisceral segment in people who have prior EVARs in place,” Arnaoutakis says. “There’s no trial in the pipeline that allows us to look at a device in this scenario.”

Which leaves the TGH PMEG IDE well placed to serve the Florida population in need of alternative options for complex aortic repair.

As Nguyen noted at the SAVS meeting in Scottsdale, TGH is among the tertiary medical centers leading the way. “Endovascular salvage of failed prior EVAR due to poor proximal seal using a PM-F/BEVAR is safe and effective,” he told those gathered. “A strategy utilizing a PMEG under the auspices of a physician-sponsored IDE clinical trial should be strongly considered as first-line therapy in patients with failed EVAR.”

Ruth Bush takes over as AVF president in Tampa

By
Bryan Kay
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Ruth Bush takes over as AVF president in Tampa

Ruth Bush, MD, associate dean in the Office of Educational Affairs at John Sealy School of Medicine, the University of Texas Medical Branch (UTMB), in Galveston, Texas, took over as American Venous Forum (AVF) president in Tampa, Florida, at the close of the society’s meeting (March 3–6), succeeding Glenn Jacobowitz, MD.

Purchase tickets for SVS Foundation Gala’s ‘Night at the Museum’

By
Bryan Kay
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Purchase tickets for SVS Foundation Gala’s ‘Night at the Museum’

Ticket information is available for the SVS Foundation’s “Night at the Museum—A Celebration of Science” Gala during the 2024 Vascular Annual Meeting (VAM 2024) on June 21. Ticket sales are expected to launch in coordination with VAM registration on March 20.

The Gala promises an unforgettable evening filled with elegance, entertainment and philanthropy at Chicago’s world-famous Museum of Science and Industry.

Attendees can choose from various ticket and table options, each offering an array of benefits. The options include: Gold table ($12,000) with $8,500 of the total tax-deductible; silver table ($8,500), $5,000 tax-deductible; bronze table ($6,500), $3,000 tax-deductible; and individual ticket sales ($600), $250 tax-deductible.

All tickets to the 2024 Gala will include complimentary round-trip transportation from the Marriott Marquis to the Museum of Science and Industry, featuring champagne and non-alcoholic beverages, admission to the Museum of Science and Industry, an open bar, a three-course dinner and snacks, live entertainment and more.

Gala organizers promise this year’s celebration to be a highlight that brings together leaders in the vascular surgery community for a noble cause. For more, visit vascular.org/Gala2024.

Gain discount on premier vascular review resources

By
Bryan Kay
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0
Gain discount on premier vascular review resources

The Society for Vascular Surgery (SVS) is encouraging members to pre-purchase the sixth edition of the Vascular Education and Self-Assessment Program (VESAP6), a premier digital resource for those preparing for qualifying, certification and recertification examinations. Presales will end on March 26. The presale period provides a 10% discount on the individual license price. Those who participate in the presale will be entered into a lottery to win a complimentary registration for the 2024 Vascular Annual Meeting (VAM 2024) exclusive. This opportunity is open only to SVS members, making membership a valuable investment for those in the field.

VESAP6 is designed to aid professionals in their examination preparation and ongoing education, with more than 600 questions covering more than 10 content areas, and serves as a comprehensive review resource. The product offers up to 102 continuing medical education (CME) credits, with 39.25 eligible for Registered Physician in Vascular Interpretation (re)certification credits. Visit vascular.org/VESAP6.

SVS seeks nominations for vice president

By
Bryan Kay
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0
SVS seeks nominations for vice president

The SVS has opened the nomination period for the position of SVS vice president, with the deadline set for March 15. Anyone can nominate/self-nominate for vice president, but only Active and Senior SVS members in good standing are eligible for the position. Following the deadline, the SVS Nominating Committee will review the nominations and select two-to-four candidates to run for office.

Previously, only two candidates were selected to run for open positions on the SVS Board of Directors. During the 2023 bylaws referendum, SVS members approved an increase in the number of candidates to between two and four, allowing members to have a broader choice when casting their votes for SVS leaders.

The Nominating Committee seeks qualified, eligible members from all aspects of gender, sexual orientation, age, ethnicity, geographic location and practice environment as nominees for the open position.

“The change to the number of potential candidates is exciting,” said SVS Nominating Committee Chair Ronald Dalman, MD. “Being the chair of this committee in a year of such monumental change is an honor, and I look forward to seeing which members will be nominated.”

Once the candidates are selected, eligible voting members can cast their votes through an online portal in June, with the results being announced at the SVS Annual Business Meeting on June 22 at the end of the 2024 Vascular Annual Meeting (VAM 2024) in Chicago.

Anyone looking to submit a nomination for themselves or another eligible candidate can visit vascular.org/2024VP.

SVS invites new compensation study participation, former participants to update information

By
Bryan Kay
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0
SVS invites new compensation study participation, former participants to update information

In 2023, the SVS collaborated with Phairify to launch a compensation study to provide vascular surgeons with tailored insights into compensation, practice and productivity data relevant to their specialty and practice in a bid to help them make informed career decisions. The SVS continues to encourage members to complete the survey and is now asking former participants to log back in to update their data for 2024. The compensation study is an SVS member benefit.

Any SVS member willing to participate can engage in a 15-minute survey to unlock enhanced power-searching capabilities with comparative functionality and an expanded career reach that allows access to a new range of opportunities.

At the end of 2023, 22% of SVS members had participated in the survey, which is two percent over the intended goal. Now all members who previously participated are encouraged to update their information to continue providing the most accurate data to those making career changes. “It is only necessary to update the information if anything has changed,” noted Keith Calligaro, MD, a senior author of the study.

To participate and/or update information, visit vascular.org/CompensationStudy2024.

 

Multi-society PAD Pulse Alliance aims to highlight importance of patient education

By
Marlén Gomez
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0
Multi-society PAD Pulse Alliance aims to highlight importance of patient education
Anahita Dua

Society for Vascular Surgery (SVS) experts are spearheading initiatives as part of the multispecialty PAD Pulse Alliance and its Get a Pulse on PAD public awareness campaign aimed at educating and raising awareness of the risk factors and potential symptoms of peripheral arterial disease (PAD) among Americans. As the campaign gathers steam, the SVS is focused on closing the health equity gap with the aim of equipping patients with essential tools for early detection and treatment.

The collaborative effort with the Association of Black Cardiologists, Society for Cardiovascular Angiography & Interventions (SCAI) and Society of Interventional Radiology (SIR) has already seen SVS members take a central role as the campaign rolls out.

“This particular disease process, even though it’s an epi­demic, is understudied, and the public does not have great awareness about the disease process and unfortunately tend to only find out about it when they’re in dire straits,” said Anahita Dua, MD, a vascular surgeon at Massachusetts General Hospital in Boston, one of the spokespeople for the alliance.

“PAD is unique in that it has multiple providers that are involved in caring for these patients. The whole point of the campaign is to show solidarity for our patients and to simul­taneously build public awareness about the disease process.”

The Get a Pulse on PAD campaign, launched Feb. 8, in­cludes a survey, media materials, a new website and a com­prehensive media strategy to promote disease awareness. Dua has completed dozens of media interviews across TV and radio, with the campaign yielding nearly 200 million impressions across various social media platforms.

Additional SVS members will assist with local market media opportunities in the coming weeks and months. The campaign is the first step in a broader branding campaign to be launched by the SVS in the next few months.

The alliance conducted three distinct surveys, covering the general, Black and Hispanic populations, aiming to gain a nuanced understanding of perceptions of PAD.

The surveys demonstrated that 70% of Americans are unaware of PAD and that there is a disconnect between perceived and actual risk, especially among Black and Hispanic populations.

William Shutze, MD, a vascular surgeon at Texas Vascular Associates and one of the initiative’s chairs, ex­pressed his initial astonishment at the survey results, em­phasizing the role of raising awareness as the primary step in addressing the severity of PAD.

To maximize the campaign’s impact, initial media efforts were strategically directed toward regions with higher ampu­tation rates. The campaign features not only digital content but also includes video and media interviews in Spanish, aiming to break down cultural and language barriers.

Dua explained how societies can utilize the information provided by the alliance to shape discussions with patients. “In this particular case, the doctors are unable to do their job for patients unless the patients themselves are aware of the disease process,” she said.

“Societies like the SVS that have a lot of power, reach and credibility can do things like this Get a Pulse on PAD aware­ness campaign where they join forces with other providers to put one message out there that says we care about you, our patients, and this is the way in which we want to provide you with the best care. There’s no point in having all these fancy tools in the hospital if the patient gets to you when it’s too late.”

A reassessment of the campaign is scheduled for October when the societies involved will collaborate to determine the next steps for­ward. Shutze emphasized the persistent nature of the problem, stating, “It’s not going to go away with one campaign. We’re going to have to roll up our sleeves and talk about how to sustain this momentum and keep it going.”

VRIC 2024 to hear from leading light on role of immunity and inflammation in atherosclerosis

By
Marlén Gomez
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0
VRIC 2024 to hear from leading light on role of immunity and inflammation in atherosclerosis

Filip Swirski, PhD, a leading figure in cardiovascular immunology research, will deliver this year’s Alexan­der W. Clowes Distinguished Lecture at the 2024 Vascular Research Initiatives Conference (VRIC).

Swirski, currently the director of the Car­diovascular Research Institute at the Icahn School of Medicine at Mount Sinai in New York City, has made groundbreaking discov­eries on the role of immunity and inflamma­tion in atherosclerosis.

His latest work, published in Nature, opens avenues for potential therapeutic interven­tions against Alzheimer’s disease, showcas­ing the interdisciplinary nature of modern vascular research.

VRIC organizers are gearing up for anoth­er round of surgeon-scientist-student com­munity engagement aimed at translating basic science more efficiently and effectively to positively impact vascular patients.

The Alexander W. Clowes Distinguished Lecture—named after the late Alexander Clowes, a luminary in vascular research—is a key part of VRIC. The lecture pays tribute to Clowes’ significant contributions and sym­bolizes the intersecting realms of surgery and science.

This year’s theme, “Immune and Struc­tural Cells in Cardiovascular Disease,” promises to unravel the complex interplay between immunity, inflammation and cardiovascular health.

“We have the most up-to-date research in this area focused on immune cells, structural cells and cardiovascular diseases,” said Kath­erine Gallagher, MD, chair of the Society for Vascular Surgery (SVS) Basic and Transla­tional Research Committee.

“We’ll be looking at multiple disease pro­cesses, including aneurysms, atherosclerosis, intimal hyperplasia, carotid disease and other themes that are relevant to surgeon-scien­tists and others in the cardiovascular arena.” “We were looking for an internationally known speaker who has transformed the field of cardiovascular therapy and is very cutting-edge at translating basic science into clinical applications,” said Gallagher. “Our speaker certainly fits the bill for all of that and has been published in the highest journals available.”

Scheduled to take place on May 15 at the Hilton Chicago, VRIC is held concurrent­ly with the American Heart Association’s Vascular Discovery: From Genes to Medi­cine Scientific Sessions, held May 15–18 in the same location. The event will provide attendees with an exploration of the latest developments in vascular research.

A translational panel will feature figures such as Kathryn J. Moore, PhD, the Jean and David Blechman professor of cardiology and director of the New York University Cardio­vascular Research Center, and Dianna M. Milewicz, MD, PhD, President George H. W. Bush chair of Cardiovascular Medicine, with insights anticipated to elevate the discourse and foster collaborative initiatives.

Gallagher emphasized VRIC’s intimate nature. “Because it is a smaller meeting and a closer-knit group, there’s a lot more collab­orations that take place and active discussion that can’t necessarily happen in some of the big meetings” she said.

“People that are there are very focused on this particular theme, making it a breeding ground for partnerships and relationships that extend beyond the conference.”

The early-bird rate for the conference is available until March 18. For more informa­tion, visit vascular.org/VRIC24.

New data underscore physician experience levels required to derive benefit from transfemoral carotid artery stenting

By
Bryan Kay
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0
New data underscore physician experience levels required to derive benefit from transfemoral carotid artery stenting

Data from a new study that maps out the levels at which ad­verse postoperative events decrease following transfemoral carotid artery stenting (TfCAS) based on depth of physician experience with the procedure represent an “absolute mini­mum threshold of learning,” the lead author says.

The analysis comes in the wake of the Centers for Medicare & Medicaid Services (CMS) decision to expand carotid stenting coverage, which loosened restrictions on the use of TfCAS.

Findings from an analysis of the Vascular Quality Initiative (VQI), due to be presented at the 2024 Society for Clinical Vascular Surgery (SCVS) annual meeting (March 16–20) in Scottsdale, Ari­zona, will show that the number of procedures a physician had to perform in order to get an in-hospital stroke and death rate below 4% in symptomatic patients was 235.

Similarly, to achieve a stroke and death rate below 2% in asymptomat­ic patients, the threshold physicians had to reach to derive benefit was 13 procedures. Rates were based on the fact the best available VQI registry data relate to in-hospital stroke and death, not the 30-day stroke and death thresholds of 6% and 3% for symptomatic and asymptomatic patients, respectively

Marc Schermerhorn, MD, chief of vascu­lar surgery at Beth Israel Deaconess Medical Center in Boston, the study’s senior author, raised concerns over how the coverage ex­pansion will interplay with data reporting and, ultimately, the tracking of stroke and death rates going forward.

“Now that CMS has done away with all the regulations and restrictions on who can do [TfCAS] proce­dures, where, etc., people may not submit data to VQI anymore, unfortunately,” he said.

“There have been a lot of other studies that have shown transfemoral stenting outcomes are not as good as TCAR [tran­scarotid artery revascularization] and carotid endarterectomy, but I think the concern now is, by opening up the doors for anybody to do carotid stenting, there could be a lot of people who have never done ca­rotid stenting before who now decide to get into the game.

“I think that the way things were before, when you had to be an approved center and you had to have credentialing committees that had to collect data, monitor that local data and submit it to Medicare, that prevent­ed a lot of people from doing the procedure. So it concentrated in the people who have the most experience.”

But the respective thresholds for symp­tomatic and asymptomatic cases repre­sent the basement of learning, continued Schermerhorn.

“You have to remember that transfemoral stenting has been around since the turn of the century—and even before that,” he said. “The VQI didn’t start collecting data on ca­rotid stenting until 2005, and that was only in New England. It wasn’t until 2011 that we started to collect national data. So, most people who were in the carotid stent registries in the VQI had experience before they started submitting data, so we actually don’t think this is a full represen­tation of the learning curve.

“We know almost certainly most people had been doing cas­es prior to entry of data into the VQI, so this is an absolute mini­mum threshold of learning curve, and the true learning curve is likely larger. I don’t know how much, but it’s higher numbers.”

Schermerhorn said that with the possi­bility of “a lot more novices” performing TfCAS in the wake of CMS coverage expan­sion, his team’s latest study clearly demon­strates “results are highly dependent on ex­perience.” Even supposing a lot of TfCAS experience, he added, “the results don’t seem to be as good as with either TCAR or endarterectomy.”

Despite the potential for TfCAS entries into the VQI registry to decrease, Scher­merhorn expects monitoring to continue, including via administrative databases, albeit with a lower level of clinical detail available, but expressed hope enough interest would persist in submitting data to the VQI.

“That’s my other concern,” he said, “The people who are interested in submitting data are probably the ones who are more com­mitted to quality improvement and striving toward knowing what their outcomes are— and improving them.”

That raises another dimension of the study set to be presented at SCVS 2024, not­ed Schermerhorn: the research team also looked at whether those who had bad out­comes when they first started doing proce­dures were less likely to continue perform­ing TfCAS. They found that this was indeed the case.

“The people who went on to do more than 25 procedures had better outcomes than the people who quit at up to 25 and then didn’t do anymore,” he said.

“We presume that there is some feedback to people and that, if they’re finding that their own results are not that good, then they don’t continue to do the procedure. If people don’t track their outcomes somewhere, then they may not know.

“That’s the problem. When you have a procedure with a low adverse outcome event rate, it’s hard for people to gain personal perspective.”

US FDA Breakthrough Device designation granted for Biotronik’s Freesolve BTK resorbable magnesium scaffold

By
Jocelyn Hudson
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US FDA Breakthrough Device designation granted for Biotronik’s Freesolve BTK resorbable magnesium scaffold
Freesolve

Biotronik has been granted Breakthrough Device designation (BDD) from the US Food and Drug Administration (FDA) for the Freesolve below-the-knee (BTK) resorbable magnesium scaffold (RMS).

The Freesolve BTK RMS is designed for individuals suffering from chronic limb-threatening ischaemia (CLTI).

To qualify for a Breakthrough Device designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the programme is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment and review while maintaining regulatory standards for pre-market approval.

A press release notes that the newly CE-launched Freesolve RMS for coronary artery lesions, based on the Biomag magnesium alloy and the proven Orsiro drug-eluting stent (DES) coating technology, provides safety, improved deliverability, and optimal performance and vessel support during and after implantation. It has shown 99.6% degradation of magnesium observed 12 months after implantation in coronary arteries, the release details.

These characteristics of the Freesolve RMS may be of particular value in BTK interventions, where vessel scaffolding is desired in the short-term to resist vessel recoil, yet ultimately leave the vessel implant-free.

“Biotronik’s focus on vascular interventional excellence is evident in our strategic investments and persistent dedication to innovation”, said Jörg Pochert, president of Vascular Intervention at Biotronik. “Our efforts to expand therapeutic possibilities, underlined by the introduction of the Freesolve RMS for coronary artery disease treatment, will continue in the BTK indication with this groundbreaking innovation.”

“This Breakthrough Device designation for the Freesolve RMS for BTK treatment is a significant milestone in advancing treatment options. Biotronik is committed to design our products to enhance the lives of patients,” stated Ryan Walters, US president at Biotronik. “Our next generation RMS represents a leap forward over existing resorbable technology, incorporating technical innovations intended to address physicians’ needs and optimise outcomes for patients suffering from CLTI.”

Vascular external support system use found to boost key functional outcomes for surgical arteriovenous fistula creation

By
Urmila Kerslake
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0
Vascular external support system use found to boost key functional outcomes for surgical arteriovenous fistula creation
Alik Farber
Alik Farber

Alik Farber, MD, professor of surgery and radiology at Boston University, is set to present the results of a multicenter U.S. study at the 2024 Society for Clinical Vascular Surgery (SCVS) annual meeting (March 16–20) in Scottsdale, Arizona, that will show creating arteriovenous fistulas with a vascular external support system, VasQ, decreases the median time to achieve two-needle cannulation by reducing the need to perform maturation procedures.

The study set out to assess the functional outcomes of fistulas created with an external vascular support device as compared with rigorously matched controls of unsupported fistulas for end-stage kidney disease (ESKD) patients by the same surgeons.

Farber focuses on the unreliable trajectory of unsupported fistula functional success that surgeons grapple with: “Arteriovenous fistulas (AVF), when they work, are much more durable and much better for patients [than central venous catheters or arteriovenous grafts],” he said. “But to work, they require maturation, which means that the vein that is plugged into the artery needs to grow in diameter and thickness. We are asking the body to do this, but the problem is, this doesn’t work all the time. Sometimes the vein may grow in diameter but not in thickness, or it may not grow in diameter and simply grow in thickness. So, the corollary to that is many surgically created fistulas do not mature; some fistulas require procedures to help with maturation, and these may or may not be successful.

“In the ideal world, the best thing for the ESKD patient is the creation of a fistula that, after a certain period of time, say six weeks, is usable 100% of the time without any other interventions. That’s the predictable ideal, but doesn’t happen very often. So, anything that improves outcomes to get us closer to that ideal is going to be a very good thing for our patients,” he added bluntly.

One approach to overcoming this quandary is the concept of external support during surgical fistula creation. The VasQ device is a nitinol-based permanent vascular reinforcement implanted around the artery-vein connection. The device is designed to reduce both hemodynamic and mechanical stress to create more functional fistulas. The device, implanted during the surgical creation of either upper arm or forearm fistulas, guides the remodelling in the juxta-anastomotic region to promote outward wall thickening by maintaining the optimal angle, reducing wall tension and facilitating a more stable, laminar flow profile.

“It appears that externally supporting the fistula and making the fistula take an improved angle has promise in increasing functional patency and decreasing the number of interventions to get to maturation,” Farber told Vascular Specialist.

Six U.S. sites that participated in the VasQ U.S. pivotal study and enrolled more than six patients were eligible to participate in a retrospective chart review of unsupported AVFs to compare them to fistulas that had VasQ support. The cohort for this analysis included 104 ESKD patients with 52 in the unsupported group and 52 in the VasQ group. Both groups were well-matched with no significant differences in baseline parameters, including vessel diameter. The researchers evaluated the functional outcomes of time and intervention rate prior to first use, as well as functional success, which was defined as the proportion of fistulas used for hemodialysis at three and six months after AVF creation.

Farber is expected to present the results showing a nearly 30-day reduction in median time to first use driven by a significantly lower need for maturation procedures in the VasQ group as compared to the unsupported cohort. Additionally, significantly more fistulas in the VasQ cohort achieved functional success by the three-month timepoint. The VasQ cohort also showed a trend toward higher functional success rate at six months, but that finding did not reach statistical significance.

“We’re going to present that the immediate days to first use is typically shorter with VasQ fistulas. The ratio of interventions to first use is also significantly less in the VasQ-supported fistulas and the functional success is higher in this group,” commented Farber, adding that the device is relatively easy to place and doesn’t add significant time to the procedure.

Commenting on the results, he said: “The study offers encouraging evidence for the efficacy of an external vascular support of fistulas, especially in lowering intervention rates and shortening the time to achieving functional success.

“I think it’s exciting that there is new clinical science in this space. There’s a huge opportunity that we have with these patients because the maturation rates are currently 50 to 60%, at best. And that’s a pretty small number. So, there’s a considerable need to improve the maturation rates and I applaud Laminate Medical and other companies that are trying to develop ways to address this issue.”

VAM abstract submissions hit near-historic high

By
Kristin Spencer
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0
VAM abstract submissions hit near-historic high
Andres Schanzer
VAM 2024 takes place in Chicago in June

A nearly record-breaking 794 Abstracts were submitted for the SVS 2024 Vascular Annual Meeting (VAM 2024). The abstracts were scored by the VAM Program Committee in early February 2024 and notice letters were sent out later that month. VAM 2024 is taking place June 19–22 in Chicago.

Several types of abstracts can be submitted each year for VAM, such as plenary, “How I Do It,” the Vascular and Endovascular Surgery Society (VESS) session, International Forum and posters. The abstracts are submitted topic areas like aortic, practice management, wound care and more. Once the submission period closes, the Program Committee breaks into small groups when the abstracts are blindly reviewed, given a score and then presented to the full Program Committee. Of the 756 submitted abstracts, 407 were accepted and added to the meeting’s program, which is consistent with the levels in previous years.

Andres Schanzer

“I’m really excited about the diversity of content. This year proved to be one of the most difficult when it came to abstract scoring,” said VAM Program Committee Chair Andres Schanzer, MD. “Every submission was great, but we can’t choose them all. I’m confident that the meeting will have pieces of content that will resonate with vascular surgeons at all career levels.”

VAM 2024 will be the third and final year of Schanzer’s tenure as the chair of the VAM Program Committee. The full VAM 2024 program will be available later this month. To learn more, visit vascular.org/VAM.

Registration will launch March 20 with an early-bird rate that will be in place through April 10, after which prices will increase to the advance registration rate, which will last through June 17. An increased, on-site registration fee will be available to anyone who cannot register for VAM 2024 in advance.

In addition to the early-bird registration discounted prices, SVS members will see an additional discount on their rates when compared to those of non-members. Any non-member wanting to take advantage of the member discount can apply for SVS membership by May 1 to receive the refunded difference, pending application approval.

Medical students advocate for women’s vascular health

By
Marlén Gomez
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0
Medical students advocate for women’s vascular health
Nishita Vootukuru, Shannon McDonnell, Kundanika Lakkadi
Nishita Vootukuru, Shannon McDonnell, Kundanika Lakkadi

In celebration of Women’s History Month, the Society for Vascular Surgery (SVS) Foundation’s “Voices of Vascular” series is underscoring women’s contributions to the specialty. The SVS Foundation initiative champions female accomplishments, emphasizing the pivotal role they play in helping shape vascular surgery, enhancing patient care and contributing to a healthier world.

Three medical students, Nishita Vootukuru, Shannon McDonnell and Kundanika Lakkadi, have shared their insights on why it is imperative to fund the future of medicine, particularly in the context of women’s health.

Vootukuru, a second-year medical student at Rutgers New Jersey Medical School, emphasizes the urgent need to address women’s unique challenges in receiving diagnoses and treatments for vascular disease.

“As a student in the vascular community, the imperative nature of addressing the unique challenges women face in receiving diagnoses and treatments for vascular disease is evident. Through initiatives like Voices of Vascular, we can work towards supporting research tailored to women’s health needs, ultimately improving outcomes for all,” said Vootukuru.

Throughout the month, the SVS Foundation and the SVS Women’s Section Steering Committee will honor SVS members for their life-saving care and pioneering research in the fight against vascular disease. The Society shared a video from members on its social media channels explaining the importance of giving for Women’s History Month.

McDonnell, currently in her fourth year of medical school at Loyola University in Chicago, credits the mentorship she received from female vascular surgeons as a driving force behind her decision to pursue vascular surgery. She highlights these mentors’ multifaceted roles, serving as researchers, leaders in their field and mothers.

McDonnell emphasizes the importance of representation, stating, “Envisioning myself in similar roles not only served as an enormous inspiration but also underscored the importance of representation as a minority in such an important and ever-growing specialty.

“As the field of vascular surgery continues to evolve, sponsoring women’s research will allow our many female surgeons to improve patient outcomes and recruit more diverse perspectives to the specialty.”

Lakkadi, a fourth-year medical student at the University of Queensland-Ochsner Clinical School, emphasizes the broader significance of supporting vascular research.

Lakkadi believes that funding research contributes to raising public awareness about the critical importance of vascular health.

“I believe it is important to support and fund vascular research to raise public awareness about the critical significance of vascular health. Initiatives like the Voices of Vascular campaign play a vital role in spotlighting the diversity within our field, fostering its growth, innovation and improved health outcomes,” said Lakkadi.

The SVS Foundation extends its support through grant assistance and scholarships that pave the way for opportunities for aspiring female vascular surgeons for years to come. Boston Scientific, the presenting sponsor for the initiative, will give a $25,000 match, doubling every donation made through March 31.

The SVS Foundation calls upon individuals to join in uplifting and celebrating women in vascular medicine by offering their support. Visit vascular.org/Voices to learn more.

I’m just a bill: An overview of health-related committees on Capitol Hill

By
Kelli L. Summers
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I’m just a bill: An overview of health-related committees on Capitol Hill

In the U.S., the legislative process is complex. Among the most important in this process are congressional committees, which play a pivotal role in shaping policy concepts, drafting legislative proposals and shepherding them through the path to becoming law. These committees are specialized groups of members with expertise in relevant policy areas. There are key committees known as our “Committees of Jurisdiction,” where legislation relevant to vascular surgery is channeled.

When a bill is introduced in the House of Representatives or the Senate, it typically undergoes a series of committee hearings and markups. Committee members gather valuable information through hearings. During “markups,” committee members critically review and refine the proposed legislation, incorporate amendments and deliberate the proposed legislation. Following these deliberations, the committee votes on whether to advance the bill to the full chamber for consideration. This process allows for thorough examination and refinement of legislation before reaching the broader legislative body.

The Senate Finance Committee, responsible for matters pertaining to taxation and revenue measures, wields extensive jurisdiction within the Senate. These large and powerful committees are broken down into subcommittees, where legislation is analyzed by subject matter. The Subcommittee on Healthcare has jurisdiction over anything related to healthcare finances, meaning it can have joint or sole jurisdiction over the activities of various agencies and offices. This includes the Department of Health and Human Services (HHS), which oversees the Centers for Medicare & Medicaid Services (CMS). This overarching influence makes this committee powerful regarding any legislation that touches federal revenue streams. Another example is the Senate Appropriations Committee, where subcommittees are tasked with drafting legislation to allocate funds.

Outside of the budgeting process, there are subject matter committees, such as the Committee on Health, Education, Labor, and Pensions, simply known as HELP. The HELP Committee’s jurisdiction includes most federal labor and employment laws, including those that regulate wages and hours of employment. For vascular surgeons, the HELP Committee holds significant importance due to its jurisdiction over legislation related to healthcare policies and regulations. The committee’s decisions on healthcare reform, medical device regulations, workforce training, and research funding profoundly influence the practice environment, reimbursement structures, and access to innovative treatments. The actions and policies shaped by the Senate HELP Committee have a direct bearing on advancing vascular surgery services and patient care outcomes.

The House of Representatives has a complementary structure, with its own Committee on Appropriations with a Subcommittee on Labor, Health and Human Services, Education and Related Agencies. The House of Representatives and Senate committees individually create budgets and then come to an agreement by the end of each fiscal year to prevent a government shutdown.

In terms of subject matter, two of the most influential committees on health policy in the House are the Committee on Ways and Means and the Committee on Energy and Commerce, both of which have health subcommittees. The Ways and Means Committee primarily deals with taxation, social welfare programs and trade, whereas the Energy and Commerce Committee addresses energy, healthcare, telecommunications and consumer protection issues. These committees differ from appropriations as they work with the content of the proposed legislation, compared to the Appropriations Committee, which focuses on simply allocating federal funds.

The committees of jurisdiction in both chambers of Congress serve as crucial gatekeepers in the legislative process, overseeing specific policy areas and shaping the trajectory of proposed bills. Their role is pivotal in ensuring that proposed laws undergo rigorous scrutiny and reflect a comprehensive understanding of the issues. By serving as conduits for legislative action, these committees contribute to the effectiveness and integrity of the legislative process, fostering informed decision-making and accountability within Congress.

Kelli L. Summers, MD, is a graduate of the SVS’ Advocacy Leadership Program.

Grit: The value of growth mindset and persistence as a vascular trainee

By
Kevin Mangum
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Grit: The value of growth mindset and persistence as a vascular trainee
Kevin Mangum, MD
Kevin Mangum, MD

One of the biggest mental shifts I had to make during residency was my view on failure. I literally had to rebrand failure. As a medical student, and like many of my peers, I had been conditioned to automatically feel shame if I didn’t know an answer. Even as an intern, I held the view that if I didn’t know an answer on rounds, in the operating room, or if I made a mistake during my 24-hour call shift overnight, that I was a terrible resident. Fortunately, this view was gradually debunked through perspectives and experiences that highlighted the necessity, importance and inescapable reality of failure.

Often, our views of failure are self-defined, meaning that when we “fail,” it’s because we haven’t met our own standards and expectations for how we think we should have performed. Such a fixed perception of oneself as a “good” or “bad” resident, with zero gray area in between, impedes that of a growth mindset, in which the central driver is “how can I be better than I was before, even in the smallest way possible?” This concept of a growth mindset is not novel. Referred to in the business field as “continuous improvement” or “incremental theory,” growth mindset has been considered a beacon not just at the individual level but has been applied to improvement within large corporations as well. A Harvard Business Review article distinguishes those who are motivated, arguably even obsessed with learning and growing after failure, in contrast to individuals who are paralyzed and shut down after failure.

So can a growth mindset be taught? In particular, can those who respond negatively to failure be taught how to thrive and perhaps even learn to enjoy failure? The education arena is one of the best and most studied examples of this. In fact, a 2019 national study of learning mindsets published in Nature was the largest intervention-based study on the effect of mindset on achievement and found that teaching growth mindset skills could improve grades among lower-achieving students and increase enrollment in advanced mathematics classes.

But can growth mindset be applied to surgical training, especially in vascular surgery? Vascular surgery is a fluid and growing specialty. In a field of rapidly evolving technology and newly published trials that influence how we practice, it’s fundamental to grow with the specialty. As a vascular trainee, one of the aspects I love most is the need to adapt while staying grounded in fundamental skills. With all of this said, however, I acknowledge that mastering the abundance of skillsets in the field amid an ever-growing body of knowledge is intimidating.

So I go back to my initial question: how can growth mindset be incorporated into vascular surgery, to fully embrace all of these developments in which “failure” to some degree is inevitable? As trainees, we have to start seeing the opportunities for growth in every aspect of our training and patient care. For example, during an operative case, we must be goal-directed and hold ourselves accountable for identifying how we can improve, especially seeking out targeted, specific feedback. Effective strategies can include asking attendings for three areas of improvement at the conclusion of a case, or even going into a case knowing precisely what skills you want to develop. How we receive the feedback is equally as important as getting it; we can’t take it personally, which can be challenging, since so much of our identities as surgeons in training is wrapped up in our performance. We can also detach from our performative view of ourselves, instead leaning into our identity as continuous learners.

With our own recognition of and connection to our identity as seekers of continuous improvement, we can become more resilient and persistent in the face of challenge, since we no longer count ourselves out of the game if we don’t meet our own expectations. In this manner, we can give ourselves some grace, such that in the face of real challenge, we can persevere and insist of ourselves that we keep going—that we keep growing.

So perhaps we can reframe training as a bridge to continuous improvement of our patients and ourselves as practitioners, realizing that the specialty we’ve chosen is naturally and excitingly one that is constantly growing. We have the privilege to grow with it.

Kevin Mangum, MD, is a PGY5 vascular surgery resident in his second research year at the University of Michigan.

The devil we don’t know: The case against private equity in medicine

By
Malachi Sheahan III
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The devil we don’t know: The case against private equity in medicine
Malachi Sheahan III

My household had a longstanding Christmas tradition. In the months leading up to the big day, my wife would craft a gift budget for our three sons. She would then blow said budget on mirth-busters like socks, books and, heaven forbid, educational toys.

Around Dec. 20, I’d look through this impending wreckage of our children’s hopes and dreams and offer up a passive-aggressive comment like, “I never would have thought to buy the New York Times crossword puzzle desk calendar for a four-year- old.” Her standard reply isn’t really printable here, but let’s just say I knew what to do. I understood the secret about boys that eluded my wife. They don’t really want specific things. They just want things. So every year I take what’s left of the budget and it’s go time. Shock and awe.

Pulling up to the Toys R Us on Christmas Eve, I looked much like the other deadbeat dads. But I was different. I had a PLAN. Grabbing two shopping carts, as I strolled down the center aisle my demeanor announced: “Make way fools, amateur hour is OVER. We may all be slackers and procrastinators here, but I am your king.”

There are three general categories of toys that my sons love. Things with teeth, things with wheels, and things that can be used to (hopefully just) simulate maiming your brothers. With Terminator-like efficiency, I quickly process the aisle labels. Jurassic Park Playsets (things with teeth), Matchbox/Monster Trucks (things with wheels), Nerf Missile Launchers (things that maim), Barbie/Disney Princesses (abandon all hope ye who enter here).

Passing this last aisle, I avoid eye contact with all of its desperate residents. Dads (it’s always dads) who clearly have not spent enough time with their daughters and are now trying to make up for it with a grand gesture. They are the Last and the Furious. It’s almost midnight Chad. Which My Little Pony does Sophie have her heart set on? Rainbow Sparkle or Pinkie Pie? Tick tock.

My secret power was that I actually knew my kids. This may not seem like much but compared to my fellow consumers in this rural Louisiana Toys R Us at 10:33 p.m. on Christmas Eve, I was Father of the Frickin’ Year.

Our time-honored tradition ended in 2017 with the bankruptcy of Toys R Us. What killed this profitable national chain? Private equity.

And now, as they say, the barbarians are at our gates. Are we ready? First, let’s review private equity FAQ style. Don’t worry, my financial education capped at ECON 101. There will be no mention of Adam Smith or The Wealth of Nations.

What is private equity?

Private equity (PE) is best thought of as a financial strategy. The basic goal is to achieve higher returns than are generally possible in the public market. Therefore, PE investments are made in companies or entities that are not publicly traded. If the company is public, the PE firm takes it private after the acquisition.

Why does PE take their companies private?

In response to the rampant corporate fraud that led to the stock market collapse of 1929, Congress passed the Securities Act of 1933 and the Securities Exchange Act of 1934. These laws forced corporations seeking money from the public to disclose a wide array of financial and legal information. All of this information would be regularly reviewed by the Securities and Exchange Commission (SEC). Private companies were limited to only 100 investors. However, following a wave of deregulation in the 1980s, the National Securities Markets Improvement Act of 1996 allowed private funds to raise unlimited money from an unlimited number of investors. Following this Act, the number of private companies skyrocketed as they faced significantly less regulation than public firms.

Why is the strategy so successful?

PE investments usually have a time horizon of four to seven years to yield favorable returns. General strategies revolve around cost-cutting: pay cuts, store closings and layoffs. In addition to Toys R Us, Sports Illustrated, Nabisco, Twitter and even Taylor Swift were all significantly affected by PE investments. However, not all PE interactions have negative outcomes. Dollar General and Michaels survived their buyouts as healthy companies. Under ideal circumstances, PE firms can offer the expertise to turn around poorly performing businesses by eliminating operational inefficiencies and increasing profits.

How does a PE firm finance its acquisitions?

Most of the money is borrowed, and this debt is immediately transferred to the acquired company. In the case of Toys R Us, the PE firm transferred billions of debt to the corporation. This is referred to as a leveraged buyout. So, at a time when Toys R Us should have been overhauling its infrastructure and strategies to compete with the growing online market, it had to use its revenue to pay off this massive debt. Despite remaining profitable, Toys R Us ultimately had to declare bankruptcy.

What else can PE firms do to ensure profit even if the acquired business eventually fails?

Since the PE firm now owns the acquired business, it can do a lot to harvest cash. A common tactic is the sale- leaseback. In this case, the PE firm will instruct the company to sell assets to pay off the debt it has now incurred from the leveraged buyout. Often, a company’s most valuable asset is its real estate. In a sale-leaseback, the PE firm directs the company to sell its land to the firm, and then the firm will lease it back to the company. PE firms can also charge the acquired corporation exorbitant “management” fees. Since the firm owns the business, it doesn’t need to do anything to earn these fees.

One instructive example is the purchase of the nursing home chain HCR ManorCare by a PE firm, the Carlyle Group, in 2007. As detailed in the New York Times, Carlyle paid just over $6 billion, most of which was borrowed. It then saddled ManorCare with the debt and recovered its investment by selling ManorCare’s real estate. ManorCare then had to pay rent for the buildings it once owned. Carlyle also charged ManorCare $80 million in transaction and advisory fees. ManorCare began cost-cutting programs and layoffs, resulting in health code violations. Eleven years after the purchase, ManorCare filed for bankruptcy with over $7 billion in debt. Carlyle, however, made millions over its initial investment. Carlyle executives even give talks at industry conferences about structuring investment portfolios to include nursing homes.

What would it look like if you planned a PE takeover of your household?

I’m glad you asked this oddly specific and leading question. I imagine the conversation with my wife would go as follows, “Look, you’re a good earner, but under investments and assets you wrote one word, ‘shoes.’ The nanny seems pretty frugal. I’m making Luisa the CFO. The two older kids are sunk costs at this point. But the youngest’s grammar school is crazy expensive. Also, he says he wants to be an artist. That’s a long road to a return on our investment. We are going to have to lay off Luke. And the dog.”

What makes healthcare attractive to PE firms?

The healthcare industry is often seen as recession proof. The U.S. spends about $4.5 trillion on healthcare, almost 20% of its gross domestic product, the highest among developed countries. PE firms see this spending as a spigot, unlikely to be turned down.

Over the past decade, almost $1 trillion has been spent by PE in acquiring medical practices. And now that we know the PE playbook, the results are predictable. The goal of purchasing physician practices is the same as for buying companies. Turn a 20–30% profit on investment in four to seven years.

PE acquisitions of physician practices rose from 75 in 2012 to 484 in 2021. In more than one fourth of metropolitan areas, a PE firm has at least a 30% market share in a medical specialty. Studies have shown that prices rise when PE firms achieve this 30% threshold. Nationally, 25–40% of emergency rooms are staffed by PE firms.

A JAMA Internal Medicine study by La Forgia and colleagues showed that prices charged by PE-backed anesthesia groups rose 26% from 2012–2017. The financial burden is passed on to patients through higher out- of-pocket fees and rising premiums. The No Surprises Act was a response to unsavory PE billing policies. It is unlikely that physicians see much of the increased revenue, as PE’s goal is to increase profits for its investors. In fact, many PE-owned anesthesia practices replace physicians with nurse anesthetists to save money.

In dermatology practices, physicians have been told to generate profits by increasing elective procedures, ancillary services, and charges. This profit-driven model also threatens health equity. Reimbursements can be maximized by prioritizing commercially insured patients in higher-income communities. Quicker, lower-complexity procedures are also emphasized over delivering complex care.

Scale of PE role in medicine

The true influence of PE in medicine is difficult to measure as their firms have few ownership disclosure requirements. Also, the physicians are routinely required to sign non-disclosure agreements. Even for doctors getting acquired, it can be impossible to tell who is truly buying their practice. This lack of transparency makes monitoring the actual effects of PE on healthcare nearly impossible. Still, what we do know is damning. In deference to my poorly enforced word count and readers’ attention span, I will not detail all of PE’s plundering and blundering exploits in medicine. But for those not convinced, simply search Envision Healthcare, US Anesthesia Partners, Kool Smiles, or Prospect Medical Holdings.

I believe PE acquisitions are just a symptom of healthcare’s overall problems. Physicians are selling their practices because it is too hard to remain financially solvent on their own. Paperwork, legal requirements, electronic health records and insurance practices have all placed incredible strain on private practitioners. The majority of physicians enter practice with extraordinary educational debt. Hospital system consolidations make it difficult for smaller practices to compete. Many physicians reject the notion of hospital employment but have few options. PE employment offers a potentially lucrative alternative.

The specter of non-compete clauses and loopholes

In addition to raising prices, PE firms strive to generate more income from physician practices by purchasing lower-cost supplies, substituting lower-paid staff such as medical assistants for nurses, having physicians see more patients, and seeking a better payor mix. The firms also lock the physicians into the practice through non-compete clauses.

The American Academy of Emergency Physicians notes: “The goal of non-compete clauses is to intimidate the emergency physician into unquestioning servitude to business interests. Given physicians’ ethical obligation to patients, many continue to speak out for patient safety; however, knowing that they can be fired at will and then forced to relocate their family to another city or state can have a chilling effect on physicians’ advocacy for patients.”

The legal ability of PE firms and their medical management companies to control medical decision- making and clinical care is determined at the state level and varies enormously. Nearly 20 states have no rule prohibiting medical management companies from manipulating clinical practice and medical judgment. Even where regulations exist, PE firms can find loopholes, such as naming the physicians as practice owners while having a parent company control the actual finances.

In the world of corporate medicine, these are known as “friendly” or “straw” doctors. Often, they will have their name attached to hundreds of practices. Amazon’s One Medical primary care subsidiary and UnitedHealth-owned Optum Health have been accused of this practice. Oregon is currently debating a bill to outlaw this “corporate practice of medicine.” Both Amazon and UnitedHealth Group have retained lobbyists to oppose it.

PE firms also protect themselves politically. Their employees include former cabinet members, secretaries of state, chairmen of the SEC, chairmen of the Federal Trade Commission. speakers of the House, a CIA director, a vice president, and various senators.

Still, much can be done to combat PE’s influence on medicine. Financial and bureaucratic burdens on practicing physicians must be eased. Indiana, for example, recently passed a tax credit for independent physicians. Other possible financial improvements include Centers for Medicare & Medicaid Services (CMS) payment reforms, reconsidering fee-for-service, and capitated payments for quality care.

Uniting with other specialties to support complete ban

The most direct and achievable method for curbing the undesired aspects of PE influence on physician practices may be to enforce the FTC’s proposed ban on non-compete clauses. If PE firms could not prevent physicians from walking away, it would force them to change their approach to management. Instead of rampant cost-cutting and forcing physicians to do more with less, this could incentivize PE to retain doctors by improving salaries and working conditions.

Even if enacted, the FTC’s proposed non-compete ban will likely face many challenges in court. Most conservative judges, including some on the Supreme Court, have signaled that they don’t favor federal agencies asserting new regulatory authority based on old statutes.

Vascular surgeons should join with other specialties that have already been pillaged by PE to support a complete ban on non-compete clauses for doctors. Only by uniting our physician advocacy efforts do we stand a chance against the private equity-backed lobbyists.

Malachi Sheahan III, MD, is the chief medical editor of Vascular Specialist. His opinions do not reflect SVS policy or positions. 

Longer fasting before venography appears to impact stent size selection, new study finds

By
Brian McHugh
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Longer fasting before venography appears to impact stent size selection, new study finds
Kurt S. Schultz
Kurt S. Schultz

During the 2024 American Venous Forum (AVF) annual meeting in Tampa, Florida (March 3–6), Kurt S. Schultz, MD, a general surgery resident at the Yale University School of Medicine in New Haven, Connecticut, presented data from a study exploring how fasting duration prior to venography is associated with stent sizing in patients with iliac vein compression, finding that a longer fasting duration was associated with a smaller iliac vein stent size. 

He stated that, while iliac vein stenting is a viable treatment option, “inappropriate sizing of venous stents can have catastrophic complications, and there’s been an increased rise in reports of stent migration to the heart and lungs. Iliac vein size, as we know, depends on several factors, like BMI [body mass index] and whether the patient is prone or supine.” 

Schultz and colleagues divided patients into two groups— those who received their procedures before 11 a.m. (early group) and those who received their procedures after 11 a.m. (late group). 

The number of patients in the study was 64, with 30 being in the early group and 34 in the late group. Of the 64 patients, the mean age was 52 years old and 48 of the 64 were female. 

Since these patients are typically fasting starting at midnight the day of their surgeries, “patients who are having elective procedures later in the day are likely to be more dehydrated,” Schultz told the audience. 

“So, our hypothesis was patients undergoing iliac vein stenting later in the day would have smaller stents placed compared to those who had stents placed earlier in the day.” 

The clinical outcomes supported the hypothesis, with the left common iliac vein and external iliac vein being larger in terms of surface area in the early group when compared with the late group. However, Schultz explained, “this didn’t reach statistical significance.” 

The study found that, while delayed start times were associated with a smaller stent size, patients who were prone were also more likely to have a smaller stent size. The difference in fasting times for the two groups was significant, with a mean of eight hours and 45 minutes for the early group and 13 hours and 33 minutes for the late group. 

“In conclusion, based on our linear regression we found that a nine-hour fasting duration was associated with an approximately 2mm decrease in stent size,” Schultz stated. “So, the longer fasting duration was associated with smaller iliac vein stent size.” 

During the question-and-answer portion of the presentation, Schultz was asked about whether there were any complications in patients due to the size of the stents. He explained that, while he and his team have these data, they have yet to analyze it. 

When asked about whether the patients had chronic pain associated with the oversized stents, as there is a larger issue with chronic pain as compared to catastrophic complications such as a stent migration, Schultz responded by saying that his team has the data to look at those complications, adding, “I think that’s an appropriate next step.” 

Schultz explained that the study group will now look to develop a pre-procedural hydration protocol. 

Vascular surgery resident reflects on Match Day experience

By
Marlén Gomez
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Vascular surgery resident reflects on Match Day experience
Eric Smith
Integrated vascular surgery resident Eric Smith, MD, tells Vascular Specialist how he handled the lead up to Match Day. 

For medical students hoping to specialize in vascular surgery, the eagerly anticipated Match Day (March 15) marks a pivotal career moment. Organized by the National Resident Matching Program (NRMP), it is the culmination of years of hard work, education and clinical experience. 

The excitement of imminent professional growth is tinged with the uncertainty of where they will spend the next phase of their medical journey. The days preceding Match Day are a flurry of final preparations, with SVS members revisiting residency programs and seeking advice from mentors to navigate the pivotal decisions ahead. 

Eric Smith, a postgraduate year one (PGY-1) integrated vascular surgery resident at the University of California San Francisco and a 2021 SVS Diversity Medical Student Vascular Annual Meeting (VAM) Travel Scholarship winner, shares insights into the emotional whirlwind leading up to Match Day. 

“Once your exams are done, the thing that people should try to remember is to focus on everything that you’ve accomplished to reach this point, so that it keeps you grounded. Medical school goes by so fast, and it’s nice to just sit and take a breather,” said Smith. 

Recalling the sleepless nights and stressful dreams preceding the decision, Smith emphasizes the importance of maintaining mental well-being during this anxious period. His advice to medical students is to take control of their situation and time, ensuring a comfortable mental space. He and his partner would engage in activities such as hiking or spending time with family to clear his mind. 

“I spent a lot of time travelling—but even though I wanted to be back in the operating room, people had to keep me away for my own good,” said Smith. 

Finally, Match Day arrives, and the anticipation peaks. Medical students, alongside their counterparts across the nation, will open their envelopes to discover where they will be completing their vascular surgery residencies. The mixed emotions are evident—joy, relief and perhaps a touch of nostalgia for the programs that brought them to this point. 

Smith shared his personal experience, recounting how, by 9 a.m., he learned he was matched with his top choice. The waves of excitement that swept over him were met with a surreal sense of disbelief, prompting him to reread the acceptance letter. However, even after securing his first preference, Smith grappled with the experience of mourning the many alternative paths in front of him. 

“What’s particular about Match Day is that you have all these different versions of yourself that were split apart with each decision of what could have been,” said Smith. 

Match Day for vascular residents is not just a day, but a culmination of years of dedication and perseverance, Smiths reflected. The days leading up to this event are filled with a unique blend of excitement, camaraderie and support from the SVS community, he added. 

New analysis points to lack of vascular surgical voices in news coverage of vascular disease

By
Bryan Kay
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New analysis points to lack of vascular surgical voices in news coverage of vascular disease
Babak Abai
Babak Abai

A new study set to be aired at the 2024 Society for Clinical Vascular Surgery (SCVS) annual meeting (March 16–20) in Scottsdale, Arizona, sheds a statistical spotlight on the state of the specialty’s reach into the mainstream consciousness.

A team led by Babak Abai, MD, program director of the vascular surgery fellowship at Thomas Jefferson University in Philadelphia, performed a Google News analysis across both the medical and lay press to detect the scale of representation of vascular surgical voices in news coverage of vascular disease compared to other specialists who treat vascular pathologies.

What they found, Abai told Vascular Specialist ahead of SCVS 2024, demonstrated that vascular surgeons are “very underrepresented” in articles focused on both peripheral arterial disease (PAD) and carotid disease. In the case of the former, almost 20% of the articles included in their analysis involved vascular surgical voices, with just 17% of the items focused on carotid disease involving vascular surgeons.

The study comes in the wake of a series of articles appearing in the mainstream press in recent months, some of it controversial and involving coverage of inappropriateness in vascular interventions. More recent popular media reports saw the Society for Vascular Surgery (SVS) join a multispecialty coalition aimed at raising public awareness of PAD, which led to widespread coverage of vascular surgical voices in mainstream outlets.

Since initially performing the analysis on articles related to PAD and carotid disease, Abai and colleagues—including medical student Joshua Chen, BS, who helped develop the study—have probed vascular surgical involvement in news covering aneurysmal disease, arteriovenous fistulas and venous disease. Altogether, the results are “astounding,” he said.

Abai emphasized the need for vascular surgeons to push themselves to the front of vascular disease coverage to help the specialty gain brand awareness.

“The question becomes: how do we become the leaders in the dissemination of data, because we are the experts in these areas,” Abai said. “To us, it was very surprising we had such a low percentage in terms of our representation.”

He continued: “We have a branding issue. We need to go out there, do interviews on news channels, on TV, in newspapers and on the internet—the latter, in fact, might be the best channel for us to disseminate and use to promote vascular surgery as a brand and have much better representation on the disease processes that are key to vascular surgery.”

Addressing some of the more negative coverage that has appeared in the mainstream press in recent times, Abai sees a potential silver lining. “It’s just like Hollywood,” he said. “Even bad press is not necessarily bad because it can bring visibility to your cause and what you are doing. Ultimately our goals are good. Our goals are to save limbs, our goals are to prevent strokes.

“Although I would hope we could [promote vascular surgery] in a more positive way because we don’t want the population to lose trust in us as physicians and as people who provide care for them.”

Tackling DVT head on: Single-session, wall-to-wall thrombus removal with the ClotTriever BOLD

By
BIBA Publishing
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Tackling DVT head on: Single-session, wall-to-wall thrombus removal with the ClotTriever BOLD
Nicolas Mouawad

This advertorial is sponsored by Inari Medical.

Several years ago, when Nicolas Mouawad, MD, division chief of vascular surgery at McLaren Health in Bay City, Michigan, was confronted with an emergency case of deep vein thrombosis (DVT) in which the patient presented with phlegmasia, he faced a dilemma. With the traditional lytic intervention off the table due to the urgent need for an immediate response, Mouawad turned to a new device he hadn’t used before. For the first time, the ClotTriever® System provided Mouawad a DVT intervention procedure with a lytic-free approach in a single-session treatment with wall-to-wall thrombus removal, providing the patient with immediate symptom relief.1 

Here, he outlines the current picture of his venous thromboembolism (VTE) practice, how that emergency case helped evolve how he tackles DVTs in appropriate patients, and how he sees the DVT treatment landscape developing going forward. 

What does your current venous disease practice look like? 

We have a comprehensive venous practice. We manage superficial veins and deep venous disease as well as pulmonary embolism (PE)—the full VTE disease spectrum. We see a significant number of patients who come in with DVT and post-thrombotic syndrome (PTS), as well as with venous leg ulcers, so we feel very comfortable managing the wide array of patients suffering from venous insufficiency and VTE. 

Could you expand upon how you go about managing patients with DVT? 

Our DVT management is multi-fold. The goal is to, first, relieve the patient’s symptoms, such as significant venous claudication or severe swelling that they find quite bothersome, or pain. Of course, we start with anticoagulation; however, a proportion of patients presenting with this pathology we feel benefit from intervention. Thinking further down the line, we want to avoid patients having significant sequelae of DVT, which, in up to 50% of patients with DVT, means PTS.2 Presently, these PTS patients are treated using the current standard of care, which is anticoagulation and elastic compression stockings. Even though they’re undergoing currently recommended treatments, these patients still develop long-term sequelae of PTS, so our goal here is to help mitigate the possibility of them developing these sequelae. 

Can you describe how the ClotTriever first made its way into your toolkit? 

Like a lot of other vascular specialists, I was using other devices on the market for the management of patients with DVT. I remember very vividly the first patient I treated with the ClotTriever System presented with phlegmasia. Even though I would consider our traditional treatment algorithm which was thrombolytic therapy, that would not be able to deliver an immediate resolution of the problem. What we needed was an immediate treatment for this patient who essentially had a surgical emergency. My hand was forced to try something that was immediate, single session and able to deliver a result without long infusion times. That case was around six years ago, and, frankly, we haven’t looked back since I started doing this type of treatment. 

How does the ClotTriever System differ from other modes of intervention for the treatment of DVT? 

Multiple variables of the system are beneficial to me. First, the ClotTriever is a single-session device. Bringing the patient back can be challenging, so a single-session device is important to me. Next, I don’t worry about the chronicity of the thrombus. Patients present within one or two days of discomfort, but we all know that the thrombus has probably been there longer. The symptoms may be acute, but the thrombus itself is likely sub-acute and even older. I have been using the ClotTriever BOLD Catheter to eliminate any guesswork on clot chronicity. Lastly, the unique device design allows me to remove wall-adherent thrombus to minimize residual vein obstruction. In terms of residual vein obstruction, creating more than just a channel with other thrombectomy devices is an important consideration regarding long-term outcomes. 

Can you outline ways in which the device has evolved your DVT practice? 

There is no associated ICU [intensive care unit] stay like there is when using thrombolytic therapy. There are no associated costs for pharmacologic therapy. There is no need for any capital equipment. Those were the benefits early on. To date, more than 50,000 ClotTriever cases have been performed. Additionally, there exists a plethora of data to support the device. Very aggressive efforts have been made to look at the data. The CLOUT registry is the largest study to assess mechanical thrombectomy to date, with interim two-year outcomes that showed 93% of limbs had none or mild PTS.3 Additionally, my experience—and histological analyses of ClotTriever cases— have not identified any cases where there has been venous valve or vessel wall damage.4 I’ve performed more than 200 DVT cases using the ClotTriever System and seen patients back with marked improvement in their discomfort and Villalta scores for PTS. I don’t think that would have been possible if we were ripping out valves or damaging the vein walls. 

What do you think the future holds for DVT treatment? 

For me, it’s important to be able to work with the groups investing in data. Unfortunately, the guidelines lag well behind what we see in practice. Of course, that is because a lot of data are necessary before guidelines can be created. Those data are forthcoming, however. The DEFIANCE randomized controlled trial (RCT)—currently the only RCT assessing DVT interventions—will be one such source. DEFIANCE, which compares iliofemoral DVT patients treated with the ClotTriever System versus anticoagulation only, should help support what we see day-to-day in our regular practice. 

CASE REPORT 

A woman in her early 60s presented with right leg pain and swelling. An ultrasound revealed unilateral right iliofemoral DVT, and the decision to intervene using the ClotTriever BOLD Catheter was made. 

Procedural overview 

The right popliteal vein was accessed with a micropuncture needle and wire under ultrasound guidance, and exchanged for a microsheath, ultimately upsizing to a short 10F sheath. A venogram demonstrated significant thrombus within the femoropopliteal segment, common femoral vein and extending into the external iliac vein. The lesion was crossed into the inferior vena cava (IVC). Next, pullback intravascular ultrasound (IVUS) from the IVC to the access site was performed to identify the extent of thrombus. A glidewire was advanced up into the right subclavian vein, and a vertebral catheter was advanced over it. Next, the glidewire was exchanged for a guidewire 7cm tip. A 19F dilator was used, followed by insertion of the ClotTriever sheath. The funnel was deployed under fluoroscopic guidance and the ClotTriever BOLD Catheter was advanced into the popliteal vein. The nitinol coring element and mesh collection bag were then deployed at the iliac vein, and the catheter was then retracted, capturing and removing significant acute thrombus. In total, four ClotTriever BOLD passes were completed. Completion IVUS showed complete thrombus removal. Completion venogram demonstrated brisk cephalad flow. Total procedure time was 35 minutes, while total device time was 10 minutes. There was estimated total blood loss of 20ml. 

Conclusion 

The patient’s pain resolved immediately postprocedure, with the swelling improving greatly. In follow-up, the swelling was resolved and the patient is doing well. 

References

  1. Dexter D et al. JSCAI. 2024.
  2. Kahn SR, et al. J Thomb Thrombolysis. 2016.
  3. Dexter D. Interim two-year outcomes from the fully enrolled CLOUT registry. AVF. 2024.
  4. Silver MJ, et al. Catheter Cardiovasc Interv. 2021.

The ClotTriever Thrombectomy System is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels; and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature, including deep vein thrombosis (DVT). Refer to IFU for complete indications for use, contraindications, warnings and precautions. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. All trademarks are property of their respective owners. 

Vascular Specialist–March 2024

By
Bryan Kay
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Vascular Specialist–March 2024

In this issue:

 

IVUS use in claudicants not associated with improved outcomes, claims data show

By
Bryan Kay
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IVUS use in claudicants not associated with improved outcomes, claims data show
Caitlin Hicks

The use of intravascular ultrasound (IVUS) for the treatment of claudication doubled over a four-year period but there was “no clear relationship between IVUS use and improved patient outcomes,” a recently presented retrospective analysis of claims data showed.

Researchers found the rate of use of the diagnostic tool in peripheral vascular interventions went from 15.5% in 2018 to 29.2% in 2022 among Medicare beneficiaries undergoing index femoropopliteal interventions for claudication.

Use across all procedure types also increased over the time period, with the steepest rate of increase in cases treated using atherectomy.

Looking at site of service, the study showed that IVUS use in hospital settings nearly doubled (4.8% to 8.8%), while in ambulatory surgery centers (ASCs) and office-based labs (OBLs) IVUS was being used in 48.5% of all femoropopliteal interventions performed for claudication by 2022—up from 30.6% in 2018.

The data were delivered during the 2024 Vascular and Endovascular Surgery Society (VESS) winter annual meeting in Sun Valley, Idaho (Jan. 18–21).

Statistical analysis showed that the cumulative incidence of repeat interventions was “significantly greater when IVUS was used during the index femoropopliteal [procedure] than when it was not,” Sanuja Bose, MD, a postdoctoral research fellow in the Division of Vascular Surgery and Endovascular Therapy at Johns Hopkins University in Baltimore, Maryland, told VESS 2024.

“Overall, IVUS was associated with greater conversion to chronic limb-threatening ischemia after adjusting for the baseline patient characteristics and clustering by physician.”

Senior author Caitlin Hicks, MD, Johns Hopkins’ associate vascular fellowship program director, later told Vascular Specialist IVUS has a “definite role” to play in settings such as the recanalization of chronic total occlusions “but I think that it’s frequently used more than that, and I don’t think it necessarily contributes any meaningful improvement to patient outcomes in all settings.”

CLOUT registry: Interim two-year rates of PTS ‘significantly lower’ than those in historical DVT studies

By
Bryan Kay
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CLOUT registry: Interim two-year rates of PTS ‘significantly lower’ than those in historical DVT studies
one-year
David Dexter

Rates of post-thrombotic syndrome (PTS) among deep vein thrombosis (DVT) patients treated with the ClotTriever thrombectomy system (Inari Medical) who are logged in the real-world CLOUT registry demonstrated “significant and sustained improvement” out to 24 months, according to interim two-year data recently delivered at the 2024 American Venous Forum in Tampa, Florida (March 3–6).

The rate of moderate-severe PTS at the two-year mark was reported as 7.3% among 228 patients included in the interim analysis, presenter David Dexter, MD, a vascular surgeon at Sentara Vascular Specialists in Norfolk, Virginia, told AVF 2024 attendees. The overall rate of PTS in the interim results was 19.9%.

PTS rates reported in CLOUT are “significantly lower” than those from historical DVT studies such as ATTRACT and CAVA, which reported moderate-severe PTS rates ranging from 18–24%, he added.

The interim results are the largest prospective, multicenter two-year dataset in DVT since the ATTRACT trial. Patients had low incidence of independently adjudicated safety events related to re-thrombosis, with only 5% and 8.4% at 30 days and six months, Dexter reported.

“With third-party adjudication of all safety events in this robust, large dataset, ClotTriever has a strong safety profile,” said Dexter. “And the longer-term results are suggestive of sustained benefit through a critical window when longer-term sequalae typically manifest in DVT patients. The low PTS rate that continues to improve over time is a testament to the safety and effectiveness of wall-to-wall thrombus removal with ClotTriever.”

Single-center analysis suggests improved longer-term outcomes with endarterectomy versus TCAR

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Single-center analysis suggests improved longer-term outcomes with endarterectomy versus TCAR
Ali AbuRahma

A large, single-center analysis has found that, despite parity between the two procedures in terms of perioperative clinical outcomes, carotid endarterectomy (CEA) was associated with a reduced rate of late stroke/death compared to transcarotid artery revascularization (TCAR).

Writing in the Journal of Vascular Surgery (JVS), Ali AbuRahma, MD, from Charleston Area Medical Center/West Virginia University in Charleston, West Virginia, and colleagues also conclude that CEA produced a marginally lower rate of restenosis ≥80% at two years—although this difference did not reach statistical significance. The data were presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27).

The authors initially note that multiple registry studies—primarily ones conducted within the Society for Vascular Surgery’s (SVS) Vascular Quality Initiative (VQI)—have compared early outcomes, and outcomes up to one year, between TCAR, CEA and carotid artery stenting (CAS). However, no large, single-centre studies have reported on late clinical outcomes between these procedures and, as such, they conducted a retrospective analysis comparing intermediate outcomes with TCAR versus CEA.

Their study analyzed data collected from the TCAR Surveillance Project on patients at the Charleston Area Medical Center, with these data being compared and subsequently propensity matched against patients undergoing CEA. Patients in both groups were treated by the same providers across the same time period, the authors note.

The primary outcome of the analysis was a combination of perioperative stroke/death and late stroke/death rates, while secondary outcomes included combined stroke/death/myocardial infarction (MI), cranial nerve injury (CNI), and bleeding. Kaplan-Meier analyses were used to estimate patients’ freedom from stroke, stroke/death, and also rates of restenosis ≥50% and ≥80%.

Across 637 patients, a total of 646 procedures (404 CEAs and 242 TCARs) were analysed, with AbuRahma and colleagues finding no significant differences in indications for carotid intervention between these two groups—although TCAR patients had more high-risk criteria including hypertension, coronary artery disease, congestive heart failure, and renal failure.

The authors report that there was no significant difference between CEA and TCAR in terms of the rates of 30-day perioperative stroke (1% vs. 2%, respectively), stroke/death (1% vs. 3%), or major hematoma (2% vs. 2%). However, the rate of early CNI was found to be significantly higher with CEA (5%) versus TCAR (1%; p=0.0138). In addition, late follow-up analyses at two years revealed results favouring CEA over TCAR, as the former produced lower rates of stroke (1% vs. 4%, respectively; p=0.0273), stroke/death (8% vs. 15%; p=0.008), and restenosis ≥80% (0.5% vs. 3%; p=0.0139).

AbuRahma and colleagues’ propensity-matched analysis, under which 242 CEAs and 242 TCARs were included, found broadly similar perioperative outcomes regarding stroke rate (CEA, 1% vs. TCAR, 2%), stroke/death rate (CEA, 2% vs. TCAR, 3%) and CNI rate (CEA, 3% vs. TCAR, 1%). Once again, however, their later follow-up analysis generally favoured CEA, as demonstrated by a rate of stroke of 1%—compared to 4% with TCAR (p=0.0615)—and a rate of stroke/death of 8%—compared to 15% with TCAR (p=0.0345).

Finally, the authors also note a marginally smaller difference in the occurrence of restenosis ≥80% following propensity matching, as compared to their regular analysis, with rates of 0.9% associated with CEA versus 3% with TCAR (p=0.099). This difference was not deemed statistically significant, they add, and rates of restenosis ≥50% were not statistically significantly different between the two procedures either.

“In propensity-matched analysis, both CEA and TCAR have similar perioperative clinical outcomes. However, CEA was superior to TCAR for the rates of late stroke/death and had somewhat lower rates of ≥80% restenosis at two years,” AbuRahma told NeuroNews, outlining the salient message from the paper. “The type of intervention, CEA versus TCAR, should depend on risk stratification—anatomical and/or physiological.”

ISC 2024 examines TCAR ‘explosion’ alongside advances in intensive medical therapy

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ISC 2024 examines TCAR ‘explosion’ alongside advances in intensive medical therapy
Seemant Chaturvedi and Caitlin Hicks

This year’s International Stroke Conference (Feb. 7–9) in Phoenix, Arizona, hosted discussions on the current state of play in carotid stenosis treatment—and, most notably, advances that may erode the dominance of long-established carotid revascularization procedures in the U.S.

Session moderator Larry Goldstein, chair of neurology at the University of Kentucky, Lexington, provided a fitting initial comment on the lack of up-to-date trial data evaluating different carotid disease treatments: “Looking around the room, some of you weren’t even born when these trials were done!”

As Goldstein noted, the trials in question—NASCET in the U.S. and ECST in Europe—were conducted and published some 30 years ago, and only included patients with symptomatic carotid artery stenosis.

“For some of you, this is almost ancient history—but, if you go to our national guidelines, this is all the grade A, level one evidence that we have,” he continued. “When the studies were done, they were internally valid, but time marches on, and things that we thought were true 40 years ago may not be true today.”

Dwindling need for revascularization?

This proved to be an appropriate segue into a presentation from Seemant Chaturvedi, MD, from the University of Maryland School of Medicine, Baltimore, Maryland, who began by stating that things have “dramatically changed” since the advent of those original trials in the 1990s. The succeeding decades have seen well-established medical therapies like antiplatelets, statins, blood-pressure control, physical activity and dietary modification joined by numerous modern options, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, bempedoic acid, semaglutide, and combination antithrombotic therapy.

Here, Chaturvedi touched on the various studies that have demonstrated the ability of these newer medications to safely reduce low-density lipoprotein (LDL) levels and ultimately minimize cardiovascular events. Evolocumab—an example of a PCSK9 inhibitor—and inclisiran have been tested and performed well in large-scale trials, while bempedoic acid serves as an alternative for patients who are unable or unwilling to take high-potency statins.

Chaturvedi then somewhat facetiously summarized “all of the data” evidencing the superiority of surgical revascularization over intensive medical therapy for asymptomatic carotid stenosis—presenting the audience with a completely blank slide.

“But, we do have some emerging evidence that, maybe, revascularization is not as good,” he continued, alluding to the fact that carotid endarterectomy (CEA) and medical therapy produced similar outcomes in the SPACE-2 trial, and highlighting the importance of data from the CREST-2 trial, which are expected in early 2026.

“On the symptomatic side, we also don’t really have much evidence that revascularization is much better than modern medical therapy [either]—there hasn’t been a large-scale study since 1991, and so there is a void in the current data,” Chaturvedi added. Once again, he drew attention to the relevance of ongoing studies in the area, including the SCORE registry.

“In 2024, we need to have very intensive medical therapy,” he summarized, also stating there is “no excuse” not to aim for lowering LDL levels to at least <70mg/dl in carotid stenosis patients—as per the target in CREST-2. However, he did note that he aims for LDL levels of <55mg/dl, if not lower, in his own practice. Starting medication alone is “not enough” in modern-day care, Chaturvedi continued, emphasizing the importance of administering treatment with certain goals in mind.

Lipoprotein (a), factor XIa inhibitors, colchicine, and agents that target vascular inflammation, are among additional medications “on the horizon” in carotid disease, according to Chaturvedi, who speculated that the neurovascular community is likely to hear more about each of these over the next 1–2 years.

“There is a plethora of new treatment options which have been proven to be associated with cardiovascular event reduction and, if we’re able to optimally use all of these agents, that should decrease the need for carotid revascularization.”

The third mode

Following this, Caitlin Hicks, MD, a vascular surgeon at Johns Hopkins Medicine in Baltimore, discussed another frontier that appears to have moved alongside CEA and carotid artery stenting (CAS) over the past decade: transcarotid artery revascularization (TCAR). Developed by Silk Road Medical via the Enroute stent system, TCAR’s intended benefits include avoiding the aortic arch, providing proximal protection, and improving particle capture.

TCAR received Food and Drug Administration (FDA) approval in 2015 for use solely in high-risk carotid stenosis patients, but with the caveat that physicians had to contribute clinical data—including perioperative and one-year outcomes—to the Vascular Quality Initiative TCAR Surveillance Project (VQI-TSP) in order to actually gain reimbursement for the procedure.

This has created a greater wealth of both comparative and non-comparative data on TCAR, and studies evaluating it have “exploded” over the past few years as a result, Hicks relayed. Broadly, these studies have suggested TCAR produces stroke/death rates, comparable to those seen with CEA out to one year, across asymptomatic and symptomatic patients alike. Additional studies demonstrating non-significant differences in rates of stroke/death/myocardial infarction between the two—specifically those involving standard-risk patients—ultimately supported an expanded indication of the procedure from the FDA in 2022.

Figures suggest TCAR has “taken off” in the USA over the past few years, with CEA and CAS declining slightly—a trend that is especially pronounced for high-risk carotid stenosis patients, in whom TCAR is now the predominant revascularization approach nationally. Hicks did also acknowledge that the 2023 Centers for Medicare and Medicaid Services (CMS) coverage expansion, under which CAS is no longer limited to certain lower-risk patients, will likely lead to an increased stenting uptake and TCAR “losing ground” in more high-risk patients. However, “on the flipside”, with TCAR also being covered by this expansion, physicians are no longer mandated to contribute to the VQI-TSP database, potentially making the procedure less expensive to accommodate and thus boosting uptake at smaller community hospitals in the USA.

Hicks then noted that “there has been very close oversight of the use of TCAR by industry”—although she feels this is likely to be “unsustainable” in the long term, especially if the procedure continues to expand and is taken up by multiple other specialties. She also highlighted the fact that data on TCAR remain limited, overall, as the majority come from the industry-sponsored ROADSTER studies as well as the VQI-TSP registry, which are helpful indicators of real-world patient outcomes, but certainly not equivalent to a randomized controlled trial (RCT).

“People always call for an RCT comparing TCAR to CEA—and/or transfemoral stenting,” she continued. “As much as I would love to see that happen, it almost certainly will not. It’s not financially viable. Silk Road Medical has seen a large market-share increase, and there’s really no reason for them to fund a study like that. So, unless something like that is funded by the government or another format, this will likely not be in our future.”

Nevertheless, Hicks feels data on longer-term outcomes are needed to help understand “where TCAR fits into our carotid revascularization armamentarium”.

Patient-centric decisions

“Ultimately, I think having patients see physicians that are able to perform all three procedures is probably the best bet, because we can really try to weigh up the risks and benefits, and have patient-specific decision-making,” Hicks commented.

In a subsequent discussion, Thomas Ford, MD, from UMass Memorial Health in Worcester, Massachusetts, said that, while an “ideal world” would see a single proceduralist offer all three of the aforementioned procedures, there is a certain “division of labour” in many centers whereby vascular surgeons often perform the majority of CEAs and TCARs, while interventionists perform a lot of non-invasive procedures like CAS.

Responding to Ford’s question on how best to navigate this, Hicks admitted it is “difficult, for sure”, but that the keys to success are the conversations had between vascular surgeons, interventional neuroradiologists, and stroke neurologists, where necessary.

“I certainly don’t think that there’s a perfect way,” she added. “The new carotid NCD [National Coverage Determination] calls for shared decision-making, with a discussion of all three carotid revascularization options prior to choosing one. There is no current, validated shared decision-making tool to use with patients, so that’s a little bit misaligned with what we have available in the clinical realm—but, I think, as that develops moving forward, at least being able to have a conversation about the three choices and then trying to steer the patient in the right direction is what we all need to aim for.”

The top 10 most popular Vascular Specialist stories of February 2024

By
Éva Malpass
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The top 10 most popular Vascular Specialist stories of February 2024

top 10In February, the most read stories from Vascular Specialist include a study of metformin and its potential as the first-ever medical treatment that can manage aneurysm disease; the SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) release the highly anticipated Office-Based Lab (OBL) Handbook; and a case series evaluation of aortoiliac endarterectomy, among several more. 

1.‘Get a Pulse on PAD’: Multi-society public awareness campaign launched

The Society for Vascular Surgery (SVS), in partnership with three other medical societies operating in the vascular disease space that form the PAD Pulse Alliance, is taking part in a peripheral arterial disease (PAD) public awareness campaign called “Get a Pulse on PAD.”

2. SAVS 2024: A journey to the heart of DEI like no other

David L. Cull, MD, delivers a captivating presidential address, laying bare his own challenging journey as a vascular surgeon and the hidden lessons on diversity, equity and inclusion his life story may hold.

3. More than half of medical students altered Match ranking order after post-virtual interview site visits, APDVS survey finds

Amid the build-up to residency Match Day 2024, the Association of Program Directors in Vascular Surgery (APDVS) has delivered data from a VISIT (Vascular In-Person for Students in the Match Trial) pilot study that took place last year showing some 57% of medical students who took part changed their rank list of integrated vascular surgery programs based on post-virtual site visits to institutions on their radar.

4. Re-evaluating aortoiliac endarterectomy: Case series shows ‘acceptable durability’

The uncommonly performed aortoiliac endarterectomy—one of the open procedures on which the vascular surgical specialty was founded—provides acceptable durability in aortoiliac occlusive disease patients with smaller native vessels, especially among females, a 25-patient case series review performed at Louisiana State University (LSU) Health Sciences Center in New Orleans has shown.

5. Serration angioplasty associated with reduced recoil in infrapopliteal arteries compared with plain balloon angioplasty

A study comparing the extent of early infrapopliteal re­coil after serration and plain balloon angioplasty has found the former produces “substantially less” arterial recoil in the treatment of these lesions and has demonstrat­ed “technical feasibility” in measuring early recoil using standard angiography.

6. A proposal to save vascular surgery

Russell H. Samson writes in response to recent articles in the lay press suggesting vascular surgeons were performing unnecessary procedures, following a talk he gave at the 2023 VEITHsymposium.

In this article he begins: “At that meeting I provided data demonstrating which specialties are treating vascular patients and the rate of insurance denials dependent on provider specialty. I was originally reluctant. I had stopped writing editorials for Vascular Specialist because I had said all that I had on my mind. I was also concerned that, eventually, I would write a piece that readers would find so controversial that I would never be able to show my face in public again.”

7. How the best leaders ensure psychological safety at work

Bhagwan Satiani writes on his understanding of psychological safety, stating that this is when people feel safe expressing differing opinions and thoughts in the workplace. Although, he believes, psychological safety must be part of every organizational culture, it is critical for high-performing teams.

8. Could metformin be first-ever medical treatment that is effective at managing aneurysm disease?

There is a global interest in assessing whether metformin, which has a long track record of safety and efficacy, is relatively inexpensive and is taken by millions of people every day for type-2 diabetes, has an effect on the progression of abdominal aortic aneurysms (AAAs). 

9. FORS-powered LumiGuide 3D imaging technology is rolled out at specialized centers in U.S. and Europe

Andres Schanzer, MD, has hailed it “one of the most exciting changes” seen in imaging during the course of his career. Philips’ LumiGuide “human GPS” technology—which uses light reflected along an optical fiber inside a guidewire to generate three-dimensional (3D), high-resolution, color images of devices inside a patient’s body in real-time powered by Fiber Optic RealShape (FORS)—is now available to specialized hospitals in Europe and the U.S., the company has announced.

10. SOOVC releases handbook for outpatient care

The SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) has released the anticipated Office-Based Lab (OBL) Handbook to guide practitioners and aid with safety and cost-effectiveness, as well as expand patients’ access to care. 

AVF 2024: Outgoing president addresses history, future direction of American Venous Forum

By
Brian McHugh
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AVF 2024: Outgoing president addresses history, future direction of American Venous Forum
Glenn Jacobowitz addresses AVF 2024 in Tampa, Florida

At the 2024 American Venous Forum (AVF) in Tampa, Florida (March 3–6), Glenn Jacobowitz, MD, professor of vascular and endovascular surgery at NYU Langone Health in New York City and 2023-24 AVF president, tackled the future direction of the society—and from where it has come.

Jacobowitz used his outgoing presidential address to outline plans to expand international outreach programs, increase diversity and equity amongst members, and focus on young venous specialists. He also stated that since it has been five years since the previous group retreat where the current AVF five-year plan was outlined, it is time to start looking ahead and what the next five years hold.

Jacobowitz participated in a retreat last year with former AVF President William A. Marston, MD, professor in the Division of Vascular Surgery at the University of North Carolina Hospitals in Chapel Hill, North Carolina, where there was a focus on making sure all persons have access to prevention and treatment options, improving on the current inequalities of venous care, and increasing access to understanding venous disease prevention and treatment.

Jacobowitz peered back into AVF history for help determining what its future should look like. “The AVF went through a brief time of financial stress and lower membership,” he told those gathered for the AVF 2024 address. “But our leaders identified a need to redefine our mission goals and align these goals in a way to expand our membership and diversify, and also restructure our management team and our strategic plan.

“We can’t have a myopic view of the world,” Jacobowitz said. The AVF has partnered with 35 international societies “to increase collaboration, improve management of venous disease globally, leading to information exchange and joint project proposals, including guideline summaries, collaborative research, and education,” he added.

The AVF now has educational offerings around the world, including early training programs, webinars, and planned symposia in South America, Europe, Egypt and China. There are also international webinars, the first of which was viewed in over 60 countries and had more than 1,000 registrants. The plan is to hold them every three months, Jacobowitz said.

Jacobowitz also mentioned that the AVF recently established around $200,000 in annual grants. Those include the AVF-Jobst Clinical Research Grant ($85,000), AVF-BSCI Translational Research Grant ($85,000), AVF-NIH/NHLBI Grant ($25,000), AVF Basic Science Research Grant ($15,000), and the AVF Janssen Fellowship ($50,000).

In the new year, there will be “increased focus on young venous specialists,” Jacobowitz stated. “We have a record number this year.” He continued by mentioning the importance of advanced practice providers (APP) and the need to engage more with them to “help mitigate the equities of care.”

Jacobowitz issued a call to action on equity of care. “It’s a complex problem, a large problem, but it involves the disease process … we need to develop programs over hurdles, understanding this and the geographically and economically underserved,” he said.

He concluded by saying the AVF will “lead the way in venous care in the U.S. and abroad through our own initiatives and through collaborative work with our global partners and industry. All the while we’ll maintain focus on research, mentorship, education and advocacy.”

Non-pneumatic compression device performed better than advanced pneumatic compression for lower extremity lymphedema

By
Brian McHugh
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Non-pneumatic compression device performed better than advanced pneumatic compression for lower extremity lymphedema
Dayspring data emerge in a breaking trials session at AVF 2024

A new study presented during the 2024 American Venous Forum (AVF) in Tampa, Florida (March 3–6), that compared a novel non-pneumatic compression device with an advanced pneumatic compression modality in the treatment of lower extremity lymphedema demonstrated “statistically significant disruption” in limb volume that favored the former.

The multicenter, randomized controlled crossover study’s primary endpoint was change in limb volume from baseline, change in quality of life using the LYMQOL validated quality-of-life scoring system, and treatment adherence during the study period, presenter Todd Berland, MD, director of outpatient vascular interventions at NYU Langone Health in New York, New York, told those gathered in a late breaking session at AVF 2024.

The patients in the study had an average of 58 years old, and a majority of them were White women. Of the cohort, there were 11 with primary and 60 with secondary lymphedema, 34 were unilateral and 37 bilateral, and they had an average of eight years since diagnosis.

Berland outlined the non-pneumatic technology at hand: the Dayspring (Koya Medical) device, a battery-powered without a foot portion, which allows users to walk, features components that “stretch and release, and fake or simulate a manual lymphatic massage experience,” he said. “Between the static compression that you get with the actual garment,” Berland continued, “the stretching and elongating phenomenon—and the fact that you can walk with the device, and really activate that calf muscle pump—may account for what we see here in this study, [where] we compare this device to commercially available advanced pneumatic plug-in-the-wall devices.”

“We had nine study sites with 121 patients consented,” he told AVF 2024. “There were 22 screening failures, leaving us with 99 patients.”

The team randomized patients to the non-pneumatic or advanced compression device, which patients then used for three months. “At the end of that three-month period, we checked quality-of-life and limb-volume measurements,” Berland said. “We then had them use nothing for one month, the washout period, to give us a new baseline. We rechecked limb volume and quality-of-life, and then the patients crossed over.”

After cross over, they used the opposite device that they were originally given for another three-month period. Measurements were taken of the patients’ lower extremities. Quality of life was also taken at the end of three months. Finally, patients were given a diary to record their thoughts of the devices throughout the study.

Results showed a “statistically significant disruption in limb volume favoring the Dayspring device,” Berland told the audience. “A 370mm volume reduction in this group compared to an 83mm reduction in advanced pneumatic compression.”

“When we look at the foot, there was actually no statistical significant difference here. Both devices and subgroups trended toward improved diameters and circumference of the foot,” he said.

The quality-of-life questionnaire also favored the Dayspring device, with the function, appearance and symptoms being rated as better than the advanced pneumatic compression device. Even when it came to how committed the patients in the study were, the Dayspring device had an adherence rate of 81% compared to the advanced pneumatic compression rate of 56%, Berland added.

Finally, when it came down to which of the two devices the patients preferred, “78% of patients preferred the Dayspring device compared to 22% for advanced pneumatic compression,” Berland said.

Adoption of AI into workflow associated with faster time to assessment of PE patients

By
Jocelyn Hudson
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Adoption of AI into workflow associated with faster time to assessment of PE patients
Jacob Shapiro

An abstract presented at the 2024 American Venous Forum (AVF) annual meeting (March 3–6) revealed that, in the treatment of patients with pulmonary embolism (PE), the implementation of artificial intelligence (AI) software has been linked to a shorter time to assessment.

At the Tampa, Florida, meeting, Jacob Shapiro, MD, shared this and other key findings from a review of patients diagnosed with PE at a single center over a six-year period.

Shapiro, a resident at TriHealth in Cincinnati, Ohio, and colleagues outline in their abstract that the serious and potentially life-threatening nature of PE necessitates a “streamlined PE workflow with timely assessment and initiation of treatment” to potentially improve a patient’s chance of survival. They add that AI has been increasingly used in healthcare to improve clinical efficiency.

The authors detail that, in October 2022, TriHealth implemented an AI-powered parallel workflow tool designed to automatically detect and triage patients with suspected PE. The aim of the study, they share, was to evaluate the clinical impact of AI software on time to assessment, time to anticoagulation, and patient outcomes at the institution.

Shapiro et al reviewed 150 patients diagnosed with PE between January 2017 and July 2023, retrospectively collecting data on these patients prior to AI implementation and comparing it against those of PE patients following AI implementation. The researchers looked at scan-to-assessment time, scan-to-alert time—which they note was used as a surrogate for scan-to-assessment time following AI implementation assuming best practice—time to anticoagulation administration, Pulmonary Embolism Response Team (PERT) activations, and in-hospital mortalities.

Shapiro reported at AVF that scan-to-alert time in the post-AI group of 45 patients was “significantly faster” than scan-to-assessment time in the pre-AI group of 113 patients. He added that anticoagulants were administered faster for post-AI cases with PERT activation compared to cases without PERT activation, and that in-hospital mortalities decreased from 8.4% (pre-AI) to 2.2% (post-AI), with all mortalities occurring in cases without PERT activation.

“Adoption of AI into our workflow was associated with faster time to assessment of PE patients,” Shapiro and colleagues conclude in their abstract. They elaborate that, with an average AI alert time of under six minutes, AI “optimizes standard of care by promoting quicker triage.”

Furthermore, they note that the combined benefit of AI and PERT activation was highlighted by faster anticoagulation administration and decreased mortality in their sample. “These findings suggest a link between earlier anticoagulation and reduced risk of mortality,” they write.

Speaking ahead of AVF, Shapiro stated that “further research is needed to determine if long-term patient outcomes are impacted by this technology.”

On the learning curve with this AI software, Shapiro remarked that it is “very minimal.” He explains: “The interface for reviewing CT [computed tomography] scans is very intuitive and the chat feature is easy to navigate. The patient’s lab values are also automatically imported and obviously displayed.”

Shapiro commented that overreliance on AI could be a drawback of the technology. However, he emphasized his overall opinion that, as an adjunct to an expert reviewer, there are “no real downsides.” Specifically, he gives the example of the ability to look at scans in views other than axial (i.e. coronal or sagittal) as a benefit for reviewers.

On the wider endorsement of this software, Shapiro notes that it has already been widely adopted by neurosurgeons for strokes and that his institution has been using it for PE for over 18 months. “We are already seeing it integrated into clinical practice,” he says.

VESS 2024: Determining success in vascular surgery across the generations

By
Brian McHugh
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VESS 2024: Determining success in vascular surgery across the generations
Mark Conrad

Outgoing Vascular & Endovascular Surgery Society (VESS) President Mark Conrad, MD, used the 2024 VESS presidential address to illustrate how he got into vascular surgery, what determines success for different generations, what does and does not factor into building a career, and how he would advise those coming into the profession.

“It actually started at Henry Ford Hospital with Alex Shepard,” the chief of vascular surgery at St. Elizabeth’s Medical Center in Brighton, Massachusetts, told those gathered in Sun Valley, Idaho, for VESS’ annual winter meeting (Jan. 18–21). “My first two months as an intern were on vascular; it was the most horrible experience I can ever describe. Every time my pager went off, I got a shot of adrenaline that made me want to throw up, because it meant someone was dying, someone needed to be intubated, someone needed something else.”

Shepard wasn’t the only one to have a lasting impact on Conrad and his career. Former VESS President Emerick Szilagyi, MD, the Hungarian vascular pioneer, taught at Henry Ford in Detroit after working as a medical director at a rubber plantation in Brazil for the Ford Motor Company.

Szilagyi’s skepticism of technology around how its advancement could lead to a lack of fulfillment for surgeons in their jobs led Conrad to ponder technology’s role: does it lead to a lack of fulfillment and a lack of success? “It made me question, what determines success? Certainly, most of us think of success by outside factors … I think you’re judged based on your timeline, and I think that’s important,” Conrad stated. “Success based on a person’s timeline is an interesting concept, but it makes sense: we don’t look back at the failures of doctors such as Szilagyi, we look at their successes for the changes they helped create in the medical world.”

Conrad then looked ahead to the future of medicine, as Generation X doctors slowly give way to millennials. He mentioned how he and other Gen X doctors have tended to try to teach millennials to network the way they had been taught, but found that, “you see there are certain students that take over, they lead it, they pass it on, and it’s just this organic thing that happens. Maybe we need to step back and let the millennials do it their own way,” he told VESS 2024.

Closing, Conrad reflected again on one of those people who got him into vascular surgery—Szilagyi—and called upon his words. “The art of surgery is not yet perfect and advances now unimaginable are still to come. May you have the wisdom to live with them with grace and humanity,” Conrad recited to the crowd. He finished with a quote of his own: “We can’t imagine what’s going to occur in vascular surgery by 2074. As you progress through your career, don’t be derailed by outside influence. Be true to yourself.”

Frank J. Veith joins ViTAA Medical Solutions’ board of directors

By
Jocelyn Hudson
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Frank J. Veith joins ViTAA Medical Solutions’ board of directors
Frank J Veith
Frank J Veith

ViTAA Medical Solutions has announced the appointment of Frank J Veith, MD, professor of surgery at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Cleveland, Ohio, and New York University Medical Center in New York City, to its board of directors.

With a career spanning several decades, Veith has earned international acclaim for his contributions to vascular surgery, particularly in the areas of limb salvage, lung transplantation, and endovascular treatments. A press release details that his work includes performing the first endovascular aortic repair in North America, a milestone that has significantly influenced the direction and capabilities of modern vascular surgery. His leadership and expertise have also been instrumental in managing VEITHsymposium, one of the largest annual conferences regrouping vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists to learn the most current information about what is new and important in the treatment of vascular disease.

“We are honoured to welcome Dr Veith to our board of directors,” said Mitchel Benovoy, CEO of ViTAA Medical Solutions. “His unparalleled expertise, visionary leadership, and commitment to improving patient care align perfectly with ViTAA’s mission. We are confident that Dr Veith’s guidance will be invaluable as we continue to innovate in the vascular health industry.”

“I am honoured and excited to join the ViTAA board of directors and contribute to their mission of transforming vascular care,” said Veith. “I look forward to working alongside a team that is as dedicated to advancing the field of vascular surgery as I have been throughout my career.”

Endologix initiates postmarket study of the Detour system

By
Jocelyn Hudson
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Endologix initiates postmarket study of the Detour system
PTAB using the Detour system
PTAB using the Detour system

Endologix has announced the initiation of the Percutaneous transmural arterial bypass (PTAB)1 postmarket study. This study marks the beginning of a comprehensive postmarket study aimed at evaluating the real-world performance of the Detour system in patients undergoing treatment for long complex superficial femoral artery (SFA) disease.

The study will leverage the Vascular Quality Initiative (VQI) registry infrastructure developed and supported by the Society for Vascular Surgery Patient Safety Organization (SVS PSO), a company press release notes.

The PTAB1 postmarket study evaluates the Detour system’s performance in patients with very long (TASC D) SFA lesions. The study plans to enrol up to 450 patients, with a focus on including at least 200 women and also features an imaging substudy. Recruitment will involve up to 200 sites, with five-year follow-up.

“The initiation of the PTAB1 postmarket study represents a pivotal moment in our ongoing commitment to advance the treatment of complex peripheral arterial disease [PAD]. Through this study, we aim to further validate the Detour system’s innovative approach to overcoming complex PAD challenges,” expressed Matt Thompson, president and CEO of Endologix.

Thomas Maldonado

Thomas S Maldonado, the Schwartz-Buckley endowed professor of surgery in the Vascular Division at New York University Langone Medical Center (New York City, USA), underscored the significance of being the inaugural site to enrol a PTAB patient: “Our privilege of enrolling the first patient in the PTAB1 postmarket study underscores our commitment to advancing patient care in complex PAD. The Detour system offers a glimpse into a future where minimally invasive treatments could redefine our approach to extensive SFA lesions. We are optimistic about the contributions this study will make towards evolving patient treatment paradigms.”

EACTS and STS guidelines recognize aorta ‘as an organ in its own right’

By
Will Date
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EACTS and STS guidelines recognize aorta ‘as an organ in its own right’

New guidelines from the European Association for Cardio-Thoracic Surgery (EACTS) and the Society of Thoracic Surgeons (STS) have, for the first time, recognized the aorta as “an organ in its own right.”

“Recognizing the aorta as an organ puts it on a par with the heart, lungs or brain. This is a big step,” says Martin Czerny, MD, from the Clinic for Cardiovascular Surgery at the University of Freiburg in Freiburg, Germany, chair of the writing committee responsible for putting the new guidelines together.

“The new guidelines clearly recommend bundling the treatment of the aorta in a separate speciality, naturally in close coordination with other specialities. We have been practicing this integrative approach at the Medical Center-University of Freiburg for a long time and I am delighted that our work is now also being recognized internationally,” said Czerny. “I am certain that this will improve the treatment of patients with aortic rupture and other serious diseases.”

Published simultaneously in the European Journal of Cardio-Thoracic Surgery and The Annals of Thoracic Surgery, the guidelines take into consideration the impact and risk of different diagnostic or therapeutic methods for the treatment of aortic disease, and are designed to serve as a support tool for physician decision-making in the treatment of diseases such as aortic aneurysm.

The aorta is responsible for transporting oxygen-rich blood from the heart to the rest of the body. In recent years, it has become increasingly clear that it also plays an important role in regulating blood pressure and blood flow velocity. In addition, it is involved in the production of certain hormones and has its own layer of smooth muscle cells that help to maintain its structure and function.

“Our understanding of the aortic organ is continually evolving, especially in regard to its pathophysiology, the timing for treatment and the application of current and the development of new therapeutic strategies. Aortic disease has emerged as a specialty with significant health economic relevance. Several components of this guideline already establish the foundational structure necessary to meet the needs of treating the aortic organ within a specialized centre by a dedicated interdisciplinary aortic team,” the document states.

FORS-powered LumiGuide 3D imaging technology is rolled out at specialized centers in U.S. and Europe

By
Bryan Kay
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0
FORS-powered LumiGuide 3D imaging technology is rolled out at specialized centers in U.S. and Europe
Phillips LumiGuide technology

Andres Schanzer, MD, has hailed it “one of the most exciting changes” seen in imaging during the course of his career. Philips’ LumiGuide “human GPS” technology—which uses light reflected along an optical fiber inside a guidewire to generate three-dimensional (3D), high-resolution, color images of devices inside a patient’s body in real-time powered by Fiber Optic RealShape (FORS)—is now available to specialized hospitals in Europe and the U.S., the company has announced.

The LumiGuide system enables doctors to navigate through blood vessels during endovascular procedures using light, instead of X-ray, and was first used to treat patients in late 2023 at Maastricht University Medical Center in Maastricht, The Netherlands, closely followed by the University of Alabama at Birmingham.

LumiGuide initially has been made available to aortic centers of excellence that perform complex aortic repairs in the U.S. and Europe, a Philips press release states. The radiation-free technology enables physicians to reduce their reliance on X-ray during complex aortic procedures that can take significantly more time, resulting in a higher radiation dose for patients and clinicians. LumiGuide can be used to see devices including off-the-shelf catheters from any angle and in multiple views, the company adds.

Following a limited release of FORS to nine aortic centers, more than 900 patients have undergone procedures using the technology, with one site conducting a historic cohort comparison showing a 37% reduction in complex aortic procedure time, and a 56% reduction in radiation exposure compared to X-ray.

As detailed in a presentation of the 2023 VEITHsymposium in New York City last November by Joost van Herwaarden, MD, of University Medical Center Utrecht in The Netherlands, the Limited Edition FORS technology—Food and Drug Administration (FDA) 501k-cleared in 2020—saw more than 800 completed cases by October of last year. The newly released LumiGuide includes workflow enhancements such as artificial intelligence (AI)-based automatic registration, along with visualization of a wider array of catheters, van Herwaarden pointed out

Geert Willem Schurink, MD, from Maastricht University Medical Center, Maastricht, The Netherlands, who performed the first procedure with LumiGuide, said: “This artificial intelligence-based semi-automatic registration is very quick and accurate, even in the presence of stent grafts. Especially, if there is a need to re-register the device being guided in the patient’s body during the procedure, it is extremely helpful.”

U.S. study highlights racial and ethnic disparities in the placement of ‘overused’ IVC filters

By
Jocelyn Hudson
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0
U.S. study highlights racial and ethnic disparities in the placement of ‘overused’ IVC filters
IVC filters
IVC filter

A nationwide U.S. study, recently published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL), showed that Black patients had the highest inferior vena cava (IVC) filter placement rate per 100,000 persons compared with white and Latino patients in the United States from 2016 to 2019.

“Given the known long-term complications and uncertain benefits of IVC filters, coupled with the 2010 US Food and Drug Administration [FDA] safety warning regarding adverse patient events for these devices, proactive measures should be taken to address this disparity among the Black patient population to promote health equity,” authors Jordan J. Juarez, MS,  (Philadelphia, USA) and colleagues remark.

Juarez, a medical student at Lewis Katz School of Medicine at Temple University, et al detail that they performed a retrospective review of National Inpatient Sample data to identify adult patients with a primary discharge diagnosis of acute proximal lower extremity deep vein thrombosis (DVT) from January 2016 to December 2019, including self-reported patient race and ethnicity.

The authors note that weighted multivariable logistic regression was used to compare IVC filter use by race and ethnicity. The regression model was adjusted for patient demographics, hospital information, weekend admission, and clinical characteristics.

Juarez and colleagues report in JVS-VL that, of 134,499 acute proximal lower extremity DVT patients included in the review, 18,909 (14.1%) received an IVC filter. Of the patients who received an IVC filter, 12,733 were white (67.3%), 3,563 were Black (18.8%), and 1,679 were Latino (8.95%). They relay that IVC filter placement decreased for all patient groups between 2016 and 2019.

After adjusting for the US population distribution, the investigators explain that the IVC filter placement rates were 11 to 12 per 100,000 persons for Black patients, seven to eight/100,000 persons for white patients, and four to five/100,000 persons for Latino patients. They share that the difference in IVC filter placement rates was statistically significant between patient groups (Black patients versus white patients, p<0.05; Black patients versus Latino patients, p<0.05; Latino patients versus white patients, p<0.05).

In discusssing their findings, Juarez et al look into possible reasons behind the uncovered disparities. “Although the reasons behind this racial and ethnic disparity need further investigation,” they write, “factors such as clinician bias related to concern for medication adherence could play a role.”

The authors also consider their results more generally in the context of IVC filter usage in the USA. They point to previously reported literature showing an implantation rate much higher in the USA than in Europe (three per 100,000 persons based on data from five large European countries). Against this background, they comment that higher placement rates in the Black community are “especially concerning” and “suggest that IVC filters are still overused in the USA”.

Focusing next on some of the limitations of their research, Juarez and colleagues underscore the possibility of unmeasured confounders not assessed and adjusted for in their multivariable regression analysis, among others.

“Future work should assess whether clinical bias for adherence to other treatments could be perpetuating this disparity in minoritized communities,” the authors write as a forward-looking concluding remark.

Mechanical thrombectomy demonstrates superior outcomes to anticoagulation in DVT patients, analysis of RCT and registry data shows

By
Bryan Kay
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0
Mechanical thrombectomy demonstrates superior outcomes to anticoagulation in DVT patients, analysis of RCT and registry data shows
Steven Abramowitz
Steven Abramowitz

Mechanical thrombectomy using the ClotTriever device (Inari Medical) for iliofemoral deep vein thrombosis (DVT) was found to be “associated with significantly” lower Villalta scores and a lower incidence of post-thrombotic syndrome (PTS) out to 12 months compared with treatment using anticoagulation, a propensity score matching analysis of a large randomized controlled trial (RCT) and registry data showed.

The study findings, led by first author Steven Abramowitz, associate professor of surgery at Georgetown University School of Medicine and chair of the Department of Vascular Surgery at MedStar Washington Hospital Center in Washington, DC, USA, were published online in the Journal of Vascular Surgery-Venous and Lymphatic Disorders (JVS-VL).

To assemble a propensity matched cohort, Abramowitz et al plumbed ATTRACT, the largest trial in the venous space to assess pharmacomechanical catheter-directed thrombolysis (pCDT) compared to anticoagulation, and the single-arm CLOUT registry, which included patients receiving mechanical thrombectomy with the ClotTriever.

A total of 164 pairs were matched, with no significant differences in baseline characteristics after matching, the authors noted.

They found that there were fewer patients with any PTS at six months (19% vs. 46%; p<0.001) and 12 months (17% vs. 38%; p< 0.001) among patients receiving mechanical thrombectomy.

Abramowitz and colleagues discovered upon statistical modeling that, after adjusting for baseline Villalta scores, patients treated with anticoagulation had “significantly higher odds” of developing any PTS (odds ratio [OR] 3.1; 95% confidence interval [CI], 1.5–6.2; p=0.002), or moderate-to-severe PTS (OR 3.1; 95% CI, 1.1–8.4; p=0.027) at 12 months compared with those treated with mechanical thrombectomy. They further found that mean Villalta scores were lower through 12 months among those receiving mechanical thrombectomy versus anticoagulation (3.3 vs. 6.3 at 30 days; 2.5 vs. 5.5 at six months; and 2.6 vs. 4.9 at 12 months; p <0.001).

“Propensity score matching of patients in the ATTRACT and CLOUT studies showed that, despite more limited use of compression stockings, treatment with mechanical thrombectomy resulted in a significantly lower PTS incidence and improved Villalta scores compared with anticoagulation treatment,” the authors wrote. “Those treated with mechanical thrombectomy had 27% and 21% lower rates of PTS at six and 12 months, respectively, as well as significantly lower mean Villalta scores at 30 days, six months, and 12 months. Similarly, matched patients treated with anticoagulation were found to have 3.1 times the odds of developing PTS at 12 months in logistic regression modeling adjusting for baseline Villalta scores.”

The authors noted the inherent limitations of propensity score matched analyses like the one they conducted. “A comparison of different clinical studies using propensity score matching by its nature introduces the possibility of bias from factors that differ between studies that are either unknown or unable to be controlled for,” Abramowitz et al wrote.

They highlighted how a RCT comparing iliofemoral DVT treatment using contemporary mechanical thrombectomy or anticoagulation would address most of their study’s limitations.

“Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of PTS following an acute DVT event,” the authors concluded.

Large administrative databases enter crosshairs as comparative analysis shows percutaneous mechanical thrombectomy as superior to CDT for acute PE

By
Bryan Kay
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0
Large administrative databases enter crosshairs as comparative analysis shows percutaneous mechanical thrombectomy as superior to CDT for acute PE
Photo by DIGITALE on Unsplash
Photo by DIGITALE on Unsplash

The pitfalls of large administrative databases came to the fore during the presentation of a propensity-match scoring analysis demonstrating that percutaneous mechanical thrombectomy (MT) was superior to catheter-directed thrombolysis (CDT) in patients diagnosed with acute pulmonary embolism (PE). Junji Taukagoshi, a vascular surgery resident at the University of Texas Medical Branch (UTMB) in Galveston, USA, presented the results from the retrospective analysis of patients drawn from the multi-institutional TriNetX network during the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 24–27) in Scottsdale, USA.

Taukagoshi and colleagues—including senior author Mitchell Cox, the vascular surgery program director at UTMB—showed that MT was associated with fewer 30-day perioperative complications, improved long-term pulmonary hypertension and right heart failure, and significantly fewer emergency room (ER) visits.

They performed the 1:1 propensity-match analysis with around 1,100 in each group who underwent the respective interventions within three days of a PE diagnosis from January 2017 to August 2023.

But the question of whether large administrative databases like TriNetX to produce the granularity of data can enable robust enough analysis quickly emerged when the study came under post-presentation scrutiny, with one questioner suggesting the research team perform sensitivity analysis to “potentially tease out these patients a little bit more precisely to make sure you don’t have a melting pot of individuals.”

Taukagoshi and Cox both acknowledged this limitation, with the latter describing both its benefits—large size, breadth and ease of use—along with the chief drawback that means “you can only get certain data from it.”

Taukagoshi detailed 30-day results show comparable mortality and number of blood transfusions. “However, MT was clearly superior when it comes to gastrointestinal bleed and intracranial hemorrhage. it is interesting that it was also superior with both lower rates of myocardial infarction and immediate post-procedural pulmonary hypertension. So, it looks like MT is the clear winner in the acute phase.”

Long term, MT continued to have better outcomes out to five years, Taukagoshi continued. “While mortality is not that much different, the incidence of chronic pulmonary hypertension and right heart failure are much improved in patients who had MT. They also had significantly fewer ER visits.”

Commenting further, he said 30-day data clearly showed MT as associated with “significantly fewer bleeding complications compared to CDT, which can be explained by thrombolytics,” alongside the lower incidence of MI and immediate postoperative pulmonary hypertension.

“Why is that?” he asked.

“We would speculate that more rapid clot clearance with MT might result in less myocardial strain and more rapid improvement in pulmonary hemodynamics.”

At five years, MT was also shown to be better, Taukagoshi added. “However, the overall incidence of chronic pulmonary hypertension is certainly higher than in previous studies. Clearly, our patient cohort had a high percentage of very significant high-risk PE events.”

So, is MT truly better? Taukagoshi asked, as he pointed to the limitations inherent in large databases. He further revealed that such data had persuaded his institution to shift away from thrombolysis toward MT in the majority of cases where interventions are required for massive or submassive PE.

“In the future, we would like to see if these results can be replicated with other large multi-institutional series or large datasets.”

Discussion points to lack of PE risk stratification information

Jean Panneton

Designated discussant Jean Panneton, a professor of surgery at Eastern Virginia Medical School in Norfolk, USA, led queries of the paper. He pointed to a lack of PE risk stratification information. “How do you believe that this may have impacted your results—[with] a propensity match that only matched for regular comorbidities, but nothing specific to the actual PE?”

In light of the administrative database source of the data and attendant Current Procedural Terminology (CPT) codes, Panneton questioned whether it was possible to know whether all of the interventions for suction thrombectomy or CDT were indeed “actually done for PE.”

“Could they have been possibly done for ischemic legs or for the 43% of patients with acute deep vein thrombosis [DVT] in that database?”

Jason Chin, a vascular surgeon at MedStar Health in Baltimore, USA, pointed out the different CDT regimens available and how that might have impacted results.

“It doesn’t seem like this database can parse that out,” he said. “I’m not sure if there is a code for ultrasound-assisted thrombolysis versus no-ultrasound assisted thrombolysis.”

Nitinol stents placed in iliac veins “not associated with prolonged back pain,” study finds

By
Jocelyn Hudson
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0
Nitinol stents placed in iliac veins “not associated with prolonged back pain,” study finds

In a retrospective review of over 600 patients who underwent iliac vein stent placement, the development of back pain was found to be unrelated to stent type, diameter, length or covered vein territory.

Chloe Snow (Greenbelt, USA) and colleagues share this and other findings in a recent Phlebology paper. The review was a joint investigation by researchers at Greenbelt’s Center for Vein Restoration, to which Snow is affiliated, and the Center for Vascular Medicine, also in Greenbelt.

Snow et al write in their introduction that endovascular stenting is the standard of care for the management of symptomatic chronic venous obstruction. However, they note that the increased radial resistive force and longer lengths of nitinol stents often used have “led to questions over persistent postoperative back pain”. The purpose of this investigation, therefore, was to assess the incidence and severity of postoperative back pain associated with nitinol stents compared to Wallstents (Boston Scientific).

The researchers performed a retrospective review of data from the Center for Vascular Medicine, assessing patient demographics and preoperative, one-week, three-, six- and 12-month visual analog pain scores (VAS) for back pain, stent type, diameter, length, and vein locations.

In the period April 2014–November 2021, a total of 627 patients—comprising 412 women and 215 men—were assessed for the presence of postoperative back pain after an initial iliac vein stent placement. The authors detail that the stents utilized were Wallstents (n=114), Venovo (BD; n=342) and Abre (Medtronic; n=171). The most common nitinol stent diameter and lengths were 14mm, 16mm and 120mm, respectively, they add, noting a p-value of ≤0.03.

The Venovo venous stent was granted Food and Drug Administration (FDA) premarket approval in 2019. BD reported at the time that theirs was the first stent indicated to treat iliofemoral venous occlusive disease. The previous year, one-year results from the prospective, multicenter, single-arm VERNACULAR trial had been shared, demonstrating the safety and effectiveness of Venovo for the treatment of symptomatic iliofemoral venous outflow obstruction.

In 2020, Medtronic announced that the Abre venous self-expanding stent system had received FDA approval to treat venous outflow obstruction. The approval was based on 12-month results from the ABRE clinical study, which assessed the safety and effectiveness of the Abre stent in patients with iliofemoral venous outflow obstruction.

Results

Snow and colleagues report in Phlebology that the incidence of back pain at one week was 66%, occurring in 411 out of the 627 patients assessed in the review.

They add that VAS scores at one week and one, three and six months postoperatively were the following: Wallstents 2.6±3 (n=66), 1.7±2.6 (n=43), 0.7±2 (n=51), and 0±0 (n=27); Abre 3.5±3 (n=130), 3.8±3 (n=19), 1.2±2.5 (n=12), and 1±2 (n=5); and Venovo 2.5±3 (n=216), 2.4±3 (n=70), 0.9±2 (n=68), and 0.6±1.7 (n=49).

The authors state that there was no difference in the severity of back pain at any time point (p≥0.99) and that the development of back pain was unrelated to stent type, diameter, length or covered vein territory.

In their conclusion, Snow et al reiterate that postoperative back pain was observed in 66% of patients at one week, and that the average pain score at one week for the entire cohort was three, which declined to less than one at one month. Furthermore, they found that no difference in the severity of back pain between groups was observed at any time point, and that the development of back pain is unrelated to stent type, diameter, length or covered vein territory.

Consortium led by vascular surgeon-scientist secures $6.4 million funding to develop sustainable alternative to contrast CT imaging

By
Jocelyn Hudson
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0
Consortium led by vascular surgeon-scientist secures $6.4 million funding to develop sustainable alternative to contrast CT imaging

The European Union Horizon Europe, with joint funding from UK Research Innovation, has awarded the NetZeroAICT Consortium €6 million ($6.4 million) in funding to develop a novel artificial intelligence (AI)-based computed tomography (CT) technology that has the potential to promote climate neutral and sustainable healthcare.

The international, transdisciplinary NetZeroAICT Consortium is headed up by Regent Lee, MBBS, a vascular surgeon scientist at Oxford University Hospitals NHS Foundation Trust and associate professor of vascular surgery at the University of Oxford in Oxford, England.

According to the multidisciplinary group—which further includes Vicente Grau, professor of engineering science at the University of Oxford—the new technology (CT Digital Contrast) can make CT scans “safer, faster, more equitable and more sustainable.”

Lee provided a high-level description of how the Technology works: the idea is to use AI to enhance non-contrast CT scans with the aim of getting the equivalent outcomes to a contrast scan. He elaborated: “When you do a contrast CT scan, you typically go through the scan twice. The first time, you have a non-contrast CT, and then, based on that non-contrast CT, the radiologist will calculate how tall you are, etc., and calculate the timing of the injection of the contrast. Next, the patient gets scanned a second time to get the contrast-enhanced CT. What we propose is that with AI, we would only require the first non-contrast CT scan. We can extract high-level information from the non-contrast CT scan using AI, overlay where contrast should be on the native non-contrast scan and display it as a digital contrast enhanced scan, without the need for the second scan.”

The funding received will allow the researchers to move Forward with development of the technology. Lee anticipates that the team will face some challenges along the way. He highlights, for example, that clinical acceptance may take time. “What we are proposing to do is quite radical,” he said. “Essentially we are proposing a complete change of how radiology services can be delivered, and there will be questions and reluctance amongst the clinicians to get used to this new way of looking at images.” He likened the task of launching the technology as “almost like trying to introduce a new language into the profession.” Lee also mentioned that patients may be fearful of using an entirely new method of imaging to treat them.

In a press release announcing the new funding, Lee commented on the wider significance of the consortium’s work: “The combined NetZeroAICT Consortium expertise will enable us to develop and deploy trustworthy ‘green’ AI software as a medical device with the ultimate goal to reduce the environmental footprint from CT imaging.

“European patients will have access to safer, faster, equitable and sustainable healthcare delivery while the healthcare systems strengthen their alignment with the European Green Deal. This is a new era of translational research. In addition to improving patients’ health, our aspiration is to improve planetary health for future generations.”

VAM 2024 pricing now available

By
Marlén Gomez
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VAM 2024 pricing now available

Pricing information for the 2024 Vascular Annual Meeting (VAM 2024) is now available. The event, scheduled in Chicago from June 19–22, is promoted as the year’s premier educational event for all vascular professionals. Organizers urge prospective attendees to secure funding from their institutions before the March registration launch.

VAM 2024 will reintroduce last year’s tiered registration model with an early registration period, a concept that was reintroduced to VAM for the 2023 conference. Early-bird registration will take place from March 20–April 10. After the April 10 deadline, prices will increase to the advance registration rate, which will last through June 17. An increased, on-site registration fee will be available to anyone who cannot register for VAM 2024 in advance.

The tiered registration model offers a significant discount for SVS members, which organizers say is consistent with other SVS education offerings. Individuals who register for the meeting before applying for SVS membership will be eligible to receive the refunded difference if the application is submitted. All membership applications are subject to approval. Visit vascular.org/Join to become a member.

Make a plan to secure your funding for VAM 2024 so you can register early and save. Visit vascular.org/VAM24Pricing to learn more.

New editorial team selected for Rutherford’s 12th edition

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Marlén Gomez
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New editorial team selected for Rutherford’s 12th edition

The SVS Executive Board has appointed the editorial team for the upcoming 12th edition of Rutherford’s Vascular Surgery and Endovascular Therapy. The team now includes Linda Harris, MD, Audra Duncan, MD, and Peter Henke, MD.

Duncan and Henke, alongside Harris, will work with 11th edition editors Tony Sidawy, MD, Bruce Perler, MD, to prepare the new editorial team for their upcoming tasks.

SVS President Joseph L. Mills, MD, expressed gratitude for the new appointments made to lead the title.

“The Publications Committee and Executive Board had a very difficult decision on its hands with three stellar proposals,” noted Mills. “All would do an outstanding job, and we thank them for their vision and interest in improving Rutherford’s. Drs. Harris, Duncan and Henke are uniquely positioned to take Rutherford to the next level.”

Speaking on behalf of the editorial team, Harris said: “We are excited and honored to have been selected to edit Rutherford’s 12th edition. We look forward to ensuring that it remains our ‘Vascular Bible’ for years to come.

“We expect to continue to innovate so that Rutherford’s is seen as the go-to book for all generations of learners.”

Rutherford’s 11th edition will come out during fiscal year 2025–26, when planning for the textbook’s 12th edition begins.

JVS group open-access papers

By
Marlén Gomez
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JVS group open-access papers

The Journal of Vascular Surgery (JVS) editors announced the open-access articles available in the flagship title’s March 2024 issue.

The relevant papers are: “Creating hemodialysis autogenous access in children and adolescents” (vascular.org/JVShemodialysis); “Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia” (vascular.org/JVSsafety); “Safety and learning curve of percutaneous axillary artery access for complex endovascular aortic procedures” (vascular.org/JVSLearningCurve); and “Preoperative predictors of non-home discharge after F/BEVAR of complex abdominal and thoracoabdominal aortic aneurysms” (vascular.org/JVSpreoperative).

JVS-Venous and Lymphatic Disorders, now a fully open access peer review title within the JVS stable, is available at www.jvsvenous.org.

JVS-CIT releases special issue on genetic arteriopathy

By
Marlén Gomez
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JVS-CIT releases special issue on genetic arteriopathy

The Journal of Vascular Surgery Cases, Innovations and Techniques (JVS-CIT) has published its latest virtual special issue, which covers genetic arteriopathy. This is the second special issue published in the journal. JVS-CIT currently plans to publish four per year.

JVS-CIT editors report that there are data showing manuscripts published in virtual special issues have a higher number of publications and are read more often.

The latest special issue theme is dedicated to the diagnosis of underlying aortopathy or arteriopathy etiology, and management of these conditions. The two guest editors are Sherene Shalhub, MD, of Oregon Health and Science University, and J.Westley Ohman, MD, of Washington University School of Medicine.

“Drs. Shalhub and Ohman are national thought-leaders in the management of genetic arteriopathies and were the key to making this issue possible,” said JVS-CIT Editor-in-Chief Matthew Smeds, MD. “They have been able to provide insight into the topic that would have otherwise been missing and helped put together a valuable resource for all vascular surgeons.”

The editorial board and guest editors of JVS-CIT spent six months recruiting content for the genetic arteriopathy issue. It contains 14 case reports and short communications. It can be found at vascular.org/JVSCITvsiGenetic.

JVS-CIT is currently recruiting manuscripts for the next two virtual special issues. The topics being studied include aortic dissections, guest edited by Firas Mussa, MD, and Bernardo Mendes, MD, and vascular trauma, guest edited by Mario D’Oria, MD, and Erica Leith Mitchell, MD. Release dates will be announced soon.

Audible Bleeding podcast expands horizons with new senior editor

By
Marlén Gomez
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0
Audible Bleeding podcast expands horizons with new senior editor

In the fast-evolving landscape of medical education, podcasts have emerged as a powerful medium for disseminating knowledge and fostering community among professionals. Among these, Audible Bleeding has carved a niche as an auditory experience and formal publication dedicated to shaping the minds of early-career surgeons.

Founded in 2018, the podcast has seen remarkable growth, culminating in 204,841 downloads in 2023. It boasts an average of 561 unique daily listeners, indicating a steady and engaged audience within the surgical community. Popular Audible Bleeding sub-series include “Lost in Translation,” which explores how vascular surgeons and patients communicate, and Journal of Vascular Surgery (JVS) “Author Spotlights,” which discuss that month’s articles in the JVS journals.

Last year marked a pivotal moment for the podcast as Imani McElroy, MD, a member since 2021, became the senior editor. Currently a senior general surgery resident at Massachusetts General Hospital in Boston, McElroy’s passion for addressing healthcare disparities stems from her first hand experiences in San Francisco. Her research interests, spanning implementation sciences and examining racial/ethnic and gender disparities within healthcare and vascular surgery, align with the podcast’s commitment to equity.

I am excited to contribute to the educational mission of Audible Bleeding. We are currently working on streamlining procedures to ensure consistent, high-quality content. My goal is to foster collaboration, making Audible Bleeding a hub for knowledge exchange within the vascular surgery community,” said McElroy.

In 2024, the podcast will introduce two new sub-series to diversify its content. The SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) will delve into developing a series of office-based lab (OBL) podcasts. In contrast, the “Managing, Organizing, and Navigating Investment Choices for Economic Success (MONIES)” sub-series will explore managing finances for medical professionals. These additions aim to cater to the audience’s diverse needs.

As McElroy steps into her role, Adam Johnson, MD, the podcast founder, expressed his confidence in the transition, stating: “I am thrilled to welcome Dr. McElroy as the senior editor. Her dedication to addressing disparities and robust research background make her the ideal leader for the podcast’s next chapter. I look forward to seeing the podcast flourish under her guidance.”

Listen to the Audible Bleeding on the podcast website, available at: www.audiblebleeding.com.

Budget neutrality and code valuation basics

By
Natalie D. Sridharan
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Budget neutrality and code valuation basics

So, what is budget neutrality and how does it affect physician payment? The Medicare Physician Fee Schedule (PFS) is a resource-based relative value scale (RVS) payment system, where relative value units (RVUs) are based on resource costs associated with physician work, practice expense and malpractice. The PFS has a budget neutrality requirement that has been in place since 1992. Budget neutrality is the federal mandate that requires an upward adjustment in expenditures in one area of the Medicare program to be offset by a downward adjustment in other areas. In the simplest terms, budget neutrality requires that the Centers for Medicare & Medicaid Services (CMS) make an overarching negative adjustment to the PFS to counterbalance any increases in PFS resources that CMS implements. This process occurs by implementing changes to the conversion factor (CF). The CF, a national dollar multiplier, is used to “convert” geographically adjusted Relative Value Units (RVU) to determine the Medicare-allowed payment amount for a particular physician service.

A significant budget neutrality adjustment went into effect in 2021 as a result of the revaluation of office/outpatient evaluation and management (E/M) codes within the PFS. However, coordinated advocacy efforts across the provider community resulted in Congress advancing legislation to mitigate the impact of the budget neutrality adjustment. They have taken similar action in each of the following years. Efforts to reverse the 2024 reduction in the PFS are still underway.

How are codes valued?

The American Medical Association (AMA) Relative Value Scale Update Committee (RUC) is an expert panel of physicians and healthcare professionals that makes recommendations to the federal government on the resources required to provide medical services. Medical services are described by Current Procedural Terminology (CPT) codes. CPT codes offer doctors and healthcare professionals a uniform language for coding medical services and procedures to streamline reporting, and increase accuracy and efficiency. CMS reviews RUC recommendations and determines the RVUs for CPT codes.

The AMA CPT panel meets three times per year in sequence with the RUC meetings. The CPT panel debates and approves new procedural codes, revises existing codes, and deletes obsolete ones. Typically, a code that has been revised or newly approved by the CPT panel will then be reviewed at the next RUC meeting for new or revised valuation.

Medical specialty societies such as the SVS—with 20% AMA membership and recognized by the AMA House of Delegates—nominate a specialty society member to advocate on behalf of their membership for appropriate values for medical services they provide.

These “RUC Advisors” present survey data to the AMA RUC panel. This panel is made up of physicians and other healthcare professionals.

There are 29 seats on the RUC. The majority of seats are filled by delegates from medical specialty societies. The RUC meets three times per year. Historically, greater than 90% of RUC recommendations were adopted by CMS, although that percentage fluctuates.

The survey data that the advisors present to the AMA RUC panel come from RUC surveys that the specialty societies disperse to the membership. The panel determines the questions and timeline for completion. The surveys include questions related to physician time, intensity, typical patients and pre-/postoperative care. The specialty society’s RUC advisor and coding committee review the data and prepare recommendations for the RUC panel.

Crucial role

Budget neutrality plays a critical role in these discussions; increasing the value of a particular code will result in a corresponding across-the-board decrease in reimbursement for all other procedures.

The exploration of topics such as budget neutrality and the valuation of CPT codes explains the crucial role these factors play in shaping healthcare reimbursement policies.

By highlighting how these processes occur, we hope to equip early-career vascular surgeons with the knowledge and insight necessary to actively engage in advocacy efforts and thereby contribute to the evolution of healthcare policies that directly impact their practice.

Natalie D. Sridharan, MD, and Nicolas J. Mouawad, MD, are both graduates of the SVS Advocacy Leadership Program.

‘Where are you from? Where are you really from?’

By
Saranya Sundaram
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‘Where are you from? Where are you really from?’
Saranya Sundaram
Vascular resident Saranya Sundaram, MD, shares a story of finding cultural understanding and community.

“It’s Sundaram, S-U-N…” I’m interrupted by a nurse asking me if I’d like to call anesthesia for an airway. I quickly nod and ask them to grab the crash cart.

“I’m sorry, you said… S-U-N-D-A-M?” the radiology resident repeats over the phone.

“No, I said S-U-N-D-A-R-A-M.” Another nurse asks me if this was the central line I wanted, and I give a thumbs up. They let me know they are still struggling to get another IV, but they could push the calcium through the remaining 16 gauge in the left arm. I tuck the phone against my shoulder and start grabbing the ultrasound, some flushes and gauze.

“I’m sorry, I still can’t find you. Can you spell it again?” he says a little louder over the phone, to get my attention. “It’s, what, S-U…” I try cutting him off, asking if there’s another way to look me up. I understand he needed my name for the wet read and thanked him for letting me know about the subdural on bed 11, but I had a man in the ICU a full minute into chest compressions, and I needed to get control of the room. He starts to argue, though I was saved by my intern who, after witnessing my frustrated expressions from across the room, grabbed the phone from me and promised to handle it. I thanked him quietly and refocused on the room.

I find myself back at this experience every once in a while. Sometimes, it’s while reflecting on my own, at home snuggled up with my dog, about the general absurdity of the situation. Yes, the absurdity that while running my first code as ICU chief, I was spelling my last name to a person who couldn’t be bothered to figure it out.

If I really thought about it, there wasn’t a clinic where I hadn’t gotten the I-know-you-aren’t-from-around-here-and-I’m-going-to-figure-you-out stare. And I had grown accustomed to the questions that followed— “Where are you from?” “Where are you really from?” And the occasional and bold, “You’re Indian right?”

In truth, Charleston wasn’t much different from the towns that I grew up in. My parents were deeply religious South Indians who just happened to settle on sleepy Carbondale, Illinois, as their opportunity for a life in America. Regardless, my parents had always been good at finding “the community,” even in places like Emporia, Kansas, where their children were born, or Grand Rapids, Michigan, where they grew up. It wasn’t until my later years that I realized my parents and Brother were the only aspect of “the community” I needed.

With thousands of miles now separating us, that quiet comfort of feeling seen and understood felt farther than it had ever been. But I’d like to think my time on research this year has allowed me a certain clarity. That out-of-place feeling is dealt more subtly outside of the hospital. And without the defense mechanism clinical efficiency had allowed me, I am forced to think about things as they happen and also pay more attention to how the people around me respond to similar situations.

Two of my co-residents have found ways to make themselves feel a little more at home, trying all the Vietnamese pho spots they happen upon or finding the best beef broccoli in Charleston at the back of a Chinese grocery store. And I realize now that spending time with them has always brought me closest to that feeling of community. Thinking back, things like the annual “Happy Diwali” phone calls from my program director were opportunities to be a part of “the community,” even if I didn’t realize it at that moment. It wasn’t until I was in the middle of a debriefing with one of my attendings, who happens to be one of a few Black female surgeons practicing in South Carolina, that it hit me—that feeling of “otherness” could be shared and understood across vastly different backgrounds.

I’ve started to lean into that clarity and the people who may not look like me but can understand me. The comfort that I have found from shared experiences has been life and outlook altering. Every once in a while, yes, I get that twinge of discomfort when I use a nickname at restaurants or spell my name over the phone. But I notice myself smiling more when I think about how much my co-residents or attendings would enjoy hearing about this new absurdity. And, for a moment, I realize that I have found my own sense of community.

Saranya Sundaram is a vascular surgery resident at Medical University of South Carolina in Charleston.

As temporal trends in hemodialysis access creation emerge, notion of AV fistula superiority comes under scrutiny

By
Bryan Kay
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As temporal trends in hemodialysis access creation emerge, notion of AV fistula superiority comes under scrutiny
Bright Benfor (left), Charmaine Lok (middle), and James J. Fitzgibbon (right)

The 2024 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 24–27) hears three separate talks—two scientific papers and one from an invited guest lecturer—that separately and from different angles checked the pulse of the arteriovenous fistula (AVF)-first era.

Sandwiched neatly between two complementary dialysis access papers on the SAVS 2024 program, a prominent nephrologist and chair of the taskforce responsible for the 2019 update of the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines delivered a point-by-point take down of the myths that she says surround the idea that AVFs are superior to arteriovenous grafts.

Charmaine Lok, MD, a professor at the University of Toronto in Canada, and medical director of the chronic kidney diseases and vascular access programs at Toronto General Hospital, was delivering the Scottsdale, Arizona-hosted meeting’s Jesse E. Thompson, MD, Distinguished Guest Lecture, the first non-surgeon to do so.

Taking attendees on a tour through the literature, she sought to debunk key aspects around why AVFs are accepted as superior to AV grafts, Lok challenged the argument that fistulas last longer than grafts. However, she said, the key data from which that assertion is derived do not compare all fistulas created vs. all grafts created. “They’re comparing fistulas that actually worked to all grafts,” she explained, making it a “flawed, biased analysis.”

After repeating the analysis, she found that after accounting for primary failure, there was no difference between fistulas and grafts—which was “true for both forearm and upper-arm fistulas.”

Lok added, “And when we looked at upper-arm access only, there was no difference between fistulas and grafts, whether or not we include or exclude primary failures.” Randomized controlled trial data tell a similar story, she said. In one, grafts “actually had superior survival [or lasted longer] compared to fistulas for both primary patency as well as secondary patency.”

Turning to the idea that fistulas have fewer complications, Lok pointed to a rare study in this area that focused on infection rates: among 200,000 patients, the investigators found that, between fistulas and grafts, the rate was the same, she said.

Moving on to the similar contention that fistulas require fewer interventions than do grafts, Lok drew on a study she said summarizes the evidence thus far: “Patency outcomes of fistulas and grafts is a trade-off between non-maturation and long-term outcomes,” she explained, also pointing to evidence from a study with follow-up out to six years showing that 50% of fistulas needed more interventions before use versus only 17% of grafts.

As for the proposition that AVFs lower costs, she pointed to evidence that demonstrated fistulas cost less only when the AVF maturation rate was greater than 82%. “We have already shown you that that is not happening—our fistula maturation rate was only about 40%,” Lok noted.

Finally, she rested on the idea that fistulas are associated with lower mortality when compared with grafts. She cited a study that demonstrated mortality risk was best with fistulas compared to catheters and grafts. Ultimately, Lok said, the higher mortality in those subjects was attributed to the higher comorbidity burden of patients receiving these access types. It boiled down to selection bias, she added.

Which led her to two ultimate questions: What do you think of fistulas now? she asked. Are they really that superior?

“It all depends on your point of view,” Lok said. “Fistula-first was a population-based perspective versus the patient perspective. Now, in this new era, we are looking at patient-centered care—and can you really apply a one-sized fits all to vascular access?”

AVFs in the forearm: Unchanged rates

At the podium immediately before Lok, James J. Fitzgibbon, MD, set the tone, as he presented data from a study on temporal trends in hemodialysis access creation in the fistula-first era among a patient cohort who were all recipients of first-time AVF and AV grafts in the upper-extremity.

The Brigham and Women’s Hospital, Boston, resident and colleagues set about answering the central question of whether rates of AVFs in the forearm are increasing. In short, they found that forearm fistulas constituted only a quarter of first-time accesses in the Vascular Quality Initiative (VQI) dialysis access database, with no significant increase seen across the 2012–2022 study period.

Upper-arm AVFs made up 57% of the 52,000 patients included in the retrospective cross-sectional analysis, with 15% upper-arm AV grafts and 1.5% AV grafts in the forearm. “There was no significant change in forearm AVFs across our study period,” Fitzgibbon told SAVS. “The only significant change we did find was there was a decrease in forearm AV grafts.”

Fitzgibbon and colleagues had a particular backdrop in mind as they conducted the analysis: the fistula-first approach described by Lok that was encapsulated in movements to promote autogenous access across the U.S., first with the “Fistula-First” initiative of 2005, and then the “Fistula First-Catheter Last” campaign it morphed into by 2015.

They looked at the impact of the latter by conducting an interrupted time series analysis of the rates of AVFs and AV grafts both before and after it was launched, but they did not detect a significant effect on the rates of AVFs or AV grafts after implementation. However, they did uncover significant increases in upper-arm AV grafts in women, elderly and Black patients, Fitzgibbon added.

“The goal of this project was to broadly report practice patterns across the U.S.,” he concluded. “This is by no means a comment on appropriateness of access; this is not trying to say that every patient should receive a forearm fistula, or is appropriate for a forearm fistula.”

Exploring appropriate access selection

Near the close of SAVS 2024, Bright Benfor, MD, a research fellow at Houston Methodist in Houston, Texas, stepped into the dialysis access fray with a study that compared surgeon choices of AVF to that recommended by an emerging app called “My Vascular Access.”

The program, which grew out of expert consensus and the KDOQI guidelines, is aimed at helping guide the right type of access for patients.

“Two days ago, we heard Dr. Lok talk a lot about the new KDOQI guidelines and how they focus more on a shift from fistula-first to the right access, for the right patient, at the right time, and for the right reasons,” Benfor told attendees.

With that in mind, Benfor and colleagues conducted a review of patients undergoing autologous AVF creation at Houston Methodist to determine how its surgeons’ choices between January and August 2021 held up against the app’s appropriateness rankings, ultimately asking, “Do we need it?”

They looked at 113 accesses performed during the study period. “We can see that there is a high number of radiocephalic fistulas that we created during that time, and we saw the number actually created were statistically significantly higher than the numbers that were recommended,” Benfor said. “Also, in other cases, the app recommended a graft be placed, but our surgeons went ahead and put in a fistula.”

Overall, 61% of the accesses were ranked as appropriate by the app, with 22% deemed inappropriate and 10% intermediate. “There is a significant mismatch between what the app is recommending and access actually created by the surgeons,” he concluded. “One thing we believe influences the choice of access is the level of expertise of the surgeon, which is not taken into account by an app.”

Vascular Verification Program green-lights first three outpatient centers

By
Marlén Gomez
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Vascular Verification Program green-lights first three outpatient centers
Joseph L. Mills (left) and Anil Hingorani (right)

The American College of Surgeons (ACS) and the Society for Vascular Surgery (SVS) have verified the first three outpatient centers under the newly launched Vascular Verification Program (Vascular-VP), with initiatives that focus on ensuring the highest quality of vascular surgical and interventional care in both inpatient and outpatient settings.

The verified centers, namely Albany Medical Center Vascular Outpatient Lab in Albany, New York, Total Vascular Care in Brooklyn, New York, and Michigan Vascular Center in Flint, Michigan, have demonstrated their commitment to improving patient outcomes and delivering treatment, said Clifford Y. Ko, MD, director of the ACS division of research and optimal patient care.

“These three centers have, first as pilot sites and now as verified centers, established themselves as leaders in outpatient vascular care. They have paved the way for many more centers to join us in their journey to continuous improvement by using data and ACS standards and resources to deliver the best possible patient care,” said Ko.

The Vascular-VP, a collaborative effort between the ACS and SVS, offers two levels of participation, one for inpatient and one for outpatient centers. Built on a foundation of quality metrics, program resources, facility standards, and service provisions, the program emphasizes data collection and quality improvement activities. The shared standards across all levels ensure a comprehensive and standardized pathway for centers to enhance their vascular care infrastructure.

“This is a tremendous initiative and joint effort between the SVS and the ACS to address a very important issue in today’s healthcare landscape, as much care is now being delivered in the outpatient setting. These three verified centers are at the forefront of efforts to improve, monitor and optimize the outcomes of outpatient care for patients with vascular disease,” said SVS President Joseph L. Mills, MD.

To achieve verification, the three centers met the standards outlined in the Optimal Resources for Vascular Surgery and Interventional Care—Outpatient Standards framework. This set of standards addresses essential elements of vascular surgical care and quality, ensuring that verified centers maintain the highest standards in patient care.

“Participating in Vascular-VP brought together a lot of our resources, including nursing, vascular lab, office-based lab, front desk and others, to improve the care we are providing to the vascular patient,” said Anil Hingorani, MD, FACS, a vascular surgeon with Total Vascular Care. “These resources have helped set us apart from our competitors. It’s not just the quality or safety in this competitive market; you must be aware it’s a continuous cycle of looking at your results to find solutions and improvements to improve patient quality.”

Their Vascular-VP verification gives these centers the status of ACS Surgical Quality Partners, which signifies their commitment to continuous improvement, adherence to rigorous standards and dedication to delivering quality care. Patients seeking services at Surgical Quality Partner centers can trust that they are receiving care of the highest standards in surgical quality.

Both inpatient and outpatient centers interested in joining this initiative and continuing their vascular service quality improvement journey are encouraged to make an application online.

Learn more about the Vascular Verification Program at vascular.org/Verification.

Landmark BEST-CLI trial gains recognition as top cardiovascular advance in 2023

By
Marlén Gomez
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Landmark BEST-CLI trial gains recognition as top cardiovascular advance in 2023
Alik Farber (left) and Matthew T. Menard (right)

The American Heart Association (AHA) has named the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) trial one of the top cardiovascular advances of 2023. This study—led by vascular surgeons Alik Farber, MD, and Matthew T. Menard, MD, and interventional cardiologist Kenneth Rosenfield, MD—compared open and endovascular treatments for chronic limb-threatening ischemia (CLTI) and was aimed at exploring the effectiveness of each treatment modality.

“First and foremost, it brought surgery back into the discussion of CLTI care against a backdrop of a progressive decline in the use of surgical bypass and a dramatic escalation of the use of endovascular therapy,” commented Menard.

“Given the primary finding that surgery was more effective at preventing the main endpoint of major adverse limb events [MALE] or death, it was a wakeup call of sorts to the vascular surgical world in terms of the ongoing importance of surgery as a treatment option.”

Menard, from Brigham and Women’s Hospital, and his counterpart Farber, at Boston Medical Center, both in Boston, brought together their expertise in vascular and endovascular surgery to embark on a journey that spanned well over a decade. The duo initiated the idea for the BEST-CLI trial in 2007, during a break at the New England Society for Vascular Surgery annual meeting that year, recognizing the need to address the uncertainty surrounding the optimal treatment for CLTI patients. Rosenfield, from Massachusetts General Hospital, joined before the trial was approved and provided an interventionalist perspective to the project.

Farber said that neither he nor Menard had experience conducting clinical trials when they first conceptualized the idea. However, reaching out to the Society for Vascular Surgery (SVS) leadership proved crucial in securing the necessary support to turn their vision into reality.

The trial began enrolling patients in 2014 and concluded in 2019, though it encountered numerous challenges and roadblocks. Despite the complexities involved, Rosenfield acknowledged the enthusiasm within the medical community to answer the question of the optimal treatment for CLTI. To pursue the trial and provide impetus over the ensuing decade, the investigators confirmed the high degree of equipoise associated with the two standard-of-care open surgery and endovascular treatment strategies through a survey conducted early in the process. Involving over a thousand investigators across 150 sites worldwide, the trial required a substantial commitment to complete.

“The SVS has been critical, from the first outreach we undertook in 2009 to the support provided by every one of the SVS presidents since that time. They not only formally endorsed the trial,” said Farber, “they played a key role in our successful fundraising effort towards the end of the trial. They also helped us throughout the process by allowing us to showcase the trial in publications such as Vascular Specialist, within Society-sponsored webinars and at the SVS annual national meetings.”

The trial’s secondary findings, unveiled at the 2023 Vascular Annual Meeting (June 14–17) in National Harbor, Maryland, revealed that both open and endovascular procedures were equally safe for CLTI patients, and that, notably, the major adverse cardiovascular event (MACE) and mortality rates were similar between the two study arms. Farber stressed the study’s broader implications, noting its impact on raising awareness and interest in CLTI care, and in reinforcing a focus on CLTI globally, especially in the context of the increasing prevalence of diabetes.

“It’s the patient that suffers the most when we, as a community of physicians and caregivers, are unclear about best practices,” added Farber.

“We owe an incredible amount of gratitude both to the patients who were brave enough and generous enough to allow us to investigate this clinical problem through their experience, and to all the investigators, including many SVS members, who worked so hard to see the trial through to completion. The benefits of BEST will continue to be paid forward, as the wealth of generated data will serve as a foundation on which we as a community can base future efforts to better understand the numerous unanswered questions that remain in CLTI care.”

AAA and complex repair: ‘We need more evidence,’ says UChicago chief

By
Jocelyn Hudson
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AAA and complex repair: ‘We need more evidence,’ says UChicago chief

A randomized controlled trial (RCT) of open repair versus endovascular aneurysm repair (EVAR) for the treatment of abdominal aortic aneurysms (AAAs), as well as head-to-head trials for additional information on EVAR and complex repairs, are warranted. This was the main conclusion of Ross Milner, MD, during a presentation he delivered as part of an “EVAR Developments” session at the recent Critical Issues America (CIA) annual meeting (Feb. 2–4) in Miami, Florida.

The professor of surgery and chief of the Section of Vascular Surgery at the University of Chicago Medicine in Chicago opened his talk with reference to a 2020 Journal of Vascular Surgery paper by Konstantinos Spanos, MD, and colleagues titled “A new randomized controlled trial on abdominal aortic repair is needed.”

In response to this need, Milner highlighted that Medtronic has launched three trials—HERCULES, ADVANCE and SOCRATES—the latter being the main focus of Milner’s talk at the CIA meeting. He homed in first on HERCULES. The purpose of this multicenter, global, randomized controlled post market trial, he shared, is to compare endosuture aneurysm repair (ESAR) to standard EVAR in the treatment of AAAs with wide proximal necks, and will be the first comparative trial to do so. He noted an enrollment goal of 300 patients at 40 sites across Europe and the U.S.

Milner then turned his attention to ADVANCE, which he said is the first EVAR head-to-head RCT looking at aneurysm sac regression outcomes between two devices. “The ADVANCE clinical study will progress the work of sac regression as a key early indicator of long-term outcomes,” he remarked. The study will “bring EVAR evidence into the current decade,” Milner added, and “empower physicians to make precise, evidence-based clinical decisions that improve patient outcomes.”

SOCRATES, meanwhile, will focus on treatment modalities for an especially complex group of AAA patients. Its purpose, Milner elaborated, is to compare the safety and performance of ESAR versus fenestrated EVAR (FEVAR) for the treatment of AAA patients with infrarenal aortic proximal neck lengths of 4–15mm and minimal proximal sealing zone lengths of 8mm.

“Hostile aortic necks can lead to a loss of proximal seal over time,” he said by way of background to the study, detailing that short necks are associated with increased risk of type Ia endoleak and secondary procedures. Milner noted that there are two treatment options available here: extending the sealing zone proximally or reinforcing the sealing zone. SOCRATES will compare the two.

The trial will be conducted at up to 40 sites in the U.S. and Europe, with Milner listing Austria, Belgium, France, Germany, Italy, The Netherlands, Spain and Switzerland as the European countries participating in the trial.

In terms of patient selection, Milner relayed that at least 204 patients are due to be randomized (1:1) and evaluated for non-inferiority. Patients will be treated by one of two methods: ESAR with Medtronic’s Endurant II/IIs with Heli-FX EndoAnchor implants, or FEVAR with either Cook’s Zenith fenestrated stent graft system or—in Europe only—Terumo’s fenestrated Anaconda equivalent.

“[SOCRATES] will be the first comparative trial of ESAR and FEVAR in the treatment of patients ineligible for standard EVAR due to challenging anatomical criteria but within the IFUs [instructions for use] of the two treatment modalities,” Milner summarized. He added that the trial is actively enrolling.

The latest update from the trial, Milner shared, is from August of last year, when the first U.S. patient was treated in the study by co-principal investigator BrantW. Ullery, MD, in Portland, Oregon.

“We need more evidence,” Milner said in his closing statement, looking at the field of AAA repair as a whole. Looking forward, he specified that an RCT of open repair as compared to EVAR—as well as FEVAR and branched EVAR (BEVAR)—is needed, and that head-to-head trials “will ideally provide additional safety and efficacy information for EVAR and complex repairs.”

Fifth edition of SVS leadership program reaches capacity

By
Kristin Spencer
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Fifth edition of SVS leadership program reaches capacity

The fifth cohort in the society for Vascular Surgery (SVS) Leadership Development Program (LDP) reached capacity in early February due to limited space and high interest from members.

According to LDP faculty, the curriculum draws from the highest quality evidence-based model of leadership contained in the Jim Kouzes- and Barry Posner-penned book, The Leadership Challenge, with an intense focus placed on applying this knowledge into the world of real-life challenges.

Manuel Garcia-Toca, MD, Faisal Aziz, MD, Dawn M. Coleman, MD, Randall R. De Martino, MD, Kristina Giles, MD, and SVS Executive Director Kenneth M. Slaw, PhD, will lead the program.

“We all will have an opportunity to be leaders in some way shape or form as our careers evolve,” said LDP graduate Leigh Ann O’Banion, MD. “The LDP is a great way to learn from your colleagues and develop a foundational skill set that will be a valuable tool throughout your career!”

Garcia-Toca, who chairs the SVS LDP, added: “The direct correlation between effective leadership and improved patient outcomes makes this program beneficial not just for the surgeons themselves but also for the broader healthcare community they serve”.

A proposal to save vascular surgery

By
Russell H. Samson
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A proposal to save vascular surgery

In response to recent articles in the lay press suggesting vascular surgeons were performing unnecessary procedures, Vascular Specialist medical editor, Malachi Sheahan, has asked me to write an editorial based on a talk I presented at the 2023 VEITHsymposium. At that meeting I provided data demonstrating which specialties are treating vascular patients and the rate of insurance denials dependent on provider specialty. I was originally reluctant. I had stopped writing editorials for Vascular Specialist because I had said all that I had on my mind. I was also concerned that, eventually, I would write a piece that readers would find so controversial that I would never be able to show my face in public again.

Well, here it is. I am going to come right out and say it in big, bold, black-and-white letters: “We need the insurance industry to save vascular patients and vascular surgeons.” To those few of you still reading, please stay with me. I am not suggesting that we continue the current system of prior authorization, since it is time-consuming, expensive, a nuisance for the provider and patient, and still does not guarantee quality care. Rather, I am going to propose a different system that I think has merit.

But first, here is some background as to how I came to the unfortunate conclusion that these companies could be the answer and not the problem. This will require that I detail some of the data that I addressed at the VEITHsymposium and my takeaway from the recent barrage of articles about unnecessary atherectomy. Further, how an American Board of Vascular and Endovascular Surgery (ABVES) aligns with my proposal, and why I keep urging that the Society for Vascular Surgery (SVS) change its name to the American College of Vascular and Endovascular Surgery (ACVES).

First, which specialty is responsible for most of vascular surgery in the United States? For the last two years I have been involved in developing and overseeing a major insurance carrier’s 100% outpatient Medicare Advantage prior authorization (PA) program involving 10 endovascular codes dealing with iliac, femoropopliteal and tibial arteries (Codes 37220–372230), and recently all vascular surgery. Medicare Advantage programs are now insuring more than 50% of all Medicare participants, so my experience has provided me a good overview of who is doing what and why. Cardiologists accounted for 48% of the requested PAs, with 42.6% from vascular surgeons, 8.3% from interventional radiologists, and 1% from general surgeons, thoracic surgeons, or nephrologists. There was a geographic variation with vascular surgeons, cardiologists, and interventional radiologists requesting, for example, 40%, 53%, and 6% PAs in Florida; 42.6%, 28.7%, and 28.7% in Texas; and 63%, 26%, and 11% in New York State, respectively. Irrespective of the variation, these data clearly show that, overall, vascular surgeons are probably doing less than half of the vascular procedures in the U.S. Now that the Centers for Medicare & Medicaid Services (CMS) has approved carotid stenting for asymptomatic patients, it is likely that cardiologists will take away even more procedures.

Diminishing voice

The fact that cardiology is now dominant has enormous repercussions. It diminishes the voice of vascular surgeons such that government entities, insurance companies, the lay press, and the public will turn to cardiologists and their societies for information, advice and treatment. This must have a negative impact on the viability of vascular surgeons’ practices and on patients’ health. Now, why do I say that it will affect patient health?

The answer to that also comes from my program, which has evaluated well over 20,000 requests for PA. Last year I presented a small sample of 1,488 PA requests (946 original PA, 172 peer-to-peer, and 370 appeals) for outpatient procedures from 20 states, with New York, Texas and Florida accounting for the majority. All PAs were evaluated predominantly by vascular surgeons or, on occasion, Board certified interventional cardiologists. Subsequent peer-to-peer discussions were performed by vascular surgeons. Let me assure you that this program was initiated because the company was convinced that abusive practices were causing harm not only to its bottom line, but also to its members’ (patients’) health and well-being. Since there is only one Local Carrier Determination (LCD 35998) dealing with non-cardiac stents, and since that LCD can only be used in six states for outpatient care, most insurance companies have developed their own documents outlining indications and appropriate use criteria. Some also use proprietary guidelines such as InterQual.1 For the most part, these are carefully researched, well-written attempts to curtail unnecessary procedures, yet ensure that necessary ones are authorized.

Our program predominantly used InterQual but also SVS appropriate use guidelines,2 as well as guidelines sponsored by the American College of Cardiology and American Heart Association.3 Overall denial rates were 44.8% for initial PAs, 45.8% for peer-to-peers, and 41% for appeals. Denials were more frequent for PA requests from cardiologists (56%) than interventional radiologists (47%) and vascular surgeons (30%). Admittedly, some denials were for lack of information or incorrect coding, but many were because patients were being rushed to the office-based lab (OBL) without attempts at conservative therapy. Some case scenarios attributed to cardiologists and interventional radiologists may shock even the most jaded reviewer. For example: a request to perform tibial atherectomy for claudication on a dialysis patient who one month previously had the peroneal artery perforated requiring two units of blood transfusion, fasciotomy, and resultant myocardial infarction; superficial femoral artery (SFA) and tibial atherectomy performed via pedal approach yet no prior or post attempt to treat proximal complete occlusion of the common iliac, external iliac and common femoral arteries; a patient with clearly defined significant femoropopliteal and tibial disease and a leg ulcer booked for an arteriogram but first having bilateral saphenous vein ablations thus destroying the potential for a tibial saphenous vein bypass; and now that we are reviewing all aspects of vascular surgery, an epidemic of PAs to treat “May-Thurner syndrome” affecting octogenarians with bilateral ankle swelling and congestive heart failure.

Since many of these latter requests are coming out of Florida, I suspect that May-Thurner syndrome must be caused by mosquito bites, as this would be the only way this epidemic could be explained. Further, radiologists are now offering endovascular embolization of genicular arteries to treat arthritis of the knee. In one case, the radiologist performed one of these procedures on a knee contralateral to a below-knee amputation and where the SFA was already showing evidence of atherosclerosis. What an amazing indictment that about half of all requests from these other specialists were denied.

Need I say more about how the expanded role of cardiologists will affect vascular patients? Well, if this is not sufficient, what about all the recent articles in the lay press? There is now an avalanche of material detailing the abusive use of atherectomy predominantly by cardiologists. However, as our PA program highlights, it is not just atherectomy but all the peripheral endovascular procedures.

‘Operate, Medicate and Dilate’

We must also recognize that, unfortunately, vascular surgeons accounted for 30% of the denials in this Medicare Advantage program. In a past editorial for Vascular Specialist, I made it abundantly clear that I believed that vascular surgeons, like the Knights of the Round Table (or more aptly, the rectangular table?) in the Arthurian legend, follow a chivalrous code of honor that guides us in placing a patient’s well-being ahead of financial reward. We ride out, catheter, stent and knife at the ready to defeat the malevolent atherosclerotic enemy. We proudly fly our banner proclaiming that only we “Operate, Medicate and Dilate.” We denounce other specialists involved in vascular care as Dark Knights whose evil intent is to plunder, their poor behavior induced by disparate payment schedules that favor dilating, rather than operating or medicating.

Yet, I am now chagrined to acknowledge that we too have knights who forsake their code of chivalry—vascular surgeons who value the attainment of wealth or prestige as their raison d’être. Perhaps a few examples of PAs requested by vascular surgeons will highlight that not all vascular surgeons follow appropriate guidelines: a stroke patient is wheelchair-bound and has no complaints relating to her legs but the duplex scan shows a “serious” SFA 80% occlusion that, if it occludes, can cause amputation; a request to treat an occluded anterior tibial artery at the same time as an SFA endovascular treatment for claudication, yet the posterior tibial and peroneal arteries are widely patent; an iliac angioplasty for claudication in a patient on home oxygen with limiting shortness of breath while being treated concomitantly for lung cancer; and four repetitive procedures within six months to treat recurrent right SFA occlusions with a patent popliteal and two-vessel runoff, yet no discussion of a surgical alternative? We need to make these “Dark Knights” aware of how their actions have a negative effect on the rest of us. Because, if left unchecked, castigation in the media and government action will punish all vascular surgeons and our legendary contributions to the management of vascular disease will fade from memory, just like Arthur and his knightly court.

Before I move on, let me speak to those of us who try to follow exemplary practice. Let us look deeply at our own experience and assess whether the following scenarios may be impacting what we do. In general, endovascular procedures are much easier to perform than open surgery, so a stent rather than a bypass. Complications may not be as devastating, so perhaps an inclination to intervene earlier in the disease process. As endovascular procedures replace open surgeries, new graduates and even older surgeons may begin to feel uncomfortable performing complex surgeries, so an angioplasty when a bypass may be preferable. Use a well-reimbursed new technology, though unproven, since it has a novel cache that can be advertised to referring physicians. Do some of these scenarios seem familiar?

Now let us return to the articles that were published in the New York Times and ProPublica since they are painting vascular surgeons with the same paint brush as cardiologists. It would take a highly educated layperson to realize that vascular surgeons accounted for very few of the 200 or so accused of overutilization since the word used most frequently is “vascular” not “cardiology,” and the authors often referred to the procedures as surgeries. So perhaps for the first time, the lay public is becoming aware of vascular surgeons, but surely this is not the way we had hoped? Let’s face it, the magician David Copperfield could not make vascular surgeons more invisible than we are now. Dr. Alan Dietzek, in his presidential address to the Society for Clinical Vascular Surgery,4 titled his first chapter, “The anonymity of our specialty,” and the following quotation remains true today. “Why are we still not recognized as the go-to physicians for the treatment of vascular disease? Why are we still fighting a battle for recognition that never seems to end? When will it change and how can we change it? Will our specialty survive?” Alan goes on to make an impassioned case for an American Board of Vascular Surgery (ABVS) independent from the American Board of Surgery (ABS), and he has remained committed to this quest.

I am suggesting that it rather be named the American Board of Vascular and Endovascular Surgery. Recently, cardiologists have approached the American Board of Medical Specialties (ABMS) requesting that their Board separate from the American Board of Internal Medicine, thus establishing a separate Board of Cardiovascular Medicine. If vascular surgery does not achieve its own board first, it will finally relegate vascular surgeons to being second-class purveyors of vascular treatment. Soon, I suspect the American College of Cardiology will adopt the name “American College of Cardiovascular Medicine.” That will be even more devastating; however, we cannot prevent it from happening. What we need instead is to immediately adopt a name change for the SVS. Some years ago, when the logo of the SVS was about to change, I suggested it was an opportune time to give up on the name Society for Vascular Surgery and rather become the American College of Vascular and Endovascular Surgery (ACVES). This has an imprimatur that will result in respect for its members and its messaging. It is more important now than ever before. Now, some will say it is too costly to change the name of the SVS and to have a separate ABVES. Stay tuned because my proposal will also pay for these changes. Together with the American Board of Vascular and Endovascular Surgery (ABVES), these renamed and new organizations will restore our preeminent position as the primary thought leaders and providers of vascular care.

If vascular surgery does not achieve its own board first, it will finally relegate vascular surgeons to being second class purveyors of vascular treatment

To summarize, it is apparent that cardiology is taking over much of the management of vascular surgery patients in the U.S. The quality of their care is suspect. However, we must admit that some vascular surgeons do not offer optimal care either. Part of the reason for cardiologists’ increasing supremacy is that vascular surgeons have failed to market who they are and what they do. By allowing the ABS to represent vascular surgeons, we have abrogated our ability to stand as a unique entity. The SVS has not been aggressive in marketing vascular surgeons and even the name of the Society does not assure that vascular surgeons are the go-to specialists for vascular interventions. Insurance companies are aware of an increasing number of unnecessary procedures and are ramping up prior authorization programs. Hence my proposal.

Program of spot-checks

I propose that the American College of Vascular and Endovascular Surgery, in conjunction with the ABVES, develop the following program. Member vascular surgeons agree to have 10 procedures a year spot-checked randomly by the carrier after the procedures have been completed. In return, participating physicians will not require PAs for their patient procedures and surgeries. The review will include actual images rather than just reports since the written word can manipulate the truth, but images do not lie. If patients had wounds or varicose veins, photographs would also be provided. The review will be performed by Board-certified vascular surgeons who have been rigorously trained by a program developed by the ABVES. The reviewers will be required to be thoroughly versed in Medicare rules as they apply to vascular surgery, the various LCDs and their jurisdictions, and appropriate use guidelines and peer reviewed manuscripts selected by the ABVES. Before being accredited as a certified reviewer, they will have to undergo a test developed and run also by the ABVES. The program will also assist in procuring and paying for state licensure where necessary. Appropriate insurance will also be provided. Importantly, these reviewers will be well compensated for their work. All would have to sign an agreement that they will not review a potential competitor, or someone closely affiliated. A peer-to-peer will be mandatory before any denial. The goal should be remedial education and not punishment. Denials will be reviewed by a second reviewer before a final determination. Denials will not be considered evidence of negligence but rather noncompliance with insurance standards. Vascular surgeons who provide appropriate care will not be required to undergo a similar review in the following year. Providers who fail such a review will undergo further spot checks at six monthly intervals until they are seen to comply with appropriate standards of care. Continuing abusive behavior may warrant exclusion from Medicare or the insurance carriers’ panel. The ACVES, being primarily responsible for this program, will market it to the various insurance carriers who, if they agree to participate, will pay a premium over the costs to be divided by the ABVES and the ACEVS.

The program has multiple benefits. The ACVES and the ABVES will be provided with a source of income that will keep these organizations solvent for the foreseeable future. Payers will see a significant reduction in the cost of provider oversight, a drastic reduction in the number of costly unnecessary procedures, and, by improving the health of their members, a further reduction in expenses. Vascular surgeons will not have to put up with time-consuming, expensive and frustrating PAs. Most importantly, they will be able to advertise to patients that they voluntarily agreed to a program of oversight and that their services have met the highest standard of peer review. Further, insurance carriers choosing providers for their panel will likely seek only those who are part of this program. This will guarantee that vascular surgeons are once again promoted as the appropriate providers of vascular services. Most importantly, the standard of care for vascular patients will be vastly improved. I am hopeful that eventually cardiology and interventional radiology will partner with us to improve the vascular health of the nation.

References

  1. InterQual. Evidence-Based Criteria/Guidelines. Utilization Management. InterQual. Change Healthcare
  2. Society for Vascular Surgery appropriate use criteria for management of intermittent claudication. Journal of Vascular Surgery volume 76, issue 1, p 3–22 April 2022
  3. ACC/AHA/SCA/SIR/SVM 2018. Appropriate use criteria for peripheral arterial intervention. Journal of the American College of Cardiology volume 73 No2 2019
  4. Dietzek A. Vascular surgery is the best kept secret in medicine and my thoughts on how we can change that. Journal of Vascular Surgery Vol. 69 Issue 1 p 5–14 Published in issue: January, 2019

RUSSELL H. SAMSON is president of The Mote Vascular Foundation and past medical editor of Vascular Specialist.

Trial assessing AI-powered tissue microsensor technology in PAD begins enrollment

By
Jamie Bell
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Trial assessing AI-powered tissue microsensor technology in PAD begins enrollment

Sensome has announced enrollment of the first patients into a feasibility clinical study using the Clotild smart guidewire in peripheral arterial disease (PAD). Clotild was designated a breakthrough medical device for use in brain arteries by the Food and Drug Administration (FDA) in 2021.

The clinical trial, named SEPARATE, is designed to assess the artificial intelligence (AI)-powered Clotild sensor’s capability to detect various characteristics of blood vessel blockages in PAD patients. The first five patients have been enrolled at AZ Sint-Blasius Hospital in Dendermonde, Belgium, and preliminary results are anticipated in mid-2024.

Koen Delosse

A key focus of the SEPARATE clinical trial—according to a Sensome press release—is to evaluate the Clotild sensor’s capacity in differentiating between soft and friable “fresh” clots, and organized “old” clots. This critical information empowers physicians to select the most suitable endovascular therapeutic approach, thereby mitigating complications, avoiding embolization, and enhancing long-term treatment outcomes, the release adds.

“Understanding the makeup of a total occlusion in peripheral artery disease is essential to choose an adequate treatment approach to ensure lower complication rates and more durable long-term outcomes in this complex group of vascular patients,” said Koen Deloose, MD, head of the Department of Vascular Surgery at AZ Sint-Blasius Hospital and principal investigator of the SEPARATE clinical trial. “Sensome’s tissue microsensor technology could become a novel tool to characterize the total occlusion in an objective and simple-to-use way that integrates perfectly with our current existing workflow.”

More than half of medical students altered Match ranking order after post-virtual interview site visits, APDVS survey finds

By
Bryan Kay
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0
More than half of medical students altered Match ranking order after post-virtual interview site visits, APDVS survey finds
David Rigberg appears at SAVS 2024

Amid the build-up to residency Match Day 2024, the Association of Program Directors in Vascular Surgery (APDVS) has delivered data from a VISIT (Vascular In-Person for Students in the Match Trial) pilot study that took place last year showing some 57% of medical students who took part changed their rank list of integrated vascular surgery programs based on post-virtual site visits to institutions on their radar. 

The headline finding emerged during the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27). 

“These VISIT data show that a visiting process with a locked ranking order list can really provide meaningful data to applicants—I say that in the context of 57% of them changing their rank lists following these visits,” said co-first author David Rigberg, MD, vascular surgery program director at the University of California, Los Angeles (UCLA), who was presenting on behalf of the APDVS executive council. 

The study was launched after the Association of American Medical Colleges (AAMC) released a position paper stressing the importance of diversity, equity and inclusion (DEI) practices, in-person interview affordability, and the environmental impact of interview travel in the wake of the COVID-19 pandemic-induced re-arrangement of the Match process landscape. 

COVID-19 yielded a transition to the virtual interview, but as the pandemic receded the AAMC continued to recommend the virtual interview process, Rigberg noted. 

In light of debate over whether or not to return to in-person interviews, or the potential for a third way involving a hybrid approach, through the VISIT pilot study the APDVS sought to answer the question: Do post-virtual interview site visits that take place after participating programs have already locked in their student rank lists provide benefit to applicants in the Match process? 

The study findings prompted incoming SAVS President Alan Lumsden, MD, chair of the Department of Cardiovascular Surgery at Houston Methodist in Houston, Texas, to emphasize the value of in-person visits, which, he said, “can’t be replicated by online interviews.” 

“To me, unfairness is asking a medical student to commit five years of their life to an institution, and the first day they walk through is for orientation,” he added. “The risk is more on the applicant side than it is on the institution side.” 

Some 21 of the 74 integrated vascular surgery residencies in the U.S. that took part in the 2023 National Resident Matching Program participated in the study, which involved a survey being disseminated to both the applicants and the institutions’ program directors. 

The post-virtual interview site visits took place within the month between programs locking their rank lists and students submitting their own ranking lists. The validated surveys were then later sent out, with the main question being probed whether in-person visits after virtual interviews impacted rank lists. 

“The answer was a resounding yes,” reflected Rigberg. Among the 57% who answered that they changed their rank lists, 37% increased a program’s rank after a visit. Another 10% said visits had no impact. 

“An additional 33% stated that although they did not change their rank list, [visits] affirmed their rank list, so they sent their rank list in with more confidence,” Rigberg said. 

The most common factor affecting decisions to change was esprit de corps—”so that relationship between attendings and trainees that you really have trouble seeing in a Zoom-type format,” added Rigberg. 

The survey results also demonstrated that 21% of programs would have—if they could—changed their rank lists following the in-person visits. 

“We don’t have granular data on whether this [movement] was up or down, but it is important to recognize the programs are locking themselves into something where they are getting information that they might not be able to act upon,” explained Rigberg. 

On the question of whether or not applicants would recommend a return to in-person interviews, the data showed a near 50-50 split among respondents, he continued, emphasizing that the medical students participating had decided they “wanted to visit in person and did so.” 

Among the program directors asked the same question, “interestingly enough, about 20% were kind of agnostic on it. Then there was a 37-37 split between ‘yes’ and ‘no’ about returning to in-person interviews. Again, there is some selection bias there as these are programs that wanted to have a program where they had some type of in-person visit,” Rigberg added. 

Vascular Specialist–February 2024

By
Bryan Kay
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Vascular Specialist–February 2024

In this issue:

‘Voices of Vascular’ campaign celebrates diversity for Black History Month

By
Marlén Gomez
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‘Voices of Vascular’ campaign celebrates diversity for Black History Month

During Black History Month, the Society for Vascular Surgery (SVS) Foundation will shine a spotlight on the contributions of Black vascular surgeons through its “Voices of Vascular” campaign. This initiative is dedicated to recognizing the diverse voices within the SVS and promoting awareness of various cultures and communities.

The “Voices” campaign—whose presenting sponsor this year is Boston Scientific—spans multiple months, each dedicated to acknowledging different facets of diversity.

Following Black History Month in February, the campaign extends its focus to Women’s History Month in March, Asian American and Pacific Islander Heritage Month in April, Pride Month in June and National Hispanic Heritage Month from mid-September to mid-October. The goal is to engage members and the public in sharing crucial information about each highlighted group, fostering awareness and appreciation for their unique contributions.

Recognizing the campaign’s impact, the SVS and its Foundation received the Profile of Excellence Award from the American Association of Medical Society Executives (AAMSE) last September. This annual award program honors member organizations achieving excellence in areas such as diversity, equity, and inclusion (DEI), advocacy, communications, education, membership and leadership.

For Black History Month, the SVS has curated a series of profiles spotlighting the accomplishments and stories of Black vascular surgeons.

One featured professional for the 2023 initiative was Channa Blakely, DO, who was matched into vascular surgery in Galveston, Texas. Currently finishing up her residency at the University of Texas Medical Branch, Blakely recognized the implicit trust and understanding she shares with patients who look like her. As an African American woman in a surgical specialty, she emphasized the importance of her role in building connections with patients.

“I find that my patients express their pride and the comfort of me having a similar background to them. They often look at me for reassurance,” said Blakely.

The profiles aim to inspire the next generation of vascular surgeons and underscore the significance of diversity within the medical community. Daemar Jones, a fourth-year medical student at Texas Tech University Health Science Center School of Medicine, was featured for 2024 Black History Month. Jones, a 2023–24 social media ambassador for the SVS, emphasizes the impact of scholarships and donations to the Foundation that support physicians and students.

“Coming from me—a student who had all odds statistically [against him] as someone who’s not supposed to be here—if I get a Match acceptance, I aspire to advance my career academically and become an academic mentor. My goal is to be a resident with skills that impact my community. Those are the aspirations that drive me forward, and I am determined to break barriers and inspire the next generation,” said Jones.

The “Voices” campaign serves as a valuable resource for those interested in gaining insights into the multifaceted world of vascular surgery and the individuals shaping its future.

To learn more about “Voices of Vascular,” visit vascular.org/VoicesOfVascular.

SVS webinar aims to tackle upcoming changes to CMS reporting requirements

By
Marlén Gomez
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0
SVS webinar aims to tackle upcoming changes to CMS reporting requirements

The SVS will host a webinar Feb. 29 to help equip members with insights on impending Centers for Medicare & Medicaid Services (CMS) reporting requirements that impact vascular specialists.

Jessica Simons, MD, chair of the SVS Quality Improvement Committee, emphasized vascular surgeons’ role at the intersection of high-quality patient care and the financial viability of their practices.

“The SVS Quality Measures and Performance Committee [QPMC] is actively engaged in developing vascular-specific Merit-based Incentive Payment System (MIPS)Value Pathways (MVPs) designed to optimize reporting and payment structures for our dedicated vascular specialists,” said Simons.

The webinar—“How Medicare Quality Requirements Will Impact Reimbursement”—aims to address the financial challenges posed by changes in reimbursement and government policies. Simons stressed the importance of adapting to current and future requirements to maintain high standards of care and ensure financial sustainability within the field.

CMS mandates that all healthcare providers, irrespective of their practice setting, submit quality measures through either MVP, MIPS or an Alternative Payment Model (APM). Effective reporting and compliance require the development of vascular-specific pathways as upcoming requirements have the potential to impact all SVS members.

In a collaborative effort, the SVS QPMC and the Quality Improvement Committee will provide insights during the webinar. Register for the webinar at vascular.org/QMPCwebinar

Make a ‘PLAN’ for CLTI by tuning into new webinar

By
Marlén Gomez
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0
Make a ‘PLAN’ for CLTI by tuning into new webinar

An upcoming webinar is set to provide insights for healthcare professionals aiming to enhance their expertise in treating patients with chronic limb-threatening ischemia (CLTI).

Titled “Structured Decision-Making in the CLTI Patient: Understanding the PLAN,” the webinar’s goal is to delve into patient risk assessment, limb severity evaluation, and anatomic complexity considerations. Registration for the online session is now open and will be held at 6 p.m. CST on Feb. 27.

Organized through a grant from the Council of Medical Specialty Societies (CMSS), focused on fostering diagnostic excellence, the webinar seeks to explore the complexities of CLTI treatment through the lens of the PLAN algorithm (patient risk, limb severity, anatomic complexity).

According to webinar moderator Michael Conte, MD, professor and chief, Division of Vascular and Endovascular Surgery at the University of California, San Francisco, the webinar’s focus on the PLAN algorithm aligns with the global vascular Guidelines in CLTI, emphasizing the importance of a systematic approach to patient-centered decision-making.

For more information on the webinar, visit vascular.org/PLAN.

Breakthrough Device designation granted for Efemoral scaffold system designed to treat CLTI

By
Bryan Kay
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0
Breakthrough Device designation granted for Efemoral scaffold system designed to treat CLTI
Lewis B. Schwartz

Efemoral Medical has announced the granting of Food and Drug Administration (FDA) Breakthrough Device status for its novel Efemoral vascular scaffold system (EVSS) designed to treat de novo or restenotic lesions of the infrapopliteal arteries in patients with chronic limb-threatening ischemia (CLTI).

Using multiple, serial, intravascular scaffolds, the device’s patented FlexStep technology combines flexibility with support to open clogged vessels and sustain healthy blood flow while accommodating tortuosity and skeletal movement, the company states.

The system is formulated with sirolimus antiproliferative drug elution, with the bioresorbable scaffolds set up to restore normal vessel diameter at the time of the procedure, deliver therapeutic benefits across all lesion lengths and morphologies, and maintain durable patency while leaving no permanent implant behind. The device—designed for femoropopliteal intervention—is currently being tested in a first-in-human trial, EFEMORAL I, at investigative sites in New Zealand and Australia. Encouraged by early clinical results, Efemoral Medical is now developing an additional device for treating infrapopliteal arteries in patients with CLTI.

“Diseased human arteries are most simply, reliably, and successfully treated with drug-eluting, balloon-expandable stents,” said Lewis B. Schwartz, MD, co-founder and chief medical officer of Efemoral Medical. “However,” he continued, “it is extremely challenging to implant these permanent devices in the long and twisting arteries of the lower extremities. The EVSS uses a unique design of alternating, dissolvable, drug-eluting scaffolds that, for the first time, allows the long arteries of the legs to be treated with the same, effective, drug-eluting technology proven to be successful in multiple other vascular beds.”

SAVS 2024: A journey to the heart of DEI like no other

By
Bryan Kay
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0
SAVS 2024: A journey to the heart of DEI like no other
David L. Cull delivers the SAVS 2024 presidential address
David L. Cull, MD, delivers a captivating presidential address, laying bare his own challenging journey as a vascular surgeon and the hidden lessons on diversity, equity and inclusion his life story may hold.

Like nearly everyone else assembled, when Alan Lumsden, MD, took to the podium to deliver the customary presidential address preamble, he had little idea of the allegorical story that was to follow. Not even the program book quite captured what lay in store. “How my perspective on diversity, equity and inclusion has changed after I removed the log from my eye,” reads the entry under the presidential address in the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting guide. 

The title of the 2024 SAVS presidential address, a meeting highlight, of course suggested a diversity, equity and inclusion (DEI)-related topic, Lumsden—whose job it was as president-elect to introduce the sitting president—later shared. But what he and many others did not expect was the jaw-dropping tale of the lens with which 2023–24 SAVS President David L. Cull, MD, now looks at DEI through. Even for Lumsden, after he had just included in his introductory roast details of Cull’s early academic struggles, the presidential address caught him slightly off-guard. 

For, Cull revealed—bringing the true meaning of “the log from my eye” phrase into focus—he has considerable experience of the benefits of gaining acceptance: he has battled a learning disability his entire life. Until this moment, it had been a battle that took place privately, concealed from most of those professionally close to him. Yet that in itself carried the point, Cull told those gathered. The challenges he worked to overcome were hiding in plain sight. In turn, the idiosyncrasies to which his learning disability gave rise posed a different kind of challenge to his colleagues. A couple of years ago, this led to an epiphany for Cull: his story represented that of a DEI beneficiary. 

Cull, from the University of South Carolina School of Medicine in Greenville and formerly vice president of academic and clinical integration at Prisma Health, almost did not give the presentation. Tucked in his pocket as he followed Lumsden to the podium was an alternative address, there in case he decided to “bail” on the topic upon which he’d settled. As a Baby Boomer, a male and a surgeon, he has tendency not to share, he said. But the force of the moment, the divisiveness to which those three letters—DEI—can sometimes lead, helped compel him to overcome his discomfort. 

Raised in rural Virginia, Cull said he grew up inculcated with the mantra that “hard work and success were strongly linked,” and insulated from the cultural shifts that began taking place during his formative years. By the time he arrived in Greenville to start practice, he brought with him that sort of bias, he said, and that formed the bedrock of his views on DEI. 

“The segregated bubble in which I lived resulted in several biases which I carried with me to Greenville in 1997 when my vascular surgery practice began,” Cull said. “These biases dominated my perspective on DEI for the first decade in Greenville.” 

Until 2008. That’s when he first took part in DEI training as he entered the leadership of his institution’s Department of Surgery. Lots of reading, conversations with his adult children and their spouses, as well as roles in DEI initiatives eventually helped shift his views. 

Whereas before Cull held beliefs in keeping with the hard-work-yields-success mantra—such as people should fit and feel comfortable in a work environment, more women surgeons would harm the culture of surgery, LGBTQ discussions are uncomfortable and best avoided—now he’d evolved to adopt two core beliefs. “Systemic racism, sexism, and bias toward sexual orientation exist, and efforts to fix them are just and worthwhile,” he said. “And diversity strengthens businesses, organizations and our society.” 

These were intellectual decisions, not based on personal experiences, and many surgeons of his generation and gender might have embarked upon similar journeys, Cull reflected. At this point, skeptics might object and suggest his transformation “was more an indoctrination than an education,” he continued. 

Not long after his perspective on DEI reached a point of transformation, Cull also finally began to accept, within himself—if not publicly outside a small circle of close friends and partners—the fact he had a learning disability. Up to that point, he had developed a particular way of avoiding this explanation for his struggles. It had been long in the making: Cull was first diagnosed back during the latter part of his surgery residency at Wilford Hall Medical Center in San Antonio, Texas. 

During his presidential introduction, Lumsden trailed the early educational struggles Cull had encountered in elementary and middle school. “He studied a lot, but that was not reflected in his grades,” Lumsden quipped, revealing report cards with less-than-flattering scores. “With scores like this he was probably not exactly destined for surgery, but a big turnaround was made academically.” 

What Lumsden was not to know was the true nature and scale of the source of the issue. 

Following him, Cull revealed all, detailing the learning disability from symptom to diagnosis to aftermath. What he had was expressive and receptive language processing disorder. The disability meant he struggled to translate thought into speech. That explained the need to write down even basic instructions because of an inability to follow verbal instruction. An inability, for example, to present off-the-cuff on rounds, or respond to even basic questions for which he knew the answer. The poor grades early on. The necessity to work harder than his peers to attain required levels. 

Yet, at the point of diagnosis, he refused to accept that he had the disorder in question. “I considered a disability as uncorrectable, and if disclosed might be seen as an excuse for poor performance or something I was trying to use for secondary gain,” he told SAVS. “I found it more comfortable to accept I was on the lower end of the bell curve for intelligence compared to my colleagues.” 

That’s where that early grounding in rural Virginia re-entered the lexicon: you overcome those shortcomings with hard work because “hard work is highly valued in the surgery culture,” he said. “I held tightly to this less-intelligent narrative for most of my surgery career.” 

Despite at this point being unwilling to accept he had a learning disability, Cull had nevertheless already developed a retinue of techniques to help him adapt. Characteristics for which he would become well known were formed in this crucible. Extensive preparation. Meticulous planning. Never, ever procrastinating. Later, in leadership roles, he would similarly incorporate adaptive techniques aimed at thriving. “My partners would not recognize these techniques as adaptations to my disability because I had not disclosed my disability to them. Instead they would recognize them as endearing David Cull quirks,” he explained. 

The era prior to the endovascular revolution lent itself well to Cull’s abilities. During the late 1980s and 1990s, he said, “vascular surgery only required learning 10–12 operations, and the indications were well established. This narrow focus was a factor in me choosing vascular surgery, for it was a field I felt I could master.” 

The high case volume he experienced at Eastern Virginia Medical School during his fellowship allowed him to develop step-by-step instructions for every one of these operations. That lent him great confidence as he entered practice in Greenville and tackled the first few years of his career as a vascular surgeon. 

However, the specter of the endovascular revolution loomed. Ultimately, the complex range of catheters, wires, stents and balloons, as well as procedural bailouts, it yielded was not an arena to which Cull could re-tool his adaptive techniques in order that he could continue to thrive. “My partners would tell you that after considerable effort and time with them in the endovascular suite, I was never able to advance beyond the most basic endovascular skills,” he said. 

Instead, he found ways in which he could maximize his value to his group wherever he could, taking on “less appealing areas to my partners.” He found a home in the likes of vascular access and amputation, for instance, and thrived as a teacher. 

All of which leads up to this moment of public revelation. “It has taken me more than 25 years to accept I have a learning disability, and I have been successful at hiding this disability from everyone except a handful of close friends and colleagues,” he confided. “Even today I have difficulty disclosing this, because, for my entire career, I have been inculcated into a surgical culture that hasn’t seen diversity as a strength, rather as a weakness.” 

The year 2022 held an even deeper reckoning for the now retired surgeon. That was the year in which Cull realized his was a story of diversity and its benefits. In recent years, he recalled trying to explain to senior partners the characteristics of his disability that prevented him from being able to perform endovascular interventions. All he got in return were blank looks. After first being bothered by the response, he eventually came to realize they were unflinching because his value to the group had been long established. “They focused on what I could do rather than what I couldn’t do, and they accepted me as a full partner,” Cull noted. 

He drew on an example of how this inclusion played out in practice. Whenever he took vascular call and an emergency requiring an endovascular intervention reared its head, those same partners, if in town, always would be on deck to lend a hand, Cull said. “How I was treated by my partners is what a diverse, equitable and inclusive environment looks like. I was fortunate to have landed in a practice where I thrived and gained fulfillment from doing what Bill Marston called the routine work of vascular surgery.” 

Back on the subject of the title Cull chose for his presidential address, suggestive of a DEI topic but clearly representing something more, he explained how he settled on the particular wording. “The title came from the realization two years ago that my story is a diversity, equity and inclusion story, and I can use my experiences to gain insights into what it must be like in our profession and in our society to be a woman, a person of color, a member of the LGBTQ community or a disabled person,” he told SAVS as he came to the end of his address. “While my experiences have given me new insight, I can’t fully understand their life experience because I have had the advantage of being a White male who was able to hide his disability over a 30-year career—and was given the benefit of the doubt when I failed.” 

The top 10 most popular Vascular Specialist stories of January 2024

By
Éva Malpass
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The top 10 most popular Vascular Specialist stories of January 2024

top 10In January, the most read stories from Vascular Specialist include a U.S. Aortic Research Consortium analysis of F/BEVAR preoperative risk factors in AAAs/TAAAs; a reflection on lessons learnt one year on from BEST-CLI; Southern Vascular’s election of its first female president and more. 

1. The utility of renal stenting in hemodialysis patients: One in five found to come off dialysis after being stented

A fifth of patients among a chronic kidney disease (CKD) cohort on hemodialysis—a rare subset pulled from a large repository of national data—were able to come off the treatment following renal artery stenting, a team of researchers from the University of Texas (UT) Southwestern Medical Center in Dallas has found.

2. University of Pittsburgh awards $100,000 grant to SVS member for AI-based healthcare project

Last October, the University Pittsburgh’s Clinical and Translational Sciences Institute hosted its 10th Pitt Innovation Challenge (PinCh), providing a total of $550,000 in prizes, with the top-three winners each receiving a $100,000 grand prize. PinCh 2023 announced that SVS member Nathan Liang, MD, and his co-founders Timothy Chung, PhD, and David Vorp, PhD, were awarded $100,000 for developing Aneurisk, an artificial intelligence (AI)-based tool designed to assess the risk and prognosis of patients with abdominal aortic aneurysms (AAAs), who share an update on their progress since winning.

3. U.S. Aortic Research Consortium maps out F/BEVAR preoperative risk factors for one-year mortality in complex AAAs, TAAAs

A series of preoperative risk factors—including currently smoking, chronic kidney disease (CKD), congestive heart failure (CHF), aneurysm size greater than 7cm, more advanced age (75 or over), Crawford extent I–III thoracoabdominal aortic aneurysms (TAAAs), known chronic obstructive pulmonary disease (COPD), and anemia at baseline—were found to be predictive of one-year mortality among patients undergoing fenestrated and branched endovascular aneurysm repair (F/BEVAR) for complex AAAs and TAAAs with custom-made devices.

4. BEST-CLI: A year down the road

A dedicated session at the 2023 VEITHsymposium (Nov. 14–18) in New York City aimed to unpack the ways in which clinical practice and attitudes in the field of chronic limb-threatening ischemia (CLTI) have changed since the BEST-CLI trial was published back in November 2022. The trial’s principal investigators (PIs)—Boston-based vascular surgeons Alik Farber, MD, and Matthew Menard, MD, and interventional cardiologist Kenneth Rosenfield, MD, also of Boston—share their thoughts and highlight some unanswered questions. 

5. First procedures announced in study of novel peripheral IVL system

FastWave Medical has announced the successful completion of enrollment for its first-in-human (FIH) study with the company’s peripheral intravascular lithotripsy (IVL) technology. The prospective, single-arm study aims to assess the safety and performance of FastWave’s IVL system in patients with peripheral arterial disease (PAD) of the superficial femoral or popliteal arteries with moderate to severe calcium.

6. Southern Vascular elects first woman president-elect

The Southern Association for Vascular Surgery (SAVS) elected Margaret (Megan) Tracci, MD, to become its first ever woman president for the 2025–26 cycle.

Tracci, a professor of surgery at the University of Virginia in Charlottesville, will serve as SAVS president-elect during 2024–25. Tracci is a past president of the Virginia Vascular Society.

7. Gore receives FDA approval for breakthrough endovascular device in complex aortic aneurysms

Gore has announced Food and Drug Administration (FDA) approval for the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE), which the company states is the first off-the-shelf endovascular solution for the treatment of complex aneurysmal disease involving the visceral aorta.

8. International collaboration unveils updated PAD guidelines in diabetic foot ulcers

The International Working Group on the Diabetic Foot (IWGDF), the European Society for Vascular Surgery (ESVS) and the Society for Vascular Surgery (SVS) have jointly released updated guidelines for the diagnosis, prognosis and management of peripheral arterial disease (PAD) in individuals with diabetes mellitus and a foot ulcer.

9. Coding: Increasing complexity and lost RVUs—a drop in the ocean?

A vascular surgery team at Audie L. Murphy VA Medical Center in San Antonio, Texas, uncovers “staggeringly low” numbers of correctly coded billing for three commonly performed vascular procedures, raising concerns over cases with more complex coding.

10. Centers for Medicare & Medicaid Services grants Transitional Pass-Through payment for Endologix’s Detour system

Endologix recently announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Transitional Pass-Through (TPT) payment for the Detour system, effective since 1 January 2024.

Re-evaluating aortoiliac endarterectomy: Case series shows ‘acceptable durability’

By
Bryan Kay
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Re-evaluating aortoiliac endarterectomy: Case series shows ‘acceptable durability’
Shivik Patel

The uncommonly performed aortoiliac endarterectomy—one of the open procedures on which the vascular surgical specialty was founded—provides acceptable durability in aortoiliac occlusive disease patients with smaller native vessels, especially among females, a 25-patient case series review performed at Louisiana State University (LSU) Health Sciences Center in New Orleans has shown.

Results from the analysis, presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27), by Shivik Patel, MD, demonstrated freedom from major adverse limb events of 89% and 81% at two- and three-years post-procedure, while primary and secondary patency out to three years were 86% and 89%, respectively.

The patient sample, dating from 2006–2022, was 72% female with a mean age of 53.6 years. Overall survival was 94%. “Two patients had early postoperative thrombosis, and both of those patients had undergone procedures in an acute limb ischemia type of event,” explained Patel, formerly a vascular surgery resident at LSU and now an attending surgeon at WellSpan Health in York, Pennsylvania, in an interview with Vascular Specialist. “Among the patients who underwent the procedure in an elective circumstance, there was one instance of late reintervention that was needed., but, overall, this series shows pretty durable outcomes after three years.”

A subanalysis involving mean aortic and iliac diameter measurements further demonstrated that the patient cohort had smaller native vessels than the means of a general population, Patel continued.

“We went through all of the patients’ imaging and measured their juxtarenal aorta, their infrarenal aorta, distal aorta and bilateral iliac arteries, as we wanted to compare our group to standard population means for the age group,” he said. “We saw that our aortic diameters and iliac diameters were less than those means.”

Patel conceded study shortcomings, principally the lack of a control group. “Our study involved predominantly females, which could provide some bias in terms of having a mostly female sample, but I think it speaks to the benefit something like this procedure can have in the female population,” he added.

An aortoiliac endarterectomy case from the LSU series

Patel argued that given the surgery’s relatively uncommon use in practice, the 25-patient sample provides a “fairly robust” dataset with which to introduce numbers that suggest a role among a specific patient group.

“We have noticed, especially in my clinical experience, patients in whom we place stents in their smaller vessels, they are not going to have the durability, and, down the road, you’re going to be placing an aortobifemoral bypass,” he noted. “If you have a reason to avoid a large prosthetic graft, as in an aortobifemoral graft, or avoiding femoral incisions, this is a very durable procedure to do if you have isolated aortic and iliac disease, as long as the patient has acceptable operative risk, which if you’re planning on doing an aortic bypass, the risk is more or less in the same vein at that point.”

Patel sees his data set, for a procedure first performed in the early 1950s, and described in a 2006 Annals of Vascular Surgery paper as “almost a lost art,” as a moment for repose.

“This is an interesting opportunity for us to re-evaluate one of the traditional operative techniques that our specialty is founded on and to make sure we don’t forget about procedures like it,” he said. “They may come back to play a role, and aortoiliac endarterectomy is a surgery I think may re-emerge as a more popular option in patients with specific anatomic specifications.”

‘Get a Pulse on PAD’: Multi-society public awareness campaign launched

By
Bryan Kay
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‘Get a Pulse on PAD’: Multi-society public awareness campaign launched
Joseph Mills
SVS President Joseph L. Mills

The Society for Vascular Surgery (SVS), in partnership with three other medical societies operating in the vascular disease space that form the PAD Pulse Alliance, is taking part in a peripheral arterial disease (PAD) public awareness campaign called “Get a Pulse on PAD.”

Alongside the Association of Black Cardiologists (ABC), the Society for Cardiovascular Angiography & Interventions (SCAI) and Society of Interventional Radiology (SIR), the group aims to educate people on PAD risk factors and potential symptoms, as well as to encourage patients to advocate for their own health with their doctors.

The awareness campaign, taglined “Kick Off the Conversation,” kicked off as the PAD Pulse Alliance released survey data showing that 70% of Americans are unaware of the disease, contributing to 400 amputations performed each day in the U.S.

“The collaboration among these medical societies is a testament to the devastating impact PAD can have on people, families and whole communities if not diagnosed and treated early, and, importantly, early treatment usually consists of medication and lifestyle changes,” said SVS President Joseph L. Mills, MD. “We hope that care teams will continue to collaborate to ensure early and proper diagnosis with the ultimate goal of improving outcomes for patients.”

To help educate patients and give them the tools to start the conversation, the PAD Pulse Alliance published a website and patient toolkit at PADPulse.org.

Measuring plaque inflammation via SCAIL scores may improve carotid stenosis risk stratification

By
Jamie Bell
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Measuring plaque inflammation via SCAIL scores may improve carotid stenosis risk stratification

The use of a relatively novel scoring system, referred to as Symptomatic carotid atheroma inflammation lumen-stenosis (SCAIL), has produced favourable predictive qualities versus the Oxford carotid stenosis tool (OCST) and Essen stroke risk score (ESRS). According to researchers, the SCAIL score led to superior recurrent stroke predictions after minor stroke/transient ischaemic attack (TIA) and symptomatic carotid stenosis before revascularisation—as compared to these more established approaches—in a recent study involving three pooled, prospective cohorts of patients.

Writing in the European Stroke Journal, Sarah Gorey (Stroke Clinical Trials Network Ireland/University College Dublin, Dublin, Ireland) et al note that SCAIL led to discrimination “better than chance”, and provided added value for prognosis when used in conjunction with the clinically based ESRS system. These findings indicate that a combined assessment of stenosis and plaque inflammation on fluorodeoxyglucose positron-emission tomography (FDG-PET) imaging like the one utilised in SCAIL “may improve risk stratification in carotid stenosis”. The authors also stress the need for further studies to fully determine the role FDG-PET could play in evaluating plaque inflammation as a means for patient selection within randomised carotid revascularisation trials of the future.

Gorey and colleagues pooled three prospective cohort studies of patients with recent (<30 days), non-severe ischaemic stroke/TIA (modified Rankin scale [mRS] ≤3) and internal carotid artery stenosis ≥50%, and used these data to compare SCAIL—and its ability to predict ipsilateral stroke recurrence in symptomatic carotid stenosis—with both OCST and ESRS. The researchers detail that all of the included patients had carotid FDG-PET/computed tomography (CT) angiography and late follow-up data, with censoring at carotid revascularisation.

Across a total of 212 included patients, 16 post-PET ipsilateral recurrent strokes occurred in 343 patient years of follow-up—and occurred at a median timepoint of 42 days. Relaying their results, the authors state that baseline SCAIL predicted recurrent stroke with an unadjusted hazard ratio (HR) of 1.96 (confidence interval [CI] 1.2–3.22, p=0.007) and an adjusted HR of 2.37 (CI 1.31–4.29, p=0.004). In contrast, the HR for OCST was 0.996 (CI 0.987–1.006, p=0.49) and for ESRS was 1.26 (CI 0.87–1.82, p=0.23). The concordance (c-statistic) for each of the scoring systems evaluated in the study—with higher numbers indicating better discriminatory power—was 0.66 (CI 0.51–0.80) with SCAIL, 0.52 (CI 0.4–0.64) with OCST, and 0.61 (CI 0.48–0.74) with ESRS.

As per comparisons with ESRS alone, the addition of plaque inflammation measures (maximum standardised uptake value [SUVmax]) to ESRS gave rise to improved risk prediction outcomes when analysed both continuously (HR 1.51, CI 1.05–2.16, p=0.03) and categorically (p=0.005 for risk increase across groups; HR 3.31, CI 1.42–7.72, p=0.006; net reclassification improvement 10%). SUVmax plus ESRS was found to carry an adjusted HR of 1.57 (CI 1.04–2.36, p=0.03), and stratified recurrent stroke risks were low in 2.6% of patients, moderate in 5%, and high in 17.3%. However, Gorey et al report that their recurrent stroke prediction findings were unchanged by the further addition of carotid lumen stenosis measures—the other metric taken into consideration, alongside plaque inflammation, by SCAIL.

“The SCAIL score has demonstrated validity to predict early and late recurrent stroke,” the authors add. “In our study, SCAIL improved identification of patients with recurrent stroke when directly compared to established clinical risk scores. However, SCAIL correctly classified just over half of [the] patients in our study, and the addition of clinical variables in the ESRS provided only modest further improvements. Prediction models including measures of vascular inflammation—either alone or in combination with clinical risk factors—need to be further refined and validated before they can be applied in clinical practice for patient selection for carotid revascularisation.”

UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for PAD

By
Bryan Kay
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UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for PAD

Following a review, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has updated guidance on the use of paclitaxel-coated devices stating that such devices can be considered for the treatment of peripheral arterial disease (PAD), including intermittent claudication and critical limb-threatening ischemia (CLTI).

The MHRA had previously issued a statement in April 2022 on the use of paclitaxel drug-coated-balloons or drug-eluting stents in patients with CLTI which stated that they should only be used in patients where ‘the benefits may outweigh the risks’. The parameters for use outlined that exposure should be kept to a minimum, which referred to using the lowest dose device available and avoiding/reducing repeated exposure to a device. Furthermore, the 2022 guidelines noted that paclitaxel devices should not be used in the routine treatment of patients with intermittent claudication due to the reported risk of longer-term increased mortality.

The updated guidance has been issued following an extensive review of the most recent published literature alongside the MHRA’s request for the advice of the Interim Devices Working Group (IDWG) and other invited experts. The IDWG advised that the new studies did not support a statistically significant increased risk of harm associated with the use of paclitaxel-coated devices in patients with PAD, irrespective of disease type or severity.

In this update, the MHRA make reference to the 2023 evaluation of numerous randomized controlled trials and real-world studies which compared paclitaxel-coated devices versus control devices in a patient-level pooled analysis. Led by Sahil A. Parikh, MD, an interventional cardiologist at Columbia University Irving Medical Center in New York City, the analysis included a total of 2,666 participants with a median follow-up of 4.9 years. Their results showed that no significant increase in deaths were observed for patients treated with paclitaxel-coated devices, providing reassurance to patients, physicians and regulators on the safety of said devices.

Subsequently, the MHRA has removed its previous restrictions on indication, dose and repeated exposure for paclitaxel-coated devices for both intermitted claudication and CLTI.

Serration angioplasty associated with reduced recoil in infrapopliteal arteries compared with plain balloon angioplasty

By
Éva Malpass
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Serration angioplasty associated with reduced recoil in infrapopliteal arteries compared with plain balloon angioplasty
Serranator PTA serration balloon catheter

A study comparing the extent of early infrapopliteal re­coil after serration and plain balloon angioplasty has found the former produces “substantially less” arterial recoil in the treatment of these lesions and has demonstrat­ed “technical feasibility” in measuring early recoil using standard angiography.

The investigation, led by Venita Chandra, MD, of Stanford University in Stanford, California, as well as Michael Lichtenberg, MD, and Stefan Stahlhoff, MD, of Arnsberg Clinic in Arnsberg, Germany, was driven by the rising prevalence of peripheral arterial disease (PAD), and the rapidly developing arsenal of balloon devices imbued with new technologies, which are aimed at providing more effective treatment options. Recoil following balloon angioplasty of tibial arteries is a known mechanism of lumen loss in this patient population and is considered to be a contributing factor in early failure or later restenosis.

The findings were published online in the Journal of Endovascular Therapy in early December.

The Serranator (Cagent Vascular) balloon, which is designed to provide a controlled lumen gain while minimizing vessel injury when performing percutaneous transluminal angioplasty for PAD, was compared to plain balloon angioplasty. Chandra and colleagues—including first author Arash Fereydooni, MD, a Stanford vascular surgery resident—aimed to assess the ability to define and measure post-angioplasty recoil in infrapopliteal arteries, as well as to compare the two devices’ effect on recoil.

The multicenter, sequential comparative study enrolled patients with lesions of the infrapopliteal arteries who underwent alternating plain balloon angioplasty or serration angioplasty with the Serranator device. Capturing angiographic imaging pre-, immediately post-and 15-minutes following angioplasty, the study core lab measured and analyzed vessel recoil, final diameter stenosis and dissection grade.

A total of 36 patients were enrolled, with 39 infrapopliteal lesions treated. There were no significant differences concerning demographics or lesion characteristics between the Serranator (n=20) and plain balloon angioplasty (n=19) groups. Arterial recoil, defined as greater than 10% lumen loss at 15 minutes, occurred in 25% of Serranator-treated lesions compared to 64% in the plain balloon angioplasty group. The investigators also report that clinically relevant recoil, defined as greater than 30% lumen loss at 15 minutes, was present in only 10% of patients who underwent serration and in 53% of patients after plain balloon angioplasty.

The authors note that, although their study was undertaken to test the feasibility of measuring early arterial recoil, they were able to compare the performance of a serration balloon against plain balloons in a prospective, randomized fashion.

Fereydooni et al conclude that, to their knowledge, theirs is the “first demonstration” of a head-to-head core lab adjudicated angiographic outcome assessment of infrapopliteal artery recoil between a plain balloon and any specialty balloon. Situating their findings among concurrent research, the investigators highlight the consistency of their results with the earlier PRELUDE (Prospective study for the treatment of atherosclerotic lesions using the Serranator device) study conducted by Andrew Holden, MD, from the Auckland Regional Public Health Service in Auckland, New Zealand, which found one- and six-month patency rates to be 100% and 64%, respectively, between the Serranator and plain balloon angioplasty. Similarly, Fereydooni and colleagues also point to the single-center PRELUDE-BTK follow-on study, which reported an average final residual stenosis of 17% vs. 34% between the groups.

Fereydooni et al contend that a possible explanation for these favorable results may be due to the serration mechanism allowing for “more controlled and predictable delivery of radial force” compared with plain balloons.

Although their findings may add to a body of literature that favors serration angioplasty, Fereydooni and colleagues underline that their small sample size and the “preliminary nature” of their feasibility endpoints “[limit] the analysis power” for comparing serration and plain balloon angioplasty in specific patient anatomy.

Among other limitations, the authors add that the study protocol did not include an assessment of long-term outcomes of early arterial recoil and how this translates to long-term patency between the two devices. “It would be of interest to obtain three-dimensional data using intravascular ultrasound (IVUS) to better characterize changes in area and lesion morphology with SA [serration angioplasty],” they write.

Giving Tuesday brings in five-figure sum

By
Marlén Gomez
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Giving Tuesday brings in five-figure sum

The SVS foundation celebrated another philanthropic success through its Giving Tuesday efforts, raising $20,000 in funds. Presenting sponsor W. L. Gore and Associates doubled the final funds through their match, further magnifying the donations. As a result, Giving Tuesday raised a total of $40,000 for vascular health.

SVS Foundation Chair Michael C. Dalsing, MD, said this day is a beacon of hope and charity, aligning with the true spirit of the holiday season. Notably, this season’s celebration extended to the Foundation’s “Celebration of Science” campaign, transforming into a months-long commemoration in honor of the Foundation’s mission.

“Anytime we have an infusion of funds to this level, it allows us to be more innovative and supportive of existing research grants and potentially to address new research opportunities,” said Dalsing. “It allows us to promote the health of our patients and gives us an opportunity to benefit them in an exponential manner by virtue of cutting-edge research.”

Giving Tuesday messaging, a Celebration of Science campaign component, was spread across multiple media outlets from the Foundation Board of Directors, sharing messages on reasons to donate to the Foundation. Dalsing even braved the social media world to spread the message to his colleagues.

Palma Shaw, MD, chair of the Industry Relations Advisory Committee, praised the donors for their generosity, expressing that the dedication exhibited by supporters on Giving Tuesday had been inspiring. Her goal within her role is to strengthen the relationship between the SVS and industry partners.

Donors can visit vascular.org/givingtuesday to learn how to join the celebration and support the Foundation’s ongoing work.

Redemption through perseverance

By
Arthur E. Palamara
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Redemption through perseverance
Arthur E. Palamara, MD

In the late 1970s, a neurosurgeon at New York’s St. Luke’s Hospital operated on a beautiful, young, rising soprano who studied opera at a major New York conserva­tory. She was delightful, full of the joy of liv­ing, and orphaned at an early age to raise her teenage brother. Having already overcome significant adversity, her only impediment to a blossoming career and a happy life was a brain tumor. The tumor appeared benign, and its resection was considered routine. The neurosurgeon was top notch, capable and clinically at the top of his game. There was not much that could go wrong.

But as happens in the arcane realm of neu­rosurgery, things went terribly wrong. After the skull was opened and the surgeon began to remove the tumor, the brain increased in size and poured out of the brain cavity. The surgeon was devastated. He and the anesthe­siologist performed all of the maneuvers to shrink it back to size. It was of no use. More and more brain fungated from the skull. In a fit of absolute frustration, the surgeon gath­ered a fistful of brain tissue and disgustedly threw it against the wall. Despondent and defeated, the neurosurgeon turned to the resident assisting him and said: “She will not live. Close the skull as best you can.” Over­whelmed by a crushing sense of helplessness, he rushed hurriedly from the room.

It was my night to take care of patients and the neurosurgeon came to me. In a voice filled with anguish and despair, he bared his instruction. “Arthur, she may live a couple of days, but she will not survive. It would be best if you allowed her to die. There is no point in prolonging her suffering.”

An hour later, the patient arrived in the recovery room. Not culpable of any misdeed, her heart and lungs functioned perfectly. Her brain had betrayed her. I, in my innocence, could not let her die. I found I could not ne­glect her in her hour of need. I meticulously cared for her throughout the night with the concern of a shepherd guarding his injured lamb. I was too inexperienced and naive to do otherwise.

Persistence

For the next month, she became my charge. Her brother came in daily, cried, stayed for a while, and left. I performed every aspect of her care that required correction.

While her body stayed perfectly intact, she remained in a deep coma. Every morn­ing I would jab a large needle into her left femoral vein and withdraw blood to be sampled. Every afternoon I would make whatever adjustments were necessary. My patient and I endured the ridicule of more sanguine colleagues who laughed—but did not interfere—with this ritual. I admit that without her active mental interaction, I be­gan to think of her as a “thing” devoid of human qualities.

After more than a month, the neurosur­geon decided to try an operation, a ventric­ular-atrial shunt, to relieve the pressure in her brain. Since I was her de facto guardian, he allowed me—under his tutelage—to per­form the entire operation. I drilled a hole into her skull, inserted a long needle into the right lateral ventricle, and was rewarded with the presence of clear, white fluid. The needle was connected to a thin plastic tube inserted into a vein in her neck. Perhaps fu­tile, perhaps extravagant, the operation was at the very least, an attempt to remedy a ca­tastrophe. Sometimes the human condition demands an act of expiation.

The next morning, to our utter surprise, the patient woke up. She actually sat up in bed, talked to us and ate solid food. Because of her youth, her recovery was rapid. Her sole disability was dyslexia. Everything she attempted to read was backwards. Given the immensity of the alternatives, dyslexia was a small price to pay and no great impediment; her memory was sharp.

Six months later, on a Sunday afternoon, I was invited to her recital at Juilliard. She gave a concert where she sang beautifully. She possessed a superb, operatic voice, with great control, range and command. Her brother, her only relative, was in attendance. To me, it was a triumph of perseverance over adversity. Medically, it was probably a mira­cle. At the reception following her concert, I summoned up the courage to ask her: “Did you feel any of those needles that I stuck into your groin?”

“Yes,” was her response, “and they hurt like hell.” Some 45 years later, and still mind­ful of this acknowledgment, I never dehu­manize a patient.

The world of vascular surgery

Terri Schiavo was famously a patient in a veg­etative state confined to a nursing home in Tampa 18 years ago. She was in a coma for 10 years. She was unable to meaningfully in­teract with her environment. We really don’t know what Terri Schiavo could perceive.

My patient was in a coma for only a month. Yet Terri’s condition demanded answers as to a timeless question: what is life? More profoundly: how do we respond to individuals who don’t con­form to our definition of life? Do we have the right to terminate a life that we don’t find meaningful? Or are we simply imposing our biases on a defenseless human being? Our response says more about societal values than it does about a legislative or legal maelstrom.

This moral dilemma is even more con­flicting today over the subject of abor­tion. There is little doubt that both sides are sincere in their belief, while the gulf remains irreproachable.

Part of my training took place at Harlem Hospital in New York. Back in the 1970s, Harlem was part of the Columbia Presbyte­rian system. As interns, we did a one-month rotation on the vascular ward. In those days, vascular surgery at a large city hospital was largely an amputation service. While revas­cularization was sometimes attempted, it was rarely successful, which led to a number of multilevel amputations.

The huge floor was comprised of large rooms, each of which housed eight African American patients. They were all poor, all alone, and all suffering withered limbs with varying levels of amputations. Wounds would be dressed daily. Healing was slow and their hospitalizations were long. These patients were uniformly cheerful and bore their lot in life with grace and good humor. After dinner, they would go out on a balco­ny to smoke, then return to their room to watch—and good naturedly argue over—the Yankees or Mets game on a beat-up televi­sion with rabbit ears. After retiring for the night, they would repeat the same sequence the following day.

One afternoon after making rounds and frustrated by any lack of progress of any of the patients, I made a statement to the group: “I would rather be dead than live like those patients.”

Our African American attending turned to me with a calm, unemotional voice and said: “Doctor, these patients may not be a White, young doctor from New Jersey with aspirations of becoming a great surgeon, but they have achieved something you don’t yet have. They enjoy a roof over their head, three meals a day, entertainment, and emo­tional support for each other. Their expecta­tions may not be yours, but they have found contentment.”

In a slightly more forceful voice, he added: “You do not have the right to impose your values on them.”

Our medical landscape

Some people are slow learners. Some years ago, an elderly, very ill patient presented with a contained ruptured abdominal aortic aneu­rysm (AAA) and acute cholecystitis. It is an understatement to say he was sick and sep­tic. In true Crawfordian fashion, I repaired the aneurysm, closed the retroperitoneum, covered it with omentum, then removed the bulging, necrotic gallbladder. I drained ev­erything. He hung on for several weeks in the intensive care unit (ICU) experiencing multiple complications. He was returned to surgery several times, but the details have been forgotten.

Finally, one Saturday morning, he was again declining, some other problem having cropped up that could benefit from operative intervention. His overly supportive family was at his bedside.

As I explained the alternatives, his daugh­ter with whom I enjoyed a very good rela­tionship said:

“Whatever you think is best, doctor. We trust you.”

“We can try. Although he is very ill and may not survive,” I responded.

I walked towards the nurse’s station to book the case with the operating room. His hospital course replayed itself in my mind as I slowly acknowledged that he was not going to survive. I abruptly stopped. Retracing my steps, I re-entered the room.

The family looked at me expectantly. “I think I am operating for myself, not for your father’s benefit,” I explained. It is time to let him go. They cried and hugged me.

The story about the opera singer is true. The book is called Seizure. It was made into a television movie starring Leonard Nimoy.

As a doctor, I have fought death and illness for too many years to concede even one pa­tient. Unfortunately, I’m not sure that my reverence for the profession is shared by pri­vate equity firms that increasingly dominate our medical landscape.

Perhaps I am still imposing my values on others.

Arthur E. Palamara is a vascular surgeon practicing in Hollywood, Florida, for 44 years. He is active in county, state and national medical organizations.

SVS launches VESAP6 presales in January with discount

By
Kristin Spencer
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0
SVS launches VESAP6 presales in January with discount

The SVS is set to launch the sixth edition of the Vascular Education and Self-Assessment Program (VESAP6) in April. The highly anticipated review resource became available for pre-sales Jan. 10, which will continue through March 26, allowing users access upon launch. VESAP is a digital aid for vascular surgeons in preparing for qualifying, certification and recertification examinations and to remain current in the specialty of vascular surgery and endovascular therapy.

Vascular and general surgery residents and fellows consistently report the utility of the program in their preparation for the Vascular Surgery In-Training Examination (VSITE) and American Board of Surgery In-Training Examination (ABSITE).

VESAP6 will come with over 600 questions, accompanied by detailed discussions and references. The resource can be used in learning mode, where users can review the correct answers, rationale and references; and exam mode, where the user will complete entire modules without seeing the answers, rationale or references, in hopes of passing with a score of 75% or higher to earn Continuing Medical Education Credit (CME).

VESAP6 has been allocated 97.5 CME credits. Pre-sales for VESAP6 will open with a 10% discount available on all individual purchases. Additionally, SVS members who take advantage of the presale will be entered into a lottery for complimentary registration for VAM 2024.

Visit vascular.org/VESAP to access more information on the resource.

SVS points to 2023 achievements, challenges in coming year

By
Marlén Gomez
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0
SVS points to 2023 achievements, challenges in coming year
Joseph L. Mills (L) and Kenneth M. Slaw (R)

The Society for Vascular Surgery (SVS) reflects on a year marked by notable achievements on multiple fronts. In a communication to members in mid-December, Executive Director, Kenneth M. Slaw, PhD, underscored the organization’s growth, collaborative endeavors and key milestones attained in 2023.

“Our members’ dedication and collaborative efforts across various councils, committees and departments have propelled us forward. 2023 stands out as a year of significant achievements that our members can take pride in,” said Slaw. “As we look forward to 2024, the SVS remains steadfast in its commitment to championing quality and safety in patient care, the best science in the field, and advancing vascular surgery through meaningful collaboration, innovation, and, as a specialty, by letting the world know how special our members are as vascular surgeons.”

SVS takes to the Hill

  • Over 50 SVS leaders and staff participated in a Hill visit before the 2023 Vascular Annual Meeting (VAM) in Washington, D.C.
  • SVS members engaged with over 100 Congress representatives to advocate for immediate changes to Medicare payment policies, which led to initiatives to consider legislation, including a “Clinical Labor Bill”
  • The SVS plans to host an advocacy skill-building conference in 2025

Quality improvement goes national

  • The SVS successfully initiated the Vascular Verification Program with the American College of Surgeons, demonstrating achievement in both inpatient and outpatient standards programs
  • The SVS Patient Safety Organization (PSO)/ Vascular Quality Initiative (VQI) surpassed 1,000 subscribing practice sites and recorded over 1 million procedures in the VQI database
  • The VQI introduced the Smoking Cessation National Quality Initiative, highlighting the SVS’ commitment to addressing critical public health issues associated with vascular care
  • The SVS/PSO Fellowship in Training program was launched as part of ongoing efforts to enhance professional development and education
  • SVS mobilized dozens of member letters expressing concern for patient safety relative to the Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) rule that will expand carotid stenting. The SVS is on record with CMS, expressing its concerns, and has offered solutions to minimize potential harm

Health reporters contacted the SVS numerous times, seeking comment and guidance regarding stories featuring poor patient outcomes.

“The role of clinical practice guidelines, appropriate use criteria (AUC), greater understanding of health and practice economics, and focus on substantial challenges and flaws in current CMS payment/incentive policies were all subjects of discussion,” said Slaw

“The SVS plans to strengthen its communications infrastructure as it anticipates more frequent and continued contact with media professionals in 2024 and beyond.”

Translation to transformation in clinical practice

  • The launch of the inaugural “Translating Guidelines into Practice” webinar attracted hundreds of SVS members. The course covered the translation of global chronic limb-threatening ischemia (CLTI) guidelines, Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) results and updated varicose veins clinical practice guidelines
  • The SVS secured a $100,000 educational grant from the Council of Medical Specialty Societies (CMSS) to support ongoing translational efforts
  • The SVS initiated a national compensation study and program for vascular surgery in response to member queries to address gaps in credible data

Emphasizing its ongoing commitment to office and outpatient care in the community, the SVS Section on Outpatient and Office Vascular Care (SOOVC) developed the Handbook on Outpatient Vascular Care, released at the end of 2023.

“Each month of the year brings new ideas, energy and opportunities, as well as new challenges and threats that make strategy and change a universal constant for the SVS,” said Slaw.

The pace of change has accelerated and has become its unique challenge. SVS leadership commits to continue evolving the Society to address new opportunities and challenges.”

Rolling with the changes

  • SVS membership reached a total of 6,400 diverse members
  • SVS Affiliate membership, encompassing over 500 vascular physician assistants, nurse practitioners, and advanced care providers, played a substantial role in shaping the future of vascular care delivery
  • Bylaw changes were ratified, concluding a multi-year journey to update SVS bylaws, explicitly focusing on modifying the composition of the Executive Board
  • During the 2023 Executive Board retreat in July, significant resources were committed to augmenting and accelerating branding efforts initiated in 2021, with the refreshed branding set to be unveiled in 2024

Advancements in education

  • The SVS achieved its highest attendance at the Vascular Research Initiatives Conference (VRIC), with over 130 registrants
  • The organization completed its second Complex Peripheral Vascular Intervention Skills Course and ongoing improvements in the Coding and Reimbursement Workshop
  • The SVS launched virtual coding courses in December
  • The sixth edition of the Vascular Education and Self-Assessment Program (VESAP6) is set to launch in Spring 2024. A new audio supplement/companion for VESAP6 will be piloted, allowing learners to listen to case discussions
  • The launch of the fifth journal in the Journal of Vascular Surgery portfolio, Journal of Vascular Surgery-Vascular Insights, showcased open-access publishing models

The 2023 “Great Gatsby” Gala proved to be a resounding success, raising more than $200,000 to support the future of vascular health. The Vascular Health Step Challenge increased participation from last year, with participants collectively walking 44,000 miles and raised more than $100,000.

“As the year concludes, I encourage you join us in 2024 for the ‘Night at the Museum’ Gala at Chicago’s Museum of Science and Industry,” said Slaw.

SVS member volunteers have pressed forward to sculpt the future with numerous new task forces in 2023, including Pediatric Vascular Care, Patient Engagement, Innovation in Vascular Care, Clinical Trials and a proposed new Section for Senior Members.

SVS President Joseph L. Mills, MD, addressed achievements the Society will target in the new year.

“2024 will bring about a new set of challenges for our Society to overcome,” he said.

“The SVS reaffirms its unyielding commitment to advancing excellence and innovation in vascular health through education, advocacy, research and public awareness. Together, we will continue to emphasize quality and patient safety, push boundaries, foster innovative solutions, and empower our members with the knowledge and resources needed to excel in the dynamic field of vascular surgery.

“Our collective dedication will be the driving force behind the sustained success of the SVS and will continue to impact the evolving landscape of vascular healthcare favorably.”

First patient enrolled in HERCULES randomized trial comparing ESAR and EVAR

By
Bryan Kay
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0
First patient enrolled in HERCULES randomized trial comparing ESAR and EVAR
Michel Reijnen

The first patient has been enrolled into the HERCULES trial, which compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) in the treatment of abdominal aortic aneurysms (AAAs) with wide proximal necks. 

HERCULES is an investigator-driven trial led by Michel Reijnen, MD, a consultant vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands, and Konstantinos Donas, MD, head of the Department of Vascular and Endovascular Surgery at Asklepios Clinic Langen in Langen, Germany, in collaboration with Medtronic. Rijnstate Hospital is sponsoring the trial.

Patients will be randomly allocated 1:1 into ESAR and EVAR groups: the former arm will be treated with the Endurant II/IIs stent graft system plus the Heli-FX EndoAnchor System, and the latter using the Endurant II/IIs stent graft system.

A total of 300 participants will be recruited worldwide at approximately 20 hospitals in Europe and another 20 in the U.S. They will be followed out to five years.

The primary endpoint of the trial will be the absence of type Ia endoleak, migration of the upper portion of the stent graft of ≥5mm (as compared to the one-month post-treatment CT scan), and aneurysm sac growth of ≥5mm (as compared to the one-month post-treatment CT scan).

Could metformin be first-ever medical treatment that is effective at managing aneurysm disease?

By
Urmila Kerslake
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0
Could metformin be first-ever medical treatment that is effective at managing aneurysm disease?
Ronald L. Dalman

There is a global interest in assessing whether metformin, which has a long track record of safety and efficacy, is relatively inexpensive and is taken by millions of people every day for type-2 diabetes, has an effect on the progression of abdominal aortic aneurysms (AAAs). 

The LIMIT trial, a prospective randomized, level one, placebo-controlled, blinded trial, sponsored by the National Institutes of Health (NIH), is designed to investigate whether metformin significantly prevents the enlargement of existing AAAs in non-diabetic people. 

“It is difficult to make an asymptomatic patient better. And so, you want a treatment that is not going to be very arduous, and not be very high risk. [It should be] relatively inexpensive, [and] easy to take, and metformin checks all those boxes,” explains Ronald L. Dalman, MD, from Stanford University in Stanford, California, at the 2023 VEITHsymposium in New York City (Nov. 14–18), who invites the U.S. vascular community to get involved in the trial. 

“If metformin works in this application, it may also work in secondary treatment after [a] patient has had endografting to reduce the need for secondary procedures for endoleaks, for graft migration, or aneurysm enlargement. It could be [used] in a variety of applications both as a de novo treatment, as well as an adjunctive treatment following surgery. Here is something that could be a complement to surgical management, both before, during or after surgical intervention,” adds Dalman, who is the Walter C. and Elsa R. Chidester professor and vice chair of surgery for clinical affairs at Stanford Medicine. He is also the inaugural executive editor for the Journal of Vascular Surgery suite of publications. 

There is some evidence available, albeit not without its limitations, to support the use of metformin in AAA management. A systematic review and meta-analysis of drug repurposing for the treatment of AAA—published online ahead of print the week following VEITH 2023 in the European Journal of Vascular and Endovascular Surgery (EJVES)—indicates that metformin and statins “may provide some effect in slowing AAA progression.” 

Authors led by Joachim Sejr Skovbo Kristensen, from Odense University Hospital and the University of Southern Denmark in Odense, Denmark, do acknowledge, however, that “no definitive evidence was found for any of the [12] investigated drugs in this study.” 

They posit that publication bias “may have influenced the positive findings,” and go on to stress that “further research is needed to identify effective medical treatments for AAA progression.” 

How the best leaders ensure psychological safety at work

By
Bhagwan Satiani
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0
How the best leaders ensure psychological safety at work
Bhagwan Satiani

My limited understanding of psychological safety is when people feel safe expressing differing opinions, and thoughts in the workplace. Amy Edmondson, a pioneer in this area, defines it as “the belief that the environment is safe for interpersonal risk-taking.”1 Although psychological safety must be part of every organizational culture, it is critical for high-performing teams. Cues and actions to enable this behavior and impact organizational culture are the responsibility of the leader. High-innovation companies thrive on emotional energy compared to healthcare, where a high-safety environment—such as a hospital, for instance—relies on psychological safety. However, healthcare is also a combination of research, innovation and caring for human beings. This requires leadership to share their aspirations and push for a healthy balance of both. 

Why is psychological safety important in the workplace? Because it is key for people to perform optimally. A McKinsey & Company survey confirms that 89% of employees corroborate that their ability to voice their thoughts and feel safe is essential in the workplace. Gallup has calculated that doubling the percentage of employees who believe their opinion in the workplace counts from 30% to 60% resulted in a 27% reduction in turnover, a 40% reduction in safety incidents, and a 12% increase in productivity. Not surprisingly, it is also one of the strongest predictors of team performance. 

While the lack of such safety for employed physicians can be seen in any scenario, I have been most exposed to it in the academic environment. To assume that the impact of lack of such safety must only be on junior faculty or trainees is erroneous. Surprisingly, even senior tenured professors have expressed fear of speaking the truth in public, and often in meetings. I once had a chair express his fear of speaking out in front of a dean several years ago to me thus: “If anyone says anything to the contrary at a meeting, the dean will cut your b***s out.” Imagine how junior faculty must have felt. One can only assume that expressing an opinion counter to the leader in such an environment could result in ill-treatment in the form of compensation, further career advancement, recommendations and discretionally awarded titles. If senior professors are reluctant to speak up, newly hired or junior faculty will not risk their careers, leading to fear of speaking, a “yes” culture and stunted productivity. 

Most of us have encountered leaders who may be successful at soliciting ideas and driving change but lacking in spotting cues at meetings where no one feels free to disagree. Rather than psychological safety, there is a culture of silence. What makes employees feel safe and engaged at work and in teams? Some have described four progressing stages of feeling safe at work: safety to be included, to learn, to contribute and, finally, to feel safe in challenging the status quo.2 William Kahn, an expert on employee engagement in the context of psychological safety, has identified three conditions for optimum engagement: “feeling safe, meaningfulness and having access to the right energy and resources.” There are consequences of a culture where there is lack of such safety. Research shows that this culture leads to an 85% rate of project failure. 

Edmondson has offered an interesting two-by-two grid or matrix with performance standards (apathy and anxiety) on the x axis and psychological safety on the y axis (comfort and learning).1 She advocates for leaders to attempt to push people into the right upper quadrant or the learning zone. Learning, innovation, and productivity will proceed with psychological safety, she counsels. However, she warns that this one item is only a part of a range of leadership behaviors that accelerates high-performance teams. The obvious goal is for all team members to be in harmony with each other, able to speak and share ideas towards a common purpose, without fear of appearing inane or fearing reprisal. It is the leader’s job to remove any risk associated with speaking out. 

So, how should leaders advance a “speak up” culture in order to enable psychological safety? 

First, the leader must remember their role in a team. It is to facilitate, empower others, be a catalyst and model the desired behavior. This means having the awareness to be cognizant of the thoughts and feelings of others. Silence does not equal agreement. Then, asking themselves if the silence is a pattern or a “one-off ” behavior? Solutions for each are different. Are team members actively engaged in making eye contact with you and others? If you sense hesitation, encouragement with a self-deprecating anecdote of some kind may work. Or better still, mention one of your own shortcomings. If you are truly self-aware you know what they are or have heard it said about you. 

Second, if the leader senses silence during a discussion, ask for advice, not feedback. This is sometimes called the “feed-forward” technique. Feedback is often understood as either an “ask,” or after a decision has been made and interpreted as being judgmental. Using the word “advice” puts the onus on the other person, as well as being heard as being for the future rather than the past. A safe way to elicit advice is to admit that you are still pondering over the issue and that you are probably missing critical pieces of the matter. Not hearing people with a different mindset, leaders may be missing these pieces at a huge cost. 

Ron Carucci, co-founder and managing partner at Navalent, mentions two national disasters as examples where “employee voices” were not given importance because their opinions were either not solicited or ignored. These were the Challenger space shuttle in 1985 and the Columbia shuttle in 2003. Give people room to brainstorm out loud. Even if someone presents ideas or suggestions that lack substance, listen and understand the thought first, show empathy, and offer a counter idea, improving on their own statement by asking if they had considered it. People will generally remember what was decided at the meeting. It follows that if a certain position is accepted at a team meeting, progress must be reported at the next meeting. 

Third, every team needs a naysayer(s) or a contrarian. Sometimes uncomfortable? Yes. A facial expression or other tic may indicate disagreement but sometimes not. Ask for other viewpoints. To make a point, express a contrary view yourself to lead the discussion off. This allows others the freedom to express divergent opinions. 

Fourth, there is a risk that some team members may see the “safe” environment as a license to say whatever they want. Or, while all ideas may be welcome, many do not fit with the goals, mission, or task for the limited time at a team meeting. Remember, there is an “opportunity cost” associated with ideas/projects that do not sync with the goals and objectives of the team. Time and resources wasted on an unworthy project is time lost from a worthwhile one. After listening, gently steer the discussion away and remind everyone that although the idea was good, we can consider this for another time. 

Fifth, while I have seen good and bad leaders in a team environment, successful ones have two qualities that stand out. Calmness and confidence when their status or opinion is challenged. They do not get aggravated when the status quo is contested, and especially if team comportment or performance is deteriorating. Certainly, most team members will make errors. Give team members the freedom to fail as part of the team. Indeed, bring them up as learning opportunities, and avoid finger pointing. Emotions must be controlled. Focus on the error itself and how to avoid it in the future. This is where the fundamental pillar of leadership—self-awareness and knowledge of one’s own triggers—is so important for emotional regulation. 

Finally, consider a few steps that clearly demonstrate a team leader’s positive energy. People are loathe to report a problem with culture they see as incompatible with organizational values. The leader must encourage conversation about toxic behaviors in a secluded setting if necessary. Be generous with compliments. And please do not ask for advice from team members as you are close to walking out the door. I have seen this repeatedly. 

As I see it, providing psychological safety should be a part of all syllabi associated with developing physician leaders. Part of my learning has come from my own mistakes and being associated with our leadership program where I have watched groups go through the training, particularly during the team sessions. Although, data from McKinsey points to several other skills predictive of positive leadership, training in open dialogue skills, sponsorship, situational humility, and consultative behaviors (as in suggestion one and two) are especially important.3 McKinsey also reports that only 28% of leaders develop skills necessary to create psychological safety in team settings. We can do a whole lot better than that, right? 

References 

  1. https://amycedmondson.com/psychological-safety-%e2%89%a0-anything-goes/ 
  2. https://www.leaderfactor.com/post/why-are-some-leaders-afraid-of-psychological-safety) 
  3. https://www.mckinsey.com/featured-insights/mckinsey-explainers/what-is-psychological-safety 

Bhagwan Satiani, MD, is a Vascular Specialist associate medical editor.

First patient treated in ZFEN+ fenestrated endovascular graft study

By
Bryan Kay
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0
First patient treated in ZFEN+ fenestrated endovascular graft study
Zenith Fenestrated+ endovascular graft

Cook Medical has announced the first patient treated in the clinical study of the Zenith Fenestrated+ endovascular graft (ZFEN+) in the U.S. The procedure was performed on Jan. 29, 2024, at the University of Texas Health (UTHealth) in Houston, Texas, by Gustavo Oderich, MD, global principal investigator.  

“We are ecstatic at UTHealth Houston to have treated this first ZFEN+ patient. This is a huge step forward in getting the first patient-specific device for complex abdominal and extent IV thoracoabdominal aneurysms with fenestrations. Rather than a one-size-fits-all approach, the ZFEN+ device design aims to optimize patient needs,” said Oderich.

The ZFEN+ clinical study is being conducted under an investigational device exemption (IDE) from the Food and Drug Administration (FDA). This clinical study will assess the safety and effectiveness of the ZFEN+ used in combination with the investigational Zenith Universal distal body 2.0 graft (Unibody2), the investigational Bentley BeGraft balloon-expandable fenestrated endovascular aortic repair (FEVAR) bridging stent graft system, and the commercially available Zenith Spiral-Z abdominal aortic aneurysm (AAA) iliac leg graft (ZSLE).

The ZFEN+ clinical study will enroll patients in need of treatment of aortic aneurysms involving one or more of the major visceral arteries. Patients with juxtarenal, pararenal and extent IV thoracoabdominal aortic aneurysms meeting specific anatomical requirements may be included in the study. The ZFEN+ device is designed with fenestrations aligned to a patient’s unique anatomy and to extend the proximal margin of aneurysmal disease that can be treated endovascularly.

SVS seeks volunteers for open committee slots

By
Kristin Spencer
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0
SVS seeks volunteers for open committee slots

The SVS is accepting applications for vice chairs and volunteers. SVS members in good standing can apply for up to two committee positions and serve for a one-year appointment term renewable for a maximum of three years based on evaluation of performance. 

This call for committee members comes with new eligibility terms for committee members and vice chairs. Any Early-Active SVS member in good standing can apply to serve. 

In November, membership votes made the change official. The Appointments Committee and Executive Board have expanded the pool of eligible vice chairs to include anyone who has served on a committee within the past six years. 

Once the application window closes, the SVS Appointments Committee will review all SVS committees, their leadership and assembled applications, analysing for gaps in knowledge, experience, practice type and diversity. Recommendations that come out of this process will be presented to the SVS Executive Board for approval. 

Eligible SVS members can apply for open positions from mid-January until late March. For questions about eligibility, email governance@vascularsociety.org. 

Mentor Match available for all SVS members

By
Kristin Spencer
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0
Mentor Match available for all SVS members

The SVS has expanded its Mentor Match program, which is now available to all SVS members in good standing. The program aims to connect vascular surgery professionals with experienced mentors who can help them achieve goals. 

Mentor Match began in 2019 and was open to medical students and general surgery residents. The program allowed for future vascular surgeons to request a mentor who could provide guidance on their impending career. Between 2019 and 2023, over 200 individuals took advantage of the free program. 

The Society’s Membership Section leaders initiated the expansion of the program when they inquired about mentorship opportunities for their Section members in late 2023. In addition to allowing all members to become mentees, the Society will also enable more members to become mentors. 

Interested members can visit SVSconnect.vascular.org to learn more and sign up. 

SOOVC releases handbook for outpatient care

By
Marlén Gomez
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0
SOOVC releases handbook for outpatient care
Anil Hingorani

The SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) has released the anticipated Office-Based Lab (OBL) Handbook to guide practitioners and aid with safety and cost-effectiveness, as well as expand patients’ access to care. 

Anil Hingorani, MD, chair of SOOVC, emphasized the increasing prominence of outpatient vascular care, constituting over 50% of lower extremity angioplasties. The handbook aims to fill the existing resource void, offering guidance on starting and maintaining office-based labs (OBLs) and ambulatory surgery centers (ASCs), catering to new practitioners and those with established practices. 

“We don’t have many resources for how to manage this and develop and maintain these new types of practice models. This handbook is a resource meant to help a new practitioner or even a practitioner who already has an up-and-running OBL or ASC and assist them in maintaining these new paradigms,” said Hingorani. 

He highlighted the dynamic nature of the handbook, describing it as a live document that will evolve as the field progresses. This adaptability, made possible by its online format, enables timely updates and additions. Three new chapters have already been added since the initial version, reflecting the field’s rapid evolution. The handbook will have both an online and a print version for accessibility, with the online version available now. 

The handbook covers crucial topics for practitioners, including finance, research, anesthesia, equipment and accreditation. Hingorani said the chapters, designed to be concise and focused, feature formats such as bullet points, regular text, pictures and charts that are easy to understand. 

Addressing the timeline of the handbook’s creation, Hingorani mentioned that the process began about a year ago, with authors submitting chapters within a relatively short timeframe, facilitated by their familiarity with the subject matter. The SVS team played a crucial role in the editing process, ensuring the quality of the content. 

Hingorani mentioned the challenges practitioners face in the evolving field of outpatient vascular care, mainly focusing on financial considerations, regulations, and ensuring patient safety and quality care.“We want to make certain that these OBLs are financially solvent, and a lot of planning is done before you put the shovel in the ground,” said Hingorani. “Quite frankly, you want to ensure you have a financial plan. Fortunately, this handbook has chapters written by experts who know how to develop those. In medicine, we don’t train our trainees how to do that.” 

The handbook authors continuously contribute and provide updates to ensure the handbook remains a comprehensive and up-to-date resource. 

Regarding the future of the handbook, Hingorani mentioned the possibility of turning chapters into podcasts, leveraging the growing popularity of audio-based content. The aim is to make the content more accessible for practitioners. 

“This is an important contribution and advancement to the field that many of our practitioners are getting increasingly involved with, but more importantly for our patients, it’s quite important because they prefer an effective environment to perform these procedures.” 

For more, visit vascular.org/SOOVC. 

Viabahn VBX stent graft receives FDA approval

By
Bryan Kay
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0
Viabahn VBX stent graft receives FDA approval
GORE(R) VIABAHN(R) VBX Balloon Expandable Endoprosthesis
Viabahn VBX balloon expandable endoprosthesis

Gore has announced recent Food and Drug Administration (FDA) approval of a lower profile Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) for the treatment of complex iliac occlusive disease.

“Our team is pleased to be the first commercial implanter of the new lower profile VBX stent graft,” said Darren Schneider, MD, chief of vascular surgery and endovascular therapy at Penn Medicine in Philadelphia. “Combined with the flexibility, strength and deployment accuracy I’ve always trusted with the device, the new lower profile will enable me to treat most of my complex cases with a 6 or 7F device, reducing the risk of access complications while bringing trusted VBX stent graft outcomes to more of my patients.”

Gore details in a press release that no changes to the stent design were made to achieve the lower profile. “By focusing on improvements to the delivery system only, the valued characteristics and trusted performance of the stent graft itself remain unchanged and are joined by the enhanced versatility a lower profile provides. Depending on the practice, physicians may be able to use the VBX stent graft with a broader set of patients, experience a lower risk of complications at the access site,” the company explains.

The lower profile device will be rolled out to the U.S. market over the coming months and is also being studied in the TAMBE trial of type 4 thoracoabdominal aortic aneurysms (TAAAs).

In January, Gore has announced that the first patients had been enrolled in the Gore VBX FORWARD clinical study, a global prospective, multicenter, randomized controlled trial to compare the Gore Viabahn VBX balloon expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease.

Endospan releases early TRIOMPHE IDE study results at Society of Thoracic Surgeons annual meeting

By
Jocelyn Hudson
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0
Endospan releases early TRIOMPHE IDE study results at Society of Thoracic Surgeons annual meeting
Nexus system
TRIOMPHE
Nexus system

Endospan shared 30-day results from the first 22 patients enrolled in the TRIOMPHE investigational device exemption (IDE) study in a late-breaking presentation at the 60th annual meeting of the Society of Thoracic Surgeons (27–29 January, San Antonio, USA).

TRIOMPHE is a multi-arm, multicentre, non-randomised, prospective clinical study to evaluate the safety and effectiveness of Nexus in treating thoracic aortic lesions involving the aortic arch. The study will enrol 110 patients at up to 31 sites.

“We were pleased to see that in this high-risk patient population, the 30-day data for these first 22 patients showed a low mortality rate, no disabling strokes, paraplegia, or renal failure and short ICU [intensive care unit] and hospital lengths of stay,” said Bradley Leshnower, director of thoracic aortic surgery at Emory University School of Medicine (Atlanta, USA). “One year data are pending.”

A press release details that more than 120,000 patients suffer thoracic aortic arch disease every year in the USA and Europe, with only about 25% diagnosed or treated. Despite significant advancements, open surgical aortic arch repair maintains high mortality and morbidity. Patients with excessive perioperative risk or anatomical factors are not indicated for surgery, yet anatomical complexity and lack of approved devices for the arch has often prohibited endovascular repair. This makes the choice of treatment difficult or even impossible for some patients. Providing the alternative of minimally invasive repair decreases the requirement for extra corporal circulation and possibility of hypothermia, translating into reduced procedure and hospitalisation time.

“Nexus is designed for total endovascular arch repair to address the specific challenges of the aortic arch anatomy,” said Kevin Mayberry, Endospan CEO. “We are pleased to see that these early data align with the results achieved during the EU clinical study. These data suggests that NEXUS may provide surgeons with a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patient outcomes.”

Southern Vascular elects first woman president-elect

By
Bryan Kay
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Southern Vascular elects first woman president-elect

The Southern Association for Vascular Surgery (SAVS) elected Margaret (Megan) Tracci, MD, to become its first ever woman president for the 2025–26 cycle.

Tracci, a professor of surgery at the University of Virginia in Charlottesville, will serve as SAVS president-elect during 2024–25. Tracci is a past president of the Virginia Vascular Society.

Alan Lumsden, MD, the Walter W. Fondren III Presidential Distinguished Chair of the DeBakey Heart & Vascular Center at Houston Methodist, is the 2024–25 SAVS president.

Lumsden took over from David L. Cull, MD, professor of surgery at the University of South Carolina in Greenville, at the SAVS business meeting, which took place Jan. 27, at the close of the association’s 2024 annual meeting in Scottsdale, Arizona (Jan. 24–27).

Beyond ‘do better’: New year reflections from a vascular surgery trainee

By
Shernaz Dossabhoy
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Beyond ‘do better’: New year reflections from a vascular surgery trainee

The new year is a time for reflection. It is also an opportunity to rededicate, or if needed, reinvent ourselves. Vascular surgery training is long, at least five to seven years for most of us. Most of our reflection happens as we progress from one academic year to the next, and often our self-feedback loop is stuck on do better, go faster, publish more. In the midst of surgical training, we regularly internalize our failures but often fail to savor our victories.

This year, I’m trying something new. In business, SWOT (strengths, weaknesses, opportunities and threats) analysis is the gold standard to evaluate performance, reprioritize and reallocate resources, and set future goals. As a current second-year research resident, soon to start year six of seven of vascular surgery training, I’m sharing my own SWOT with you. 

Strengths 

Leadership, organization, communication: After a recent busy call weekend (during research time, we cover one shift per month as the acting “chief ” resident), operating all night and then rounding on 25 new patients, my attending texted me: “Great work this weekend, chief ! You’ll do well when you come back given your natural attention to detail. Thank you for your help.” 

Weaknesses 

I have many. First, the Vascular Surgery In-Training Examination (VSITE). Each year, I am determined to do all the Vascular Education and Self-Assessment Program (VESAP) and Vascular Surgery Surgical Council on Resident Education (VSCORE) questions, review Anki flashcards, and score higher than just average on the in-service exam, but to no avail. This year, I’m buddying up with a friend in the general surgery program, and we’ve scheduled weekly study sessions on zoom for accountability. I’m also using Dr. Thomas Creeden’s The Vascular Surgery Review Book. Second, lower extremity distal bypass and upper extremity thoracic outlet syndrome exposures. No matter how many times I review the anatomy, it doesn’t click for me. This year, I am using the Complete Anatomy 3D human body atlas app while I read. Third, taking on too many projects. Research time has been a blessing in many ways, but it is also an easy time to over-commit to seemingly disparate research and writing projects and lose sight of what you actually set out to accomplish during the two years. 

Opportunities 

Anatomy and simulation courses and training. With the continued concerns regarding open surgical training volume, doubling down on program-initiated, regional, or national courses seems like a no-brainer. 

This past fall, our program had its first cadaver lab where we worked in teams of senior/junior trainees to cover all the major vascular dissections. I also attended the Midwestern Vascular Surgical Society (MVSS) simulation course, which covered everything from lower extremity bypass to ruptured endovascular aneurysm repair (EVAR), and ZFEN (Zenith Fenestrated AAA endovascular graft) to transcarotid artery revascularization (TCAR). Other courses on my list to attend are the Louisiana State University Fundamentals of Vascular Surgery Symposium, Top Gun skills competition at the Society for Clinical Vascular Surgery (SCVS) annual meeting, Houston Methodist open aortic training course, and the Weill Cornell Big Apple Bootcamp skills course. 

Threats 

Burnout and letting self-care fall to the bottom of my list. While I don’t think I have personally experienced burnout, I know that making sure to schedule yoga classes, meal prep, and family time on my calendar (just like all my other work commitments), makes me feel better and more whole. If you are clinical right now, this is hard. But even just fitting in a 15-minute high-intensity interval training video with my coffee in the morning before heading to the hospital, or after getting home from a long day before dinner, can shift my mood entirely. 

This year, rather than resolutions, I would encourage you to write out your SWOT analysis and maybe even share it with someone else. Hearing a co-resident’s struggles, and then sharing your own, is a powerful way to connect and combat burnout. Don’t let one bad day, week, or month define you. Vascular surgery also doesn’t define you, but it’s a large part of who we are, who we have chosen to become. It is also a path of continuous evolution. Just when you’ve mastered one skillset, it’s time to feel uncomfortable again. This holds true through every transition, from intern to second year, second to third year, third year to research time, and research years back to the last two clinical chief years. 

So, as I get close to starting up “Heartbreak Hill” with just a little more than two years left in training, I am reminding myself of why I chose and love vascular surgery: our patients have complex disease requiring our creativity and resilience, and yet they accept the redo-redo-redo procedure and remain grateful. We have lifelong relationships with our patients, and we are still the only surgical specialty I know to receive holiday cards and gift baskets from our patients and their families. We are the firefighters of the hospital, the service other surgeons call when they need help. We foster a culture of innovation and research. We are a close-knit community of approximately 3,000 vascular surgeons, who all seem to know each other, somehow. 

Shernaz Dossabhoy, MD, is a vascular surgery resident at Stanford University in Palo Alto, California. 

Gore receives FDA approval for breakthrough endovascular device in complex aortic aneurysms

By
Jocelyn Hudson
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Gore receives FDA approval for breakthrough endovascular device in complex aortic aneurysms
Gore Excluder TAMBE

Gore has announced Food and Drug Administration (FDA) approval for the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE), which the company states is the first off-the-shelf endovascular solution for the treatment of complex aneurysmal disease involving the visceral aorta.

A press release details that U.S. physicians have had limited options for treating patients with aortic aneurysms involving the visceral branch vessels, with the current standard of open surgical repair being complex and associated with a high rate of mortality and morbidity. It continues that existing options for a minimally invasive approach are limited to products not designed for this purpose or custom-built devices—when and if the patient’s anatomy qualifies them—which can delay treatment due to manufacturing time.

“Until now, endovascular treatment options were limited as alternatives to open surgical repair,” said Mark A. Farber, MD, national principal investigator. “TAMBE is an innovative first step forward that enables us to provide care that’s both effective and timely for complex aneurysm repair.”

TAMBE is an implantable branched device designed for use in patients with thoracoabdominal aortic aneurysms (TAAA) and high-surgical risk patients with pararenal aortic aneurysms (PAAA) of the aorta using an endovascular approach in which the physician guides the device through arteries in the groin and arm via small incisions. Using established imaging techniques, the physician deploys the device to seal off the aneurysm, allowing blood to flow directly through the endoprosthesis.

TAMBE has four built-in, pre-cannulated internal portals to facilitate placement of bridging stent grafts into the visceral arteries perfusing the internal organs within the abdomen. It is expected to become available in June 2024.

ESVS 2024 clinical practice guidelines on the management of abdominal aortoiliac artery aneurysms—what’s new?

By
Anders Wanhainen
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ESVS 2024 clinical practice guidelines on the management of abdominal aortoiliac artery aneurysms—what’s new?
Anders Wanhainen and Isabelle Van Herzeele
Anders Wanhainen and Isabelle Van Herzeele
The updated European Society for Vascular Surgery (ESVS) 2024 clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries, have been published online this month in European Journal of Vascular and Endovascular Surgery, and will be in print next month. Here, Anders Wanhainen, MD, from Uppsala, Sweden, and Isabelle Van Herzeele, from Ghent, Belgium—chair and co-chair of the guideline writing committee, respectively—highlight some important updates from the new document for vascular specialists and policymakers alike.

The ESVS 2024 guidelines document on the management of abdominal aortoiliac artery aneurysms was developed over a three-year period by a writing committee comprising of 16 aortic experts from 12 European countries. By summarising and evaluating the currently best available evidence, 160 recommendations for the evaluation and treatment of patients have been formulated and graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C to mark the level of evidence (LoE). Compared to the previous 2019 version, 59 recommendations are completely new, 49 have been revised, and only 52 recommendations have not been changed. Importantly, only 10/160 (6%) recommendations are based on Level A evidence, while 112 (70%) recommendations are supported by Level C evidence or based on consensus, illustrating lack of evidence in the aortic field. 

Screening and management of small AAAs 

Because of changing epidemiology, with the decreasing prevalence of abdominal aortic aneurysm (AAA), a thorough re-evaluation of the screening recommendations has been made. Although screening of high risk groups remains highly recommended (Class I, Level A), the target groups have not been included in the recommendations, but should be made depending on local conditions, such as prevalence of the disease, life expectancy and healthcare structure.  

People who have first-degree relatives with AAA, with other peripheral aneurysms or organ transplant recipients are established high-risk groups that should be subject to screening. Older men, especially those with a history of smoking, also remain a suitable target group in many settings. But in populations with extremely low smoking prevalence, the incidence of AAA is so low (<1%) that the value of screening can be questioned. There is also lack of support for screening women and people with cardiovascular disease. 

The importance of cardiovascular risk factor management in patients with small AAAs has been strengthened. Based on a comprehensive analysis of the available evidence it is not considered to be justified to restrict the use of fluoroquinolone antibiotics in patients with AAA as was previously suggested by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Similarly, this guideline advises against restricting exercise and sexual activity in patients with AAAs. 

Indication for repair 

In line with the evidence, a clear negative recommendation is now issued for the repair of AAA <55mm in men and <50mm in women. The diameter threshold for when repair can be considered is maintained at 55mm for men and 50mm for women; however, the recommendations have been downgraded due to the lack of supporting high quality evidence. Furthermore, in line with recent data, it is clarified that the diameter threshold for considering repair should preferably be based on the ultrasound (US) measurement, while computed tomography angiography (CTA) for treatment planning is only recommended when the diameter threshold has been met on US. 

Given the natural history of iliac artery aneurysms with slow growth rates and the very low risk of rupture below 40mm in diameter, the writing committee considers it justified to raise the recommended diameter threshold for surgical repair to 40mm. There are no data to suggest any gender differentiation of the indication for repair. Nevertheless, it may be reasonable to take gender and body size into account, in the same way as for AAA. 

Elective AAA repair 

Due to the rapid technological and medical development, the existing RCTs comparing open surgical repair (OSR) and endovascular aneurysm repair (EVAR) are partly outdated and thereby not entirely relevant for today’s situation. It is therefore necessary to also include more recent case series and register studies in the overall evaluation. Thus, despite data from multiple RCTs and meta-analyses, representing the highest level of evidence, the existing level of evidence was rated as mediocre (Level B). Overall, evidence suggests a significant short-term survival benefit of EVAR over OSR, with similar long-term outcome up till 15 years of follow-up. Thus, the impetus towards EVAR as the preferred treatment modality for AAA in most patients is retained in the 2024 guideline.  

Following reports of failing devices in EVAR, this guideline advocates the use of devices with proven durability, and advises against EVAR outside the manufacturer’s instruction for use (IFU) in the elective setting. Long-term follow up in prospective registers of updated devices based on established platforms is recommended as before, however with the increased requirement for 10 years of durability data.  

Due to the lack of evidence of a clinically relevant benefit, routine pre-emptive coiling of side branches or non-selective aneurysm sac embolisation before EVAR is not recommended, and in OSR of AAA routine use of antimicrobial coated grafts to prevent aortic graft infection is not recommended.  

The previously preferred endovascular approach for iliac aneurysms has been amended. Neither technique is generally considered superior to the other, but instead the choice of surgical technique (open or endo) for iliac aneurysm repair should be based on patient and lesion characteristics. 

Ruptured AAA repair 

The benefit of EVAR for rAAA has been demonstrated in RCTs and large cohort studies, which is why the recommendation for EVAR as the first option in rAAA remains as Class I, whereas it is considered justified to upgrade the LoE to Level A. 

The recommendation of using aortic balloon occlusion for proximal control is downgraded due to the uncertainty of its effect, while the recommendation for vacuum assisted open abdominal closure has been upgraded, with the addition of mesh traction. Other news includes the need for proper stent graft oversizing, anticoagulation in the emergency setting, management of colonic ischaemia, and treatment of aorto-caval fistula. 

EVAR follow-up 

An updated recommended follow-up algorithm after standard EVAR has been included. All patients are recommended for early post-operative CTA imaging (within 30 days), to assess the presence of endoleak, component overlap and sealing zone length.  

Patients stratified as low risk of complications (no endoleak, anatomy within IFU, without high risk features (proximal neck diameter <30mm and angulation <60°, and iliac diameter <20mm), adequate overlap and seal of ≥10mm proximal and distal stent graft apposition to arterial wall) should be considered for low frequency imaging follow-up during the first five years.  

Patients deemed at high risk (presence of type 2 endoleak [T2EL], insufficient overlap or seal <10mm, anatomy outside IFU, large proximal neck (>30mm), ectatic iliac fixation zones (>20mm) or extreme angulation (>60°) and EVAR failures (direct endoleak [type 1 or 3 endoleak], obvious degradation of seal zones with impending endoleak, or aneurysm sac growth > 10mm) should instead be managed more actively with intensified and/or additional imaging or consideration of treatment.  

Several new and updated recommendations on the management of endoleaks are presented and a suggested diagnostic step up for occult undetermined endoleaks is described, where the option of conversion to open surgical repair (OSR) with stent graft explantation is highlighted. 

Complex AAA 

The coverage of complex AAAs has been expanded significantly to reflect advances in technology since 2019 and now covers the management of juxta- and pararenal AAAs as well as suprarenal AAAs and type 4 thoraco-abdominal aortic aneurysms (TAAAs). Treatment recommendations have been updated based on an increasingly comprehensive body of knowledge, including preliminary data from the most recent UK Complex aneurysm study (UK COMPASS trial). Endovascular repair with fenestrated and branched endografts is considered to have some benefit and is advocated in patients with high surgical risk and complex anatomy.  

Further updated recommendations have been issued on preservation of renal function, prevention of spinal cord ischaemia, and new technologies, such as off the shelf branched devices, physician modified fenestrated endografts (PMEGs), and in situ fenestration. Parallel graft techniques should only be considered as an option in the emergency setting, or as a bailout, and ideally be restricted to ≤2 chimneys. The use of new techniques and concepts for treatment of complex AAAs is not recommended in routine clinical practice, and should be limited to studies approved by research ethics committees after obtaining patient’s informed consent, until adequately evaluated. Of note, this includes the use of endostaples to treat short- neck AAAs with standard EVAR devices. 

Centralisation 

The firm evidence of a volume-outcome relationship of surgical repair in general, and AAA repair in particular, makes it necessary and justifiable with a continued centralisation of AAA repair. The recommended minimum yearly caseload has been upgraded to at least 30 standard AAA repairs per centre (no less than 15 of each OSR and EVAR), and a consensus recommendation on a minimum yearly caseload of 20 complex AAA repairs has been added. Rare and complex conditions, such as aortic graft infections, mycotic aortic aneurysms and patients with genetic syndromes should only be managed in highly specialised centres.  

Conclusion 

We encourage everyone to carefully read the new ESVS aortic guidelines in its entirety. We realise that it is an extensive document but it offers more recommendations of clinical importance and a comprehensive supporting text summarising the literature and motivating our positions. We hope you will find it relevant and useful for your practice.  

Anders Wanhainen, MD, is professor and chair of vascular surgery at Uppsala University in Uppsala, Sweden.

Isabelle Van Herzeele, MD, is associate professor of vascular surgery in the Department of Thoracic and Vascular Surgery at Ghent University in Ghent, Belgium.

Coding: Increasing complexity and lost RVUs—a drop in the ocean?

By
Bryan Kay
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Coding: Increasing complexity and lost RVUs—a drop in the ocean?
A vascular surgery team at Audie L. Murphy VA Medical Center in San Antonio, Texas, uncovers “staggeringly low” numbers of correctly coded billing for three commonly performed vascular procedures, raising concerns over cases with more complex coding.

Not long after becoming chief of vascular surgery at Audie L. Murphy Memorial Veterans Hospital—one of the larger of the Veterans Affairs institutions in the U.S.—in the past year, Alissa Hart, MD, started to look at her team’s productivity, and identified a problem. Despite car­rying out a brisk load of complex vascular cases for a VA setting like hers, there appeared to be a problem in terms of the level of relative work value units (RVUs) being captured by the center’s coding service. So she went “down the rabbit hole.” What she found astounded her.

“Only 42% were coded correctly, so the majority weren’t coded cor­rectly,” Hart tells Vascular Specialist. “These are simple cases. The TCARs [transcarotid artery revascularizations] were actually coded pretty correct­ly, but the other two—EVARs [endovascular aneurysm re­pairs] and fenestrated EVARs (FEVARs)? This isn’t even a pedal access atherectomy with stent placement, or some­thing along those lines.

“What I realized, when we looked at this in general, I went back and started trying to re-code my own cases, and there was a point where we did five EVARs in a month—which is pretty good for a VA—and only two of them were coded with a code that had RVUs attached to them.”

Based on her initial discovery, Hart and colleagues—including presenting author Luke Perry, DO, a first-year vascular sur­gery fellow at UT San Antonio—carried out a retrospective study of the total number of cases, those coded correctly, total number of RVUs, and the number of RVUs actually captured for TCARs, EVARs and FEVARs carried out at their center across a five-year period. The data are set to be presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 24–27) in Scottsdale, Arizona.

Total RVUs completed were 1,764.42 but only 1,196.82 were captured, SAVS 2024 will hear. “When I started looking at this, and look­ing at our productivity numbers, I thought, ‘How is this possible?’” Hart recalls. “We’re doing atherectomy cases, doing TCARs, EVARs and FEVARs, and all these things that a tertiary-level center would do at a VA. I was quite proud of our department. So having just come from private practice, where I had started to get more familiar with how outpatient-based labs code, and how many RVUs you can get out of a single procedure, I started looking at the way our coding was coming back from our central­ized coders. That led me down a rabbit hole where I started to realize that, not just the VA but other organizations as well, are using coders that are primarily used as outpatient coders to code surgical packages.

“For vas­cular surgery, in addition to complex cod­ing, you also have all these modifiers that really increase your RVUs. If a coder is not really sure how to do that properly, we’re doing all this work and we’re not getting the productivity value out of that, or the bonus value for our surgeons. We’re constantly being told you’re not productive enough and our system is trying to find ways for us to cut costs, when the reality is, if they would spend the time and put the energy into coding, then they could justify our existence as is—and probably provide us with more resources.”

With Hart being on the younger side— 34, she reveals—on becoming a chief all of sudden she realized she hadn’t really been prepared, either in her residency or during a stint in private practice, how to improve productivity or, for instance, justify the sal­aries of new hires.

There is also a vascular identity within hospital systems as well as resource alloca­tion dimension to consider. “Vascular sur­gery should get the resources that it needs based on the services it provides,” Hart says. “Some of our cases, we are back-up for cardiology, or we are back-up for inter­ventional radiology when they have access complications.

“To make sure vascular surgery gets the recognition and the resources that it de­serves to provide both surgical back-up and radiological assistance to so many different departments is really important.”

The next step in this line of study will see Hart and colleagues delve deeper into their more complex endovascular cases in order to ascertain the extent of incorrect coding issues. “We’re trying to find out what that looks like now because one of the other is­sues that I’ve found in my department in my particular system is that we don’t get RVUs

Alissa Hart

associated with reading vascular labs,” she explains. “What I’ve learned in the complex­ity of the bureaucracy in the federal govern­ment, your [productivity] scores are only as good as the data put in.”

So now Hart’s team will look to in­corporate that data with their operat­ing room coding in

order to determine what is being missed—“not just with vascular lab readings, but also on the ra­diological interpretation, ultrasound guidance, all those things for those CPT [Current Procedural Terminology] code modifiers, and see how many RVUs we’re losing.”

SVS announces on-demand coding courses are now available

To expand coding educational resources, the Society for Vascular Surgery (SVS) and long-term partner KarenZupko and Associates Inc. (KZA), a consulting and education firm, plans to release a series of on-demand courses quarterly that will examine the intricacies of coding for vascular surgery. The first course launched in December 2023.

Each fall, the SVS hosts an in-person Coding and Reimbursement Workshop, but the need for additional resources was clear, stated SVS Advocacy Council Chair, Megan Tracci, MD. “Coding is a critical part of running a successful practice for all vascular surgeons and we’re in need of resources, but they’re scarce,” she explained. “The SVS is working to ensure our members have access to the information they need.”

The first course focuses on surgical modifiers in vascular surgery. Modifiers tell the payor what happened in surgery and, more importantly, how they impact on reimbursements. The course dives into the most common modifiers and how they are used accurately in vascular surgery scenarios. New courses will drop throughout 2024.

The courses will provide American Academy of Professional Coders continuing education credits. Vascular surgery professionals and their office staff can access the first on-demand course by visiting vascular.org/codinginquiries.

Midterm CARAS study results show cerebral ischaemic event incidence “should not be underestimated”

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Midterm CARAS study results show cerebral ischaemic event incidence “should not be underestimated”

The final publication of midterm results from the observational CARAS study suggest that cerebral ischaemic event (CIE) incidence in asymptomatic carotid stenosis patients “should not be underestimated”, so say authors Rodolfo Pini (University of Bologna, Italy) and colleagues, relaying these findings in the Journal of Stroke and Cerebrovascular Diseases.

The authors further conclude that plaque progression and contralateral stenosis are among factors that may serve as primary predictors of CIEs, as per the results of their midterm analyses—which were initially presented at last year’s Vascular Annual Meeting (VAM; 14–17 June 2023, National Harbor, USA).

“Carotid endarterectomy [CEA] in patients with asymptomatic carotid stenosis remains a subject of debate,” Pini and colleagues initially state. “Current recommendations are based on randomised trials conducted over 20 years ago and improvements in medical therapies may have reduced the risk of CIEs. This study presents a midterm analysis of results from an ongoing, prospective, observational study of [asymptomatic carotid stenosis] patients to assess their CIE risk in a real-world setting.”

CARAS is a prospective, observational study of a cohort of asymptomatic patients with >60% carotid stenosis—as per criteria from the original NASCET trial—identified in a single duplex ultrasonography vascular laboratory. Short life expectancy and absence of signs of plaque vulnerability are among the factors cited by the authors for patients in the study not being considered for CEA.

The study’s primary endpoint is to assess CIEs ipsilateral to asymptomatic carotid stenosis, including strokes, transient ischaemic attacks (TIAs), and amaurosis-fugax, along with plaque progression rate and patient survival.

Patient enrolment took place from January 2019 to March 2020, with a sample size of 300 patients being targeted and a five-year follow-up scheduled. CARAS ultimately included a total of 307 patients (average age, 80 years; 55% male), of whom 61 (20%) had contralateral stenosis >60% and some 77% were on best medical management.

At a mean follow-up of 41 months, seven ipsilateral strokes and nine TIAs occurred, resulting in a total of 14 CIEs, Pini and colleagues report. They also note that two patients experienced both stroke and TIA during the follow-up period. And, as per a Kaplan-Meier analysis, the four-year CIE rate was 6%, with an annual CIE rate of 1.5%.

Disclosing further detail on their midterm results, the authors relay that 58 patients (19%) had a stenosis progression that was associated with a higher four-year estimated CIE rate compared to patients with stable plaque (10.3% vs. 3.2%, p=0.01). Similarly, contralateral carotid stenosis >60% was associated with a higher four-year estimated CIE rate (11.7% vs. 2.9%, p=0.002). A multivariate cox analysis revealed that these factors were independently associated with a high CIE risk, with hazard ratios of 3.2 and 3.6, respectively.

“The midterm results of this prospective study suggest that the incidence of CIE in [asymptomatic carotid stenosis] patients should not be underestimated, with plaque progression and contralateral stenosis serving as primary predictors of CIEs,” Pini and colleagues conclude.

University of Pittsburgh awards $100,000 grant to SVS member for AI-based healthcare project

By
Marlén Gomez
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University of Pittsburgh awards $100,000 grant to SVS member for AI-based healthcare project
The Aneurisk founders are in the front row (seated from left to right): Nathan Liang, David Vorp and Timothy Chung. The Aneurisk team (standing left to right) are Pete Gueldner a PhD student, lead software developer Chris Niles, and Micah Guffey, director of operations

Last October, the University Pittsburgh’s Clinical and Translational Sciences Institute hosted its 10th Pitt Innovation Challenge (PinCh), providing a total of $550,000 in prizes, with the top-three winners each receiving a $100,000 grand prize. PinCh 2023 announced that SVS member Nathan Liang, MD, and his co-founders Timothy Chung, PhD, and David Vorp, PhD, were awarded $100,000 for developing Aneurisk, an artificial intelligence (AI)-based tool designed to assess the risk and prognosis of patients with abdominal aortic aneurysms (AAAs). 

The grand prize teams presented their proposals to a panel of judges at the Petersen Events Center, where six finalist teams and 10 “elevator pitch” finalists showcased their ideas to address critical health issues. The Aneurisk technology aims to reduce adverse patient outcomes and surveillance costs by providing clinicians with a tool to project growth and likely outcomes upon diagnosis. 

With their collective backgrounds in clinical medicine, biostatistics, biomechanics, artificial intelligence and machine learning, the team collaborated to utilize a retrospective dataset from UPMC to develop a machine-learning model that predicts patient outcomes after approximately five years. 

“The results of our prototype algorithm got us really excited,” said Liang, a vascular surgeon at the University of Pittsburgh Medical Center (UPMC) and assistant professor of surgery and bioengineering at the University of Pittsburgh. “There is a potential opportunity to use our technology for treating or, at the very least, understanding these aortic aneurysms better. It became clear that this was a technology that could become something, and that’s where we were encouraged by the Pitt Innovation Institute to spin out a startup company.” 

Aneurisk focuses on utilizing AI to assess the risk of AAA patients. The patent-pending technology has the potential to revolutionize the field by providing a preliminary prediction of aneurysm behavior, offering clinicians valuable insights for treatment decisions, said Liang. Work on the technology goes back over five years and led to the recent incorporation of the company in February 2023. Since they started working together, the team has received more than $1 million in funding for research and development. 

Chung highlighted the importance of engaging with potential end-users during the development phase. The team spent six weeks contacting vascular surgeons across the country and other potential customers to gauge interest and refine their hypothesis and technology approach. The team expressed their gratitude for the responses received from SVS members who took the time to speak about common pain points in managing patients with AAAs. 

“We have developed AI tools to accelerate image-based analyses, all while modeling clinical outcomes. Acceleration is critically important in offering point-of-care solutions for identifying which patients are at higher risk,” said Chung. 

“The power of the machine-learning approach we are taking is that the prediction algorithm will be trained using many types of data and will determine which types and which specific parameters are critical in forecasting future aortic aneurysm enlargement or even eventual outcomes. We now know that biomechanics—specifically the balance between wall stress and strength—is important in considering the current risk of aneurysm rupture, but what other factors—and combinations of factors—can predict future rupture accurately now? What groups of parameters can predict future growth or time to critical size for the aneurysm? When fully constructed and clinically validated, Aneurisk will be able to do this on a patient-specific basis,” explained Vorp. 

The Aneurisk team is now seeking additional funding to transition their technology from a proof-of-concept to a practical tool clinicians can use for patients. “I’ve been doing this long enough to know that many people promise a lot, but not everyone follows through. We’re trying to ensure that we’re offering something that meets the needs of patients and our fellow vascular surgeons,” said Liang. 

International collaboration unveils updated PAD guidelines in diabetic foot ulcers

By
Marlén Gomez
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International collaboration unveils updated PAD guidelines in diabetic foot ulcers
New guidelines cover

The International Working Group on the Diabetic Foot (IWGDF), the European Society for Vascular Surgery (ESVS) and the Society for Vascular Surgery (SVS) have jointly released updated guidelines for the diagnosis, prognosis and management of peripheral arterial disease (PAD) in individuals with diabetes mellitus and a foot ulcer. 

The guidelines were developed using GRADE (Grading of Recommendations, Assessment, Development and Evaluations) methodology and were supported by several systematic reviews organized by Vivienne Chuter, MD, professor of podiatry at the University of Newcastle, Australia. The aim is to provide consistent, multidisciplinary and inter-societal recommendations applicable to clinicians everywhere. 

SVS President Joseph Mills, MD, affiliated with Baylor College of Medicine in Houston, who co-chaired the writing committee along with Rob Fitridge, MD, of the University of Adelaide, Australia (IWGDF) and Rob Hinchliffe, MD, of the University of Bristol, England (ESVS), shed light on the significant developments. 

“This collaboration, with extensive input from multiple specialties, represents a critical step forward in addressing diabetes-related foot complications across the globe,” Mills said. 

Building upon the 2019 IWGDF guideline, the updated guidelines cover a spectrum of crucial aspects of diabetic foot care. The writing committee, consisting of 18 experts from various disciplines, including vascular surgery, angiology, interventional radiology, vascular medicine, endocrinology, epidemiology and podiatry, worked collaboratively to develop recommendations that span the entire continuum of care. 

The guidelines were jointly published in the Journal of Vascular Surgery, the European Journal of Vascular and Endovascular Surgery and Diabetes/Metabolism Research and Reviews. 

The guidelines include five critical recommendations for diagnosing PAD in individuals with diabetes, both with and without a foot ulcer or gangrene. Additionally, the guidelines offer five recommendations for prognosis, aiding in estimating the likelihood of healing and amputation outcomes in those with diabetes and a foot ulcer or gangrene. 

A comprehensive set of 15 recommendations focuses on PAD treatment, prioritizing individuals for revascularization, selecting appropriate procedures and post-surgical care. The writing committee, conscious of potential gaps in current evidence, also highlighted key research questions for further exploration. 

Mills stressed the importance of these guidelines in improving patient care and reducing the burden of diabetes-related foot complications. “By becoming familiar with and following these recommendations, healthcare professionals can enhance their ability to provide better care to individuals with diabetes, ultimately improving outcomes,” he said. 

Mills indicated that the international, multidisciplinary approach to developing these guidelines reflects a concerted effort to address the diverse needs of patients with diabetes around the world. 

“As healthcare professionals begin to implement these updated recommendations, we hope to substantially diminish the burden of diabetes-related foot complications, reduce preventable, major limb amputations and improve outcomes for individuals worldwide,” said Mills. 

First procedures announced in study of novel peripheral IVL system

By
Bryan Kay
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0
First procedures announced in study of novel peripheral IVL system
A FastWave first-in-human case

FastWave Medical has announced the successful completion of enrollment for its first-in-human (FIH) study with the company’s peripheral intravascular lithotripsy (IVL) technology.

The prospective, single-arm study aims to assess the safety and performance of FastWave’s IVL system in patients with peripheral arterial disease (PAD) of the superficial femoral or popliteal arteries with moderate to severe calcium. Principal investigators Miguel Montero-Baker, MD, a vascular surgeon from Houston Methodist Hospital and HOPE Vascular & Podiatry Clinic in Houston, Texas, and Venkatesh Ramaiah, MD, a vascular surgeon from HonorHealth Vascular Group and Pulse Cardiovascular Institute Scottsdale, Arizona, conducted the procedures successfully in collaboration with the hosting investigator, Antonio Muñoa, MD, of San Lucas Hospital in Tuxtla Gutiérrez, Mexico.

Montero-Baker stated: “I am excited to be part of the initial cases to evaluate FastWave’s peripheral IVL platform. Their team has rapidly developed an easy-to-use system to address existing technological gaps, marking a significant milestone in achieving the company’s near-term goals.”

FastWave’s IVL platform is designed to treat calcific artery disease by fracturing calcium deposits using a balloon catheter that delivers shockwaves. The company’s peripheral IVL technology offers a user-friendly design with a highly deliverable, low-profile, rupture-resistant balloon that generates durable and predictable circumferential ultrasonic pressure, the company says in a press release.

“Calcium poses significant therapeutic challenges in treating peripheral artery disease, and many of the existing modalities are not optimal for addressing medial and deep plaque,” stated Ramaiah. “FastWave’s peripheral IVL technology is a promising advancement in calcium modification, and I am excited by the procedural success in these initial cases.”

New Florida vascular chief sets vision aimed at improving outcomes through multidisciplinary collaboration and innovation

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BIBA Publishing
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New Florida vascular chief sets vision aimed at improving outcomes through multidisciplinary collaboration and innovation
Jean Bismuth and Murray Shames

This advertorial is sponsored by Tampa General Hospital.

Early on, Jean Bismuth, MD, acquired a passion for vascular surgery from a world-class source. Back in his Danish homeland, he was drawn into the specialty as an intern by pioneering vascular surgeon and former European Society for Vascular Surgery (ESVS) President Henrik Sillesen, MD. Under Sillesen at the University of Copenhagen, he quickly acquired a keen awareness for how innovation drives the vascular field forward and the part it plays in improving patient outcomes. Add into the mix a keen sense for the important role played by multidisciplinary teamwork, and key elements of Bismuth’s approach to vascular surgery come into focus.

As Tampa General Hospital (TGH) and the University of South Florida (USF)’s new chief of vascular surgery, those core values are set to perform an important function. TGH’s Heart & Vascular Institute (HVI)—of which the Division of Vascular Surgery is a central plank—is growing and evolving. Long-standing vascular chief Murray Shames, MD, was appointed TGH chief of staff and USF chair of surgery. So Bismuth takes over at a critical juncture.

“It was clear to do justice to the growing division and the HVI that we needed to bring in a new leader—somebody with experience, an excellent clinical reputation, an innovator with an established research portfolio, and a commitment to our education mission for our residency program,” says Shames, who has been connected to TGH for three decades and division chief since 2017. “Dr. Bismuth brings national and international recognition to the division and the Department of Surgery. It was important that we find somebody with that experience who we could trust with a division that means a lot to me personally from an emotional and career development perspective. I have been part of USF and TGH for 30 years and so it was important to pass that baton to an established leader who would take it to the next level, beyond what I have been able to do.”

At TGH, the HVI service line model has evolved from a legacy academic department into its current guise: more collaborative and multidisciplinary.

For his part, Bismuth, in post two months now, is clear about the direction of travel. “What is necessary to make the TGH HVI successful? It’s really innovation in care,” he says. Bismuth doubles up as the HVI Vascular Center of Excellence medical director. He has wasted little time setting his vision in motion.

“The willingness here to have an open mind about how to build and how to structure this model so that the three units that belong under the HVI are successful is actually imperative,” Bismuth reflects. “One of the things we want to do is innovate in the therapies we deliver. Already, I have been reaching across platforms. Part of the vision is to demonstrate that there is a mission across borders. We have to break down these barriers between the specialties. Working across specialties really has defined my career.”

Bismuth came to Tampa from Houston. There, he was an associate professor of surgery at Houston Methodist, landing in Texas to complete his fellowship. Initially expecting to move back to the East Coast soon after finishing his training, Bismuth stuck around. Houston holds significant vascular surgical history, the home base of luminaries such as Michael DeBakey, MD, and E. Stanley Crawford, MD.

He credits much of his technical acumen to his time there, crediting a somewhat unlikely source for his education. “My grounding in terms of skill came primarily from one of my cardiac mentors there, Dr. Michael Reardon ,” he says. “A lot of the techniques I use today, they come from him. It’s a little ironic that cardiac surgery taught me vascular surgery!”

That pioneering spirit of Houston vascular surgery sharpened a natural gravitation toward innovation and collaboration. “It’s a big center there,” Bismuth explains. “It opened some doors for me, particularly with respect to my attributes. I work well across specialties. We had the good fortune of having a structure around the Heart and Vascular Center, which really allowed us to work well across specialties, so much so that I would say that probably 90%—if not more—of all my research were collaborations with cardiology in particular, and also cardiac surgery. It made for a very fruitful interaction. From an innovation standpoint, because it’s such a large medical center, it attracts a lot of medical startups, and I worked with a lot of new companies during my time there.”

Bismuth covers the full range of vascular disease but has particular clinical and research interests in aortic dissection, peripheral arterial disease (PAD) and central venous pathologies. That innovative spirit found early purchase during his days in Houston, where the specter of aortic dissections initially stumped him.

“Initially, I didn’t understand aortic dissections, and I don’t mean technically but from an imaging standpoint—they really perplexed me, by how they behaved and how they evolved,” he says. “As I worked across specialties, with cardiology, we started to develop specific imaging techniques for better understanding of these dissections.”

In the immediate term, Bismuth has his sights set on defining how the TGH HVI vision will translate on the ground in Tampa for the community at large. Longer term, he wants TGH to be an extension of what is a rapidly growing city. “It’s about being at the forefront of the trials, making sure industry is interested in bringing trials to Tampa,” he says. “I also think it is important that we have physician-driven innovation. And we have a unique structure in that we have CAMLS [Center for Advanced Medical Learning and Simulation], a fantastic 30,000-square-foot training location that almost nobody else in the country has. We have a common vision here in making Tampa an education destination.”

For Shames, stability has been a defining facet of his TGH department since he first landed 30 years ago. “We have not had a lot of turnover at the helm of vascular surgery here during my time, and I’m looking forward to a long career and legacy that Dr. Bismuth is going to leave behind,” he says.

“Tampa itself is evolving,” adds Bismuth. “Its expansion and what it promises is second to none. Migration to Tampa is huge. There is a general sense of innovation in the whole city.”

First patients enrolled in VBX FORWARD clinical study

By
Jocelyn Hudson
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First patients enrolled in VBX FORWARD clinical study
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Gore Viabahn VBX balloon expandable endoprosthesis

Gore has announced that the first patients have been enrolled in the Gore VBX FORWARD clinical study, a global prospective, multicenter, randomized controlled trial to compare the Gore Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) to bare metal stenting for patients with complex iliac occlusive disease. 

The trial aims to enroll an estimated 244 patients across 40 sites in the U.S., Australia, New Zealand and Europe, randomizing them 1:1 to the VBX stent graft group or the control group (BMS) and conduct follow-up visits through five years from the initial procedure.

“Treating complex iliac occlusive disease often comes with significant challenges, including tortuous anatomy and calcified lesions with the potential for rupture,” remarked Melissa Kirkwood, MD, professor and chief of vascular surgery at the University of Texas Southwestern Medical Center in Dallas, Texas, and study steering committee member. “The outcomes of this important trial will help determine whether the VBX stent graft, with its unique and versatile design, plays a meaningful role in addressing these challenges.”

A Gore press release details that the VBX stent graft offers precise delivery and supports positive outcomes in complex aortoiliac applications. It states that recently published long-term follow-up of patients treated with the stent graft for aortoiliac occlusive disease (AIOD) demonstrates the robustness and durability of the device through five years.

Vascular Specialist–January 2024

By
Bryan Kay
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Vascular Specialist–January 2024

In this issue:

  • Coding: Increasing complexity and lost RVUs—a drop in the ocean? 
  • The utility of renal stenting in hemodialysis patients: one in five found to come off dialysis after being stented
  • SVS points to 2023 achievements, challenges in coming year
  • Guest editorial: How the best leaders ensure psychological safety at work 
  • Aortic Research Consortium: F/BEVAR risk factors and one-year mortality 

 

U.S. Aortic Research Consortium maps out F/BEVAR preoperative risk factors for one-year mortality in complex AAAs, TAAAs

By
Bryan Kay
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U.S. Aortic Research Consortium maps out F/BEVAR preoperative risk factors for one-year mortality in complex AAAs, TAAAs
Adam Beck

A series of preoperative risk factors—including currently smoking, chronic kidney disease (CKD), congestive heart failure (CHF), aneurysm size greater than 7cm, more advanced age (75 or over), Crawford extent I–III thoracoabdominal aortic aneurysms (TAAAs), known chronic obstructive pulmonary disease (COPD), and anemia at baseline—were found to be predictive of one-year mortality among patients undergoing fenestrated and branched endovascular aneurysm repair (F/BEVAR) for complex AAAs and TAAAs with custom-made devices.

That is the key finding from one of the latest papers to come out of the U.S. Aortic Research Consortium (U.S. ARC) of investigational device exemption (IDE) trials set to be presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27).

The 10-center, more than 3,000-patient research conglomerate aims to use the data generated to create a risk stratification calculator to help inform a preoperative decision-making process that balances risk of aneurysm rupture if no intervention takes place, and mortality risk at one year if the disease is operated upon, Adam Beck, MD, a U.S. ARC investigator and vascular surgery division director at the University of Alabama at Birmingham in Birmingham, Alabama, told Vascular Specialist ahead of the SAVS 2024 meeting.

“The typical discussion when we are in clinic talking to patients about whether or when they should repair their aneurysm always focuses on the risk of rupture,” he said. “And that risk of rupture is usually put into the context of annual rupture risk. We did this project because we wanted to give a counterpoint to that risk of rupture. That was the idea behind this one-year mortality risk. So, you can say, ‘This is the risk of doing nothing, and here is the risk of doing something,’ in the setting of the patient’s overall state of health and quality of life.”

Operative mortality can be very low—from 1–2%—depending on the extent of the aneurysm and complexity of the repair, Beck observed. “But the mortality when you go out to a year can be much higher than that. So, something is happening to these patients after they get repaired. It’s not rupture of their aneurysm. Many of them are dying of their other medical comorbidities.” 

The U.S. ARC researchers looked at the full range of preoperatively available risk factors—gender, race, age, coronary disease, CHF, emphysema, cerebrovascular disease, diabetes, renal disease, hypertension, as well as both smoking and preoperative functional status. They were stratified by Crawford extent of their aneurysm: one complex AAA (juxtarenal/suprarenal) and two separate TAAA groups—one comprising Crawford type IV and V and the other the particularly high-risk extent I–III group, Beck explained.  

“The things that we found that were predictive of one-year mortality in a multivariable Cox regression was if they were a current smoker, if they had CKD, CHF, a very large aneurysm (greater than 7cm), more advanced age (75-plus), extent I–III TAAAs, patients with known COPD, and those who were anemic at baseline,” he said.

“The aneurysm size is a tough one. That one always falls out in an analysis like this: the bigger your aneurysm, the higher your risk of one-year mortality. It’s an interesting thing because the bigger your aneurysm, the more likely we are to offer you a repair—even in the setting of higher-risk patients, because we’re weighing that risk-benefit with rupture.”

During SAVS 2024, the research team will break down what the risk looks like in their predictive model by increasing risk factors. The risk calculator the U.S. ARC investigators hope to generate would enable individual patient data to be plugged in to gauge their one-year mortality risk.    

“Hopefully this could be something that will allow you to discuss with the patient in clinic and say, ‘Here is your risk of rupture, and here is your risk of mortality at one year. I think that it makes sense to proceed with your repair.’ Or you could say, ‘It really doesn’t make sense at your current size for us to put you at the risk of the operation,’” explained Beck. “This could also help you with your discussions about smoking cessation. If we could show patients on our phones apps and say, ‘This is your risk of mortality at a year with you being a current smoker. If I take this risk factor out, here is your risk factor at one year, and it will be a sizable difference.’ I think that will really help that discussion with the patient and our clinical decision-making.”

Further down the road, U.S. ARC is set to continue building on its body of work with additional analyses in areas such as target-vessel outcomes based on type of stent graft used, the impact of aortic aneurysm sac behavior after repair, the impact of renal insufficiency on outcomes, and the impact of endoleaks on mortality. The group has also recently completed a pilot study for a randomized controlled trial (RCT) for prophylactic spinal drains in patients with extent I–III TAAAs. The latter particularly excites Beck owing to his long-standing interest in preventing spinal cord ischemia as a complication of complex aortic aneurysm repairs.

Another recent development saw U.S. ARC include aortic arch procedures in its registry. “A few of the centers are capturing data for their endovascular aortic arch reconstructions,” Beck noted. “This is still in its infancy, but we’ll have some consortium data to publish in the next year or two, once we have more patients.”

Despite being only about six years old, U.S. ARC is having a big impact on evolving the arena of complex repair of TAAAs and AAAs, Beck said. “In our group, we have each changed our practices based on our publications,” leading to quality improvement, he added. “I’m biased because of my personal academic interests, but I think if we can actually get a [large, nationwide] RCT going for spinal cord ischemia, that would be one of the biggest contributions that we could make to the aortic surgery world. It will take a few years to enroll the number of patients we will need, so successfully initiating the trial may be one of our next big landmarks.”

The utility of renal stenting in hemodialysis patients: One in five found to come off dialysis after being stented

By
Bryan Kay
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0
The utility of renal stenting in hemodialysis patients: One in five found to come off dialysis after being stented
J. Gregory Modrall

A fifth of patients among a chronic kidney disease (CKD) cohort on hemodialysis—a rare subset pulled from a large repository of national data—were able to come off the treatment following renal artery stenting, a team of researchers from the University of Texas (UT) Southwestern Medical Center in Dallas has found.

The findings—set to be presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27)—have been hailed as being potentially the best evidence available in the field of renal stenting for decades to come, among a patient population so few in number that a randomized controlled trial (RCT) would almost never be viable, senior investigator and vascular surgeon J. Gregory Modrall, MD, a professor of surgery at UT Southwestern Medical School, told Vascular Specialist ahead of SAVS 2024.

“I have worked in the area of renal artery stenting for a number of years, but we have always focused on patients who had CKD and were not yet on dialysis,” Modrall explained.

When working on a larger study, using the TriNetX clinical database, he realized an opportunity had presented itself because of the repository’s sheer size. “It has a very large number of patients who were already on dialysis when they got stented,” said Modrall. “I realized that this presented a unique opportunity to address something that the literature is completely lacking.”

Among 173 patients who met inclusion criteria, Modrall and colleagues show that 33 (19.1%) were rescued from dialysis after stenting and were categorized as responders. At 30–90 days post-stenting, the median eGFR (estimated glomerular filtration rate) for responders was 51.6 ml/ min/1.73 m2 and remained stable over a median follow-up of 1.1 years. Survival was superior for responders, compared to non-responders, they found.

“We looked at patients who were on recent dialysis or current dialysis at the time of the renal artery stenting,” Modrall explained. “We defined recent stenting as within 60 days. The goal was to avoid inclusion of patients who maybe had dialysis six months ago but were no longer on it.

“Many of us in this field have had the sense there may be a small subset who can come off dialysis if stented at the right time but we have never had any data to guide us in patient selection, so, by and large, providers have just decided if patients are already on dialysis then they’re not going to stent that patient.

“What we found was that there is a subset that will come off dialysis—it’s about 19% of stenting patients came off in this cohort.”

Modrall and his team established that there were three basic predictors: duration of pre-stenting dialysis <79.5 days, diabetes and smoking. Two were dominant, he said. “Diabetes was a negative predictor.”

Those two dominant variables within the cohort alone “predicted 83–84% of the outcomes accurately,” Modrall continued. “So, we think that’s pretty solid data that suggest that we should be looking especially at those two variables in choosing the patients for stenting.”

With no RCT ever likely to be carried out in this subset of patients because the number who were stented in any given institution while already on dialysis are so few up to now, the data from his SAVS paper “might be the best we have for decades,” reflected Modrall.

“I personally wouldn’t stent every patient who was recently on dialysis, had renal artery stenting and was not a diabetic, because we have got to look at other factors like long-term survival, ability to tolerate the procedures, etc., but I think that is a good starting place and a lot more than we had before this study began,” Modrall added.

“It’s always going to be a difficult decision and it’s something that should be made in conjunction with a nephrologist, the patient and after looking at life expectancy and the patient’s ability to tolerate the procedure. With good education, the patient should be very active in making that decision. The chances are not high, one in five, but if we can take you off dialysis, it will have a huge impact on your life going forward.”

The ongoing larger study on which Modrall and colleagues are working revealed that patients in CKD stages 3b and 4 (eGFR 15-44 mL/min/1.73m2) are the only sub-groups with a significant probability of improved renal function after renal stenting, with the rate of decline of preoperative eGFR over the months prior to stenting a powerful discriminator of patients who are most likely to benefit.

Those results, delivered during SAVS 2023 in Rio Grande, Puerto Rico, last January, bore the ultimate aim of creating a prediction tool. At the time, Modrall pointed out that the predictors highlighted were “putative,” or “candidate predictors,” that have not been validated in a prospective series. “The next step is to take the data from this study, combine it with two of our prior studies, and in doing so we will have close to 1,800 patients with renal artery stents,” he said at the time. “That represents the single largest dataset of renal artery stenting patients in existence to my knowledge.”

Modrall and his team explained how they had hoped to leverage the enlarged dataset to create an outcome prediction tool that clinicians can use in practice. He envisaged a desktop- or phone-based application into which a patient’s parameters could be input in order to establish a probability of improved renal function.

“It turns there are variables that we haven’t defined,” he said prior to SAVS 2024. “The predictive capacity is better than we have now, but it is not as high as I’d like to see it. We are continuing to work on that.

“If I cannot get to a predictive capacity with this database that I think is sufficient, the next step would be to take a machine-learning approach to try to identify variables that maybe we haven’t even considered before.”

BEST-CLI: A year down the road

By
Jocelyn Hudson
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0
BEST-CLI: A year down the road
Alik Farber presents data from BEST-CLI for the first time in November 2022

A dedicated session at the 2023 VEITHsymposium (Nov. 14–18) in New York City aimed to unpack the ways in which clinical practice and attitudes in the field of chronic limb-threatening ischemia (CLTI) have changed since the BEST-CLI trial was published back in November 2022.

The trial’s principal investigators (PIs)—Boston-based vascular surgeons Alik Farber, MD, and Matthew Menard, MD, and interventional cardiologist Kenneth Rosenfield, MD, also of Boston—invited a multidisciplinary panel of opinion leaders from both the U.S. and Europe to share their thoughts and highlight some unanswered questions. 

‘We don’t cure these people’ 

First to comment was vascular surgeon Peter Schneider, MD, from the University of California San Francisco in San Francisco. “One thing I think is worth calling out is the change over one year,” he began. Schneider recalled that, during a 2022 VEITHsymposium session on BEST-CLI, “everybody was worried in some way” about what was going to happen next. A year later, however, he pointed out that “that’s melted away completely.” This change in opinion, in Schneider’s view, is testament to the leadership of the three PIs. 

Schneider’s main point was that BEST-CLI has contributed to a recognition that CLTI treatment is “much more complicated” than revascularization alone, predicting that the field is “going to become more like cancer treatment.” He continued: “These people have cancer. It was clear to all of us how sick they are, but now it will be clear to a much broader audience” 

Vascular surgeon and SVS President Joseph Mills, MD, from Baylor College of Medicine in Houston, expanded on Schneider’s point. “This cancer analogy works really well,” he said. “We don’t cure these people, and what we want to do is try to put them in remission for as long as possible.” Here, Mills advocated the use of endpoints that look at disease-free survival and wound-free period, suggesting they are probably the most useful for assessing long-term outcomes. “We should start looking at what’s better for [patients’] long-term care and not even one- or two-year results, but what happens over the lifespan of that patient,” he said. 

Antiproliferative therapy key 

Interventional radiologist Robert Lookstein, MD, from Mount Sinai Health System in New York, echoed Schneider’s sentiment that “the discourse [around BEST-CLI] has become more constructive than deconstructive” over the course of the past 12 months, in large part thanks to the trial leadership. 

He was keen to stress, however, that it is “obviously concerning” BEST-CLI reached different outcomes to BASIL-2, presented in April 2023. “It should be recognized they’re studying different populations,” he noted. Lookstein also highlighted the fact that there were very few women and underrepresented minorities enrolled in these two trials, urging caution with regard to extrapolating the results to these specific demographics. 

Lookstein’s pointed to the importance of antiproliferative therapy. He referenced a retrospective analysis presented earlier in the session by vascular surgeon Michael Conte, MD, from the University of California San Francisco, that suggested the endovascular arm of BEST-CLI “would probably have better outcomes” had the endovascular protocol been standardized with the level one evidence available on antiproliferative therapy and the infrainguinal circulation. “We have massive amounts of data [showing] that [antiproliferative therapy] is superior to non-antiproliferative therapy,” he stressed, asking why—against this backdrop of evidence— any vascular specialist would withhold this technology from their patients. 

Rosenfield, from Massachusetts General Hospital, pointed out that if he were to place a bare metal stent in a coronary vessel, “that would almost be malpractice nowadays.” 

Menard, of Brigham and Women’s Hospital, also picked up on Lookstein’s point, saying that one of the very important current challenges is that of “how to get the best endo[vascular] and the best surgery out there.” 

Lookstein added: “I think it behooves all of us to either lobby the guidelines or to speak out.” He mentioned the “profound” data presented by Conte on the impact of antiproliferative therapy on patency. “I firmly believe drug-coated balloons and stents must be considered the standard of care at this point.” 

Put the patient first 

Vascular surgeon Elizabeth Genovese, MD, from Penn Medicine in Philadelphia, noted the endovascular-first nature of her clinical expertise, which stemmed from the fact that she had worked for five years in the southeast of the U.S., where her patients had been “very medically complex and often poor surgical candidates.” 

Once BEST-CLI was published, Genovese stated that she moved to offering a more “patient-first” approach. Now, she relayed, her practice is framed around the question of which patients fall into the BEST-CLI cohort that does well with bypass first compared to an endovascular-first approach. “These are the patients who not only have good vein, but that tend to be on the healthier spectrum of the patient population; these are the patients that I didn’t necessarily see in the first five years of my practice,” Genovese noted. “But simultaneously, the patients in the open cohort had a fairly high anatomic complexity,” she added, referencing that over 60% of patients had infrapopliteal targets and 51% of the endovascular arm required tibial interventions. “What this study has done for us is made us realize that, in the right patient population, in more complex anatomic patients, bypass first remains still a really good and durable option,” Genovese summarized. 

Responding, Rosenfield stressed that “we need to be better about case selection for all of our techniques.” 

No more silos 

Interventional cardiologist Carlos Mena-Hurtado, MD, from Yale School of Medicine in New Haven, Connecticut, remarked that—for him and his institution—BEST-CLI had been “incredibly important” because “it made us come out of silos and it made us understand […] that CLTI is more than simply just revascularization.” He stressed that, while there is “a lot of work to do,” it is important not to put blame on each other. “I think we need to create the spaces where we can come together and discuss how best to [treat these patients],” he said. 

“The single most important thing that I learnt from the trial was the fact that when we had a patient with CLTI come into our facility, we would be forced to look at [the case] together,” Mena-Hurtado added. “We continue that practice up until today, and I think it has made not only our outcomes better, but our patients better.” 

‘There’s more work that needs to be done’ 

Vascular surgeon Maarit Venermo, MD, from Helsinki University Hospital in Helsinki, Finland—who noted that her center was the first site outside the U.S. to join the trial—pointed to the “huge number” of future studies in the works, which she believes will inform decisions around which treatment is best for which subgroups of CLTI patients. “Also, there will be a population who don’t benefit from endo[vascular] or surgery,” she added, stressing the importance of taking this into account when making clinical decisions. 

Farber, of Boston Medical Center, also encouraged audience members to look ahead to what is next, stressing that BEST-CLI and BASIL-2 are just the start. “No matter what your views are on [BEST-CLI] or BASIL-2 […], the exciting thing is that we have data coming in this space, which did not have a lot of data [before],” he said. Farber said more work needs to be done, with the “top priority” now to “harmonize” BEST-CLI and BASIL-2 using patient-level data. “It’s an exciting time,” he added. 

No increased risk of complications found with transradial access for carotid artery stenting

By
Jamie Bell
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0
No increased risk of complications found with transradial access for carotid artery stenting
Santiago Ortega-Gutierrez

Carotid artery stenting (CAS) delivered via transradial artery access has demonstrated no increased risk of stroke, death, myocardial infarction, transient ischaemic attack, or access site complications, as compared to the more traditional transfemoral approach. That is the concluding finding of a recent Stroke: Vascular and Interventional Neurology publication from Santiago Ortega‐Gutierrez (University of Iowa Hospitals and Clinics, Iowa City, USA) and colleagues.

“The transradial approach shows promise as an alternative method for CAS, offering potential benefits without increased risk of complications,” the authors write. “However, further studies are needed to confirm these findings.”

Ortega-Gutierrez and colleagues initially aver that transfemoral arterial access, while still the most widely used and preferred method for CAS, is associated with “inherent limitations and potential complications”, primarily related to access. The authors further state that positive results and experiences within interventional cardiology have seen transradial displace transfemoral access, becoming the primary approach for many cardiovascular procedures.

“Consequently, exploring transradial artery access as a potential option [due to innovative advances in large bore catheters] becomes crucial in optimising patient outcomes and procedural success rates,” they add, also noting that there are limited data comparing the approach and its outcomes to transfemoral access in CAS.

As such, the authors conducted a systematic review and meta-analysis of the existing literature in this space. From an electronic search of four databases, randomised and non-randomised studies alike involving CAS via transradial or transfemoral approaches were included. Overall, six studies comprising a total of 6,917 patients featured in their analyses. Some 602 of these patients (8.7%) underwent transradial access for the procedure, while 6,315 (91.3%) received transfemoral access.

Ortega-Gutierrez and colleagues’ subsequent meta-analysis showed “no significant difference” between the two access approaches in terms of stroke occurrence, with strokes being observed in 1.7% of patients in the transradial group and 1.9% in the transfemoral group (odds ratio [OR], 0.98). Furthermore, no significant differences were detected regarding death (1% vs. 0.9%, respectively; OR, 0.95), myocardial infarction (0.2% vs. 0.3%; OR, 1.53), transient ischaemic attack (0.4% vs. 1%; OR, 0.46), or access site complications (2.2% vs. 1%; OR, 0.97).

These findings align with other, previously published meta-analyses of the data in this area, according to the authors. However, in contrast to those analyses, the present study employed a Grading of recommendation, assessment, development, and evaluation (GRADE) approach to assess the certainty of the evidence—with the hope of providing “a more comprehensive and robust evaluation of the safety of CAS to better inform decision‐making”.

“Although these results indicate the potential viability of the transradial approach as an alternative to the traditional transfemoral access for CAS, the relatively small number of studies, considerable heterogeneity [in outcome definitions] among them, and the low certainty of evidence, highlight the need for caution in relying on these findings,” Ortega-Gutierrez and colleagues write. “The clinical decision‐making process should therefore be guided by a personalised approach that considers individual patient characteristics and anatomical considerations. Further studies, including RCTs [randomised controlled trials] with larger sample sizes, are warranted to confirm and refine these findings, and to guide clinical decision‐making in the selection of the optimal access approach for CAS.”

FDA approves ENGULF US pivotal trial of Hēlo thrombectomy system

By
Will Date
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FDA approves ENGULF US pivotal trial of Hēlo thrombectomy system

Endovascular Engineering (E2) has announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for its ENGULF US pivotal trial.

The study will evaluate the safety and effectiveness of the Hēlo thrombectomy system in treating pulmonary embolism (PE). The approval of the IDE follows the successful completion of the company’s 25-patient feasibility study.

“We are excited to be at the forefront of this innovative procedure with the completion of the ENGULF feasibility study. This significant achievement sets the stage for definitive results in the ENGULF pivotal trial. The Hēlo thrombectomy system represents a significant leap forward in pulmonary embolism treatment, and I am enthusiastic about investigating its full potential in the upcoming phase of the study,” said Jay Giri (University of Pennsylvania, Philadelphia, USA) the national principal investigator (PI) for the ENGULF feasibility study.

“We intend to build upon the robust foundation of clinical success we’ve seen thus far, solidifying the Hēlo thrombectomy system’s role as a transformative force in the treatment of pulmonary embolism,” said Andrew Klein (Piedmont Heart Institute, Atlanta, USA), the national PI for the ENGULF pivotal study.

Mike Rosenthal, CEO of E2, commented: “The positive results from our feasibility study give us confidence as we enter the pivotal phase. The Hēlo system introduces a differentiated technology with the potential to advance PE treatment options. Embarking on our ENGULF pivotal trial is a significant step, further validating the system’s safety and efficacy. It advances our efforts toward introducing this innovative technology to the market, ultimately helping patients with PE.”

SCAI, SIR, SVS jointly publish proceedings from multispecialty peripheral IVUS roundtable

By
Bryan Kay
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0
SCAI, SIR, SVS jointly publish proceedings from multispecialty peripheral IVUS roundtable
ivus
IVUS imaging

Proceedings from an expert consensus roundtable that discussed the benefits of intravascular ultrasound (IVUS) in lower extremity revascularization procedures were released today in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), Journal of Vascular and Interventional Radiology (JVIR), and Journal of Vascular Surgery-Vascular Insights.

The roundtable focused on the current challenges in diagnosing and treating lower extremity revascularization, knowledge and data gaps, and the potential role of IVUS in addressing these challenges. Experts shared their insights and experiences from the fields of interventional cardiology, interventional radiology, and vascular surgery. The expert consensus meeting was convened by SCAI and co-sponsored by: the American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), Society of Interventional Radiology (SIR), Society for Vascular Medicine (SVM), and Society for Vascular Surgery (SVS).

“Improvements in outcomes following peripheral vascular intervention have lagged compared to other endovascular treatments, such as percutaneous coronary intervention. Both clinical experience and evidence support the greater use of peripheral IVUS to reduce adverse events and extend the patency of our lower extremity revascularization procedures. By gathering experts from different specialties, we aimed to foster collaboration and exchange ideas to improve patient care for peripheral IVUS,” said Eric A. Secemsky, MD, lead author of the proceedings document and Director of Vascular Intervention, Beth Israel Deaconess Medical Center. “The roundtable provided a unique opportunity to identify knowledge gaps and discuss how IVUS can enhance our understanding and treatment of peripheral arterial and deep venous pathology.”

Lower extremity revascularization is a critical procedure used to restore blood flow to the legs and feet in patients suffering from peripheral arterial disease (PAD) and deep venous pathology. It is estimated that millions of people worldwide are affected by these conditions, which can lead to severe pain, non-healing wounds, and even limb loss if left untreated. Although angiography is the dominant imaging modality in revascularization, it has inherent limitations. IVUS is a minimally invasive imaging technique that allows physicians to visualize the inside of blood vessels in real-time. It provides detailed information about the vessel wall, plaque composition, and blood flow characteristics, enabling more accurate diagnosis and treatment planning.

During the roundtable, participants highlighted the potential of IVUS in guiding revascularization procedures, such as angioplasty and stenting, to optimize outcomes for patients. They also emphasized the need for further research and evidence to support the integration of IVUS into routine clinical practice.

“Vascular diseases are complex conditions requiring team-based care, research and information sharing to ensure that patients have access to appropriate, quality care for their condition,” said SIR President Alda L. Tam, MD. “Ongoing collaboration among these specialties is paramount to improving outcomes for patients worldwide.”

The roundtable concluded with a commitment to ongoing interdisciplinary collaboration and knowledge sharing among physicians. Participants agreed that treatment standards, formal training programs and global quality metrics remain needed to improve patient care.

The considerations and consensus views shared in “Intravascular ultrasound use in peripheral arterial and deep venous interventions: Multidisciplinary expert opinion from SCAI/AVF/AVLS/SIR/SVM/SVS” represent the opinion of the consensus committee members.

Why should SVS members respond when they receive an invitation to complete an RUC survey?

By
Wayne Causey
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Why should SVS members respond when they receive an invitation to complete an RUC survey?

The Society for Vascular Surgery (SVS) is an active participant in the American Medical Association (AMA)/ Specialty Society Relative Value Scale Update Committee (RUC) process. A very important component of the RUC process is the RUC survey. 

The rules related to conducting an RUC survey are governed by the RUC. The specialty societies conduct the surveys, analyze the data and use those data to advocate for fair physician work relative value units (RVUs). 

RUC surveys are conducted when new CPT (Current Procedural Terminology) codes are approved by the AMA’s CPT Editorial Panel or when the Centers for Medicare & Medicaid Services (CMS) and/ or the AMA RUC identify a service as potentially misvalued. 

RUC surveys are completed online and must be completed independently without coaching or assistance, with the exception of clarification from specialty society staff. 

An RUC survey of physician work solicits information about: physician time required to perform the service; mental effort and judgment; technical skill and physical effort; and psychological stress. 

Respondents are asked to indicate whether the typical patient described in their survey is their typical patient for that procedure. However, regardless of whether the patient described is the respondent’s typical patient, the respondent should complete the survey based on the described typical patient. 

Demographic information about the person completing the survey is collected to assist with data analysis. The survey includes a reference service list of codes for currently performed procedures and their corresponding RVUs. Respondents will estimate how much time it takes to perform the surveyed procedure and the number and level of postoperative visits. 

Respondents will be asked to compare the mental effort and judgment, technical skill or physical effort, and psychological stress of the surveyed code to the reference procedure. 

In the final step, respondents are asked to estimate a relative physician work RVU for the surveyed procedure based on responses to all the previous questions. 

Members, your voice needs to be heard. Next time you receive an invitation in your email to complete an RUC survey, please take the time to complete it. Contact SVSAdvocacy@vascularsociety.org with questions. 

Wayne Causey, MD, is a member of the SVS Coding Committee. 

Centers for Medicare & Medicaid Services grants Transitional Pass-Through payment for Endologix’s Detour system

By
Jocelyn Hudson
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Centers for Medicare & Medicaid Services grants Transitional Pass-Through payment for Endologix’s Detour system
PTAB using the Detour system
Detour
Percutaneous transmural arterial bypass using the Detour system

Endologix recently announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Transitional Pass-Through (TPT) payment for the Detour system, effective since 1 January 2024.

The TPT payment was created to facilitate patient access for qualifying new medical technologies that substantially improve the diagnosis or treatment of Medicare beneficiaries. TPT will provide hospitals with additional device reimbursement when the DETOUR system is used for eligible cases in the hospital outpatient setting. Details on the TPT, code C1604, can be found in the January 2024 Update of the Hospital Outpatient Prospective Payment System (OPPS), accessible on the CMS website and the Endologix website.

Percutaneous transmural arterial bypass (PTAB) with the Detour system, a US Food and Drug Administration (FDA) Breakthrough Device, received premarket approval in June 2023. Endologix states that PTAB offers a novel approach to treating complex peripheral arterial disease (PAD). The company details that Detour enables physicians to bypass lesions in the superficial femoral artery, by using conduits routed through the femoral vein via a transmural passage, to restore blood flow to the leg. According to Endologix, this approach is effective for patients with long lesions (20–46cm in length), those who have already undergone failed endovascular procedures, or those who may be suboptimal candidates for open surgical bypass.

“Being awarded the TPT designation marks an important milestone in our reimbursement strategy and the commercial launch of the Detour system for treating patients with complex PAD. At Endologix, our core mission is to deliver healthcare innovation to improve the lives of patients with vascular disease. With the support from CMS for qualified patients, we eagerly anticipate more patients to benefit from PTAB,” said Matt Thompson, president and CEO of Endologix.

The company advises that the Detour system is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200–460mm in length with chronic total occlusions (100–425mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The Detour system, or any of its components, is not for use in the coronary and cerebral vasculature.

VAM travel scholarships open doors for underrepresented medical students

By
Marlén Gomez
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VAM travel scholarships open doors for underrepresented medical students
A scene from the VAM 2022 Residency Fair in Boston

The Society for Vascular Surgery (SVS) Resident and Student Outreach Committee (RSOC) is accepting applications through Jan. 8, 2024, for the Diversity Medical Student Travel Scholarship. The award aims to provide aspiring vascular surgeons from underrepresented racial and ethnic minorities with the opportunity to attend the 2024 Vascular Annual Meeting (VAM) in Chicago. 

Scholarship recipients will receive financial assistance for travel expenses and complimentary registration for VAM. In addition to scientific sessions, VAM will offer medical student sessions, a mock interview session, a Residency Fair, SVS Connect@VAM and the VAM Mentoring Program. 

Carlo Angello Sánchez Montaño, MD, a previous scholarship recipient, shared his experience as the only Mexican resident from his program to receive the award for VAM 2023. He emphasized the significance of the opportunity, expressing his gratitude for the chance to connect with professionals and participate in the Vascular Health Step Challenge at VAM. 

Applicants currently enrolled as medical or pre-med students must have an active SVS account before submitting their applications. Although not eligible for the monetary travel award, local applicants are encouraged to apply for complimentary registration by selecting “local student/resident” on the application form. 

“My advice to future applicants is never to surrender, do your best, be a good person and pursue what you’re passionate about. If you don’t get selected the first time, don’t lose faith,” said Sánchez Montaño. 

Learn more at vascular.org/DiversityVAMTravel. 

VAM 2024 also includes the General Surgery Resident/Medical Student VAM Travel Scholarship for aspiring vascular surgeons. This scholarship includes a financial award for travel expenses and complimentary VAM registration for medical and pre-med students, as well as general surgery residents. Local applicants can apply for complimentary registration. Learn more at vascular.org/VAMTravelScholarship. 

Meanwhile, several SVS and SVS Foundation Awards and Scholarships are now available for 2024. 

SVS awards 

James S.T. Yao Resident Research Award: Apply by Jan. 10, 2024: This award motivates early-career physicians to pursue research in vascular disease and translational therapies. The recipient receives $5,000, a one-year complimentary subscription to the Journal of Vascular Surgery and the opportunity to present his or her research at VAM (vascular.org/YaoRRA). 

SOOVC Presentation Award and SOOVC Research Seed Grant: Apply by Jan. 15, 2024 for two SVS Section on Outpatient and Office Vascular Care (SOOVC) opportunities to engage in clinical research within office-based labs (OBLs) or ambulatory surgery centers (ASCs). 

The SOOVC Presentation Award (vascular.org/SOOVCPresentationAward) recognizes three outstanding projects, offering recipients the chance to present their research and receive recognition. Additionally, the SOOVC Research Seed Grant (vascular.org/SOOVCResearchGrant) provides three grants of $10,000 each, renewable for a second year, to support data analysis for actionable insights, quality improvement and patient care. 

Excellence in Community Practice Award: Apply by Feb. 1, 2024 for this award (vascular.org/CommunityPracticeAward), which honors a practicing vascular surgeon who has demonstrated exceptional leadership within their community. 

Lifetime Achievement Award and Medal for Innovation in Vascular Surgery: Nominate by March 1, 2024 for these honors. The Lifetime Achievement Award (vascular.org/LifetimeAward) is the highest accolade bestowed by the SVS. It recognizes an individual’s outstanding and sustained contributions to the profession and the Society, and exemplary professional practice and leadership. 

The Medal for Innovation in Vascular Surgery honors individuals whose transformative contributions have had a profound impact on the practice or science of vascular surgery. 

SVS Foundation awards 

Apply by March 1, 2024 for the SVS Foundation Clinical Research Seed Grant (vascular.org/ClinicalResearchGrant) to encourage clinical investigation in vascular disease. There is a Feb. 1, 2024, deadline for the Student Research Fellowship (vascular.org/studentfellowship), which supports laboratory and clinical vascular research by undergraduate and medical school students. 

Trainees should apply by Jan. 10, 2024, for the Vascular Research Initiatives Conference (VRIC) Trainee Award can receive this award (vascular.org/VRICTraineeAward). VRIC fosters collaboration and encourages interest in research among aspiring academic vascular surgeons. 

Vascular Specialist’s top stories of 2023

By
Bryan Kay
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Vascular Specialist’s top stories of 2023

top 10Which stories captured the attention of the vascular community over the course of the past year? Read our summary of the trending articles from across Vascular Specialist in 2023. Let us know your highlights by leaving a reply at the foot of the page with your comments.

1. Coding: New CPT codes for percutaneous arteriovenous fistula creation

Back in February, Sunita Srivastava, MD, and David Han, MD, worked through the 2023 Current Procedural Terminology (CPT) code set and the two new codes governing arteriovenous (AV) fistula creation in the upper extremity.

2. SVS responds to New York Times article on overuse of vascular interventions

In July, SVS President Jospeh Mills, MD, penned a response to the swirling coverage in the mainstream media of inappropriateness in vascular care.

3. Likes, dislikes and reposts: The new age of the vascular surgery influencer

Early in the year, Jean Bismuth, MD, and Jonathan Cardella, MD, tackled the thorny topic of vascular surgeons’ use of social media, starting their piece with the searing opener: “The brave new world of social media, with its TikToks and Kar­dashians, has now invaded our once-sane specialty.”

4. From the editor: Sex, lies, and carotid stents

In our October issue, Malachi Sheahan III, MD, Vascular Specialist medical editor, entered the debate around the Centers for Medicare & Medicaid Services (CMS) decision to expand coverage for carotid artery stenting. He dealt, in part, with the issue of practitioner competence in the treatment of asymptomatic carotid disease, writing: “Vascular surgeons matriculate into the workforce with documented technical and educational experience in the treatment of carotid disease. For other specialties? Not so much.”

5. Surmodics provides regulatory update related to FDA premarket approval application for SurVeil

Surmodics announced in January how it had received a letter from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB). In the letter, the FDA indicated that the application was not currently approvable, while providing specific guidance as to a path forward. The device received approval in July.

6. Robotic surgery: ‘We’ve missed the boat on this,’ says Houston vascular chief

In April, we interviewed Alan Lumsden, MD,  the Walter W. Fondren III Presidential Distinguished Chair at Houston Methodist’s DeBakey Heart & Vascular Center in Houston, Texas, on an emerging program at Houston Methodist that aimed to help prod those practicing in the vascular surgical space deeper into the field of robotic surgery.

7. Letter to the editor: The vascular influencer

W. Michael Park, MD, from University Hospitals in Cleveland, Ohio, responded to the earlier editorial penned by Jean Bismuth, MD, and Jonathan Cardella, MD, focused on social media use by vascular surgeons. “The voices of non-academic surgeons are given a platform to broadly share their experience,” he retorted in his piece. “If legitimately good people are dissuaded from participating, only the cheap suits will remain.”

8. Vascular surgery added as named specialty to influential national hospital rankings 

In July, it emerged that U.S. News & World Report was about to rename the specialty formerly known as “Cardiology & Heart Surgery” to include vascular surgery in its national rankings of the best hospitals in the country.

9. Envision, private equity and patient care: Substituted values 2.0

Back at the start of the year, Arthur E. Palamara, MD, a vascular surgeon in Hollywood, Florida, crafted a commentary on the specter of private equity in healthcare.

10. CMS confirms broadened Medicare coverage of carotid artery stenting in final decision

In October, we reported on the final CMS decision to approve the coverage expansion for carotid stenting. National Coverage Determination (NCD) 20.7 essentially confirmed the expansion outlined in a July proposed decision memo.

Government Grand Rounds: How SVS members can contribute to actively support advocacy efforts

By
Andrew Kenney
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Government Grand Rounds: How SVS members can contribute to actively support advocacy efforts

While advocacy consistently maintains a top spot among the list of priorities for SVS members, there remains a degree of uncertainty among many in the vascular surgery community regarding how to actively support SVS advocacy-related programs, the spectrum of available activities, and methods for measuring success throughout the process. 

In response to this need, the SVS advocacy team introduced a new column dedicated to shedding light on the actions of Congress and regulatory agencies and their direct implications on vascular surgery. The Government Grand Rounds series was designed to address these uncertainties, aiming to propel the SVS towards its objective of fostering a robust culture of engagement across the entirety of our SVS membership. 

Through the series, the emphasis was placed on highlighting the significance of the various tools we can utilize across our advocacy efforts. Looking back at that advocacy toolkit, we see the importance of advocacy from a multitude of perspectives. 

Protect: Advocacy in vascular surgery aims to protect patient access to necessary procedures. 

Engage: Engaging with the full range of healthcare policymakers and professionals is pivotal in advocating for vascular surgery. 

Educate: Vascular surgery advocacy focuses on educating decision makers about the importance of the vascular surgical specialty. 

Serve: Advocacy in vascular surgery is about serving the community by ensuring access to quality care and resources for vascular health. 

Advance: Advocacy initiatives in vascular surgery strive to advance and enhance patient outcomes and overall vascular care. 

Reform: Advocates in vascular surgery work to reform healthcare policies to ensure equitable access to vascular treatments and procedures. 

Promote: Vascular surgery advocacy seeks to promote awareness of the vascular specialty. 

Amplify: Advocacy in vascular surgery amplifies the voices of medical professionals and patients, advocating for better resources and understanding. 

Build: Vascular surgery advocacy aims to build collaborative networks among medical practitioners to improve standards and innovation in the field. 

Change: Advocacy efforts in vascular surgery are committed to driving systemic changes that improve patient care, treatment options and overall vascular health outcomes. 

Government Grand Rounds will continue into next year, to serve as a vehicle to drive the SVS towards its primary goal: cultivating that vibrant culture of engagement throughout its extensive membership. This strategic initiative aimed to not only resolve doubts but to galvanize participation, uniting members under a common cause of advancing vascular surgery. 

For more information about how the SVS advocacy programs help protect vascular surgeons and the patients you serve, visit vascular.org/advocacy. 

Andrew Kenney is a member of the SVS advocacy staff. 

Corner Stitch: On the vascular trainee opportunities on the conference calendar

By
Christopher Audu
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Corner Stitch: On the vascular trainee opportunities on the conference calendar
technology
Christopher Audu
Christopher Audu, MD, surveys the 2024 meeting landscape, highlighting prime opportunities for trainees to showcase their research.

It is abstract submission, and this month I wanted to highlight a few national meetings that are “trainee friendly” for getting your work presented as a podium talk or poster presentation. This list is not exhaustive but hopefully gets you thinking about applying. 

Vascular and Endovascular Surgical Society (VESS) 

We did a deep exposé on this organization in the December 2020 issue. A premier vascular meeting, the VESS winter conference is always in January and always at a ski resort, making it very popular. There is programming for trainees from the medical student, to the resident and fellow level. In addition, there is always great science presented. A very welcoming society, if you miss the winter conference, watch out for the spring edition—that’s always paired with the SVS Vascular Annual Meeting (VAM). 

Society for Clinical Vascular Surgery (SCVS) 

This is another society that has programming for students, residents and fellows. The meeting is usually in the late winter/ early spring—in March—and is usually somewhere warm. Be on the lookout for the SCVS Top Gun Competition, where you can go head-to-head with your colleagues in friendly battle. 

Pacific Northwest Endovascular Conference (PNEC) 

Don’t be fooled by the name, this is a meeting of vascular minds that invites faculty from all over the country to participate. Usually in Seattle, and hosted by the University of Washington, this meeting also has a friendly competition where programs can send a team to compete in a variety of vascular simulations. In addition, it is a great place to present some newer work. 

Academic Surgical Congress (ASC) 

This meeting is not exclusively focused on vascular surgery, but it does accept papers discussing vascular conditions. This is a great conference for students and trainees to get on for podium presentations. The meeting usually is in close temporal proximity to VESS—in February. 

American Venous Forum (AVF) 

Have you done work looking at venous pathology? This is the premier national meeting to present your work either in talk or poster format. The AVF is usually at a resort and often seeks trainee input. While there is no dedicated trainee programming, the organizers actively seek out trainee involvement. 

Charing Cross (CX) International Symposium 

This is an international meeting, set in London, England, and is usually in April. It’s a unique-style symposium that focuses on controversies in vascular surgical management in an effort to develop a consensus. While not entirely exclusive to vascular surgeons, it serves as a great meeting to hear the latest and reconsider what may be dogma based on practice patterns at your institution. 

Vascular Research Initiatives Conference (VRIC) and Vascular Discovery (AHA) 

This is a gathering for anyone conducting basic science vascular research. VRIC is often the day before the American Heart Association (AHA) Vascular Discovery meeting, and usually in April or May. It’s a wonderful opportunity to present groundbreaking work in a friendly environment. There is a poster competition and select abstracts will be recognized and awarded. For the budding basic scientist-vascular surgeon, this is a must-attend meeting that will allow you to meet other like-minded surgeon-scientists. 

Vascular Annual Meeting (VAM) 

This is always a big hit, and is the premier vascular surgery meeting in the U.S. With excellent programming aimed at medical students, residents/fellows, and a general audience, this meeting provides ample opportunity to learn, network and gain exposure to current practices in vascular surgery. As a trainee, if there’s only one meeting you can make, this one is probably it. 

In addition to those listed above, there are a number of other meetings and conferences that are great for educational and learning purposes, although the talks at these are usually in the form of invited lectures given by attendings rather than through abstract submission. These include, but are not limited to, VIVA (Vascular Interventional Advances), The VEINS (Venous Endovascular Interventional Strategies), VEITHsymposium and the Strandness Symposium. 

In the end, these are all opportunities to meet and re-meet expert vascular surgeons as we progress on this journey towards becoming competent vascular surgeons ourselves. I look forward to seeing you on a podium somewhere as you share your awesome work! 

Christopher Audu, MD, is the Vascular Specialist resident/fellow editor.

Yao family and SVS Foundation establish James S.T. Yao Resident Research Award

By
Marlén Gomez
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0
Yao family and SVS Foundation establish James S.T. Yao Resident Research Award
James S.T. Yao

In a tribute to the late James S.T. Yao, MD, PhD, a luminary in the field of vascular surgery, the Yao family and the SVS Foundation announced the renaming of the Resident Research Award to the James S.T. Yao Resident Research Award. 

The renaming of the award serves as a testament to Yao’s unwavering commitment to the advancement of vascular surgery, said Yao’s wife, Louise. The contribution from Louise and their three children—Kathy, a surgeon; John, a musician; and Pauline, a museum curator—ensures that his legacy continues to inspire future generations. Yao resided in Wilmette, Illinois, and had a longtime association with Northwestern University. 

“He was a great believer in research and writing papers,” reminisced Louise. “I see other people like him and my daughter, who is also in medicine and has many of those traits.” 

The award supports emerging medical professionals exploring vascular disease biology and innovative translational therapies. It recognizes unpublished, original scientific work in manuscript form that demonstrates publication quality. The recipient presents the research in a plenary session at the SVS Vascular Annual Meeting (VAM). 

“The Resident Research Award was my first opportunity to present the work of our team to a large audience, including many of my heroes, including Dr. Yao, from papers I had read,” said Luke Brewster, MD, a 2005 recipient of the award. 

Louise recalled her husband’s regard for the Foundation and how “he thought so highly of this organization and the things they did to help young people get into the field.” 

Yao, known as Jimmy, passed away on Dec. 20, 2022. His career began with his medical education at the National Taiwan University Medical School in Taipei. He continued his journey with a surgical residency at Cook County Hospital in Chicago and earned a doctorate in London, England. From 1988– 2007, he served as the Magerstadt Professor of Surgery and chief of vascular surgery at Northwestern University. 

His work led to the development of the ankle-brachial index (ABI), a quick and simple test for peripheral arterial disease that is now standard practice. His contributions included formalizing protocols for noninvasive vascular studies and founding the Society for Noninvasive Vascular Technology in 1977. Throughout his career, Yao wrote 200 textbook chapters and 50 academic books. He established the first blood flow laboratory in Chicago, initiated a vascular fellowship training program and held various leadership positions in vascular surgery organizations, including serving as SVS president in 1993. 

“[Dr. Yao] wrote over 300 manuscripts; he probably influenced every aspect of vascular surgery based on their case series,” said Michael C. Dalsing, MD, SVS Foundation chair and one of Yao’s former trainees. “But with all his success, he never forgot who he was—truthful, dedicated, humble and intellectually fearless.” 

Through his leadership in the SVS History Project Work Group, Yao demonstrated his commitment to preserving the history of vascular surgery by conducting interviews with more than 85 prominent figures in the field. In 2007, he received the SVS Lifetime Achievement Award. 

The recipient of the resident award renamed in his honor receives a $5,000 award and a one-year subscription to the Journal of Vascular Surgery. 

“The award deals with research that looks at the basic mechanisms of how vascular disease pathophysiology presents, or an innovative spin on treatment and how it sets the basis of how we look at disease or vascular health. It’s an innovative process, which is always very important if science is going to move forward,” said Dalsing. 

For more information on the award, visit vascular.org/YaoRRA. Submissions for 2024 are due Jan. 10, 2024. 

Nominations open for 2024 SVS Excellence in Community Practice Award

By
Marlén Gomez
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0
Nominations open for 2024 SVS Excellence in Community Practice Award
Patricia Furey (right) pictured with Robert Molnar

The Society for Vascular Surgery (SVS) is calling for nominations for its Excellence in Community Practice Award, which recognizes outstanding leadership within the community by a practicing vascular surgeon who has made sustained contributions to patient care and community well-being. 

Patricia Furey, MD, one of last year’s recipients, highlighted the inspiration it provides. 

“This award is extremely important for many of us who are in community practice, so I was very pleased to receive the award and very grateful, and I think it’s inspiring because we have a lot of wonderful community surgeons that wouldn’t even think of nominating themselves,” she said. 

Nominees must have a minimum of 20 years as a practicing vascular surgeon, with at least five years as an SVS member to qualify. 

The selection process considers evidence of the nominee’s impact on vascular care and community health, such as leadership in a community-based practice. 

The 2024 nomination period is now open, with nominations due by Feb. 1, 2024. Any SVS member can nominate a candidate by submitting a nomination form and supporting documentation. Self-nominations are also accepted. 

Nominations will be carefully reviewed by the SVS Community Practice Section, which will determine the award recipient. 

Robert Molnar, MD, a 2022 award recipient, underscored the importance of recognizing community practice surgeons, who constitute nearly 50% of the SVS membership, he said. 

To make inquiries or to obtain more information on the award and nominations, visit vascular.org/CommunityPracticeAward. 

First patient treated in ARISE II study of ascending stent graft

By
Bryan Kay
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0
First patient treated in ARISE II study of ascending stent graft
Ascending stent graft in place

Gore has announced the first patient implantation of the company’s ascending stent graft in the ARISE II trial, describing this as an exciting step in the development of treatments for pathologies involving the ascending aorta using endovascular repair rather than traditional open surgery.

On Dec. 1, national principal investigator Eric Roselli, MD a cardiac surgeon at the Cleveland Clinic in Cleveland, Ohio, performed the case at Cleveland Clinic alongside study investigators fellow cardiac surgeon Patrick Vargo, MD, and vascular surgeon Frank Caputo, MD. The patient was identified as a candidate for the study after presenting with a fusiform aneurysm of the ascending aorta and aortic arch.

The ARISE II study is the first multicenter pivotal study approved by the Food and Drug Administration (FDA) investigating the use of a minimally invasive endovascular device to treat the ascending aorta. The study investigates the treatment of isolated lesions as well as chronic and residual type A dissections involving the ascending aorta. The Gore ascending stent graft is designed for investigational use in combination with the Gore Tag thoracic branch endoprosthesis.

“The treatment of the ascending aorta has long been a ‘final frontier’ in endovascular surgery. ARISE II is a significant step forward as we search for minimally invasive options that can be offered to higher risk patients,” said Roselli.

The ARISE II study will investigate how an endovascular stent graft, delivered via catheter, may be used to line the diseased portion of the ascending aorta as a potential alternative to open surgical repair. Endovascular technologies have been applied to other regions of the aorta to reduce the risk of complications and recovery times, but no endovascular device is currently approved for the ascending aorta.

“Our patient is recovering well. Having a minimally invasive alternative would be a significant advancement for patients not suitable for open surgery,” said Caputo.

Personalized postoperative anticoagulation needed to curb lower-limb amputations

By
Jocelyn Hudson
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Personalized postoperative anticoagulation needed to curb lower-limb amputations

Dua“We’re going to see more and more amputations if we don’t figure out the right post procedure thromboprophylaxis regime ASAP,” Anahita Dua, MD, warned during a lecture on innovative approaches to preventing amputation at the Vascular Society of Great Britain and Ireland’s (VSGBI) annual scientific meeting (Nov. 22–24). 

Diabetes is a significant and growing problem for the vascular community, the associate professor of surgery at Harvard Medical School and vascular surgeon at Massachusetts General Hospital in Boston began. She explained to the audience: “Because our diabetic drugs are doing their job and the way we take care of these patients is getting better, they are living longer so we are seeing more of these patients.” 

At the Dublin, Ireland, meeting, Dua noted that this rise in prevalence will be accompanied by a parallel increase in the number of associated complications, specifically “complications we, as a society, may not have dealt with before”. She highlighted one that is a particular cause for concern: the microvascular dissemination of the foot. And, to make matters worse, “we have nothing to help these ‘no-option’ patients,” she said. 

Dua’s talk—titled ‘Going out on a limb to save a life and a limb’—first focused on deep venous arterialization (DVA)—a new technique that, according to the presenter, “is kind of taking the world by storm”. 

She first addressed some misconceptions. “There are going to be a couple of guys in the audience who are going to turn to their friend and say ‘we did this in the 80s’. No, you didn’t—I promise. You did some version of something that was called this in the 80s, but things have changed because technology and medicine have changed,” she said.  

So, this is not a new concept, the presenter stressed, noting in fact that there are reports of attempts from 1881. Following a “big breakthrough” in the 1970s, however, she remarked that the technique fell out of favor “because it didn’t really work in the way it was meant to.” There were various reasons for this, according to Dua. “We were plagued by a lack of technology, lack of buy-in and lack of patients.”  

The presenter highlighted some data on the new and improved iteration of this technique, first mentioning the PROMISE II trial, for which she was an investigator. While amputation-free survival was the primary endpoint, Dua focused on the limb salvage rate, which was 76% in patients who otherwise may have had no other option but an amputation.  

This is where the presenter turned the audience’s attention to another study—CLariTI—designed to illuminate the ‘real-world’ amputation rate in the U.S. The presenter reported that, in this study of 180 patients at 22 sites across the country, up to 73% who underwent an amputation did not have a diagnostic angiogram, while 54% had no revascularization attempts. “We need to make sure that across the country all of these patients are getting the same level of care,” Dua stressed. 

The presenter continued that in patients who were told they had no conventional options for salvage and/or had undergone two failed attempts at revascularization, the limb salvage rate was 48% at one year—so, “about a coin toss,” as Dua put it. The pooled results from PROMISE I and PROMISE II, however, which the presenter reiterated focused on DVA, revealed a higher limb salvage rate of 73%.  

“I really think that that is the future, or the only thing we have, frankly, right now, for patients that are coming in with microvascular dissemination of the foot and no other options,” Dua opined, based on these data.  

Anticoagulation: “One size fits all doesn’t work” 

Despite the progress made for these patients technique-wise, Dua told the audience that the issue of postoperative anticoagulation is hindering outcomes. “What do we do immediately after we’ve done this amazing, futuristic surgery?” she asked. “We put them on ‘one-size-fits-all’ thromboprophylaxis because we have little idea what we’re doing.” This result is suboptimal outcomes with up to 20% of patients needing reintervention from stenosis or thrombosis in the first six months post procedure.  

Dua advocated moving away from a “one-size-fits-all” approach, talking through some of the work she is currently conducting on this in her lab at Massachusetts General Hospital.

She noted that, based on her research, a patient’s platelets need to be inhibited by 30% to get a reasonable decrease in thrombosis. In order to get to this number, she explained, every patient will take different medications. “What we should be doing is testing the blood, determining whether or not you hit a particular level, and then treating accordingly,” she said. 

The presenter mentioned, for example, that men and women require different treatment. “We are undertreating women, even though we think we’re treating them the same. Because of course our studies have not included that many women, so we haven’t seen this.” The answer? “We need to personalize it,” according to Dua. 

The presenter noted that her work in this field has been published in the Journal of the American Heart Association (JAHA), but the task now is to translate the data into practice. In this regard, Dua referenced an ongoing trial she is conducting called TEG-MED. Dua and her team have formed an anticoagulation algorithm based on the 30% figure highlighted in their previous research. The aim now is to work out which patient needs what medication to get to that figure, remarking again that “every patient is slightly different”. 

“The future for these patients is very bright,” Dua said in her concluding remarks. “We’re figuring out the coagulation story, we’re starting to understand that there are patients that can be helped with deep venous arterialization and we’re accepting this new technology, and I really feel that—over time—we don’t have to even say we’re going out on a limb to save a limb, because it’s just going to become our standard of care.” 

JVS-VL to be open access beginning in January

By
Beth Bales
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JVS-VL to be open access beginning in January
JVS-VL goes open access from January 2024

The Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL) will move from a subscription model to one of open access—freely available online—on Jan. 1, 2024. JVS-VL is the journal for both the SVS and the American Venous Forum (AVF) and is celebrating its 10th year of publication. 

The change is part of the larger overall adjustment to eliminating paywalls in scientific journals and making research accessible to all, said JVS-VL Editor-in-Chief Ruth L. Bush, MD, JD. Publishers make such decisions in part based on the number of print subscriptions versus electronic ones, as well as submission volume and impact factor. JVS-VL had already changed to electronic-only as of January 2023, as only 3.3% of AVF and SVS subscribers had a print subscription. 

“I think this reflects changing habits and demographic changes,” Bush said of the move. “It’s about people’s choices and how they interact with the literature. And it’s environmentally friendly.” 

“Open access removes restrictions and the science is available to everyone, not just those behind a privileged paywall,” she said. “Anyone with internet service can access the science.” 

Bush and other editors have been accepting articles that will be part of the new open-access system since mid- August. The final non-open-access articles were published in November’s JVS-VL. 

Under the new model 

Readers will have immediate access to cutting-edge research from around the country and the world. Reviewers will see no change, continuing to “read articles critically, improve manuscripts and then make them available to the public.” 

Authors will see both advantages and disadvantages, said Bush. Articles will be disseminated much more rapidly to the public and the science community. “As soon as an article is reviewed and accepted, after copyediting, it’s available to anyone around the globe,” Bush said. “We are accelerating the pace at which knowledge is available and, hopefully, positively influence citation behavior.” 

However, under open access, authors pay an article processing charge, which, Bush acknowledged, may anger or concern some prospective contributors and could be a major barrier. 

“However, we have in place various ways to help with the processing fee,” Bush said. “Reach out and ask.” Readers are asked to email cgreen@vascular.society.org for more information. 

In addition, many academic institutions have so-called “transformative agreements” with Elsevier, publisher of the JVS publications, to cover the charge. Her own institution in Texas covers a portion of the charges, as do many others, Bush said. 

SVS members receive a 20% discount on the fee, and both the SVS and the AVF will subsidize the processing charge for authors of manuscripts accepted for the 2024 AVF annual meeting’s plenary sessions. Bush also pointed out that a fee split between five or six co-authors, even if it’s a total fee of $1,600, reduces the per-person fee to a more manageable level. 

Open access also means the ability to reach out to people from other countries to be able to publish their work. “We’ll be more global,” said Bush. 

JVS-VL is already truly a global journal, and a top-tier one for publications dedicated to venous and lymphatic disorders, she said. In 2022, 25% of articles came from China, and 35% from the U.S, with the balance from around the world. 

“Whether the move is positive or negative, it’s where we are,” said Bush. “I am someone who fully believes, if we want our science to be appreciated, then everyone should have access to it.” 

Learn more about open access, fees and more at www.jvsvenous.org. 

SVS members pitch in to help patients kick the smoking habit

By
Beth Bales
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0
SVS members pitch in to help patients kick the smoking habit
The toolkit is aimed at helping strengthen surgeons’ existing “quit smoking” messaging

SVS members are taking advantage of the new Smoking Cessation Toolkit and resources from the Vascular Quality Initiative (VQI), adding them to existing programs and giving new life to their quest to get their patients to kick the nicotine habit and improve their health. 

The SVS Patient Safety Organization (PSO) launched the national smoking cessation initiative, CAN-DO (Choosing Against Combustible Nicotine Despite Obstacles) in June during the VQI Annual Meeting held in conjunction with SVS’ Vascular Annual Meeting. 

CAN-DO includes several components to increase smoking rates: physician and patient toolkits; including smoking cessation variables in the SVS PSO VQI’s arterial registries; and updating information on smoking cessation on the SVS website. 

Toolkit elements that physicians and surgeons may find useful include: 

  • A quick guide to treatment options 
  • Information on counseling via text messaging 
  • Use of smartphone apps and web-based services 
  • Resource documents 
  • Information on quit lines 
  • Patient-facing information doctors can distribute 
  • Billable smoking cessation codes 

The patient toolkit, meanwhile, includes links to many resources on quitting smoking. 

“As vascular surgeons, we are tasked with helping our patients navigate through some of their most challenging and life-changing moments in their lives,” said Gary Lemmon, MD, associate medical director for the SVS PSO. “It is up to us to advise them as to their best chance of success and quality-of-life improvement. Smoking cessation assistance is integral to that success.” 

Cassius Iyad Ochoa Chaar, MD, an associate professor of surgery at Yale University in New Haven, Connecticut; Yale postdoctoral research fellow Dana Alameddine, MD; and Peter Henke, MD, the section chair of vascular surgery at University of Michigan Health in Ann Arbor, Michigan, all are taking advantage of the toolkit to help strengthen their existing “quit smoking” messaging. 

“This extensive toolkit is very, very helpful and user-friendly,” said Chaar. “We can incorporate the various phrases and strategies included and get all our providers to engage with them. If someone doesn’t want to prescribe medications, he or she can incorporate other elements VQI wants to encourage, such as counseling and nicotine replacement therapy.” 

Their experiences with predecessor programs and, after reviewing the resources included in the new VQI initiative, led them to stress how an upcoming major inpatient surgery and its recovery provide a great opportunity to deliver the “quit smoking” message. Patients by and large will have to quit smoking while in the hospital, plus multidisciplinary teams are available who can reinforce the message from different angles. They also emphasized the importance of “systemizing” the effort by making sure it is part of the hospital system. “If you have to opt out, rather than opt in, that’s helpful,” said Henke. “Statewide, in Michigan, it became part of the discharge summary.” 

The surgeons also noted how smoking cessation requires the emphasis the toolkit and initiative have created. The group also stressed that the tools in the toolkit are easily adoptable to different practices and physicians. 

Surgery and recovery provide an optimal time to deliver the “quit smoking” message, said Chaar. 

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“We can basically reinforce the message on a daily basis—and we do that,” he continued. The patients also become “plugged into” the hospital smoking cessation program. Prior research shows that a lack of connection can impede patient follow-up, but inpatients receive both that link and that follow-up. “We’re able to sometimes provide them with medications, and we’ve given them nicotine patches in the hospital, so when they leave, we give them their best shot at stopping.” 

Said Henke: “Surgery, particularly an aneurysm or bypass or similar major operation, is a major life event. They’ve had to quit smoking while they’re in the hospital—for weeks of hospitalization—so if they’ve stopped and then they’re smoking sporadically, perhaps you can transition them to a nicotine patch and varenicline. They have a higher quit rate as well, as compared to a patient who may have a one-day procedure.” 

Chaar said the anti-smoking effort stretches across all medical teams that deal with smokers. “At every hospital we deliver the same message about smoking but from different angles,” he said. For example, cardiologists can point to cardiac disease, neurologists about strokes, and vascular surgeons about the many diseases smoking worsens. Oncologists can speak to the different cancers that can result.” 

Yale physicians and providers are incorporating suggested thought phrases and incorporating the elements VQI wants to capture regarding counseling and treatment for patients into electronic health records, Chaar said. “So, we’re able to be early adopters and we can track this in our own institution and our health system, and also contribute to the nationwide initiative as well,” he said. 

Yale has been very active in the smoking cessation movement, said Chaar. “It’s terrible for people with vascular disease and we’ve been trying to look at novel ways to help them quit.” 

Michigan has been active too. “We were early adopters of this,” said Henke, who practices in that state. Michigan’s statewide quality collaborative created a cessation intervention initiative several years ago, in the wake of the VAPOR clinical trial results that covered the feasibility and pilot efficacy of a brief smoking cessation intervention delivered by vascular surgeons. The trial concluded that “implementation of a brief, surgeon-delivered smoking cessation intervention is feasible for patients with peripheral arterial disease. A larger trial will be necessary to determine whether this is effective for smoking cessation.” 

The state added a fairly robust set of resources following the VAPOR trial. The new VQI toolkit, Henke said, adds impetus and heft to the state’s efforts. The initiative included nicotine replacement therapy, a referral to the telephone quit-line, and physician-delivered advice along the lines of “Smoking is harmful, it’s important to quit and how can we help you accomplish that?” 

The quit-line has proved fairly successful, he said, noting that referrals to such help lines are part of the VQI toolkit. 

Smoking cessation needs such emphasis engendered by the toolkit and initiative, Henke said, adding he hopes VQI and SVS leadership make this a top priority. 

“Vascular surgeons almost more so than those in another field, see the ramifications and results of smoking,” he said. “We see amputations, death, aneurysm growth—all so smoking-related. We’re really at the front lines of this public health program.” 

“The tools in the toolkit are easily adoptable,” he said. “And this is a super important message. It’s not as headline-striking as a new device, but it decreases amputation and death, heart attacks and strokes. It’s a no-brainer in one sense. But it’s hard to keep it in the forefront, when other topics grab headlines.” 

The toolkit, pointed out Chaar, includes not only phrases and strategies physicians can use to help their patients stop smoking, but also information on the billing component of delivering such advice and resources. “That’s important for physicians’ and surgeons’ practices,” he said. 

More information is available at www.vqi.org/quality-improvement/quality-improvement-tools. 

Ego, logistics, money: Overcoming barriers to a successful wound care program

By
Jocelyn Hudson
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Ego, logistics, money: Overcoming barriers to a successful wound care program
Vincent Rowe at VIVA 2023

Proper integration of primary care physicians (PCPs) in the multidisciplinary care of vascular wounds is going to play an increasingly important role as the popularity of the team approach spreads, according to a leading voice in the treatment of peripheral arterial disease (PAD).

“I think the key is making sure we get to the patients early,” said Vincent Rowe, MD, chief of vascular surgery at the University of California Los Angeles (UCLA) in Los Angeles, in an interview with Vascular Specialist at VIVA 2023 (Oct. 30–Nov. 2), in Las Vegas. “We need to provide education so patients can understand how they can prevent these wounds, but we also need to educate the PCPs. Do we keep these patients in our care for a while, or do we send them back and hope that nothing else happens again? Those are going to be some of the keys in how we manage these patients.”

Rowe had just given a talk on patient-specific decisions and how to determine appropriate timing, resources and management of vascular wounds. He told Vascular Specialist how his institution had approached the multidisciplinary team approach to vascular wound care—one that involves the likes of podiatry, physical therapy, cardiology and interventional radiology in addition to vascular surgery and wound care specialists.

“I think [the multidisciplinary approach] is gaining popularity,” he said. “It’s making a difference in terms of how we manage the patients—and saving limbs. But sometimes different things get in the way: ego, logistics, and sometimes even money can all be barriers to having a successful program for these patients. I think at our center the biggest barrier was logistics in terms of space—and also ego. We were able to overcome these by meeting together, trusting each other and moving forward together, and we had a successful program.”

Once patients with vascular wounds reach such programs, reflected Rowe, these teams tend to successfully array resources to provide appropriate treatment. “But I think it is going to be [determining] the role of the other specialties like the PCPs—how are they going to be integrated? And we also need to educate the patient.”

Society for Vascular Surgery addresses latest mainstream media reports on atherectomy

By
Bryan Kay
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Society for Vascular Surgery addresses latest mainstream media reports on atherectomy

The Society for Vascular Surgery (SVS) has issued a statement addressing the latest reports published by ProPublica on atherectomy use in the U.S.

The nonprofit investigative news outlet published three articles in its latest round of investigations looking into Medicare claims data.

The SVS informed members that it was aware of the latest ProPublica coverage and remains concerned that such articles, “while addressing an important issue of potential overutilization and statistical outliers, can also stoke unnecessary fear in the patient population and may contribute to a well-documented under-diagnosis issue, fostering downstream negative outcomes which can be prevented with earlier diagnosis and treatment.”

The statement continued, “It is important to note that in this series of articles the overwhelming majority of providers consistently seem to be practicing in accordance with vascular care guidelines, and this deserves acknowledgement.”

The Society pointed to previous “strong” positions it has taken regarding quality standards in the provision of vascular care. The SVS statement stressed that it would continue to advocate “that all providers of vascular care should practice in accordance with quality care and patient safety guidelines, enroll in a registry that meets or exceeds the standards of the VQI [Vascular Quality Initiative], and engage in quality improvement initiative.”

The SVS leadership will continue to review the articles, the statement added, with a more in-depth response to be released in the coming days. The Society also plans to work closely with societies in the interventional cardiology and interventional radiology worlds—the Society for Interventional Radiology (SIR) and the Society for Cardiovascular Angiography & Interventions (SCAI)—on a joint response.

Carotid stenting rebuttal: Those who live in glass houses…

By
Christopher J. White
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Carotid stenting rebuttal: Those who live in glass houses…
Christopher J. White
Christopher J. White, MD, responds to a recent editorial by Malachi Sheahan III, MD, that took a critical look at the decision by the Centers for Medicare & Medicaid Services (CMS) to expand coverage for carotid artery stenting (CAS). 

I’m grateful for the opportunity extended by Dr. Sheahan to respond to his very entertaining, and acerbic commentary in “Sex, lies, and carotid stents.” While I don’t agree with much of the opinion expressed, I enjoyed reading his well-done piece. Allow me to offer some constructive criticism, correct some misstatements and clarify my rationale for supporting the recent CMS decision to reimburse for CAS on par with carotid endarterectomy (CEA). 

First, in our spirited debates over optimal approaches to managing carotid artery disease, we must assume our surgical colleagues have good intentions and sincerely want to offer their patients the best opportunity for good clinical outcomes. Alas, some vascular surgeons appear to be influenced by an ulterior, self-serving motive designed to protect their “turf.” Thus, the goal of achieving the best patient outcome, the “raison d’etre” of our profession, becomes collateral damage. 

In many areas of medicine, there are clinical conditions treated by multiple specialties from different training pathways and backgrounds. It is generally accepted that multispecialty teams are the best solution to turf battles, offering better perspective and more balanced patient guidance than that of individual specialties who are siloed in their views. Carotid artery disease is but one example of a condition managed by clinicians from multiple disciplines: the neurosciences (neurology and neurosurgery); radiology; surgery (general and vascular); and cardiology.

The Multispecialty Carotid Alliance (MSCA), so vilified by Dr. Sheahan, is made up of a diverse group of physicians with representation from each of these specialty groups (many of whom have held leadership positions within their various specialty societies), and along with many others supported the decision by CMS to reimburse for carotid stenting. The rationale for the MSCA’s support for carotid stenting reimbursement is detailed in a letter to CMS.1 The simple contrast of a multispecialty group (which, by the way, included vascular surgeons) supporting carotid stent reimbursement versus the single specialty of vascular surgery (represented by the SVS) in opposition is revealing. Which group would have the patient’s best interest in mind versus protecting their specialty’s turf? 

The most blatant misstatement made by Dr. Sheahan was asserting a lack of training and preparation of interventional cardiologists to manage patients with carotid artery disease. In February 2023, the most recent advanced training statement on interventional cardiology was published with multiple mentions of “carotid” and “cerebrovascular” management in a very detailed and robust training document.2 This begs the question: why single out cardiologists when specialists from the neurosciences and radiology are also very much engaged in managing patients with carotid artery disease? Are their respective training programs up to par? Isn’t the best solution a multidisciplinary approach, not one dictated by a single specialty represented by the SVS? 

Dr. Sheahan’s failure to discuss transcarotid artery revascularization (TCAR)—included in the CMS coverage decision for stenting—is telling. TCAR was developed and championed by vascular surgeons and is rarely if ever performed by cardiologists. Yet, Dr. Sheahan’s concern for high-quality care failed to mention the glaring gaps in evidence regarding the efficacy of TCAR versus alternative procedures. With the earliest publications of this technique dating back to 2004, there are now 20 years of experience with this procedure. Yet, as of today, no prospective randomized trials have been performed. In stark contrast, carotid stenting is one of the most studied clinical procedures of all time, with dozens of randomized trials supporting its use. Yet, vascular surgeons happily offer their patients TCAR without any comparative evidence of benefit. For shame! It appears that the occupants of vascular surgery’s “glass house” have started a rock-throwing fight. 

Finally, my rationale for supporting CMS reimbursement for carotid stenting is to allow a flexible, informed and individualized approach. Of those patients with carotid artery disease likely to benefit from revascularization, some will be better served with surgery, some better treated with carotid stenting, and many who are candidates for either procedure and should be offered an informed choice. 

Remember, the National Institutes of Health (NIH) has determined that there is equipoise for carotid surgery and carotid stenting. In sponsoring CREST-2, a randomized clinical trial, they adopted a parallel-arm approach comparing carotid surgery with medical therapy to medical therapy alone, and carotid stenting plus medical therapy to medical therapy alone. Patients are enrolled in this trial by investigators who discuss treatment options with the patient. The patient, with physician counsel, is allowed to choose either the surgery arm or the stent arm. Sounds like a great example of patient-centered care. I rest my case. 

Thank you, Dr. Sheahan, for the opportunity to participate in this discussion. 

References 

  1. MCAS response: https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaId=311&fromTracking=Y&. 2023. 
  2. Bass TA, Abbott JD, Mahmud E, et al. 2023 ACC/AHA/ SCAI advanced training statement on interventional cardiology (coronary, peripheral vascular, and structural heart interventions): A report of the ACC Competency Management Committee. J Am Coll Cardiol. 2023;81: 1386–1438. 

Christopher J. White is the medical director of the Centers of Excellence and Service Lines at Ochsner Health in New Orleans, Louisiana. 

SVS receives CMSS grant to advance diagnostic excellence

By
Marlén Gomez
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SVS receives CMSS grant to advance diagnostic excellence

The Society for Vascular Surgery (SVS) has received a $100,000 grant from the Council of Medical Specialty Societies (CMSS) to promote diagnostic excellence across the medical field. 

The CMSS, a coalition of 53 specialty societies representing over 800,000 physicians, has recognized the importance of enhancing capabilities in healthcare and has committed resources to support innovative projects in this area. The SVS proposal, “Advancing diagnosis and staging for early detection and treatment of peripheral arterial disease [PAD] to prevent amputation,” is one of 11 grant recipients. 

The grant plays a significant role in the SVS’ commitment to improving patient care, said SVS Director of Clinical Guidelines and Quality Practice Reva Bhushan, PhD, who helped secure the grant. 

“Vascular surgeons and their care teams play a key role in screening and managing PAD patients. This grant will allow the SVS to promote the use of diagnostic, staging and quality-of-life tools for patient assessment to prevent chronic limb-threatening ischemia [CLTI] and amputation,” said Bhushan. 

CMSS projects focus on three categories of conditions known to cause a disproportionate share of preventable harm due to suboptimal diagnosis: cancer, cardiovascular disease and infection. 

The grant program, administered by CMSS and funded by the Gordon and Betty Moore Foundation and The John A. Hartford Foundation, assists medical specialty societies in promoting analytical excellence for clinicians and patients. “Diagnostic excellence is fundamental to the health and well-being of all people, especially older adults who often have multiple chronic conditions complicated by frailty,” said Terry Fulmer, PhD, RN, president of The John A. Hartford Foundation. 

“With the generous support of our funders, 20 specialties are actively engaging their members in diagnostic excellence,” said CMSS CEO Helen Burstin, MD, MPH. 

“The legacy of the CMSS grant program will be greater awareness, attention and action to prevent avoidable diagnostic harm across medicine.”

Humacyte submits Biologics License Application to FDA seeking approval of Human Acellular Vessel

By
Jocelyn Hudson
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Humacyte submits Biologics License Application to FDA seeking approval of Human Acellular Vessel
Human Acellular Vessel

Humacyte today announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.

A press release details that the BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.

“Submitting the BLA to the FDA is a pivotal milestone in achieving our goal of providing regenerative human tissues to injured patients, at commercial scale,” said Laura Niklason, chief executive officer of Humacyte. “I want to thank the patients and medical professionals who participated in our clinical studies, and our Humacyte team for their tremendous effort and dedication in completing the BLA submission for this first-in-class product candidate.”

The FDA has a 60-day review period to determine whether the BLA is complete and acceptable for filing. Humacyte has requested priority review of the application and, if granted, the review should be completed within six months of the filing acceptance date. In May 2023, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for use of the HAV in urgent arterial repair following extremity vascular trauma. In addition, the HAV was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel, such as traumatic injuries.

Humacyte details that the HAV, a bioengineered tissue, is under investigation as an infection-resistant, universally implantable conduit for use in vascular repair. “Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons and to improve outcomes and reduce complications for patients. The HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, which are expected to have the capacity to provide thousands of vessels for treating patients in need,” a press release reads.

Humacyte claims that the HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for haemodialysis, and peripheral arterial disease.

The company advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Less vain and more vein: Evaluating the perceptions of venous disease amongst the vascular surgery community

By
Sarah Wells
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Less vain and more vein: Evaluating the perceptions of venous disease amongst the vascular surgery community
3d rendered illustration of the male vascular system
Part of the venous system

Our biases permeate the fabric of our very being, as they weave their way into our training and practice. It is clear that complex aortic work is definitely in vogue and “in,” and, well… treating veins gets a bad rap. While training, our staff perpetually complained about not only treating venous disease but not having the patience to sit and listen to these “complex” patients. Current vascular surgery training paradigms focus significantly on arterial disease, and training programs rarely focus on venous disease management as part of the core curriculum.

It comes as no surprise that if those teaching the next generation of vascular specialists are not enthusiastic or motivated and possibly even deterring the pursuit of treating venous disease, the next generation will face similar sentiments. It is clear that not all vascular systems are created equal, but why? 

The management of venous disease is imperative, as it has been reported to be twice as prevalent as coronary heart disease and five times more prevalent than peripheral arterial disease (PAD). More than 25 million adults in the U.S. suffer from chronic venous insufficiency, with more than 6 million having advanced venous disease.2 Further, venous disease cost of care is estimated to range from $3 to $10 billion annually.2,4 However, there seems to be a discrepancy in its perceived importance among vascular surgery specialists. 

It has been proposed that there exists a lack of adequate, specific and practical training throughout the academic curriculum presented to future vascular surgeons, which has led to the view that venous pathology, compared to arterial conditions, is of secondary nature. 

In addition to this, themes such as less technical challenge, lower morbidity/mortality risk, ease of lifestyle, less institutional support for research or clinical programs, and fewer funding opportunities were highlighted as reasons for the existence of this perception in a survey on the topic Furthermore, the terms “ego” and “prestige” were mentioned when describing rationales for arterial work being more important than those in the field of venous disease.1 

Vascular surgeons continue to be the largest provider for venous disease care in both medical and surgical specialties.3 More than 17% of all medical and surgical venous care providers do not have active board certification. Therefore, it behooves our specialty to uphold best practices in venous disease and continue to better understand the venous disease population. Our versatility in open and endovenous surgical management provides our specialty the skillset to care for venous disease when compared to other specialties. 

Another important and complex layer involved in this perception of venous and arterial work differing in value is gender bias and disparity. There is a significant lack of literature in venous disease compared to arterial disease regarding healthcare disparities. 

Racial/ethnic, gender and socioeconomic disparities impact venous disease similarly to arterial disease, driving how we approach our patients’ care. Chronic venous insufficiency can involve a difficult disease pattern superimposed with various risk factors that vascular surgeons must navigate in a similar way as they do with arterial diseases. 

It cannot go unsaid that vascular surgery is a male-dominated specialization and that, interestingly enough, the perception that venous diseases are of less importance stemmed mainly from younger female respondents. It is difficult to disseminate clearly why this may be the case, but the survey data suggest that this disparity in perception paves the way for a key new body of research. An in-depth analysis of existing and potentially inherent gender-based values as drivers for framing systemic perceptions in vascular surgery could be a valuable step in reducing gender bias within the field. 

Above all, the scarce exposure of trainees to the array of levels of venous interventions that exist seems to have driven and deeply embedded this perception that venous work is less of a challenge, and, in turn, of less interest to vascular specialists. As vascular surgery residents and fellows have reported feeling deficient in venous training, this is logically a root cause in the lack of value it has been historically attributed. 

One could argue it is ironic, as venous diseases pathologies are often complex, even more so than arterial ones, yet lack of attention to this nature during training is a recurring theme. A shift in this perception, however, is necessary. Potential avenues for improving such a deficit could include various mandates with regard to trainee exposure to venous pathologies and interventions, as well as the inclusion of continuing education initiatives, similar to that of advanced aortic training and formal limb salvage. Addressing and reducing the gender bias in existing perceptions may also pave the way for a more equitable view of both venous and arterial work. 

References 

  1. Kiguchi MM, Drudi LM, Jazaeri O, Smeds MR, Aulivola B, MacCallum K, et al. Exploring the perception of venous disease within vascular surgery. JVS: Venous and Lymphatic Disorders. 2023:11(5);1063–1069. 
  2. Kim, Young, et al. Defining the human and healthcare costs of chronic venous insufficiency. Seminars in Vascular Surgery. Vol. 34, no. 1, Mar. 2021, pp. 59–64. DOI.org (Crossref), https://doi.org/10.1053/j.semvascsurg.2021.02.007. 
  3. Gabel, Josh, et al. Who is treating venous disease in America today? Journal of Vascular Surgery: Venous and Lymphatic Disorders. Vol. 7, no. 4, July 2019, pp. 610–14. DOI.org (Crossref), https://doi.org/10.1016/j.jvsv.2019.03.009. 
  4. O’Banion, Leigh Ann, et al. A review of the current literature of ethnic, gender and socioeconomic disparities in venous disease. Journal of Vascular Surgery: Venous and Lymphatic Disorders. Vol. 11, no. 4, July 2023, pp. 682–87. DOI.org (Crossref), https://doi.org/10.1016/j.jvsv.2023.03.006. 

Sarah Wells, MS, is a clinical research assistant at Centre Hospitalier de l’Université de Montréal (CHUM) in Montreal, Canada; Eric Pillado, MD, is an integrated vascular surgery resident at Northwestern Medicine in Chicago; and Laura Marie Drudi, MD, is an assistant professor of surgery at CHUM. 

‘There is no reliable way to measure carotid stenosis—methods have changed and tend to overestimate the degree of narrowing’

By
Bryan Kay
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0
‘There is no reliable way to measure carotid stenosis—methods have changed and tend to overestimate the degree of narrowing’
Anne Abbott addresses VEITH 2023. Thomas Brott (seated) is pictured at the far right
The recent move to expand Medicare coverage of carotid stenting formed the basis of a recent debate over the wisdom of the decision taken by the Centers for Medicare & Medicaid Services (CMS). Two heavyweights in the stroke arena went head-to-head, sparring over whether the decision should have been taken at all. 

Two luminaries in the field of stroke prevention weighed in on opposite sides of a still-raging debate over whether the recent decision by CMS to expand Medicare coverage for carotid artery stenting (CAS) was the right move to make amid conflicting opinion on what the weight of the scientific evidence says on carotid revascularization interventions. 

Thomas Brott, MD, a professor of neurology at the Mayo Clinic in Jacksonville, Florida, and a principal investigator of the ongoing and keenly followed CREST-2 (Carotid Revascularization Endarterectomy vs. Stenting Trial-2) study, and Anne Abbott, MD, a neurologist at Central Clinical School, Monash University, in Melbourne, Australia, took up opposing positions during the 2023 VEITHsymposium back-and-forth in New York City (Nov. 14–18). 

Brott took up that position that, “Since TCAR [transcarotid artery revascularization] already has it, reimbursement for transfemoral and transbrachial carotid stenting should be expanded to include asymptomatic patients.” Abbott pushed back strongly, arguing, “There should be no reimbursement for CAS or TCAR in asymptomatic or symptomatic [patients].” 

Brott took issue with recent published writings from Abbott in which she stated that stenting near the transaortic root causes more procedural stroke, death and heart attacks than does carotid endarterectomy (CEA); that there is no randomized trial evidence of patient benefit from any carotid procedure compared with current standards of non-invasive care alone; that crucially needed trials such as CREST-2 to assess procedural efficacy will be exceedingly difficult if not impossible to complete; and that the CMS funding changes “will open the floodgates.” 

Regarding Abbott’s point on unfavorable outcomes in stenting vs. CEA near the transaortic root, “where she emphasizes randomized trial evidence,” Brott contended that “that’s not true for CREST; that’s not true for ACST-2 [Asymptomatic Carotid Surgery Trial-2]; it’s not true for ACT-1 [Asymptomatic Carotid Stenosis]; and it’s not true for the combined analysis of CREST and ACT-1—all randomized trials.” 

Brott turned to Abbott’s assertion of no randomized trial evidence of patient benefit from any carotid procedure compared to current standards of non-invasive care. “These are 70-year-old patients on average, and you can see here 10-year ipsilateral stroke [rates],” he said, pointing to a slide illustrating relevant data. “Six percent in CREST, 6% in ACST-2. Remember, these patients came in with risk factors for stroke, high-grade stenosis, and that is 0.6% per year in this patient population. In the United States, for a random population in that age group, any stroke is 0.6% per year. This is an achievement.” 

Brott continued: “What about current standards of non-invasive care? With people that have high-grade carotid stenosis and all the attendant risks of that disease, we do not know. And that is why the medical arm is actually the experimental arm in CREST-2.” 

Brott also addressed Abbott’s statement that crucially needed trials will be difficult, if not impossible, to complete. “CEA enrollment in CREST-2 is complete,” he argued. “With CAS enrollment, we have only got about 80 or so patients to go.” Finally, he focused on Abbott’s claim over the CMS funding changes and increased usage. “Atherosclerosis is getting less and less common,” he retorted. “We are seeing fewer and fewer patients. We don’t know what is going to happen, but the changes in medical care are decreasing the numbers of patients with asymptomatic carotid stenosis.” 

Stepping up to the VEITH 2023 debate podium after Brott, Abbott hit back, standing behind her recent writings with which Brott took issue. “In a major coup for bad medicine, U.S. Medicare has just announced it finds coverage for carotid stenting is reasonable and necessary for beneficiaries with symptomatic carotid stenosis of at least 50%, or asymptomatic stenosis of at least 70%,” she told the gathering. “This is greatly expanded coverage, including to average-surgical-risk patients. Further CMS—or third-party—accreditation or certification are no longer required. Facilities will now be responsible for their own procedural standards and training. Formal shared decision-making with beneficiaries has been encouraged. Facility oversight committees are encouraged to apply published guidelines.” 

She called the move “a major breach of U.S. Medicare’s duty of care to the public—and there are many reasons for this.” First, Abbott said stenting “does cause more harm” than CEA. “In randomized trials, stenting caused more 30-day periprocedural stroke, death and heart attack in symptomatic patients, and in a meta-analysis of randomized trials stenting caused more 30-day periprocedural stroke and death in asymptomatic patients,” she continued. “Stenting was worse with risk-factor long-term stroke rates, and registry stroke shows similar, if not worse, results with stenting compared to endarterectomy.” 

Furthermore, Abbott argued that “there is no reliable way to measure carotid stenosis—methods have changed and tend to overestimate the degree of narrowing. Guidelines worldwide are outdated and encourage procedural overuse. Procedural outcomes are highly dependent on operator expertise, and removal of externally applied standards will encourage harm.” 

Abbott also addressed the case of TCAR. “It has not been compared to endarterectomy,” she said, “and its efficacy has not been assessed and compared to non-invasive care alone, so there is no procedural indication and, in fact, there is no current procedural benefit for any carotid artery so-called revascularization procedure compared to current standards, particularly of best practice non-invasive care alone.” 

At the debate conclusion, the VEITH 2023 audience overwhelming voted to back the arguments put forward by Abbott. 

Need for ‘clear, well-defined guidelines’ in patient selection for surgical implantation of baroreflex activation therapy devices identified

By
Bryan Kay
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0
Need for ‘clear, well-defined guidelines’ in patient selection for surgical implantation of baroreflex activation therapy devices identified
The Barostim device

The emergence of a baroreflex activation therapy device for heart failure patients is drawing in the assistance of the open surgical expertise of vascular surgeons in the arena of the carotid bulb— and drawing attention to a need for “clear and well-defined guidelines.” 

Discussion was stirred after the delivery of a case experience from the University of Miami, Florida, during the 2023 Eastern Vascular Society (EVS) annual meeting (Sept. 7–9) in Washington, D.C., in which presenter Christopher Chow, MD, a vascular surgery resident at the institution, raised the possibility of a randomized controlled trial comparing the Barostim device (CVRx) to a sham therapy. 

Chow described the University of Miami experience working with his institution’s heart failure-cardiology team who identify patients who would benefit. 

He reported successful intraoperative therapy among all patients treated, many of whom returned home the same day. “Patients by and large tolerate the procedure without significant complications,” he told EVS 2023. “Discomfort associated with device activity is actually a common complaint, known as extraneous stimulations. It’s been described as stimulations of the nerves around the carotid bulb.” They can take the form of headaches and a painful buzzing sensation in the chest, Chow added. 

The baroreflex activation therapy device is an implantable pulse generator designed to deliver continuous electrical stimulation to carotid baroreceptors through a lead sewn into the adventitia of the carotid bulb, with a subsequent increase in parasympathetic outflow and a reduction in symptoms of heart failure, Chow said. 

“There have been some early studies that it may be beneficial,” Chow said. “The implantation of the device is very neatly suited for the skillset of vascular surgeons. It requires a small carotid cutdown at the carotid bulb through ultrasound identification and then sewing of the lead onto the adventitia of the bulb.” 

But Chow emphasized a need for clearer guidelines. 

“Further research is definitely needed, such as a randomized controlled trial—we would suggest a sham device therapy,” he said. “Vascular surgeons are very keen on generating this data. We should continue working with heart and cardiovascular teams to find the best practice guidelines for Barostim therapy.” 

Under audience questioning, Chow underscored the point: “In general, I would say there is really no clear and well-defined guidelines about who would actually benefit from this therapy, and that is actually one of the aims of this discussion—to try to foster that conversation,” he said. 

The baroreflex activation technology is relatively new but is gaining traction, Chow observed, with work already starting on a percutaneous approach. “You can imagine what that may imply for future carotid interventions,” he added.

Bylaws referendum approved by SVS voting members

By
Marlén Gomez
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0
Bylaws referendum approved by SVS voting members

The voting members of the SVS have approved amendments to the Society bylaws following a referendum that closed on Nov. 20. The proposed changes were focused on two areas: adjustments to membership privileges for early-career members and adjustments to the composition of the SVS Executive Board. 

A total of 453 voting members participated, exceeding by a factor of three the quorum requirement of 150 votes (5% of voting members). A two-thirds majority of those voting is required for ratification of bylaw changes. 

On the question of changes regarding early-career membership, the referendum passed with 92.72%. On Executive Board composition, it passed with 81.24%. 

“The approval of these amendments reflect the ongoing interest and commitment of our members to advancing the SVS and ensuring that our membership and governance structures align with the evolving needs of our dynamic medical community,” said SVS President Joseph Mills, MD. 

The voting, which began on Nov. 6, asked members to consider and ratify proposed amendments that had been formally approved by the SVS Strategic Board of Directors. 

The amendments are aimed at accelerating engagement of early-career vascular surgeons within the SVS and fostering diversity of perspective. The bylaw changes go into effect immediately regarding early-career membership revisions. 

For Executive Board composition, the changes will begin to apply for 2024–2025, which will include potential expansion of the number of candidates in officer elections from the current two, to a maximum of four; and expansion of the appointed members of the board from three to five, and making each position “at-large,” selected on the basis of merit, qualifications and identified gaps in expertise on the Executive Board. 

A review of the changes is available at vascular.org/2023BylawsRef. For answers to any questions regarding the referendum, email governance@vascularsociety.org.

SVS makes fresh call for active participation in compensation survey

By
Marlén Gomez
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0
SVS makes fresh call for active participation in compensation survey
Keith Calligaro

The Society for Vascular Surgery (SVS) has made a fresh call for members to participate in a compensation survey, a collaboration with Phairify, that aims to provide vascular surgeons with tailored insights into compensation, practice and productivity data relevant to their specialty and practice situations, helping them make informed career decisions. 

The SVS seeks a 20% response rate from its members to ensure the survey’s scientific validity. 

“Ensuring a robust response rate from SVS members is crucial for the scientific credibility of the compensation survey,” said Keith Calligaro, MD, chair of the SVS Compensation/Phairify Committee that developed the survey. “The data obtained will not only benefit individual vascular surgeons, but will also contribute to a comprehensive understanding of compensation and practice trends within our specialty. Your participation is key to the success of this initiative,” he said. 

Phairify, a web-based data collection and visualization platform, offers free access to SVS members. Members can complete an anonymous 15-minute survey that allows them to filter and access compensation, productivity and practice data specific to the specialty. The survey provides members with a better understanding of their compensation and productivity through data comparisons with their peers. Members can participate by visiting vascular.org/CompensationStudy2023. 

“Over the last few years, many SVS members have noted that when vascular surgeons apply for a job somewhere—whether after completing a fellowship or a mid-career move—they are not sure what to expect in terms of financial compensation. This survey will help in terms of dealing with future employers, what to expect and maybe even what to ask for,” Calligaro previously stated when assessing the importance of the survey

Changing course: The natural history of tibial claudication comes under scrutiny as interventions for ‘relatively benign’ disease trend upward

By
Bryan Kay
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0
Changing course: The natural history of tibial claudication comes under scrutiny as interventions for ‘relatively benign’ disease trend upward
Michael Conte

In the end, reflected Michael S. Conte, MD, “it’s not the evidence.” The leading vascular surgeon and peripheral arterial disease (PAD) expert made the bold statement during the recent 2023 VEITHsymposium (Nov. 14–18) as he pointedly asked a room full of colleagues: what is behind the trend that appears to show tibial interventions for intermittent claudication are growing? 

The question of whether or not the practice carries a reasonable risk or, rather, if the risks “exceed the benefits” has long lingered, the chief of vascular and endovascular surgery at the University of California San Francisco (UCSF) told the New York City gathering. 

Ultimately, the preponderance of the data, Conte said, suggests the latter. 

So what of those reasons behind the recent trend? 

Conte, finding his rhythm, first turned to datasets outlining pattern of use. 

Vascular Quality Initiative (VQI) data from 2003–2018 demonstrated that about 11% of claudication interventions involved infrapopliteal arteries, with isolated infrapopliteal interventions or combined interventions associated with a higher risk for major amputation compared to femoropopliteal interventions alone, he said. “This finding was particularly true in patients with diabetes,” Conte added. 

Then to some of the factors potentially responsible: One research group looked at the influence of a competitive marketplace and found that working in an area with high market competition seemed to be associated with a higher rate of using tibial interventions—particularly atherectomy—for claudication patients. “I guess, if you have a lot of competition around you, you may be prone to be more aggressive in the patients that you treat; these data seem to imply that competition in the area affects the utilization of tibial interventions in claudicants,” Conte said. 

He moved onto Medicare data from 2017–2019. “Now you can see the numbers are a little bit different: 28% of all claudication interventions involved infrapopliteal arteries, and of these more than a third were isolated infrapopliteal and about a third were multiple tibial arteries,” Conte continued. “This pattern was more prevalent in patients who are Black, Hispanic and who had kidney disease.” He delved deeper, pointing to evidence showing that the providers who were associated with higher use were more likely to be early-career interventionalists or surgeons, in the western half of the U.S., in higher volume practices, more often based at ambulatory surgery centers (ASCs) or office-based labs (OBLs), and more commonly interventionalists versus vascular surgeons. 

Conte then turned to recent VQI-VISION (Vascular Implant Surveillance and Interventional Outcomes Network) data on patients who received infrapopliteal interventions, presented at last year’s VAM. 

“You can see looking downstream that the risk of conversion to chronic limb-threatening ischemia [CLTI] was significantly higher among patients who underwent tibial interventions versus patients who had isolated femoropopliteal interventions for claudication—and the risk of needing repeat interventions was significantly higher, suggesting that patients getting these procedures are being placed at greater risk for deterioration of their disease and multiple additional procedures,” he explained. 

As the data pile up, and many have questioned the wisdom of such interventions, Conte asked: “Are we really doing the right thing?” 

“This alarming trend, from 11% to more recently around 30% of peripheral vascular interventions in the U.S. involving a tibial artery for claudication, suggests we may be at risk of changing the natural history of a relatively benign disease,” he summarized. 

Conte went further. A systematic review that looked at 11 studies covering current conservative management and intervention, and 16 studies probing peripheral vascular interventions or open surgery for claudication “found that there were consistently higher rates of major amputation or repeat intervention associated with revascularization, and particularly with tibial interventions,” he said. 

What of the guidelines and appropriate use criteria (AUC) in the arena of treatment for intermittent claudication? It’s a mixed bag, said Conte. While the Society for Vascular Surgery (SVS) guidelines from 2015 recommend against endovascular therapies for isolated infrapopliteal disease for claudication “because it is of unproven benefit and possibly harmful,” other bodies, such as the Society for Cardiovascular Angiography & Interventions (SCAI), suggest that “this practice may be occasionally or rarely appropriate,” Conte said. 

The recent SVS AUC for intermittent claudication, a multispecialty collaboration, saw unanimous agreement that the risks outweighed the benefits regarding revascularization for infrapopliteal disease, he added. 

So, to Conte’s original question: what explains the increasing use of tibial interventions for claudication? “It certainly is not the evidence that it is helping people, because the evidence is simply not there to support this concept of full revascularization for claudication, with treatment of every lesion in sight on the angiogram,” Conte elaborated. 

The data suggests other practice-level factors may be at play, he reflected: economic incentives and the current reimbursement framework; elevated use in ASCs and OBLs; strong associations with atherectomy; higher use among certain types of providers; meetings where live case demonstrations focus on technical elements of the interventions rather than their appropriateness. 

“I guess that some providers believe that the short-term risk of these interventions is low, and the downstream harms are not tangible at the time, so they have convinced themselves they may be providing a benefit,” Conte concluded. 

“That’s certainly not a basis for evidence-based practice, and with growing signals of harm, the vascular community needs to address the overuse and misuse of interventions that will erode the public trust.” 

Enrollment complete in APEX-AV study of mechanical aspiration system for acute PE

By
Bryan Kay
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0
Enrollment complete in APEX-AV study of mechanical aspiration system for acute PE
AlphaVac system

Patient enrollment is now complete in the APEX-AV trial evaluating the safety and efficacy of the AlphaVac F1885 (AngioDynamics) multipurpose mechanical aspiration system for the treatment of acute intermediate-risk pulmonary embolism (PE).

APEX-AV is a single-arm investigational device exemption (IDE) study involving 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the U.S. The primary efficacy endpoint of APEX-AV is the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint is the rate of major adverse events (MAEs), including device-related death and major bleeding within the first 48 hours. Patients will be followed for 30 days post-index procedure.

AngioDynamics initiated the study in partnership with the Pulmonary Embolism Response Team (PERT) Consortium. It is led by co-principal investigators William Brent Keeling, MD, associate professor of surgery at the Emory University School in of Medicine in Atlanta and immediate past president of Tthe PERT Consortium, and Mona Ranade, MD, assistant professor of interventional radiology at the David Geffen School of Medicine at the University of California, Los Angeles.

“Data from the APEX-AV study expands the current body of literature on the safety and efficacy of mechanical thrombectomy and broadens the PE treatment options, particularly in this space,” said Ranade.

The AlphaVac F1885 system is cleared for the removal of thromboemboli from the venous system. APEX-AV was designed to provide safety and efficacy data for a clearance specific to PE.

Vascular Specialist–December 2023

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Bryan Kay
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0
Vascular Specialist–December 2023

In this issue:

  • Changing course: The natural history of tibial claudication comes under scrutiny as interventions for “relatively benign” disease trend upward 
  • Our guest editorial this month looks at perceptions of venous disease in the vascular surgery community 
  • VEITH 2023 plays host to lively debate over CMS decision to expand coverage of carotid artery stenting 
  • Comment & Analysis: Christopher White, MD, rebuts a recent editorial from our medical editor Malachi Sheahan III, MD, entitled, “Sex, lies and carotid stents” 

 

The top 10 most popular Vascular Specialist stories of November 2023

By
Éva Malpass
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The top 10 most popular Vascular Specialist stories of November 2023

top 10 In November, the most read stories from Vascular Specialist include a reassessment of which carotid revascularization treatment modality is best after the recent Centers for Medicare & Medicaid Services (CMS) coverage expansion; updated analyses from the VOYAGER PAD clinical trial; Bhagwan Satiani, Vascular Specialist associate medical editor, considers time-management techniques and tools; and Peter Schneider provides insight on 36-month data from Surmodics’ TRANSCEND clinical trial.

1. New survey shows transcarotid artery revascularization patients report faster recovery than their endarterectomy counterparts

For Scott Berman, MD, patient responses when confronted with an explanation of the extent of their asymptomatic carotid disease tend to be quite stark. They are either so petrified of having a stroke that they express clearly that they want to be operated on as a matter of urgency, the Tucson, Arizona-based vascular surgeon explains, or else they are steadfastly against surgery under any circumstance.

2. The pulmonary arterial tree—it is time we branch out

Nicolas Mouawad, MD, chief of vascular surgery at McLaren Health System in Bay City, Michigan, urges vascular surgeons to “get out of their comfort zone” and become more involved in pulmonary embolism (PE) care.

3. Computer-assisted vacuum thrombectomy system for patients with pulmonary embolism demonstrates ‘rapid, statistically significant’ improvement in RV/LV ratio

Patients undergoing computer-assisted vacuum thrombectomy with the Indigo Aspiration System (Penumbra) for pulmonary embolism (PE) showed 2.7% rates of both major adverse events (MAEs) and major bleeding at 48 hours post-procedure alongside “a significant reduction” in right ventricle/left ventricle (RV/LV) ratio of 25.7%, according to an interim analysis of the STRIKE-PE study.

4. Carotid disease: Getting to the right decision

The recent move by the CMS to expand coverage for carotid artery stenting brought with it the requirement for a shared decision-making interaction between physicians and patients as they establish which carotid revascularization treatment modality is best for their disease. Currently, a validated tool does not exist—but investigators at Dartmouth Hitchcock Medical Center are working on research aimed at changing that.

5. VOYAGER PAD analyses shed light on use of rivaroxaban in high-risk patient populations

New analyses from the VOYAGER PAD clinical trial in both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD) were presented at the American Heart Association (AHA) 2023 Scientific Sessions (Nov. 11–13) in Philadelphia.

6. Intravenous anesthesia delivery during varicose vein treatment proves safe and reduces pain scores, researcher reports

A new intravenous anesthesia delivery technique used during endothermal ablation for varicose veins demonstrated comparatively low pain scores according to first-in-human (FIH) data recently presented at the 2023 VEITHsymposium.

7. Can you count the ‘monkeys’ on your back?

Bhagwan Satiani, Vascular Specialist associate medical editor, considers time-management techniques and tools and how a “high-level approach to separate the chaff from the wheat may start with things such as your own goals, organizational objectives followed by a variety of individual objectives”.

8. SVS announces leadership development program for vascular surgeons

Now set to welcome its fifth cohort, the SVS Leadership Development Program (LDP) continues to help vascular surgeons across the U.S. and Canada to hone their leadership skills.

Manuel Garcia-Toca, MD, chair of both the Leadership Development Committee and LDP, said he believes the seven-month program can revolutionize the leadership skills of vascular surgeons, empowering them to make a remarkable impact both in their field and beyond. The program will begin April 11, 2024.

9. Specialty representation at all levels of a healthcare organization is ‘increasingly important’ in value-based systems

A 14-year effort to achieve departmental status for vascular surgery at a large healthcare system in Southern California resulted in significant gains for the specialty within the organizational apparatus, according to an administrative case report on an effort finalized last year.

10. TRANSCEND 36-month data “continue to demonstrate safe and effective performance” of SurVeil DCB

Peter Schneider (University of California San Francisco, San Francisco, USA) recently presented 36-month data from Surmodics’ TRANSCEND clinical trial at the VEITHsymposium 2023 (14–18 November, New York, USA).

Intravenous anesthesia delivery during varicose vein treatment proves safe and reduces pain scores, researcher reports

By
Bryan Kay
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0
Intravenous anesthesia delivery during varicose vein treatment proves safe and reduces pain scores, researcher reports
Solutio
anesthesia
Solutio catheter

A new intravenous anesthesia delivery technique used during endothermal ablation for varicose veins demonstrated comparatively low pain scores according to first-in-human (FIH) data recently presented at the 2023 VEITHsymposium. 

The investigational Solutio catheter (MedVasc), which contains both a bent needle for tumescence deployment through the vessel wall into the perivascular space and endothermic fiber for ablation treatment, produced a median score of 5 (0–24) on the visual analogue scale (VAS) in nine consecutive patients in Sweden, Michael Åkesson, MD, an interventional radiologist and developer of the device, told the New York City gathering (Nov. 14–18). 

He hailed the catheter as a safe and feasible solution resulting in a single puncture as opposed to several. 

Traditionally, Åkesson observed, patients find the anesthesia part of the ablation treatment process unpleasant, with VAS pain scores often varying from 20–60. 

Results from the FIH study showed two “mild” device deficiencies and no serious adverse events. Patients—eight women and one man—underwent treatment by a single vascular surgeon. They were recorded as having a great saphenous vein median length of 41cm. 

“The subject with the 24 VAS score reported that the pain came from the puncture site area in the lower leg,” Åkesson, a researcher attached to Lund University in Lund, Sweden, told VEITH 2023. “The surgeon suspected this was caused by a dissection while accessing the vein. He generally considered the catheter to be safe and easy to use, but with a short learning curve. Two minor device-related defects were reported—low flow rate in the long needle and catheter with high friction while pushing the needle out of the catheter. Both problems will be resolved with the prototype.” 

During the four-week follow-up period following treatment, no serious adverse events emerged and no signs of bleeding were reported, Åkesson added. 

VOYAGER PAD analyses shed light on use of rivaroxaban in high-risk patient populations

By
Will Date
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VOYAGER PAD analyses shed light on use of rivaroxaban in high-risk patient populations
Marc Bonaca

New analyses from the VOYAGER PAD clinical trial in both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD) were presented at the American Heart Association (AHA) 2023 Scientific Sessions (Nov. 11–13) in Philadelphia.

The randomized, double blind VOYAGER PAD trial enrolled more than 6,500 patients in 34 countries who had peripheral arterial disease (PAD) and had undergone lower extremity revascularization.

Patients were randomly assigned to receive either rivaroxaban (Xarelto, Janssen) or a placebo in addition to daily aspirin. The research team reported in a late-breaking clinical trial presented at ACC.20/WCC that VOYAGER PAD met its primary endpoint, with a 15% statistically significant reduction in the risk of a first major adverse limb or cardiovascular event (MALE or MACE) seen in patients who received rivaroxaban compared with those who received the placebo.

Fragile patients with PAD can be at a heightened risk for MALE, defined as a composite of acute limb ischemia (ALI) and major amputation. In the first of the two analyses presented by Mario Enrico Canonico, MD, from the University of Colorado Anschutz Medical Campus in Aurora, Colorado, fragile patients were defined as being older than 75 years, weighing less than 50kg, or having a baseline estimated glomerular filtration rate (eGFR) less than 50 mL/min/1.732.

Rivaroxaban plus aspirin (2.5mg twice daily plus aspirin 100 mg once daily) was shown to be effective in reducing the occurrence of MALE in both fragile and non-fragile patients, compared to aspirin alone. In fragile patients treated with rivaroxaban plus aspirin, 6.2% of patients experienced a MALE compared to 10.3% of patients treated with placebo. In non-fragile patients, 7.9% of patients treated with rivaroxaban plus aspirin experienced a MALE compared to 9.7% of patients treated with placebo.

The second analysis examined the role of rivaroxaban plus aspirin on myocardial infarction (MI) in patients with PAD with and without concomitant coronary artery disease following lower extremity revascularization (LER).

Following LER, patients with PAD are four times more likely to experience acute limb ischaemia, or a rapid decrease in lower limb blood flow, which is often associated with long hospitalisations and high incidences of amputation, disability, and death unless appropriate treatment is given.

Patients with PAD are also at a heightened risk of MACE, defined as MI, ischaemic stroke, or cardiovascular death. In this analysis, 14.1% of patients with PAD and coronary artery disease treated with rivaroxaban plus aspirin experienced a MACE versus 17.6% of patients treated with placebo (aspirin alone). In patients with PAD only, 11% of patients treated with rivaroxaban plus aspirin experienced a MACE versus 9.8% of patients treated with placebo. Overall, rivaroxaban plus aspirin showed a consistent benefit in reducing MACE in patients with and without coronary artery disease.

“These analyses reinforce the consistency of the favorable benefit-risk profile of Xarelto plus aspirin for patients with vascular disease, regardless of comorbidity. For example, patients categorized as ‘fragile’ are often undertreated due to concerns about benefit-risk, particularly with antithrombotic treatments,” said Marc Bonaca, MD, also from the University of Colorado Anschutz Medical Campus. “We hope the ongoing wealth of data coming from VOYAGER PAD presented at AHA offers clinicians the information they need to support shared decision-making in prescribing Xarelto plus aspirin as the standard of care for their PAD patients, including those who are high-risk or complex.”

In August 2021, the Food and Drug Administration (FDA) approved an expanded PAD indication for Xarelto to include patients following a recent LER due to symptomatic PAD. Xarelto acts on a dual pathway inhibition (DPI) approach to target both clotting mechanisms, thrombin and platelet activation.

VRIC submissions are now open

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VRIC submissions are now open

Researchers may now submit abstracts for the SVS Vascular Research Initiatives Conference (VRIC), to be held in conjunction with the American Heart Association’s annual Vascular Discovery meeting.

The conference, which emphasizes basic and translational vascular science, will take place all day May 15, 2024, at the Hilton Chicago, 720 S. Michigan Ave., in Chicago.

VRIC registration will open in early 2024. Learn more and get the abstract submission link at vascular.org/VRIC24.

SVS 2024 dues renewal deadline approaches

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Marlén Gomez
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SVS 2024 dues renewal deadline approaches

SVS members are reminded to act promptly before the year’s end to ensure uninterrupted access to their 2024 membership benefits.

Renewals are due on or before the close of the year on Dec. 31. SVS members can pay their dues now by logging on at vascular.org/invoices.

Renewal guarantees the continuation of all the benefits associated with the Society, including reduced or no-cost access to all Journal of Vascular Surgery peer-review publications, exclusive entry to the SVS Education Portal, reduced rates for the Vascular Annual Meeting (VAM) and other educational courses and workshops, access to the SVS Branding Toolkit, and more.

For any questions, email membership@vascularsociety.org.

TRANSCEND 36-month data “continue to demonstrate safe and effective performance” of SurVeil DCB

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Jocelyn Hudson
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TRANSCEND 36-month data “continue to demonstrate safe and effective performance” of SurVeil DCB
Peter Schneider
Peter Schneider

Peter Schneider (University of California San Francisco, San Francisco, USA) recently presented 36-month data from Surmodics’ TRANSCEND clinical trial at the VEITHsymposium 2023 (14–18 November, New York, USA).

The TRANSCEND trial is a prospective, multicentre, single-blind randomised controlled trial to assess the safety and efficacy of the SurVeil drug coated balloon (DCB; Surmodics) versus the IN.PACT Admiral DCB (Medtronic) for treatment of superficial femoral and proximal popliteal artery lesions. A total of 446 patients were randomised to either the low-dose paclitaxel (2.0µg/mm2) SurVeil DCB (n = 222) or the high-dose (3.5µg/mm2) paclitaxel IN.PACT Admiral DCB (n=224) at 65 sites in the USA, Australia, Austria, Belgium, Czech Republic, Germany, Italy, Latvia and New Zealand.

The primary efficacy endpoint is 12-month primary patency, defined as freedom from binary restenosis or clinically driven target lesion revascularisation (CD-TLR). Primary patency was comparable between the SurVeil DCB and IN.PACT Admiral (82.2% vs. 85.9%). The primary safety endpoint is freedom from device- or procedure-related death within 30 days and above-ankle amputation or CD-TLR within 12 months, which also demonstrated comparable outcomes between SurVeil DCB and IN.PACT Admiral DCB (91.8% vs. 89.9%). Non-inferiority was tested using a multiple imputation approach at one-sided alpha 0.025.

Data demonstrate the SurVeil DCB is non-inferior to the IN.PACT Admiral DCB with regards to both safety and efficacy while delivering a substantially lower drug dose, a Surmodics press release reports. Both the SurVeil and IN.PACT Admiral DCBs utilise coatings with the antiproliferative drug paclitaxel. However, the IN.PACT Admiral DCB has a 75% higher drug load of paclitaxel (3.5μg/mm2) than the SurVeil DCB, which has a 2.0μg/mm² drug load.

Patient outcomes are being collected at one, siz, 12, 24, 36, 48, and 60 months. Intermediate-term (36-month) secondary outcomes included CD-TLR, major target limb amputation (TLA), thrombosis at the target lesion, and historical major adverse events.

A total of 352/363 (96.97%) patients completed their 36-month visit.

Surmodics states that the SurVeil DCB, which previously demonstrated noninferior primary safety and effectiveness outcomes through 12 months with a lower paclitaxel dose, continues to demonstrate similar outcomes at intermediate-term follow-up of 36 months compared with the high-dose IN.PACT Admiral DCB in the treatment of patients with symptomatic peripheral arterial disease (PAD) caused by stenosis of the femoral and/or popliteal arteries. Results at 36 months for SurVeil versus IN.PACT Admiral were statistically comparable, including CD-TLR (20.3% vs. 19.5%; p=0.897), major TLA (0.0% vs. 0.5%; p=1), thrombosis at the target lesion (0.6% vs. 0.0%; p=0.475), and historical major adverse events (MAEs; 28.6% vs. 28.5%; p=1).

“The TRANSCEND 36-month data continue to demonstrate safe and effective performance of the SurVeil DCB. SurVeil DCB is a best-in-class, high-quality treatment option for our PAD patients utilising a next-generation surface coating with a lower dose of paclitaxel compared to IN.PACT Admiral DCB,” said Schneider.

SVS announces leadership development program for vascular surgeons

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Marlén Gomez
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SVS announces leadership development program for vascular surgeons

The 2023 cohort of the Leadership Development Program gathered in Washington D.C.

Now set to welcome its fifth cohort, the SVS Leadership Development Program (LDP) continues to help vascular surgeons across the U.S. and Canada to hone their leadership skills.

Manuel Garcia-Toca, MD, chair of both the Leadership Development Committee and LDP, said he believes the seven-month program can revolutionize the leadership skills of vascular surgeons, empowering them to make a remarkable impact both in their field and beyond. The program will begin April 11, 2024.

He encouraged participants to “build lifelong relationships, have some fun and invest in your future and the profession’s future,” while earning continuing medical education (CME) credit.

The LDP, developed primarily for vascular surgeons with five to 10 years of experience, offers an immersive learning experience, emphasizing evidence-based leadership models. The curriculum draws from authors Jim Kouzes and Barry Posner’s The Leadership Challenge.

A significant change in the program from previous years is its commitment to flexibility, recognizing the demanding schedules of vascular surgeons, said Garcia-Toca. On-demand didactic presentations, live online faculty-led discussions, mentoring and a 1.5-day in-person workshop have replaced the traditional webinars.

“This format change allows participants to engage with the material more effectively and in a manner that best suits their busy lives. The program’s goal is to empower participants to reach their full potential as leaders, not only in their medical practices but also in their communities and other areas of their lives,” said Garcia-Toca.

The core faculty for the cohort includes Manuel Garcia-Toca, MD, MS; Faisal Aziz, MD; Dawn M. Coleman, MD; Randall R. DeMartino, MD; Kristina Giles, MD; and SVS Executive Director Kenneth M. Slaw, PhD. Participants will have until Dec. 2, 2024, to claim credits or earn their certificates.

For more information on registration, visit vascular.org/LDP5.

SVS Foundation gears up for Giving Tuesday

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Beth Bales
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SVS Foundation gears up for Giving Tuesday

As the holiday season comes into focus, the SVS Foundation is preparing to celebrate science and honor our vascular heroes on Giving Tuesday, a time dedicated to philanthropy and giving back to the community.

Giving Tuesday is celebrated annually on the Tuesday following Thanksgiving—Nov. 28 this year. It stands as a beacon of hope and charity consistent with the true spirit of the holiday season, said Foundation Chair Michael C. Dalsing, MD. For the SVS, this year the celebration will expand past the day, leading to a month-long celebration following Giving Tuesday, in honor of the Foundation’s history.

The Foundation has achieved personal milestones in medical research, grants, awards and fundraising initiatives throughout the year, said Dalsing. They include its Voices of Vascular campaign to highlight the diverse voices within the SVS, the Foundation’s yearly Gala and the Vascular Health Step Challenge, a campaign to raise funds for and awareness of peripheral arterial disease (PAD).

“Giving Tuesday is not just a day; it’s a chance to make a significant difference in the lives of those who rely on our assistance and expertise. We are dedicated to furthering our mission and fostering a community that cares,” said Dalsing.

The Foundation’s efforts have propelled research initiatives, enabled the distribution of crucial grants, recognized outstanding contributions through awards, and facilitated innovative projects that promise to improve the lives of countless individuals.

“Every donation, regardless of size, contributes to our broader mission,” said Dalsing. “Whether you’re a longtime supporter or new to our cause, your contribution is invaluable and greatly appreciated.”

Donors can visit vascular.org/Donate to learn how to join the celebration and support the Foundation’s work.

SOOVC award initiatives offer opportunities to advance outpatient vascular care

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Marlén Gomez
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SOOVC award initiatives offer opportunities to advance outpatient vascular care
Anil Hingorani, MD,

The SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) has opened applications for its Presentation Award and Research Seed Grant, allowing practitioners to contribute to an ever-changing outpatient and office-based vascular care sector.

The Presentation Award recognizes the work of vascular surgeons who have completed research projects in an office-based lab (OBL) or an ambulatory surgery center (ASC) setting. The award is open to active SVS members and will allow three recipients to present their research findings at the SOOVC session during the 2024 Vascular Annual Meeting (VAM). Anil Hingorani, MD, chair of SOOVC, highlighted the significance of these awards, stating, “This is an opportunity to focus on procedures being done in the outpatient setting. These procedures are more cost-effective and efficient, and patients prefer them, making it a win-win situation.”

The three recipients of the 2023 Presentation Award were Michael A. Curi, MD, Keerthi Harish, MD, and Pavel Kibrik, MD. Their projects demonstrated the evolving landscape of vascular care.

Research Seed Grant recipients receive a $10,000 grant to fund analysis of research data for actionable insights, quality improvement and enhanced patient care. The 2023 Research Seed Grant recipients were Michael Curi, MD, Robert G. Molnar, MD, Heather Waldrop, MD, and Christina Cui, MD.

“These abstracts can be related to quality and safety, patient experience, billing, or anything that influences the patient’s journey in an OBL or ASC. It doesn’t have to be solely focused on procedures,” said Hingorani on the broad scope of research areas within the initiatives.

He encouraged all practitioners, from early-career physicians to students, nurse practitioners, physician assistants and nurses, to apply. In addition to promoting diversity and inclusivity, Hingorani stressed the importance of involving community practitioners and those working in lower socioeconomic areas. The deadline to apply is Jan. 15, 2024. Recipients will be announced at VAM 2024, which is set for June 19-22.

Learn more at vascular.org/SOOVCPresentationAward and vascular.org/SOOVCResearchGrant.—Marlén Gomez

VAM abstract submissions window opens

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Marlén Gomez
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VAM abstract submissions window opens
Andres Schanzer

VAM program chair Andres Schanzer, MD, makes a call for cutting-edge new science for next year’s meeting in Chicago.

Researchers who want to present new science at the 2024 Vascular Annual Meeting (VAM) are encouraged to prepare their abstracts for Nov. 15, when submissions open, to take advantage of the eight-week submission window.

“What we’re looking for is innovative new topics, new areas of research that haven’t yet been presented or published elsewhere, representing the very front edge of evolving knowledge and technology across the field of vascular surgery,” said Schanzer, SVS Program Committee Chair. Abstract submissions will close Jan. 10, 2024.

Schanzer emphasized the significance of the abstract submission process in setting the stage for VAM. Organizers post guidelines and policies in the submission instructions to serve as a blueprint for researchers and professionals preparing to submit their work.

The 25-member committee, under Schanzer’s leadership, evaluates all abstracts to present top research for the meeting. Schanzer highlighted relatively recent changes to the program, including the division of scientific content in the mornings and concurrent educational sessions in the afternoons, in order to ensure diversity and quality.

Schanzer assigns several specialized teams of content experts to tackle the multitude of submissions. Each group focuses on all submissions in that given category to score them. The teams are responsible for updating the larger committee on their rankings and leading a discussion for the submissions in their content area.

He said the broad expertise of the committee helps promote the full spectrum of vascular surgery research, all of it appropriately reviewed blindly and considered for inclusion. Despite the increasing number of submissions, there is no fixed target for abstract acceptance.

Learn more at vascular.org/VAM24Abstracts.

SVS Foundation step challenge helps place lens on ‘under-appreciation’ of country’s PAD problem

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Marlén Gomez
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SVS Foundation step challenge helps place lens on ‘under-appreciation’ of country’s PAD problem
Vikram Kashyap hits the trails during the Step Challenge

“We have a critical problem in America, which is the under-appreciation of peripheral arterial disease [PAD],” says Vikram Kashyap, MD, on his first time par­ticipating in the SVS Foundation’s Vascular Health Step Challenge, which concluded in September.

Kashyap, a member of the SVS Foundation board of directors, was one of more than 500 individuals globally who came together in September for a month-long initiative to promote vascular health and raise awareness and funds for the Foundation’s mission. The annual SVS Foundation challenge concluded with participants walking a collective 44,000 miles and raising $100,000.

It corresponded with National PAD Awareness Month, aiming to help encour­age individuals to maintain an active and healthy lifestyle. Participants pledged to walk 60 miles throughout the month, symboliz­ing the 60,000 miles of blood vessels in the human body.

Kashyap notes that this symbolic jour­ney aimed to underscore the importance of maintaining a healthy vascular system and emphasizes the critical role vascular sur­geons play in keeping those systems in opti­mal condition. “I think this is the first step,” he says. “No pun intended. I hope we can use this momentum and continue to grow in the years ahead.”

This year’s challenge introduced the “Pay-it-Forward” initiative, asking registrants to help ensure patient participation in the chal­lenge. More than 70 Pay-it-Forward dona­tions were received.

The Step Challenge also garnered sponsor­ship support, with a 77% increase compared to the previous year. Sponsors included or­ganizations in the medical and healthcare industry, including presenting sponsor Ad­vanced Oxygen Therapy, Inc.; W. L. Gore & Associates; Medtronic; 3M; the Way to My Heart organization; and the Society for Vascular Nursing.

As part of his efforts, Kashyap visited several walking destinations throughout September, including his new hometown of Grand Rapids, Michigan; Traverse City, Michigan; Los Angeles; Central Park in New York City; and Columbus, Ohio.

He emphasized that the challenge does not require an “all-or-nothing” mentality. The Foundation aims to use monies raised to provide necessary treatments and improve the quality of life for those in need, while also driving innovations in vascular care.

Change: A driving force behind SVS advocacy initiatives

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Mounir Haurani
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Change: A driving force behind SVS advocacy initiatives
Mounir Haurani

Change is a constant in life, and advocacy is no exception. The healthcare landscape is always evolving, and the SVS Advocacy Council is working to maintain a voice in the decision-making process. The council is committed to driving change that will improve the lives of vascular surgeons and their patients. By working to influence government policy, the Advocacy Council can make a real difference in the practice of vascular surgery and the care patients receive.

To create meaningful change, the SVS has identified several pieces of legislation that the Advocacy Council believes will result in impactful changes in federal policy that will drive positive outcomes for vascular surgeons and patients. Members identified several bills to help:

  • R. 3674, the “Providing Relief and Stability for Medicare Patients Act of 2023”
  • R. 2474, the “Strengthening Medicare for Patients and Providers Act”
  • R. 1202/S. 704, the “Resident Education Deferred Interest (REDI) Act”
  • R. 2389/S. 1302, the “Resident Physician Shortage Reduction Act of 2023”
  • R. 731/S. 220, the “Workforce Mobility Act of 2023”
  • R. 4261, the “Amputation Reduction and Compassion (ARC) Act”

There are many ways members can get involved in driving this change, such as getting acquainted with grassroots advocacy. There are few advocacy tools more powerful than direct engagement between a constituent and a member of Congress. Engaging with your federal lawmakers helps to amplify SVS’ legislative priorities on Capitol Hill because elected officials want to hear from their constituents about the issues that are important to them. Your representative and senators are not experts in vascular care and need to hear from you about policies that impact your practice and patients. The SVS offers several opportunities for members to get involved in grassroots advocacy. For instance, sign up as a REACH 535 key contact, where you become the bridge between SVS legislative priorities and your elected officials. You can also participate in Voter Voice activities. Meanwhile, members can also support the SVS Political Action Committee (PAC).

Mounir Haurani, MD, is vice chair of the SVS Government Relations Committee.

The pulmonary arterial tree—it is time we branch out

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Nicolas Mouawad
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The pulmonary arterial tree—it is time we branch out
Nicolas Mouawad, MD
Nicolas Mouawad, MD, chief of vascular surgery at McLaren Health System in Bay City, Michigan, urges vascular surgeons to “get out of their comfort zone” and become more involved in pulmonary embolism (PE) care.

With more than 1 million cases of deep vein thrombosis (DVT) and/or PE diagnosed each year in the U.S. alone,1 the management of patients with venous thromboem­bolic disease (VTE) is a critical public health concern.2 So much so that in 2008, the U.S. Surgeon General declared a formal call to action against VTE. Despite an initial mod­est increase in awareness, it has been the recent COVID-19 pandemic that truly erupted a flurry of VTE therapies and catapulted this pathology from the sidelines to center-stage. Although DVT and PE are a continuum of the same disease state, untreated acute PE has a mortality of 30%.3 The sever­ity of impact is primarily based on the embolic burden and the resultant effect on the right ventricle (RV), in addition to underlying comorbid conditions. The vicious cycle com­mences with acute increases in pulmonary arterial pressure secondary to the embolic obstruction which increases right ventricular afterload, increasing RV myocardial oxygen con­sumption and impairing RV contractility. This in turn affects the left side manifest by decreased cardiac output that can eventually lead to cardiogenic shock and death.

Pulmonary embolism response teams (PERTs) have emerged as an effort to battle the crisis of pulmonary em­boli. Akin to “doctor-heart” for ST-elevation myocardial infarctions (STEMIs) and code stroke activations, the PERT is a multidisciplinary team focused on early triage, assessment, risk stratification and rapid coordination of an organized re­sponse to mobilize resources as necessary for PE care. These traditionally have been composed of interventional medical specialties with surgical counterparts as backup. The role of the vascular surgeon in the management of PEs varies widely and is based on their interest, their comfort (particularly nav­igating the heart), geography and the institutional politics.

The main issue in my opinion is that it feels outside of our “comfort zone” to be in the thorax. Whether surgically or by endovascular means, the thorax has historically been a black box—a void—for the vascular surgeon. From an in­terventional perspective, it is a domain of cardiothoracic surgery, interventional cardiology and interventional radiol­ogy, among some others. Furthermore, dedicated training paradigms have not been established for formal education in navigating the heart and the pulmonary vasculature for vascular surgeons. Most of us who are involved in PE care learned it from our interventional colleagues, training cours­es, or “on the job.” But why do we not take a more active role in this disease process? After all, we are vascular spe­cialists very comfortable in diseases of the arteries, veins and lymphatics, whether medical, minimally invasive or maximally open.

And who gets an intervention? Unfortunately, risk strat­ification of patients with PE remains in development. The most common system separates them into low risk, inter­mediate risk, and high risk. An in-depth evaluation of cost, resource utilization, risk and safety profiles, as well as clinical efficacy, such as HI-PEITHO, PEERLESS II, STORM-PE, PE-TRACTS, among others, are currently underway to help answer many of these questions.

For those that qualify for intervention based on current­ly used criteria, vascular access is obtained in the standard fashion with ultrasound guidance. Caval venography is per­formed to ensure no anatomic abnormality, thrombosis or clot in transit. The right heart is then catheterized—I am a fan of the angled pigtail more so than a balloon-tipped catheter such as the Swan-Ganz as I feel its shape mirrors the anticipated trajectory. For each one of my PE interventions, a full right heart catheterization is performed. A comfort with waveform analysis traversing right atrium, right ventricle and into the main pulmonary artery is paramount. These are standard displays in a cardiac catheterization laborato­ry, although not usual in the operating suite, so depending on your site of care, it is important to equip your lab with the ability to transmit and display these data. Clearly this will help monitor critical patient vitals and also assist in evaluating the effectiveness of some interventions. The procedure is then completed in the standard fashion.

Just as we have adopted many new dis­ruptive technologies for the management of our patients, the pulmonary vascula­ture is an extension of the vascular tree we are trained to treat. I submit that it is time we branch out in the pulmonary arterial tree and become comfortable navigating the heart. We are trained for quick decision-making in high-stakes situations. It is time to dust off our old physiology textbooks and revisit right heart pressures, pulmonary vascular resistance and dynes/sec!

A multidisciplinary group is imperative for the manage­ment of patients with PE—and for a successful PERT—and vascular surgeons should get out of their comfort zone and play an active role in this patient population and pathology. We have a duty to our trainees to develop training paradigms to tackle all components of vascular disease and offer a fa­miliarity and applicability of endovascular concepts while addressing barriers to implementation. Through continued awareness, education, and support, we can help cement vas­cular surgery as an integral component of comprehensive PE care and focus on improving PE patient outcomes.

References

  1. Lutsey PL, Zakai NA. Epidemiology and prevention of venous thromboembolism. Nat Rev Cardiol. 2023 Apr;20(4):248–262. doi: 10.1038/s41569-022-00787-6. Epub 2022 Oct 18. PMID: 36258120; PMCID: PMC9579604.
  2. US Department of Health and Human Services. Surgeon General’s call to action to prevent deep vein thrombosis and pulmonary embolism 2008. http://www.surgeongeneral.gov/topics/deepvein.
  3. Bˇelohlávek J, Dytrych V, Linhart A. Pulmonary embolism, part I: Epidemiology, risk factors and risk stratification, pathophysiology, clinical presentation, diagnosis and non-thrombotic pulmonary embolism. Exp Clin Cardiol. 2013 Spring;18(2):129–38. PMID: 23940438; PMCID: PMC3718593.

Nicolas Mouawad is chief and medical director of vascular and endovascular surgery at McLaren Health System in Bay City, Michigan.

Twelve-month first-in-human data from Xeltis’ aXess haemodialysis vascular conduit trial presented at VEITHsymposium 2023

By
Jocelyn Hudson
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Twelve-month first-in-human data from Xeltis’ aXess haemodialysis vascular conduit trial presented at VEITHsymposium 2023
Frans Moll
Frans Moll

Xeltis has announced “highly encouraging” 12-month results from its first-in-human (FIH) aXess vascular conduit trial. The data were presented by Frans Moll (University Medical Center Utrecht, Utrecht, The Netherlands) at this year’s VEITHsymposium (14–18 November, New York, USA).

At 12 months, 100% secondary patency, 78% primary assisted patency and 0% infections were observed in data from 20 patients implanted with the aXess conduit. According to Xeltis, these results represent a significant improvement over current standard of care. This performance builds on the six-month data presented in April 2023 at the Vascular Access Society Congress in Porto, Portugal. To date, more than 3,500 dialysis sessions have been conducted across the six centres in Belgium, Italy, Latvia and Lithuania.

aXess is a restorative conduit which enables the creation of a new, long-term living vessel for haemodialysis vascular access. The aXess FIH trial is a single-arm feasibility study in Europe evaluating the preliminary safety and performance of the aXess graft in patients older than 18 years with end-stage renal disease and deemed unsuitable for fistula creation. Follow-up visits were conducted at regular intervals after the initial procedure, with study follow-up visits to be conducted for five years. A separate pivotal trial of aXess is underway, enrolling up to 110 patients across up to 25 sites in nine EU countries, with over 40 patients already implanted.

The full data were presented by Moll in a presentation entitled ‘Novel application of polymer technology to create endogenous tissue with host collagen and endothelium compatible with flowing blood: One-year clinical results of the aXess graft’.

Moll and member of Xeltis’ medical advisory board said in a press release:“The 12-month data from the aXess FIH trial are highly encouraging, and continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of AVG [arteriovenous graft], such as early cannulation and no maturation needed, with the long-term advantages of AVF [arteriovenous fistula], including better patency rates, a reduced need for intervention and low infection rates.”

Eliane Schutte, CEO of Xeltis commented: “The outstanding 12-month data from our FIH study highlights aXess’ potential to transform the field of vascular access as a whole by stopping the cycle of interventions and infections. These latest results, alongside the excellent progress in enrollment for our pivotal trial, brings us closer to bringing our breakthrough solution to haemodialysis patients worldwide.”

Randomized trial set to elucidate value of image fusion technology for aortic repair

By
Jocelyn Hudson
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Randomized trial set to elucidate value of image fusion technology for aortic repair
technology
Rachel Clough

An ongoing UK National Institute for Health and Care Research (NIHR)-funded randomized controlled trial seeks to illuminate the value of an image fusion guidance technology for endovascular aortic repair.  

In a presentation on the trial at this year’s VEITHsymposium (Nov. 14–18) in New York City, Rachel Clough, MD, a consultant vascular surgeon at King’s College London in London, England, first outlined the issue at hand. While endovascular devices are available to treat complex aortic disease using a combination of branches and fenestrations, she said, challenges arise when positioning these devices in three-dimensional spaces. 

“We currently use high-contrast and high-spatial resolution CT [computed tomography] angiography to both plan these procedures and to design these custom-made devices,” Clough said. Until recently, however, she noted that there was “no direct link” between these preoperative image data and intraoperative two-dimensional fluoroscopy images. 

To remedy this, Clough detailed that a new technology—Cydar Maps (Cydar Medical) image fusion guidance—was designed in order to accurately and in real time automatically overlay preoperative CT, volume-rendered aortas onto intraoperative fluoroscopy data. 

The presenter noted that Cydar Maps is now a cloud-based product that incorporates three phases—planning, navigation and review. The benefits of a cloud-based system, Clough relayed, include the fact that it is always updated, enables remote planning and review of cases, and provides a platform for sharing data with other organisations or device companies.  

Furthermore, Clough said, the technology has the benefit of being able to aggregate data in an effort to develop data-driven clinical decision support. “During the planning, navigation and review phases, the data are pooled and then analytics can be used to try to predict outcomes,” the presenter explained. She continued that a particular patient could be matched to similar previous patients, and not just necessarily in one centre, but across multiple centres, after which predictions of outcomes based on different device type usage could be provided. 

Data-wise, Clough shared that the technology has been demonstrated in independent case-control series in both the UK and the USA to result in reduced radiation and procedure times in both standard and complex endovascular repair. In fenestrated cases, she added, it has also been shown to reduce the amount of iodinated contrast agent used. The presenter further noted a sustained reduction in radiation exposure for the operator after just 10 cases. 

Integration into healthcare systems, however, will require further data. “We need to demonstrate that [Cydar Maps] provides similar operator benefit and similar or lower overall costs compared to comparators, as the UK is a value-based healthcare system,” Clough stated. She noted that the UK National Institute of Health and Care Excellence (NICE) has a digital evidence framework that requires a high-quality randomized trial for any technology designed to guide treatment. 

Against this backdrop, Clough and Tom Carrell (co-creator of Cydar Maps) applied for funding to NIHR for a randomized controlled trial to investigate the technology’s value. The funding was granted, and the investigators subsequently set up a prospective, multicenter, two-arm randomized controlled trial recruiting patients with abdominal aortic aneurysm (AAA) and thoracoabdominal AAA trial in 10 sites across the UK.  

“[The trial] is designed to capture real-world practice, so it is deliberately relatively simple,” Clough commented. “We screen patients at MDT [multidisciplinary team meetings] or in clinic and collect routine clinical data and CT imaging data, as would be usual practice,” the presenter elaborated. A quality-of-life questionnaire (the 10-question EQ5D) is really the only additional element needed for the trial. 

Clough continued that patients will be randomized in a 1:1 fashion, with the aim being to recruit a total of 340 patients. Clinical, technical and cost-effectiveness data will be collected to evaluate the technology. 

The presenter closed with a progress report, detailing that 213 patients—just over 60% of the cases required—have been enrolled so far. “We are pleased that, on the whole, sites are recruiting patients well,” she remarked, noting that around 80% of all eligible patients that are screened are being recruited to the trial.  

“Health technology has the potential to drive efficiency and cost savings, but its value must be demonstrated,” Clough stressed in her conclusion. “Cydar Maps has been shown to provide benefit compared to standard treatment in smaller studies for both complex and simple endovascular aortic repair, and we hope this NIHR-funded trial will provide data of sufficient quality for submission to NICE for evaluation, to understand the true value of this technology.” 

Impact of the CMS proposed rule on the QPP for 2024

By
Caitlin Hicks
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Impact of the CMS proposed rule on the QPP for 2024

This summer the center for medicare and Medicaid Services (CMS) published its annual Physician Fee Schedule and Proposed Rule for calendar year 2024, and on Nov. 2 the Final Rule was published. The proposed rule included several proposals within the Quality Payment Pro­gram (QPP) that would impact vascular surgeons. The fol­lowing article reviews highlights and the SVS responses.

One active area for CMS is the development of Mer­it-Based Incentive Payment System (MIPS) Value Pathways (MVPs). MVPs are viewed as the gateway for providers to transition into Alternative Payment Models (APMs). Their development for vascular conditions was covered in a recent Vascular Specialist article.

In the proposed rule for 2024, CMS proposed five new MVPs, which would bring the total to 12 optional MVPs for physician reporting. CMS also proposed to increase public comments during MVP development by soliciting feedback for 30 days following submission and making changes with­out input from the society or stakeholder that submitted the MVP if CMS deems those changes are appropriate. The agency also proposed to solicit recommendations for MVP updates annually. While the SVS appreciated CMS’ plan for public outreach, we argued that the persons and/or specialty societies who developed an MVP should be able to view and respond to public comments once received, as they will have a more nuanced view regarding how the proposed changes would impact the MVP and might create unintended con­sequences. The SVS also recommended that CMS provide a one-year lead time regarding the clinical areas under consid­eration for condition, specialty or procedure-based MVPs.

Subgroup reporting will become an option for MVP par­ticipants, which the SVS believes is important for broadening specialists’ reporting options and for the development of MVPs. The SVS emphasized the need for a transparent sign-on and a sufficient transition period for providers choosing to report via subgroups.

In the MIPS Quality Performance Category, CMS proposed maintaining the 30% weight of the final MIPS score but in­creasing the data completeness measure from 70% to 75% beginning with the 2024 performance year. The SVS noted that this increased reporting requirement was counter to CMS’ goals of reducing administrative burden within the MIPS program, particularly at a time when data and care integration are challenged and the costs of doing so are borne by physicians and their practices. Additionally, until more valid claims or easy-to-access electronic health measures are made available, it seems unfair to increase this requirement.

Under statute, the MIPS Cost Performance Category will continue to have a 30% weight. CMS proposed to establish a maximum cost improvement score of one point out of 100. The SVS recognized the flexibilities that CMS put in place to hold physicians harmless from undue MIPS penalties during the COVID-19 pandemic and asked that CMS continue to allow for hardship exemptions. The SVS also asked that CMS consider a maximum cost improvement score of at least five bonus points.

CMS proposed maintaining the 15% weight for the Im­provement Activities (IAs) category and proposed four ad­ditions and five removals of IAs. The SVS encouraged de­velopment of methods for IA credit awards for performing activities that overlap with similar Quality, Cost and Promot­ing Interoperability (PI) measures.

CMS proposed that PI category remain at 25% of the over­all MIPS score. CMS suggested requiring a yes/no response for Public Health and Clinical Data Exchange measures, with the requirement to submit level of active engagement. CMS also proposed to make the Query of Prescription Drug Monitoring Program (PDMP) a required measure. The SVS opposed the PDMP requirement, as many physicians and health systems remain incapable of interconnecting with PDMP systems. The SVS also strongly urged CMS to recon­sider its proposal to tie physicians’ PI category success to the “all or nothing” approach proposed for Public Health and Clinical Data Exchange objective requirements.

There are many other components of the rule that cannot be covered here. For a more detailed review and/or the final SVS comment letter, visit the CMS Final Rule fact sheet at vascular.org/24FeeSkedFactSheet.

References

  1. Vascular Specialist June 2023 Volume 19 Number 06: vascular.org/June23VascularSpecialist
  2. Proposed rule: vascular.org/ProposedRulefor24
  3. SVS comment letter: vascular.org/2024PaymentPolicyResponse
  4. QPP Fact Sheet: vascular.org/2024QPPProposedRuleFactSheet

CAITLIN HICKS is vice chair and EVAN LIPSITZ the chair of the SVS Quality Performance Measures Committee.

Two-year SWING data ‘continue to show promise’ for sirolimus DCB in treating BTK disease

By
Jocelyn Hudson
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0
Two-year SWING data ‘continue to show promise’ for sirolimus DCB in treating BTK disease
Ramon Varcoe
SWING
Ramon Varcoe presented the new data at VEITHsymposium 2023

Two-year data from the SWING trial, a first-in-human study of the safety and performance of the Sundance sirolimus drug-coated balloon (DCB; Surmodics), have been presented at this year’s VEITHsymposium (Nov. 14–18) in New York City.

The SWING trial is a 35-patient prospective, multicenter, single-arm feasibility study to evaluate the safety and performance of the Sundance sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries. The SWING trial enrolled patients with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter of 2–4mm, and a total lesion length of ≤230mm for treatment with the Sundance sirolimus DCB at eight sites in Australia, New Zealand, and/or Europe. Study patients will be followed for 36 months post index procedure.

The primary safety endpoint is defined as the number of patients with a composite of freedom from major adverse limb event (MALE) and perioperative death at 30 days following the index procedure. The primary efficacy endpoint is the rate of late lumen loss at six months, as assessed by quantitative vascular angiography. Both primary endpoints of the SWING trial were achieved.

Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major reintervention was reported among the 35 trial patients. The per protocol (PP) population reported an 8.3% rate of major adverse events (two clinically driven target limb revascularizations) at six months, with no additional adverse events reported for PP subjects in the 12 or 24-month data. Primary efficacy data show late lumen loss of 1mm (±0.79mm) across 35 lesions at six months, indicating that the large luminal gain achieved immediately after the procedure was sustained post procedure.

Target lesion primary patency rate, defined as freedom from target vessel occlusion or target lesion revascularisation associated with deterioration of Rutherford clinical classification and/or increase in size of pre-existing wounds (or occurrence of new wounds), and lesion restenosis >50%, was 71.4% at 24 months in the PP population. The Rutherford clinical classification describes seven categories of peripheral arterial disease, including both the patient’s clinical symptoms as well as objective findings, and is used to assess disease progression.

Andrew Holden

“The two-year safety and performance results of the SWING trial continue to show promise for the Sundance sirolimus DCB in treating below-the-knee disease in a challenging CLTI [chronic limb-threatening ischaemia] patient population where options are currently limited,” said Andrew Holden, MD, from Auckland City Hospital in Auckland, New Zealand, co-lead investigator, in a Surmodics press release.

“We need to continue to strive for better treatments for treating infrapopliteal disease,” added co-lead investigator Ramon Varcoe, MD, from Prince of Wales Hospital in Sydney, Australia, who presented the new data at VEITHsymposium 2023. “These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.”

On gratefulness as a vascular surgery trainee

By
Christopher Audu
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0
On gratefulness as a vascular surgery trainee

I enjoy listening to podcasts. In addition to my usual rotation through Audi­ble Bleeding and Behind the Knife, I’ve found insight in listening to Hidden Brain. A recent episode centered on the concept of grati­tude, where it was highlighted how quick we are to dismiss the good things that happen to us and perseverate on the negative, inconve­nient or unsavory parts of our day—both for ourselves and those around us.

In training, this is sometimes expressed in complaint form. We complain about how difficult residency is; how certain residents/attendings/consulting specialties treat us. We find it cathartic to air out these grievanc­es, all the while forgetting that once upon a time, this present state of being a trainee, was a dream—a position achieved through very hard work.

So, then, why should we be grateful?

There are a number of benefits, I think, that accrue from gratitude as a resident. Most important is the sense of being situ­ationally aware and outward-focused. This allows for a growth mindset.

Such a framework sets the tone for becom­ing better—in skill and knowledge—at our job as surgical trainees. Challenges become opportunities; roadblocks become chances. For me, this means seeing my call status, not as a “black cloud,” but as an opportunity for learning. I’m not always successful at this, but it is an aspirational goal.

Another benefit that I identified from past chief residents and fellows is that the grateful ones were often superlative leaders. Because simply acknowledging the difficulties of pro­viding care for patients at various levels— from the intern on the wards, to the OR staff setting up—is encouraging and uplifting. Fre­quently, this attitude would translate into a certain work ethic in the team and a cultural ethos that had patient care as the top priority. It’s nice to be noted for the hard work being put into quality patient care.

Finally, gratitude comes best through seemingly small acts that can become a habit. For instance, a congratulatory fist bump to a co-trainee, saying “well done” when some­thing goes well, or even just taking the time to listen to the patient’s concerns, are all acts of being grateful for the opportunity to learn from the best clinical teachers—our patients.

This Thanksgiving month, as many con­template gratefulness, on the wards, in the operating room, or in the angiography suite, I hope we are imbued with a sense of added gratitude to be living what was once a dream for all of us.

Christopher Audu, MD, is the Vascular Specialist resident/fellow editor.

Can you count the ‘monkeys’ on your back?

By
Bhagwan Satiani
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0
Can you count the ‘monkeys’ on your back?

HappinessPeriodically, when under pressure at work, and sometimes at home, I would think about what I could do to free up more time for myself and the family. How I could pri­oritize or drop tasks that were unimportant. There were and are many books and articles advising us how to prioritize assignments. Over time, most of us have devised an imperfect system to deal with non-urgent tasks. A high-level approach to separate the chaff from the wheat may start with things such as your own goals, organizational objectives followed by a variety of individual objectives. However, the day-to-day pesky problems added to our calendar continue to test our time-management skills.

Time-management techniques and tools have progressed from handwritten notes and checklists to paper and now electronic calendars. Many years ago, Stephen Covey postulated that we are managing ourselves, not just our time, and that our goal should be prioritizing relationships and results. His book, called The 7 Habits of Highly Effective People, is one of the best time management books I have read. Since this was written in 1990, many of my younger colleagues may not have read it. Besides discussing how to cultivate the seven habits, the book has practical advice about separating tasks by urgency and importance in a time management matrix. The two-by-two grid with four quadrants has “important” and “not important” on the y axis and “urgent” and “non urgent” on the x axis. This matrix also goes by the “Eisenhower matrix.” If you are still struggling with time management, it may be worth using this simple tool.

While the grid was helpful in prioritizing tasks one has already accepted, I soon realized that the advice was useful after I had already committed and taken on many of these management tasks. This is where the “monkeys” arrived into my life.

I came across an article in Harvard Business Review in 2011 about tasks or “monkeys” in relation to time management problems for managers.1 The source of this metaphor is uncertain. Speculation ranges from Sinbad the Sailor in Arabian Nights carrying a person or an ape across water who would then not leave, to denoting lugging a load of anger or even carrying the burden of drug or alcohol addiction. In general terms, the idiom means dealing with a difficult-to-resolve task or problem, but in practical terms it connotes a task or burden that has been transferred to you, willingly or not.2

An older “Grady” physician like me (alumnus of Grady Hospital in Atlanta, part of Emory University and Morehouse) quoted George Michael as singing, “Watch out! Baby who’s that? Don’t look now—there’s a monkey on your back!” and reminded readers of that idol of yesteryear Peter Gabriel, who, while made up as a shaman, sang, “Don’t you know you’ve got to shock the monkey?”3 Gabriel’s context was not about animal cruelty or People for the Ethical Treatment of Animals (PETA), but about jealousy, which can trigger animal-like behavior. I think he may have been onto something. The constant scratching and emotional toll of one or more monkeys on our backs for months or years may in fact lead us to overreact and act like wounded spirits—not due to jealousy but helplessness.

The ex-Grady doc discusses management time at work in three practical categories: boss-imposed, system-imposed and self-imposed time. At work, the monkeys are usually boss or system-imposed varieties.

While monkeys have many species, for discussion purposes, our monkeys come in three varieties: those that are invited in, others who we unintentionally invited in and feed for a while, and those that are forced on us who live on our backs till we get rid of them.

Then there are those monkeys who are unwittingly invited through emails or phone calls. If you are known to be a “giver,” according to psychologist Adam Grant, chances are you are highly susceptible to this dialogue. The shifting, or giving of a task (“monkey transfer”) may go like this: “I have heard you are an expert in… so, can you help me make sense of this? It will only take a few minutes… (take your pick: chapter, abstract, manuscript, statistics)?” Full disclosure: I have shamelessly used this tactic too.

Or: “I just need to pick your brains for a few minutes about… since our mutual acquaintance Dr. Y told me you helped her with…’ I am guilty of this too, but only after helping someone several times, which then forces me to switch to becoming a “matcher” so I can seek reciprocity.

The uninvited monkeys are a different problem. These are friends of friends, or relatives of relatives, who forward their images or reports. Outside of work, it’s the same pattern. In my experience as a “retired” physician, most of them are invited in. Sometimes, the transfer is so well done that I am not aware that I invited them in. I am guessing others may also have read this Harvard Business Review article and know how to seamlessly transfer the monkey(s)! Some weeks, I am dealing with the health issues of at least two to three relatives, good friends or acquaintances across the globe. Most of us gladly accept these demands, but the pace picked up after my retirement. Please do not get me wrong: I derive satisfaction from being able to assist in whatever way I can, whether it is getting someone a quicker appointment, a second opinion, or guiding them to the right physician. Any person I can direct to appropriate care, I count as a victory. It is when a five-minute informal advice changes to making a medical decision for someone who ends up asking the usual question: “What would you do if you were in my place?” One must be careful here as the “monkey” is now in transfer mode and ready to make the jump to your back.

It is a cliché, but prevention is the best medicine for this very underestimated time waster. My advice is, unless you are looking to impress your boss, or do not wish to spend any time at home, be on “monkey alert” so you can spot the incoming transfer prior to it leaving the transferor. If the creature has already started jumping through neutral space, the game is lost. Most often, it starts with an attempt to make it a mutual problem with statements like, “How should we deal with this?” The monkey is now in neutral territory or, as the authors put it, “the monkey in each case begins its career astride both their backs,” and then makes the leap.1

If you do not prevent the transfer, plot carefully about getting rid of the monkey. But where does the creature finally go? Your options are convincing someone that the monkey belongs to them, to punt it upstairs with the task resolved, boot it down to a subordinate, or ignore it hoping the other side forgets. Based on experience, the last option is your best one. Another piece of advice offered is to “pet the monkey” while it is in someone else’s lap, or on their shoulder/back, and solicitously show some empathy while changing the topic and discouraging transfer.

William Oncken, Jr. and Donald L. Wass have a few useful rules for managers struggling to deal with the “care and feeding of monkeys.”1 First, one either feeds them or gets rid of them, but does not continue to deal with them through vague language. Next, do not spend more than 15 minutes on a single monkey, and feed them only face-to-face or by telephone—and only with an appointment. They suggest avoiding being at your desk too long since that is where your computer and phone are. This is also where monkeys are waiting to switch parties. Much easier to be elsewhere since you do not have your calendar with you, or are busy in the clinic or the OR. Finally, they advise an assigned feeding time and to pre-determine the degree of effort you wish to put in it. Better still, you could offer some time next Wednesday at 5 p.m. to hear more about the potential transfer. Chances are they have forgotten, and you will not get the call. But if you do, they probably really need your help.

Alas, some of these rules are hard for we “retirees,” as people assume we sit around all day waiting to welcome the monkey. My best advice is to beware of this type of “transfer.” After you have received a monkey or two, you will know which people are anxious to make their own load lighter.

References

  1. Management Time: Who’s Got the Monkey? https://hbr.org/1999/11/management-time-whos-got-the-monkey
  2. https://www.idioms.online/monkey-on-your-back/
  3. http://www.gradydoctor.com/2013/09/dont-look-now-theres-monkey-on-your-back.html

BHAGWAN SATIANI is a Vascular Specialist associate medical editor.

Specialty representation at all levels of a healthcare organization is ‘increasingly important’ in value-based systems

By
Bryan Kay
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0
Specialty representation at all levels of a healthcare organization is ‘increasingly important’ in value-based systems
Jeffrey Hsu presents at VEITH 2023

A 14-year effort to achieve departmental status for vascular surgery at a large healthcare system in Southern California resulted in significant gains for the specialty within the organizational apparatus, according to an administrative case report on an effort finalized last year.

Jeffrey Hsu, MD, the regional chief of vascular surgery at Kaiser Permanente Southern California, charted the course of departmentalization at his institution amid resistance from general surgery and organization-level bylaw changes necessary to define a transition process during a 2023 VEITHsymposium (Nov. 14–18) session in New York City.

The process originated after a general consensus was reached among the healthcare system’s vascular surgeons in 2008 that they needed their own department due to issues around inadequate representation for the specialty, lack of administrative control over vascular surgery resources, and “a general sense of recognition and identity for the specialty,” Hsu told attendees.

After changes to the Kaiser Permanente bylaws were defined and approved, it became apparent vascular surgery met all the criteria required to become a department.

“In 2016, vascular surgery was granted divisional status by the executive leadership,” explained Hsu. “However. operationally this had little effect, and the majority of vascular surgery chiefs wanted to continue to pursue department status. In 2017, vascular surgeons in our organization collectively decided to transition from a division to a department. Through a lengthy process of negotiations and discussions, we were finally able to achieve in unanimity. In 2021, we were able to gain the support of the general surgery department to proceed.”

Finally, in 2022, the Kaiser Permanente board of directors “unanimously voted to form the department of vascular surgery,” added Hsu.

The stakes couldn’t be higher, he observed.

“It stands to reason that specialty representation at all levels of healthcare organizations will become increasingly important as we move toward value-based systems, increased administration and more corporate control of healthcare,” Hsu said. “Vascular surgery’s place in the organizational structure is an important factor to consider.”

He listed the benefits witnessed in the year since the department was formed. Surgical service line operations now include vascular surgery decision-making, Hsu said. Collegiality with general surgery “remains strong and unharmed,” and “the medical school has established vascular surgery clerkships and appointed vascular surgery preceptors.” Surgical residents are given increased exposure and longer rotations in vascular surgery, and vascular surgery chiefs are now invited to all surgical leadership meetings, both regionally and locally, Hsu added.

“This report demonstrates that departmentalization of vascular surgery is possible in large healthcare organization,” he concluded. “So I ask our colleagues who take leadership positions in your organizations who are faced with mounting administrative challenges—it is my hope that you will consider departmentalization as a viable option.”

NIH-funded research on the use of AI in vascular surgery: A decade in the making

By
Jocelyn Hudson
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0
NIH-funded research on the use of AI in vascular surgery: A decade in the making

Vascular surgeon-scientist Elsie Gyang Ross, MD, recently secured coveted funding through the National Institutes of Health (NIH) Research Project Grant Program (R01)—a rare feat for one so young having managed to achieve the career landmark before the age of 40.

Here, the associate professor of surgery at the University of California San Diego tells Vascular Specialist how she got started researching the use of artificial intelligence (AI) in vascular surgery, where it could improve care and how the $3 million-plus NIH funding will be used to build AI models that can predict peripheral arterial disease (PAD) in diverse patient populations.

“Not just at one hospital, but across the country,” she says, explaining the scope of her work. “And to see if these models—when we put them in the clinician’s hands—will actually change care.”

Video attributions

Footage attribution:
Hyperlapse Media/stock.adobe.com

Music:
Quirky-tension-investigation-(sleek-sneak)/performed by Apollo Audio/FineTune Music/stock.adobe.com

SVS executive director elected to executive council of Council of Medical Specialty Societies

By
Marlén Gomez
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0
SVS executive director elected to executive council of Council of Medical Specialty Societies
Kenneth M. Slaw

The Society for Vascular Surgery (SVS) Executive Director Kenneth M. Slaw, PhD, has been elected to executive council of the Council of Medical Specialty Societies (CMSS).

The Council of Medical Specialty Societies (CMSS) is an organization of 53 boarded medical specialties representing over 800,000 specialty physicians in the U.S. whose mission is to “advance the expertise and collective voice of specialty societies in support of physicians and the patients they serve.” Its vision states that “working together, specialty societies advance healthcare for patients and physicians.”

CMSS is a highly effective collaborative body that brings all of the medical specialty societies together to work on common issues, challenges, and national initiatives, Slaw tells Vascular Specialist. “CMSS has established cross-society policies for ethics, relations with industry, diversity, equity and inclusion [DEI], and takes formal advocacy positions when essential to foster and protect specialty medicine,” he says.

Staff executives in specialty societies meet across numerous professional peer groups to share best practices and optimize education, marketing, communications, governance, legal, industry relations, registries and quality improvement.

Additionally, CMSS has received numerous grants from the Centers for Disease Control and Prevention (CDC) and private foundations in the past several years to accelerate progress in the areas of diagnostic quality, health equity, and many other areas of interest, Slaw points out. The SVS was recently awarded a $100,000 grant from CMSS to foster diagnostic excellence in chronic limb-threatening ischemia (CLTI).

“I am proud and honored to do all I can to accelerate the movement of specialty societies and CMSS to face a litany of future challenges” notes Slaw. “Vascular health and healthcare span the lifespan and interact with dozens of other medical specialty physicians and societies. Serving CMSS will tighten these important relationships for SVS and help improve care for patients.  SVS will have a front row seat and active role in addressing the future of healthcare.”

Slaw is in his eighth year as executive director of the SVS, and has served specialty societies in a senior or executive role for more than 35 years.

Vascular Specialist–November 2023

By
Bryan Kay
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0
Vascular Specialist–November 2023

In this issue:

  • Carotid revascularization: Getting to the right decision
  • SVS reveals proposed changes to Society bylaws
  • Meta-analysis: The complete patient-level dataset on paclitaxel and death that helped sway FDA 
  • PE care: The pulmonary arterial tree—is it time to branch out? 
  • Obituary: Roger M. Greenhalgh, SVS International Lifetime Achievement Awardee, dies aged 82 

New survey shows transcarotid artery revascularization patients report faster recovery than their endarterectomy counterparts

By
BIBA Publishing
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0
New survey shows transcarotid artery revascularization patients report faster recovery than their endarterectomy counterparts

This advertorial is sponsored by Silk Road Medical.

Scott Berman and Stacey LeJeune

For Scott Berman, MD, patient responses when confronted with an explanation of the extent of their asymptomatic carotid disease tend to be quite stark. They are either so petrified of having a stroke that they express clearly that they want to be operated on as a matter of urgency, the Tucson, Arizona-based vascular surgeon explains, or else they are steadfastly against surgery under any circumstances. 

That’s why Berman sees patient-reported outcomes as a crucial component to factor into certain areas of his treatment decision-making. So, a recent patient satisfaction survey—which demonstrated those carotid disease patients who underwent transcarotid artery revascularization (TCAR) recovered more quickly than those who received carotid endarterectomy (CEA)—confirmed what already seemed intuitive. 

“As soon as we started doing TCAR, we could see early on that these patients were recovering a lot more quickly than CEA patients,” says Berman, of Pima Heart & Vascular, a study author who contributed a tranche of patients to the survey. “The overall experience seemed to be better.” 

The survey, conducted across nine medical centers, drew 304 responses (161 TCAR; 143 CEA) from 64 patients across a total of 13 questions on post-procedure pain, lifestyle limitations and activity ability. A hospital staff member at each of the nine participating hospitals conducted the surveys over the phone once per week for four weeks. 

Berman contributed 10 patients—five each for TCAR and CEA. “It really reinforced what we had observed—that TCAR patients seemed to have a less eventful recovery after revascularization than endarterectomy patients,” he says. “The overall experience has seemed to be better with TCAR, and the early results with this survey support that.” 

Among the key findings, the study—which was completed Silk Road Medical—established that patients who were treated with TCAR experienced less pain over all time periods than those who underwent CEA. TCAR patients also reported significantly less facial numbness, swallowing issues, facial drooping and voice changes over time than their CEA counterparts. Furthermore, TCAR patients reported more ease in completing ordinary tasks 48 hours to one week post-procedure. 

“Even in my subset, we were able to see that there was statistical significance in many areas, including pain control and returning to activities,” notes Stacey LeJeune, MD, of Surgical Associates and a community hospital vascular surgeon in Wausau, Wisconsin, another author involved in the patient satisfaction study. 

Carotid revascularization patient satisfaction survey data

LeJeune contributed 20 patients to the survey—10 for each procedure. 

“As someone who does a lot of carotid surgery, both endarterectomy and TCAR are overall felt to be relatively safe. Patients tend to do well, and the majority go home the next day. But this study is very interesting because it gets the patients’ perspective on the little things that matter to them during their recovery. I was greatly surprised by the one-week post-procedure results regarding patients returning to driving their car.” 

The relevant data from the survey show that 71.4% of TCAR patients reported having driven their car at the one-week post-procedure mark versus just 25% of CEA patients responding that they had done so. 

Berman drills further into what the data mean for patients in their day-to-day lives in the days after treatment. 

“Globally, patients seemed to recover quickly,” he reflects. “if you look at the actual numbers: less pain, less trouble moving, able to drive. Return of normal voice, lack of numbness, no facial droop. With all of these things, they really reinforced what we had already observed.” 

Berman sees such patient-reported outcome measures as sitting at the vanguard of surgeons and interventionalists being better healthcare spending stewards. 

“We have to make sure that the treatment we provide is actually helping the patient, and making them feel better,” he says. 

“There are some things that are a little objective—if a patient has a giant aneurysm, we don’t operate on them to make them feel better; we operate on them to prevent death. Claudication is the classic example of when we try to improve a patient’s lifestyle, so we certainly should be able to measure whether or not lifestyle improved as a result of our treatment.” 

Carotid disease sits somewhere in between the aortic aneurysm and claudication analogy, Berman explains. “We certainly want to improve or reduce the risk of stroke, but that risk of stroke impacts how people conduct their life.” 

LeJeune, meanwhile, looks at patient satisfaction through the lens of appropriate patient selection. 

“Through my experience performing TCAR on my own patients, and also teaching the procedure to many colleagues, it’s clear to see how much faster, smoother and less invasive this procedure is, particularly for those who have the right anatomy,” she explains. 

“Patient selection is key to good outcomes, and I think that we are going to continue to see positive outcomes for these patients—both standard risk and high risk— as we move forward. As a surgeon my priority is a good clinical outcome, but if we’ve proven that that is equivalent, it then gets down to time, cost and patient satisfaction. In a world where patient satisfaction is very important for a lot of reimbursement type of issues, I think patient-reported outcomes are very important.” 

Berman points toward the future direction of the survey and how it had dovetailed with his experience investigating patient-reported outcomes in the claudication arena. 

“With claudication, there are a lot of validated surveys of patient-reported outcomes,” he observes. “There are none for carotid disease.” Berman says the challenge now is to take “a robust questionnaire” and put it through the rigors of statistical validation. 

“Vascular surgeons in general are very data driven, and quick to challenge data to make sure it’s been collected appropriately,” he adds. “That’s the next step but this is an important first step.” 

Which is only going to become more important in light of recent events regarding Centers for Medicare & Medicaid Services (CMS) moves to incorporate patient preference: “I think it’s important to have this kind of data from patients to make informed decisions,” says Berman. 

For LeJeune, bolstering patient enrollment is key to strengthening the survey data going forward. As the authors look at the survey as it currently stands, the results point to a truism, she adds. 

“Having this good subset of patient responses is supporting what we know already, but as clinicians sometimes understimate—the part of a patient’s healing where we assume they are doing well. We see them back a few weeks later and don’t appreciate these nuances. 

“This study has teased out some of that, showing how much faster TCAR patients feel better and recover in the short-term.” 

Cyclical-pressure Topical Wound Oxygen therapy emerges as a proven wound-healing device for diabetic foot ulcers, showing great promise in venous leg ulcers

By
BIBA Publishing
-
1
Cyclical-pressure Topical Wound Oxygen therapy emerges as a proven wound-healing device for diabetic foot ulcers, showing great promise in venous leg ulcers
Enrico Ascher and Natalie Marks

This advertorial is sponsored by AOTI.

Enrico Ascher, MD, and Natalie Marks, MD, currently combine for close to 60 years of vascular surgery practice experience in New York City’s 3 million-strong populous borough of Brooklyn. Between them they see a steady stream of patients with various types of acute and chronic wounds—arterial, venous and mixed etiology nonhealing ulcerations not being properly treated. 

Over the years, Ascher, a vascular surgeon with the Vascular Institute of New York, has established a wound care center, built expertise in the wound-healing space and developed hyperbaric oxygen therapy experience, seeking to fill a void in appropriate therapy for a sick population of patients with peripheral arterial disease (PAD). 

More recently, Ascher and Marks, a vascular medicine and board-certified wound specialist in the same practice, have developed a “small but impressive” experience with Topical Wound Oxygen (TWO2) therapy in treating not only diabetic foot ulcers (DFUs) but also venous leg ulcers (VLUs). Ascher says the home-based TWO2 therapy—which combines supplemental oxygen with non-contact cyclical compression and humidification through a single-use extremity chamber system—is emerging as an effective alternative with independently proven advantages involving cost, simplicity and patient comfort. 

He points to a recent systematic review of randomized controlled trials (RCTs) he says confirmed RCT evidence showing that topical oxygen therapy increased the likelihood of DFU healing compared to controls. 

“We have a small experience—but significant in our initial interpretation—of the outcome of this therapy,” Ascher explains. “We did 29 limbs with patients who absolutely would not heal with anything, and for months we followed these patients. When we tried this new methodology, most of them did well.” 

Introducing two cases in which TWO2 was used to treat two patients with VLUs, Ascher expresses hope similar evidence will emerge showing effectiveness in the healing of ulceration with a venous etiology. 

Case no. 1 

Ascher and Marks describe the case of an 82-year-old male patient who first presented to their practice in 2021 with recurrent lower-leg circumferential ulceration, seo-sanguinous discharge, severe itching, inflammation and venous stasis. 

“He had some venous procedures in the past—he had had his veins closed, a stent placed in the iliac vein, several sessions of foam sclerotherapy of varicose veins—to decrease swelling in his leg and to promote healing,” explains Marks. “He had been going to different specialists, but was getting worse. We also found that in addition to his venous insufficiency, he had vasculitis, and we tried topical and oral steroids. After starting TWO2 at home, in five months— there were a couple of hiccups in the middle to do with coverage issues—we were able to heal his wound completely, and it stayed healed.” 

Case no. 2 

Turning to a second case—that of an 84-year-old female who presented with a large lower leg ulcer of venous etiology in the setting of recurrent cellulitis—Ascher and Marks outline a lingering wound that had worsened over weeks. 

The patient, who was housebound, had comorbidities that included hypertension and hyperlipidemia, and had sought treatment through her primary care doctor. Her symptoms included progressive swelling, skin hyperkeratosis and peeling, itching, dermatitis changes and increased discharge. 

“After she came here, we were wrapping her with compression dressings,” says Marks. “Then, after gaining coverage approval for TWO2 within a week, in just four weeks of oxygen therapy at home, the wound healed and has not recurred since.” 

Home-based care 

Ascher highlights TWO2’s simplicity. “This is a methodology that is much simpler, less complicated, less burdensome to the patient and actually very comfortable,” he says. “The patient is sitting in their home watching TV, listening to some music or reading a book, and they put a boot on over existing compression dressings.” 

Among its advantages, he lists how it helps reduce edema with the non-contact cyclical compression, addresses infection resistance, and aids the production of good collagen in the wounds, resulting in wound coverage with healthy tissue. “There is evidence it also can increase angiogenesis,” Ascher adds. The topical mode of oxygenation to the tissue is delivered with a partial pressure of approximately 800mmHg. 

Contrasting TWO2 with hyperbaric oxygen therapy, Ascher reflects that some had trouble tolerating the hyperbaric machine. “But most of the complaints were that they had to spend two hours inside the chamber, and some were claustrophobic. So TWO2 has been shown, so far mostly by our podiatry colleagues, in the literature that it is an alternative for these patients, and maybe for more patients if they want to have this kind of comfort with equally or almost equally good results.” 

Marks notes how patients interact with the device, an extremity chamber, or boot, which extends up to and above the knee. “We have seen meaningful results in terms of patient comfort and willingness to stick with the treatment,” she says. “They see the results with each treatment as the wound gets a little bit better looking—less pain, less swelling, less discharge. So they persist because they see constant and gradual improvement.” 

Combined with the evidence provided in the meta-analysis, Ascher says the “small but impressive experience” from his own practice encourages him to push on with TWO2 as a component feature of his wound-healing armamentarium. “I think we will try to treat these ulcers by fixing the cause of the ulceration: If it is an infection, we have to clean the wound—maybe administer antibiotics. If it is of arterial origin, we have to improve the circulation. If venous, we have to fix the vein issue as best we can. Then we give a chance for the ulcer to heal. If it does not heal, then I think that is the time to provide the option of having topical oxygen therapy.” 

Marks also highlights a cost-savings dimension. “TWO2 provides not only patient comfort, healing of the wound and decreased chances of complications, I think financially it makes a lot of sense,” she says. “Give a little bit of extra resource up front for this topical oxygen therapy but provide faster healing, instead of having all of these wasted resources.” Ascher points to what chronic wounds cost the U.S. in dollar terms: “Anywhere from $50 to $60 billion,” he concludes. “It’s a big problem and has been forgotten for years. Only now, fortunately, people are much more tuned into it.” 

Carotid disease: Getting to the right decision

By
Bryan Kay
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0
Carotid disease: Getting to the right decision
Brianna Krafcik at NESVS 2023
The recent move by the Centers for Medicare & Medicaid Services (CMS) to expand coverage for carotid artery stenting brought with it the requirement for a shared decision-making interaction between physicians and patients as they establish which carotid revascularization treatment modality is best for their disease. Currently, a validated tool does not exist—but investigators at Dartmouth Hitchcock Medical Center are working on research aimed at changing that. 

Now that the decision has been made to expand Medicare coverage for carotid artery stenting to include patients who have symptomatic carotid stenosis ≥50% and asymptomatic ≥70%, the stage has been set. 

Yet, as Brianna M. Krafcik, MD, a vascular surgery resident at Dartmouth Health in Lebanon, New Hampshire, reflects, just over a year ago, long before the controversial move went under the spotlight, she and colleagues failed to garner much attention when they submitted a review paper that looked at the decision aids available to carotid stenosis patients considering intervention versus medical therapy. 

Now there is a need. A shared decision-making interaction has been mandated in CMS’ final decision memo. Amid the vacuum, the work of Krafcik and colleagues is suddenly taking center stage. This includes a paper recently presented at the 2023 New England Society for Vascular Surgery (NESVS) annual meeting in Boston (Oct. 6–8) that lays down some foundational pieces in the process toward creating such a tool—one that can be used across the multiple specialties treating carotid stenosis patients, and incorporate all options, including transcarotid artery revascularization (TCAR), approved in 2015 and not part of prior decision aids. 

“When we did the review paper—which is currently submitted for publication—more than a year ago, we only found four studies that looked at decision aid instruments with any kind of scientific method,” Krafcik explains in an interview. “I think that review paper shows that even those four instruments that have been studied, anecdotally and in the literature, it has been shown that they are pretty underutilized both by vascular surgeons and also interventional radiologists—for interventionalists who are working in carotid disease there is almost nothing. Medicare is asking for a decision aid that doesn’t exist, so the stage is set to create such an instrument.” 

The latest research from the Dartmouth group, led by Krafcik and senior author Jesse A. Columbo, MD, an assistant professor of surgery at Dartmouth, looks to plug a gap in qualitative data regarding patient understanding of carotid disease. 

They found that there is a “complicated interplay between patient values, understanding of the procedures, and preferred level of involvement in medical decision-making” that contributes to a patient’s ultimate decision. They carried out longitudinal perioperative semi-structured interviews with 20 carotid stenosis patients eligible for both carotid endarterectomy and transcarotid artery revascularization (TCAR)—10 for each procedure. 

“In the patient surveys, the most important source of information regarding the procedures was the vascular surgeon followed by any written materials they may have received, while TV or videos were generally less important,” Krafcik told NESVS 2023. “When patients were asked about their feelings towards shared decision-making, most would like to discuss all treatment options with the physician and make a decision together. However, only approximately 70% of patients agreed that they understood their carotid disease and the treatment options available. Patients reporting on factors important to them when considering procedures in general felt the surgeon’s experience with the procedure and the presence of long-term outcomes data were very important, while the length of the operation and size of the incision were less important.” 

Concluding, Krafcik and colleagues said in the present era of multiple treatment options, “patients should be presented with all available information when discussing carotid revascularization. A shared decision-making discussion consistent with the patients’ values and level of desired involvement improves patient satisfaction and compliance.” 

Krafcik tells Vascular Specialist the Dartmouth team are currently working with social scientists, the Vascular Quality Initiative (VQI) and other organizations in order to try to create a pilot instrument that can be studied “in an iterative way.” “From there, once we have a prototype, then we can study it for usability, accessibility and feasibility so it can then be scaled up to a multicenter study that takes into account different regions, education level and sociodemographic factors. That’s the long-term plan,” she added. 

Importantly, Krafcik explains, the goal is to create a decision feed that will have “buy-in” across the different specialties treating carotid stenosis. “If a patient were to see a cardiologist and be given this decision aid, and based on the information says, ‘I actually would prefer an open carotid endarterectomy,’ that the cardiologist would be OK saying, ‘Then, I’ll refer you to a vascular surgery colleague.’ I think now that more providers are going to be doing these procedures, our decision aid should encompass and have buy-in from all of the different specialties.” 

Krafcik says two things in particular from the study struck her— the impact that the surgeon has on patients and that not every patient wants to participate in shared decision-making or wants to participate in the same way. “A lot of the patients would, when I asked them to explain the procedure in their own words, reiterate what their surgeon told them,” she relates. “When asked why they decided, they said it seemed like their surgeon felt that this one was better than the other.” Preoperative conversations are time-limited, Krafcik adds, “so understanding first how involved the patient wants to be, how much info they want, and how they prefer to receive it is helpful in guiding the discussion, because there is not really a one-size fits-all preoperative discussion.” 

DETOUR1 and DETOUR2 pooled analysis of bypass system reveals primary rate of 68.1% through 24 months

By
Bryan Kay
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0
DETOUR1 and DETOUR2 pooled analysis of bypass system reveals primary rate of 68.1% through 24 months
Sean Lyden

Endologix has announced results from a pooled analysis of the DETOUR1 and DETOUR2 studies evaluating percutaneous transmural arterial bypass (PTAB) with the Detour system.

The Detour system offers a novel approach to treating complex peripheral arterial disease (PAD), enabling physicians to bypass lesions in the superficial femoral artery (SFA), by using conduits routed through the femoral vein via a transmural passage, to restore blood flow to the leg. This approach is effective for patients with long lesions (20–46cm in length).

Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multicenter, international studies. Inclusion criteria and prespecified endpoints were similar. Both studies utilized imaging core lab and independent adverse event adjudication. Endpoints included freedom from major adverse events (MAEs) through 30 days, symptomatic deep vein thrombosis (DVT), and length of stay. For the pooled analysis, primary patency was defined as freedom from target vessel revascularization (TVR).

The results from the 275 pooled patients were presented at VIVA 2023 (Oct. 30–Nov. 2) in Las Vegas by one of the study’s principal investigators, Sean Lyden, MD, chair of vascular surgery at the Cleveland Clinic in Cleveland, Ohio.

The presented results included the following:

  • Primary patency, defined as freedom from TVR, was 79.1% at one year and 68.1% through two years
  • Freedom from MAEs through 30 days was 97.8%
  • Clinical success rate was 92.9%, 96%, and 95.3% at 30 days, one year and two years, respectively
  • Symptomatic DVT was 3.3% and pulmonary embolism (PE) rate was 0%, respectively through the two-year time point
  • Average length of hospital stay was 1.3 days.
  • Ninety-four percent of the patients had chronic total occlusions of the SFA, with a mean lesion length of 31.6cm

“These results not only demonstrate the clinical utility of this therapeutic strategy in managing long complex femoropopliteal lesions but also highlight that PTAB with the Detour system achieves similar results to open surgical prosthetic femoropopliteal bypass without the need for general anesthesia, long length of stay, and high rate of complications. We eagerly await more comprehensive data from broader real-world settings to further corroborate these findings,” stated Lyden.

Use of IVUS reduces patient risk of MALE or death by up to 28%: Data support consensus views on importance of advanced visualization for peripheral vascular disease interventions

By
Steven D. Abramowitz
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0
Use of IVUS reduces patient risk of MALE or death by up to 28%: Data support consensus views on importance of advanced visualization for peripheral vascular disease interventions

This advertorial is sponsored by Philips.

The benefits of utilizing intravascular ultrasound (IVUS) in peripheral vascular interventions has been widely demonstrated in the literature. In nearly every vascular bed studied, we have seen an improvement in overall outcomes. Over the last several years, clinical data in support of IVUS has exploded, including the first-ever randomized controlled trial (RCT) of the modality that demonstrated its use has changed treatment plans in 79% of arterial cases.1

In addition, an analysis of over 500,000 patients demonstrated that IVUS improved outcomes with a 27% reduction in major adverse limb events (MALEs).2 The use of IVUS in the venous vasculature has also demonstrated clinically significant improvements in outcomes. A real-world analysis of IVUS use in the treatment of venous disease demonstrated a 28% risk reduction for repeat intervention, hospitalization or death.3

These data build on the VIDIO (Venogram vs. IVUS for diagnosing iliac vein obstruction) study findings, which like the arterial RCT, demonstrated IVUS changed treatment plans in nearly 60% of venous cases,4 identifying patients with severely symptomatic central pelvic vein occlusive disease that would have been missed with other routine imaging. With these compelling data in mind, a group of 40 cross-specialty physicians published a consensus paper regarding the use of IVUS in peripheral interventions, where they agreed that the use of IVUS was strongly recommended in all interventional phases of both arterial and venous procedures.5 

With advanced visualization tools like IVUS, we can get a 360-degree view inside the vessel, allowing us to accurately assess the severity of disease and create a specialized approach to treatment. 

Case review: Arterial example 

Here, we present a case of a patient with severe ischemic rest pain and an ankle-brachial index (ABI) of 0. The patient was a prior smoker who had multiple prior interventions for critical limb ischemia (CLI) and tissue loss. In 2021, the patient had a second femoral-to-tibial artery bypass and was lost to follow-up. 

On angiogram, there was redemonstration of superficial femoral artery and popliteal artery stent occlusion, and chronic occlusion of both the anterior tibial and posterior tibial target bypasses. There was no arterial reconstitution of viable open or endovascular target vessels in the foot. 

Deep venous arterialization (DVA) was performed using the Pioneer Plus catheter for IVUS-guided arterial re-entry (see Figure 1). Visualization of the popliteal artery re-entry target by IVUS allowed for rapid crossing from the posterior tibial venous access site (see Figure 2). 

The use of covered self-expanding stents and percutaneous balloon angio-and venoplasty formalized the iatrogenic arteriovenous fistula. Post-intervention IVUS using the Reconnaissance .018 OTW IVUS catheter verified appropriate luminal gain and aided identification of incomplete venous valvular disruption in the foot (see Figure 3). Target areas of venous outflow were addressed with repeated venoplasty. At one-month follow-up, the patient reported marked symptomatic improvement, and non-invasive duplex imaging showed DVA patency. 

Venous example 

Here, we present a case of a 65-year-old Caucasian female with a three-year history of left leg swelling, heaviness and achiness, which improved with elevation. 

She had no history of prior deep vein thrombosis (DVT), venous interventions, peripheral artery occlusive disease, leg trauma, congestive heart failure or chronic kidney injury. The symptoms improved overnight while in bed, and returned the next day. She woke up in the morning free of these symptoms, but, by evening, she was quite uncomfortable. On physical exam, she had erythema in the gaiter distribution of the lower- and mid-calf circumferentially, with skin induration and edema of the calf. She had no open wounds. She had no visible varicose veins. 

On left lower-extremity venous duplex ultrasound exam, the patient had no significant infrainguinal superficial vein disease. There was significant multi-segmental deep vein reflux, with a reflux time of >1 second. There was no acute DVT, nor any evidence of deep vein scar to indicate a prior DVT. 

Evaluation of the central veins in the pelvis with venogram revealed no focal iliac vein stenosis or filling defect, and there were no cross-pelvic or lumbar collaterals noted. IVUS with the Visions .035 system was performed, identifying a severe cranial external iliac vein (EIV) stenosis (73%), compared to the normal suprainguinal caudal EIV, due to a non-thrombotic iliac vein lesion (NIVL). Normal suprainguinal caudal EIV and severe cranial external iliac vein stenosis (see Figures 4 and 5). 

Post-angioplasty and stent, there was no residual stenosis (Figure 6). On follow-up exam one week later, the stent was widely patent on duplex ultrasound, and the patient remarked, “I can see my ankle again!” 

The heaviness, achiness and erythema resolved during the following weeks. Through five years of follow-up, she had no recurrence of her symptoms or physical findings of chronic venous hypertension and insufficiency. 

References 

  1. Allan R, Puckridge P, Spark J, et al. The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions. J Am Coll Cardiol Intv. 2022 Mar, 15 (5) 536–546. https://doi.org/10.1016/j.jcin.2022.01.001 
  2. Divakaran S, Parikh SA, Hawkins BM, et al. Temporal Trends, Practice Variation, and Associated Outcomes With IVUS Use During Peripheral Arterial Intervention. JACC Cardiovasc Interv. 2022;15(20):2080- 2090. doi:10.1016/j.jcin.2022.07.050 
  3. Divakaran S, Meissner MH, Kohi MP, et al. Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries. J Vasc Interv Radiol. 2022;33(12):1476-1484.e2. doi:10.1016/j.jvir.2022.08.018 
  4. Gagne PJ, Tahara RW, Fastabend CP, et al. Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstruction. J Vasc Surg Venous Lymphat Disord. 2017;5(5):678-687. doi:10.1016/j.jvsv.2017.04.007 
  5. Secemsky EA, Mosarla RC, Rosenfield K, et al. Appropriate Use of Intravascular Ultrasound During Arterial and Venous Lower Extremity Interventions. JACC Cardiovasc Interv. 2022;15(15):1558-1568. doi:10.1016/j.jcin.2022.04.034 

Steven D. Abramowitz, MD, is a vascular surgeon in Washington, D.C. Abramowitz has been compensated for his services for Philips’ further use and distribution. Paul J. Gagne, MD, is a vascular surgeon with the Vascular Care Group in Darien, Connecticut. Gagne has been compensated for his services for Philips’ further use and distribution. 

PROMISE II 12-month data show durable outcomes with the LimFlow system in no-option CLTI patients

By
Jocelyn Hudson
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0
PROMISE II 12-month data show durable outcomes with the LimFlow system in no-option CLTI patients

One-year results from the PROMISE II US pivotal trial demonstrate the durability of outcomes of transcatheter arterialisation of the deep veins (TADV) using the LimFlow system (LimFlow) and that the procedure is safe and reproducible.

Daniel Clair (Vanderbilt University Medical Center, Nashville, USA) recently presented the new data for the first time at VIVA 2023 (30 October–2 November, Las Vegas, USA). He reported a limb-salvage rate of 69% at 12 months, among other key results, in patients who have chronic limb-threatening ischaemia (CLTI) with no suitable endovascular or surgical revascularisation options. 

Clair, who served as co-principal investigator of the trial alongside Mehdi Shishehbor (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA), noted that the new data are an extension of the six-month PROMISE II results that were presented at VIVA 2022. Following publication of these results in the New England Journal of Medicine (NEJM), the US Food Administration (FDA) approved the LimFlow system in September of this year.

At 20 centres without roll-ins across the USA, 105 no-option CLTI patients were enrolled in a non-randomised manner. All enrolled patients had Rutherford class 5 or 6 disease and were deemed by an independent committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow.

The median age of the patient cohort was 70 years, two-thirds were male, and one-quarter were Hispanic or Latino. Most patients presented with pre-existing comorbidities, including diabetes, hypertension, dyslipidaemia, and a history of intervention on the index limb. All patients presented with a non-healing ulcer or frank gangrene and were classified as either Rutherford class 5 or 6.

Clair revealed at VIVA that, at one year, limb salvage was maintained in 69% of patients. “You can see—and this has been noted before—a drop-off through the first three months, but those who were able to keep their limbs to that point usually did significantly well over time,” he commented.

In addition, the presenter shared that the average wound area was 0.2cm2 at 12 months. “You are talking about minimal wounds that these patients had when they did have remaining wounds,” he said. Clair also noted an average pain score (scale 0–10) of 1.4 at 12 months, representing a “significant reduction” from an average of 5.3 at enrolment. More than half of patients were classified as Rutherford class 0 at one year.

In addition, Clair reported pooled results from PROMISE I and PROMISE II. “The PROMISE I trial did not include dialysis patients and did not include COVID deaths, but other than that these two trials were very similar,” he remarked. In the pooled analysis, the presenter noted an overall survival rate of 85%, a limb-salvage rate of close to 75%, and a 63% rate of amputation for this population.

“In conclusion, the [US] FDA has approved this product with the six-month data that have been published in the [NEJM], and these 12-month data extend upon that and show that this is a durable, sustainable outcome,” Clair summarised. He added that the outcomes are consistent even with new users. “The procedure is reproducible and generalisable—most operators in PROMISE II had essentially no experience with this technique—and I continue to believe that as we gain experience with this, over time we will learn more and do better as we move forward.”

“I am very proud to be able to present this information and happy with where we are headed with this complex group of patients,” he said in closing.

The top 10 most popular Vascular Specialist stories of October 2023

By
Éva Malpass
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0
The top 10 most popular Vascular Specialist stories of October 2023

Last month, the most popular stories from Vascular Specialist included The Centers for Medicare & Medicaid Services (CMS) confirmation of carotid artery stenting coverage expansion; data on a “next generation” inferior vena cava (IVC) filter retrieval device presented at the annual meeting of the New England Society for Vascular Surgery (NESVS); and recent study data supporting the findings of the BEST-CLI trial results. 

1. From the editor: Sex, lies, and carotid stents

Malachi Sheahan III tackles the nascent debate over carotid stenting (CAS) vs. endarterectomy (CEA) amid a CMS decision over proposed expanded coverage for CAS.

2. CMS confirms broadened Medicare coverage of carotid artery stenting in final decision

The Centers for Medicare & Medicaid Services (CMS) has released its final decision regarding National Coverage Determination (NCD) 20.7 covering carotid artery stenting (CAS), essentially confirming the coverage expansion outlined in a July proposed decision memo.

3. Obituary: Roger M. Greenhalgh (Feb. 6, 1941–Oct. 6, 2023)

Roger Malcolm Greenhalgh, MD, the surgeon internationally renowned for his unparalleled contribution to vascular education, training and research, died peacefully on Oct. 6. He was 82. At the time of his death, he was emeritus professor of surgery at Imperial College in London and head of its Vascular Surgery Research Group.

4. NESVS 2023: Novel IVC filter retrieval device slashes procedural time and radiation exposure during in vivo experiments, Yale researchers report

An inferior vena cava (IVC) filter retrieval device dubbed the next-generation in removal of the venous thromboembolism-fighting tools could substantially cut procedural times and radiation exposure, according to data emerging out of in vivo testing at Yale University.

5. Vascular branding: Determining a vascular surgeon’s value

A vascular surgeon’s value includes far more than direct revenues from procedures performed, said SVS member Robert Tahara, MD, recently. He told surgeons to remember not only these direct revenues, but also the help a surgeon provides other specialties in the hospital, as well as legal savings from “near misses—rarely considered and certainly rarely acknowledged.”

6. CLTI: European cohort study provides ‘strong positive evidence’ for surgery over endovascular approach, supporting BEST-CLI results

A recently published study has shown that lower limb bypass surgery offered a significantly higher probability of amputation-free survival and wound healing compared with endovascular treatment in patients with chronic limb-threatening ischemia (CLTI). This and other key findings from the study are reported in the European Journal of Vascular and Endovascular Surgery (EJVES).

7. Enrollment of first patient in Neuroguard carotid stent system trial announced

Contego Medical has announced enrollment of the first patient in the prospective, multicenter PERFORMANCE III trial aimed at further evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) direct system—a carotid stent system designed for direct transcarotid access.

8. George Lavenson, Vietnam and Gulf War veteran, advocate for carotid disease screening in seniors, dies

George S. Lavenson Jr., lovingly referred to as “Doc” by his many friends, died Saturday, Aug. 19, 2023, on the beautiful island of Maui, Hawaii, where he chose to share a life in majestic Lahaina with his loving wife, Judy. He was 91. George leaves behind four children, Mark, Jim, Patricia and Dean, and three grandchildren, Kelsey, Luke, and Oliver.

9. Survey suggests venous work less valued than arterial interventions

The majority of more than 300 vascular surgeons who responded to a recent survey indicated that they perceive the management of venous disease to be of less value than that of arterial disease. Investigators Misaki M. Kiguchi, MD, of MedStar Washington Hospital Center in Washington, D.C., and colleagues share this and other key findings in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

10. SVS varicose vein guideline webinar set for Oct. 10

A virtual roundtable on Oct. 10 will cover the new Society for Vascular Surgery (SVS) varicose veins guidelines. Set for 6–7:30 p.m. CDT, the session will address the latest in the diagnostic evaluation of patients with the venous condition using duplex scanning.

Researchers report 30-day outcome data for pair of investigational carotid stenting systems

By
Bryan Kay
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0
Researchers report 30-day outcome data for pair of investigational carotid stenting systems
William Gray delivers Neuroguard data at VIVA 2023

Thirty-day results from two trials assessing the performance of investigational carotid artery stenting systems—the Neuroguard and the CGuard—were recently presented at VIVA 2023.

Stenting with the CGuard embolic protection carotid stent system (InspireMD) in patients with carotid artery stenosis and at high risk for carotid endarterectomy (CEA) had a death (all-cause mortality), any stroke or myocardial infarction rate of 0.95% from procedure through 30 days of follow-up, reported D. Christopher Metzger, MD, an interventional cardiologist at OhioHealth in Columbus, Ohio, at the Las Vegas meeting (Oct. 30–Nov. 2).

The C-GUARDIANS U.S. investigational device exemption (IDE) pivotal trial looked at 316 patients from July 2021–June 2023 who were prospectively enrolled in the single-arm study performed at 24 sites in the U.S. and Europe. The primary endpoint was a composite of either incidence of major adverse events including death (all-cause mortality), any stroke or myocardial infarction through 30 days post-index procedure; or ipsilateral stroke from day 31 to day 365 post-procedure.

InspireMD anticipates reporting primary endpoint results from C-GUARDIANS—which the company stated may support a premarket approval (PMA) application to the Food and Drug Administration (FDA)—in the second half of 2024.

In the PERFORMANCE II prospective, multicenter study evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) system, the reported 30-day stroke rate was 1.31% in the intention-to-treat analysis and 0.98% in a per-protocol analysis, with no major strokes or contralateral strokes, and all patients returning to baseline neurologically within 30 days, William Gray, MD, the system chief of cardiovascular disease at Main Line Health in Philadelphia, told VIVA 2023.

The Neuroguard (Contego Medical) PERFORMANCE II single-arm study is assessing the device among 305 patients at 40 clinical sites in the U.S. and Europe. At one-year follow-up (all stroke within 30 days, and ipsilateral stroke between day 31 and 12 months), the reported stroke rate was 1.68% in the intention-to-treat analysis and 1.35% in a per-protocol analysis, Gray added. No major strokes or neurological deaths occurred in the study.

In addition to the PERFORMANCE II study—in which the Neuroguard was placed via transfemoral or transradial access—the PERFORMANCE III study is currently enrolling patients to evaluate the same stent placed via direct transcarotid access, Contego Medical reported.

LimFlow announces agreement to be acquired by Inari Medical

By
Jocelyn Hudson
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0
LimFlow announces agreement to be acquired by Inari Medical
Vein becoming artery with LimFlow crossing stent
agreement
Vein becoming artery with LimFlow crossing stent

LimFlow announced today that it has entered into a definitive agreement to be acquired by Inari Medical.

A press release details that, under the terms of the agreement, LimFlow will receive US$250 million in cash at closing and be eligible to receive up to US$165 million in additional payments based on certain commercial and reimbursement milestones, for a total potential transaction value of up to US$415 million. The transaction is expected to close in the fourth quarter of 2023.

LimFlow’s acquisition by Inari Medical is expected to increase patient access to its LimFlow system for transcatheter arterialisation of the deep veins (TADV), which is designed to re-establish blood flow in deep veins for “no-option” chronic limb-threatening ischaemia (CLTI) patients who have no other suitable endovascular or surgical treatment options and are facing major amputation.

US Food and Drug Administration (FDA) approval for the LimFlow system was received in September 2023 based on successful outcomes seen in the PROMISE II pivotal trial, recently published in the New England Journal of Medicine, and from positive clinical results seen in earlier studies. In the PROMISE II study, 76% of no-option CLTI patients were able to keep their leg and experienced progressive wound healing, with many having significant pain relief during the time following LimFlow treatment. LimFlow details that its system is the first and only FDA-approved device for TADV and previously received Breakthrough Device designation from the FDA.

“We are thrilled to join forces with Inari Medical, expanding the reach of our remarkable technology to bring renewed hope to patients who are currently suffering,” said LimFlow CEO Dan Rose. “Our heartfelt gratitude goes out to the exceptional LimFlow team, our dedicated clinical partners, and our investors who believed in our mission. Together, we eagerly anticipate advancing our shared vision of addressing crucial unmet needs in the realm of vascular disease.”

LimFlow investors include Sofinnova Partners (through its Crossover Strategy), Bpifrance, Balestier (an affiliate of M&L Healthcare Investments), Longitude Capital, Soleus Capital and Inari Medical. LimFlow was incubated by MD Start and co-founded by Martin Rothman and Tim Lenihan.

“The acquisition of LimFlow is closely aligned with our mission to address significant unmet patient needs and adds another highly differentiated growth platform into our portfolio,” said Drew Hykes, CEO of Inari. “We see the CLTI market as poised for durable growth, driven by compelling technology, outstanding clinical results, and multiple opportunities for expansion As a minority investor and board observer in LimFlow since early 2022, we have seen firsthand the life-changing impact this technology has on patients, as well as how complementary our two businesses are.”

Computer-assisted vacuum thrombectomy system for patients with pulmonary embolism demonstrates ‘rapid, statistically significant’ improvement in RV/LV ratio

By
Bryan Kay
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0
Computer-assisted vacuum thrombectomy system for patients with pulmonary embolism demonstrates ‘rapid, statistically significant’ improvement in RV/LV ratio
Ido Weinberg

Patients undergoing computer-assisted vacuum thrombectomy with the Indigo Aspiration System (Penumbra) for pulmonary embolism (PE) showed 2.7% rates of both major adverse events (MAEs) and major bleeding at 48 hours post-procedure alongside “a significant reduction” in right ventricle/left ventricle (RV/LV) ratio of 25.7%, according to an interim analysis of the STRIKE-PE study.

“The STRIKE-PE dataset is very encouraging as it confirms the promise of computer-assisted vacuum thrombectomy to restore blood flow quickly, safely and effectively while also showing promising, prompt and lasting improvement in patient outcomes,” said Ido Weinberg, MD, a vascular medicine specialist at Massachusetts General Hospital in Worcester, Massachusetts, who presented the data during a late-breaking science session at the Vascular Interventional Advances (VIVA) 2023 annual meeting (Oct. 30–Nov. 2) held in Las Vegas.

The interim analysis—comprising 150 patients of a real-world, multicenter study at up to 55 global centers aimed at eva

luating 600 subjects with acute PE symptoms of ≤14 days and a RV/LV ratio ≥0.9—demonstrated that mean RV/LV ratio significantly decreased from 1.39 at baseline to 1.01 at 48 hours post-thrombectomy. Four patients experienced MAEs within 48 hours. From baseline to 48 hours, the median clinical measures of heart rate and respiratory rate significantly decreased, Weinberg informed VIVA 2023.

In terms of secondary outcomes out to 90 days, Weinberg said the dyspnea scale significantly improved from presentation to discharge and from presentation to the three-month follow-up marker. Additionally, the six-minute walk test distance significantly improved from discharge to 90-day follow-up.

“STRIKE-PE interim results demonstrated a rapid, statistically significant improvement in RV/LV ratio and clinical measures while maintaining safety,” Weinberg concluded. “At 90-day follow-up, treatment with computer-assisted vacuum thrombectomy with the Indigo Aspiration System improved patients’ functional capacity.”

STRIKE-PE will follow patient outcomes out to one year.

SVS launches expansion of coding resources

By
Beth Bales
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SVS launches expansion of coding resources

The SVS has announced an expansion of its coding-related information and help in response to increasing member demand. The new resources will assist vascular surgeons in navigating medical coding and billing complexities, in line with the Society’s ongoing commitment to provide valuable tools and knowledge in vascular surgery.

On the SVS website, members can review a list of frequently asked questions and answers explicitly tailored to vascular surgery coding. The FAQs will evolve over the next year, with monthly updates.

The SVS and long-term partner Karen Zupko and Associates Inc. (KZA), a consulting and education firm, will launch a series of quarterly on-demand educational courses that will examine the intricacies of coding for vascular surgery. 

The SVS will release the first of these courses later this month. The new courses are an addition to the annual SVS in-person Coding and Reimbursement Workshop held each fall.

The SVS Coding Committee can assist members who encounter specific coding inquiries or issues that require individualized support. Members can review the resources and submit questions at vascular.org/CodingInquiries.

The course, he said, was designed by vascular surgeons for vascular surgeons. 

CLTI: European cohort study provides ‘strong positive evidence’ for surgery over endovascular approach, supporting BEST-CLI results

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Jocelyn Hudson
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CLTI: European cohort study provides ‘strong positive evidence’ for surgery over endovascular approach, supporting BEST-CLI results

A recently published study has shown that lower limb bypass surgery offered a significantly higher probability of amputation-free survival and wound healing compared with endovascular treatment in patients with chronic limb-threatening ischemia (CLTI). This and other key findings from the study are reported in the European Journal of Vascular and Endovascular Surgery (EJVES).

The research group, led by Jean-Baptiste Ricco, MD, PhD, professor of vascular surgery at CHU de Poitiers in Poitiers, France, aimed to compare the long-term efficacy of lower limb bypass with that of endovascular treatment in patients with CLTI.

Ricco and colleagues conducted a retrospective, multicenter study with propensity analysis to evaluate the outcomes of patients with CLTI who underwent first-time infrainguinal bypass or endovascular treatment. In the methods section of their paper, the authors elaborate that the retrospective cohort study design was employed using hospital charts of patients treated between January 2015 and December 2021 in four European vascular centers—three in France (the University of Poitiers, the University of Clermont-Ferrand and the University of Toulouse) and one in Italy (the University of Rome, Sapienza). 

They detail that the primary outcome was to compare amputation-free survival rates between the two propensity score matched groups. The secondary outcome was to compare wound healing within the first six months. Major adverse events were compared according to the type of revascularization, Ricco et al note.

The authors share that, overall, 793 patients fulfilled the eligibility criteria, from whom 236 propensity score matched pairs were analyzed. They specify that the 236 bypass procedures included 190 autogenous bypass grafts (80.5%), 151 (64%) of which were infrapopliteal. The mean follow-up was 52 months.

Ricco and colleagues add that, among the 236 endovascular treatment procedures, the target lesion was the femoropopliteal segment in 81 patients (34.3%), the femoropopliteal and infrapopliteal segments in 101 patients (42.8%), and the infrapopliteal segment in 54 patients (22.9%). 

The investigators report in EJVES that amputation-free survival was significantly better in the bypass group at five years (60.5±3.6%) compared with the endovascular treatment group (35.3±3.6%), citing a p value of 0.001.

Furthermore, they reveal that major amputation occurred in 61 patients (25.8%) in the bypass group and 85 (36%) in the endovascular treatment group (hazard ratio 0.66, 95% confidence interval 0.47–0.92; p=0.14). 

In other results, Ricco et al share that the probability of healing was significantly better in the bypass group at six months compared with the endovascular treatment group (p=0.003) and that the median length of stay was shorter for the endovascular treatment group (four days) than for the bypass group (eight days) with a p value of 0.001. Finally, they detail that urgent reintervention and readmission rates were high and did not differ significantly between the groups.

In the discussion section of their paper, Ricco and colleagues acknowledge some study limitations. They write, for example, that this was a retrospective study and, “despite propensity score matching, the possibility of unmeasured confounders cannot be excluded”. They also recognize that disparities in state funding of French and Italian university hospitals did not allow conduct of a cost analysis of the endovascular therapy and bypass groups.

Also in their discussion, Ricco and colleagues touch upon the significance of the outcome measures used in the study. Amputation-free survival and ischemic wound healing rates are two outcomes of “primary importance” for CLTI patients, they state. “Most previous studies have focused on survival, limb salvage, or amputation-free survival, but these outcomes cannot determine whether, and after how many weeks, wound healing is achieved in patients with CLTI. In this study, amputation-free survival and wound healing together made it possible to assess the effectiveness of revascularization,” the authors elaborate.

The investigators also consider the context of the recently published BEST-CLI trial, which they note provides “substantial clarity” about the midterm outcome—2.7 years median follow-up—showing a lower incidence of a major adverse limb event or death in bypass patients compared with the endovascular treatment group. The authors write, “The present research supports these results with 80.5% of autogenous bypasses made possible by systematic pre-operative DUS assessment of saphenous veins and arm veins, together with the deliberate choice of a bypass inflow located downstream from the common femoral artery in 62.3% of patients with a combination of SFA angioplasty above a distal origin graft allowed the patient to be offered autogenous grafting to a distal target.”

They highlight several similarities and differences between the BEST-CLI and the present study. For example, they note that both included the use of up-to-date endovascular techniques such as drug-coated balloons or drug-eluting stents, citing figures of 62% and 60.6%, respectively. On the other hand, they note that mean follow-up was a point of difference between the two studies, with follow-up being 52 months for the present study compared to 32 months for BEST-CLI.

In their conclusion, Ricco et al stress that their results provide “strong positive evidence” that patients receiving bypass surgery for CLTI have a “significantly higher probability” of amputation-free survival and wound healing compared with patients treated with an endovascular procedure. They reiterate that the rate of urgent reintervention and readmission remains high for individuals receiving either procedure. 

For Diabetes Month, diabetes resources for SVS members, patients

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Beth Bales
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For Diabetes Month, diabetes resources for SVS members, patients

November is National Diabetes Month. Because SVS members treat patients with the condition—and its complications—the Society has numerous educational resources available. 

“Diabetes and Vascular Disease” is one of nearly 10 patient education fliers produced by the SVS Foundation as part its awareness and prevention mission. Available at vascular.org/PatientFliers, it outlines what the disease is, its effects, where it can lead in terms of additional health problems, treatment, preventive care and more. 

Other patient education fliers may also be of interest to diabetes patients, such as those on carotid artery disease, cholesterol and physical activity, vascular health and smoking, all of which come into play for people with diabetes. 

Each flier is English and Spanish and includes a link to the SVS “Find a Specialist” web page. A second set of fliers that can be customized with a member’s contact information and then printed, is available at vascular.org/BrandingToolkit.

Visit vascular.org/Diabetes for an overall look at diabetes and vascular disease. This page provides numerous resources for patients and families on how diabetes affects vascular health, including on keeping feet healthy, FAQs about diabetes, the benefits of walking and information from other medical societies, including the American Podiatric Medical Association. It also provides links to diabetes-related illnesses and related resources for physicians. 

Akura thrombectomy system for PE appears safe and demonstrates reduction of RV/LV ratio in first-in-human study

By
Jocelyn Hudson
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Akura thrombectomy system for PE appears safe and demonstrates reduction of RV/LV ratio in first-in-human study
Jay Mathews
Akura
Jay Mathews

Results from a first-in-human, prospective, single-arm study of the Akura Medical thrombectomy system (Akura Medical) for pulmonary embolism (PE) were revealed this week at The VEINS 2023 (28–30 October, Las Vegas, USA).

Presenter Jay Mathews (Manatee Memorial Hospital, Bradenton, USA) detailed that the study enrolled five patients at two sites in Tbilisi, Georgia, in March and April 2023 to evaluate the safety and performance of percutaneous mechanical thrombectomy using the Akura Medical thrombectomy system. The Akura system is a low-profile system that combines targeted clot removal with a platform capable of providing objective data on haemodynamics to help clinicians understand the relationship between thrombus removal and alleviation of pulmonary artery pressures.

The key inclusion criteria included medically eligible patients aged >18 years with clinical symptoms consistent with acute PE or sPESI (simplified PE Severity Index) ≥1, with symptom onset ≤14 days, proximal PE confirmed by computed tomography angiography (CTA), a stable heart rate <130 bpm prior to procedure, and systolic blood pressure ≥90 mmHg, with a right ventricular/left ventricular (RV/LV) ratio >0.9. Five patients were enrolled, treated, and followed through seven-day follow-up.

The patients successfully received treatment with the Akura thrombectomy system to remove pulmonary thrombus in the pulmonary vasculature. The average procedure time from anaesthesia start to closure was 117±50 minutes, with an average fluoroscopy time of 30±21 minutes (range, 13–68 minutes). Total blood loss was 247±80mL on average, with 189±120mL of contrast used per procedure. After 48 hours, the RV/LV ratio decreased by 0.35 from 1.29±0.15 to 0.94±0.12 (p<0.05; 26.85% reduction). Through seven-day follow-up, there were no deaths, device-related major bleeding, or device-related adverse events.

Mathews concluded that the Akura thrombectomy system for PE appears safe, and preliminary evidence shows that this platform technology leads to a significant reduction in RV/LV ratio and thrombus burden.

No relationship found between DW-MRI lesions and long-term stroke risk following carotid revascularisation

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No relationship found between DW-MRI lesions and long-term stroke risk following carotid revascularisation
Gert J de Borst

A secondary analysis of existing clinical trial data has indicated that new ischaemic brain lesions detected via diffusion-weighted magnetic resonance imaging (DW-MRI) following carotid artery revascularisation—either with carotid artery stenting (CAS) or carotid endarterectomy (CEA)—do not appear to have a relationship with long-term stroke risks.

“The results from our analysis do not support the role of ischaemic brain lesions discovered on [DW-MRI] after carotid revascularisation procedures as risk markers for long-term recurrent stroke or TIA [transient ischaemic attack],” authors Gert J de Borst (University Medical Center Utrecht, The Netherlands) et al write, concluding their report in the journal Stroke. “However, as new periprocedural [DW-MRI] lesions seem to be a marker for early recurrent cerebrovascular events, future randomised studies are needed to evaluate whether the effect of treatment on these lesions corresponds to the effect of treatment on procedural stroke before surrogacy can be validated.”

The researchers initially posit that five-year follow-up findings from the randomised International Carotid Stenting Study (ICSS) indicate an increased risk of recurrent stroke or TIA following a CAS procedure, but that the trial failed to demonstrate any association between DW-MRI lesions and recurrent stroke/TIA risks following CEA.

“The establishment of the longer-term clinical relevance of the [DW-MRI] lesions after carotid revascularisation procedures is essential in the process of implementing a universally accepted surrogate outcome,” De Borst and colleagues note. “Today, thus far, there are no data describing adverse events in [DW-MRI]-positive patients beyond five-year follow-up. Therefore, in this study, we intended to determine the long-term cerebrovascular outcome in [DW-MRI]-positive compared with [DW-MRI]-negative patients after carotid revascularisation procedures.”

The authors report that their study—a secondary, observational, prospective cohort analysis—included 162 patients with symptomatic carotid stenosis who were previously randomised to CAS or CEA in ICSS, and were subsequently included in the ICSS MRI substudy. They further relay that the primary composite clinical outcome of their analysis was the time to any stroke or TIA during follow-up. Patients with new DW-MRI lesions on post-treatment MRI scans (DWI+) were compared with patients without new lesions (DWI–), De Borst et al add.

For the 162 patients included in the ICSS-MRI substudy between January 2004 and October 2008, 110 general practitioners (GPs) ultimately provided long-term follow-up data for the present study. Discussing the baseline characteristics of this patient population, De Borst et al note that those in the DWI+ group were more often treated with CAS, while total cholesterol at randomisation was higher in the DWI− group.

Relaying their results, the authors state that the median follow-up time was 8.6 years, and that Kaplan-Meier cumulative incidence for the primary outcome after 12.5 years of follow-up was 35.3% in DWI+ patients and 31.1% in DWI− patients. With respective hazard ratios of 1.5 and 1.3, univariable and multivariable regression analyses did not show significant differences between these two patient cohorts, they add. Separate analyses, specifically relating to CAS and CEA, showed that the higher primary outcome rate in DWI+ patients across the entire cohort was mainly caused by events in the CAS group.

“In the ICSS MRI substudy, both the presence and count of [DW-MRI] lesions were associated with recurrent stroke/TIA occurring after the post-treatment scan, with most events seen in the first six months after treatment,” De Borst and colleagues write. “The results of the present study showed that this association was no longer present after 12.5 years of follow-up. In addition, the analyses with [DW-MRI] counts were largely influenced by the small number of patients with high [DW-MRI] lesions, which lost the association with the clinical outcomes after bootstrapping the HR CIs [hazard-ratio confidence intervals].

“This supports the hypothesis that [DW-MRI] lesions are caused by thromboembolic material or atherosclerotic plaque debris during and after the carotid revascularisation procedure, and therefore might be used as surrogate markers of early recurrent stroke/TIA but not for long-term ischaemic events.”

Six-month outcomes from phase-one trial of anti-inflammatory drug to assess benefit in acute DVT patients demonstrate ‘promise’

By
Bryan Kay
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Six-month outcomes from phase-one trial of anti-inflammatory drug to assess benefit in acute DVT patients demonstrate ‘promise’
David J. Dexter during The VEINS 2023

The open-label phase of the DEXTERITY-AFP trial investigating the Bullfrog microinfusion device—which involves the perivenous injection of the anti-inflammatory drug dexamethasone to improve patency and post-thrombotic syndrome (PTS) six months after thrombus removal in symptomatic deep vein thrombosis (DVT) patients—has shown positive results.

That’s according to late-breaking data revealed during The VEINS 2023 meeting (Oct. 28–30) in Las Vegas by David J. Dexter, MD, co-principal investigator and a vascular surgeon at Sentara Healthcare in Norfolk, Virginia.

From a trend standpoint, Dexter told attendees, the 20-patient cohort, fully enrolled with six months of follow-up, showed a 5% rate of any PTS and currently no patients through 12 months with moderate-to-severe PTS.

The femoropopliteal segment study is moving in its second phase during which 60 patients will be enrolled 1:1 to receive the perivenous steroid or saline injections in a dual-blinded randomized controlled trial (RCT), and is considered the first known trial to investigate local drug delivery intended to reduce venous inflammation associated with DVT.

Of the total 21 patients initially enrolled in the first phase, one withdrew after one-month follow-up. In terms of safety, there were no device (Mercator MedSystems) or drug-related serious adverse events observed. The primary efficacy endpoint—clinically relevant loss of primary patency—will be examined as combined with the RCT phase, the investigators revealed. Of the 21 patients followed at one month, 19 (90.5%) had fully compressible and two had partially compressible common femoral veins. Other key secondary endpoint data for the 20 participants with in-window, six-month follow-up included reduction from baseline to six months in average Villalta score (7.3 to 1.6) and 10-point pain score (3.2 to 0.5).

“Iliofemoral DVT continues to have poor outcomes,” Dexter told The VEINS 2023. “Femoropopliteal DVT has been neglected because we have really poor therapeutic outcomes yet they compromise more than half of DVT cases we see. Inflammation appears to be linked to vein wall scarring and PTS. Dexamethasone appears to show really promising results both in pre-clinical studies as well as in our single-arm, early-phase data. The biomarker work, the compressibility work and the Villalta score all show really favorable early outcomes.”

One-year CLOUT data demonstrate low rate of PTS following treatment with ClotTriever

By
Jocelyn Hudson
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One-year CLOUT data demonstrate low rate of PTS following treatment with ClotTriever
David Dexter
David Dexter

David Dexter (Sentara Vascular Specialists, Norfolk, USA) shared one-year data from the CLOUT registry this week at The VEINS 2023 (28–30 October, Las Vegas, USA).

Long-term, prospective outcome data after mechanical thrombectomy for deep vein thrombosis (DVT) are lacking. The CLOUT (ClotTriever Outcomes) registry is a prospective, multicentre study evaluating patient outcomes for proximal lower extremity DVT treated with the ClotTriever system (Inari Medical).

CLOUT is the largest mechanical thrombectomy study in the field of DVT, said Dexter, and although positive results have been previously published, this is the first report of one-year outcomes for all available patients. Patients in CLOUT were aged ≥18 years and enrolled regardless of bilateral disease, duration of symptoms, prior treatment failure for the current DVT event, or contraindications to thrombolytic therapy. A total of 310 patients completed the one-year follow-up visit.

One year after mechanical thrombectomy, moderate-to-severe post-thrombotic syndrome (PTS; Villalta score ≥10) was observed in 8.8% of treated limbs. The overall PTS rate (Villalta score ≥5) was 19.3%. Venous patency, as measured by the presence of flow with normal or partial compressibility on duplex ultrasound, was observed in 94.2% of cases. Additionally, significant improvements from baseline in revised Venous Clinical Severity Score, Numeric Pain Rating Scale score, and EQ-5D questionnaire score were demonstrated.

In the real-world, all-comer CLOUT registry, one-year outcomes demonstrate a low rate of PTS following treatment with the ClotTriever system, which was complemented by patient-centric improvements in symptom relief and quality of life. Study follow-up through two years is ongoing.

Dexter stated that these favourable clinical outcomes highlight the need for randomised controlled trial data comparing mechanical thrombectomy with standard of care anticoagulation treatment. The recently initiated randomised controlled DEFIANCE trial will compare the ClotTriever system to anticoagulation for the treatment of symptomatic iliofemoral DVT.

New varicose vein management guidelines released

By
Marlén Gomez
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New varicose vein management guidelines released

The SVS, in collaboration with the American Venous Forum (AVF) and the American Vein and Lymphatic Society (AVLS), has un­veiled part two of the clinical practice guidelines for the manage­ment of varicose veins of the lower extremities. Building upon the foundation laid by part one, which was published online in Octo­ber 2022, this latest installment offers evidence-based guidance to healthcare professionals and patients navigating the complexities of varicose vein care.

The new guidelines, endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine, were published in the Journal of Vascular Surgery-Venous and Lymphatic Disorders in September, and are set to become a trusted resource for medical practitioners and individuals seeking effective varicose vein management strategies, according to co-primary author of the guideline writing group, Peter Gloviczki, MD.

SVS clinical practice guidelines are rooted in an evaluation of scientific literature, weighing the likely benefits and potential harms of various treatments.

The guideline writing group utilizes systematic reviews to distill key recommendations from the vast body of available evidence, ensuring that these guidelines remain both current and reliable.

Gloviczki emphasized the trustworthiness of the guidelines, stating, “These guidelines offer the most current and reliable source of information for both patients and healthcare providers.”

The guidelines address critical issues concerning the management of lower-extremity varicose veins, using the PICO (patients, interventions, comparators and outcomes) framework to provide evidence-based answers to crucial questions.

Part I focused on the role of duplex ultrasound scanning in evaluating varicose veins and treating superficial truncal reflux. Part II delves into several aspects, including the prevention and management of varicose vein patients with compression, treatment with venotonic drugs and nutritional supplements. It also covers the evaluation and treatment of varicose tributaries, superficial thrombophlebitis, venous aneurysms and the management of complications associated with varicose veins and their treatment.

The guidelines place emphasis on incorporating contemporary endovascular venous interventions, both thermal and non-thermal procedures, aligning them with compression therapy and pharmacological treatment for managing varicose veins.

The document encompasses a wide range of recommendations spanning parts I and II, ungraded consensus statements, pragmatic implementation notes and best-practice directives. It provides guidance for the appropriate management of patients with symptomatic lower-extremity varicose veins.

“When evaluating patients for varicose veins and conducting duplex ultrasounds, it is important that all physicians use the CEAP (Clinical-Etiological- Anatomical-Pathophysiological) classification system.

All patients with varicose veins C2 disease should have duplex ultrasound evaluations to evaluate the reflux in the saphenous veins and other superficial veins. This exam should be performed with the patient standing, whenever possible,” said Gloviczki.—Marlén Gomez

SVS submits comment letter on Medicare fee schedule to CMS

By
Beth Bales
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SVS submits comment letter on Medicare fee schedule to CMS

In September, the Society for Vascular Surgery submitted a detailed comment letter to the Cen­ters for Medicare and Medicaid Services (CMS) in re­sponse to a proposed rule that could mean a 3–4% cut in Medicare payments.

The letter responds to CMS’ Calendar Year (CY) 2024 Medicare Physician Fee Schedule Proposed Rule (MPFS). SVS members are urged to address lawmakers on the issues, via grassroots advocacy. Pre-written messages are available at vascular.org/Grassroots.

Depending on practice setting, vascular surgeons face a 3 to 4% cut based on current Medicare policies proposed in the MPFS rule.

These cuts result from a reduction in the temporary update to the conversion factor under current law and a negative budget-neutrality adjustment stemming in large part from CMS moving forward with implementation of separate pay­ment for add-on code G2211 to account for visit complexity associated with certain office/outpatient evaluation and management visits. The code was initially proposed three years ago, but implementation was delayed as a result of an aggressive advocacy campaign led by surgical societies, including the SVS.

In addition, payment reductions for many vascular sur­geons are compounded by the third year of CMS’ phased-in implementation of its clinical labor pricing update, which was finalized in the CY2022 MPFS Final Rule.

“Systemic issues such as the negative impact of the Medi­care physician fee schedule’s budget neutrality requirements and the lack of an annual inflationary update will continue to generate significant instability for health care clinicians moving forward, threatening beneficiary access to essential health care services,” the letter includes.

The SVS, in collaboration with medical specialty societies, is continuing to work to mitigate the scheduled cuts and advance policies to stabilize the payment system in the short term and reform the system for the future.

To that end, the SVS supports legislation to provide an inflationary update for the MPFS (H.R. 2474) and is leading the effort that brought forth the introduction of legislation to provide targeted relief for codes most impacted by the clinical labor update policy (H.R. 3674).

The SVS is also seeking further delay of the G2211 code implementation via both regulatory and legislative initiatives.

Read the letter to CMS at vascular.org/CMS.9.23.

The ‘modern’ VA has made great strides with patient outcomes and satisfaction scores

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The ‘modern’ VA has made great strides with patient outcomes and satisfaction scores

Data can be granular and clarifying. Conversely, data without appropriate context can lack nuance—like a paint-by-numbers portrait using only one crayon.

A recent article publivenshed by Becker’s Hospital Review, and promoted by the medical network Doximity, listed the top 10 hospitals with the lowest and highest rate of 30-day readmission based off data from the Centers for Medicare & Medicaid Services’ (CMS) Care Compare Website.1 Eight of the nine hospitals with the highest re-admission rate (I know it was supposed to be 10 but I didn’t write it; blame ChatGPT) are part of the U.S. Department of Veterans Affairs (VA) system.

This information has been in the press lately because facilities in the VA system are now being included in the CMS Overall Hospital Quality Star Ratings. The metric is based off five categories: mortality, safety of care, readmission, patient experience, and timely and effective care. Five stars is the maximum a facility can attain based on its aggregate score.

The dataset from CMS’ Care Compare website encompassed readmissions from July 1, 2018, through June 30, 2021. However, the data in the article were isolated to July 2020 and June 2021: a heterogenous time pre- and post-COVID-19 vaccine filled with quarantining people who refused to go to the hospital.

In the United Kingdom, deaths at home rose by almost a third in 2020 while in-hospital deaths fell, except those related to COVID-19.2

It is difficult to glean accurate data on readmissions during this time. Furthermore, readmission at VA facilities occur due to manifold reasons: including housing uncertainty, mental health and lack of resources.

The main offender listed in the Becker article was the VA Pittsburgh Healthcare System (VAPHS). What the article doesn’t mention is that since that time, the Pittsburgh VA has implemented the Surgical Safety Net as championed by the Interdisciplinary Medical Preoperative Assessment Consultation and Treatment Clinic Impact team.3 This is a multidisciplinary clinic comprised of Anesthesiology, Care Management and Social Work Services, Office of Primary Care, Physical Medicine and Rehabilitation, and Surgery.4

The team used a prediction model to identify high-risk veterans for readmission after surgery. Members then used a nurse-navigator preoperatively to counsel patients and their families on what to expect perioperatively, as well as calls on post-discharge days two, five, 14 and 30. The Department of Physical Medicine and Rehabilitation (PRM) worked with prehabilitation for the patient. A telehealth team taught the patient and the family to use virtual devices, and provided hotspots if the family had no internet access. There was now 24/7 access postoperatively for the veteran that he or she knew how to use.4

VAPHS dropped its readmission rate from 11.2 in October 2019 to 8.4 in October 2022. This program was selected as the winner for the VA’s 2022 Shark Tank competition. It is in trials at select sites across the country.

This article cherry-picks only readmissions from the list of components for the star system. Other factors, such as mortality and patient experience, have long been analyzed by the VA, especially in relationship to surgery. The American College of Surgeons’ National Surgical Quality Improvement Program for the VA has been used to improve risk-adjusted surgical outcomes.5

The VA has many metrics, such as SAIL (Strategic Analytics for Improvement and Learning Value Model), that it uses to grade its facilities. Started in 2012, SAIL uses 27 quality measures and two measures of overall efficiency and capacity to monitor such factors as acute-care mortality, access to care and employee satisfaction.6

While historically not receiving the best press, the “modern” VA has made great strides with patient outcomes and satisfaction scores.

Many recent articles have found that patients cared for by the VA have equal to—if not better—outcomes than those cared for in the civilian world.7

To that very point, Becker’s Hospital Review published an article on July 26 reporting that 67% of the VA facilities eligible received four or five stars in the latest batch of CMS data.8 What a difference 27 days make.

References

  1. https://www.beckershospitalreview.com/rankings-and-ratings/10-hospitalswith-highest-lowest-rate-of-unplannedreadmissions.html
  2. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/articles/deathsathomeincreasedbyathirdin2020whiledeathsinhospitalsfellexceptforcovid19/2021-05-07
  3. https://news.va.gov/120638/castingsurgical-safety-net-reduce-readmissions/
  4. https://marketplace.va.gov/innovations/preventing-post-operative-readmissionswith-surgical-safety-net
  5. ha AK, Perlin JB, Kizer KW, Dudley RA. Effect of the transformation of the Veterans Affairs Health Care System on the quality of care. N Engl J Med. 2003; 348:2218–2227.
  6. https://www.gao.gov/assets/700/699359.pdf
  7. Blegen M, Ko J, Salzman G, et al. Comparing Quality of Surgical Care Between the US Department of Veterans Affairs and Non-Veterans Affairs Settings: A Systematic Review. Journal of the American College of Surgeons. 237 (2): p 352–61.
  8. https://www.beckershospitalreview.com/rankings-and-ratings/67-of-va-hospitals-receive-4-or-5-star-cms-ratings-for-patient-safety.html

AMIT CHAWLA is a member of the SVS Veterans Affairs Vascular Surgeons Committee. Chawla is chief of vascular surgery at Southeastern Louisiana Veterans Healthcare System in New Orleans.

Government Grand Rounds: Opportunity knocks as Congressional ‘busy season’ beckons

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Government Grand Rounds: Opportunity knocks as Congressional ‘busy season’ beckons

With the congressional “busy season” upon us, the SVS is gearing up for big tasks ahead on the legislative and regulatory fronts. Having stepped into the role of chair of the SVS Advocacy Council this past June, I have to start by highlighting the generosity of our members and the ser­vice of surgeon-volunteers who have provided an incredibly strong foundation to build on for the work that lies ahead.

Mark Mattos, MD, and Peter Connolly, MD, led our politi­cal advocacy efforts (via the SVS Political Action Committee [PAC] Steering Committee) to achieve a new fundraising record during the last election cycle. This is due to all the donors who have provided invaluable resources to ensure that vascular surgery’s voice is heard on all of the matters important to our members. Already, incoming PAC Chair Yazan Duwayri, MD, is working with the advocacy staff to deploy these funds for maximum impact, including combin­ing forces across specialties where there is common cause. In the upcoming year, we will build on the excellent grass­roots efforts of the past year in establishing our “grass-tops” reach 535 program and supporting these volunteers in developing lasting relationships with members of Congress.

Some great opportunities are also on the horizon as Con­gress starts to ask long-overdue questions. A recent “Request for Information” issued in September by the House Ways and Means Committee notes, “Patients across America are facing increasing healthcare facility closures, travel distances and wait times, driven by a shrinking healthcare workforce, healthcare consolidation and patchwork financing models. This access challenge is uniquely difficult for patients and families living in rural and underserved areas in America.” See the request at vascular.org/RuralHealthCareRFI.

This is preaching to the choir—who knows these challeng­es better than vascular surgeons and patients? The committee “is seeking broad stakeholder input … with an emphasis on solutions to reshape our nation’s healthcare system and bring new access to care in rural and underserved areas.” We are working to answer that, building on the work of the Population Health Task Force with the establishment of an SVS Health Policy Research Consortium to marshal what our researchers have learned about vascular deserts and access challenges in both rural and urban areas, and to enlist our own best minds to fill gaps in the data needed for the strongest, best-informed advocacy.

As the conversation about reform moves forward, from sustainable funding to more efficient and humane delivery, the SVS will also be working to build alliances to help physi­cians and patients speak with the single voice needed to rise above the cacophony of interested parties. This holds true for reform at the congressional level and certainly for the upcom­ing task at the Relative Values Scale (RVS) Update Committee (RUC) of examining how lower-extremity interventions are valued—one in which SVS members can appreciate the foun­dation of expertise and credibility laid by leaders like Robert Zwolak, MD, Sean Roddy, MD, and Matthew Sideman, MD, and carried forward by Sunita Srivastava, MD, and David Han, MD, on the SVS Coding Committee.

And last, but not least, advocacy looks forward to hearing from SVS members about how we can help you where you are and about your interests and priorities. For instance, we hear from surgeons across the country that prior authori­zation practices and denials are becoming more onerous, seemingly by the day. The SVS has always worked to analyze and respond to these trends and to work hand-in-hand with members needing support in payer relations. The Society is exploring avenues to most effectively combat barriers to timely, high-quality care. Visit vascular.org/AdvocacyQues­tion, or contact svsadvocacy@vascularsociety.org.

Margaret C. Tracci is chair of the SVS Advocacy Council.

SVS unveils proposal outlining changes to Society bylaws

By
Beth Bales
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SVS unveils proposal outlining changes to Society bylaws

Voting members of the SVS will have the opportunity to consider a bylaws referendum, with key amendments related to membership and the composition of the SVS Executive Board.

The voting follows the SVS Strategic Board of Directors’ formal approval of the Executive Board’s proposals. Voting will begin Nov.6 and run through Nov. 20.

Key amendments include Article III changes, which involves providing enhanced privileges for Early Active members. Approval will “codify” the establishment of “Early Active” membership in the SVS for those who have completed their training but are not eligible for Active membership. This has been piloted over the past year with great success and support. Early Active members will be able to serve on committees and vote in SVS elections. Currently, only Active and Senior SVS members may vote.

There are also changes to Articles V and VII concerning the composition of the Executive Board. Approval will alter the composition of the Executive Board so it aligns with current best practices for medical societies to establish “competency-based” models of governance that provide greater diversity of perspective for decision-making and governance, as well as provide for greater flexibility and agility to address evolving needs over time. The composition of the EB would change in two distinct ways:

The first change increases the size of the Executive Board from nine to 11 members. Currently, the nine members include six elected officers (three elected, and three acceding from previous election) and three appointed members determined by their committee positions: chair of the SVS Community Practice Section, chair of the Program Committee and a representative from the Strategic Board of Directors. Under the proposal, two additional non-officer members would be added, with all five serving as “at-large” members, on staggered terms. These members would be selected and appointed by the EB, following consultation with the Nominating Committee and Strategic Board of Directors, based on identified priority gaps in expertise or perspective. At-large members will be required to have been SVS members in good standing for at least five years.

The second change will alter the nominating process for SVS officers (vice president, secretary and treasurer). The Nominating Committee will have the flexibility to bring forward a minimum of two, and maximum of four candidates for each vacant officer position. This will provide opportunity to expand diversity of choice amongst highly qualified candidates and permit the voting membership to choose. Additionally, the Executive Board and the Strategic Board of Directors will actively compile existing competencies in their respective memberships, identify gaps of needed perspective and expertise and share these findings with the Nominating Committee.

A review of the changes is available at vascular.org/2023BylawsRef. For answers to any questions, email governance@vascularsociety.org.

Alert! Pay SVS 2024 member dues by Dec. 31.

By
Beth Bales
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Alert! Pay SVS 2024 member dues by Dec. 31.

SVSSVS members must act before the end of the year to avoid interruption of their 2024 membership benefits. Members can pay their dues on or before Dec. 31 to support the SVS mission and advance vascular health.

Membership renewal includes continued access to all membership benefits, including all Journal of Vascular Surgery publications at reduced or no cost, access to the SVS Education Portal, reduced rates to VAM and more.

Members can pay their dues at vascular.org/invoices; login is required. While paying their dues, members can also donate to the work of the SVS Foundation.

Additionally, members also can update their SVS profiles, including adding mobile numbers to receive infrequent text alerts on critical society communications, such as dues renewals and election notices when updating their SVS profiles.

For questions, email membership@vascularsociety.org.

Applications open for awards, grant

By
Beth Bales
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Applications open for awards, grant

Applications open this month for the SVS Excellence in Community Practice Award and the Sub-Section on Outpatient & Office Vascular Care (SOOVC) Research Seed Grant and Presentation Award.

The Excellence in Community Practice Award honors members who have exhibited outstanding leadership within his or her community as a practicing vascular surgeon. Criteria include a minimum of 20 years as a practicing vascular surgeon and minimum of five years as an SVS member.

Applicants/nominees must present evidence of leadership in a community-based practice, such as implementation of services or innovations to advance community health, partnerships or collaborations with organizations in the community, and contributions that elevate the stature of the specialty of vascular surgery in the community.

Learn more at vascular.org/CommunityPracticeAward. Applications close Feb. 1.

The SOOVC Presentation Award recognizes vascular surgeons who have completed clinical research projects in an office-based lab (OBL) or ambulatory surgery center (ASC). Three recipients will be selected for the award.

The Research Seed Grant supports research in an OBL or ASC practice, providing vascular surgeons with funds for a data analyst to analyze research data for actionable insights, quality improvement and patient care. Three recipients will be selected, and each will receive a $10,000 grant.

Visit vascular.org/SOOVCResearchGrant and vascular.org/SOOVCPresentationAward. Applications close Jan.15.

REAL-PE demonstrates statistically significant lower major bleeding rates with Ekos system compared to mechanical thrombectomy for PE treatment

By
Jocelyn Hudson
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REAL-PE demonstrates statistically significant lower major bleeding rates with Ekos system compared to mechanical thrombectomy for PE treatment
EkoSonic
EkoSonic
EkoSonic

Data from the REAL-PE study were presented this week at TCT 2023 (23–26 October, San Francisco, USA) demonstrating that patients treated for pulmonary embolism (PE) with the Ekos endovascular system (Boston Scientific) had lower rates of adverse events, including statistically significant lower rates of major bleeding, within seven days following their procedure compared to the FlowTriever system (Inari Medical).

According to Boston Scientific, the analysis is the largest comparative study to use near real-time health system-based electronic health record (EHR) data to understand clinical practices and outcomes related to PE.

A press release details that, while treatment for PE has historically included anticoagulant medication, the use of new interventional therapies—such as the EKOS system—is increasing. The EKOS system uses a combination of ultrasound energy and a low thrombolytic drug dose to restore blood flow in patients with PE and other occlusions in the peripheral vasculature.

The REAL-PE study reviewed data from Truveta, a data and analytics company that provides EHR data from more than 30 US health systems and 100 million patients, including lab values, comorbidities, images, demographics and clinical outcomes, as well information about the performance of specific medical devices. In the REAL-PE analysis, 2,259 patients who experienced PE and received interventional treatment with either the EKOS system or the FlowTriever system between 2009 and 2023 were identified, and safety events associated with both devices were compared.

“In the past decade, there have been a number of advances in interventional therapies for the treatment of PE, but gaps in clinical evidence still exist when it comes to determining the optimal modality for each patient’s unique needs,” said Peter Monteleone, an interventional cardiologist with Ascension (Austin, USA) and principal investigator of the REAL-PE study. “The REAL-PE study provides comprehensive data and unprecedented insight into the real-world performance of specific interventional devices, which can help physicians make more informed clinical decisions.”

Major bleeding events in the REAL-PE study were based on definitions derived from established clinical criteria and guidelines, with statistically significant lower rates within seven days of the procedure consistently found in the cohort of patients treated with the EKOS system:

  • A rate of 12.4% for patients treated with the EKOS system vs. 17.3% for those treated with the FlowTriever system (p=0.0018), using the International Society on Thrombosis and Haemostasis (ISTH) definition, and;
  • A rate of 11.8% for patients treated with the EKOS system vs. 15.4% for those treated with the FlowTriever system (p=0.0190), using the Bleeding Academic Research Consortium type 3b (BARC3b) definition.

Medical coding data in the analysis also demonstrated that intracerebral haemorrhage within seven days following the procedure occurred statistically significant less frequently among patients treated with the EKOS system (0.3% vs. 1.3%, p=0.005). All other studied safety events also trended in favour of the EKOS system, including in-hospital mortality (2.6% vs. 3.7%) and all-cause 30-day readmission rates (5.1% vs. 5.4%). Median lengths of hospital stay were comparable at 3.6 days for both groups.

“Electronic health record data of this scale provides in-depth information about larger, more diverse patient populations, while also accounting for multiple variables including complex medical histories or comorbidities that often exclude patients from clinical trials,” said Michael R Jaff, chief medical officer and vice president, clinical affairs, technology and innovation, peripheral interventions, Boston Scientific. “While data from clinical trials and registries will always play an important role in healthcare, access to the breadth of data such as that used in the REAL-PE study has the potential to better inform and accelerate clinical decision-making and, ultimately, improve patient care.”

To date, Boston Scientific shares, the EKOS system has been used to treat more than 100,000 patients with PE globally, and the next-generation Ekos+ endovascular system received US Food and Drug Administration 510(k) clearance in 2022.

Thrombolex announces new insights from the RESCUE trial with the Bashir endovascular catheter

By
Jocelyn Hudson
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Thrombolex announces new insights from the RESCUE trial with the Bashir endovascular catheter
Bashir endovascular catheter
Bashir endovascular catheter

Thrombolex has announced never-before-reported major reductions in obstruction in all of the segmental pulmonary arteries (PA), based on independent core lab data analysis of 107 patients from 18 sites in the USA, with acute intermediate-risk pulmonary embolism (PE), using the Bashir endovascular catheter and small doses of tissue plasminogen activator (tPA).

The National Institutes of Health (NIH)-sponsored RESCUE trial also showed unsurpassed efficacy and safety in this patient population compared to recently published studies with other US Food and Drug Administration (FDA)-cleared devices, Thrombolex reports in a press release. These new data have just been published in the Journal of the American College of Cardiology (JACC): Advances online.

The RESCUE trial demonstrated that pharmacomechanical catheter-directed thrombolysis (PM-CDT) therapy using the Bashir endovascular catheter to administer recombinant tPA (r-tPA) in small doses (7mg for unilateral and 14mg for bilateral PE over five hours) resulted in a 71.1% (40.5% to 11.7%; p<0.0001) reduction in the number of segmental PA branches with total or subtotal occlusions at 48 hours, using contrast-enhanced chest computed tomography angiography. Proximal PA branch total or subtotal occlusions decreased by 61.3% (28.7% to 11.0%; p<0.0001). The reduction in segmental artery occlusions correlated significantly with the reduction in right ventricular/left ventricular (RV/LV) ratio (P=0.0026) whereas that in the proximal PA did not (p=0.173).

Gregory Piazza, associate professor of medicine, Harvard Medical School (Boston, USA) and chairman of the RESCUE Data Safety Monitoring Board noted: “A growing body of literature supports the hypothesis that reperfusion of the distal pulmonary vasculature is a critical therapeutic target, influencing right ventricular recovery, symptom relief, and gas exchange.”

“The critical finding in the present study is that by using the Bashir endovascular catheter and small doses of tPA we are able to markedly reduce segmental and main pulmonary arterial occlusions. Assessment of segmental artery patency after catheter-based therapies of acute PE may be critical to understanding the long-term benefits of these therapies and should be part of all future clinical trials in acute PE,” said Brian G Firth, chief scientific officer, Thrombolex.

VAM 2024 gala set for chicago’s museum of science and industry

By
Beth Bales
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VAM 2024 gala set for chicago’s museum of science and industry
Pictured at the 2023 Gala are Leigh Ann O’Banion (top), and (bottom, left to right) Anna Boniakowski, Bernadette Aulivola, Dawn Coleman and Misty Humphries

During the vascular annual meeting that celebrates science and research, the SVS Foundation’s annual Gala will take place in a museum that also honors science. “A Night at the Museum—A Celebration of Science” is set for Friday, June 21, 2024 at Chicago’s world-famous Museum of Science and Industry.

Chairs of the 2024 Gala are Michael Dalsing, MD, chair of the SVS Foundation; Bernadette Aulivola, MD, member of the SVS Foundation Board of Directors; and Leigh Ann O’Banion, MD, co-chair of the 2023 Gala.

Tickets for this annual event, which typically sell out quickly, will go on sale in March. Included in the evening are transportation to the museum, live and silent auctions, plated dinner, dancing to a DJ, and much more. “Guests will be able to visit the exhibits on the main floor, which is where the event will be located,” said O’Banion. That includes the museum’s “Yesterday’s Main Street,” the Coal Mine, “Numbers in Nature: A Mirror Maze” and exhibits on “The Great Train Story” (in the Transportation Gallery), “Science Storms,” “Extreme Ice,” “Earth Revealed,” and more. “I practice in Chicago and am no stranger to this fantastic museum,” said Aulivola. “I’m thrilled that we’ve secured this location for our upcoming Gala and I cannot wait to show it off to our Gala attendees. I am certain that this will be an incredibly fun event for all.”

For information contact Catherine Lampi at clampi@vascularsociety.org.

Corner Stich: Bridging knowledge gaps and meeting new demands of vascular surgical training

By
Christopher Audu
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Corner Stich: Bridging knowledge gaps and meeting new demands of vascular surgical training
Christopher Audu and Scot Stanulis

This month in Corner Stitch, we highlight a trainee-centric study presented at the 2023 Midwestern Vascular Surgical Society (MVSS) annual meeting held in Minneapolis, Minnesota (Sept. 7–9). With the rise of Entrustable Professional Activities (EPAs) and the diminishing number of open aortic cases being performed across the country, this study from the group at Southern Illinois University provides an idea of how we may begin bridging these knowledge gaps and meeting the new educational demands coming to surgical training. For this, Christopher Audu, MD, interviews vascular surgery resident Scot Stanulis, MD, who presented his work on “Video-based self-assessment is an effective method of open surgical education for vascular surgery trainees.”

CA: In your study, your group evaluated open surgical skills using cadavers. Can you share the origin story for this idea? What prompted a cadaveric simulation study?

SS: An important topic in vascular surgery education at the moment, with the advent of integrated residencies and as the proportion of endovascular procedures increases, is that our residents may be exposed to fewer open vascular cases in their training. We wanted to start looking at solutions to this problem, and as we already have a great relationship with our surgical simulation lab, we thought this would be a natural start. The surgical literature, particularly in general surgery, shows promise for integrating more simulation into resident education, and we wanted to see if we could step it up a notch by including complete operations from skin-to-skin, and to see if video recordings, along with faculty and self-assessment, could increase the educational value.

CA: Bravo on taking on a really cool project to meet the need for open skills. How did you go about procuring permission from your anatomy department for this simulation? Is this something any residency can do to improve their resident/fellow open skills?

SS: Luckily, we already have a great relationship with our anatomy department, and many surgical subspecialties at our institution use the surgical simulation lab for cadaveric-based education. For standardization purposes, we needed to request cadavers that had not already underwent dissection in the operative field for a carotid endarterectomy (CEA), and we needed to ensure we could set up a live video-feed with overhead cameras. We were able to work with our simulation lab faculty to solve these pretty quickly. If a residency program does not already have access to cadavers, this would be a bigger obstacle to overcome; however, cadaveric education is an important part of robust simulation education, even outside of our project, and we would recommend any program strive to include some form of cadaveric education in their curriculum.

CA: In the paper you presented, you focused on carotid endarterectomies. What were the areas that the juniors improved in the most? Needle handling? Draping? Steps of the procedure?

SS: For our first exploration in video-based simulation, we chose CEAs for a few reasons: it is a procedure that all our residents had some exposure to; it has well-established, replicable steps, which aids in standardization; and it encompasses a broad range of vascular surgical skills.

In our experience with CEA, we found that the junior residents improved the most in the initial parts of the procedure, including draping and positioning, incision, and initial dissection and exposure. Additionally, there were some specific steps; for example, the PGY1 was able to clamp in the correct order the second time around; and the PGY2 improved at identifying each nerve during dissection. Our senior residents nearly aced our evaluation forms from the first attempt, so there was not much room for improvement—meaning we need to challenge them with more stringent evaluation criteria or a more difficult operation.

CA: That makes sense. What was your observed correlation between areas identified by the resident and those identified by the faculty? Can you infer anything about how a resident is able to assess their own growth?

SS: Residents and faculty were generally congruent on objective measures like “clamping order,” but for subjective measures like “overall proficiency” or even “proper nerve exposure,” we found more of a difference. We did see some improvement in resident self-assessment ability across sessions, but at this point it is clear that a junior resident will need faculty feedback to properly assess their operative performance, at least until they further develop their skill of self-assessment.

CA: That is very interesting. Did the improved residents notice greater autonomy in the operating room (OR) for carotid cases?

SS: At our program, our residents do already get a fair bit of autonomy, and it is hard to say how much that improved from this one experience, particularly as our experience was blinded and the faculty did not get to see an individual resident’s improvement to then grant more autonomy. However, residents did say that they felt more confident and prepared going into their next CEA, and we do believe that this preparation can make it so residents get more out of their real cases once they have overcome some of the learning process in simulation.

CA: I see. So, one unintended benefit of this is improving resident/trainee confidence, which then translates into OR proficiency. How do you envision the platform being used for other vascular cases? Did your faculty find this a helpful exercise in their assessment of residents?

SS: I think the real benefit for this type of experience is augmenting surgical education in operations that our residents will see less often. Providing residents with confidence and foundational skills in open abdominal cases will be invaluable as we see a trend of residents reporting fewer of these cases in the endovascular era.

Faculty did report that it was useful to see the general weak points of residents so they could better direct teaching in the OR, but our experience was set up more for resident learning, and we did not assess if faculty improved at teaching or assessment.

CA: Right on. I suppose faculty evaluation of their teaching can be a future project. What open vascular operation are you going to do next?

SS: The next operation we will evaluate will be an open abdominal aortic aneurysm (AAA) repair. We chose this because we want to challenge our senior residents more, and see if this model holds up with a more complex operation. Challenges include keeping a larger operative field in the camera view, creating reasonable standardized evaluation forms, and increased time requirements in the simulation lab. If this model works for both a CEA and an open AAA, I don’t see many reasons that would prevent it from being used for a multitude of other open vascular surgery cases.

CHRISTOPHER AUDU is the Vascular Specialist resident/fellow editor. He is a resident at the University of Michigan in Ann Arbor, Michigan.

Highlighting original work by women: Peer-review title blazes new trail in vascular surgery

By
Bryan Kay
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Highlighting original work by women: Peer-review title blazes new trail in vascular surgery

The September issue of Annals of Vascular Surgery featured 37 original, peer-reviewed scientific papers whose lead authors and researchers are women vascular surgeons. Here, editor Caitlin W. Hicks, MD, discusses the mechanics of getting the publication out, coming amid recent trials and tribulations in the vascular space that saw her come under personal attack.

The work had been more than a year in the making, so to see the final title reach the point of release filled those behind the Annals of Vascular Surgery special issue, “Original Work by Women,” with a sense of accomplishment. Hicks said the mere fact the entire edition is fully open access has attracted positive feedback, but, for her, something else stands out as a particular achievement. “The biggest highlight is just the fact we were able to get so many articles with first and last women authors, which given the number of female vascular surgeons is relatively small, and the articles still underwent standard, strict peer review, is probably the most exciting and impactful component,” she tells Vascular Specialist. Solidifying the point, Hicks reveals that somewhere in the region of about 30% of the articles received for inclusion in the issue were rejected.

Reaching the point where such a dedicated women’s issue is possible didn’t occur in a vacuum, Hicks observes. The Medbikini fiasco that kicked off in 2020 lit a fire, she says. “There was sort of an influx of women stepping up to say ‘We’re here,’” she continues. “I think since then, we’ve seen a real presence of women in all aspects of vascular surgery, which is really exciting. This issue doesn’t really come out of the blue. It feeds off of that progress we have made in recent years.”

Strides toward better representation of women vascular surgeons in leadership positions continue to be made, Hicks says, with vascular surgery currently “bottom heavy in the societies because, out of training, we’re seeing 50/50 men vs. women, but 15 years ago it was not that way.” The Women’s Vascular Summit, started by Linda Harris, MD, out of Buffalo, has also planted roots in recent years. “We continue to push forward and continue to champion the leaders that we have in our women’s group, and then create our own opportunities,” Hicks explains. “What has come out of the [SVS] election findings over the last couple of years has increased focus on the role of women in the vascular surgery space. Linda Harris has had a meeting for a few years now, and that group is going to codify into a women’s vascular society, which I think is exciting.”

Lately, just as the Annals issue was heading for publication, on a personal level Hicks had to confront a backlash to her contributions to the public conversation that followed the NYT exposé on inappropriateness in vascular care. “I have done a lot of research in this space, and the motivation behind my research is to improve patient care, so when you do things for the right reasons and you get personally attacked, it’s always challenging,” she reflects. “There was definitely a component of ageism in the posts,” adding, “It’s always hard to know, but I do believe if I had been a male I wouldn’t have gotten that type of attack.”—Bryan Kay

Women’s champion: Freischlag marks out value of diversity and surgeons as hospital leaders

By
Bryan Kay
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Women’s champion: Freischlag marks out value of diversity and surgeons as hospital leaders

Julie A. Freischlag, MD, used her turn as honorary guest lecturer at the 2023 Midwestern Vascular Surgical Society (MVSS) annual meeting to make a pitch for vascular surgeons to step up to the plate as hospital and institutional leaders—because that is “who you are,” she told the gathering in Minneapolis, Minnesota (Sept. 7–9).

“I would challenge you as vascular surgeons to go and run things,” she said. “Surgeons are really, really good at running things. You make decisions with very little data, and go do it on a Friday night. You make mistakes; things bleed and clot; and you strive to go fix it. You walk into that operating room every day with high hopes.”

Many CEOs and the types of C-suite operators involved in the likes of mergers and acquisitions, on the other hand, walk into the room with “a whole different thought,” Freischlag said. Often, they assume things are going to fail, and “they may not always tell the truth.”

That’s the opposite of the archetypal vascular surgeon, she continued. “What you need to do is get in those rooms and lead those processes, because that is who you are. You make good decisions, are able to own up to your mistakes, and you actually care—about your patients, teams, families and where you are going.”

Freischlag’s lecture was built around the theme of “Daring to do hard things.” Detailing snapshots from her own journey—which, in addition to a lofty career trajectory, also included road bumps such as a divorce—she highlighted themes of resilience, diversity, mentorship and bravery in leadership.

She placed a particular emphasis on the importance of diversity in surgery, referencing the recent publication of the special women’s issue of Annals of Vascular Surgery, for which she was invited to write the introduction.

To illustrate the point, Freischlag detailed her first open aneurysm repair, in San Diego in 1987, when she was just 32 years old. The 82-year-old patient, who presented with a 6cm aneurysm, was due to undergo the procedure when Freischlag walked into the room to a less than rapt wider audience. “Her family was aghast,” she recalled. “Who is this kid, they were thinking,” although the actual patient herself had no reservations, underwent the operation, and came out the other side, Freischlag said. The tale ended with Freischlag receiving two gifts from the lady and her family: a cross-stitched handkerchief crafted by the patient, along with an inscribed gold bracelet marking out the gratitude of the family. Freischlag cherishes the keepsakes still, explaining: “I was the most diverse vascular surgeon anybody saw doing that work back in the 80s— doing her procedure and trusting me, just like our patients trust us in our clinical trials. It’s really important that that continues to happen in all shapes and forms.”

Meanwhile, inclusive leadership means “you take somebody with you wherever you go. If you haven’t introduced one of your students, residents or fellows to somebody at this meeting, shame on you,” Freischlag implored. “You need to take them by the arm, introduce them to leadership, let them present … Watching them grow to do it even better than you did is a wonderful feeling, and it makes the world a better place.”

Leadership is a journey, Freischlag added. It is about helping those around you, but, just like in her case, “it isn’t always easy.” As the COVID-19 pandemic demonstrated, she said, “you get interrupted.”

TCT 2023: LIFE-BTK breathes life into drug-eluting resorbable scaffolds in breakthrough for below-the-knee arteries

By
Jocelyn Hudson
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TCT 2023: LIFE-BTK breathes life into drug-eluting resorbable scaffolds in breakthrough for below-the-knee arteries
L-r: Ramon L Varcoe, Britan G DeRubertis and Sahil A Parikh

Results of the LIFE-BTK randomized controlled trial have just been presented at TCT 2023 (Oct. 23–26) in San Francisco. The data show that, in patients with chronic limb-threatening ischemia (CLTI) due to infrapopliteal artery disease, an everolimus-eluting resorbable scaffold was superior to angioplasty at one year with respect to the primary efficacy endpoint. 

Ramon L. Varcoe, MBBS, from Prince of Wales Hospital and University of New South Wales in Randwick, Australia, shared this and other key findings at TCT on behalf of co-principal investigators Brian G. DeRubertis, MD, from New York Presbyterian–Weill Cornell Medical Center in New York, and Sahil A. Parikh, MD, from Columbia University Irving Medical Center, also in New York. The trial results were simultaneously published in the New England Journal of Medicine (NEJM). 

Parikh shares his thoughts on the significance of these results with this newspaper: “This trial is the first of its kind to demonstrate superiority of a technology for below-the-knee [BTK] intervention along a relatively long time point for this patient population.” He describes the effects of the technology as durable and notes they are “continuing to diverge” at the 12-month time point. “It is a highly clinically significant result.” 

Peter Schneider, MD, from University of California San Francisco in San Francisco, provides some context, noting that LIFE-BTK follows multiple failed trials in the BTK segment. “The key thing I think is that we do not have the tools we need to treat BTK disease. Yes, catheter-based treatments for limb salvage are quite good, they performed well in both the BEST-CLI and BASIL-2 trials, but it is still somewhat limited in terms of the number of options we have,” he says. “We have had a number of failed trials below the knee—three failed [drug-coated balloon] trials and one failed drug-eluting stent trial—and the fact that we now have a successful trial is really I would say wind in the sails of this whole effort to try to improve the tools and the approaches that we have for BTK disease.” 

In this multicenter, randomized controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive an everolimus-eluting resorbable scaffold (Esprit BTK; Abbott Vascular) or angioplasty. 

The primary efficacy endpoint was freedom from amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion at one year. The primary safety endpoint was freedom from major adverse limb events at six months and perioperative death. 

The authors report in NEJM that the primary efficacy endpoint was observed—by which they mean no events occurred—in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan–Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; p<0.001 for superiority). This is “a highly statistically significant result,” Parikh remarks in conversation with this newspaper. 

Parikh adds that the primary safety endpoint was “statistically indistinguishable between the two groups.” Writing in NEJM, the investigators elaborate that this endpoint was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0).  

Finally, the investigators relay in their NEJM report that serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. 

Lessons learned 

Parikh, an interventional cardiologist, notes that resorbable scaffold technology has “significantly improved” since the early iterations used in the coronary arteries. He expresses his hope for use of this technology in the peripheral vessels: “I would like to make clear that this is a new iteration of this technology,” he says. “The scaffold thickness is substantially less, it is in fact comparable to the contemporary drug-eluting coronary stents that we now use, with a thickness of less than 100 microns.” 

Parikh adds that the lesion lengths that can be treated now are much longer. “In fact, in this trial, the lesions that were treated were up to 17cm, with overlapping scaffolds,” he shares. 

According to Parikh, the success of current resorbable scaffold technology is a testament to lessons learned from past versions. “It is a similar technology to predecessors, but has benefitted from the experience that we have learned from other trials, and what we have learned is that fastidious implantation technique, adequate sizing, and appropriate pharmacotherapy are really the mainstays of treatment, and they are probably critically important to all vascular interventions, but specifically using a drug-eluting resorbable scaffold.” 

He urges caution when comparing use of resorbable scaffolds in different vessels, although notes that “in this specific instance, the technology has proven itself to be superior in a randomized controlled clinical trial.” 

Based on the positive findings from LIFE-KTK, Parikh is hopeful for the future of treatment in patients with CLTI due to infrainguinal disease: “We are extremely excited about the prospect of this technology being part of our armamentarium.” 

On whether the results will change practice, Schneider opines that “this is a tool that all of us are going to want to have on our shelf.” However, he advises that interventionalists “keep in mind that a randomized controlled trial […] is not the same as an everyday algorithm of when to use and in which patients and in which situation.” The next step, according to Schneider, should be to develop that algorithm.  

Questions remain, he says, including “is this something we are going to be using every day, or something we are going to be using once in a while in specific situations?” and “that is the part that I think we need to go forward and figure out.”

TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the FDA

By
Will Date
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0
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the FDA
patient-level
L-r: Sahil Parikh, Peter Schneider and William A Gray

Data from a patient-level meta-analysis—a factor in the Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD)—have been made public for the first time at TCT 2023 (Oct. 23–26) in San Francisco.

The analysis led investigators to conclude that there is no association between mortality risk and paclitaxel-coated device exposure or dose, and should provide reassurance to patients, physicians and regulators on the safety of paclitaxel-coated devices, they say.

The release of the data, which has also been published today in The Lancet, draws a line in the sand over the question of the safety of paclitaxel, which is used in peripheral interventions to prevent restenosis, after data  from a summary-level meta-analysis put forward in 2018 pointed to an increased risk of death at two and five years following the use of paclitaxel-coated devices in the femoropopliteal artery.

William A. Gray, MD, of Lankenau Heart Institute in Wynnewood, Pennsylvania, told TCT attendees that the analysis provides the most complete and current follow-up data of pivotal studies associated with FDA-approved paclitaxel-coated devices and represents the most complete patient-level analysis to date, or likely to be available in the future.

Gray presented the findings on behalf of an independent physician steering committee, comprising Sahil Parikh, MD, from Columbia University Irving Medical Center in New York, Peter Schneider, MD, from University of California San Francisco in San Francisco, Christopher Mullin, MS, and Tyson Rogers, MS, both from North American Science Associates (NAMSA) in Minneapolis, Minnesota, who were enlisted by the regulator and industry to dig into the final and updated patient-level datasets and address limitations of prior paclitaxel meta-analyses. Funding for the study came from BD, Boston Scientific, Cook, Medtronic, Philips, Surmodics and TriReme Medical, though the funders of the study had no role in its design, data analysis, data interpretation, or writing of the report, but did provide patient-level data for the analysis, which was independently conducted.

The use of paclitaxel-coated devices for the treatment of PAD dropped by as much as 50% due to changes in practice patterns worldwide, Gray said, which was in response to the FDA’s 2019 statement that use of paclitaxel-coated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”. This change in position came after a meta-analysis from Konstantinos Katsanos, MD, from University of Patras in Patras, Greece, et al had first raised the specter of a mortality risk. FDA removed the red flag in July this year, stating that “additional data from the pivotal randomized controlled trials (RCTs) ha[ve] become available” in a letter to healthcare providers in which it set out the decision.

Gray presents the findings at TCT 2023

To inform this decision, Gray and his co-investigators analyzed randomized trials that evaluated FDA-approved paclitaxel-coated devices versus uncoated devices for the treatment of femoropopliteal artery disease, looking primarily at the mortality risk on an intention-to-treat basis, with key secondary analyses including dose/mortality and covariate interactions.

Data from 10 trials were included, encompassing 2,666 participants over a median follow-up of 4.9 years. One-year follow-up was available in 98.7% of evaluable participants and five-year follow-up in 95%, which Gray noted represents an additional 3,355.5 patient years since a 2020 analysis by VIVA Physicians, in which investigators identified an absolute 4.6% increased mortality risk associated with paclitaxel-coated devices, albeit demonstrating a weaker mortality signal than was initially reported in December 2018 by Katsanos et al.

Results of the latest analysis presented by Gray and published in The Lancet demonstrated an overall hazard ratio (HR) for the intention to treat population of 1.14 (95% confidence interval [CI] 0.93–1.40). In post-hoc analyses assessing the proportional hazards assumption, there was no evidence the assumption was violated. HRs for individual studies ranged from 0.32 to 1.52, and there were no studies in which the CI did not include the null value of 1. The HR for the as-treated analysis was 1.13 (0.92–1.39). Furthermore, the as-treated crossover analyses also did not show a significant difference in deaths between the paclitaxel-coated and control groups, with an HR of 1.07 (0.87–1.31) when late crossovers were censored, and 1.04 (0.84–1.28) in the time-varying analysis of late crossovers. Examination of late crossover using iterative parameter estimations also failed to detect a significant effect on deaths.

In their report of the findings in The Lancet, investigators describe their dataset as “very likely to be the most complete and thoroughly vetted dataset to emerge regarding paclitaxel-coated devices and death, given the likelihood that randomized trials against control devices will no longer have clinical equipoise for effectiveness, and the substantial coordination efforts for data collection, analysis and multilateral consensus will be difficult to recapitulate.”

They also praise the collaborative and thorough efforts of many clinicians, industry sponsors, and regulators over several years that enabled this research.

“The most important takeaways are that: number one, we [have] learned a tremendous amount about how future studies should be planned, so that we do not go down a blind alley again to be fooled by a summary level meta-analysis,” Schneider tells this newspaper, reflecting on the takeaways from the research.

“The second thing is that this was a tremendous effort to resolve this problem, and that included collaboration like we have never had before between physicians of different specialties in different parts of the world, with industry and with regulatory bodies all over the geography, but especially with FDA, [which] has been extremely collaborative and has been all about problem solving since the beginning of this issue.”

“Here we have probably the most complete dataset that will be feasible from the randomised controlled trials,” comments Parikh. “We looked at the overall percentage of patients identified with vital status at five years, and it was 95% of the total cohort of almost 2,700 patients. I think it will be hard to find a more complete dataset at this level of detail.”

More importantly, adds Parikh, was the opportunity to conduct crossovers analyses.

“We are identifying exposure to paclitaxel in any way, to the maximum extent possible, and, with each subsequent iteration of the analysis, our findings showed a closer and closer point estimate to no hazard at all, to unity,” he says. “That really emphasizes that going the extra mile to identify every exposure to paclitaxel, in this case most often with a contralateral limb intervention or reintervention, was the appropriate approach to adjudicate paclitaxel exposure and its risk.”

TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the US FDA

By
-
0
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the US FDA
patient-level
L-r: Sahil Parikh, Peter Schneider and William A Gray

Data from a patient-level meta-analysis—a factor in the US Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD)—have been made public for the first time at TCT 2023 (23–26 October, San Francisco, USA).

The analysis led investigators to conclude that there is no association between mortality risk and paclitaxel-coated device exposure or dose, and should provide reassurance to patients, physicians and regulators on the safety of paclitaxel-coated devices, they say.

The release of the data, which has also been published today in The Lancet, draws a line in the sand over the question of the safety of paclitaxel, which is used in peripheral interventions to prevent restenosis, after data  from a summary-level meta-analysis put forward in 2018 pointed to an increased risk of death at two and five years following the use of paclitaxel-coated devices in the femoropopliteal artery.

William A Gray (Lankenau Heart Institute, Wynnewood, USA) told TCT attendees that the analysis provides the most complete and current follow-up data of pivotal studies associated with FDA-approved paclitaxel-coated devices and represents the most complete patient-level analysis to date, or likely to be available in the future.

Gray presented the findings on behalf of an independent physician steering committee, comprising Sahil Parikh (Columbia University Irving Medical Center, New York, USA), Peter Schneider (University of California San Francisco, San Francisco, USA), Christopher Mullin and Tyson Rogers (both North American Science Associates [NAMSA], Minneapolis, USA), who were enlisted by the regulator and industry to dig into the final and updated patient-level datasets and address limitations of prior paclitaxel meta-analyses. Funding for the study came from BD, Boston Scientific, Cook, Medtronic, Philips, Surmodics and TriReme Medical, though the funders of the study had no role in its design, data analysis, data interpretation, or writing of the report, but did provide patient-level data for the analysis, which was independently conducted.

The use of paclitaxel-coated devices for the treatment of PAD dropped by as much as 50% due to changes in practice patterns worldwide, Gray said, which was in response to the FDA’s 2019 statement that use of paclitaxel-coated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”. This change in position came after a meta-analysis from Konstantinos Katsanos (University of Patras, Patras, Greece) et al had first raised the spectre of a mortality risk. FDA removed the red flag in July this year, stating that “additional data from the pivotal randomised controlled trials (RCTs) ha[ve] become available” in a letter to healthcare providers in which it set out the decision.

To inform this decision, Gray and his co-investigators analysed randomised trials that evaluated FDA-approved paclitaxel-coated devices versus uncoated devices for the treatment of femoropopliteal artery disease, looking primarily at the mortality risk on an intention-to-treat basis, with key secondary analyses including dose/mortality and covariate interactions.

Data from 10 trials were included, encompassing 2,666 participants over a median follow-up of 4.9 years. One-year follow-up was available in 98.7% of evaluable participants and five-year follow-up in 95%, which Gray noted represents an additional 3,355.5 patient years since a 2020 analysis by VIVA Physicians, in which investigators identified an absolute 4.6% increased mortality risk associated with paclitaxel-coated devices, albeit demonstrating a weaker mortality signal than was initially reported in December 2018 by Katsanos et al.

Results of the latest analysis presented by Gray and published in The Lancet demonstrated an overall hazard ratio (HR) for the intention to treat populationof 1.14 (95% confidence interval [CI] 0.93–1.40). In post-hoc analyses assessing the proportional hazards assumption, there was no evidence the assumption was violated. HRs for individual studies ranged from 0.32 to 1.52, and there were no studies in which the CI did not include the null value of 1. The HR for the as-treated analysis was 1.13 (0.92–1.39). Furthermore, the as-treated crossover analyses also did not show a significant difference in deaths between the paclitaxel-coated and control groups, with an HR of 1.07 (0.87–1.31) when late crossovers were censored, and 1.04 (0.84–1.28) in the time-varying analysis of late crossovers. Examination of late crossover using iterative parameter estimations also failed to detect a significant effect on deaths.

In their report of the findings in The Lancet, investigators describe their dataset as “very likely to be the most complete and thoroughly vetted dataset to emerge regarding paclitaxel-coated devices and death, given the likelihood that randomised trials against control devices will no longer have clinical equipoise for effectiveness, and the substantial coordination efforts for data collection, analysis and multilateral consensus will be difficult to recapitulate”.

They also praise the collaborative and thorough efforts of many clinicians, industry sponsors, and regulators over several years that enabled this research.

“The most important takeaways are that: number one, we [have] learned a tremendous amount about how future studies should be planned, so that we do not go down a blind alley again to be fooled by a summary level meta-analysis,” Schneider tells this newspaper, reflecting on the takeaways from the research.

“The second thing is that this was a tremendous effort to resolve this problem, and that included collaboration like we have never had before between physicians of different specialties in different parts of the world, with industry and with regulatory bodies all over the geography, but especially with FDA, [which] has been extremely collaborative and has been all about problem solving since the beginning of this issue.”

“Here we have probably the most complete dataset that will be feasible from the randomised controlled trials,” comments Parikh. “We looked at the overall percentage of patients identified with vital status at five years, and it was 95% of the total cohort of almost 2,700 patients. I think it will be hard to find a more complete dataset at this level of detail.”

More importantly, adds Parikh, was the opportunity to conduct crossovers analyses.

“We are identifying exposure to paclitaxel in any way, to the maximum extent possible, and, with each subsequent iteration of the analysis, our findings showed a closer and closer point estimate to no hazard at all, to unity,” he says. “That really emphasises that going the extra mile to identify every exposure to paclitaxel, in this case most often with a contralateral limb intervention or reintervention, was the appropriate approach to adjudicate paclitaxel exposure and its risk.”

Survey suggests venous work less valued than arterial interventions

By
Jocelyn Hudson
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0
Survey suggests venous work less valued than arterial interventions
3d rendered illustration of the male vascular system
Venous disease is perceived to be of less value

The majority of more than 300 vascular surgeons who responded to a recent survey indicated that they perceive the management of venous disease to be of less value than that of arterial disease. Investigators Misaki M. Kiguchi, MD, of MedStar Washington Hospital Center in Washington, D.C., and colleagues share this and other key findings in the Journal of Vascular Surgery: Venous and Lymphatic Disorders. 

The authors note that biases and gender disparities influence career pathways in medicine, with vascular surgery being no exception. They continue that, despite venous disease comprising an estimated 1–3% of total healthcare expenditures, its value among vascular surgeons is ill defined. It was the aim of the present study to address this, by investigating the factors that influence vascular surgeons’ current perceptions of superficial and deep venous disease treatments. 

Kiguchi et al share that an anonymous survey was distributed electronically to practicing vascular surgeons in December 2021, with respondents stratified by gender and practice breakdown. They detail that a venous-heavy practice was defined as one with venous work comprising ≥25% of the total volume. 

The investigators note that a total of 315 practicing vascular surgeons responded to their survey, with a majority of 81.5% from the U.S. The respondents had a mean age of 46.6±9.6 years, the authors detail, and almost two-thirds (63.3%) identified as men. 

In terms of race and ethnicity, Kiguchi and colleagues state that 63% of respondents identified as White (non- Hispanic), 17.1% Asian or Asian Indian, 8.4% Hispanic, Latinx, or Spanish, 1.6% Black. The remaining 9.9% selected ‘unknown’ for this category. 

Nearly half of respondents (47%) shared that their practice setting was academic, compared to 26.5% private practice, 23.3% hospital employed, and 3.2% ‘other’. 

The investigators also note that the female respondents were “significantly” younger than their male counterparts (p<0.0001). In addition, they had fewer years in practice (p<0.0001) and were more likely to perceive a gender bias within a career encompassing venous disease compared with the male respondents (p=0.02). 

Of the 315 participants in the survey, Kiguchi et al relay that 143 (45.4%) had a venous-heavy practice, with no differences found in age or gender between the venous-heavy and venous-light practices. They continue that those with a venous-heavy practice had significantly more years in practice statistically (p=0.02), had sought more venous training after graduation (p<0.0001), were more likely to be in private practice (p<0.0001), and were more likely to desire a practice change (p=0.001) compared with those with a venous-light practice. 

Kiguchi and colleagues report that, overall, 74.3% of respondents indicated that venous work might be less “valued” than arterial work in the field of vascular surgery. On multivariable regression, they detail, the predictors for the perception of venous work being less valued were female gender (odds ratio 2.01, 95% confidence interval 1.14–4.03) and completion of a vascular surgery fellowship (odds ratio 2, 95% confidence interval 1.15–3.57). 

In their conclusion, Kiguchi et al state that vascular surgeons perceived the management of venous disease to be of less value than that of arterial disease, particularly by women and fellowship-trained vascular surgeons. “The prevalence of venous disease, as measured by its proportion of the U.S. healthcare budget, cannot be overstated,” the authors state. As a result, they stress that “efforts to elevate the importance of chronic venous disease within the scope of vascular surgery practices are essential to ensure patients are provided with appropriate specialty care.” 

NESVS 2023: Cambria takes over as New England SVS president

By
Bryan Kay
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0
NESVS 2023: Cambria takes over as New England SVS president
Sean Roddy, left, and Robert Cambria

Robert Cambria, MD, recently took over as president of the New England Society for Vascular Surgery (NESVS). He was passed the presidential baton by Sean Roddy, MD, during the NESVS 2023 annual meeting, held in Boston (Oct. 6–8).

Cambria is a vascular surgeon at Northern Light Health/Eastern Maine Medical Center in Bangor, Maine. Roddy is a professor of vascular surgery at Albany Med Health System in Albany, New York.

At the same meeting, Jessica Simons, MD, was elected as NESVS president-elect, and will become the first-ever female NESVS president in 2024. Simons is a professor of surgery at UMass Chan Medical School in Worcester, Massachusetts.

Prepare to submit research for VAM 2024

By
Beth Bales
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0
Prepare to submit research for VAM 2024

Organizing a Vascular Annual Meeting (VAM) takes a whole lot of time and a whole lot of long-range planning. 

Thus, members of the SVS Postgraduate Education Committee (PGEC) have already evaluated the 90 submitted proposals (an SVS record) for educational sessions at VAM 2024. And Program Committee members, who select the scientific abstracts, are looking ahead to the November opening of the abstract-submission site. 

Researchers can submit abstracts for possible inclusion from Nov. 15 through Jan. 10, 2024. 

“The science is a critical part of the Vascular Annual Meeting,” said Program Committee Chair Andres Schanzer, MD. “While VAM of course offers opportunities for participants to get together for meetings, exhibits, dinners, catching up with friends and casual events, the scientific and educational sessions continue to be a main highlight. We received the most PGEC submissions in the history of the meeting and hopefully will do the same with the upcoming scientific abstract submissions.” 

Many VAM sessions feature abstract presentations, including the large-scale plenary sessions; the International Young Surgeons and International Poster competitions; the International Fast Talk and International Forum scientific sessions; the Vascular and Endovascular Surgery Society (VESS) presentations; the “How I Do It” video session; and the Poster Competition. 

VAM 2024 will be held June 19–22 at McCormick Place in Chicago. Educational sessions will run across all four days. 

Multicenter study points to favourable safety and efficacy of radial access for peripheral interventions

By
Will Date
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0
Multicenter study points to favourable safety and efficacy of radial access for peripheral interventions
Mehdi Shishehbor

New research examining the safety and efficacy of using radial access for peripheral artery interventions has found that radial access allows early ambulation and same-day discharge with no serious adverse events.

These are the conclusions of a study published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), conducted by a team of researchers from eight prominent U.S. medical centers, aimed at examining the safety and feasibility of radial artery access for complex endovascular lower extremity interventions.

Peripheral artery interventions are commonly performed to treat vascular conditions that obstruct blood flow to the lower extremities, though traditionally these procedures have used a femoral artery access approach. In recent years, there has been increasing interest in using radial access, which involves accessing the arteries of the wrist or forearm, as an alternative approach.

From June 2020 to June 2021, 120 patients at eight centers were enrolled. The mean age of the patient population was 68.7 years and 31.7% were women. The 224 lesions treated were in iliac (12.9%), femoropopliteal (55.3%), isolated popliteal (11.9%) and tibial (19.5%) vessels.

The primary efficacy endpoint, procedural success, defined as the successful completion of the procedure without conversion to femoral access and without radial access complications peri-procedure, was achieved in 112 (93.3%) patients. One patient (<1%) required femoral access conversion to complete the procedure. Thirty (25%) patients required one or more additional access to facilitate crossing and/or to complete the planned treatment (five femoral, 10 tibial, and 17 pedal). No serious adverse events were adjudicated to the procedure. Mean procedure time and time to ambulation was 74 minutes and three hours 30 minutes; respectively, with 93.3% same day discharge. At 30 days, 97.2% of patients had ultrasound-confirmed radial access patency.

The findings of the study also demonstrate that radial access for peripheral artery interventions was associated with favorable safety profiles. Notably, the incidence of access site complications and major adverse cardiovascular events was significantly lower compared to the traditional femoral access approach. The results also showed comparable procedural success rates and long-term clinical outcomes between the two approaches.

Additionally, radial access was found to have the potential to be a safe and effective alternative for performing peripheral artery interventions. The researchers believe that the wrist and forearm offer several advantages over the traditional femoral access site, including improved patient comfort, reduced bleeding complications, and faster ambulation. Further research and clinical trials are warranted to validate these findings and establish radial access as a mainstream approach in this field, the study’s authors note.

“This study contributes to the growing body of evidence supporting the use of radial access for peripheral artery interventions,” stated Mehdi Shishehbor, MD, from University Hospitals Harrington Heart & Vascular Institute in Cleveland, Ohio, lead author of the study. “As medical professionals continue to explore different approaches, advances in technology and techniques are expected to further enhance the safety and efficacy of these procedures. With its potential to improve patient outcomes and satisfaction, radial access may revolutionize the field of peripheral artery interventions.”

Writing in the conclusion to their paper, the study’s authors note that their research shows the safety and efficacy of the radial access approach for treating complex, multilevel peripheral arterial disease. “Radial approach allowed same day discharge for most patients with no serious adverse events,” Shishehbor et al write. “Future randomized trials should examine the clinical and cost effectiveness of this approach compared with femoral access for patients with peripheral arterial disease.”

NESVS 2023: Novel IVC filter retrieval device slashes procedural time and radiation exposure during in vivo experiments, Yale researchers report

By
Bryan Kay
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0
NESVS 2023: Novel IVC filter retrieval device slashes procedural time and radiation exposure during in vivo experiments, Yale researchers report
Valentyna Kostiuk

An inferior vena cava (IVC) filter retrieval device dubbed the next-generation in removal of the venous thromboembolism-fighting tools could substantially cut procedural times and radiation exposure, according to data emerging out of in vivo testing at Yale University. 

The Articulating Atraumatic Grasper is the brainchild of Cassius Iyad Ochoa Chaar, MD, associate professor of vascular surgery at Yale in New Haven, Connecticut, and colleagues, with in vitro and in vivo testing data presented at the 2023 American Venous Forum in San Antonio, Texas, earlier this year. 

The grasper got a fresh airing during the 2023 annual meeting of the New England Society for Vascular Surgery (NESVS) in Boston (Oct. 6–8), during which presenting author Valentyna Kostiuk, a Yale medical student and aspiring vascular surgeon, showed attendees how an advanced technique currently used in practice was deployed to retrieve a tilted filter in a patient, compared to a similarly positioned filter in a porcine model that was captured using the emerging grasper. In the case of the former, the procedural time was 55 minutes. During the example taken from in vivo testing, the procedural time was 11 minutes. 

The data show great promise for the novel retrieval device to improve the efficiency of IVC filter removal procedures, Kostiuk told NESVS 2023. 

So far, in vitro testing—which involved IVC filters being anchored to the inner wall of a flexible tube simulating the IVC and a high-contrast backlit camera view simulating 2D fluoroscopy projection during retrieval in the operating room—has demonstrated comparable retrieval times between the grasper and a standard-of-care snare device to remove a retrievable IVC filter in a centered configuration. However, the grasper device was also effective to remove permanent filters in both centered and tilted configurations that could not be retrieved using a standard snare device. Additionally, Ochoa Chaar and colleagues found that grasper removal of a centered permanent filter required “significantly less time”—29 seconds vs. 79 seconds when compared to the snare removal of a retrievable filter in a centered configuration. 

In the case of in vivo testing in a porcine model, six tilted infrarenal IVC filters were retrieved with the grasper via the right jugular approach. Comparison analysis between animal and patient procedures was performed for total procedure time, and both retrieval and fluoroscopy time. 

They showed that all IVC filters were retrieved using the grasper with no adverse events. The total procedure and fluoroscopy times were reduced by more than 50% in the pig group compared to the 12-patient match group—“significantly shorter,” the Yale researchers report. “Moreover, in the patient group, 16.7% of retrievals required advanced endovascular techniques and one IVC filter could not be retrieved [success rate= 91.7%], while all the IVC filters were successfully retrieved in the animal model without the use of additional tools.” 

Kostiuk, speaking to Vascular Specialist after delivering her video presentation at NESVS 2023, highlighted the potential advance of the grasper over current standard of care in IVC filter removal. “Standard removal devices we have right now consist of a snare, so in order to remove the filter, you need to have the hook available to be captured by the snare loops,” she said. 

The more advanced current technique—involving a wire loop and a snare—that was used in the case of a 27-year-old patient with a 9-degree tilted configuration who featured in her NESVS presentation further elucidates where practice currently stands, Kostiuk explained. 

“You have one big wire loop already holding the filter, and one snare device with multiple loops, to try to capture the hook,” she said. “The problem is, if you have a filter with significant lateral tilt, the filter can abut the IVC wall, and it is really impossible to capture the hook using the snare only. Such complex configuration requires the use of a wire loop to reposition the IVC filter and make its hook more accessible to be captured by the snare device. Thus, the use of multiple devices—snares and wire loops—during advanced endovascular retrievals significantly prolongs the total procedure and fluoroscopy time, and is associated with complications.” 

The advantage of the grasper, on the other hand, lies in a novel design consisting of two unique features: the articulating arm with lateral movements that allow the grasper device to be directed to the tilted IVC filter in any configuration; and a pair of grasping jaws that can grasp the filter hook or neck—particularly useful for filters with extreme lateral tilt or hook abutment to the IVC wall, Kostiuk explained. “Even if the hook is embedded in the IVC wall, or if the filter has been there for years and the hook is covered with scar tissue and not available to be captured by a snare and wires, you can still use the grasping jaws to engage the neck of the filter and to capture the filter,” she said. “The hook is not that critical anymore.” 

Kostiuk emphasized the in vivo case featured in the NESVS video: “This procedure took 11 minutes in the pig, while the other procedure that we showed in the patient, using the wire loop and the snare—it took 55 minutes,” she said. “That is five times the amount of time to capture the filter. This also means much more radiation. So, we make it significantly safer for the patient—and faster for the vascular surgeons carrying out these procedures.” 

The Yale researchers are currently carrying out market analysis with a view to advancing development of the grasper device as they look to perform clinical studies to evaluate its safety for use in patients. 

Vascular branding: Determining a vascular surgeon’s value

By
Beth Bales
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0
Vascular branding: Determining a vascular surgeon’s value
Robert Tahara

A vascular surgeon’s value includes far more than direct revenues from procedures performed, said SVS member Robert Tahara, MD, recently. He told surgeons to remember not only these direct revenues, but also the help a surgeon provides other specialties in the hospital, as well as legal savings from “near misses—rarely considered and certainly rarely acknowledged.” 

The total will add up to considerably more than the direct revenues usually cited, he told attendees at the 2023 Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM). His presentation was part of the SVS Community Practice Section’s special educational session, “Recognizing, Enhancing and Promoting the Value of the Vascular Surgeon.” 

The presentation covered a variety of financial topics, including whether to get a master of business administration degree, a surgeon’s ancillary value, incorporating the use of advanced practice providers and more. 

The SVS for many years has sought to determine a vascular surgeon’s true value to his or her institution, Tahara said. An SVS Valuation Work Group produced “The Value of the Modern Vascular Surgeon to the Healthcare System,” report, which includes many of the details he planned to discuss. Tahara recommended surgeons read the report, which was published in February 2021 (visit vascular.org/PowellReport). 

In terms of revenues, “Direct revenue is usually the only number physicians ever talk about,” he said. However, indirect (or enabling) revenue, from helping other specialties, and “near-miss” revenue, also are important. 

The indirect revenue is that derived “from what we enable other non-vascular services to keep in the institution,” which can lead to increases in the case mix index (CMI). A higher CMI value indicates the hospital has treated more complex, resource-intensive cases, and the hospital may be reimbursed at a higher rate for such cases. “The CMI bump in indirect revenue is poorly accounted for and highly variable,” he said. In analyzing his work at his own facility, his work “added $650,000 a year.” 

Tahara also highlighted the “near-miss value, the amount of money that we just saved that hospital by scrubbing in and over-sewing that big rip in the aorta or iliac. I get about one a year,” he said. In one such case, he said, he determined his work saved $300,000 in institutional legal fees, $100,000 in legal fees for him, and $130,000 for the patient. 

With wrongful death settlements averaging $1 million, attorneys estimated that because of this patient’s age, had the “save” not occurred, a settlement in this case would have been $5 million instead. 

“This is not a trivial amount of money and never gets accounted for. Your ‘near-miss value’ is never acknowledged, but the value is substantial,” Tahara said. 

He recommended all surgeons log every near-miss, to assist when building data packages for compensation negotiations. “At least once a year you save one of these patients,” he told attendees. 

CMI and near-miss contributions nearly double a surgeon’s financial value, Tahara said. “Do your homework before negotiating with your hospital about anything,” he told the crowd. 

He summarized a vascular surgeon’s financial value: the direct revenue of $886,000; enabling revenue of $640,000; the CMI bump of $650,000; and the total from saved near-miss cases ($450,000 in legal fees plus approximately $1 million for a wrongful death settlement totaling $1.45 million). This brings a vascular surgeon’s full-time equivalent value to more than $3.62 million. “It adds up to almost double what’s quoted in the literature,” he said. 

“It is critically important that the value that a vascular surgeon brings to an institution or facility is not unrecognized,” said Robert Molnar, MD, chair of the SVS Community Practice Section. “Vascular surgeons are the hub of the wheel, and we provide the essential base needed for any hospital system to offer multispecialty care.” 

Registered VAM attendees can view the section’s session, held from 1:30–3 p.m. EDT on Friday, June 16, at vascular.org/OnlinePlanner23. 

SVS Foundation Board of Directors welcomes two new members to its leadership team

By
Marlén Gomez
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0
SVS Foundation Board of Directors welcomes two new members to its leadership team
Edith Tzeng and Palma Shaw

The SVS Foundation’s Board of Directors announced the appointment of two new board members, Edith Tzeng, MD, and Palma Shaw, MD, at the board’s fall meeting in September. Tzeng was approved as the new chair of the Foundation Development Committee. 

Tzeng is the University of Pittsburgh Medical Center chair, professor of surgery and chief of vascular surgery at the Veterans Affairs Medical Center in Pittsburgh, Pennsylvania. She brings to the board her dedication to advancing vascular surgery research and education, focusing on the problems of blood vessels healing after injury, bypass or angioplasty, and the translational potential of nitric oxide and carbon monoxide for vascular healing. 

“I am deeply honored to lead the Development Committee. Together with our dedicated team, we will continue to work diligently to support the Foundation’s mission and to further enhance the future of vascular surgery through research, disease prevention, community outreach and inclusivity,” said Tzeng. 

Shaw, recently appointed chair of the Foundation’s Industry Relations Committee, comes to the board following a bylaws change that provides a board seat for that committee chair. She is a professor of surgery at the State University of New York Upstate Medical University program and a member of the division of vascular surgery at Upstate Medical Center in Syracuse, New York. Her clinical expertise includes aortic surgery, peripheral and venous intervention, diabetic foot management and wound care. 

“I am thrilled to join the SVS Foundation board as the chair of the Industry Relations Committee. I look forward to working closely with our industry partners to advance the field of vascular surgery and improve patient care,” said Shaw. 

The Foundation’s board is committed to funding the future of vascular health through its four pillars: research and innovation, community vascular care and patient education, disease prevention, and diversity, equity and inclusion.

Vascular Health Step Challenge emerges as beacon of awareness and action

By
Marlén Gomez
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Vascular Health Step Challenge emerges as beacon of awareness and action

This September, 533 people put their feet to the ground to raise awareness about peripheral arterial disease (PAD) as part of the SVS Foundation’s Vascular Health Step Challenge. The challenge raises funds and awareness, with participants pledging to walk 60 miles throughout the month, a symbolic journey that mirrors the 60,000 miles of blood vessels in the human body. 

The annual initiative emphasizes the importance of vascular health and promotes healthy vascular habits. Funds raised during the challenge will support the future of vascular surgery and fulfill the Foundation’s mission. 

New this year was the “Pay it Forward” initiative, allowing registrants to cover the $60 sign-up fee for low-income patients, ensuring their participation in the challenge. 

The challenge saw a 77% increase in sponsorship compared to 2022. Sponsors include AOTI, Gore, Medtronic, 3M, the Way to My Heart organization, and the Society for Vascular Nursing (SVN). 

Participants in the Step Challenge have more than just the goal of a healthier vascular system to strive for; prizes await. Those who achieve the 60-mile target will receive a backpack, and those who raise $600 or more will receive a Stanley drink cup. Team members that meet the $6,000 team goal will be able to sport a Step Challenge cap, and the top individual walker and fundraiser each will receive an outdoor blanket. 

By Sept. 19, the campaign had already met its walker goal, at that point with 525 registered participants. In 2022, 457 walkers collectively raised over $80,000. Halfway through this year’s challenge, donations raised were at $60,000, and firmly on track to reach its target.

Visit vascular.org/Step23. 

SVS webinar covers insights learned from experiences of mass-casualty disasters

By
Beth Bales
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SVS webinar covers insights learned from experiences of mass-casualty disasters
an “SVS Presents” webinar in August that focused on disaster preparedness

A mass shooting in Las Vegas. A bombing at the finish line of the Boston Marathon. A shooting at a Fourth of July parade. Healthcare workers may not be on the actual front line of disasters, but they’re definitely in the pipeline for the aftermath, when victims flood hospital emergency and operating rooms. 

The question is, are those doctors, nurses, surgeons—and the institutions—ready? 

Two trauma surgeons relayed their medical centers’ experiences with mass-casualty incidents during an “SVS Presents” webinar in August that focused on disaster preparedness. The webinar looked at mass casualties and how such incidents may affect the vascular surgery community. Moderator April Boyd, MD, PhD, chair of the SVS Education Committee, said SVS members told SVS leadership, in a needs assessment survey, that they want educational programs on leadership, particularly leadership in crisis. 

Susan Briggs, MD, is an acute care and trauma surgeon and director of the International Trauma and Disaster Institute at Massachusetts General Hospital in Boston and discussed the 2013 Boston Marathon bombing. Deborah Kuhls, MD, is a trauma surgeon and medical director of University Medical Center’s Trauma Intensive Care Unit. She relayed the experiences at University Medical Center in Las Vegas following the 2017 shooting during the Route 91 Harvest music festival on the Las Vegas Strip. 

Three people were killed in the bombing and hundreds were injured, including nearly 20 who lost limbs. In the shooting and its aftermath, 60 people died and more than 850 were wounded. 

“Disaster medical care is not the same as conventional medical care,” Briggs said. That’s in terms not only of the severity of the injuries but also how likely a patient is going to survive, as well as the available resources. 

In the acute phase, providers are working on “minimally acceptable, not maximally acceptable, care due to the large number of victims,” she said, adding, “Both are difficult lessons. 

“The key principle in a mass casualty event is that the critical patients with the greatest chance of survival and the least expenditure of time and resources are treated first.” 

Vascular surgeons who partner with other physicians and surgeons frequently are invaluable members of a disaster preparedness team, both doctors said. Vascular trainees would be invaluable as well. 

“They can work with other surgeons of any specialty,” said Kuhls. “They have special skills.” 

Briggs said, “Vascular surgeons are surgeons first. They can help with almost any operation. More and more we’re getting away from titles and functional capabilities and helping each other. We utilized vascular surgeons in almost every case with trauma surgeons.” 

In the 2017 Las Vegas shooting, the shooter fired 1,100 rounds of military-grade ammunition in 13 minutes, toward more than 22,000 people at a multi-day concert on the Las Vegas strip. “We went from zero to 40 patients that were very critical within five minutes. Some had already died,” said Kuhls. 

Because Las Vegas is a tourist destination used to hosting huge events, disaster training in different scenarios, particularly among the trauma centers, occurs at least quarterly, she said. 

The shooting taught hospital leaders that “hospitals themselves need to be prepared, and not just individual healthcare workers,” said Kuhls. The Disaster Management Emergency Preparedness Course focuses on the institution as a whole, including how entire hospitals should go about doing drills and being prepared. 

Both Briggs and Kuhls relayed other lessons learned during the respective events, which are available on the video recording. 

The webinar was a collaborative effort of the SVS Education and Leadership Development committees, plus the Young Surgeons and Women’s sections. It can be viewed at vascular.org/MassCasualtiesWebinar. SVS members may watch at no charge; non-members will pay $35. 

CMS confirms broadened Medicare coverage of carotid artery stenting in final decision

By
Bryan Kay
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CMS confirms broadened Medicare coverage of carotid artery stenting in final decision

The Centers for Medicare & Medicaid Services (CMS) has released its final decision regarding National Coverage Determination (NCD) 20.7 covering carotid artery stenting (CAS), essentially confirming the coverage expansion outlined in a July proposed decision memo.

In a communique to its members today, the Society for Vascular Surgery (SVS) said the final decision contained “few substantive changes from what was proposed in July.”

CMS outlined in the decision memo, dated Oct. 11, that it had found “coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting is reasonable and necessary with the placement of a Food and Drug Administration [FDA]-approved carotid stent with an FDA-approved or cleared embolic protection device” for Medicare patients who have symptomatic carotid stenosis ≥50% and asymptomatic carotid stenosis ≥70%.

In the July proposed decision, the federal agency detailed an expansion that would significantly broaden coverage for carotid stenting, expanding Medicare coverage to individuals previously only eligible for coverage in clinical trials, removing the limitation of coverage to only high-surgical-risk individuals, and removing facility standards and approval requirements.

“While this outcome was anticipated, the SVS remains concerned,” the SVS said in its statement to members. “The SVS Executive Board will convene next week to thoroughly discuss and will issue a formal statement soon thereafter.”

Rates of stroke, death and myocardial infarction post-TCAR do not differ by patient sex

By
Jamie Bell
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0
Rates of stroke, death and myocardial infarction post-TCAR do not differ by patient sex
Vikram Kashyap

While sex disparities regarding the outcomes of carotid revascularization have “long been a concern,” new prospective data published in the Journal of Vascular Surgery (JVS) indicate that no such disparity exists between male and female patients treated with transcarotid artery revascularization (TCAR)—one of the most prominent approaches used to treat carotid artery stenosis.

Writing in JVS on behalf of the ROADSTER trial investigators, Vikram Kashyap (Frederik Meijer Heart and Vascular Institute at Corewell Health, Grand Rapids, Michigan) and colleagues report “exceptionally low” rates of stroke, death and myocardial infarction (MI) derived from prospective TCAR trial data. They further note that these low rates “do not differ by patient sex”.

Previously, several studies of carotid revascularization have demonstrated increased frequencies of postoperative death and stroke for female patients after either carotid endarterectomy (CEA), or transfemoral carotid artery stenting (CAS). In addition, adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases, the authors relay.

In prospectively analyzing results from the ROADSTER 1, ROADSTER 2 and ROADSTER Extended Access TCAR trials, Kashyap and colleagues’ objective was to investigate post-TCAR outcomes stratified by patient sex. They hypothesized that the results would be similar between males and females.

All included patients had verified carotid stenoses meeting the criteria for carotid intervention (≥80% in asymptomatic and ≥50% in symptomatic patients), and were included based on anatomical or clinical high-risk criteria for carotid stenting. The researchers’ primary outcomes were a combination of stroke/death (S/D) and stroke/death/MI (S/D/M) at 30 days, while secondary outcomes were the individual components of stroke, death, and MI.

Kashyap and colleagues included a total of 910 patients for analysis, roughly two thirds of whom were male (n=604; 66.4%). They note that female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%), and were more often of Black/African American ethnicity (7.5% vs 4.3%), as compared with their male counterparts.

“There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria,” the authors disseminate. “General anaesthetic use, stent brands used and procedure times did not differ by sex—although flow reversal times were longer in female patients, [and] more contrast [was] used in procedures for female patients.”

In addition, both the 30-day rates of S/D (2.7% male vs 1.6% female) and S/D/M (3.6% male vs 2.6% female) were similar between the two groups of sex-stratified patients. The researchers also found that these key outcome measures did not differ when patients were stratified by symptom status either. Comparable findings were identified in terms of secondary outcomes—including stroke rates at 30 days—too.

“Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR] 4.19) and S/D/M (OR 2.78), as was symptomatic presentation with increased odds for S/D (OR 2.78),” Kashyap and colleagues aver in conclusion.

SVS varicose vein guideline webinar set for Oct. 10

By
Marlén Gomez
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SVS varicose vein guideline webinar set for Oct. 10
Painful varicose and spider veins on active womans legs, self-helping herself in overcoming the pain. Vascular disease, varicose veins problems, active life concept
The roundtable will address the latest in the diagnostic evaluation of patients with varicose veins

A virtual roundtable on Oct. 10 will cover the new Society for Vascular Surgery (SVS) varicose veins guidelines. Set for 6–7:30 p.m. CDT, the session will address the latest in the diagnostic evaluation of patients with the venous condition using duplex scanning. 

The assembled faculty will use case vignettes to design treatment strategies and demonstrate how to put the recommendations from the evidence-based clinical practice guidelines into practice. 

Lead author of the guidelines, Peter Gloviczki, MD, will introduce subject matter and provide an overview. 

Other topics and presenters are: diagnostic evaluation of vein incompetence, by Mark H. Meissner, MD; compression therapy for varicose veins, by Andrea T. Obi, MD; drug therapy for varicose veins, by Monika L. Gloviczki, MD; percutaneous endovenous ablations of saphenous veins, by Jose Almeida, MD; thrombotic complications of endovenous ablations, by Peter F. Lawrence, MD; and treatment of superficial thrombophlebitis, by Suman M. Wasan, MD. 

Learn more and sign up at vascular.org/VVpart2Roundtable. 

From the editor: Sex, lies, and carotid stents

By
Malachi Sheahan III
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From the editor: Sex, lies, and carotid stents
Malachi Sheahan III

First, a disclaimer. This commentary is woefully short of sex-related content. Not even the wholesome gender-based outcomes stuff. So, if that key term brought your internet search here, feel free to press on with your illicit journeys my friend. Now, let’s get to the lies. 

In 2008, Christopher White, MD, then chair of the Department of Cardiology at the Ochsner Clinic Foundation, published an editorial accusing vascular surgeons of various crimes and misdemeanors in the nascent debate over carotid stenting (CAS) vs. endarterectomy (CEA). Eloquently titled “Liar, liar, pants on fire,” the article begins, “At the most recent Society of Vascular Surgery [SVS] meeting, held in a secret location, deep in a mountain bunker, shielded against critical and independent thinking, surgeons regaled themselves with tales of science fiction, disguised as scientific data, and told to make the endovascularly challenged among them feel safe and secure from the ‘bogeyman’ of carotid artery stenting.” Now, before everyone can post their Spidermen-pointing-at-each-other memes, I will acknowledge the inherent hypocrisy in calling out another medical editor for utilizing hyperbole and provocative titles. So let’s get to the substance of his argument. 

The two abstracts that drew White’s ire utilized national databases and showed that CEA demonstrated dramatic benefits over CAS in terms of stroke, mortality and cost. White points out the limitations of the studies, including the lack of independent neurological evaluations to document stroke. He states, “In reporting the superiority of CEA compared to CAS without any qualification, should we give the authors the benefit of the doubt that they are not sophisticated enough to comprehend the inherent ‘bias’ that invalidates their intended comparison, or have we caught them red-handed in an attempt to purposely deceive their audience?” While bemoaning the lack of a limitations section makes me suspect that White does not know how abstracts work, the request for an exam by an independent neurologist seems fair. 

So, surely when he published a study in the same issue of this journal, making the provocative claim that carotid artery stenting is safe in the very elderly (>80 years), he held himself to the same lofty standard? After all, the lead-in phase of CREST had just shown a 12% risk of stroke with CAS in octogenarians. White and colleagues, however, reported only a 1.8% risk of stroke in this same age range, even though half were performed without embolic protection. It seems that independent neurologists don’t grow on trees, though, and White’s group often employed vascular medicine physicians from his institution to perform these evaluations, despite no clear evidence that they are either independent or adequately trained to assess for stroke. So perhaps White’s group did achieve these outlier results, or perhaps, as he stated in his editorial, the underreporting of complications is a dirty little secret that is “very difficult to prove without an independent audit.” 

White also disputes the finding of higher hospital costs associated with CAS. He states that “the biased data reported in this abstract fly in the face of thousands of reported CAS patients with audited independent data who have had short hospital stays and lower or comparable procedure costs.” I wonder then what he thought of the excellent 2011 analysis by W. Charles Sternbergh, MD, which found that CAS was 40% more costly than CEA and did not provide better clinical outcomes or a reduction in length of stay. I am certain White is aware of this study, as the data came from his own institution. 

Over the past 15 years, a plethora of new data has arrived with a series of randomized controlled trials (RCTs). While many used perplexing endpoints (the inclusion of myocardial infarction [MI] seems the logical equivalent of considering ambiance while comparing delivery pizzas), and most were underpowered to detect a statistically significant difference in the risk of stroke, a clear trend emerged. CREST-1 (4.1% vs. 2.3%), ACT-1 (2.8% vs. 1.4%), ICSS (7.7% vs. 4.1%), SAPPHIRE (3.6% vs. 3.1%), SPACE-1 (6.5% vs. 5.1%), EVA-3S (9.2% vs. 3.5%), and ACST-2 (3.6% vs. 2.1%) all demonstrated a persistently increased incidence of 30-day stroke with CAS over CEA. Only CAVATAS was an outlier (7.2% vs. 8.3%), although only 504 patients were randomized. 

I was certain that White and his fellow stent enthusiasts would be happy that these new data have brought some much-needed clarity. Surely we can all agree that a good degree of caution must be employed when performing transfemoral carotid stent procedures, particularly in asymptomatic patients where the treatment efficacy is razor-thin? Well reader, I regret to inform you that I was wrong. Last year, the Centers for Medicare & Medicaid Services (CMS) accepted a formal request from the Multispecialty Carotid Alliance to consider greatly expanding coverage for carotid stent procedures while also removing several safeguards currently in place. Although “The Alliance” may sound like the bad guys from a mid-tier Liam Neeson movie, in reality, they are a collection of neurologists, surgeons and interventionalists, including White, who seemingly formed solely to petition CMS to reconsider percutaneous carotid stent coverage. 

Medicare began coverage for CAS procedures in 2001 for those performed within investigational device exempt (IDE) studies. In 2005, this expanded to high-risk patients who are symptomatic with greater than 70% lesions, which is essentially where it stands now. Currently, outside of clinical trials, no asymptomatic patients are covered. The last CMS coverage reconsideration for CAS occurred in 2009. According to the Alliance, special interest groups intervened and successfully restricted access to CAS. These “special interest groups” were the SVS, the American Association of Neurological Surgeons, and the American Academy of Neurology. 

The Alliance now requests that CMS expand CAS indications to all asymptomatic lesions >70% and all symptomatic lesions >50%. They also request the removal of all facility standards, calling them obsolete. Privileging and credentialing standards, in their plan, will be up to local hospitals. Similarly, all quality assurance would be left to the local peer-review level, eliminating the requirement for participation in a quality registry. Libertarian principles like these are usually better in theory than practice. Allowing folks to police themselves often leads to things like emotional support leopards on domestic flights. Where the evidence does not support expanding CAS indications, the Alliance is quick to find fault. They refer to the stroke/death outcomes in SPACE, EVA-3S, and ICSS as “unacceptable by 2021 standards.” They criticize the inexperience of the CAS operators and the technology and techniques employed at the time. The Alliance would have us believe that EVA-3S was performed in the 1500s by a bunch of French peasants launching stents at unsuspecting patients with trebuchets. 

In critiquing the International Carotid Stenting Study (ICSS), presumably because of its 7.7% CAS stroke rate, the Alliance notes that two operators caused five of the strokes despite enrolling only 11 patients. Even though the operators were suspended, the Alliance points out that the strokes were included in the final analysis. To this, I would reply that these practitioners were only removed because the study was carefully monitoring outcomes. How many more real-world strokes are we going to see if guardrails such as registries are removed, as the Alliance recommends? In their submission to CMS, the Alliance states that there are four modern RCTs comparing CAS to CEA in asymptomatic patients. They opine that all have shown comparable outcomes for periprocedural complications, as well as rates of ipsilateral stroke. In reality, none of the protocols were powered to detect a statistically significant difference in stroke outcomes. 

The Asymptomatic Carotid Trial (ACT-1) randomized 1,453 patients out of an intended 1,658. The study reported a stroke rate of 2.8% in the stent group and 1.4% in CEA group. Stent-Protected Angioplasty vs. Carotid Endarterectomy-2 (SPACE-2) planned to enroll 3,640 patients but only randomized 513. There were three groups: CEA with best medical therapy (BMT), CAS with BMT, and BMT alone. The five-year cumulative incidence of any ischemic or hemorrhagic stroke was 5.3% in the CEA group, 9.8% with CAS, and 6.5% with BMT. The CAS group also demonstrated the highest (4.4%) five-year cumulative ipsilateral ischemic stroke rate (2% CEA, 3.1% BMT). The Asymptomatic Carotid Surgery Trial-2 (ACST- 2) randomized 3,625 patients. The 30-day stroke rates were higher with CAS (3.6% vs. 2.4%, p=0.06) but did not achieve significance. At five years, the composite risk of ipsilateral stroke or death was 5.5% for CAS and 3.6% for CEA. The Stenting vs. Endarterectomy for Treatment of Carotid-Artery Stenosis (CREST) trial randomized 2,502 patients and did find a significantly higher risk of periprocedural stroke with CAS (4.1% vs. 2.3%, p=0.01). Of course, CREST famously used a combined stroke, MI, and death primary endpoint, which did not demonstrate a significant difference between the modalities. So even though all four modern asymptomatic carotid trials showed a higher incidence of stroke with CAS, the Alliance assures us not to worry. Why? Well, we are better now. Smarter. We have a greatly improved understanding of the anatomic and clinical characteristics that increase risk for CAS. In fact, they even provide them. 

So fans of precision medicine take note: Criterion #1— vasculopathy. Vascu-what now? In fact, of the high-risk characteristics provided by the Alliance, the majority are vague definitions like atherosclerotic arch, complex great vessel anatomy and carotid tortuosity. The Alliance correctly touts the importance of patient selection and operator experience in asymptomatic patients, yet they would like to remove all of the guardrails. 

So clearly, to offer safe treatment to patients with asymptomatic carotid disease, the practitioner must be technically experienced as well as a content expert. Where will this expertise be gained? Interest does not translate to competence. Vascular surgeons matriculate into the workforce with documented technical and educational experience in the treatment of carotid disease. For other specialties? Not so much. The words “cerebrovascular” and “carotid” appear a total of zero times in the ACGME Program Requirements for Graduate Medical Education in Interventional Cardiology. If CMS follows the recommendations of the Alliance, only one thing is certain. More transfemoral stents will be placed in asymptomatic carotid lesions in Medicare patients by interventionalists under less regulation. The Alliance states that this is in the best interests of patient care. Who is lying now? 

Malachi Sheahan III, MD, is the chief medical editor of Vascular Specialist. His opinions do not reflect SVS policy or positions.

Enrollment of first patient in Neuroguard carotid stent system trial announced

By
Jocelyn Hudson
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Enrollment of first patient in Neuroguard carotid stent system trial announced
Sean Lyden, co-national principal investigator of the PERFORMANCE III trial

Contego Medical has announced enrollment of the first patient in the prospective, multicenter PERFORMANCE III trial aimed at further evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) direct system—a carotid stent system designed for direct transcarotid access.

The study is a follow-on to the fully enrolled PERFORMANCE II study of the Neuroguard IEP system, which was conducted to evaluate the stent placed via percutaneous transfemoral or transradial access. Both PERFORMANCE II and PERFORMANCE III are being conducted under an investigational device exemption (IDE) through the Food and Drug Administration (FDA).

“We look forward to studying the Neuroguard IEP direct system and determining its potential as a new option for patients with carotid artery stenosis,” said Sean Lyden, MD, chairman of vascular surgery at the Cleveland Clinic in Cleveland, Ohio, co-national principal investigator of the PERFORMANCE III trial.

According to a company press release, the Neuroguard IEP and Neuroguard IEP direct systems leverage Contego’s IEP technology, a “unique” platform with a microfilter integrated on the delivery catheter, designed to provide added safety where it matters most—during stent placement and balloon dilation. The microfilter captures the micro-emboli that other protection mechanisms do not, giving physicians the procedural confidence that comes with advanced stroke protection in the treatment of their patients, the release adds.

The Neuroguard IEP direct system also includes a novel, single-access point blood flow reversal system specifically designed for direct transcarotid access. The system is a three-in-one catheter with the stent, balloon and microfilter all in one device, minimizing catheter exchanges and improving treatment efficiency. In addition, Neuroguard utilizes FlexRing stent technology, which Contego says provides the best properties of both open- and closed-cell stents while leveraging the proven, long-term material performance of nitinol.

Obituary: Roger M. Greenhalgh (Feb. 6, 1941–Oct. 6, 2023)

By
Jocelyn Hudson
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Obituary: Roger M. Greenhalgh (Feb. 6, 1941–Oct. 6, 2023)

Roger Malcolm Greenhalgh, MD, the surgeon internationally renowned for his unparalleled contribution to vascular education, training and research, died peacefully on Oct. 6. He was 82. At the time of his death, he was emeritus professor of surgery at Imperial College in London and head of its Vascular Surgery Research Group.  

Professor Greenhalgh, born in Derbyshire, was not from a medical background. His parents were very entrepreneurial in their different ways, and his grandfather, Fred Poynton, broke the world record in road walking over 20 miles in 1924. He went to Ilkeston Grammar School, a state school with entry by scholarship only. There he followed the advice of his headmaster, John Hewitson, that he should consider medicine as a career. He was the first in his family to attend university. Within a term of arriving at Clare College, Cambridge, his medical tutor, Dr. Gordon Wright, predicted that Roger would be a surgeon. At St. Thomas’s Hospital in London, he qualified as a doctor and was allowed to move up the surgical ladder with a rotation to learn research methods at the Hammersmith Hospital after his surgical training at St. Thomas’s. During this time, he discovered a love of vascular surgery. The pioneer vascular surgeon, Peter Martin, inspired him by saying that he would go on to solve problems that he could not. Whilst in training, in 1974, he won the prestigious Moynihan Fellowship of the Association of Surgeons of Great Britain & Ireland. The £1,000 stipend enabled him to visit many worldwide vascular centers of excellence using the connections of his mentors, including Martin, Frank Cockett and Professor Gerry Taylor.  

Roger joined the surgical consultant staff as senior lecturer at Charing Cross Hospital in 1976, less than 10 years after being a medical student. His career did not follow a conventional path by moving from the St. Thomas’s system to St. Barts and, finally, to Charing Cross. He went on to become professor of surgery, head of the university department and dean of the Charing Cross & Westminster Medical School for four years, between 1993 and 1997, during which time he oversaw a merger with Imperial College London. His junior at St. Bart’s and then secretary of the Vascular Society of Great Britain and Ireland (VSGBI), Professor Bruce Campbell, said to Professor Greenhalgh, who was the millennium president of the Vascular Society from 1999–2000: “You always do your own thing, you know you do.” 

Michael DeBakey (far left), Karin Greenhalgh and Roger Greenhalgh in 1989

Professor Greenhalgh’s long and distinguished research career started with an interest in hyperlipidemia when he was a resident, during which he attempted to elucidate the role played by serum lipids and lipoproteins in arterial disease as lead author of a 1971 paper published in The Lancet. His research, with more than 300 original published papers, spanned all areas of vascular surgery: venous, carotid, peripheral and aortic. His most significant contributions came from his early adoption of the rigor of prospective randomized trials to address the gray areas in vascular disease management. He led more than a dozen trials in the field of aneurysm management to promote level-one evidence in clinical practice, including the UK Small Aneurysms Trial (UKSAT) and the UK endovascular aneurysm repair (EVAR 1 and 2) trials. UKSAT was the first trial to show that there was no long-term survival benefit of early elective open repair of small abdominal aortic aneurysms. The 15-year follow up of the EVAR 1 and 2 trials were published in The Lancet in 2016 showing EVAR has an early survival benefit but an inferior late survival compared with open repair, which needs to be addressed by lifelong surveillance of EVAR and reintervention if necessary. Professor Greenhalgh was also the principal investigator of the mild to moderate intermittent claudication (MIMIC) trials, which finally proved the adjuvant benefit of angioplasty over supervised exercise and best medical therapy in patients with stable mild and moderate intermittent claudication.   

Inspired by the impact of these many landmark trials, Andrew W. Bradbury, the Sampson Gamgee Professor of Vascular Surgery at University of Birmingham, England, and principal investigator of the randomized controlled BASIL trials, wrote to Professor Greenhalgh: “Your achievements are greater than anyone alive or dead.” Professor Bradbury recently presented first-time results from the BASIL-2 trial at the 2023 Charing Cross (CX) International Symposium during a session chaired by Professor Greenhalgh. 

Professor Greenhalgh founded the Charing Cross series of international symposia and annual books in 1978 when he was 37 years of age. This started as a small, focused symposium, with topics such as smoking and arterial disease, held at the Charing Cross Hospital. The earliest symposia had just 100–200 delegates but were always accompanied by a book covering the main presentations and discussions. The CX Symposium has grown exponentially and has been forced to move to much bigger venues to cope with the increasing popularity of the meeting, which peaked at over 4,000 in-person attendees in the years immediately before the COVID-19 pandemic. Pioneers such as Michael DeBakey, Denton Cooley, Jesse Thompson, John Mannick, John Bergan, Jimmy Yao, Ted Diethrich, Juan Parodi and Frank Veith have all graced the podium. Tom Fogarty spoke of his catheter and Andreas Grüntzig spoke of his angioplasty in the 1980s. Julio Palmaz gave news of EVAR at CX 1990. CX continues to provide top-class vascular education and critical discussion of cutting-edge developments in the management of vascular disease. Professor Greenhalgh presided over the 45th symposium earlier this year. Many speakers feared his acerbic wit and the tolling of the bell if they strayed overtime.  

Princess Anne attends the CX Symposium in 1982

Professor Greenhalgh, who was quick to embrace digital methods of transmission, recently spoke from the state-of-the-art CX Vascular studio in London to detail the global interest in the Charing Cross brand of education. In 2023, the symposium saw registrations from 2,500 in-person attendees and an additional 7,000 people participated digitally, tuning in mainly from China. He was always in his element at the CX podium, his secret passion for the theatre on full display, enjoying the cut and thrust of discussing the current, hot-button issues in the vascular field with global experts. Age did not wither nor custom stale his delight in unpicking an argument to get to the core of the matter, always endeavoring to outline the research and education required to drive the topic forward. In the days before his passing, Professor Greenhalgh’s passion for the quality of the CX Symposium program burned brightly right to the very end as he worked on the CX 2024 version in the Hammersmith Hospital’s De Wardener ward intensive care unit.  

Professor Greenhalgh played a pivotal role in the creation of the European Society for Vascular Surgery (ESVS) and the establishment of its journal. The ESVS was launched at CX in 1987 and Professor Greenhalgh wrote the constitution. He was founder and chairman of the editorial board for the European Journal of Vascular and Endovascular Surgery (EJVES) from 1987–2003. He became the first ESVS European honorary member because of his role in the ESVS foundation. He also played a major role in the development of surgical training and standards across Europe through his role as president of the European Board of Surgery for the European Union of Medical Specialists (Union Européenne des Médecins Spécialistes—UEMS) from 1998–2002 and the European Board of Vascular Surgery (2002–2006). The European Board of Vascular Surgery honored Professor Greenhalgh as Honorary Life President in recognition of his founding role. 

His brilliant surgical skills were recognized by innumerable international surgical societies as well as the White House Medical Unit for the support he provided during the visit of President George H. W. Bush to London in 1991. More recently, Professor Greenhalgh became a company director, founding BIBA Medical with his son, Stephen, in 1994. Professor Greenhalgh was editor-in-chief of the company’s foremost medical publication, Vascular News, from its inception in 1999–2023, overseeing a total of 100 editions of the newspaper in this time. He captured his experiences in the roles of surgeon, professor and company director in his 2011 autobiography, Born to be a Surgeon. 

Roger Greenhalgh receiving the first Living Legend or International Lifetime Achievement Award from the Society for Vascular Surgery (SVS) in 2018 from Enrico Ascher

Professor Greenhalgh received recognition for his lifelong contributions to vascular surgery from multiple prestigious groups, including most recently, an honorary Fellowship of the American College of Surgeons in October 2018 and the first Living Legend or International Lifetime Achievement Award from the Society for Vascular Surgery (SVS) in June 2018 after being nominated by the ESVS. Enrico Ascher, of New York University in New York City, who presented the award and is a past president of the SVS, said of Professor Greenhalgh at the time: “He leads by example. Not only by his contributions, or his political influence, or his knowledge, or trials, but actually as a person. As a person who is totally committed to his profession, to his family, to his friends, to his peers. He thinks first about them, and not about himself. That is what makes him a moral leader, and what sets him apart.” 

Writing in EJVES following Professor Greenhalgh’s receipt of this award, his long-time research partner, Professor Janet Powell, of Imperial College in London, England, described him as a “brilliant” clinician with a “long and distinguished” research career, as well as highlighting his prowess as an educator and mentor, noting that “medical students and junior doctors have queued for the opportunity to work in his team.” She also hailed him as a “legendary figure” whose wit, humor and charm “have made him many friends across the world.” 

Professor Greenhalgh had many sporting skills and interests. He rowed in international regattas with future Olympian, Peter Thomas, at stroke whilst he was captain of boats as a medical student at St. Thomas’s Medical School. He remained a strong supporter of the Imperial College Boat Club and even had a boat named after him. His love of skiing saw him create the Association of International Vascular Surgeons (AIVS), which was used to forge international professional friendships and the AIVS continues to this day under the chairmanship of Mark A. Adelman. He was supported throughout by his Austrian wife, Karin, whose ability to speak multiple European languages and communicate with people from all cultures, proved invaluable.  

Roger Greenhalgh was married to Karin Maria (née Gross), who died in April 2020 from COVID-19. They were happily married for over 55 years and her constant support was integral to his success. He was at his most relaxed amongst his family. He is survived by his two children, Stephen (Lord Greenhalgh) and Christina, and three grandchildren Sebastian, Francesca and Marcus, of whom he was immensely proud. 

The Professor Roger M. Greenhalgh book of condolence can be found here: https://www.memorialstory.com/memorials/8cb0e8f5-acc6-49b4-8ffa-ebe3047d2cba/roger-malcolm-greenhalgh. Please post your messages, stories and photos to commemorate his life and legacy.

Behind the procedure: Removing in-stent thrombosis with the RevCore Thrombectomy Catheter

By
BIBA Publishing
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Behind the procedure: Removing in-stent thrombosis with the RevCore Thrombectomy Catheter
Rishi Roy

This advertorial is sponsored by Inari Medical.

For patients with in-stent thrombosis (IST), one of the most critical unmet needs has been an effective method to remove acute-to-chronic material. Here, Rishi Roy, MD, a vascular surgeon at Advanced Vascular & Vein Associates in Flowood, Mississippi, discusses his experience with the first mechanical thrombectomy device to be able to do so—the RevCore thrombectomy system.

RevCore is a minimally invasive, over-the-wire device indicated to treat thromboemboli in the peripheral vasculature, including venous stents. It includes a catheter with an expandable element for venous stent treatment. It also has a reinforced catheter shaft for precise movements and a diameter-control knob for adjusting the element to treat vessels 6mm-plus and venous stents from 10–20mm. 

Prior to RevCore, how did you treat in-stent thrombosis? 

Previously I would take a multimodal approach using suction thrombectomy, along with balloon venoplasty, or even a non-compliant balloon. The goal was to get some lumen gain, to restore some outflow to decompress the limb. 

How does this new device work? 

RevCore makes it possible to extract thrombotic material from an occluded stent. The diameter of the coring element can be increased or decreased manually to accommodate the size of the vessel . You engage or disengage with the stent, as needed, and you can be more aggressive as you work through the material that caused the occlusion. 

How do you size the catheter and capture liberated clot? 

When sizing the element in the stent, low and slow is key. There is a tactile feel to the device when “revving,” and it’s important to note resistance level. Some resistance is good—too much means the element is likely oversized and should be decreased by turning the external diameter-control knob to the minus sign on the handle. An important consideration for these cases is to have another device placed in the inferior vena cava (IVC) to capture the cleared material. 

When do you know that RevCore worked? 

Immediately postprocedure, I can gauge whether the device worked when I visualize blood flow on imaging. Because the device is new, I have an intensive follow-up protocol and, working with a wound care group, even closer follow-up is possible. I generally see the patient back in four weeks. After that, we see them at three and six months, and then every six months. If over a two-year period we don’t see recurrent stenosis, and the patient is comfortable, we could get it down to once a year. 

What anticoagulation regimen do you give these patients? 

I send them out on either a novel oral anticoagulant (NOAC) or Coumadin. You know, people often ask me, “Which do you prefer?” My honest answer is I prefer whatever the patient can afford. Because if they can’t afford a NOAC, then they’re not going to take it, and we’re back at square one. 

How do you think RevCore will change the treatment pathway? 

RevCore allows us to consider intervention sooner for patients who are suffering from symptoms related to IST. Some had stents placed when they were in their 20s or 30s, and when these stents are put in, they’re in forever. Now it’s decades later, and they have recurrent IST with chronic material that requires reintervention every three-six-eight months for symptom relief. Now, if we can debulk and get back to the original stent diameter, that patient will require close follow-up every six months or so, but they may be able to go for a couple of years between interventions. Fewer interventions also means decreased anesthesia time, operative time, chance of adverse events and morbidity. If we can decrease the number of cases because we’re able to remove IST in a single procedure, that’s a game changer. 

Case report: Complete thrombus extraction after severe right EIV stent stenosis 

Patient history 

A man in his mid-50s presented with ulceration and swelling in his right foot with the intention to transfer care. Several months prior, a right external iliac vein (EIV) to right common femoral vein (CFV) stent had been placed. A venous duplex ultrasound study showed proximal stent occlusion and non-occlusive venous thrombosis in the left proximal femoral, popliteal, posterior tibial, and gastrocnemius vessels, as well as thrombosed varicosities. Right lower extremity venography and intravascular ultrasound (IVUS) performed two-and-a-half weeks later confirmed 65% stenosis of the left EIV stent (image A). An in-hospital mechanical thrombectomy and balloon angioplasty procedure was planned. 

Procedural overview 

The patient was positioned supine and ultrasound guidance was used to access the right CFV. A J-wire was advanced into the IVC. An 8F sheath was placed and a venogram showed stenosis within the right EIV stent (B). Similarly, access was gained to the left CFV, and a J-wire was advanced into the IVC. An 11F sheath was placed and a venogram confirmed there was no stenosis in the selected segments. 

A FlowTriever catheter (Inari Medical) was advanced over a stiff wire to the infrarenal segment of the IVC, and two of the catheter’s XL disks were deployed. From the right side, a stiff wire was advanced to the IVC via a Bern catheter (Boston Scientific), followed by an Amplatz wire. The catheter was removed, and then a 16F sheath was placed. 

IVUS was performed in the IVC, revealing that the stent extended into the very distal IVC; no stenosis was seen. IVUS of the right common iliac vein (CIV) showed overlapping stents but no stenosis. A venous ultrasound probe inserted to the level of the right EIV showed 50–60% stenosis. IV heparin was administered. 

The RevCore catheter was advanced over the Amplatz wire to the right EIV, and the coring element was deployed within the stent in an unexpanded state. The coring element was then slowly enlarged and rotated, loosening the material within the stent. RevCore was then withdrawn and cleaned. A Triever16 Curve catheter (Inari Medical) was advanced and suction thrombectomy performed, removing a combination of subacute and chronic thrombotic material (C). Balloon venoplasty of the stented portion of the right CFV, EIV and CIV was performed with an 18mm noncompliant balloon. 

Additional passes with the Triever16 Curve catheter were conducted along the right iliac segments and within the IVC, removing thrombotic material that had been captured by the FlowTriever XL disks. Thrombus capture with either FlowTriever XL disks or the Protrieve sheath is critical to the RevCore procedure. Blood was returned to the patient using FlowSaver. 

A final IVUS showed nearly 100% lumen gain, restoring the right EIV to CFV in-stent diameter to 16.4 mm (D). A final venogram demonstrated appropriate flow through the right CFV, EIV, CIV and IVC, and resolution of the stenosis within the right EIV (E). The FlowTriever disks and all other devices were removed, and manual pressure was held. 

Total procedure time: 40 minutes. Estimated blood loss: <50mL. The patient tolerated the procedure well. He was discharged on dabigatran the following day. At four-week follow-up, stent patency was maintained per venous duplex ultrasound, and the patient’s right lower extremity pain and edema had improved. Progress was also seen in a previously non-healing ulceration of the right foot. 

He will continue wound care and daily medication and return every six months for repeat imaging. 

Conclusion 

Use of the novel RevCore system (F) allowed for thorough extraction of in-stent thrombosis and complete lumen restoration post-thrombectomy, with sustained patency and symptom relief at follow-up. The results show promise for improving quality of life in patients who had exhausted their treatment options previously. 

Vascular Specialist–October 2023

By
Bryan Kay
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Vascular Specialist–October 2023

In this issue:

  • Preventing spinal cord ischemia: Novel techniques for direct segmental artery revascularization show promise
  • Eastern Vascular: New data chart underrepresentation of women at the head of national clinical trials
  • Women’s champion: Freischlag marks out value of diversity and surgeons as hospital leaders
  • From the Editor: Malachi Sheahan III, MD, on sex, lies and carotid stents 

 

EVS 2023: New data chart underrepresentation of women at the head of national clinical trials

By
Bryan Kay
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EVS 2023: New data chart underrepresentation of women at the head of national clinical trials
Valentyna Kostiuk

The underrepresentation of women vascular surgeons in national clinical trial leadership formed the central theme of data coming out of a new study that probed all clinical trials in five main areas of vascular disease between 1997 and 2003. 

Delivered before the 2023 Eastern Vascular Society (EVS) annual meeting in Washington, D.C. (Sept. 7–9), investigators revealed that female vascular surgeons constituted 10.3% of all investigators leading clinical trials, with solo female principal investigators (PIs) making up just 9%. Additionally, only 5% of women vascular surgeons were solo PIs on industry-sponsored trials, and women were also less likely to lead interventional compared to non-interventional treatment trials, EVS 2023 heard. 

The data were presented by Valentyna Kostiuk, a medical student from Yale School of Medicine in New Haven, Connecticut, who opened her talk with a baseline remark: “Female vascular surgeons constitute about 15% of the workforce, but remain underrepresented in vascular societies and NIH [National Institutes of Health] funding. Additionally, female patients are more likely to be enrolled in clinical trials if they are led by female investigators.” 

To evaluate representation, the Yale study group looked at all national PIs, their specialties and their presenting gender. When comparing vascular surgeon PIs to non-vascular surgeon PIs, female investigators constituted 10.3% in the vascular surgeon group compared to 19.9% of investigators in the non-vascular surgical group, Kostiuk said. 

They looked at 114 clinical trials focusing on abdominal aortic aneurysms (AAA), analyzing 101: these were led by 125 vascular surgeons, of which 8.8% were women. Similarly, 138 carotid disease trials were identified, with 122 analyzed. This revealed that 38 were led by vascular surgeons, with 13.2% of them women. Another 100 hemodialysis access trials yielded 86 for analysis. These were led by 52 vascular surgeons (9.6% women). In the venous space, 26 thrombectomy and stenting trials showed 30 vascular surgeon as PIs, with 15.4% of them women. Finally, 536 peripheral arterial disease (PAD) trials yielded 432 for analysis, with 169 headed up by vascular surgeons (10.7% women). 

“Overall, out of all the investigators, for five major vascular conditions, 10% of them were female investigators,” explained Kostiuk. “On subgroup analysis, we looked at clinical trials led by solo PIs, and 9% of these PIs were women. Additionally, women were less likely to lead clinical trials investigating interventions compared to non-interventional treatments. For industry funding, we identified 11% of investigators as women for non-industry sponsored clinical trials as compared to 8% for industry sponsored trials. Out of this 8%, 5% were solo female investigators.” 

Kostiuk concluded by pointing toward the 10.3% figure, which constituted the representation of women vascular surgeons in national clinical trial leadership. “This study identifies a specific issue with diversity and inclusion in our specialty,” she said. “It represents an opportunity for growth and improvement, and also encourages vascular societies and industry sponsors to define pathways for women to lead clinical trials.” 

In response to a query from the EVS audience, Kostiuk said the Yale research team will now look to break down whether the numbers are improving over time or remain stagnant. “The numbers are low and could be improved.” 

Last month, Vascular Specialist reported on the issues surrounding gender representation at the head of clinical trials and female patient enrollment. One of the starkest portraits of the scene was painted by leading vascular surgical voice Melina R. Kibbe, MD, in an interview. 

“We would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and, ultimately, better outcomes in women,” stated the dean at the University of Virginia School of Medicine in Charlottesville, Virginia, as she reflected on two decades of missed opportunities, the underrepresentation of women as clinical principal investigators (PIs), and women’s under-enrollment as participants in vascular trials. 

George Lavenson, Vietnam and Gulf War veteran, advocate for carotid disease screening in seniors, dies

By
Benjamin W. Starnes
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George Lavenson, Vietnam and Gulf War veteran, advocate for carotid disease screening in seniors, dies
George S. Lavenson Jr.

George S. Lavenson Jr., lovingly referred to as “Doc” by his many friends, died Saturday, Aug. 19, 2023, on the beautiful island of Maui, Hawaii, where he chose to share a life in majestic Lahaina with his loving wife, Judy. He was 91. George leaves behind four children, Mark, Jim, Patricia and Dean, and three grandchildren, Kelsey, Luke, and Oliver. 

As a vascular and general surgeon, George worked tirelessly up until his last days educating and advocating for screening seniors for stroke prevention. When not at his desk researching and writing, George enjoyed reading, cooking, photography, jazz, flying, surfing, cycling, and driving his bright candy-apple red Miata, or cruising on his yellow Harley Davidson motorcycle around the island. 

Born in Tacoma, Washington, on Jan. 29, 1932, George graduated from the University of Washington in 1954, and the University of Washington School of Medicine in 1957. He completed his residency in general surgery at Tripler Army Medical Center in Honolulu in 1965. George went on to complete a vascular surgery fellowship at Walter Reed Army Medical Center in 1968 under the mentorship of Col. (retired) Norman Rich. 

George served as a surgeon in the Vietnam War with the 24th Evacuation Hospital in Long Binh in 1968 and 1969, and was one of the pioneers of Doppler ultrasound to assess blood flow and viability in injured extremities on the battlefield. As an active-duty Army surgeon at the time, stationed at William Beaumont Army Medical Center in El Paso, Texas, George presented this first-of-its-kind experience as a study and manuscript from the podium at the International Society of Cardiovascular Surgery (ISCVS) in Philadelphia in June 1971. The paper was accepted two weeks later and published in Archives of Surgery (now JAMA Surgery) later that fall. Traveling to Philadelphia as an Army officer in 1971 and presenting this paper in uniform amidst the intense anti-war sentiments of the country at the time was undoubtedly an act of courage itself, not to mention the groundbreaking clinical results from their downrange experience using Doppler ultrasound. 

Later in life, George returned to active duty during the Persian Gulf War with the 44th Evacuation Hospital in Saudi Arabia. Despite his civilian practice and then distance traveled when he lived in Lahaina, George had an unwavering commitment to military surgeons and trainees. 

He showed up. George rarely missed the annual December meeting of the Military Vascular Surgery Society in Bethesda, Maryland. He made in-person visits to Walter Reed and the Uniformed Services University to see faculty, residents, and students. And, since Frank Veith, MD, started them at the VEITHsymposium in 2005 or 2006, George never missed sessions that are a tribute to military surgery. 

For a decade-plus, as military surgeons were enduring deployments and caring for the injured during the Iraq and Afghanistan wars, George was present to discuss cases, provide his perspectives and, most importantly, his encouragement. Nothing epitomized George’s commitment to military surgery more than his volunteering to participate in the Society for Vascular Surgery Senior Visiting Surgeon Program, which included him spending time at Landstuhl Regional Medical Center in Germany during the height of the wars. After 20 years of service as an Army officer, George never abandoned the needs of military personnel, volunteering his trauma surgical and critical care skills at various times and in various locations. 

Most recently, during the COVID-19 pandemic, George volunteered to participate in the Department of Defense’s global pandemic response teleconferences. George joined remotely during the spring of 2020 from his home in Lahaina, astutely pointing out the similarities between COVID-related pulmonary dysfunction and lessons he and his generation had learned from managing Da Nang lung in the combat-injured in Vietnam five decades earlier. George was enthusiastic in conveying his wartime critical care experience, and his perspective as to how today’s Military Health System might optimize management of pulmonary failure amidst the pandemic. 

In addition to his years of military service, George had a busy clinical practice in Visalia, California, for 30 years, serving as chair of the Department of Surgery from 1978–1983. 

Amongst George’s proudest achievements in civilian medicine was development of a cost-effective stroke prevention screening protocol involving the “LAV Scan” after his own name. George’s innovation and lifelong advocacy for stroke prevention was recognized and honored by the Western Vascular Society as recently as last year. On his deathbed on Aug. 17, George wrote his final statement: 

  1. Carotid artery disease is the leading immediate cause of strokes. 
  2. Some 80% of cases in carotid artery disease are asymptomatic prior to the stroke that it causes. 
  3. The only possible means of reducing strokes in a large epidemiology scale is to find asymptomatic carotid disease so that a stroke can be managed preventively by screening senior populations for asymptomatic carotid disease. 
  4. Controls for proper application can be applied. 
  5. How to screen seniors: The only way to find carotid artery disease is to screen seniors, which can be done with a LAV Scan. 

George’s presence was a constant for decades and he will be greatly missed. But rest assured George’s legacy lives. Rest in peace George. Mahalo. 

Online condolences: www.NormansMortuary.com. Donations in George’s honor can be made to The Red Cross Maui Disaster Relief Fund. 

MVSS 2023: Human Acellular Vessel proves ‘safe, effective bypass conduit’ in complex CLTI cohort

By
Bryan Kay
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MVSS 2023: Human Acellular Vessel proves ‘safe, effective bypass conduit’ in complex CLTI cohort
Sebastian Cifuentes reports results from a recent study of the Human Acellular Vessel in a cohort of CLTI patients

An investigator-sponsored clinical study conducted at the Mayo Clinic in Rochester, Minnesota, of the investigational Human Acellular Vessel (HAV) in patients with chronic limb-threatening ischemia (CLTI) was presented at the Midwestern Vascular Surgical Society (MVSS) annual meeting in Minneapolis, Minnesota (Sept. 7–9). 

Delivered by Sebastian Cifuentes, MD, from the Department of Vascular and Endovascular Surgery at the Mayo Clinic, the researchers concluded that in the clinical study the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage. 

The presentation reported the outcomes of 29 patients—with a mean age of 71 who had no available vein to use as a bypass graft—who underwent HAV implantation. Of these patients, 97% had previously experienced unsuccessful revascularization procedures on the extremity and 21 (72%) had tissue loss or gangrene. Based on the state of this disease, this patient group had a 30–50% one-year risk of amputation. Notably, surgery in 22 (76%) patients necessitated a tibial artery target, a surgical procedure involving the fusion of two 42 cm long HAVs to achieve the required bypass length. The Mayo team, led by Todd Rasmussen, MD, reported that the operations to implant the HAV achieved a 100% technical success rate, without any HAV-related major adverse events reported. At a median follow-up of nine months, the secondary patency rate for patients implanted with the HAV was 72%. The limb salvage rate was 86%, corresponding to only a 14% amputation rate. 

“In a complex cohort of patients with CLTI and no autologous options, the HAV is a safe and effective arterial bypass conduit,” Cifuentes reported at MVSS 2023. “This experience using the Food and Drug Administration (FDA) Expanded Access Program provides real-world data that can inform regulatory deliberations and future trials of the HAV. Further studies will evaluate the HAV as a first-line bypass conduit to define patency and limb-salvage potential in less severe cases of CLTI.” 

The HAV, a bioengineered tissue, is under investigation as an infection-resistant alternative for revascularization. Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons and to reduce discomfort and complications for patients. The HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and PAD, Humacyte, the company behind the product, reports. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. 

Meanwhile, Humacyte also recently announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. A company press release reported that the single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the FDA during the fourth quarter of 2023. 

The V005 trial was a single-arm study conducted in the U.S. and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events. Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft. As a result, had the patients not received the HAV, they likely would have been treated with synthetic grafts, ligation of the bleeding artery, and/or amputation. 

MVSS president outlines why vascular surgery is special and how ‘people need to know what we do’

By
Bryan Kay
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MVSS president outlines why vascular surgery is special and how ‘people need to know what we do’
Jeffrey Jim at MVSS 2023

Outgoing Midwestern Vascular Surgical Society (MVSS) President Jeffrey Jim, MD, used his recent presidential address to call upon vascular surgeons to spread the word far and wide—from Main Street to hospital C-suites—of what marks out vascular surgery as the truly “special” specialty. 

Jim struck on familiar themes during the talk at the 2023 MVSS annual meeting in Minneapolis, Minnesota (Sept. 7–9): the uniqueness of vascular surgery as a comprehensive provider of vascular care; the roots of the “vascular firefighter” analogy; and the value of the specialty to a hospital system. He prefaced with a slight apologia that the content of his talk might lean pollyannaish, but his core purpose was unwavering: that “vascular surgery is the best”—and here is why… 

What do patients do when they need medical help? “Call a medical doctor,” Jim expanded. “When a medical doctor needs help, who do they call? They call a surgeon. When a surgeon needs help, who do they call? A vascular surgeon.” He delved into the necessity of vascular surgical presence in the context of case mix indexes so complicated, they cannot function without vascular being called in. Vascular surgery is the best, Jim told his audience—“and how can we keep it that way?” 

So how should vascular surgeons go about doing so? 

“We know [all this],” Jim continued, “but we need to spread the word. For the longest time we have been hiding out—walking in, walking out. We need to own vascular disease in the community.” 

If that means heading out into the community to give a rudimentary talk about what vascular disease is, “you need to do it,” he implored. If the setting is a dinner with other healthcare providers, ditto, Jim said. “We need to let them know. We are the ones with the complete toolbox. We need to collaborate and explain what we do and how we can help them.” 

Top of mind, too, should be letting leadership figures and hospital administrators in on the vascular story, “because I think we are very undervalued,” he commented. “People barely know what we do.” 

It can play out along tired conversation lines, Jim outlined: “Are you in the cath lab? Are you doing open? Are you doing endo? 

“We are much more than that,” he emphasized. “We are there to make sure we promote a safe environment, and we let them go ahead and do other service lines. We let them do other cases that otherwise they are not going to be able to do, because we are there to back them up. You need to take ownership and make sure people in your hospital system know that.” 

Vascular surgeons also need to become the leaders of quality in vascular care, Jim said. “We may be small in number, but we are really knowledgeable. We happen to have very diverse experience of what we do. We need to look at patient outcomes and experience.” 

Cost-effectiveness, too, requires vascular leadership, he pointed out—and independent of specialty. “We can’t just sit there and have arguments with people that we are better because we are vascular surgeons, or you’re not as good because you’re not. We need to talk about who is actually giving better cost-effective care.” 

Jim also called out the special nature of vascular surgery in terms of how it plows an innovation trail. In that particular vein, he highlighted the Midwest region of the U.S. as particularly fertile ground. 

“I think there is something unique about the healthcare system in the Midwest,” he said. “We have gigantic hospitals. Not that they don’t have big hospitals at UCLA, Stanford, LSU, but we have really big hospitals everywhere. We take care of a lot of surrounding areas, rural areas, and, because of that, I think we have the ability to get high, significant clinical volumes that you might not always get in the big populated city.” 

Ergo, the opportunities to advance vascular care by innovation abound. 

In his own case, Jim has become known for his special interest in carotid disease and his work with Silk Road to train vascular surgeons in the use of transcarotid revascularization (TCAR). “One of the things I am really proud of is when I go teach the course, I don’t care whether you do the procedure,” he said. “But if you are, I want to make sure you do it right— that’s what vascular surgeons do.” 

Expiation, Karl Wallenda, Oppenheimer and us

By
Arthur E. Palamara
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Expiation, Karl Wallenda, Oppenheimer and us
Arthur E. Palamara

On March 22, 1978, Karl Wallenda went up on a high wire in Puerto Rico strung between two high-rise buildings. There was no safety net. The winds were blowing hard. A crowd was massed below, awaiting the event. As a seasoned circus performer, he knew that a star never disappoints the crowd. Even at the risk of his own death. He was the founder of the world-renowned family circus troupe called The Great Wallendas, famous for performing daredevil acts without a safety net. 

In 1962, The Great Wallendas began forming their “human pyramid,” a stunt they had been performing for many years. As they made their way to the wire, the pyramid collapsed. Two family members were killed and one was paralyzed. Karl, the patriarch of the family, managed to catch one performer with his legs, saving his life. Karl ultimately fell, broke his ribs, but miraculously survived. Although he continued to perform, the memory of that tragic day haunted him incessantly. 

On that day in 1978, standing ringside at Madison Square Garden, I was watching Tito Gaona, renowned aerialist for the Barnum and Bailey Circus, attempt his quadruple somersault. He was a master in his own right, performing the triple somersault so effortlessly that it became boring. He came out of the rotation easily, but his catcher, his cousin Laio Murillo, could not hold on, and Tito fell to the net. As show time approached, they tried four times and gave up. 

Tito and his cousin went to their dressing room to change into their costumes. The ringmaster could be heard in the background starting the show. “Ladies and Gentlemen, and children of all ages…” bellowed in the distance. The show had begun. Tito and his cousin came into the doctor’s office, a few paces from the Madison Square Garden arena, waiting for their event. The office was a hangout for entertainers, security guards, executives and whoever passed by to chew the fat, and often to receive a vitamin B shot, which they thought was universally curative. A cheap black-and-white television, perched on the desk, droned mindless blather. As Tito and his cousin entered, programming was interrupted to announce a tragedy that had just occurred in Puerto Rico: the great Karl Wallenda had fallen to his death. 

We stood there in stunned silence. The reporter described the scene and attempted to attribute cause. “Karl should have never been up there in the first place; the wire had not been set properly; the winds were too high; he was too old.” He was a great performer for the ages, he continued. 

After several minutes of reflection, Tito broke the silence remarking: “Karl has finally paid for his sin.” It was a statement that seemed incongruous with those offered by the television reporter a few moments earlier. The group standing around the TV performed similar tricks and risked their lives nightly. Clearly their protective confidence had been penetrated by Karl’s death. 

Afraid to break reverence of the moment, I mindlessly blurted, “What sin?” 

Tito replied, “Karl never dropped his pole. Doing so, he may have killed spectators below. But, had he done that, he could have pulled himself back onto the wire and saved himself. He knew it was time to pay for his sin”: the human pyramid that had killed members of his family, for which he had never forgiven himself. 

Self-reproach takes many forms. 

Oppenheimer—both the film and the individual—is a complex depiction of existential choices faced by imperfect men at critical junctures in human history. “Oppie,” as he was called by his friends, was a Jewish scientist and an expert in quantum physics, tasked with the responsibility of creating the atom bomb. He was selected because of his intense desire to avenge the death of Jews in the Nazi concentration camps. J. Robert Oppenheimer was offered the responsibility of creating a weapon so powerful it would redefine warfare. It would also instill existential fear. Like Prometheus, who brought both salvation and fiery destruction to humanity, this weapon would bring hope for ending the war in Japan—but bore the potential of causing cataclysmic destruction to end humanity. 

“Could this bomb vaporize the atmosphere?” Oppenheimer was asked. 

“We don’t know, but almost zero probability,” was his reply. Almost zero? Is that the best we can do? 

Back then, as Oppenheimer discovers the purpose of the project is to bomb two Japanese cities and end the war, he becomes increasingly despondent. Aware that the 200,000 Japanese casualties will be comprised of combatants and innocents alike, he vigorously opposes creating the far more lethal hydrogen bomb. Rich in symbolism, he names the site for the first detonation, Trinity. 

Oppenheimer has now become the angel of death. Unlike Prometheus, his liver will not be eaten daily by an eagle sent as punishment by Zeus, but his conscience will perpetually search for moral relief. Prometheus’ liver regenerated at night. Oppenheimer woke every day to face the same self-reproach. President Harry S. Truman offered him respite by saying that he didn’t make the decision to drop the bomb and kill those people: “I did! “You only made it!” In that confrontational meeting, an exasperated Truman yelled at his Secretary of War, Henry L. Stimson, to “get that cry-baby out of here!” He was referring to Oppenheimer. 

As a means of seeking vindication, he appealed to a committee arranged to decide if Oppenheimer should continue his leadership of the Atomic Energy Commission. The committee was ostensibly centered on national security and support for the even deadlier hydrogen bomb. Its real purpose was to get rid of Oppenheimer, a troubled human who realized what he had released into the world. 

Before Oppenheimer’s appearance, he bellowed to his wife, “They [the people] must hear this.” The hostile meeting was a surrogate for his anguish. Members of the committee were selected to prevent his continued leadership since he realized that further development of weapons of mass destruction would only hasten mankind’s demise. Anticipating the committee’s decision, his wife said: “They will never give it to you.” What she meant was: they will grant you neither the chairmanship, nor forgiveness. 

Predictably, he was rejected. 

How does this apply to vascular surgery? Some years ago, my partner and I performed an open aneurysm repair on a healthy 60-year-old male. The patient worked out every day and was a prominent lawyer in the community. The operation went along flawlessly: the graft was sewn in and the retroperitoneum closed. Heparin was reversed with protamine with no issue. Vital signs were stable. My partner scrubbed out to enter post-op orders. The anesthesiologist asked if I wanted to return the cell-saved blood. Although we had not lost much, I reasoned that it was his blood and would make his recovery that much easier. I agreed and the perfusionist spun down the blood and began the infusion. At that moment, disaster struck. 

His blood pressure and saturation fell to zero. We immediately performed a transesophageal echocardiogram. The images were staggering. Both atria and ventricles were filled with clot, as were the pulmonary artery and aorta. The patient had suddenly clotted his vascular system for no apparent reason. We thought of extracorporeal membrane oxygenation (ECMO), but there was literally nothing to be done. 

We called around the country seeking information or if anyone had ever experienced a similar complication. A professor at Emory in Atlanta suggested antiphospholipid antibody syndrome or preformed anti-heparin antibodies. Our hospital did an investigation and came up with nothing. We met with the widow multiple times and tried (but failed) to give her an explanation. 

Understandably, the wife obtained the best malpractice law firm in the area. When I received the intent-to-sue letter, I did something I had never done before and called the attorney. I told him that I had no idea why that patient clotted his heart, that I had never seen that happen before, and that I hoped to never see it again. I told him of the research that we did and that, if his experts had any insight, to please share it. We never heard from him again. 

The renowned Boston vascular surgeon, Alan Callow, used to say that the ghosts of our failures parade around our bed at night. Yet, every patient we place on the operating table is put at risk. It takes a special person to accept this heavy responsibility, and we all carry the emotional burden of our failures. How we seek expiation is a matter of personal accommodation. A resident who worked with Dr. Charles Bailey, a pioneer in pediatric cardiac bypass surgery in the 1950s, told me that Bailey lost his first 74 patients. The resident approached Dr. Bailey, asking: “Dr. Bailey, don’t you think we should stop?” Bailey responded: “No! We are close!” The 75th patient survived. 

I’m not sure that many of us would have had the callousness to continue after losing 74 patients, nor would it even be possible today. But we surgeons all face similar responsibilities and bear the weight of our failures. And somehow, we return to the operating room the next day wizened, but humbled. To survive, we either develop emotional callousness, or realize that the good we do for most patients outweighs our failures. Or both. 

Before he accepted the leadership of the atom bomb project, Albert Einstein asked Oppie: “Do you think you will be able to handle the consequences?” Oppenheimer did not answer. 

As each practitioner seeks their own reconciliation, we acknowledge that our choice is not an easy profession—replete with gratification but often humbling. 

Arthur E. Palamara, MD, is a vascular surgeon in Hollywood, Florida. 

The top 10 most popular Vascular Specialist stories of September 2023

By
Éva Malpass
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0
The top 10 most popular Vascular Specialist stories of September 2023

top 10Last month, the most read stories from Vascular Specialist included data releases from the recent Midwestern Vascular Surgical Society (MVSS) using direct revascularization of segmental arteries to prevent spinal cord ischemia; a reflection on the crucial role of vascular nurses during Vascular Nurses Week and a multi-society update on new guidelines for the management of varicose veins of the lower extremities.

1. When women are PIs: A story foretold on the vascular frontlines

“Multifactorial” issues persist in gender representation in vascular leadership and trial enrollment, leading women vascular surgeons tell Vascular Specialist. “We would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and, ultimately, better outcomes in women,” states Melina R. Kibbe, MD, dean at the University of Virginia School of Medicine, Charlottesville, Virgina, as she reflects on two decades of missed opportunities.

2. Why CMS should still not extend reimbursement indications for carotid stenting or other carotid ‘revascularization’ procedures

This commentary—authored by Anne Abbott, PhD, MBBS, Lawrence Schott, MD, Lan Gao, MMed, PhD, Hrvoje Budincevic, MD, PhD, Rishad Faruqi, MD, Tatjana Rundek, MD, PhD, Jean-Baptiste Ricco, MD, PhD, Saeid Shahidi, MD, and Gert J. de Borst, MD, PhD—consists of a multinational, multispecialty, multidisciplinary updated evidence review and policy advice.

3. Preventing spinal cord ischemia: Novel techniques for direct segmental artery revascularization show promise, WVS 2023 hears

A vascular surgery team from the University of Southern California (USC) in Los Angeles demonstrated the feasibility of multidisciplinary direct revascularization of segmental arteries to prevent spinal cord ischemia (SCI) using novel endovascular or extra-anatomic bypass techniques in high-risk patients with complex thoracoabdominal aortic aneurysms (TAAAs).

4. Vascular Nurses Week shines spotlight on vital role in patient care and innovation

Vascular Nurses Week—Sept. 10–16—serves as a reminder of the role vascular professionals play in patient care, education and research. Kristen Alix, MS, ANP-BC, AGACNP-BC, CVN, a vascular nurse since 1997 and the president of the Society for Vascular Nursing (SVN), emphasizes that this celebratory week is about more than receiving recognition.

5. Multi-society guidelines on varicose vein management published

The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society (AVLS) have released the second and final part of new guidelines for the management of varicose veins of the lower extremities.

6. SAVS makes travel scholarship applications call for 2024 meeting

The Southern Association for Vascular Surgery (SAVS) has put out a call for applications from medical students and general surgery residents for 20 travel scholarships now available to attend the 2024 SAVS annual meeting.

7. MVSS 2023: Aulivola takes over Midwestern Vascular reins

Bernadette Aulivola, MD, the division director of vascular surgery and endovascular therapy at Loyola University in Maywood, Illinois, took over as president of the Midwestern Vascular Surgical Society (MVSS) at the conclusion of the MVSS annual business meeting held in Minneapolis, Minnesota, on Sept. 8.

8. SVS urges members to take part in compensation survey—and bolster results

Organizers behind an SVS-commissioned financial compensation survey are calling on more members to fill out the short list of questions so that they can break a key 20% response-rate target and begin to publish data gleaned from participants.

9. FDA approves LimFlow system for ‘no-option’ CLTI patients

The Food and Drug Administration (FDA) today announced approval of LimFlow therapy—a novel and minimally invasive procedure designed to bypass blockages in arteries of the legs and restore blood flow for many thousands of people suffering from chronic limb-threatening ischemia (CLTI).

10. Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel in treatment of patients with vascular trauma

Humacyte has announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair.

EVS 2023: Putting artificial intelligence to use in vascular practice

By
Bryan Kay
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EVS 2023: Putting artificial intelligence to use in vascular practice
Reid Ravin

The potential for large language-learning models like ChatGPT to take over tedious writing tasks such as emails and parts of PowerPoint presentations—or even be put to use to help collate Current Procedural Terminology (CPT) code data—was put to attendees of an artificial intelligence (AI) and social media issues session at the recent Eastern Vascular Society (EVS) annual meeting (Sept. 7–9) in Washington, D.C. 

Reid Ravin, MD, an attending vascular surgeon at ChristianaCare in Newark, Delaware, outlined the advantages of the generative technology, highlighting such AI technology’s ability to understand and generate human language using advanced mathematics and deep neural networks, with “essentially the entire internet fed into them.” 

Highlighting a pertinent use in daily vascular practice, he illustrated how he uses ChatGPT to circumnavigate CPT code acquisition. When searching for codes via Google, either the search engine gets the code wrong or “you end up on a site behind a paywall,” Ravin said. 

In the case of ChatGPT, “the entire internet lives inside of it.” Ravin demonstrated for EVS 2023 an example: for the past three procedures he carried out, he used the model to list the operations and work them up into a chart alongside a list of their relative value units (RVUs). 

He also pointed out Aidoc, an AI-powered triage and notification system, which he said interfaces with electronic medical records to detect patients with specific pathologies. 

Ravin also pointed to potential dangers, such as in the case of systems like Aidoc, which could end up “pulling out patients that really don’t need screening—and people who end up getting procedures they don’t need.” 

WVS 2023: President emphasizes importance of ‘tolerance’ in vascular specialty

By
Bryan Kay
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0
WVS 2023: President emphasizes importance of ‘tolerance’ in vascular specialty
Wei Zhou
Wei Zhou

Outgoing Western Vascular Society (WVS) President Wei Zhou, MD, used her presidential address to put out a call for the vascular specialty to embrace tolerance in order that it thrives amid rising cases of physician burnout and the mounting pressures of practice. 

She was speaking during the 2023 WVS annual meeting held in Koloa, Hawaii (Sept. 9–12). “As a specialty we face many challenges,” she told her audience. “Some reflect differences in cultural background, training experience and personal priorities.” 

Zhou, an immigrant from China, shared a personal experience, which involved a case in which she suffered illness while at work, dating from her time as an intern. “I tried to stay strong for the team and minimize my illness, scrubbing for a long pancreatic case,” she remembered. Eventually, Zhou threw up into her surgical mask about four hours into the case. As she was walking out of the operating room to clean herself up, she explained, the surgeon on the case declared before the surgical team that Zhou was “pregnant.” “He did not ask, he just assumed that pregnancy is the reason for nausea in a young woman,” she said. “On that day I lost my respect for that surgeon.” Zhou asked the WVS attendees to realize that “we are different,” and “we need to figure out other people’s perspectives.” 

“To keep an honest discussion, we also need to explore our own points of view. Oftentimes, we can find more things in common than differences,” she added. That means empathy, Zhou continued. 

“We don’t look like each other, sound like each other or act like each other. Being tolerant is not always easy. It requires us to accept our own limitations, look past our differences and accept each other’s flaws—and accept uncertainty.”

JVS-VL peer-review title launches virtual special issue on diversity topics

By
Beth Bales
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0
JVS-VL peer-review title launches virtual special issue on diversity topics

The Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL) has launched its first virtual special issue on diversity, equity and inclusion (DEI) in vascular surgery. 

“DEI issues have come to the forefront and affect multiple aspects of the care we render our patients every day,” said Anil Hingorani, MD, JVS-VL associate editor and DEI officer. “This peer-reviewed collection is meant to be a living set of articles focused on DEI, and more articles will be added in the future.” 

Hingorani likened the virtual issue to print supplements of previous years, which “really drill down into a topic important to vascular surgery and really get into the weeds. This is a modern version.” 

DEI issues are “sort of the elephant in the room,” pointing out many parts of the country will be majority non-white in the foreseeable future, he said. “As diversity spreads across the nation, we all need to be aware of this.” 

In healthcare, diversity packs an impact, Hingorani continued. “It directly affects how patients present, how they’re diagnosed, treatment algorithms and support. Everything we do is affected by the patient’s identity.” 

The collection currently includes four articles: “Race, sex and socioeconomic disparities affect the clinical stage of patients presenting for treatment of superficial venous disease”; “Black or African American patients undergo great saphenous vein ablation procedures for advanced venous disease and have the least improvement in their symptoms after these procedures”; “Importance of sensitivity to patients’ individual background in venous care”; and “A review of the current literature of ethnic, gender, and socioeconomic disparities in venous disease.” The fourth article is available via open access at vascular.org/JVSVL-DEIdisparitiesReview. 

Each takes a slightly different tack. “It’s not just patient outcomes and presentations; DEI affects a lot more than patient-centered outcomes,” said Hingorani. 

Four more, presented at the 2023 American Venous Forum and Society for Clinical Vascular Surgery (SCVS) meetings, are in the process of being added to the site. 

The journal website permits JVS-VL to “bring together the best and most recent articles—top-notch, state-of-the-art ideas from around the world,” Hingorani said. The work to update the site, as opposed to a print journal, is simple, he added. It’s all part of the transition to open access and the online world, he said. “It’s something that’s happening, and I think it will continue. This is part of that process.” 

Editors are always looking for new articles, he said, as he invited researchers to submit their work. Those who are submitting papers are excited about the new initiative. “There is a lot of enthusiasm to have a focus on DEI issues,” Hingorani said. 

Visit www.jvsvenous.org/DEIinvascularsurgery to read the collection. 

SVS History Digital Archive Task Force calls for notabilia

By
Beth Bales
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0
SVS History Digital Archive Task Force calls for notabilia

The SVS History Digital Archives Task Force is soliciting contributions as it aims to present a curated collection to SVS members and the medical community. The initiative came from the SVS Executive Board earlier this year as members saw a need to foster a comprehensive digital repository of the specialty. 

Task Force Co-Chairs Jerry Goldstone, MD, and Craig Miller, MD, have outlined a list of topics of potential interest. These include historical figures, technological advancements, scientific discoveries and novel procedures of significant clinical impact. Miller emphasized that members with primary-source items are encouraged to submit. 

“One of the things we’re doing right now is assembling documents that we’ve created ourselves … We aim to assemble these items to create a cohesive narrative. This is a project that should be ongoing. Moving forward, what is present will become past. As another generation comes along, there are things that will turn out to be of historical significance.” Submit at vascular.org/DigitalArchive. 

Amplifying advocacy: SVS tool for vascular influence on the federal stage

By
Sean Lyden
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0
Amplifying advocacy: SVS tool for vascular influence on the federal stage
Sean Lyden

In the dynamic arena of healthcare advocacy, the Society for Vascular Surgery (SVS) stands as a champion, harnessing the power of amplification to thrust the voices of vascular surgeons into the forefront of federal decision-making. Over the past year, the SVS has orchestrated three compelling “Week of Action” campaigns, underscoring the Society’s commitment to advancing legislative priorities on Capitol Hill and invigorating advocacy participation within its membership. 

Recognizing the evolving landscape of advocacy, the SVS has embraced a multi-pronged approach to the “Week of Action,” aimed at advancing the interests of vascular surgery. 

Grassroots campaigns: Embracing the strength of collective voices, SVS empowers its members to actively participate in grassroots campaigns via the “Voter Voice” platform. This digital rallying cry amplifies the concerns of vascular surgeons, magnifying their impact on pivotal issues. By channeling the diversity and energy of its membership, the SVS cements its position as an influential force. 

Supporting candidate and incumbent lawmakers through the SVS Political Action Committee (PAC): the SVS not only raises its voice, but also invests in the future of advocacy for vascular surgery. The SVS PAC serves as a pivotal tool, bolstering the campaigns of lawmakers who champion healthcare policies aligned with the SVS’ overarching mission. Through backing candidates who resonate with the principles of vascular surgery, the SVS proactively shapes a legislative landscape conducive to the field’s growth. 

Traditional legislative advocacy and lobbying: Capitol Hill has borne witness to the presence of SVS representatives as they advocate for policies that resonate with the core of vascular surgery. Through deliberate engagements with federal lawmakers, the SVS ensures that the intricacies and concerns of vascular surgeons are not only acknowledged but also deeply understood. This timeless approach remains a cornerstone of the SVS’ advocacy efforts, forging relationships that pave the way for well-informed decision-making. 

Amplification transcends mere volume: The SVS has wielded this principle to increase our level of influence, ensuring that the aspirations and concerns of vascular surgeons are heard at the federal level. The “Week of Action” campaigns further underscore the SVS’ dedication, showing how a collective voice can serve as an agent of transformation. 

As the SVS charges ahead, the tool of amplification remains a central pillar of its advocacy strategy. With every campaign, each engagement, and participation of its members, the SVS fortifies its position as a resounding voice, propelling change in the healthcare landscape and securing a positive future for vascular surgery. 

To learn more about SVS advocacy efforts, or catch up on previous “Week of Action” campaigns, visit vascular.org/advocacy. 

Sean Lyden, MD, is a member of the SVS Advocacy Council. 

Preventing spinal cord ischemia: Novel techniques for direct segmental artery revascularization show promise, WVS 2023 hears

By
Bryan Kay
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0
Preventing spinal cord ischemia: Novel techniques for direct segmental artery revascularization show promise, WVS 2023 hears
Anand Ganapathy

A vascular surgery team from the University of Southern California (USC) in Los Angeles demonstrated the feasibility of multidisciplinary direct revascularization of segmental arteries to prevent spinal cord ischemia (SCI) using novel endovascular or extra-anatomic bypass techniques in high-risk patients with complex thoracoabdominal aortic aneurysms (TAAAs) following a retrospective review of fenestrated or branched endovascular aneurysm repairs (F/BEVARs) over a five-year period, attendees of the recent Western Vascular Society (WVS) annual meeting (Sept. 9–12) were told.

The early work, which involves 12 patients undergoing either an endovascular or open approach, was hailed by audience member Benjamin W. Starnes, MD, chief of vascular surgery at University of Washington Medicine in Seattle, who said, “This is a new idea. I applaud the courageousness of our colleagues at USC for pursuing this.”

USC integrated vascular surgery resident Anand Ganapathy, MD, who presented the study results, told WVS 2023, held in Koloa, Hawaii, that nine patients were treated endovascularly, with a total of 11 segmental arteries incorporated. Ganapathy outlined how seven were revascularized using a directional cuff sewn directly onto a physician-modified graft that was extended with self-expanding Viabahn stents; two of the arteries were treated using stented fenestrations; and the remaining two—located along the seal zone—were tackled using unbridged, large fenestrations without covered branched stents. The other three patients received an extra-anatomic bypass.

Extents I and II were the most common type of TAAA among the patient group, Ganapathy continued. Procedural details for endovascular repair of the aneurysms demonstrated an average of 4.3 target vessels (2–6) treated, with a technical success rate of 83%. Failures (two patients) involved a bridging stent to a renal artery “that was dislocated from the fenestration and not recoverable” and a malalignment of an unstented fenestration to an intercostal artery “maintained with an uncovered stent.” Nine patients had successful prophylactic spinal drain placement. The three patients who underwent open repair of their segmental arteries received their bypass an average of three days prior to the F/BEVAR procedure.

Ganapathy reported no mortality at 30 days post-procedure. Two patients—one who had a staged extra-anatomic bypass, the other an unstented fenestration—incurred spinal cord ischemia that “resolved completely by discharge.” Both had prophylactic spinal drain placement. Average follow-up was 472 days. Three of the 14 targeted segmental arteries occluded during follow-up, Ganapathy added. Occluded branches involved one extra-anatomic bypass and two directional cuffs. “They occurred beyond one year without causing spinal cord ischemia,” he said.

Ganapathy concluded: “Spinal cord ischemia remains a serious complication of F/BEVAR, despite current mitigation strategies. Our initial experience demonstrates feasibility of endovascular and extra-anatomic bypass for segmental revascularization in select patients. Further work is planned to improve patient selection through anatomic and dynamic assessment of spinal cord perfusion patterns, as well as the safety and efficacy of segmental artery revascularization procedures through a multidisciplinary, collaborative effort across expertise from a growing list of specialists. Our vision is that someday this might be serve as another adjunct to the current spinal cord ischemia mitigation protocols.”

Karthikeshwar Kasirajan, MD, a clinical professor of vascular surgery at Stanford University, who was the designated discussant of the paper at WVS, summarized the study’s headline findings, outlining how the novel techniques had been employed in 3.8% of F/BEVAR patients reviewed during the study period. Some 11% of the endovascular group and 33% of the open group developed transient paraplegia, he said. Kasirajan commented: “In my opinion, it should be noted that stent grafts have a lower instance of paraplegia when compared to open repairs in general. This is despite the fact that length of coverage is often more extensive as to require landing zones that are much more extensive than open repairs. Additionally, during open repairs we can reimplant intercostals. This cannot be done during stent grafts [implantation], hence intercostal revascularization may not be the holy grail in the prevention of paraplegia.”

Alan Lumsden, MD, chair of the Department of Cardiovascular Surgery at Houston Methodist in Houston, Texas, congratulated the USC team on the ground-breaking nature of their work, asking Ganapathy and colleagues to drill down on any guidelines they follow to determine which patients should receive the novel approach.

Senior author of the study, Sukgu Han, MD, co-director of the Comprehensive Aortic Center at USC’s Keck Hospital, said: “Patient selection is everything. There’s probably more value from putting this protocol together with people from different specialties, maybe actually in the characterization of the spinal perfusion and individual variability. Because, so far, really the only surrogate marker we are looking at, in really very few select patients, is the size and assumption that that carries dominant collateral to the spinal cord.”

VasQ AVF creation device receives FDA clearance

By
Bryan Kay
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0
VasQ AVF creation device receives FDA clearance
VasQ external vascular support

Laminate Medical Technologies has announced their flagship device, the VasQ external vascular support, has been cleared by the Food and Drug Administration (FDA) for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a breakthrough technology, was cleared based on a de novo review of the 144 patient VasQ U.S. pivotal study, as well as a track record of safety and effectiveness of use in multiple studies from outside the U.S.

As recently published in the Journal of Vascular Surgery, VasQ patients in the VasQ study met the primary endpoint of improved primary patency (freedom from intervention plus adequate flow for hemodialysis) at six months. No serious adverse event associated with the device was reported over the two year study.

Additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study, reported statistically superior rates of functional success (confirmed use of the AVF for dialysis), and reduced need for additional procedures. The result was central venous catheters (CVC), the primary source of hospitalization due to infection in dialysis patients, were able to be removed in 80% of the patients within the first year as compared to 62% of unsupported fistulas as reported by the National Institute of Health’s United States Renal Data System.

Ellen Dillavou, MD, division chief of vascular surgery at WakeMed Hospital Systems in Raleigh, North Carolina, stated, “I, along with other study investigators who have used the device, are excited that we can now offer VasQ to our fistula patients. We believe this will give our patients a better chance to receive a functioning fistula with fewer additional procedures and will allow earlier removal of central venous catheters before they lead to serious infections.”

VasQ is a nitinol-based device implanted around the artery and vein during the surgical creation of an arteriovenous fistula. The device was designed to provide structural reinforcement of the mobilized vessels now freed from its native supporting tissue as well as guides a more stable arterial flow profile as it transitions into the vein. Magnetic resonance imaging as well as computational fluid dynamic models have supported the proposed mechanistic benefits of the VasQ design that have led to consistent beneficial clinical outcomes in multiple studies.

New clinical data support AI solution for improved PE detection and care coordination

By
Bryan Kay
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0
New clinical data support AI solution for improved PE detection and care coordination
Viz.ai

Viz.ai has announced new clinical data supporting advancements in pulmonary embolism (PE) detection. Two studies have demonstrated the real-world clinical efficacy of Viz.ai’s PE module to quickly and accurately identify PE and associated right heart strain, accelerate care coordination, and improve healthcare workflow efficiency, the company reports. 

The first study—”Automated PE clot detection and RV/LV ratio measurement using AI [artificial intelligence]-based deep learning algorithms: A preliminary validation study”—evaluated the performance of Viz PE and Viz right ventricle/left ventricle (RV/LV) algorithms. The study found that, across 100 retrospectively collected chest computed tomography pulmonary angiogram (CTPA) images, Viz PE demonstrated a sensitivity of 91.1% and specificity of 100%. Furthermore, the study revealed a significant positive correlation between algorithmic and manual calculation of RV/LV ratio.

“Our preliminary findings underscore the remarkable performance of Viz PE and Viz RV/LV,” said Parth Rali, MD, associate professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University in Philadelphia. “We are excited to partner with Viz.ai and pioneer investigator-initiated research that will reveal the impact of AI technology in revolutionizing patient care.”

The second—”The use of artificial intelligence technology in the detection and treatment of pulmonary embolism at a tertiary referral center”—demonstrated how Viz PE directly improves patient wait times for evaluation, the company commented. Adoption of Viz.ai’s technology significantly reduced time to consult on average from four hours to six minutes, leading to faster diagnosis and initiation of treatment. When combined with multidisciplinary evaluation by an existing pulmonary embolism response team (PERT), time to radiology report was reduced by 109 minutes, showcasing the potential combined benefits of AI technology and the PERT model of care on PE care and management.

“The integration of AI technology into our PE workflow has significantly shortened the time-to-consult, helping us to promptly evaluate and triage these potentially unstable patients,” said Jacob Shapiro, MD, a vascular surgery resident at TriHealth in Cincinnati, Ohio. “This advancement has the possibility to reshape the landscape of PE management.”

‘Voices of Vascular’ attracts national recognition with diversity award

By
Beth Bales
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0
‘Voices of Vascular’ attracts national recognition with diversity award
Voice of Vascular

“Voices of Vascular,” an initiative to highlight the diverse voices within the SVS, has earned the Society and the SVS Foundation a Profile of Excellence Award from the American Association of Medical Society Executives (AAMSE). 

Catherine Lampi, the Foundation’s director of development, accepted the award on behalf of the Society, in the “diversity, equity and inclusion” (DEI) category, at the AAMSE conference, which took place in mid-July. 

The annual awards program recognizes member organizations that have achieved excellence in one of several categories: DEI, advocacy, communications, education, membership and leadership. 

Voices of Vascular honors several months of diversity throughout the year, including Black History Month in February; Women’s History Month in March; Asian American and Pacific Islander Heritage Month in April; Pride Month in June; and National Hispanic Heritage Month, which runs from Sept. 15 through Oct. 15. 

During each of the given months, the SVS and the Foundation share important facts about the groups to spread awareness. The campaign also involves posting profiles of SVS members and, on occasion, patients too. 

“Every person has a story,” said Foundation Chair and Immediate Past President Michael Dalsing, MD. “Voices of Vascular shares our members’ stories and experiences, not only as a vascular surgeon, but also as a member of a particular group. The initiative has proved very popular and insightful.” 

During June, Pride Month, Eric Pillado, MD, an integrated vascular surgery resident at Northwestern University in Chicago, shared his life’s story. 

“I think the future of vascular involves Pride Month, making sure all our patients, regardless of their background, are included, and the future of vascular surgery involves providers of various backgrounds being included in our specialty.” 

Visit Voices of Vascular at vascular.org/VoicesofVascular. 

Why CMS should still not extend reimbursement indications for carotid stenting or other carotid ‘revascularization’ procedures

By
Anne Abbott
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0
Why CMS should still not extend reimbursement indications for carotid stenting or other carotid ‘revascularization’ procedures
This commentary—authored by Anne Abbott, PhD, MBBS, Lawrence Schott, MD, Lan Gao, MMed, PhD, Hrvoje Budincevic, MD, PhD, Rishad Faruqi, MD, Tatjana Rundek, MD, PhD, Jean-Baptiste Ricco, MD, PhD, Saeid Shahidi, MD, and Gert J. de Borst, MD, PhD—consists of a multinational, multispecialty, multidisciplinary updated evidence review and policy advice, which was published on the U.S. Centers for Medicare & Medicaid Services (CMS) website on Aug. 8, 2023. This review and policy advice was prompted by CMS’ proposed decision to fund “free-for-all” carotid artery “stenting” procedures in any American aged at least 65 years, on certain disability benefits and/or with end-stage renal failure who is determined as having at least “50” or “70%” carotid stenosis (despite no accurate and reproducible method of classifying degree of carotid stenosis). This manuscript is based on a longer group submission posted on the CMS website in February 2023. 

We classify the types of misinformation being used to errantly push U.S. Medicare to expand reimbursement indications for carotid artery stenting (CAS) and a new hybrid procedure known as transcarotid arterial revascularization (TCAR). This is already an environment with too many unnecessary carotid procedures done in the name of stroke risk reduction. Founding members of the Faculty Advocating Collaborative and Thoughtful Carotid Artery Treatments (FACTCATS) explained in 2012 why reimbursement indications for CAS should not be expanded.1,2 The fundamental reasons were higher risks with CAS (stroke, death and myocardial infarction) compared to carotid endarterectomy (CEA) and declining carotid procedural indications due to greatly improved non-invasive stroke risk reduction methods. The situation has not changed, except that the excessive hazards with stenting are clearer, non-invasive medical intervention for stroke risk reduction has improved further and the safety and efficacy of TCAR remain unproven. Once again, we advise that expanding reimbursement indications for carotid procedures “would have serious negative health and economic repercussions for the USA and any other country that may follow such inappropriate action.”1

Introduction 

Since 2005, CMS has limited carotid stenting (CAS) reimbursement indications to individuals considered at high-risk from carotid surgery (carotid endarterectomy, CEA) who are symptomatic with >70% carotid stenosis and to other high-CEA-risk patients if used in appropriate studies (those with 50-70% stenosis if symptomatic or >80% stenosis if asymptomatic).3 High-CEA-risk is defined by CMS as having major comorbidities and/or anatomic risk factors (including current life-threatening cardiac conditions).3 The definition is open to interpretation. CMS also created minimum standards upon which CAS coverage (reimbursement) is dependent.3

As per the January 2023 online CMS announcement,4 a “multispecialty alliance” (the “Alliance”) asked that CMS:

  • Expand CAS reimbursement indications to all individuals with >70% asymptomatic carotid stenosis and any symptomatic person with >50% stenosis (including those not considered high-CEA-risk)
  • Eliminate the minimal standards for facility requirements
  • Leave coverage for any CAS procedure (including TCAR) not described by the CMS National Coverage Determination (NCD) to the discretion of the local Medicare Administrative Contractors

Founding members of FACTCATS published evidence reviews and advice to U.S. Medicare in 2012 and 2013 outlining why reimbursement indications for CAS should not be expanded.1,2 The main reasoning then was the higher risk of stroke and death with CAS compared to CEA, as well as declining carotid procedural indications due to greatly improved non-invasive stroke risk reduction methods (risk factor identification and amelioration using lifestyle interventions and medication). The situation has not changed, except that the excessive hazards with CAS are clearer, non-invasive medical intervention for stroke risk reduction has improved further and the safety and efficacy of TCAR remain unproven.5–10

CMS reimbursement indications were not expanded following the 2012 Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting.5 The results have been greatly limited access to procedural “carotid revascularization” by non-surgically trained practitioners, the saving of up to several million older Americans from unnecessary, excessively dangerous carotid procedures, the saving of up to at least 60 billion American healthcare dollars and an excellent global health policy example.5,11 This analysis is a cut-down version of our updated evidence review and policy advice for CMS that was publicly posted Feb. 10, 2023, with 71 co-signatories.

The Alliance used an online letter to CMS and a 2022 review article as the case for ‘new evidence’ supporting expansion of reimbursement indications for CAS, TCAR and any other procedure they may consider under the umbrella of CAS in the future.4,12,13 However, the case for expansion consists of misinformation favoring procedural over-use and lacks a cost-effectiveness analysis. We have classified the most important forms of misinformation encouraging procedural overuse into four types: factual errors (untrue statements), fact distortion (a fact is conveyed then misconstrued), omitted information (omission of information relevant to clinical decision making) and speculation. We would like to emphasize that we are not targeting individuals, rather we are addressing misinformation. Further, this misinformation is common in the medical literature.

Factual errors

  1. CAS is not equivalent, or noninferior, to CEA as claimed12,13

CAS is more dangerous for patients than CEA. In every adequately powered randomized trial comparison, CAS (when used for primary or secondary stroke risk reduction) was associated with approximately 1.5–2 times as many peri-procedural strokes or deaths as CEA.5 Several individual randomized trials of symptomatic patients showed a statistically significant higher periprocedural rate of stroke or death from CAS compared to CEA (including the International Carotid Stenting Study [ICSS], the Carotid Revascularization Endarterectomy vs. Stenting Trial [CREST-1], and the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis [EVA-3-S] trial).5 Registries and administrative databases have also consistently shown higher periprocedural rates of stroke or death with CAS compared to CEA.2,5,14

By contrast, no individual randomized trial of CAS versus CEA in patients with asymptomatic (or recently asymptomatic) carotid stenosis has been sufficiently powered for this comparison because of low event rates and, hence, the requirement for larger study samples.5,15,16 Underpowered trials involving asymptomatic patients include the 2nd Asymptomatic Carotid Surgery Trial (ACST-2), published in 2021.17,18 However, all individual randomized trials of asymptomatic, or recently asymptomatic patients, with more than 200 subjects have shown trends towards more periprocedural stroke or death with CAS than CEA. For example, in ACST-2, the odds ratio (OR) for 30-day peri-procedural death or stroke with CAS versus CEA was 1.35 (95% confidence interval [CI] 0.91–2.03). The comparison reached statistical significance in a 2019 meta-analysis of randomized trials (eight trials and 3,467 patients: OR 1.64, 95% CI 1.02–2.64)15 and borderline significance in a 2020 meta-analysis of randomized trials (seven trials and 3,378 patients: OR 1.72, 95% CI 1.00–2.97).16

In randomized trials, myocardial infarction was generally less common with CAS than CEA. However, where published, in randomized trials of CAS versus CEA involving symptomatic and/or asymptomatic patients, peri-procedural stroke (mostly caused by CAS) was overall 4.6 times more common than clinically defined myocardial infarction.19 Further, periprocedural death was 34% higher with CAS and periprocedural stroke, death, and clinically defined myocardial infarction were 1.6 times more common after CAS than CEA.5,19 The difference in this latter, triple-composite outcome measure reached statistical significance in meta-analyses involving symptomatic patients.5,15,16

There are still insufficient randomized trial data to adequately power this triple-composite comparison for asymptomatic patients.5,15,16 However, randomized trial results indicate that it is highly likely that if CAS is rolled out into routine practice (involving many more asymptomatic patients than in trials with/or without lower procedural standards) it would cause significantly more strokes, deaths and myocardial infarctions than CEA. That would be clinically and economically highly significant.5

Further, in adequately powered randomized trial comparisons, rates of periprocedural stroke or death and later ipsilateral stroke have been higher with CAS compared to CEA for as long as patients have been followed up.5 Rates of new ipsilateral stroke beyond the periprocedural period were generally similar with each procedure. This indicates that patients who have a periprocedural stroke tend to live long-term with their stroke. Meanwhile, those that die in the periprocedural period do not recover. Therefore, compared to CEA, the harm from CAS is durable.5 Differing results have been reported with respect to ‘protection devices’ for lowering the CAS-associated risk of stroke or death.5 Further, severe carotid re-stenosis is more common after CAS than CEA and CAS tends to cost more.20,21 Complications (apart from stroke and death) that are more likely with, or particular to, CAS compared to CEA include hemodynamic instability (severe hypotension or bradycardia, including the need for a permanent pacemaker) and retroperitoneal haemorrhage.5

  1. Age is not the only risk factor for harm from CAS as claimed12,13

In randomized trials, CAS has not been shown to be more beneficial than CEA or non-invasive medical intervention alone in any subgroup of patients. Particularly vulnerable to stroke from CAS compared to CEA are:

  • The most senior patients (aged >70 years). Randomized trial comparisons in younger patients have been underpowered, probably because of lower event rates and less representation5
  • Those who are most recently symptomatic (especially within the previous 7–14 days, which is when best practice CEA is most likely to be beneficial)5,22
  • Women. However, men are also at higher risk of stroke or death from CAS compared to CEA5
  • Those with certain carotid anatomical features, such as longer, angulated, or tandem lesions5
  • Those who have CAS in low volume centers or outside trials5
  • Regression of carotid plaque has been seen from non-invasive medical intervention alone, in contrast to what was claimed12,13

Studies have shown that statin and ezetimibe therapy can cause carotid plaque regression and content stabilization.23-28 Moreover, statins, ezetimibe and PCSK9 inhibitors reduce the risk of stroke and other arterial disease morbidity and mortality whether or not individuals undergo a carotid artery procedure.29–31

Fact distortion

  1. Inappropriate dismissal of ‘minor’ or ‘nondisabling’ strokes in attempt to justify CAS12,13

The most severe or fatal periprocedural strokes are usually defined as being associated with a modified Rankin score of >3.5 Fortunately, severe strokes are less common than milder strokes. A well-recognized method of falsely claiming equivalence between CAS and CEA is to ignore milder strokes.19 However, this distorts the facts in two ways. Firstly, so-called ‘minor’ strokes may impose significant disability and reduced quality of life and should not be discounted.32,33 Secondly, past randomized trials of CAS versus CEA were underpowered to compare the peri-procedural rate of the most severe strokes. Therefore, it is incorrect to claim that CAS and CEA are similar with respect to causing severe strokes.5

  1. Inappropriate use of periprocedural myocardial infarction to justify CAS12,13

As explained above, in all adequately powered randomized trial comparisons, CAS was associated with significantly more periprocedural stroke, death and clinically defined myocardial infarction than CEA.15,16,19 However, because myocardial infarction was often more frequent with CAS than CEA in randomized trials, including it in a primary outcome measure with stroke and death means the adverse outcomes are more evenly distributed between CEA and CAS. Therefore, larger sample sizes are required to show statistically significant procedural differences. As explained above, this has been achieved in meta-analyses of randomized symptomatic patients.15,16 Underpowered triple-composite outcome comparisons camouflage the statistically significant higher periprocedural rate of stroke or death with CAS compared to CEA. “No statistically significant difference” is often due to underpowering, and this is demonstrated with meta-analyses involving larger subject numbers.5,15,16,19

  1. Inappropriately using the SAPPHIRE trial to justify CAS in high-CEA-risk patients12,13

The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial was inappropriate to determine a role for carotid artery procedures in individuals considered at high-CEA-risk because it lacked a non-invasive-treatment-only option.34 Performing randomized trials of only procedures and concluding that a procedure is best, or indicated, constitutes procedural bias.19,35 Outcomes with non-invasive treatment alone have not been measured in these patients. Further, high-surgical-risk medical comorbidities (such as unstable angina, congestive cardiac failure and advanced age) identify individuals with high rates of procedural complications and not likely to live long enough to benefit from a carotid artery procedure.36-40 Interestingly, patients deemed high-CEA-risk using CMS criteria do not appear better off with CAS compared to CEA.41

The SAPPHIRE trial had other major limitations for applicability in clinical practice. It included myocardial infarction in the primary outcome measure (the pitfalls of this are described above). Further, myocardial infarction was unusually defined as a “creatinine kinase level >2 times the upper limit of normal with a positive myocardial band (MB) fraction.”34 However, elevated cardiac enzymes are not necessarily indicative of significant heart damage, are not rare after non-cardiac surgery, and are perhaps more common after CEA than CAS.42-44 Further, the SAPPHIRE sample size was very small (334, 70% asymptomatic) with only 17 total 30-day periprocedural strokes or deaths (OR for CAS versus CEA: 0.9, 95% CI 0.3–2.3) and 55 total strokes or deaths by one year (OR for CAS versus CEA: 0.6, 95% CI 0.3–1.1). The trial was underpowered, particularly with respect to analysis of asymptomatic and symptomatic patients separately. As far as we know, the SAPPHIRE trial is the only randomized procedural trial of high-CEA-risk patients.12,13 SAPPHIRE’s limitations, and unknown outcomes with current best practice non-invasive treatment alone, underscore the lack of evidence supporting a procedural approach in “high-surgical-risk” individuals and an outstanding over-reliance on SAPPHIRE in health policy and guidelines.45

  1. Inappropriately using outdated and overreaching guidelines to justify CAS12,13

It is inappropriate to cite outdated procedural standards (such as a 30-day periprocedural stroke or death rate <2–3% for asymptomatic carotid stenosis patients or <6% for stroke or TIA patients with carotid stenosis) to encourage ongoing routine use of carotid artery procedures, let alone reimbursement expansion. The randomized trials upon which such guidelines and standards are based are long outdated due to ongoing advances in non-invasive stroke prevention.5,45 Further, prevailing guidelines encourage carotid artery procedures for many more patient subgroups than have ever been shown to benefit (see below).5,45

  1. Patient choice in treatment decisions12,13

The Alliance repeatedly referred to patient choice, or preference, as a reason to expand reimbursement indications. Patient preference, and informed consent, are prerequisites for any medical intervention.46 This is usually the last “bastion” in protecting patients.46 However, patient preference strongly depends on the way information is presented (or omitted). This has already been demonstrated with decision-making in asymptomatic carotid stenosis patients.47 This demonstrates the importance of how physicians talk to patients. Meanwhile, “shared decision-making” could be a way of making patients take responsibility for treatment that, rather than help, is more likely to harm them.

Omitted information

  1. Implications of improved non-invasive risk reduction12,13

The efficacy of any carotid procedure in stroke risk reduction can only be established using sufficiently powered comparisons against current best practice non-invasive medical intervention alone (healthy lifestyle habits and appropriate medication). This point was consistently missed by the Alliance. Mention was made in the 2022 review of very low (approximately 1%) annual stroke rates in asymptomatic carotid stenosis patients leading to new trials (CREST-2 and the 2nd European Carotid Surgical Trial [ECST-2]) comparing procedures to non-invasive treatment alone.13 In the Alliance letter of request, “expanded” non-invasive medical intervention was deemed “experimental,” instead of the gold standard against which all procedures should be compared.5,12

The ‘Alliance’ advocating for expansion of CAS reimbursement neglected to explain an evidence base showing that stroke rates have dropped by >50-65% with non-invasive care alone in asymptomatic and symptomatic individuals with carotid stenosis, and other cerebrovascular disease populations, since all past randomized trials of CEA versus non-invasive treatment alone.5,7,8,48–53 The Alliance did not mention that these outstanding achievements with non-invasive care mean that there is no current evidence of patient benefit from any carotid procedure. However, there are ongoing reported rates of periprocedural stroke or death of >1–6%.14 Even if procedural stroke and death rates of consistently zero were possible, this is insufficient to justify carotid procedures in the absence of a clinically significant benefit compared to current best-practice non-invasive care alone.5,54

  1. Degree of 50–99% asymptomatic carotid stenosis does not justify a procedure12,13

The Alliance cited a recent Oxford Vascular Study publication describing how patients with 80–99%, compared to 50–79%, asymptomatic carotid stenosis had a higher ipsilateral stroke rate.12,13,55 However, they did not explain that the highest average annual ipsilateral stroke rate seen in that study approximated only 3%, not high enough to ensure a procedural benefit if Asymptomatic Carotid Atherosclerosis Study (ACAS) results are used as an indicator.51,54,56 Furthermore, they neglected to explain that the non-invasive stroke prevention treatment used in that study (and particularly in the associated meta-analysis studies) was suboptimal. Therefore, it is highly likely that the 3% average annual ipsilateral stroke rate is higher than that achievable with current best practice non-invasive care alone.54

  1. TCAR has not been shown to be as safe as CEA or more effective than non-invasive care12,13

Even with large numbers of registry patients, there is no clear evidence that TCAR is as safe as CEA in terms of the risk of stroke or death, at least in standard-surgical-risk patients.32,57–61 TCAR (like CEA) appears to be safer than CAS in the Vascular Quality Initiative (VQI) registry 57–59 However, definitive interpretation of TCAR studies is impossible because of underpowering, lack of randomization, mismatch in patient comorbidity loads, combined patient symptomatic status, predominance of asymptomatic patients, retrospective interrogation and lack of comparison with current best practice non-invasive care.9,10,61,62 CEA remains the safest carotid revascularization procedure and should still be considered in selected symptomatic patients.5,10 However, patients and their carers need to understand that the evidence for an overall CEA benefit compared to non-invasive care alone was collected decades ago and needs re-evaluation.5,63

  1. Differentiating ‘asymptomatic’ and ‘symptomatic’ and those shown to benefit12,13

The Alliance request expansion of reimbursement in “selected candidates.” However, no details are provided about how to select patients. Definitions are not given for asymptomatic or symptomatic patients or for categorizing degree of carotid stenosis.12,13Further, the Alliance omitted to explain the patient subgroups ever shown to have an overall benefit from a procedure (only CEA) compared to non-invasive treatment alone in randomized trials.48–51,64 The overall CEA benefit was small (approximately 1%/year for asymptomatic/recently asymptomatic carotid stenosis patients and up to approximately 3.2%/year for symptomatic patients with ipsilateral carotid stenosis).5 Further, patients had to satisfy all trial selection criteria, have a life expectancy of at least 3–5 years and fit into one of the four following groups:5

  • Men aged <75–80 years with 60–99% asymptomatic (or recently asymptomatic) carotid stenosis (defined using conventional intra-arterial angiography or ultrasound and North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria)51,64
  • Symptomatic Women with 70–99% stenosis (defined using conventional intra-arterial angiography and NASCET criteria and without near occlusion) having CEA within 2–3 weeks of their last same-sided non-severe stroke or TIA)65
  • Symptomatic Men with 50–69% stenosis (defined using conventional intra-arterial angiography and NASCET criteria) having CEA within 2–3 weeks of their last same-sided non-severe stroke or TIA65
  • Symptomatic Men with 70–99% stenosis (defined using conventional intra-arterial angiography and NASCET criteria and without near occlusion) having CEA within 3 months of their last same-sided non-severe stroke or TIA. However, the CEA benefit fell rapidly over this time and was highest within the first 2–3 weeks65

There has never been evidence of procedural efficacy for any other subpopulation of carotid stenosis patients. Further, evidence for the groups defined above is outdated. A “lean to” approach with respect to procedural reimbursement (or “access”) in other subpopulations is inappropriate, given the large numbers of additional implicated patients, and especially when there is evidence of net harm.5 Prevailing policy should be reevaluated with appreciation of the health and economic importance of appropriate “exnovation” and independent monitoring of outcomes with all treatment modalities (procedural and nonprocedural).5,66 Further, it needs to be recognized that a randomized trial is not always needed to answer clinical question. For example, if ipsilateral stroke rates associated with carotid arterial disease are clearly sufficiently close to zero with non-invasive care alone, then randomized procedural trials are not required.5

  1. Categorizing degree of stenosis (and risk) has changed, and is fraught with error12,13

The dominant method of measuring carotid stenosis in previous randomized trials was catheter-based digital subtraction angiography and the NASCET criteria for stenosis.67 Ultrasound was used to some extent in ACAS and was used in ACST-1 (the 1st Asymptomatic Carotid Surgery Trial).51,64 However, most arterial imaging is now non-invasive. Furthermore, there is inherent error with each imaging modality and correlation is far from perfect.5,68,69 Concerningly, angiography using magnetic resonance imaging and computed tomography, and “real world” operators, tend to overestimate carotid stenosis severity, encouraging procedural overuse.70–72 Changes in imaging methodology for categorizing degree of carotid stenosis and measuring risk, along with major advances in noninvasive care and the lack of enforcement of procedural standards outside trials, are major reasons why the original randomized trials of CEA versus non-invasive intervention alone are outdated and/or non-applicable, and the Alliance requests are inappropriate.5,73–75

Speculation

It is speculation that outcomes with CAS may improve.12,13 This speculation is not relevant to funding decisions currently under discussion. In fact, the evidence base indicates that CAS (at least by the transaortic route) should be avoided.

Conclusions

In summary, rather than expansion, the evidence base clearly demonstrates that it is time for exnovation when it comes to reimbursement indications for carotid artery procedures.66 There are many reasons, and any reason alone could lead to net patient harm:5

  1. Prevailing guidelines advocate for carotid procedures on many more subgroups than have ever been shown to benefit.
  2. CAS is more dangerous than CEA, and TCAR has not been shown to be as safe as CEA.
  3. Procedural complication rates, when measured, are usually higher in practice than in trials.
  4. There is no current randomized trial evidence of carotid procedural benefit for any patient subgroup compared to current best practice non-invasive care alone. Further, all patients should receive current best practice non-invasive care. Plus, randomized trials are not required to answer every clinical question. For example, if ipsilateral stroke rates are clearly sufficiently close to zero with non-invasive care alone, then randomized procedural trials in such patients are unnecessary and may be unethical.
  5. Methods of categorizing carotid stenosis have changed and lack reproducibility.
  6. Routine procedural reimbursement blocks new, critically needed research (such as CREST-2 and the Stent-Protected Angioplasty in Asymptomatic Carotid Artery Stenosis vs. Endarterectomy [SPACE-2] trial) to assess carotid procedural efficacy against non-invasive care alone.5,76
  7. Healthcare system sustainability in the U.S. (and elsewhere) is threatened by rising costs, including from poor quality care.77,78

CMS, and other payers of health services, are key in protecting patients and healthcare resources. This is particularly pertinent in an environment already compromised by misinformation and self-serving practices.35,79,80 Overuse of carotid artery procedures is a global problem driven by entrenched misdirected incentives.5,81,82 It can be overcome by redirecting wasted resources to effective interventions, new research, and establishing outcomes-based, rather than activity-based, medicine.5,83 Patient welfare focused medicine requires putting aside pressure from those likely to gain directly or indirectly, in terms of funds and/or popularity, and objectively sorting the scientific facts. Further, it means insisting on independently maintained clinical standards which ensure healthcare excellence, free from conflict of interest, and which protect patients from harmful or unproven treatment.

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Anne Abbott is a neurologist in the Department of Neuroscience at Central Clinical School, Monash University, in Melbourne, Australia. She has received several grants for independent research on the topic of stroke prevention. However, she was not academically funded at the time of creating this manuscript. She is also the founding member of FACTCAT. All authors, and most co-signatories, are FACTCAT members. The views of particular FACTCATs do not necessarily reflect the views of others. Lawrence Schott, MD, is a retired neuroradiologist, in Ireland and was the medical officer (2000–2013) for the Coverage and Analysis Group (CAG), Office of Clinical Standards and Quality (OCSQ), at CMS, and the lead medical officer, Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), Management of Carotid Atherosclerosis, Jan. 25, 2012. Lan Gao, MMed, PhD, is a senior lecturer in health economics at the Institute for Health Transformation, School of Health & Social Development, Deakin University, in Melbourne, Australia. Hrvoje Budincevic, MD, PhD, is head of the Stroke and Intensive Care Unit and deputy dead of the Department of Neurology at Sveti Duh University Hospital, in Zagreb, Croatia. Rishad Faruqi, MD, is clinical associate professor of surgery (affiliate) at Stanford University and clinical associate professor of surgery (affiliate) at University of California, San Francisco (UCSF). Tatjana Rundek, MD, PhD, is professor of neurology in the Department of Neurology at Miller School of Medicine in Miami, Florida. She holds National Institutes of Health (NIH) grants that are unrelated to this manuscript. Jean-Baptiste Ricco, MD, PhD, is a vascular surgeon in the Department of Vascular Surgery at the University Hospital of Toulouse and University of Poitiers in France. Saeid Shahidi, MD, is a senior consultant in vascular surgery, chief consultant in supra aortic disease, research chief physician in vascular surgery, and associate professor at the University of Copenhagen and Zealand, Department of Cardiology and Vascular Surgery at Zealand University Hospital in Roskilde, Denmark. Gert J. de Borst, MD, PhD, is head of the Department of Vascular Surgery at University Medical Centre of Utrecht, the Netherlands. 

Co-signatories: Anne Abbott (Neurologist, Australia); Mohamad AbdalKader (interventional neuroradiologist, U.S.); Yogesh Acharya (vascular surgeon, Ireland); Nishath Altaf (vascular surgeon, Australia); Pier Luigi Antignani (angiologist, Italy); Omar Ayoub (neurologist, Saudi Arabia); Hernan Bazan (vascular surgeon, U.S.); Peter Bell (vascular surgeon, United Kingdom); Ruth Benson (vascular surgeon, New Zealand); Aleš Blinc (cardiologist/vascular physician, Slovenia); Alejandro Brunser (neurologist, Chile); Hrvoje Budincevic (neurologist, Croatia); Jonathan Cardella (vascular surgeon, U.S.); Robert Chang (vascular surgeon, U.S.); Alun Davies (vascular surgeon, United Kingdom); Gert J. de Borst (vascular surgeon, the Netherlands); Rishad Faruqi (vascular surgeon, U.S.); Aaron Gaekwad (neurologist physician trainee, Australia); Lan Gao (health economist, Australia); Hannah Gardener (epidemiologist, U.S.); Richard Genova (registered vascular technologist, U.S.); George Geroulakos (vascular surgeon, Greece/United Kingdom); Athanasios Giannoukas (vascular surgeon, Greece); Harry Gibbs (general & vascular medicine physician, Australia); Peter Gloviczki, (vascular surgeon, U.S.); Anders Gottsäter (vascular physician, Sweden); Guillaume Goudot (vascular physician, France); Jose Gutierrez (neurologist, U.S.); Vassilis Hadjianastassiou (vascular surgeon, United Kingdom); Kimberley Hammar (PhD candidate & resident [emergency medicine], Sweden); Robert Harbaugh (neurosurgeon, U.S.); Eitan Heldenberg (vascular surgeon, Israel); Caitlin Hicks (vascular surgeon, U.S.); Michal Juszynski (vascular surgeon, Poland); Stavros Kakkos (vascular surgeon, Greece); Anthony Kam (neuroradiologist, Australia); Zubair Kareem (neurologist, U.S.); Tien Khoo (internist [general & acute] medicine, Australia); Stefan Kiechl (neurologist, Austria); Timothy Kleinig (neurologist, Australia); Michael Knoflach (neurologist, Austria); Simona Lattanzi (neurologist, Italy); Kaitlyn Lillemoe (neurologist, U.S.); Ian Loftus (vascular surgeon, United Kingdom); Fedor Lurie (vascular surgeon, U.S.); Jonas Malmstedt (vascular surgeon, Sweden); Devender Mittapalli (vascular surgeon, United Kingdom); Wesley Moore (vascular surgeon, U.S.); Bibombe Patrice Mwipatayi (vascular surgeon, Australia); Achim Neufang (vascular surgeon, Germany); Branimir Nevajda (neurologist and stroke specialist, United Kingdom); Alexander Oberhuber (vascular surgeon/endovascular specialist, Germany); Jean Panneton (vascular surgeon, U.S.); Malay Patel (vascular surgeon, India); David Pelz (neuroradiologist, Canada); Fernando Picazo Pineda (vascular surgeon, Australia); Bartlomiej Piechowski-Jozwiak (neurologist, United Arab Emirates); Holger Poppert (neurologist, Germany); Alkoredi Fatai Radji (neurologist, France); Jean-Baptiste Ricco (vascular surgeon, France); Peter Ringleb (neurologist, Germany); Jenni Robertson (consumer representative & stroke survivor, United Kingdom); David Robinson (vascular surgeon, Australia); Sara Rostanski (vascular neurologist, U.S.); Tatjana Rundek (neurologist, U.S.); David Saloner (arterial/biomedical imaging specialist, U.S.); Felix Schlachetzki (neurologist, Germany); Lawrence Schott (neuroradiologist, Ireland); Saeid Shahidi (vascular surgeon, Denmark); Joseph Shalhoub (vascular surgeon, United Kingdom); Francesco Spinelli (vascular surgeon, Italy); Daniel Staub (angiologist, Switzerland); Francesco Stilo (vascular surgeon, Italy); Tim Stokes (consumer representative & survivor of stroke misdiagnosis, Australia); Sherif Sultan (vascular surgeon, Ireland); Costas Thomopoulos (cardiologist, Greece); Raffi Topakian (Neurologist, Austria); Francesco Torella (vascular surgeon, United Kingdom); Olise Uyagu (general medical practitioner, Australia); Claude Vaislic (vascular surgeon, France); Fred Weaver (vascular surgeon, U.S.); Martin Veller (vascular surgeon, South Africa); Maarit Venermo (vascular surgeon, Finland); Alex Vesey (vascular surgeon, United Kingdom); Tissa Wijeratne (neurologist, Australia); Joshua Willey (neurologist, U.S.); Mary-Ann Williams (consumer representative & stroke survivor, Australia); Roz Williamson (allied health, Australia); Kim Wootton (consumer representative & stroke survivor, Australia); and Wei Zhou (vascular surgeon, U.S.).

WVS 2023: Western Vascular Society presidency passes from Zhou to Fujitani

By
Bryan Kay
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WVS 2023: Western Vascular Society presidency passes from Zhou to Fujitani
Roy M. Fujitani takes over as WVS president from Wei Zhou

Roy M. Fujitani, MD, president of the University of California, Irvine (UCI) Medical Center medical staff, took over as Western Vascular Society (WVS) president at the conclusion of the WVS annual meeting recently held in Koloa, Hawaii (Sept. 9–12).

He accepted the mantle from outgoing WVS President Wei Zhou, MD, chief of vascular and endovascular surgery at the University of Arizona in Tucson.

Zhou delivered her presidential address on the on the importance of tolerance in vascular surgery in order for the profession to thrive.

SVS-ACS Vascular Verification Program marks release of new standards for outpatient vascular centers

By
Bryan Kay
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0
SVS-ACS Vascular Verification Program marks release of new standards for outpatient vascular centers
The Vascular-VP—a joint SVS-ACS effort—now offers verification for both inpatient and outpatient vascular centers

The Society for Vascular Surgery (SVS) and the American College of Surgeons (ACS) have released new standards for outpatient vascular centers to help them provide optimal care and treatment of patients receiving vascular surgical and procedural care.

These new standards, outlined in the Optimal Resources for Vascular Surgery & Interventional Care—2023 Vascular-VP Outpatient Standards manual, are part of the Vascular Verification Program (Vascular-VP), launched earlier this year by the SVS and the ACS. These standards provide the requirements necessary for outpatient vascular centers to achieve and maintain verification for their vascular programs.

“Outpatient facility verification by this program demonstrates to patients, referring physicians, regulators, and payors that high quality, high value, vascular care is being delivered. Participants who successfully complete the verification process will be setting the standard for vascular care in their community,” said William Shutze, MD, chair of the Vascular-VP Outpatient Work Group and a vascular surgeon with Texas Vascular Associates in Plano, Texas.

Vascular-VP, which now offers verification for both inpatient and outpatient vascular centers, leverages the strengths and expertise of the SVS and ACS to provide a program that provides an evidence-driven, standardized pathway for instituting and growing a quality improvement and clinical care infrastructure within a center’s vascular program.

The release of this new set of standards within Vascular-VP encourages sites to put the same emphasis on quality in outpatient settings that is applied to inpatient settings, as more surgical services are directed to outpatient centers.

These new Vascular-VP outpatient standards detail elements of vascular surgical care and quality across nine domains, including:

  • Institutional commitment
  • Program scope and governance
  • Resources for facilities, equipment, services, and personnel
  • Clinical care
  • Data abstraction and analysis
  • Quality improvement

By participating in the Vascular-VP program and complying with these standards, outpatient vascular centers can develop the tools necessary to provide safe, effective, patient-centered, timely, efficient and equitable care to all vascular patients.

Together, the SVS and ACS sought to evaluate and improve the quality of care for vascular patients with the following elements: program-specific standards; infrastructure needed to meet such standards and deliver high-quality, high-value care; data collection and analysis; and verification site visits to ensure proper implementation and maintenance of these components

Centers interested in becoming verified and continuing the quality improvement journey of their vascular service are encouraged to apply online.

SAVS makes travel scholarship applications call for 2024 meeting

By
Bryan Kay
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SAVS makes travel scholarship applications call for 2024 meeting
In this high angle view, a group of medical students stand in their classroom. They look up and smile for the camera.

The Southern Association for Vascular Surgery (SAVS) has put out a call for applications from medical students and general surgery residents for 20 travel scholarships now available to attend the 2024 SAVS annual meeting.

Applicants must be either a medical student in years 1–3 or a general surgery resident in PGY years 1–3 who are interested in vascular surgery and able to attend the meeting from Jan. 24-27 in Scottsdale, Arizona, the Society announced. Ten of the twenty scholarships are reserved for women and underrepresented minorities.

The scholarships are worth $1,000, with the application deadline Oct. 18.

Mock oral examinations designed to prepare candidate members and vascular fellows for the Vascular Qualifying Examination are again taking place at the meeting and set for Jan. 24. The application deadline is Nov. 1 at 11:59 p.m. (EDT).

The meeting will also play host once more to a Simulation Skills Competition. Admission will be based on order received, giving priority to represent as many different vascular training programs as possible, the Society stated. Each participant will perform a carotid patch, open aortic anastomosis and thoracic endovascular aortic repair (TEVAR). The application deadline is Nov. 1, also at 11:59 PM (EDT).

VRIC 2024 set for May 15

By
Beth Bales
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VRIC 2024 set for May 15

The 2024 Society for for Vascular Surgery (SVS) Vascular Research Initiatives Conference (VRIC), which concentrates on basic and translational vascular science, will take place from 7 a.m.–6 p.m. CDT on May 15, 2024, at the Hilton Chicago in Chicago. Researchers may submit abstracts from Oct. 25 through Jan. 10, 2024.

VRIC is held in the same place and in conjunction with the American Heart Association’s Vascular Discovery Scientific Sessions, set for May 15–18. Hopeful presenters may submit their abstracts for both meetings in one streamlined process.

Top-scoring VRIC abstracts submitted by trainees will be considered for the Vascular Research Initiatives Conference Trainee Award, which includes the opportunity for the authors to present their work at the conference.

The SVS Basic and Translational Research Committee organizes VRIC, which encourages thoughtful discussion among a variety of attendees, including trainees, vascular surgeon-scientists and other scientists with an interest in advancing vascular science and treatments. Highlights of the program includes abstract sessions, a scientific translational panel, poster presentations and the Alexander W. Clowes Distinguished Lecture, named for the late Clowes, an SVS member and a renowned surgeon-scientist and mentor.

More information will be published within the next few weeks.

Popliteal artery lesions: Two-year results from European DCB catheter registry announced

By
Éva Malpass
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0
Popliteal artery lesions: Two-year results from European DCB catheter registry announced
Passeo-18 Lux

“We face a scarcity of data evaluating endovascular therapy for isolated popliteal artery lesions, known as a difficult vessel bed to treat as we don’t want to leave anything behind,” said Frank Vermassen, MD, chief of vascular and thoracic surgery at UZ Gent in Ghent, Belgium. “It is encouraging to see that we can safely and effectively treat these lesions with a DCB [drug-coated balloon]-only approach.”

Vermassen was speaking as Biotronik announced the two-year results from the BIOLUX P-III BENELUX all-comers registry, which he presented as principal investigator during the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (Sept. 9–13), held in Copenhagen, Denmark.

The prospective, international, multicenter post-market registry evaluated the safety and efficacy of the Passeo-18 Lux DCB catheter in isolated popliteal artery lesions. This indication is considered a difficult vessel bed to treat due to its biomechanical constraints that usually preclude the placement of stents.

BIOLUX P-III BENELUX registry enrolled 99 patients in Belgium, The Netherlands, and Luxembourg with Rutherford 2–5 disease and at least 2cm of healthy vessel segment between lesions in the popliteal artery and lesions in the distal superficial femoral artery. All patients were treated with the Passeo-18 Lux DCB. The bail-out stenting rate was 14%. At 24 months:

  • Freedom from clinically driven target lesion revascularization (CD-TLR) was 81.6%
  • Freedom from major target limb amputation was 98%
  • Freedom from all-cause of death was 89.4%
  • Significant improvement of Rutherford classification was observed for 88.1% of the patients

When women are PIs: A story foretold on the vascular frontlines

By
Éva Malpass
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0
When women are PIs: A story foretold on the vascular frontlines
“Multifactorial” issues persist in gender representation in vascular leadership and trial enrollment, leading women vascular surgeons tell Vascular Specialist. 

“We would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and, ultimately, better outcomes in women,” states Melina R. Kibbe, MD, dean at the University of Virginia School of Medicine, Charlottesville, Virginia, as she reflects on two decades of missed opportunities, the underrepresentation of women as clinical principal investigators (PIs), and women’s under-enrollment as participants in vascular trials. Her statement is far from isolated—underpinned by a growing body of research which addresses key gender inequities in study leadership and participation. Vascular Specialist spoke to prominent names across the global vascular space on their experiences as a PI, meditations on the barriers to access, and the vital work needed to improve diversity across the board. 

Mounting data from recent research has spurred widespread review of women’s progression in the vascular field to date. In particular, focus has been placed on how the gender of PIs has affected the balance of male and female participants enrolled in trials. Conducted in April this year, Kibbe et al evaluated 1,427 clinical trials published in the Journal of the American Medical Association (JAMA), The Lancet, and the New England Journal of Medicine (NEJM), from January 1, 2015, to December 31, 2019, to determine if women’s enrollment in research correlated with the gender of first and/or senior authors. Their results showed a positive correlation between female enrollees and female first and senior authors (51.7% vs. 48.3%, p≤0.0001)—an association which endured in subset analyses by funding source, phase, randomization for study participants, drug and/or device trial, and geographic location. 

Kibbe et al’s results uncover a deficit in both leadership and enrollment which poses crucial challenges to obtaining accurate research outcomes for women and underrepresented minorities (URMs). Adding detail to this, Kathleen Ozsvath, MD, president-elect of the Eastern Vascular Society (EVS), from St Peters Health Partners in Albany, New York, tells Vascular Specialist of the fundamental anatomical differences, presentation to care, and symptom manifestation—such as acute myocardial infarction, she adds— that differ between women and men in vascular treatment. Ozsvath notes that “these differences are yet to be better understood,” a statement echoed by Caitlin Hicks, MD, associate fellowship program director at Johns Hopkins in Baltimore, Maryland, who says that gender-based differences have “only just” begun to gain attention in vascular surgical outcomes, “despite being present for decades.” 

Considering the results of her review, “no,” is Kibbe’s resounding response when reflecting on whether current journal and society efforts are sufficient in promoting diversity and inclusion. Hicks observes the SVS’ “concerted effort over the last few years to improve equity in a wide range of vascular-related initiatives,” but there remains, she adds, a “persistent gender gap in clinical trial PIs,” despite how “critically important” rectification of enrollment inequities is. Moreover, Palma Shaw, MD, professor of surgery at the State University of New York in Albany, New York, and president-elect of the International Society for Endovascular Specialists (ISEVS), delineates that “opportunities for women’s advancement differs in each society, but regional vascular societies have been more progressive”—although when looking nationally, progression is “much slower.” Shaw continues: “Some journals have made an intentional effort to increase the number of female and underrepresented minorities as reviewers and editors. The #Medbikini movement triggered a much-needed change.” 

A watershed dressed in a bikini 

In 2020, #Medbikini marked a watershed, exposing the deepening inequities that have been slow to change. The hashtag arose after an abstract, entitled “Prevalence of unprofessional social media content among young vascular surgeons,” published in the Journal of Vascular Surgery (JVS), was shared online. Labeling bikinis “inappropriate attire,” the study warned that posting pictures wearing one could be viewed as “potentially unprofessional.” This ignited a viral response on Twitter and Instagram under the hashtag #Medbikini, seeing women and men across specialties post themselves in bikinis or casual attire in shared criticism of biased targeting of women in vascular surgery. 

The virality of the movement undoubtedly reflected back an uncomfortable truth for vascular societies and institutions, which began installing strategies to support women and URMs seeking equal opportunities in research and clinical progression. In 2019, Kim Hodgson, MD, then SVS president, established the SVS Diversity, Equity and Inclusion (DEI) Task Force. Late in 2020, as the Task Force was morphing into a committee, leaders asked members to complete a census to survey demographics and member priorities. 

In a review of the dedicated DEI session named Building Diversity and Equitable Systems in Vascular Surgery at the 2022 Vascular Annual Meeting (VAM) given by Imani E. McElroy, MD, from Harvard University, in Cambridge, Massachusetts and Carla C. Moreira, MD, from Brown University in Providence, Rhode Island, “shockingly low attendance” by both members and leaders was reported, leaving the few attendees feeling as if they had “witnessed a fumble at a one-yard line.” The subsequent social media backlash drew a brief statement from the SVS committing to continued prioritization of DEI principles to address shortcomings. 

This year, at VAM 2023, the E. Stanley Crawford Critical Issues Forum raised continued concerns over workforce maldistribution relating to the SVS’ DEI declaration, which states support of “a diverse workforce with equal opportunities.” Addressing the panel, Rana Afifi, MD, associate professor of vascular surgery at McGovern Medical School, University of Texas Health Houston in Houston, Texas, maintained how data presented by former SVS president Michel S. Makaroun, MD, from the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania—whose talk concerned insufficient numbers in the workforce pipeline—do not represent her. 

After graduating from her residency-fellowship outside of the U.S., Afifi was told after “PGY-11 years” to repeat her residency when seeking a path toward U.S. Board certification, she related from the VAM floor. Afifi asserted that others too must be “struggling,” and “are broken because they feel inadequate,” highlighting key “problems” in the handling of DEI matters relating to the vascular workforce. 

Slow progress to seniority 

“Times are changing with an interest and awareness of DEI,” Ozsvath asserts, punctuating her optimism with the fact that women are still “a fraction of the membership within vascular societies” today. This detail sits amid an international rise in the number of women in the vascular field, yet runs parallel to a wealth of new research which reports how this increase does not translate to equitable gender distribution in roles of high-level seniority or decision-making in both academia and clinical care. 

A retrospective review conducted in 2021 by Misty D. Humphries, MD, of UC Davis Health in Sacramento, California, et al—including Julie A. Freischlag, MD, the first and still only ever woman SVS president, and CEO of Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina—found that between 1999–2009 and 2010–2019, the mean percentage of women who presented abstracts at five U.S. regional and national societies “increased significantly” from 10.9% to 20.6%. However, increases in the number of women as senior authors and committee chairs remained statistically insignificant throughout both early and late periods. Humphries et al commented that efforts to recruit women into the field of vascular surgery, and support for their professional development, are “facilitated” by women in leadership roles. Speaking to Vascular Specialist, Freischlag emphasizes that the progression of women and people of color to these positions is “key” to more accurate enrollment and results in clinical research. 

In Europe too, the unequal representation of women pervades. “It’s a male community,” Marianne Brodmann, MD, head of clinical research in the division of angiography at Medical University of Graz in Graz, Austria, tells Vascular Specialist, “especially in the endovascular and [vascular] surgical [space].” Weighing in, Janet Powell, MD, professor of vascular biology and medicine at Imperial College in London, England, and co-investigator in the widely endorsed WARRIORS (Women’s abdominal aortic aneurysm research: repair immediately or routine surveillance) trial, says that Europe’s advancement in this arena is “further behind” that of the U.S., which boasts the likes of Linda M. Harris, MD, who, to Powell, represents a “leading light in making life easier for women [in clinical research].” Harris set up the Women’s Vascular Summit, an annual meeting dedicated to reviewing how vascular disease presents and is treated in women. 

However, for Powell, “better representation” of women only gained significant ground around nine months ago, while the inclusion of people from minorities and lower socioeconomic groups has not yet been addressed, she adds. In particular, Powell raises concerns over the underenrollment of women and URM groups in the recent BASIL-2 and BEST-CLI trials for the management of chronic limb-threatening ischemia (CLTI). Women made up just 28% and 19% of participants in the trials, respectively, while 72% and 91% of enrollees were white. In Powell’s words, this reveals how contemporary enrollment disparities are perhaps “worse in Europe” currently, but shows a global need to urgently re-evaluate enrollment processes. 

Industry responsibility and stimulating change 

For Harris, who is a professor of vascular surgery at the University at Buffalo in Buffalo, New York, and a past president of the EVS, slow progression of diversity in PI positions and leadership roles in the vascular field is “multifactorial.” 

“Some of it is seniority, but much of it is relationships cultivated with industry in a previously more nepotistic system,” she tells Vascular Specialist. “Breaking in as a PI, especially for women, is the hard part. Once established, it is much easier to continue work with industry, and sponsorship helps immensely—or having partners from the same or different institutions.” 

However, cultivating these relationships with limited experience of the process may be “hard,” Hicks opines, and “initiative typically falls on the woman,” rather than on the industry partner’s outreach efforts. “Our industry partners need to play a role in this— many vascular trials are industry sponsored and, therefore, medical device companies need to recognize and acknowledge the lack of women PIs included in prior trials, and make a conscious effort to include women moving forward,” Hicks says. 

The rise in research concerning gender equity within vascular specialties in recent years has created a wealth of visible evidence. Hopes abound that industry and institutions will now do more. However, in a male-dominated field, fears exist that research of this nature could spark a backlash and/or result in researchers being ostracized. A study carried out by Matthew R. Smeds, MD, et al, titled “Gender disparity and sexual harassment in vascular surgical practices,” found—through an anonymous survey sent to vascular surgery faculty members at 52 training sites in the U.S. — that 32% of respondents believed that harassment most commonly occurred in surgical specialties that are historically male-dominated due to purposeful ignorance of hierarchy/ power dynamics in the field. Of the study’s conclusions, perceptions of workplace gender disparities “differed significantly” between the genders. 

Better strategies are needed 

Research such as this makes clear that alignment on gender inequities among vascular professionals must be present to affect change—in Ozsvath’s words “awareness of this deficit will encourage industry to find more diverse PIs” and support DEI initiatives more broadly. Positively, initiatives are being taken up by more institutions to improve gender disparities, such as the Athena Swan Charter—a framework used globally to support the advancement of women in higher education and research. “The initiative is taken very seriously and is supported by annual Athena Swan lectures,” Powell notes of her institution in the UK. 

For women in the vascular field, deciding to pursue academic progression can be “complex,” Harris explains, as, for women beginning down this career path, most are “also at an age when they often have young children.” Although this “does not preclude them from running studies or being academic surgeons, the work-life balance issues are still different and more complex for women than for men based on assessments of division of labor for home obligations,” she states. Yet, Harris believes that this is “starting to change” as the younger generations “[embrace] more of a work-life balance for all.” 

When speaking to Vascular Specialist, all interviewees coalesced around the idea that women’s representation in academic and clinical leadership, as well as in research enrollment, must be addressed collectively to accelerate progression to gender equity. Most vitally, through better representation, Powell says, women who have previously been “underrepresented and underserved” in clinical research can be more accurately assessed and treated with improved knowledge of their crucial vascular variations. 

For Shaw, the positioning of women in these roles and the targeted enrollment of women need to be “deliberate and established at the time of the proposal for the trial.” This approach must include women from “diverse backgrounds,” Ozsvath says, “so we can better understand how these patient populations differ in presentation and what best treatment options exist specific to them.” By measuring the impact of women’s vascular differences, including “size, biologic responsiveness, hormonal issues, social determinants and trust issues,” Harris finishes, “we will be successful in moving the needle in our understanding and care of women vascular patients.” 

 

Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel in treatment of patients with vascular trauma

By
Jocelyn Hudson
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Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel in treatment of patients with vascular trauma
Human Acellular Vessel
Human Acellular Vessel
Human Acellular Vessel

Humacyte has announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair.

A press release reports that the single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the US Food and Drug Administration (FDA) during the fourth quarter of 2023.

The V005 trial was a single-arm study conducted in the USA and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events. Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft. As a result, had the patients not received the HAV, they likely would have been treated with synthetic grafts, ligation of the bleeding artery, and/or amputation. Trauma injuries are commonly contaminated, and therefore patients are at a high risk of infection. As a single-arm study, the comparators for the HAV results were benchmark outcomes for treatment with synthetics grafts based on a systematic literature search. The principal means of evaluation was comparability of secondary patency (blood flow) at 30 days, with primary patency (blood flow without intervention) also evaluated. Secondary comparisons comprised of improvement in rates of amputation and rates of infection at 30 days. A total of 69 patients were enrolled in the V005 trial, of which 51 had vascular injury of the extremities and comprised the primary evaluation group for the study.

The V005 trial was a success, Humacyte reveals, and the principal comparison of 30-day secondary patency for the HAV in the clinical trial was 90.2% for the extremity patients (89.9% for total patients) compared to 81.1% historically reported for synthetic grafts. Primary patency for total HAV patients and for extremity patients was 81.2% and 84.3%, respectively, although no comparison to synthetic graft primary patency was possible since this measure was not reported in the benchmark publications. For the secondary comparison of amputation rates, the HAV demonstrated an improvement with a rate of 9.8% for extremity patients (10.1% for total patients) compared to 20.6% historically reported for synthetic grafts. For the secondary comparison of infection rate, the HAV demonstrated an improvement, with a rate of 2.0% for the extremity patients (2.9% for the total patients) compared to 8.9% historically reported for synthetic grafts. There were no unexpected safety signals for the HAV in this study. An expanded presentation of the results of the V005 trial is expected to be made at the upcoming VEITHsymposium (14–18 November, New York, USA).

“We are elated that the V005 results support our expectation that the HAV may improve the treatment and outcome of patients suffering major traumatic Injuries,” said Laura Niklason, chief executive officer of Humacyte. “We are pleased to reach this major milestone, and thank the medical professionals, patients, advisors and our own team members who contributed to the success of this clinical trial. We now look forward to moving to completion of our BLA filing and planned commercial launch.”

Humacyte is currently preparing a BLA for use of the HAV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and saphenous vein is not feasible to the FDA before the end of the year. In May 2023, Humacyte’s 6mm HAV received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for urgent arterial repair following extremity vascular trauma, which provides a basis for priority review of the BLA by the FDA. Based on guidance from the FDA, Humacyte plans to pursue a traditional BLA approval which may eliminate the requirement for a post-approval confirmatory study.

The FDA has advised Humacyte to include patient outcomes from a humanitarian programme conducted in Ukraine in its BLA submission. As a result, the company is also reporting preliminary results for the 16 extremity patients from Ukraine who provided consent for use of their results. For this population, 30-day secondary patency for the HAV was 93.8% compared to 81.1% historically reported for synthetic grafts. The rate of amputation for the HAV was 0.0% compared to 20.6% historically reported for synthetic grafts. The rate of infection for the HAV was 0.0% compared to 8.9% historically reported for synthetic grafts.

Humacyte advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

SVS launches national smoking cessation initiative

By
Bryan Kay
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0
SVS launches national smoking cessation initiative
The SVS PSO has launched a national smoking cessation initiative

The Society for Vascular Surgery’s Patient Safety Organization (SVS PSO) has formally launched a national smoking cessation initiative. It includes tools and resources to help physicians, surgeons and other healthcare professionals to help their patients kick the smoking habit.

CAN-DO (Choosing Against combustible Nicotine Despite Obstacles) includes three components to increase smoking quit rates: physician and patient toolkits; inclusion of smoking cessation variables in the SVS PSO Vascular Quality Initiative’s arterial registries; and updating smoking cessation information on the SVS website (vascular.org), which is completed. 

Vascular Specialist first reported on the initiative during the 2023 Vascular Annual Meeting (VAM).

“Getting our patients to quit smoking is probably the most important thing we can do, probably even more than any surgery we would talk about,” said Matthew Edwards, MD, a vascular surgeon with Wake Forest University School of Medicine in Winston-Salem, North Carolina.  

A press release details toolkit elements that physicians and surgeons will find useful, including a quick guide to treatment options, information on counseling via text messaging, use of smartphone apps and web-based services, a dictionary of electronic cigarettes and vaping products, resource documents, patient-facing information doctors can distribute and billable smoking cessation codes that will permit reimbursement.  

The Patient Toolkit, meanwhile, includes links to many resources on quitting smoking.   

Simply asking a patient, “Do you smoke?” is insufficient, said Gary Lemmon, MD, SVS PSO associate medical director, urging surgeons and doctors to extend the conversation to the “3 A’s”:  

  • The Ask: Ask if the patient wants to quit and when the patient smokes that first cigarette of the day
  • The Assist: Offer liberal use of nicotine replacement therapy and medications but tell the patient not to use e-cigarettes as a crutch while also smoking
  • The Advice: Refer patients to professional counseling, apps and other tools 

This targeted intervention is proven to improve success in smoking cessation, Lemmon said. “Smoking is the leading cause of preventable death and disability, 10 times more than the premature deaths from all wars fought by the U.S.,” said Lemmon. It is a major cause of cardiovascular disease and more than 90% of cancer of the lungs and other organs. Moreover, secondhand smoke increases the risk of death and disability to those who do not smoke, he said.  

Both SVS and the American Heart Association advise patients to quit smoking before surgery. 

Lemmon and Betsy Wymer, SVS PSO director of quality, noted that new technologies have multiplied the number of tools available to help people quit. “Most adults try to quit six times before being successful,” said Wymer. She and Lemmon urged surgeons to stress, “It is never too late to quit.”  

Learn more at www.vqi.org/smoking-cessation/. 

FDA approves LimFlow system for ‘no-option’ CLTI patients

By
Jocelyn Hudson
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FDA approves LimFlow system for ‘no-option’ CLTI patients
Vein becoming artery with LimFlow crossing stent
PROMISE II
Vein becoming artery with LimFlow crossing stent

The Food and Drug Administration (FDA) today announced approval of LimFlow therapy—a novel and minimally invasive procedure designed to bypass blockages in arteries of the legs and restore blood flow for many thousands of people suffering from chronic limb-threatening ischemia (CLTI).

LimFlow’s FDA approval follows New England Journal of Medicine publication of results from the PROMISE II multicentre prospective study, co-led by University Hospitals (UH) Harrington Heart & Vascular Institute in Cleveland, Ohio, which found that the therapy enabled most patients treated to keep their leg and experience wound healing.

Mehdi Shishehbor, DO, president of UH Harrington Heart & Vascular Institute, and Angela and James Hambrick chair in Innovation, as well as lead author and co-principal investigator of the study, said: “LimFlow is a unique alternative to major amputation, providing hope to hopeless cases. The results from this study are excellent, and expanding LimFlow’s availability beyond the hospitals participating in the clinical study has the potential to save many more limbs and lives.”

A press release details that LimFlow takes a new approach to treating patients who are facing major amputation because they have no other suitable treatment options, such as traditional bypass surgery or endovascular revascularization, due to extensive disease in the target arteries or other anatomical constraints. Using proprietary devices, the procedure essentially turns a vein into an artery. This shift rushes blood back into the foot.

Mehdi Shishehbor

The PROMISE II study evaluated 105 CLTI patients who were treated with transcatheter arterialization of the deep veins (TADV) using LimFlow therapy. All patients had non-healing wounds on their feet and were facing inevitable amputation before the procedure. At six months post-procedure, the rate of limb salvage was 76%. Within the same time period, 76% of patients had completely healed or healing wounds. Freedom from all-cause mortality was 87% at six months.

“Although vascular disease has existed for decades, research and innovations in treatment options have been lacking,” said Shishehbor. “At UH Harrington Heart & Vascular Institute, we are proud to have led the research that showed the FDA that LimFlow works, so that patients have another option to keep their leg and improve their quality of life.”

MVSS 2023: Aulivola takes over Midwestern Vascular reins

By
Bryan Kay
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MVSS 2023: Aulivola takes over Midwestern Vascular reins
Jeffrey Jim passes the gavel over to his successor as MVSS president, Bernadette Aulivola

Bernadette Aulivola, MD, the division director of vascular surgery and endovascular therapy at Loyola University in Maywood, Illinois, took over as president of the Midwestern Vascular Surgical Society (MVSS) at the conclusion of the MVSS annual business meeting held in Minneapolis, Minnesota, on Sept. 8.

Aulivola took over from Jeffrey Jim, MD, the 2022–23 MVSS president, who is chair of vascular and endovascular surgery at Allina Health Minneapolis Heart Institute in Minneapolis.

Patrick Muck, MD, chief of vascular surgery at Good Samaritan Hospital in Cincinnati, Ohio, who previously was an MVSS councilor, is the new president-elect of the Society for 2023–24.

The MVSS’ 47th annual meeting took place in Minneapolis from Sept. 7–9.

EVS 2023: Ozsvath assumes Eastern Vascular presidency

By
Bryan Kay
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0
EVS 2023: Ozsvath assumes Eastern Vascular presidency
The EVS saw the presidential mantle pass from Peter Faries to Kathleen Ozsvath in Washington, D.C.

Kathleen Ozsvath, MD, a vascular surgeon at St. Peters Health Partners in Albany, New York, took over as president of the Eastern Vascular Society (EVS) during the 37th EVS annual meeting that took place in Washington, D.C. from Sept. 7–9.

Ozsvath assumed the mantle following the Society’s business meeting on Sept. 8, before which the 2022–23 EVS President Peter Faries, MD, chief of vascular surgery at Mount Sinai in New York, delivered his parting presidential address before the assembled attendees.

 

FDA clears AAA-SHAPE trial for IDE approval

By
Jocelyn Hudson
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0
FDA clears AAA-SHAPE trial for IDE approval
Impede embolisation plug, expanded

Shape Memory Medical recently announced that the Food and Drug Administration (FDA) has granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).

A press release details that AAA-SHAPE (Abdominal aortic aneurysm sac healing and prevention of expansion) will enroll 180 patients with infrarenal AAAs across 40 sites in the U.S., Europe, and New Zealand. Study participants will be randomized 2:1, either to EVAR plus sac management with Impede-FX RapidFill (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions, and mortality through five years.

The investigational device, Impede-FX RapidFill, incorporates the novel shape memory polymer, a proprietary, porous, polyurethane scaffold that is crimped for catheter delivery and self-expands upon contact with blood. In AAA-SHAPE, Impede-FX RapidFill is intended to fill the aneurysm blood lumen around a commercially-available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.

The AAA-SHAPE pivotal trial is preceded by the AAA-SHAPE early feasibility studies which enrolled a combined 35 patients in New Zealand and The Netherlands. This early experience was recently described by Andrew Holden, MD, et al in the Journal of Vascular Surgery: Cases, Innovations, and Techniques.

“The AAA-SHAPE early feasibility studies have been key to validating the procedural techniques and best practices that we will leverage in the pivotal trial,” said Marc Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston, and principal investigator of the AAA-SHAPE pivotal trial. “We are excited to initiate this widely-anticipated trial in the U.S. and abroad.”

Joining Schermerhorn as co-principal investigators are Virendra Patel, MD, chief of vascular surgery at New York Presbyterian/Columbia University Irving Medical Center in New York, and Ross Milner, chief of the Section of Vascular Surgery and Endovascular Therapy at the University of Chicago Medicine in Chicago.

“We used to consider both aneurysm regression and stability as indicators of a successful EVAR outcome. However, contemporary data reveals that stable sacs are not as benign as once thought and that any failure of the sac to regress is associated with higher long-term mortality,” said Patel. “Shape memory polymer is a meaningful advancement in AAA repair and has the potential to address these unmet needs.”

Milner added: “I commend [Shape Memory Medical] on the decision to pursue a randomized controlled trial. This head-to-head study will offer the level 1 evidence the vascular community will seek to determine the potential role of shape memory polymer in the management of AAA patients.”

Multi-society guidelines on varicose vein management published

By
Jocelyn Hudson
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0
Multi-society guidelines on varicose vein management published
Peter Gloviczki

The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society (AVLS) have released the second and final part of new guidelines for the management of varicose veins of the lower extremities. The recommendations, which update the 2011 SVS and AVF guidance on the topic, were published online ahead of print in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL). 

The new document focusses on the following topics: 

  • Evidence supporting the prevention and management of varicose vein patients with compression
  • Treatment with drugs and nutritional supplements 
  • Evaluation and treatment of varicose tributaries 
  • Superficial venous aneurysms 
  • The management of complications of varicose veins and their treatment 

The publication—authored by Peter Gloviczki (Mayo Clinic, Rochester, USA) and 19 other members of a multispecialty guideline writing committee—follows last year’s release of part one of the guidelines, which addressed duplex scanning and treatment of superficial truncal reflux.  

Gloviczki and colleagues outline in their introduction the reason behind the two-part publication of the updated guidelines. They note that all recommendations in part one were based on a new, independent systematic review and meta-analysis that “provided the latest scientific evidence to support updated or completely new guidelines on evaluation with duplex scanning and on the management of superficial truncal reflux in patients with varicose veins”. However, the authors recognised “several additional important clinical issues” needed to be addressed, despite many having varying levels of scientific evidence associated with them. For this reason, when a systematic review was not available, the writing committee based ungraded statements on a comprehensive review of the literature, combined with unanimous consensus of the expert panel. 

Alongside a series of recommendations, the writing committee highlight “several” knowledge gaps on the natural history, evaluation, prevention and treatment of patients with varicose veins, highlighting their top 20 recommendations for future research. The most important three they identify are comparative studies of polidocanol endovenous micro-foam versus physician-compounded foam for treatment of varicose tributaries, comparative studies of polidocanol endovenous micro-foam versus other techniques of thermal and non-thermal ablation of incompetent superficial truncal veins, and best metric of axial reflux to determine ablation of superficial truncal veins. 

The guideline document can be accessed in full on the JVS-VL website: https://www.jvsvenous.org/article/S2213-333X(23)00322-0/fulltext 

Vascular Nurses Week shines spotlight on vital role in patient care and innovation

By
Marlén Gomez
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0
Vascular Nurses Week shines spotlight on vital role in patient care and innovation
Vascular Nurses Week is Sept. 10–16

In a world in which both medical breakthroughs and technological advancements seem to dominate the healthcare landscape, it’s easy to overlook the unsung heroes who work tirelessly to ensure that patients receive the specialized care they need. Vascular Nurses Week—Sept. 10–16—serves as a reminder of the role vascular professionals play in patient care, education and research. 

Kristen Alix, MS, ANP-BC, AGACNP-BC, CVN, a vascular nurse since 1997 and the president of the Society for Vascular Nursing (SVN), emphasizes that this celebratory week is about more than receiving recognition. It’s also a platform for education, advocacy and a call to raise awareness about vascular health. 

Alix’s interest in vascular nursing stems from the challenges posed by this specialty. “The vascular patient as a whole is a big medical puzzle for people to solve,” she said. “Such patients present a variety of comorbidities, including hypertension, cardiac disease, renal disease or diabetes, not to mention the complicated social challenges. The vascular nurse is an individual contributor to the patient’s success before, after and sometimes during the surgery.” 

Alix noted that vascular nursing is a vocation not for the faint of heart, as it places vascular nurses at the forefront of patient care. 

Founded in 1982, the SVN emerged as a society that formally acknowledged vascular nursing as a specialized field. 

The society is not composed solely of nurses, but incudes a diverse assembly of providers, researchers and leaders, spanning the spectrum of healthcare contributors. 

“My attraction to vascular nursing stems from the critical thinking and the creativity needed to help solve the patient’s issue,” she said. 

As Vascular Nurses Week neared, Alix and the SVN invited everyone to take a moment and express appreciation for the dedication, compassion and expertise of these healthcare professionals. Throughout the celebratory week, the SVN urges individuals to amplify the message by sharing the hashtag #IAMSVN across social media platforms. 

The SVN also advocates for individuals to consider offering the gift of membership to their nurse practitioners and nursing teams. 

To give the gift of membership and join in this movement, visit www.svnnet.org/page/ GIFTOFMEMBERSHIP. 

SVS urges members to take part in compensation survey—and bolster results

By
Bryan Kay
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1
SVS urges members to take part in compensation survey—and bolster results
Keith Calligaro

Organizers behind an SVS-commissioned financial compensation survey are calling on more members to fill out the short list of questions so that they can break a key 20% response-rate target and begin to publish data gleaned from participants. Any member completing the survey can learn the results, but the goal is to inform the entire membership of the results, they emphasized. 

Keith Calligaro, MD, chair of the SVS Compensation Task Force that developed the survey, highlighted the potential value of the data the survey is designed to produce: robust demographic statistics around vascular surgeon salaries and employment conditions. Calligaro also sought to allay confidentiality concerns expressed by some members related to the information they provide in the survey, which is being carried out in partnership with Phairify, a medical profession-focused data collection platform. 

“Over the last few years, many SVS members have noted that when vascular surgeons apply for a job somewhere—whether after completing a fellowship or a mid-career move—they are not sure what to expect in terms of financial compensation. This survey will help in terms of dealing with future employers, what to expect and maybe even what to ask for,” he explained. 

“We want to emphasize this is confidential information. There is no way anyone can find out which individual is filling out the survey. That’s been one concern we have heard about. People are concerned their responses will somehow be public information, which is not true.” 

The point of the survey is to ask questions in key areas around annual salaries, Calligaro said. “What is your annual salary? How old are you? Salaries might vary on age. How many years have you been in clinical practice? Do you identify as a man or a woman? Where do you work? If you work in Philadelphia, do you get paid less or more than if you work in a small hospital in Iowa? 

“There are about 25 questions, which are very basic and preliminary. We also created templates for those wishing to learn more about particular issues, such as being on call or serving as a medicolegal expert. If you fill out that template, you get access to the results.” 

The crux is this, continued Calligaro: “Twenty percent of the members have to fill out the survey before we can publish anything and allow all members to know the results.” 

In essence, in order for the SVS to publish any type of results, a 20% completion rate is required for scientific validity in the publication environment—and filling out the list of questions should take no longer than 10–15 minutes, Calligaro added. 

Phairify is working on the logistics to have office hours available to help each individual completing the survey access the data, the SVS pointed out. Once the process is ready, the Society will make an announcement. 

“Our members get inundated with surveys, and we understand that,” Calligaro said. “However, the latest figure we have is that only 10% of members have completed the survey, and we’re trying to build that up to at least 20%. If so, then I see the number of participants exploding because then we can start showing the results to all of the members.” 

The survey was launched at VAM 2023, which took place at National Harbor, Maryland, in June. Members can participate by visiting vascular.org/CompensationStudy2023. 

Members of the Compensation Task Force include Calligaro as chair; Bernadette Aulivola, MD; Ali Azizzadeh, MD; Sara Duson, MD; Geetha Jeyabalan, MD; Judith Lin, MD; Joseph Lombardi, MD; Dan McDevitt, MD; Richard Powell, MD; Matthew Smeds, MD; Mark Kristiansen, co-founder and CEO at Phairify; G. Randall Green, MD, of Phairify; Reva Bhushan, SVS director of clinical guidelines and quality practice; Carrie McGraw, SVS manager of quality improvement and practice; and Jim Wadzinski, SVS assistant executive director. 

Vascular Specialist–September 2023

By
Bryan Kay
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Vascular Specialist–September 2023

In this issue:

  • When women are PIs: A story foretold on the vascular frontlines
  • SVS members rally to respond to CMS carotid stenting coverage expansion proposal
  • Guest Editorial: Arthur E. Palamara, MD, on “Expiation, Karl Wallenda, Oppenheimer and us” 
  • SVS calls on members to participate in financial compensation survey—and help bolster results 
  • Elections: The SVS Executive Board breaks down the demographics

 

CMS: Proposed reduced conversion factor would cut vascular surgeon reimbursements

By
Megan Marcinko
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0
CMS: Proposed reduced conversion factor would cut vascular surgeon reimbursements
For CY2024, CMS has proposed a conversion factor of $32.75

The Centers for Medicare & Medicaid Services (CMS) in mid-July released two payment-related proposed rules—the highly-anticipated calendar year (CY) 2024 Medicare Physician Fee Schedule Proposed Rule (MPFS) and the Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule. The SVS will submit comments for both proposed rules by the Sept. 11 due date. 

For CY2024, CMS has proposed a conversion factor—a critical component for calculating Medicare payments—of $32.75, a decrease of approximately 3.4% from the CY2023 conversion factor. Preliminary SVS analysis, in addition to the impact charts provided in the proposed rule by CMS, indicate that vascular surgeons, depending on practice setting, face a 3–4% cut based on current Medicare policies proposed in the MPFS rule. 

These cuts result from a reduction in the temporary update to the conversion factor under current law and a negative budget neutrality adjustment, stemming in large part from CMS moving forward with implementation of separate payment for add-on code G2211 to account for visit complexity associated with certain office/outpatient evaluation and management care. G2211 was initially proposed three years ago, but implementation was delayed as a result of an aggressive advocacy campaign led by the surgical societies, including the SVS. 

In addition, payment reductions for many vascular surgeons are compounded by the third year of CMS’ phased-in implementation of its clinical labor pricing update, which was finalized in the CY2022 MPFS Final Rule. 

CMS is proposing an update to OPPS for hospitals that meet the quality reporting requirements by 2.8%. The update is based on the projected inpatient hospital market basket percentage increase of 3%, reduced by a 0.2 percentage point for productivity adjustment. 

The SVS is aware of the significance of the policies outlined in these rules—particularly the additional Medicare payment reductions vascular surgeons face and the potential impacts on patient care and access. 

There is broad agreement thats the Medicare physician payment system is broken and that physicians/surgeons are reeling due to yearly budget neutrality adjustments and the fact that the MPFS is the only fee schedule lacking an annual inflationary update. 

The SVS, in collaboration with medical specialty societies, is continuing to work to mitigate the scheduled cuts and advance policies to stabilize the payment system in the short term and reform the system in the long term. 

To that end, the SVS supports legislation to provide an inflationary update for the MPFS (H.R. 2474) and is leading the effort that brought forth the introduction of legislation to provide targeted relief for codes most impacted by the clinical labor update policy (H.R. 3674). The SVS will also seek further delay of the G2211 code implementation via the comment period on the rule, and legislative relief with an additional delay. Visit the SVS Advocacy Center to urge your lawmakers to support these important bills. 

The SVS is analyzing both rules and will submit extensive comments to CMS. In addition, the Society will continue to collaborate with other surgical and medical specialty societies to amplify our message on Capitol Hill for Congress to address these cuts before the end of the year. 

The SVS is also working in earnest to identify long-term solutions that will provide stability and equity across the Medicare physician payment system. SVS members should be prepared to engage in these ongoing advocacy efforts through the remainder of the year. 

Megan Marcinko is SVS director of advocacy. 

Submit ideas for VAM 2024 educational sessions

By
Beth Bales
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Submit ideas for VAM 2024 educational sessions
SVS PGEC Chair William Robinson

Organizers of VAM 2024 want members to consider what the modern-day vascular surgeon needs to know for optimal patient care and professional success. What’s the latest in the venous disease space? What are helpful tips and tricks in open surgery and endovascular intervention? How about new information on in the world of peripheral arterial disease (PAD)? What are the optimal practice management strategies? 

The SVS Postgraduate Education Committee (PGEC) is requesting proposals for Educational Sessions for VAM 2024. All proposals for the 2024 meeting are welcome and must be submitted by Aug. 23. Those whose proposals are selected for inclusion in the VAM program will be expected to collaborate with the PGEC on the development and delivery of the proposed sessions, and then co-moderate the session at VAM 2024, which takes place June 19–22, 2024, in Chicago, with educational sessions spread over all four days. 

“Each and every year, we want VAM to deliver the most cutting-edge, innovative, high-impact information to address the patient care and professional needs of those who care for vascular disease,” said PGEC Chair William Robinson, MD. 

“To do this, we need to mobilize the considerable enthusiasm and expertise of all of our members. So, we ask all interested members to submit proposals on the most important and current information and issues they believe impact vascular surgeons today. 

“The majority of the educational sessions come from these proposals, so it’s a great way to get involved and contribute to the impact of the Vascular Annual Meeting.” 

Educational Sessions are aimed at covering a breadth of subjects—both clinical and non-clinical—deemed important and timely to the ongoing education of SVS members and other attendees. 

These segments of the VAM agenda—which makes up close to 50% of programming each day of the meeting—occur in varying size, meet the educational needs of different age groups and practice settings, and take on formats such as small-group interactive lectures, case-based courses, and hands-on and innovative/non-didactic approaches. 

PGEC members judge proposals blindly through an online platform, followed by an unblinded selection meeting. Proposals scoring above a certain threshold are typically considered for inclusion in the VAM program, sometimes with suggestions for further development based on the overall content needs and related requirements. 

To see the formal call for submissions as well as to find the link to the submission guidelines, visit vascular.org/VAM24CallForProposals. Meanwhile, to view recordings of the sessions from VAM 2023, which took place in National Harbor, Maryland, in June, visit the VAM Online Planner at vascular.org/OnlinePlanner23.

SVS members rally to respond to CMS carotid stenting coverage proposal

By
Beth Bales
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SVS members rally to respond to CMS carotid stenting coverage proposal
SVS members rallied to submit comments on controversial CMS carotid stenting coverage proposal

Nearly one-third of the public comments submitted to the Centers for Medicare & Medicaid Services (CMS) on a controversial proposed coverage decision affecting carotid stenting were from SVS members. 

“We could not have been more pleased with our members’ response to a proposal that we, as a Society, believe will negatively impact patient care, result in unnecessary procedures, and increase the number of strokes across the vascular patient spectrum,” said SVS President Joseph Mills, MD. 

Of approximately 760 responses, at least 237 were initially identified as being from SVS members, he said. “There may well be even more.” 

In July, CMS released a proposed decision that would significantly broaden coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. The proposal would expand Medicare coverage of the procedure to individuals previously only eligible for coverage in clinical trials, remove the limitation of coverage to only high surgical risk individuals, and remove facility standards and approval requirements. The proposal adds shared decision-making with the patient prior to the procedure and allows Medicare Administrative Contractors (MAC) discretion for all other coverage of carotid artery PTA concurrent with stenting not otherwise addressed in the national coverage determination. 

Comments were due by Aug. 10. In the weeks prior to that, SVS leaders wrote the Society’s formal comment and embarked on a careful campaign to solicit members to add their voices to the discussion. “We focused on patient safety, because we believe it is at risk if NCD 20.7 is finalized without our issues addressed,” Mills said. 

A CMS decision is expected on or before Oct. 6. In its formal response, SVS made three recommendations. 

First, mandate utilization of a standardized “shared decision-making” tool that would be designed in collaboration with applicable medical specialty societies and/or other relevant stakeholders. 

“Shared decision-making is a vital component of allowing patients to receive a carotid treatment plan that best aligns with their wishes and values. Unfortunately, currently there is no validated carotid decision tool that captures the options offered in contemporary practice that are the subject of this NCD,” the Society said. 

Second, revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing process and requirements for reporting standards. “These elements are critical for ensuring a high degree of patient safety,” the Society commented. 

Third, revise the proposed decision memo to include a definition of a “qualified physician” with demonstrated core competency standards relating to carotid stenting. “CMS should work with relevant stakeholders to develop the core competency standards.” 

In its conclusion, the response states the SVS believes the coverage expansion is “premature and jeopardizes patient safety.” If CMS finalizes the proposed expansion of coverage, the letter states, the “finalized memorandum should reflect the outlined recommendations.” 

“SVS will continue to actively promote quality and safety for vascular patient care through its published guidelines, appropriate use criteria (AUC) documents, PSO-VQI Registry and other major initiatives such as the Vascular Verification Program. All practitioners caring for patients with vascular disease are encouraged to become familiar with these tools and to utilize them. SVS will continue to develop these resources and make them available.” 

Mills pointed out that, among other concerns, clinical trial data from the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST-2) trial have yet to be released, and such a major expansion of coverage should not be implemented until data have been released and analyzed. 

“Our primary focus remains, as it always has been, patient safety,” he said. “We are not anti-stent in the appropriate patient and setting. The sheer number and depth of responses from our members demonstrate the firm commitment of SVS members to quality and safety in the care of patients with vascular disease.” 

A sample of SVS members who contributed individual comments before the deadline for public submissions passed follows: 

  • Edward Gifford, MD, Hartford HealthCare, Hartford, Connecticut: “As a young vascular surgeon, I feel this proposed decision does not do enough to monitor for the safety of patients after removing previous guardrails for carotid artery stenting. I feel that transfemoral stenting (TF-CAS] has a role in carotid stenosis. However, on the whole, our threshold to intervene on asymptomatic disease has only increased as medical therapy advances.” 
  • Katharine McGinigle, MD, University of North Carolina at Chapel Hill: “Before the new level 1 data is available, I do not think that it is appropriate to change practice patterns. I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD 20.7 is premature and jeopardizes patient safety.” 
  • Robert Molnar, MD, Michigan Vascular Center, Flint, Michigan: “Not only is [NCD 20.7] premature, given the pending CREST-2 trial, which specifically will address the outcomes of TF-CAS with best medical therapy, but it completely removes common sense safeguards needed to allow for all-inclusive TF-CAS.” 
  • Elsie Gyang Ross, MD, University of California San Diego (UCSD): “With the expansion, we will likely see new outpatient ‘stroke prevention centers’ whereby a number of specialists who can navigate to the carotid and place a stent will do so, without the true consideration of patient risk. It is an unfortunate byproduct of healthcare today in the U.S.” 
  • Ali Azizzadeh, MD, Cedars-Sinai Medical Center, Los Angeles: “Since the level 1 evidence regarding the use of TF-CAS, particularly in standard-risk patients, is evolving, it seems that it is too premature to jump to approval of TF-CAS, even in high-risk patients, and I would disagree with the decision memo.”

Read about the proposed decision at vascular.org/CarotidNCD. Read the formal response at vascular.org/NCDResponse. 

Empowering vascular surgery to promote five pivotal healthcare bills before Congress

By
Andrew Kenney
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Empowering vascular surgery to promote five pivotal healthcare bills before Congress
In the dynamic landscape of healthcare, the promotion of positive change requires more than just clinical expertise

Welcome back to Government Grand Rounds, a campaign aimed at expanding vascular surgeons’ understanding of—and comfort with—the SVS’ many advocacy tools. In the dynamic landscape of healthcare, the promotion of positive change and the advancement of our profession require more than just clinical expertise. 

As highlighted throughout this campaign, advocacy plays a critical role in shaping the future of vascular surgery. By focusing on grassroots activations and leveraging the power of our collective voice, we can promote essential initiatives and drive impactful change. 

The SVS is currently promoting five pivotal bills. By rallying behind these legislative initiatives, we can pave the way for transformative improvements in patient care and the landscape of vascular care. Together, we can use our power to promote and champion these crucial bills. 

  • H.R. 3674, the Providing Relief and Stability for Medicare Patients Act: Legislation to increase the non-facility/office-based practice expense relative value units negatively impacted by the Centers for Medicare & Medicaid Services’ clinical labor policy for the next two years 
  • H.R. 2474, the Strengthening Medicare for Patients and Providers Act: Legislation to provide annual inflationary updates, based on the Medicare Economic Index, for Medicare physician services, similar to updates received by other healthcare providers 
  • H.R. 1202/S. 704, the Resident Education Deferred Interest (REDI) Act: Legislation to allow borrowers in medical or dental internships or residency programs to defer student loan payments without interest until the completion of their programs 
  • H.R. 2389/S. 1302, the Resident Physician Shortage Reduction Act: Legislation to provide 14,000 new Medicare-supported graduate medical education positions over seven years 
  • H.R. 731/S. 220, the Workforce Mobility Act: Legislation to free physicians from non-competes (except in limited circumstances), providing them with an option to work for a competitor and/or more easily transition from one practice type to another 

These opportunities serve as catalysts for change and empower vascular surgeons to actively promote their profession. 

By leveraging these avenues, SVS members can play a pivotal role in shaping policies, driving awareness, and elevating the vascular specialty. To promote these bills, head to vascular.org/advocacy/grassroots-advocacy and send messages to specific lawmakers. 

Interested in learning more? Staying informed is of paramount importance in the realm of advocacy, and the SVS’ DC Update newsletter serves as a vital resource for vascular surgeons who are passionate about driving change. 

This monthly newsletter provides a comprehensive and timely overview of legislative developments, policy updates, and advocacy opportunities, empowering surgeons to stay at the forefront of the advocacy landscape. 

Members who have not received the DC Update newsletter because of preferences they have set in the communications database can send an email to membership@vascularsociety.org for help. 

Andrew Kenney is a member of the SVS’ Washington, D.C. office. 

Coding and complex PAD: Register today for two SVS courses

By
Beth Bales
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0
Coding and complex PAD: Register today for two SVS courses
Participants learn complex PAD techniques at the 2022 CPVI Skills Course

Limited spots remain open for two popular SVS courses coming in October: the Complex Peripheral Vascular Interventions (CPVI) Skills Course on Oct. 1–2 and the Coding and Reimbursement Workshop (with optional half-day evaluation and management coding workshop) on Oct. 16–17.

Treating patients with peripheral arterial disease (PAD) is the largest clinical area for vascular surgeons in the U.S. Thus, being well-versed in treatment, innovations and techniques is vital. The course includes didactic and case-based learning, plus seven hours of hands-on training. Learn more and register here.

Proper coding is essential to reimbursement – and in the vascular surgery world, it’s also complicated. The workshop will provide a comprehensive review of current coding and reimbursement information, including critical updates to those who want to be well versed in vascular coding. The course is geared to both vascular surgeons and staff who perform the coding. Learn more and register here.

Step off Friday for SVS Vascular Health Step Challenge

By
Beth Bales
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0
Step off Friday for SVS Vascular Health Step Challenge

The month of September begins Friday and with it, the SVS Foundation’s Vascular Health Step Challenge.

The initiative challenges participants to walk 60 miles—representing the 60,000 miles of blood vessels in the human body—throughout the month, which is National Peripheral Arterial Disease (PAD) Awareness Month.

The challenge amplifies the importance of vascular health while also promoting health vascular health habits. The Foundation will use funds raised to fund the future of vascular surgery and fulfill the Foundation’s mission.

According to estimates, more than 12 million people in the United States suffer with PAD, caused by buildup of plaque in the lower extremities, which narrows the arteries and causes them to become stiff. In the most severe cases, PAD can lead to amputation. 

Exercise therapy—such as walking—is a first-line response to PAD, and numerous studies have confirmed the health benefits of putting one foot in front of the other. The SVS Foundation lists a number of walking benefits on its Step Challenge information page, vascular.org/FoundationStep23. And a recent meta-analysis of 17 studies study showed people who walk at least 4,000 steps a day can lower their risk of death from any cause. Those who walk only 2,337 steps a day lower their risk of death from cardiovascular disease. 

Beyond mere bragging rights are prizes: a Sport backpack for those who meet the 60-mile goal; a Stanley drink cup for those who raise $600; a Step Challenge hat for team members who meet the $6,000 team goal; and an outdoor blanket for the top individual walker and fundraiser. 

New this year is a “Pay it Forward” initiative in which registrants offer to pay the $60 sign-up fee for low-income patients. Sponsors for this year’s Step Challenge are: AOTI, Gore, The Way to My Heart organization, Medtronic, 3M and the Society for Vascular Nursing (SVN).

First US patient enrolled in SOCRATES short neck AAA trial

By
Bryan Kay
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First US patient enrolled in SOCRATES short neck AAA trial
AAA

The first U.S. patient has been treated as part of the SOCRATES trial (Short neck AAA randomized trial—ESAR and FEVAR), which compares the safety and performance of endosuture aneurysm repair (ESAR) with fenestrated endovascular aneurysm repair (FEVAR) for the treatment of abdominal aortic aneurysms (AAAs) with a short neck.

The maiden procedure performed Stateside was carried out by Brant Ullery, MD, the medical director of vascular and endovascular surgery at Providence Heart and Vascular Institute in Portland, Oregon, who is a SOCRATES trial co-principal investigator.

The randomized, postmarket, head-to-head study was designed to determine whether clinical outcomes of ESAR and FEVAR are equivalent in the treatment of infrarenal AAAs with a core lab-measured short proximal neck length of 4–15mm and minimal infrarenal sealing zone of 8mm, the trial’s sponsor, the Foundation for Cardiovascular Research and Education (FCRE), states.

Organized globally by FCRE in collaboration with Medtronic as funding partner, it randomizes patients 1:1 to either ESAR with the Endurant II/IIs stent graft system (Medtronic) and Heli-FX EndoAnchor system (Medtronic), or FEVAR with the Zenith Fenestrated AAA endovascular graft (Cook Medical) or Anaconda fenestrated stent graft (Terumo).

SOCRATES is slated to enroll approximately 204 patients at up to 40 sites globally. The prespecified safety endpoint is freedom from major adverse events through 30 days. The composite effectiveness endpoint is technical success at index procedure, freedom from type IA or type III endoleaks, freedom from aneurysm-related mortality, and freedom from secondary reinterventions through 12 months.

Heli-FX has FDA clearance for distribution in the U.S. and CE Mark approval for distribution in Europe. Zenith Fenestrated is available in the U.S. and Europe, and Anaconda is available outside the U.S.

Speaking on the design of SOCRATES at this year’s Leipzig Interventional Course (LINC 2023) in Leipzig, Germany, in June, Ullery’s co-principal investigator Giovanni Torsello, MD, from St Franziskus Hospital in Münster, Germany, expanded on the intentions of the trial, which he stated is the “first comparative” study to compare ESAR and FEVAR.

Torsello told LINC attendees how hostile aortic neck can lead to “loss of proximal seal over time,” noting how short necks are associated with increased risk of type IA endoleak and secondary procedures, ultimately asking: “How should we treat our patients with a short neck?”

Which is where SOCRATES seeks to step in.

“If we can build the first comparative trial in the treatment of such patients, and we can learn more about the fate of those treated in these ways, it will be a fantastic trial,” Torsello said.

The extension of trial enrollment to the United States from its initial European starting place would “make a great contribution to this prospective study,” he added.

The price of a cup of coffee

By
Adam Tanious
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The price of a cup of coffee
Adam Tanious
In the wake of the coverage of inappropriate vascular interventions in the mainstream press, guest editorialist Adam Tanious, MD, tackles the thorny issue of interactions with industry “reps”—particularly among younger surgeons. 

Many of us in the surgical community have had an emotional response to the recent New York Times article describing the questionable practices of some of the members of our medical community.1 Against this backdrop, as I look to tackle the subject of interactions with our industry partners as surgeons/ interventionalists, a few disclosures: 

  • I have many positive relationships with my industry representatives 
  • I have never received any form of payment from any industry partner
  • I have just completed my MBA, taking specific courses in sales and marketing

Next, I’d like to define our terms. When I say industry, I am referring to both the publicly-traded and privately-held companies that make and manufacture devices that sparked a revolution in minimally invasive surgery we have been enjoying over the past two decades. More specifically, I am referring to the device representatives at the local level who are responsible for knowing their devices and make themselves available to assist surgeons/interventionalists in using these devices correctly to achieve the best outcomes for patients.2,3 

For those newer to the world of industry, there are two main people you will work with at the local level as it pertains to industry: your local device representative and your “clinical” representative. A device representative is, by and large, a sales representative. They are required to have expert knowledge of their device and are expected to meet certain sales targets, with one key goal of expanding the sales in their respective territories. A “clinical” is a local representative who carries expert knowledge of the device or product in question, and is immediately available to clinicians to help with proper use and troubleshooting of said device in a clinical setting. They are not held to the same “targets” as their sales representative counterparts. However, based on which company you are discussing, there is likely a mutualistic relationship between a territory’s clinical and sales representatives (collectively referred to here as “reps”).2–4 

Let us delve into the relationship our specialty has with industry and how it affects surgeons in their day-to-day practices—with a particular focus on being a young surgeon/interventionalist. 

The relationship starts during training. Depending on your training institution, you are exposed to various interactions between your attendings and their industry colleagues. Reps are always excited and engaged when meeting trainees. These interactions usually happen over a much-needed cup of coffee bought by your reps. What proceeds is, hopefully, a very fruitful and positive relationship whereby your rep teaches trainees about the device they represent and its nuances, and appropriate instructions for use. Throughout our course as trainees, we become very familiar with our reps, and often engage them regarding cases where their device is going to be used. 

As a trainee, I did not appreciate at the time how much the way my attendings interacted with their reps influenced the way that I interact with reps as a young attending. This is something not discussed enough from an educational standpoint. We as attendings need to realize that trainees are watching not just how we operate or interact with the operating room (OR) and hospital staff—they are also looking to us for guidance on interacting with our industry partners. As a young intern and junior resident, I remember being incredibly quiet and simply observing the interactions of everybody in the room when reps and attendings were together. Even though I had grown up in a household raised by a rep in the world of finance, seeing this interaction in the field of medicine still did not add up—for profit companies side-by-side with physicians. 

After graduation 

Fast-forward to when trainees are ready to graduate: I recall this time in my life vividly as it is something you’ve been anticipating for the better part of a decade. Once you have decided on where you will go to practice, the inevitable invitations for a “handoff dinner” start to arrive from your local reps who are familiar with those at the location of your future job. These dinners are lovely and really a time to interact with people in a new city where you may have never lived. These dinners offer an opportunity to put a face to the name behind the person you will likely be calling on in the middle of the night during some aortic emergency, when you still have yet to figure out the hospital system, or the inner dynamics of the OR. Additionally, in most job settings you will need to be calling on your reps for a large portion of cases, as you may not have the necessary product available at your hospital to perform your desired procedure. 

While these practices may sound questionable to a layperson reading this article, everyone must understand that these interactions go hand-in-hand with our ability as a medical community to provide patients with a “minimally invasive” option for surgery. There are very few patients who, when presented with both an open and minimally invasive surgical option, opt for the maximally invasive option. Our relationship with industry is often necessary to provide the care that patients want. 

Additionally, reps have access to resources above and beyond what educators are given to help teach and train the next generation of surgeons and interventionalists. Industry has the power to help fund conferences and educational seminars where experts are allowed to teach their clinical knowledge to a large forum of future practitioners. I can personally attest that these are invaluable teaching and training opportunities that individual training programs just cannot be expected to provide.2 

Rep ‘support’ 

Now comes the hard part of being an attending—and the hard part of this article. What happens during the cases where industry representatives are not needed but can help “facilitate” cases? Reps often offer to be present for cases to “support” the case. This typically happens when you are treating a particular category

of disease that has a multitude of treatment options (i.e., peripheral arterial disease). Stated plainly, having a rep present for a case where you have multiple device options to choose from to effectively treat your patient has the strong potential to sway your decision.2–5 

My question to everyone reading is this: should we put ourselves in a position to be swayed? 

When I have predetermined the need of a particular product for a given case, I will always call upon a trusted rep with many years of experience to be present. Reps see their product used several times a day, every day of the week. It would be wrong of me to assume that level of experience with any device, as our jobs call for us to be experts in many different types of procedures, using an array of different products. As a junior attending, newly managing so many different aspects of the OR environment, why would I not welcome additional expertise that is available to me when I have predetermined a specific tool I plan on using anyway? 

What we as practitioners must understand is the strategy to sales. Anyone with a knowledge of sales and marketing should understand that, more often than not, sales reps sell themselves, not just their product.2–6 While I truly believe that it is in the nature of every rep I have worked with to be extremely helpful and engaged in the OR, we must also realize that this is a sales tactic. The more buy-in we are given by reps during a case, the more we are likely to use their product. This extends to the cup of coffee and the meals bought for us before, between, or after cases.3,4,6 Taking it a step further, there will always be more aggressive reps who try to “actively” sell you on their product. It has happened to me personally. 

This is not to say that the majority of device reps I have worked with try to actively sell during a procedure. In fact, many of the device reps I work with are the first to pull other competitors’ products during a case if it will serve the patient best. What I am saying is that there is an interaction that occurs that has meaningful outcomes for all parties involved. More importantly, it may be harder to anticipate these interactions as freshly minted attendings than we give credit to during our training of future surgeons. 

Who belongs in the OR? 

As I have grown as an attending, my ability to recognize the nuances of these interactions has evolved rapidly. Additionally, having senior partners who have good relationships with reps has also helped. Moreover, there is an earned confidence that comes with being the primary decision-maker responsible for a patient’s care that cements the relationship between physician and rep. 

My goal here is not to provide an answer for young attendings about how to interact with industry. Rather, my aim is to start a conversation. What I think we as practitioners need to be better about is controlling who belongs in the OR. While it is not possible to know every potential problem we will run into during a case, as practitioners we should be better about deciding what tools and devices we anticipate using for specific pathologies, and ensure that, no matter who is present during a case, that our plan for our patient is not swayed by individuals who are ultimately hired to support a particular product. 

More importantly, we as attendings should be actively engaged in teaching our trainees about all the tools we use, and be a sounding board for our trainees about the merits and pitfalls of these devices in conjunction with our industry colleagues. We must provide clear guidelines around the interaction between medicine and industry for the younger, more susceptible minds among us. 

So, will I continue to have device representatives present for various cases? Yes. Will I plan on the particular device I want to use for each case before deciding on which rep to call? As often as possible, yes. Do I want my trainees to interact with and learn from my reps? Absolutely—with an attending present. If an industry representative asks whether they can come to my next case “to support me,” will I let them? I can honestly say that, in this regard, I am on the fence. 

References 

  1. Thomas K, Silver-Greenberg J, Gebeloff R. They Lost Their Legs. Doctors and Health Care Giants Profited.pdf [Internet]. New York Times. 2023. 
  2. Chung KC, Kotsis SV, Berger RA, Ummersen GV. The Relationship Between Industry and Surgery. J Hand Surg 2011;36(8):1352–9. 
  3. O’Connor B, Pollner F, Fugh-Berman A. Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives. PLoS ONE 2016;11(8):e0158510. 
  4. Lively C. The Dual Role of the Medical Device Representative. Voices in Bioethics 2020. 
  5. Grundy Q, Hutchison K, Johnson J, et al. Device representatives in hospitals: are commercial imperatives driving clinical decision-making? J Méd Ethics 2018;44(9):589–92. 
  6. Moed BR, Israel HA. Device Sales Representatives in the Operating Room: Do We Really Need or Want Them? A Survey of Orthopaedic Trauma Surgeons. J Orthop Trauma 2017;31(9):e296–300. 

Adam Tanious is an assistant professor of surgery in the Division of Vascular Surgery at Medical University of South Carolina in Charleston. 

Shockwave L6 catheter expands treatment options for large-vessel cases

By
BIBA Publishing
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0
Shockwave L6 catheter expands treatment options for large-vessel cases

NOTE: This video is ONLY available to watch in selected countries and geographies [geoip-content country=”US”]

The benefits of Shockwave Medical’s new Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) catheter—designed for use in large, calcified vessels (available in 8-12 mm diameter sizes), —were highlighted recently during a case-based roundtable discussion at the Society for Vascular Surgery’s 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17).

Karan Garg, MD (New York City) was joined by Misty Humphries, MD (Sacramento, California) and Mathew Wooster, MD (Charleston, South Carolina) to explore how the new device has changed their practice and treatment approach in larger vessels.

To illustrate use of the device in clinical practice, Humphries shared a case where Shockwave L6 was used to treat a calcified iliac artery to enable delivering of a large bore device.  A  73-year-old man presented with a 7cm type 4 thoracoabdominal aneurysm and Humphries noted that physician-modified grafts are often used to treat these patients and that a percutaneous method is preferable, though she stressed that this requires a large device.

One alternative in cases such as this would be using a conduit, although Humphries highlighted that this is far from ideal, citing additional case time and increased blood loss. Essentially, she said, using a conduit makes a case “really challenging”.

For cases such as the one highlighted by Humphries, Garg remarked that the L6 is a “clear improvement” on the Shockwave M5+, an earlier, smaller-diameter device from Shockwave Medical—noting that it can be more effective at treating vessels with larger diameters.

Humphries reported a “great result” from the case using the L6, with the left common iliac (used for access) opened with no remaining stenosis.

Based on her clinical experience, Humphries advised users to oversize the device by 10% for optimal results. “This is not something to be afraid of,” she said, stressing that good wall apposition is key to breaking up calcium.

On a more general note, Garg admitted that while he was a “very slow adopter” of the L6 technology, he now holds the opinion that “once you start using it, you can’t get enough of it,” referencing his use of the technology in tibial vessels. “I find it very effective in that space”.

Similarly, Wooster noted that the L6 has expanded practitioners’ ability to get percutaneous access to the common femoral artery in patients who otherwise would have required a surgical cut-down. In addition, he shared that there are “really strong data” available showing benefit in these patients.

The Shockwave L6 catheter is available in the US-only.

This video is sponsored by Shockwave Medical.

Part 1: Shockwave L6 catheter achieves ‘almost pristine’ result in challenging case

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Endovascular stablization system for infrarenal AAAs gains FDA Fast Track designation

By
Bryan Kay
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0
Endovascular stablization system for infrarenal AAAs gains FDA Fast Track designation

Nectero Medical announced that the Food and Drug Administration (FDA) has granted Fast Track designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST) system to treat patients with infrarenal abdominal aortic aneurysms (AAAs) of maximum diameter 3.5–5cm. The company states that it is initiating a randomized, controlled Phase II/III clinical trial (stAAAble) to evaluate the product’s safety and effectiveness.

The designation allows for more frequent meetings with the FDA to ensure appropriate data collection in support of drug approval, enables eligibility for accelerated approval and priority review, and supports rolling review, where individual sections of Biologic License Application (BLA) or New Drug Application (NDA) can be submitted once completed rather than waiting for the entire application to be reviewed, the company stated in a press release.

The Nectero EAST system is a single-use, endovascular system for the treatment of infrarenal AAA. It is comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and to potentially reduce the risk of further degradation.

Nectero Medical noted that the procedure does not require any specialized tools or training, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions. If successful, the Nectero EAST system may offer patients with smaller AAAs a first approved therapeutic option beyond surveillance.

Venous stenting and the IVC: ‘Persistent problems’ in the setting of post-thrombotic syndrome

By
Bryan Kay
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0
Venous stenting and the IVC: ‘Persistent problems’ in the setting of post-thrombotic syndrome
Peter Gloviczki

The question of “persistent problems” with venous stenting among post-thrombotic syndrome (PTS) patients emerged as a key talking point during the recent Deep Venous Stenting Summit that took place during VAM 2023 in National Harbor, Maryland (June 14–17).

The issue was raised by venous disease titan Peter Gloviczki, MD, professor and chair emeritus of vascular surgery at the Mayo Clinic in Scottsdale, Arizona, after a talk by Erin Murphy, MD, director of Sanger Heart & Vascular Institute’s venous and lymphatic program in Charlotte, North Carolina, drilled into the management of stent complications—pondering whether to recanalize, explant or bypass.

Prior speaker, Mark D. Iafrati, MD, a professor of vascular surgery at Vanderbilt University Medical Center in Nashville, Tennessee, had in a prior talk on best medical treatment and surveillance protocols already provided the data behind Gloviczki’s point—published in 2013 in the Journal of Vascular Surgery by Seshadri Raju, MD, a vascular surgeon at the Rane Center in Jackson, Mississippi, and colleagues showing 90–100% patency in the setting of non-thrombotic disease and 74–89% in PTS at three to five years, outcomes which he said hold up today.

“Dr. Raju’s results are excellent, but let’s face it, about one-in-four post-thrombotic patients has problems with stents, and there are persistent problems,” Gloviczki commented from the floor during a question-and-answer session at the close of the summit. “One, for instance, is if you have a lesion very close to the IVC [inferior vena cava].

“We really don’t have a beveled stent in this country,” he continued, referring to the CE-marked sinus-Obliquus device. “Even the dedicated stents extend, at least in part, in these patients into the vena cava. So, I wanted to ask Erin if you still use the technique of combined stenting and have you had problems with the penetration of the wall by the Z-stent?”

Murphy related her early experience navigating venous dedicated stents to her intended landing spot.

“With the newer stents, I had a little bit of trouble at first trying to get them to land right at the cava and treat the cranial disease right there to the point where I almost went back to combined stenting with Z-stents,” she explained. “I’ve since fairly-well perfected landing them without jailing the other side. They are strong enough that, even if the artery is right there, they don’t collapse like the Wallstent does—it pushes the artery off, and I have not had recurrence.”

It is a different story among already-stented patients who land in Murphy’s practice, she continued. “I do see quite a bit of universal jailing of the other side. Most patients who I see in my practice that have already been stented, [the other side] is jailed. We are still pretty early—with the old stents it took us 10–15 years to say that it is a problem. I do think we have seen a couple of contralateral [deep vein thromboses] to the new stents, so I do think it will happen. And if it inadvertently happens, I encourage those patients, or If I see somebody sent [my way], I encourage them to be on low-dose anticoagulation.”

In terms of Z-stents, Murphy elaborated that she had not encountered them outside the IVC, explaining: “Typically, the ones that I’ve done in the past were inside—three quarters of them—the Wallstent, so that kind of prevents [penetration], but in the cases where they are unsupported, I have seen them outside the cava. I have not had complications from them.”

Gloviczki further pondered the specter of the external iliac vein. “We never talk about it but most of the time we stent into the external iliac vein, and mostly we do so because some of the common iliac veins are so big, but practically every time we jail the internal iliac vein, and I wonder if in the long run this is not going to be an issue.”

Murphy referred to the use of Wallstents in this setting over the years. “I don’t recall seeing a consequence of that,” she noted. “The internals are so well collateralized, but maybe we’re just not looking.”

Fellow panelist Lorena DeMarco-Garcia, MD, chief of vascular surgery at Plainview Hospital, Northwell Health in Syosset, New York, who spoke on stenting for non-thrombotic iliac vein lesions (NIVLs), concurred, saying: “The pelvic floor drains contralaterally and that is it. But I’m sure we are probably eventually causing future ostium occlusion, for sure.”

Congress considers incremental steps towards Medicare payment reform

By
Jill Rathbun
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Congress considers incremental steps towards Medicare payment reform
Capitol Hill

There is no doubt that the Medicare payment system needs reform. At this moment, the SVS is aiming to inspire reform through all facets of effective advocacy. This takes place incrementally by raising Congressional awareness of the issues that physicians face. 

Following its enactment in 2015, Congress has not conducted rigorous oversight of the implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) law. But that changed this summer with the Energy and Commerce Committee Subcommittee on Oversight and Investigations convening a hearing in June titled “MACRA Checkup: Assessing Implementation and the Challenges that Remain for Patients and Doctors.” The hearing’s intent was to give members of Congress the opportunity to hear from experts, evaluate the implementation of the law and better understand what challenges remain. 

In addition, Congressional committees with jurisdiction over healthcare matters are conducting hearings to examine the drivers of escalating healthcare costs, including consolidation and price transparency. The House Energy and Commerce, and Ways and Means committees, and the Senate Finance Committee, have held hearings on healthcare system consolidation resulting from hospital mergers, and corporate and private equity acquisition of independent physician practices. Witnesses have discussed how this practice of consolidation has demonstrated increased healthcare spending without corresponding improvements in quality of care. 

Inadequate physician payments and the instability of the Medicare physician fee schedule are factors that have led to health system consolidation. For some independent physician practices, an employment arrangement through merger with a hospital system is the only viable financial option to remain in business. 

There are many flaws in the Medicare physician fee schedule that need to be addressed so physicians receive predictable, sustainable payment. While solving these issues will necessitate a broad approach to physician payment reform, the SVS has led the Clinical Labor Coalition to advocate for the introduction of legislation providing payment relief to clinicians who provide specialty care using high-cost supplies and equipment in community-based independent practices. 

The Providing Relief and Stability for Medicare Patients Act (H.R. 3674), introduced by Reps. Gus Bilirakis (R-12- FL), Tony Cardenas (D- 29-CA), Greg Murphy (R-3-NC) and Danny Davis (D-7-IL), mitigates the reduction in payments for office-based specialty procedures due to budget neutrality and the update in clinical labor costs that the Centers for Medicare & Medicaid Services (CMS) began in 2022 and is phasing in over a four-year period. 

H.R. 3674 will provide two years of targeted relief for specialist providers who have been most adversely affected by the update of the clinical labor costs by increasing the non-facility practice expense relative value units (PE RVUs) for those procedures performed in an office-based setting that need an expensive medical device or piece of medical equipment. 

Although the SVS continues to pursue systemic physician payment reform, passage of H.R. 3674 will provide some modest relief from payment cuts that are eroding patient access to vascular care and the viability of the community-based vascular practice. This seemingly small step is a crucial piece of an effort to influence massive reform of how healthcare is funded at the federal level. 

These efforts over time can help raise awareness of the issues our specialty and physicians face, and along the way inspire reform to a more sustainable and competitive system. 

For more information on how the SVS inspires reform at the federal level, visit vascular.org/advocacy or contact svsadvocacy@vascularsociety.org. 

Jill Rathbun is a member of the SVS Washington, D.C., office. 

First patient treated in global strategic collaboration involving Cydar Maps technology

By
Bryan Kay
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0
First patient treated in global strategic collaboration involving Cydar Maps technology
Cydar Maps
Cydar Maps

Cydar Medical has announced the successful treatment of the first patient in a strategic collaboration with Medtronic. The collaboration, which spans 40 sites across the U.S., UK and Europe, involves the integration of the company’s Cydar Maps software with Medtronic’s services and case support, with the aim of improving patient care and the efficiency of medical professionals by introducing unique artificial intelligence (AI) solutions into the clinical environment.

The first patient in the pilot program was treated using Cydar Maps at Edward Hospital  in Naperville, Illinois, by vascular and endovascular surgeon George Pontikis, MD.

Cydar Maps is the first product from Cydar’s AI technology platform and, according to the company, transforms the way information is provided to clinicians undertaking image-guided minimally invasive surgery (MIS) simplifying complexities within operating theaters at leading hospitals across the globe.

The company explains that Cydar Maps generates a 3D map of patient soft tissue to support and integrate preoperative planning, intraoperative guidance and postoperative review of endovascular MIS, using AI to update the map throughout the patient journey. Cydar Maps has been shown to offer a number of benefits, a company press release reports, including halving the radiation exposure for patients and the clinical team, simplifying the clinical workflow and increasing clinician confidence, which in turn can significantly reduce procedure times.

The pilot program is also expected to inform the ongoing development of Cydar Maps, which will include predictive analytics to support optimized procedure planning based on the use of AI to compare patient anatomy and procedure outcomes from a global data set.

Pontikis said: “This cutting-edge technology empowers us with the ability to navigate complex vascular procedures with greater precision—ensuring optimal outcomes for our patients. We are honored to be a part of this innovative program and are eager to contribute to the advancement of endovascular aortic surgery.”

Shockwave L6 catheter achieves ‘almost pristine’ result in challenging case

By
BIBA Publishing
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0
Shockwave L6 catheter achieves ‘almost pristine’ result in challenging case

NOTE: This video is ONLY available to watch in selected countries and geographies [geoip-content country=”US”]

Experts gathered at the Society for Vascular Surgery’s 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17) to discuss the latest innovation from Shockwave Medical—the Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) catheter (available in 8-12 mm diameter sizes), for use in calcified large-vessel interventions.

Karan Garg, MD (New York City, USA) was joined by Misty Humphries, MD (Sacramento, USA) and Mathew Wooster, MD (Charleston, USA) to explore how the new device has changed their practice and treatment approach in larger vessels.

According to Humphries, the larger Shockwave L6 catheter “opens up the ability to do thoracic endografting and aortic endografting for patients with calcified vessels”.

Wooster added that, while the Shockwave M5+, worked and was a “great” device, the L6 simplifies certain procedures. He explained: “Instead of having to use a small Shockwave balloon that’s truly undersized and then come back with a standard balloon in order to get up to a large enough diameter for our large-bore device, you do it in one step, and it just makes things much more efficient.”
To demonstrate the benefits of the new L6 in clinical practice, Wooster shared with the group a case that showed “how the L6 can really impact our care, and change the pathways that we have available to us”.

The case involved a 70-year-old man with a 5cm juxtarenal aneurysm, subacute ischemia, and a nearly occluded common femoral artery. Sharing the outcomes, Wooster detailed that the L6 device ensured the common femoral artery was “almost pristine” following treatment.

Commenting on the case, which Wooster said he was “fully expecting to fail,” Humphries highlighted the impressive trackability of the L6, with Garg remarking on the “well-executed” nature of the treatment.

The Shockwave L6 catheter is available in the US-only.
This video is sponsored by Shockwave Medical.

[/geoip-content]

Clinical performance of Human Acellular Vessel amid war in Ukraine presented at military research symposium

By
Bryan Kay
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0
Clinical performance of Human Acellular Vessel amid war in Ukraine presented at military research symposium
Human Acellular Vessel
Human Acellular Vessel

Clinical outcomes of Humacyte’s investigational Human Acellular Vessel (HAV) were presented at the Military Health System Research Symposium in Kissimmee, Florida (Aug. 14–17), following a year-long humanitarian program in Ukraine. The bioengineered, implantable human tissue-based device was provided to five hospitals on the frontlines of the Ukrainian war to treat traumatic vascular injuries beginning in June 2022.   

War injuries in Ukraine have led to tens of thousands of amputations, many of which occur because blood flow cannot be restored after the injury, the company outlined in a press release. As of July 2023, the HAV has been used to treat 19 patients in the eastern European country suffering from a range of traumatic vascular injuries, including gunshots, shrapnel, blasts and industrial accidents.

Clinicians reported that the rate of success in treating patients with the HAV was high, Humacyte reported, with an observed 30-day HAV patency (presence of blood flow) of 95%. At 30 days after treatment with the HAV, the limb salvage rate was 100%, meaning no amputations occurred in patients treated with the bioengineered vessel. In addition, there was 100% patient survival and no cases of infection of the HAV. There was one patient whose HAV had to be removed due to shrapnel-related bleeding.

“The novel bioengineered, off-the-shelf HAV provides time to the surgeon and patient,” said Oleksandr Sokolov, MD, a Ukrainian vascular surgeon and HAV implanter in the humanitarian program. “It has the potential to be a significant advancement in treating life-threatening combat vascular injuries.”

Humacyte’s humanitarian program was initiated in May 2022, when the company provided investigational HAVs to hospitals in Vinnytsia, Dnipro, Odessa, Kyiv and Kharkiv, in response to Ukrainian surgeon requests. Humacyte worked closely with the Food and Drug Administration (FDA) and the Ukrainian Ministry of Health to obtain approval for the program. The company then subsequently trained Ukrainian surgeons by video conference on how to implant the HAV.

The HAV, a regenerative medicine product candidate, is designed to provide surgeons with a universally implantable, bioengineered human vessel. It is intended to be available to the surgeon immediately and provide a potentially life- and limb-saving option in circumstances where synthetics are not indicated and autologous vein is not feasible. Designed to be off-the-shelf, the HAV has the potential to save valuable time and reduce complications like amputations and tissue loss, Humacyte pointed out. Additionally, the HAV is comprised of the same tissue that makes up natural human vessels, thereby having the potential to repopulate with the patient’s own cells.

Clinical results suggest that the HAV is durable and highly infection-resistant, and therefore may be well suited for treating the contaminated wounds created by major wartime blast and shrapnel injuries, Humacyte said in the press release.

The new data from the frontlines in Ukraine will be included as part of Humacyte’s Biologics License Application (BLA) to the FDA, which is planned for the fourth quarter of 2023, the company said. The planned BLA will build on results from Humacyte’s pivotal trial studying the HAV in treating patients with vascular injury in the extremities, which recently completed enrollment. The HAV also received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation in May 2023 for urgent arterial repair following extremity vascular trauma.

The HAV has accumulated over 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. It is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Child-bearing age ‘should not be a contraindication to venous stenting’

By
Jocelyn Hudson
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0
Child-bearing age ‘should not be a contraindication to venous stenting’

pregnancyIn a recently published study, dedicated venous stents performed well through pregnancy and postpartum, and a protocol including the use of low-dose antiplatelets in combination with anticoagulation at either a prophylactic or therapeutic dose depending on the patient’s risk profile appeared safe and effective.

Writing in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL), authors Laurencia Villalba (Vascular Care Centre, Wollongong, Australia) and Theresa A Larkin (University of Wollongong, Wollongong, Australia) share that the aim of their study was to assess the performance of dedicated iliac venous stents during subsequent pregnancy and postpartum, including stent patency and stent integrity, as well as incidence of venous thromboembolism (VTE) and bleeding complications.

The investigators outline in their introduction that, while venous stenting has become the preferred method of treatment for non-thrombotic iliac vein lesions, post-thrombotic lesions, and lesions found after thrombus removal in the setting of an acute iliofemoral deep vein thrombosis, “concern remains about stenting women of child-bearing age”. They explain that this is because pregnancy is a hypercoagulable state, and the gravid uterus can potentially compress the stent and/or the inflow vessels and thus compromise patency. Villalba and Larkin add that the current literature on the performance of venous stentings during pregnancy comprises only six studies to date, including 66 patients and 74 pregnancies with most stents assessed being Wallstents (Boston Scientific).

This was a single-site, prospective cohort study. Villalba and Larkin detail that women of child-bearing age who had received dedicated iliac venous stents were included in a surveillance program and then, for any subsequent pregnancies, followed the same pregnancy care protocol. They explain that this included an antithrombotic regimen of 100mg aspirin daily until gestation week 36, and subcutaneous enoxaparin at a dose dependent on risk of thrombosis. Going into more detail, Villalba and Larkin specify that low-risk patients, those stented for non-thrombotic iliac vein lesions, received a prophylactic dose of 40mg/day from the third trimester, while high-risk patients, those stented for thrombotic indication, received a therapeutic dose of 1.5mg/kg/day from the first trimester. All women underwent follow-up with duplex ultrasound assessment of stent patency during pregnancy and six weeks postpartum, the authors note.

The authors report that, among 10 women who had received dedicated iliac venous stents for either a non-thrombotic or thrombotic indication, and 13 post-stent pregnancies—during which a dedicated protocol for stent thrombosis prevention was followed—there was a 100% patency rate, no bleeding complications, and no VTE during pregnancy or puerperium. Only one stent was permanently deformed /compressed by the gravid uterus, but it was a Vici stent that had been “balloon fenestrated” at the time of insertion due to concerns of contralateral caging, so it had lost its structural integrity.

In the discussion of their findings, the investigators write that the main limitation of their study is its small sample size. In addition, they acknowledge that it is still unknown whether multiple pregnancies could affect stent structure over time, despite three patients having two pregnancies each.

Villalba and Larkin also highlight the study’s key strengths, including the fact that patients were followed up prospectively, and that the investigators followed a protocol including serial imaging, multidisciplinary input and a tailored antithrombotic regime.

“Dedicated iliac venous stents perform well during subsequent pregnancy with no stent occlusion or fracture,” Villalba and Larkin conclude. They state in closing that child-bearing age “should not be a contraindication to venous stenting,” though they also stress that studies reporting on a larger sample size of patients are necessary.

Study finds no correlation between IVC filter placement position and device complications

By
Jocelyn Hudson
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0
Study finds no correlation between IVC filter placement position and device complications
IVC filter
Scott Grubman

Researchers report that inferior vena cava (IVC) filter placement position relative to the level of the most inferior renal vein was not associated with differences in IVC thrombosis in a recent single-centre cohort study.

Additional key findings from the study include a low incidence of other filter-related complications, including migration, fracture, and caval wall penetration, and no occurrence of device-related mortality. These conclusions were recently shared online in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL).

Authors Scott Grubman (Yale University School of Medicine, New Haven, USA) and colleagues write that indwelling IVC filters can cause complications, including penetration into surrounding structures, migration, and thrombosis of the vena cava. They add that, while computational fluid dynamics suggest juxtarenal placement of IVC filters decreases the risk of thrombosis, this has not been explored clinically.

Against this background, Grubman et al communicate that it was their aim in the present study to examine the effect of filter placement position on long-term device complications with an emphasis on IVC thrombosis. “We hypothesised that IVC filters placed further caudal to the renal veins were more likely to develop long-term thrombosis,” they write.

In order to investigate their hypothesis, the researchers document that they conducted a retrospective review of the medical records of patients receiving IVC filters at a single tertiary centre between 2008 and 2016. They note that they excluded patients missing follow-up or procedural imaging data.

“The placement procedure venograms were reviewed, and the distance from the filter apex to the more inferior renal vein was measured using reported IVC filter lengths for calibration,” Grubman and colleagues detail in JVS-VL, sharing their study methods. They add that they patients were divided into three groups according to the tip position relative to the more inferior renal vein: group A (at or superior), group B (1–20mm inferior), and group C (>20mm inferior). The researchers then compared patient and procedural characteristics and outcomes between the three groups, with the primary endpoints being IVC thrombosis and device-related mortality.

Grubman et al state in the results section of their paper that, of the 1,497 eligible patients, 267 (17.8%) were excluded from the present study. They write that the most common placement position was group B (64%), and that the mean age was lowest in group C (59.5 years), followed by groups A (64.6 years) and B (62.6 years), with a p value of 0.003. The team convey that no statistically significant differences were found in the distribution of sex or the measured comorbidities.

The authors continue that group C was the most likely to receive jugular access (group C, 71.7%; group A, 48.3%; group B, 62.4%; p<0.001) and received more first-generation filters (group C, 58.5%; group A, 46.6%l group B, 52.5%; p=0.045).

Sharing their key findings from the study, Grubman and colleagues report: “The short-term (<30-day) and long-term (≥30-day) outcomes, including access site haematoma, deep vein thrombosis, and pulmonary embolism, were uncommon, with no differences between the groups.” They add that cases of symptomatic filter penetration, migration, and fracture were rare (one, one, and three cases, respectively).

The authors further highlight that, although a pattern of increasing thrombosis with more inferior placement was found, the difference between groups was not statistically significant (group A, 1.5%; group B, 1.8%; group C, 2.5%; p=0.638).

Grubman et al also relay that no cases of device-related mortality occurred, and that all-cause mortality after a mean follow-up of 2.6±2.3 years was 41.3% and did not vary significantly between the groups (p=0.051).

Finally, the authors state that multivariate logistic regression revealed that placement position did not predict for short- or long-term deep vein thrombosis, pulmonary embolism, IVC thrombosis, or all-cause mortality after adjustment for the baseline patient characteristics.

In their conclusion, Grubman and colleagues summarise: “IVC filters have low rates of short- and long-term complications, including IVC thrombosis. The placement position did not affect the occurrence of device complications in this study.”

The authors acknowledge some limitations of their study, including those “common to a retrospective medical record review”, such as inconsistent information entry into the medical records, missing or incomplete records or procedural imaging studies, potential bias from loss to follow-up, and the potential for uncaptured, non-randomised confounding variables.

In addition, Grubman et al recognise that the study “likely lacked a sufficient sample size to limit type II errors when comparing the rates of the more uncommon complications between groups” and note that “larger studies would be helpful to further elucidate the relationship between filter position and the occurrence of rare adverse events”.

Learn coding intricacies at October workshop on reimbursement

By
Marlén Gomez
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0
Learn coding intricacies at October workshop on reimbursement
Sean Roddy

The SVS will host the SVS Coding and Reimbursement Workshop this fall, providing a comprehensive program designed to equip vascular surgeons and their support staff with essential knowledge and competence in appropriate billing and coding procedures. 

Over the course of the workshop, scheduled for Oct. 16– 17, attendees will receive a review of coding practices, recent changes to the current procedural terminology (CPT) and Medicare, the proper application of modifiers for streamlined reimbursement, and the impact of Medicare’s Global Surgical Package on billing and reimbursement. 

Workshop director Sean Roddy, MD, provided an overview of what attendees can anticipate during the workshop, which includes an optional half-day workshop on evaluation and management (E&M) codes. The workshop will address the intricate and distinctive aspects of vascular surgery coding that distinguish it from other medical specialties. 

“Vascular surgery has some nuances that are different from other specialties, and it is important to get the vascular lab coding correct for the ultrasounds and procedures. Endovascular procedures can be confusing on what codes you bill, so we try to clarify that with examples,” said Roddy. 

Participants can expect to receive the most up-to-date information directly from vascular surgeons who are deeply involved in the creation and valuation of codes, ensuring the most accurate and reliable recommendations. Roddy emphasized the significance of this educational event, highlighting the direct impact Medicare has on the specialty. 

“We have decreasing revenue from Medicare, which uniquely impacts vascular surgeons since up to 70% of our patient population has Medicare. Accurate coding and good documentation are crucial to optimizing our revenue for all payers, reducing denials, optimizing accounts receivable, and increasing our revenue,” said Roddy. 

The workshop demonstrates SVS’ commitment to empowering medical professionals with the tools they need to provide the highest quality of care possible, according to Roddy. 

Medical professionals interested in attending the educational course are encouraged to register early. It will be held at the OLC Education and Conference Center at SVS headquarters, 9400 W. Higgins Road in Rosemont, Illinois. 

It is designed for vascular surgeons and their office staff, including practice managers, nurse practitioners, physician assistants, nurses, surgery schedulers, coders, and others who seek to improve and expand their knowledge of accurate coding and reimbursement for vascular surgery. 

Course leaders point out the event is ideal for vascular trainees and surgeons as the level of the content is intermediate to advanced. 

Attendees can earn a maximum of 3.75 AMA PRA Category 1 Credit(s) for the optional evaluation and management (E&M) coding workshop and 10.00 AMA PRA Category 1 Credit(s) for the Coding and Reimbursement Workshop. 

The optional workshop will be held from 8 a.m.–12 p.m. Oct. 16, while the main workshop sessions will follow from 1–5 p.m. the same day and from 7:30 a.m.–4:30 p.m. on Oct. 17. 

More information about the courses and the preliminary agenda can be found at vascular.org/coding23. 

Your SVS: Executive Board sets course for year

By
Beth Bales
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0
Your SVS: Executive Board sets course for year
Joseph Mills
SVS President Joseph Mills

Phase II of a national branding campaign for vascular surgery and three new task forces are just two of several initiatives the SVS’ Executive Board highlighted for further action during its recent board retreat.

The SVS Strategic Board meets each January to review the Society’s strategic plan and develop priorities for the coming year. Each July, the Executive Board meets to accelerate implementation of those key priorities that were identified by the Strategic Board. The Executive Board met July 27–29 under the leadership of SVS President Joseph Mills, MD, and took action to move multiple priorities forward:

  • Granted approval for and agreed to provide resources for phase II of a major national branding campaign for vascular surgery
  • Established a Bylaws Subcommittee to deliberate, carefully consider and recommend any further changes regarding selection and election of SVS officers and Executive Board members
  • Established three new task forces to fast-track development: a Research Clinical Trials (RCT) Task Force to foster and accelerate new trials; an Innovation Task Force to provide education and resources to help member entrepreneurs; and a Patient Engagement Task Force to optimize patient engagement in the work of the SVS
  • Agreed to develop a new, dedicated Advocacy/Health Policy Leadership Conference
  • Approved methodology and terminology to move forward with appropriate use criteria (AUC) for management of carotid artery occlusive disease
  • Established a private practice peer review process to augment the upcoming launch of the Vascular Verification Outpatient Program

The board will continue to keep members informed across SVS communication channels, including Pulse, Vascular Specialist, social media, SVSConnect and email, and will seek volunteers to contribute to these efforts.

“The Strategic Board was preceded by a half-day meeting of major stakeholders to consider the status and progress of diversity, equity and inclusion within the SVS,” said Mills.

“Branding, advocacy, appropriate use and outpatient peer review represent just a few of the key topics we discussed and the paths forward that we initiated. We will keep members informed and engaged as we move forward, seeking feedback, contributions and broad participation from our SVS membership.”

UCLA-SVS review course is this month

By
Beth Bales
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0
UCLA-SVS review course is this month

Time is running out to plan attendance at the annual course, A Comprehensive Review and Update of What’s New in Vascular and Endovascular Surgery, to be held from Aug. 23–26 at the Beverly Hilton, in Beverly Hills, California. 

The course is a joint effort of the Division of Vascular and Endovascular Surgery at the University of California, Los Angeles (UCLA) and the SVS. Besides an in-depth review of the specialty, it also provides basic didactic education for vascular residents and fellows in training. Many attendees find it offers a good review before the Vascular Surgery Board (VSB) exams. 

The course recognizes four major pillars of vascular surgery practice: conventional open operations, catheter-based interventions (endovascular surgery), medical management and diagnostic imaging and noninvasive testing. 

For more information, including the schedule, visit vascular.org/UCLAReviewCourse23. 

Corner Stitch: Supplementing our formal learning as vascular trainees

By
Christopher Audu
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0
Corner Stitch: Supplementing our formal learning as vascular trainees
Christopher Audu

As a vascular surgery trainee, there are multiple aspects of vascular surgery that I’ve had the opportunity to learn about. And to be honest, I’m still learning. 

To that end, the SVS has put a great deal of effort in providing multiple opportunities to supplement our formal curriculum and cater to various academic and clinical interests through a number of short courses or fellowships. As trainees, I find that these are invaluable to fill gaps in the curriculum that may not exist at individual institutes. 

In this issue of Vascular Specialist, the SVS VQI Fellowship-In-Training (FIT) program is highlighted. This program was developed to support the curation of a cadre of trainees (general surgery, vascular surgery, cardiology, etc.) in the scientific pursuit of analysis of clinical data. I imagine that this pipeline of fellows will be important to shaping future policy in the world of vascular surgery. 

Another program supported by the SVS and aimed towards trainees is the Journal of Vascular Surgery (JVS) internship— now in its third year. This program is developing a pipeline of conscientious reviewers who will bring a diverse and nuanced approach to journal manuscript reviews to elevate the quality of work published in the JVS journals. 

Interested in the business of vascular surgery—including how coding, reimbursements and policy are intertwined? Then the annual SVS Coding & Reimbursement Workshop is for you. This 1.5-day course provides an extensive review of coding and critical updates. In addition to becoming savvy in coding and billing for cases/procedures, it helps to shine a light on the importance of policy reforms that affect billing codes and reimbursements for vascular surgery services. 

But academic pursuits are not the only domain where the SVS has developed programming. In this issue, there is a highlight on the Complex Peripheral Vascular Intervention (CPVI) Skills Course in which participants will be exposed to didactic and hands-on-training on the innovative aspects of interventions for peripheral arterial disease (PAD), including endovascular, open and hybrid options. This is a course for vascular surgeons, developed by vascular surgeons. It’s a quick two-day course at the SVS office headquarters. 

Another course with a similar flavor, although not formally supported by the SVS, is the Advanced Practical Exposures in Vascular Surgery (APEX) held at the St. Louis University hospital every fall. This course provides an invaluable hands-on experience to less commonly encountered exposures in the neck, chest, abdomen and lower extremities. The highlight of the course is the “How I Do It” didactic sessions prior to the cadaver exercises. 

And of course, there is the UCLA/SVS course that provides a comprehensive review of vascular surgical techniques. Held every August in Los Angeles, this three-day course is invaluable to the graduating vascular trainee and is often subsidized for trainee attendance. 

In addition, there are multiple opportunities to engage in courses offered through the likes of local regional societies and VAM. If there were any course I’d like to see developed, it is one that focuses on vascular trauma. I think that could be helpful to identify best practices for this vulnerable patient population. Nevertheless, as a trainee, I’m glad that these opportunities exist to plug knowledge gaps that exist in every program—and I hope that you too are able to partake in some of these courses. 

Christopher Audu, MD, is the Vascular Specialist resident/fellow editor. He is an integrated vascular surgery resident at the University of Michigan in Ann Arbor, Michigan. 

Breaking ground: A trial to improve the care of uncomplicated type B aortic dissection

By
Beth Bales
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0
Breaking ground: A trial to improve the care of uncomplicated type B aortic dissection
The IMPROVE-AD trial will enroll its first patient by the end of the year

Because high-quality evidence from large, prospective multicenter trials on the best treatment of uncomplicated type B aortic dissection (uTBAD) is scarce, SVS members Firas F. Mussa, MD, a professor of vascular surgery at UT-Houston in Houston, Texas, and Panos Kougias, MD, chair of the Department of Surgery at SUNY Downstate Health Sciences in New York City, are moving forward with a large randomized trial to address this unmet need. Other principal investigators are Manesh Patel, MD, Seekanth Vemalapalli, MD, and Sean O’Brien, PhD, from Duke Heart Center, Duke University and Duke Clinical Research Institute (DCRI) in Durham, North Carolina, the award recipient institution. Sherene Shalhub, MD, head of vascular surgery at Oregon Health Sciences University in Portland, Oregon, will lead the patient engagement. 

This prospective, pragmatic, randomized clinical trial, entitled IMPROVE-AD (Improving outcomes in vascular disease—aortic dissection), will enroll its first patient by the end of the year. 

Acute aortic dissection is the most common life-threatening aortic emergency, with 30–40% classified as uTBAD. The current standard-of-care consisting of optimal medical therapy with surveillance is appropriate in the majority of such dissections. However, recent data suggest early thoracic endovascular aneurysm repair, known as TEVAR, could be beneficial for some patients, said Mussa. In fact, the trial’s primary hypothesis is that the latter therapy will be superior. 

The trial will assess clinical outcomes in patients with subacute uTBAD undergoing either upfront TEVAR plus medical therapy vs. medical therapy with surveillance for deterioration. 

IMPROVE-AD is funded by the National Heart, Lung and Blood Institute (NHLBI) to enroll and randomize 1,100 patients at 60 sites in North America. It expected to last seven years and generate the sought-after quality evidence to guide daily clinical practice and future SVS guidelines. 

Panos Kougias and Firas F. Mussa

Treatment of aortic dissection is a top SVS clinical research priority in aortic disease. Writing a letter of support to Mussa, SVS Immediate Past President Michael Dalsing, MD, said, “… it is our belief that this trial addresses a significant and timely question related to the care of patients with acute type B aortic dissection as there remains clinical equipoise when considering available treatment options at the time of initial presentation. When completed, your trial will provide strong evidence that will guide clinical practice in a safe and rational manner.” 

Mussa has worked on the project for almost a decade, and, over the past several years, with support from other vascular surgeons, has refined the design and organization of the trial. “Until today, I wake up and think of the trial design, endpoint, ancillary studies, enrollment and how to get people engaged,” said Mussa. 

Personnel at the 60 sites will collect baseline history, dissection-related data and in-hospital outcomes. Duke Clinical Research Institute will collect medical events. 

To be included, uTBAD patients must be more than 21 years old and have no history of aortic intervention. The condition is defined as dissection without involvement of the aorta at, or proximal to, the innominate artery, without rupture and/or malperfusion (renal, mesenteric, or extremity). Patients will be randomized within 48 hours to six weeks, stratified by the presence of one of the high-risk features upon presentation. 

Site investigators will determine all subsequent care (including additional testing, medications/procedures), with the exception of aortic interventions. Such interventions will be allowed for: acute complications (rupture and/ or malperfusion, embolization, or aortoesophageal/aortotracheal fistula), aneurysmal degeneration of more than 55cm, significant aortic growth of more than 5mm over a six-month period, or persistent pain and/or hypertension during index admission. All participants will have their blood pressure monitored remotely, with follow-up administered through the use of a centralized call center with physician adjudication of relevant cardiovascular and aortic events. 

“In addition to determining the optimal treatment that leads to the best short-and long-term benefit, we also want to address other questions, including the impact of high-risk dissection features on outcomes,”said Kougias. “Also, we should aim to further understand what patients want; what are their priorities? That’s a critical part of what we should be asking.” 

The trial’s primary endpoint is the composite of all-cause death or major aortic complications. Secondary endpoints are quality of life, cardiovascular hospitalizations, cardiovascular death and components of the primary endpoint. 

The trial is sponsored by UT Health Houston, SUNY Downstate Health Sciences University, and Duke Clinical Research Institute. An IMPROVE-AD informational meeting held during VAM 2023 in June drew a crowd of surgeon-scientists and clinicians who wanted to learn more and become involved in the trial. 

Meeting attendees had many suggestions and thoughts, including on the “diagnosis-to-intervention” timeframe, with most selecting the six-week mark as the endpoint for intervention to be included in the trial. 

An attendee suggested the trial should include a parallel patient engagement plan to make sure patient voices are heard. Many indicated they are willing to enroll their patients. “Every one of you has a patient who would qualify,” Mussa pointed out to those in attendance. “My ‘ask’ of you is to please connect them with us.” He also asked surgeons to participate in the analysis and outcomes. 

IMPROVE-AD investigators also have proposed several ancillary studies pending further funding. 

Patrice Desvigne-Nickens, MD, from the NHLBI, stressed the importance of the shared partnership with the institute for the trial. “We really want this to go forward and succeed,” she said. 

The trial has several unique features, she explained, including that it is pragmatic. “It will enroll every eligible patient and really answer vital questions for surgeons,” she said. “Medicine is a random distribution of what the physician decides to do.” 

Determining systematically what is best in practice is a better way to make decisions, she added, encouraging all the surgeons in attendance to participate, either by enrolling patients or participating in analysis. “Your participation is really key,” Desvigne-Nickens concluded. 

VQI Fellows in Training program marks one year

By
Beth Bales
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VQI Fellows in Training program marks one year
FIT introduces residents and fellows in vascular surgery and medicine to the SVS PSO

The Vascular Quality Initiative (VQI) Fellows in Training (FIT) program is a success, said leaders as they provided a one-year review. 

FIT introduces residents and fellows in vascular surgery and medicine to the SVS Patient Safety Organization (PSO). Fellows worked closely with their mentors to participate in VQI regional meetings. They also participated in quality charter development, the quality improvement process and research initiatives using VQI data. FIT is run in collaboration with the Association of Program Directors in Vascular Surgery (APDVS). 

Adam Johnson, MD, a vascular surgeon at Duke Health in Durham, North Carolina, briefly reviewed the first year of the program during the recent VQI Annual Meeting in June. During the session, founding VQI Medical Director Jack Cronenwett, MD, announced the recipients of the second-year scholarship that bears his name. 

Year one included 16 mentors and 16 fellows representing 10 of the VQI’s 18 regions, said Johnson. Over the year, the fellows have submitted projects to research advisory committees, with refinement following review and data analysis. Some of the projects were included in the poster presentations at the annual meeting. Mentors were “very satisfied” with the projects overall, and trainees were “very or somewhat satisfied” with the program, Johnson said. 

Leaders added virtual meetings, to which mentors will be added this coming year; formalized the curriculum and made it more readily available; and helped provide local leadership in the aftermath of a few mentor changes. For year two, organizers will promote engagement via presentations by fellows at regional meetings, he said. 

The five scholarship winners will continue work with the program, receiving individual funding to continue their research and/or work more closely with VQI staff and committees. Scholarships are awarded in either the research or quality categories. 

Quality 

For 2023–24, the FIT fellows and mentors in the quality category are: Hanna Dakour Aridi, MD, from Indiana University Health-Methodist in Indianapolis—mentored by Michael Murphy, MD—who has studied postoperative day-one discharge, which is used as a quality-of-care indicator after carotid revascularization. Her project involved reviewing records of 122,560 elective carotid interventions in the VQI to identify drivers of increased length of stay. 

Christine Kariya, MD, from the University of Vermont Medical Center in Burlington, Vermont—mentored by Danny Bertges, MD—is working to incorporate patient-reported outcome measures (PROMs) into the electronic medical record (EMR) and VQI registries. 

Research 

In the research category, Caronae Howell, MD, from University of Utah Hospital and Clinics/The University of Arizona—who is mentored by Benjamin Brooks, MD—is studying racial and ethnic disparities in revascularization options for chronic limb-threatening ischemia (CLTI), with a study designed to compare anatomic patterns of disease and limb-salvage outcomes among patients from racial and ethnic groups undergoing first-time revascularization for lower-extremity CLTI. 

Brianna Krafcik, MD (mentor Phil Goodney, MD), from Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, is using the carotid endarterectomy and carotid stenting VQI modules to compare indirect quality-of-life measures such as length of stay, new neurologic events, frailty, and new medications between carotid endarterectomy and transcarotid artery revascularization (TCAR). 

Lastly, Ben Li, MD, from Toronto General Hospital in Toronto, Canada—mentored by Graham Roche-Nagle, MD—is developing machine learning algorithms to predict outcomes following major vascular surgery using the VQI database. He used VQI data to develop robust machine-learning models that accurately predict outcomes following carotid endarterectomy.

SVS members get ready for second annual vascular health awareness event

By
Beth Bales
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SVS members get ready for second annual vascular health awareness event
The annual walking initiative benefits the SVS Foundation

September’s Vascular Health Step Challenge is fast-approaching, and SVS members are preparing to step up to meet it. 

The challenge benefits the SVS Foundation, which asks people to walk 60 miles—representing the 60,000 miles of blood vessels in the human body—throughout September. Funds raised will help the Foundation amplify the importance of vascular health while also promoting healthy vascular health habits throughout the country. 

Participants all receive a Step Challenge T-shirt and can walk individually or as part of a team. Those who registered by Aug. 5 will receive their T-shirts by Sept. 1, the start of the campaign. 

September is National Peripheral Arterial Disease (PAD) Awareness Month, making it the perfect time to highlight the benefits of walking and overall vascular health. Walking is a front-line therapy for PAD, a chronic disease in which plaque builds up in the arteries to the legs. Vascular surgeons deal with PAD routinely and, thus, are the perfect advocates for walking, said SVS Foundation Chair Michael Dalsing, MD. And, as vascular surgeons are, by nature, highly competitive, they’re typically up for such a challenge. 

For example, in asking several of 2022’s top fundraisers why they put their shoes to pavement last year, answers included the importance of walking—and beating another surgeon. 

Adam Beck, MD, walked and donated for two reasons, he said: “To support the SVS and to try to encourage others to walk as well through competition and to beat Dr. [Leigh Ann] O’Banion.” He noted, “(I lost, no surprise).” 

O’Banion, who walked as part of “Team FAB,” laughed at his response, saying her two reasons were: “I am committed to advancing the care of patients with PAD in disadvantaged and rural patient populations, and I am the most competitive person ever and was so proud to be part of a FABulous group of surgeons who kicked some butt!” 

O’Banion’s 27-member team raised the most funds, a healthy $12,970. 

Said Jesus Matos, MD: “I walked and donated because I wanted to be a role model to all of our patients. Exercise is the most powerful medicine for all chronic illnesses and the best predictor of longevity,” he said, adding, “Walk with me, 2023.” 

Laurel Hastings, MD, was also part of “Team FAB.” “I walked to support programs that fund community outreach, bringing awareness to PAD, and to give Leigh Ann O’Banion a formidable competitor,” she said, adding with a smile emoji, “See fundraising results please.” (Let the record show she was the top individual fund-raiser, beating O’Banion by $60.) 

Surgeons are undoubtedly planning their competitions for this year. 

The Vascular Step Health Challenge entry fee is $60. New this year is a “pay -it-forward” registration to help cover the participation fee for low-income vascular patients. 

The program takes place on the Charity Footprints platform. During registration, participants can link their fitness tracker to the platform to automatically log steps throughout the month of September. Eligible trackers are Apple Watch, Fitbit, Garmin, Google Fit, Misfit and Strava. Those people who don’t have eligible trackers can enter their steps manually, or connect via their smartphone. 

Pay-it-forward participants, as of July 20, are: James Persky, Edward Gifford, Bethany Slater, Yong Daniel, Kate Shuman, Rhuseet Patel, Kimberly Thomas, William Shutze, Kathryn Bowser, Dejah Judelson, Simpledeep Banipal and Bill Maloney. 

SVS responds to CMS proposed coverage expansion for carotid stenting

By
Jocelyn Hudson
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SVS responds to CMS proposed coverage expansion for carotid stenting

The Society for Vascular Surgery (SVS) and its affiliated Patient Safety Organization (PSO)/Vascular Quality Initiative (VQI) have submitted a formal response to the Centers for Medicare & Medicaid Services (CMS) regarding its proposed national coverage determination on percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting.

The move would expand coverage to individuals previously only eligible for coverage in clinical trials; to standard surgical risk patients by removing coverage limitations to only high surgical risk individuals; remove facility standards and approval requirements; add formal shared decision-making with the individual prior to furnishing carotid stenting; and allow Medicare Administrative Contractors (MACs) discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.

In a letter dated 4 August, Joseph L. Mills, MD, SVS president, on behalf of the SVS executive board, and Jens Eldrup-Jorgensen, MD, medical director of the SVS PSO, state that the SVS and its affiliated PSO “remain concerned” with the expansion of coverage outlined in CMS’ Proposed Decision Memo regarding NCD 20.7. They go on to submit a series comments for consideration in advance of the CMS issuing a final decision memorandum. These include the negative impact on patient safety, the premature nature of the decision given that CREST-2 [Carotid revascularization and medical management for asymptomatic carotid stenosis trial] is still underway, the impact to the elderly patient population, the “substantial and lengthy” learning curve for transfemoral carotid artery stenting (TF-CAS), and the lack of a registry participation requirement.

Due to these concerns, Mills and Eldrup-Jorgensen write that they “urge CMS to revise its proposed decision memo relating to NCD 20.7” and set out a series of recommendations. These are as follows:

  • Recommendation 1. Mandate utilization of a standardized “Shared Decision Making” tool that would be designed in collaboration with applicable medical specialty societies and/or other relevant stakeholders.
  • Recommendation 2. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing process and requirements for reporting standards. These elements are critical for ensuring a high degree of patient safety.
  • Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Mills and Eldrup-Jorgensen conclude: “The SVS believes the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations. SVS will continue to actively promote quality and safety for vascular patient care through its published guidelines, appropriate care documents, PSO-VQI Registry and Initiatives such as the Vascular Verification Program. All practitioners caring for patients with vascular disease are encouraged to become familiar with and to utilize them. SVS will continue to develop these resources and make them available.”

Read the full response here.

WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study completes enrolment

By
Clare Tierney
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WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study completes enrolment

Merit Medical has announced that it has completed enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective, randomized, controlled, multicenter study comparing the Merit WRAPSODY cell-impermeable endoprosthesis (CIE) to percutaneous transluminal angioplasty (PTA) for treatment of stenosis/occlusion in the venous outflow circuit in patients undergoing hemodialysis. 

Creation and maintenance of an arteriovenous fistula or graft (AVF/AVG) to achieve long-term vascular access is required for patients undergoing hemodialysis. However, progressive stenosis and/or occlusion of blood vessels where the AVF and AVG are located can prevent delivery of hemodialysis, which can have life-threatening consequences. WRAPSODY was developed to help physicians treat patients with stenosis/occlusion in the vessels used for hemodialysis.

The WAVE study enrolled 244 patients with AVFs and 113 patients with AVGs across sites in Brazil, Canada, the UK, and the USA. Merit intends to collect safety and efficacy outcomes throughout the study follow-up period. Merit anticipates filing primary outcomes with the US. Food and Drug Administration (FDA) for premarket approval (PMA) after six months post-enrollment completion. Merit intends to follow patients enrolled in the WAVE study for 24 months following completion of enrollment.

SCVS president becomes chair of American Board of Surgery

By
Bryan Kay
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SCVS president becomes chair of American Board of Surgery
M. Ashraf Mansour

The American Board of Surgery (ABS) has named Society for Clinical Vascular Surgery (SCVS) President M. Ashraf Mansour, MBBS, as its 2023–24 chair. He was nominated to the ABS by the Association of Program Directors in Vascular Surgery (APDVS) in 2016.

“It is a great honor to serve as the American Board of Surgery chair this year,” said  Mansour. “I am very proud of all the accomplishments of the Board since I joined in 2016, from governance redesign to leading by example on diversity, equity, and inclusion.”

The Vascular Surgery Board (VSB), which administers the Qualifying and Certifying Exams required for board certification in vascular surgery, is part of the ABS.

“Achieving board certification is a milestone in every surgeon’s career,” said Mansour. “Being a diplomate of the American Board of Surgery tells the public that this surgeon has successfully completed surgical training and went through a rigorous certification process.”

Mansour is the chief of vascular surgery at Corewell Health in Grand Rapids, Michigan, and professor of surgery at Michigan State University. Born in Cairo, Egypt, he attended medical school at the Cairo University School of Medicine. After completing a general surgery residency at the University of Colorado Health Sciences Center in Denver,  Mansour served in the United States Army Medical Corps. He then completed a vascular surgery fellowship at Southern Illinois University in Springfield.

Mansour previously served as vice chair of the VSB from 2018–2019. He is also a past president of the Midwestern Vascular Surgical Society (MVSS).

Light-activated drug-coated balloon granted FDA approval for clinical study

By
Bryan Kay
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0
Light-activated drug-coated balloon granted FDA approval for clinical study

Alucent Biomedical has announced that the Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for a U.S. clinical study of AlucentNVS, a light-activated, drug-coated balloon catheter technology.

AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling. The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow. AlucentNVS is also designed to retain the natural functionality and flexibility of the vascular wall, while avoiding traditional complications of inserting permanent implants.

AlucentNVS is currently being evaluated in two feasibility trials in Australia and Poland, also examining its use in treating peripheral artery disease (PAD) and promoting the maturation of arteriovenous fistulas (AVF) for patients requiring hemodialysis. Enrollment in those trials is expected to conclude by the end of 2023.

Vascular Specialist–August 2023

By
Bryan Kay
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Vascular Specialist–August 2023

In this issue:

  • SVS responds to New York Times exposé on overuse of vascular interventions 
  • Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices
  • Vascular surgery added as named specialty to influential national hospital rankings
  • Guest Editorial: Adam Tanious, MD, ruminates on how to navigate industry rep exchanges 
  • uTBAD: A new randomized trial aimed at improving the lives of aortic dissection patients 

 

‘Vascular surgery should be a key member of pulmonary embolism response teams’

By
Bryan Kay
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0
‘Vascular surgery should be a key member of pulmonary embolism response teams’
The VAM pulmonary embolism session panel featuring Dennis Gable (seated, third from left)

“PERT care is the coalition of the willing,” quipped Dennis Gable, MD, a vascular surgeon at Texas Vascular Associates in Plano, Texas. He was referring to team-based care for pulmonary embolism (PE) patients and how, unlike acute stroke intervention and ST-elevation myocardial infarction (STEMI) care, PE lacks a clear owner specialty in the setting of pulmonary embolism response teams (PERTs), which represent multidisciplinary care characterized by easy accessibility, rapid response and individualized consensus-driven treatment. Gable was making the case that vascular surgeons are well poised to assume the mantle of a pivotal role during Management of Pulmonary Embolism: Fundamentals and Advances, a special session that took place during the Society for Vascular Surgery’s 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17).

“There is no specialty that has really stepped up and said we are going to own the right heart and lung, and a lot of people don’t want to deal with PE altogether—they want to send that to the specialty centers of which we are growing in number,” he told attendees.

PE is a problem whose scope is significant, with many centers lacking the ability to treat this patient population, Gable observed. The importance of “team” in PERTs is paramount, he emphasized. “That entails not only vascular surgery, which is an important part of this and a key member, but also cardiology, interventional radiology, your ER [emergency room] physicians, pulmonary critical care and CT [cardiothoracic] surgery.”

Based on his team’s institutional experience, the establishment of a PERT was associated with “significantly higher utilization” of catheter-directed interventions, less major bleeding events and reduced in-hospital and 30-day mortality, Gable said. “Overall, our data suggest a definite advantage for a full multidisciplinary team to treat these patients.”

Data from 2016 demonstrated that vascular surgery involvement in PERTs was not among the top contributors to PE care teams. Gable said he was not aware of more recently published data mapping out the specialty’s current role but believes it likely now is the second or third top contributor.

He contrasted this with an allusion to CT surgery’s diminished role in cardiac catheterization: “Our CT colleagues, when cardiac catheterization came out, they were so busy with development and initiation of cardiac surgery, they gave up the cardiac catheterization to cardiology primarily,” Gable explained. “They took a role of standby operator backing up the interventionalists—but currently that is no longer existent in most centers.”

“PERTS have demonstrated the value for patient survival and decreased utilization of critical care resources,” Gable concluded. “Vascular surgeons have demonstrated expertise in this arena and treatment space. Vascular surgery is, and should be, a key member of the PERT team. And, to maintain branding as a vascular specialist and for our specialty overall, should remain and strive to be leaders in the area.”

Elsewhere, Gable also referenced the emerging role of artificial intelligence (AI) in PE care, and how machine learning can shave considerable time off the process of determining management for individual patients. AI algorithms allow treatment determinations to be established in “a more rapid fashion,” he noted.

SVS urges members to make voices heard on CMS carotid stenting coverage expansion

By
Beth Bales
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0
SVS urges members to make voices heard on CMS carotid stenting coverage expansion

The SVS has created a template to help members transmit comments to the Centers for Medicare & Medicaid Services (CMS) regarding proposed major adjustments in National Coverage Determination (NCD) 20.7, which covers carotid artery stenting (CAS).

The CMS proposal would adjust coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting by expanding coverage to individuals previously only eligible for coverage in clinical trials and to standard surgical risk individuals by removing the limitation of coverage to only high-surgical-risk individuals.

It also would remove facility standards and approval requirements; add formal shared decision-making with the individual prior to furnishing CAS; and allow Medicare Administrative Contractor (MAC) discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.

The proposed decision was released July 11, opening a 30-day comment period that ends at 11:59 p.m. Aug. 10. The SVS-provided template for individual comments reads as follows:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardize patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing process and requirements for reporting standards. These elements are critical for ensuring a high degree of patient safety.

Recommendation 2. Mandate utilization of a standardized “Shared Decision-Making” tool that would be designed in collaboration with applicable medical specialty societies and/or other relevant stakeholders.

Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.

Conclusion

I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If, however, the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.

Comments by individuals—or on behalf of a practice—should be submitted at vascular.org/CarotidNCD. At the close of the comment period, CMS will review each submission in advance of finalizing changes to NCD 20.7.

The SVS and its affiliated Patient Safety Organization (PSO)/Vascular Quality Initiative (VQI) remain concerned with the expansion of coverage outlined in CMS’ Proposed Decision Memo regarding NCD 20.7 and are in the process of creating its formal response.

SVS leaders want members to be aware of the issue and of some of the important topics the Society will raise during the comment period. They also encourage members to make their voices heard. The template highlights several critical points that will be featured in an upcoming SVS/PSO formal comment submission.

The proposed adjustments are a result of a formal request to CMS from the Multispecialty Carotid Alliance (MSCA) in late 2022 to reconsider NCD 20.7. In it, the MSCA urged CMS to update NCD 20.7 to cover PTA and CAS with embolic protection in patients with asymptomatic carotid artery stenosis greater than or equal to 70%, and in patients with symptomatic carotid artery stenosis greater than or equal to 50%; remove the requirement that patients are at high risk for carotid endarterectomy as well as facility and operator requirements; and leave coverage for any CAS procedure not described in the NCD to MAC discretion.

With that request, CMS opened an initial public comment period than ran from Jan. 12 to Feb. 11. During this period, the SVS and the PSO/VQI both submitted formal responses opposing reconsideration.

‘FDA’s mission to bring safe and effective vascular surgery devices to market remains steadfast’

By
Ronald M. Fairman
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0
‘FDA’s mission to bring safe and effective vascular surgery devices to market remains steadfast’
The Vascular and Endovascular Devices Team (VEDT) in the Food and Drug Administration (FDA) Office of Cardiovascular Devices appreciates the Vascular Specialist editorial board’s offer to provide an update to the vascular community to enhance regulatory transparency and communication. In this commentary, Ronald M. Fairman, MD, Gordon Bryson, Carmen Gacchina Johnson, PhD, and Andrew Farb, MD, cover COVID-19’s impact on the team’s work, pre- and post-market data collection, physician-sponsored investigational device exemption (PS-IDE) studies, and ongoing collaborations to support timely access of innovative devices to U.S. patients. The authors are responding to a report—“Getting medical devices to market: The future might not be now, says regulatory expert”—carried in the April issue of Vascular Specialist. 

The COVID-19 pandemic broadly impacted the vascular community, notably numerous challenges to initiating new and conducting ongoing medical device studies. One important example was the difficulty investigators and device manufacturers faced maintaining subject follow-up compliance to collect complete and meaningful information in support of future device marketing applications. Despite the challenges during this time, sustained collaboration between FDA review staff and study sponsors helped assure access to innovative vascular surgery devices (e.g., ascending, aortic arch, descending thoracic and thoracoabdominal aortic devices). 

Two recent examples include FDA approval of the first frozen elephant trunk platform, and the first single-branch thoracic endoprosthesis for endovascular repair of descending thoracic aortic lesions that maintains blood flow into the left subclavian artery. Despite the challenges posed by COVID-19, the Office of Cardiovascular Devices worked diligently with industry sponsors to ensure novel, safe and effective devices reached the U.S. patients. In addition, there are multiple actively enrolling studies at U.S. sites for devices placed in the ascending aorta, aortic arch and thoracoabdominal aorta to treat diverse aortic pathologies.   

Given the limitations in maintaining patient follow-up compliance during the COVID-19 pandemic, as well as experience with prior studies (e.g., challenges in longer-term data collection, strict selection criteria in studies not reflecting real-world device use), and in consideration of our commitment to commercialize life-saving new therapies in a timely manner, VEDT re-evaluated our approach to post-market studies. Applying the appropriate pre-market and post-market data collection balance facilitates timely patient access to important new technology without undermining patient safety. As such, there have been new efforts to identify areas for improvement in post-market data collection.

On Nov. 3, 2021, the FDA held a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to obtain advice and recommendations on the long-term safety and effectiveness of endovascular aneurysm repair (EVAR). This meeting included industry sponsors, investigators, patient advocate organizations, and physician experts. After the panel meeting, the FDA issued a letter to healthcare providers in February 2022 and has been involved in dedicated efforts to gain alignment with stakeholders on ways to strengthen post-market data collection, which are intended to allow for a better understanding of long-term outcomes with EVAR devices, help identify safety signals, and potentially support labeling expansions. 

Independent of these post-market activities, it is important to address concerns regarding PS-IDEs evaluating the performance of devices in the thoracoabdominal aorta. These PS-IDEs typically study commercially available devices that are physician-modified or used for a new intended use, or devices that are commercially available outside of the U.S. If physician modification of a commercial aortic device or use of a commercial device for a new indication is being done on a routine basis, we continue to recommend an IDE should be submitted.    

We recognize that there are patients with complex life-threatening aortic pathologies, and PS-IDEs are an option that has been utilized to allow access to new devices or approved devices for new indications, particularly for treatment of thoracoabdominal aortic aneurysms. PS-IDEs have helped advance device design, management of bridging stent instability, patient selection, management, and prevention of spinal cord ischemia. PS-IDEs have also refined strategies to reduce radiation exposure, improve imaging, and guide accessory device use. The results of many of these studies have been published in the Journal of Vascular Surgery (JVS) and presented at the SVS’ Vascular Annual Meeting (VAM). VEDT currently has over 30 approved PS-IDEs, and the number has been growing annually.    

There are some regulatory concerns regarding PS-IDEs that can impact the availability of new beneficial therapies for patients. Typically, PS-IDEs are of limited size and scope and do not collect the definitive data needed for device approval (a reasonable assurance of safety and effectiveness). Further, PS-IDEs may have little or no industry support, such that non-clinical testing and manufacturing requirements are not met to support a marketing application. As a result, although PS-IDEs can provide important insights into device performance, the devices studied (and their physician modifications) remain investigational, and the devices are not available to treat many U.S. patients with the target clinical condition.

To address this issue, we are collaborating with investigators and manufacturers on physician-sponsored and industry-sponsored feasibility and pivotal IDE studies that will support device approval so that new safe and effective devices are available to all U.S. patients.    

There has been communication with industry and physician sponsors to discuss the future of PS-IDEs and alignment on plans to bring these life-saving aortic devices to market in a timely manner. These plans include the following: 

  • The FDA continues to consider access to devices through PS-IDEs as long as adequate information is provided to support the IDEs (e.g., non-clinical information, individual investigator experience). When there is significant interest in device access, efforts are underway to pursue manufacturer-sponsored studies and/or marketing applications in a timely manner. 
  • Device manufacturers and the FDA are working together to limit the number of PS-IDEs so as not to create situations that would in effect constitute commercializing an investigational device.   
  • Stakeholders are collaborating to determine if existing data is adequate to support pivotal studies or marketing applications. 
  • The FDA is encouraging physicians treating patients with unmet clinical needs to engage in pivotal studies for next-generation devices. 

As illustrated in the above framework, the FDA remains committed to promoting timely access to safe and effective devices. The FDA remains supportive of PS-IDEs when appropriately justified, and we would like to assure the community that there have been no measures to halt existing PS-IDEs provided the results are encouraging. We are regularly accessible to practicing physicians to discuss unmet needs of their patients and how we may work together to address them, and we encourage engagement with the FDA on such proposals through the Q-submission process.

We are also currently working with the SVS on updates to the PS-IDE template for treatment of complex aortic pathologies. We encourage physicians who may pursue a PS-IDE to obtain the template from the Society (vascular@vascularsociety.org) as it provides a clear outline, pre-populated content, and suggestions for providing study-specific information.  

We acknowledge there are increasing numbers of well-trained physicians with experience and sophisticated skills treating patients with complex aortic pathologies using investigational or modified devices. Yet, after leaving their training programs where they may have used devices under an IDE, physicians may experience limitations to access investigational devices and techniques for endovascular treatment of complex cases. The FDA does not encourage physician modifications of commercialized endovascular grafts but notes that the routine practice of physician modification of devices should be conducted under an IDE. 

VEDT is hopeful that the need for physician-modified devices will be substantially decreased as device manufacturers pursue clinical studies for devices meeting patient needs and as devices currently under study come to market with data to support a reasonable assurance of safety and effectiveness.          

In summary, the FDA Office of Cardiovascular Devices is focused on supporting and enhancing patients’ timely access to safe and effective cardiovascular devices. The FDA’s mission, enthusiasm, and the commitment of VEDT to advance medical device innovation to bring safe and effective vascular surgery devices to market—thereby supporting and improving public health—remain steadfast. We seek efficient clinical studies and commercialization of innovative technology addressing unmet needs for U.S. patients, and we are engaged with external stakeholders to navigate paths to achieve these goals. Continued stakeholder collaboration on pivotal studies, marketing applications, and robust post-market data collection plans are critical to get devices to market to address unmet needs.  

We are dedicated to working with all stakeholders in order to bring life-saving and innovative devices to the U.S. market to benefit patients.   

It was a pleasure for many VEDT reviewers to participate in the recent VAM 2023 and engage with many of you. We look forward to the ongoing collaborations. Thank you again for this opportunity to reach out to the broader vascular community with this update. 

Disclaimer: This article reflects the views of the authors and should not be construed to represent the FDA’s views or policies. Ronald M. Fairman, MD, is the FDA’s VEDT medical officer and a former SVS president. Gordon Bryson is an FDA biomedical engineer; Carmen Gacchina Johnson, PhD, the organization’s assistant director for vascular and endovascular devices; and Andrew Farb, MD, its chief medical officer in the Division of Cardiovascular Devices.

The top 10 most popular Vascular Specialist stories of July 2023

By
Éva Malpass
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0
The top 10 most popular Vascular Specialist stories of July 2023

In the previous month, Vascular Specialist delivered a range of leading commentary from the Society for Vascular Surgery (SVS) in response to the New York Times investigation on inappropriateness in vascular care; the anticipated Food and Drug Administration (FDA) update on excess mortality risk for paclitaxel-coated devices; a review of protocols addressing hypersensitivity reactions after cyanoacrylate varicose vein treatment; and rumination from the E. Stanley Crawford Critical Issues Forum on the pipeline of sources feeding the vascular surgery ranks.

1. SVS responds to New York Times article on overuse of vascular interventions

In an official Society response, SVS President Joseph Mills, MD, tackles recent coverage in the mainstream media of inappropriateness in vascular care.

2. Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices

In a letter to healthcare providers dated July 11 2023, the FDA communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on data and analyses.

3. The numbers are in: VAM 2023 adds up to another SVS classic

The 2023 SVS Vascular Annual Meeting (VAM) was heralded another big success with nearly 1,400 vascular professionals moves the needle with program innovations, slew of new science and jam-packed agenda.

4. FDA approves study of ZFEN+ for treatment of aortic aneurysms

The FDA has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+).

5. Second edition of VSITE review text released

The second edition of a hit trainee-created textbook primarily aimed at those taking the Vascular Surgery In-Training Exam (VSITE) has hit the shelves.

6. Crawford panel looks at opportunities to plug and extend vascular surgery workforce pipeline

This year’s E. Stanley Crawford Critical Issues Forum zeroed in on the pipeline of sources feeding the vascular surgery ranks. Incoming SVS President Joseph Mills, MD, assembled an expert panel to look at many of the key issues at the heart of efforts to address workforce-related concerns.

7. Surmodics receives FDA approval for the SurVeil drug-coated balloon

Surmodics announces the receipt of FDA approval for the SurVeil drug-coated balloon (DCB). A company press release notes that the SurVeil DCB may now be marketed and sold in the USA to physicians for percutaneous transluminal angioplasty, after appropriate vessel preparation.

8. Review urges development of protocols to reduce hypersensitivity reactions after cyanoacrylate varicose vein treatment

Despite being considered “generally safe,” cyanoacrylate can cause local reactions in up to 25% of patients, disproportionately affecting women, Asian race and thin patients with a body mass index of <22. This was the conclusion drawn by Eduardo Silva, MD, from Coimbra Hospital and University Center in Coimbra, Portugal, in his presentation at this year’s European Venous Forum (June 22–24) in Berlin, Germany.

9. SVS seeks volunteers to write position paper

SVS members have until July 31 to apply to serve on a new SVS writing group to develop a position paper on the scope of work of vascular surgery practice in diagnosing and treating vascular disease. Volunteers should have expertise and interest in this topic area.

10. Study finds similar rates of VTE in both flying and non-flying surgical patients

Uncertainty underlying the magnitude of risk posed by long distance air travel in venous thromboembolism (VTE) patients has created the need for a deeper, systematic dive into the guidelines and resources providers should be turning to when managing their pre-flight VTE patients.

Newest JVS peer-review title appoints editor-in-chief

By
Marlén Gomez
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0
Newest JVS peer-review title appoints editor-in-chief
Anahita Dua

The Journal of Vascular Surgery (JVS) has announced the appointment of Anahita Dua, MD, as the editor-in-chief of the Journal of Vascular Surgery-Vascular Insights (JVS-VI), the newest title in the JVS stable.

Dua, an SVS member, is an associate professor of surgery at the Massachusetts General Hospital (MGH) and Harvard Medical School in Boston. She has authored more than 180 peer-reviewed papers and has edited five vascular surgery medical textbooks. Dua also runs a National Institute of Health (NIH)-funded coagulation lab at MGH and a vascular surgery practice focusing on complex peripheral artery disease (PAD) and limb salvage. Her appointment became effective today (Aug. 1).

“It’s crucial to provide fellow vascular professionals with the most up-to-date data to make well-informed decisions in their daily practice,” Dua told Vascular Specialist. “I believe this position allows me to be part of shaping the landscape of vascular surgery by delivering high-quality data through an evidence-based journal that focuses on the ‘other’ crucial parts of success in vascular surgery in 2023, including aspects such as quality, research, DEI [diversity, equity and inclusion] efforts, innovation, administration/business, and health policy.”

JVS-VI launched in early January, coinciding with the renewal of the SVS’ publishing contract with Elsevier. In response to the changing landscape of academic publishing, JVS-VI was introduced as an online-only, open-access (non-subscription) journal, allowing for broader accessibility to the latest research and developments in the field.

Ronald Dalman, MD, executive editor of the JVS group, was editor-in-chief for JVS-VI upon its creation. However, recognizing the need for a dedicated editor to lead the journal, he noted how the its success depended on someone with a vision and passion.

“Establishing a dedicated editor-in-chief for this journal became our goal, and during the interview process, it became clear that Dr. Dua’s compelling vision made her an excellent fit for the role,” said Dalman.

The JVS editorial team integrated the journal into its portfolio of publications to capture exceptional work that other journals might have overlooked. Dua believes that JVS-VI will ensure that significant topics receive the recognition they deserve.

Under Dua’s leadership, the JVS-VI editorial team will give priority to high-quality research manuscripts that generate hypotheses and provide background information, along with review articles, single-center quality improvement projects and discussions on practice management, business, ethics topics, commentaries, and historical vignettes.

Dua emphasized that the move towards open access ensures that a wider audience can access crucial research discoveries globally without charge immediately upon publication, fostering collaboration, creativity and equity within the vascular surgery field.

“This journal is dedicated to modern vascular surgeons practicing in 2023 faced with not only ensuring optimal surgical technique but also maintaining the other parts of vascular surgery practice—quality, logistics, education, research—that support excellent patient outcomes,” she said.

“We aim to address various aspects of vascular surgery in this day and age, and I feel a great responsibility to our readership to present quality articles that discuss these topics. I’m very excited to bring fresh new ideas to our portfolio, starting with a diverse editorial board with national and international representation.”

Read JVS-VI at www.jvsvi.org.

Financial viability, appropriate use and patient safety in the operation of outpatient facilities

By
Beth Bales
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0
Financial viability, appropriate use and patient safety in the operation of outpatient facilities

The number of office-based facilities has been increasing steadily over the past several years—and more vascular surgeons may be considering becoming involved in operating such centers.

To help vascular surgeons consider the various details involved, the SVS Subsection on Outpatient and Office Vascular Care (SOOVC) held a special membership section session on The Business of Running an OBL (office-based lab) during VAM 2023 in June. 

Among the standout presentations included, Neil Poulsen, MD, from Cardiovascular Care Group in Springfield, New Jersey, delivered a talk entitled “The financial viability of the OBL” during the session. 

Top of mind, the number of office-based facilities increased 49% from 2002–2012, he told those gathered. OBLs provide ease and access to care, improved patient satisfaction, and excellent outcomes; they limit hospital exposure; and they increase efficiency, Poulsen pointed out. 

In light of recent coverage of overuse of certain procedures, Poulsen said, his presentation assumed “appropriate use by trustworthy/ethical practitioners practicing evidence-based medicine.” 

In terms of financial viability, the first step is to identify the three stakeholders: the patients, practitioners and the overall medical system, he continued. “If one is out of balance, the whole system falls apart,” Poulsen said. 

As for safety, he cited research showing that among 6,021 procedures in a particular OBL, there were no office-based mortalities, major bleeds, acute limb losses, myocardial infractions, strokes or hospital transfers within 72 hours, and a 0.5% rate of minor complications. “We do have the evidence that use of OBLs is equal to procedures performed in hospitals,” Poulsen said. 

As far as providers, an OBL practice can offset continuing declines in the professional fees for vascular interventions, allow for a more patient-centered practice model, avoid the headaches of dealing with operating room turnovers and access to block time as well as hospital policies, allow for referrals that may have gone to competing practices, and provide a new and increased revenue stream for the vascular practice. 

Research from 2020 highlighted 2017 fees for certain procedures, including a balloon angioplasty for which the physician was reimbursed $482. The hospital reimbursement was $4,592, but the provider in the outpatient facility received not only $482 in physician reimbursement but also $2,288 for the facility reimbursement, for a total of $2,770. 

Other research showed significantly increased revenues in one center, with physician reimbursement for a thrombectomy in an outpatient setting nearly quadruple that performed in a hospital. “In 12 months of procedures in [this] OBL, revenues increased approximately $1.3 million,” he said. Total reimbursements for a group of procedures (with both the provider and facility fees) was nearly $1.7 million, compared to $368,897 for the provider reimbursement alone. Of course, revenues must be weighted against the increased responsibility of owning and operating an OBL, he said, with set-up and building costs that could reach $500,000 to $1 million. Other costs involve investors, staffing, supplies and acquiring patients. 

The healthcare system as a whole saves money as well. The success of the outpatient practice model is directly related to its ability to provide high-quality patient care while reducing waste spending, and the transition also helps to conserve hospital and inpatient resources, Poulsen said. 

Data from his own group showing 1,741 procedures in a single OBL over 12 months showed hospital-based fees of $2.9 million and OBL fees of nearly $2.5 million. The Medicare system saved $462,443, or 18%, he said. Highlighting code 36902 (fistulagram with percutaneous transluminal angioplasty [PTA]), with 443 performed in a year the medical system saved 38% by having the procedures performed in an OBL. 

His group realized increased revenues of $2,453,652, compared to $376,199 for the hospital-based procedures. 

Poulsen concluded by stating that the success or failure of an OBL depends on optimizing outcomes for all stakeholders. OBLs provide a safe, efficient and effective environment for patient care, he continued, and the transition of care from the hospital setting to the OBL is associated with a significant reduction in overall healthcare costs. The financial success of an OBL is driven by the ability to limit expenses while providing high-quality, safe and evidence-based patient care, Poulsen added. 

“You’ll note I didn’t say anything about improving revenue,” he told attendees. “The revenue is going to come,” Poulsen emphasized. “Don’t go out of your way to improve revenue only. You want to limit your costs and provide appropriate patient care.” 

Comments sought on CMS proposed coverage expansion for carotid stenting

By
Beth Bales
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0
Comments sought on CMS proposed coverage expansion for carotid stenting

SVS members are encouraged to submit comments—due Aug. 10—to the Centers for Medicare & Medicaid Services (CMS) on its proposed national coverage determination on percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting.

The move would expand coverage to individuals previously only eligible for coverage in clinical trials; to standard surgical risk patients by removing coverage limitations to only high surgical risk individuals; remove facility standards and approval requirements; add formal shared decision-making with the individual prior to furnishing carotid stenting; and allow Medicare Administrative Contractors (MACs) discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.

The SVS and the SVS Patient Safety Organization (PSO) are preparing comments to CMS. Members can submit remarks at vascular.org/CarotidNCD. These will focus on the issue that these changes are premature and will jeopardize patient safety, the Society reported.

“We should be informed by data from the conclusion of CREST-2 [Carotid revascularization and medical management for asymptomatic carotid stenosis trial],” the SVS said in a statement. “While we support shared decision-making, a validated tool does not currently exist. To evaluate the impact of this change, the continued collection of registry data needs to be part of any change to NCD20.7.

“We need clear definition for ‘Qualified Physician’ and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting.”

New study reports positive performance of AI-powered assessment of biomarkers for growth prediction of AAAs

By
Bryan Kay
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0
New study reports positive performance of AI-powered assessment of biomarkers for growth prediction of AAAs
RAW Mapping

The characterization of aortic tissue by means of three key biomechanics-based biomarkers bundled into a compound Regional Areas of Weakness (RAW) Map showed “very good performance” as part of an artificial intelligence (AI)-based prediction of faster than average growth for a population of abdominal aortic aneurysm (AAA) patients under serial monitoring, according to a new study published in the Journal of Vascular Surgery-Vascular Science (JVS-VS).

The retrospective study was conducted into 36 AAA patients undergoing surveillance by electrocardiographically (ECG)-gated computed tomography angiography (CTA) at the University of Calgary in Alberta, Canada, by a team of researchers led by vascular surgeon Randy Moore, MD, and Elena Di Martino, PhD, a professor of biomedical engineering, using the emerging ViTAA Medical Solutions technology, which aims to provide an algorithm-driven route to precision care.

The RAW Mapping assessment of aortic weakness incorporates time-averaged wall-shear stress, in-vivo principal strain and intraluminal thrombus thickness. “The use of features based on the functional and local characterization of the aortic tissue resulted in a superior performance in terms of faster than average growth prediction when compared to models mostly based on geometrical assessments,” the research team concluded from the published analysis.

The technology deploys an AI model to predict accelerated aneurysmal growth, with the current study looking at RAW Mapping’s ability to predict growth and AAA evolution within a year. Future work will focus on expanding the investigation and growth prediction over a longer surveillance period, the investigators reported. Further research will also aim to broaden the applicability of the methodology to different imaging modalities and protocols used to monitor AAAs.

“The ability to access functional information related to tissue weakening and disease progression at baseline for individual aortas has the potential to benefit patient monitoring, risk stratification and treatment selection, and optimize precision-based aortic care,” the researchers added.

Vascular surgery added as named specialty to influential national hospital rankings 

By
Bryan Kay
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0
Vascular surgery added as named specialty to influential national hospital rankings 
Ronald L. Dalman speaks from the podium during his Presidential Address at VAM 2021
Ronald L. Dalman speaks from the podium during his Presidential Address at VAM 2021

U.S. News & World Report has renamed the specialty formerly known as “Cardiology & Heart Surgery” to include vascular surgery in its national rankings of the best hospitals in the country. 

The category will now be called “Cardiology, Heart & Vascular Surgery,” the media company announced ahead of the Aug. 1 publication of its 2023–2024 Best Hospitals rankings and ratings.

“The specialty formerly known as Cardiology & Heart Surgery has been renamed Cardiology, Heart & Vascular Surgery, in recognition that vascular specialists take the lead on some cases that have consistently been included in the specialty’s outcome measures,” write Ben Harder, managing editor, and Min Hee Seo, senior health data scientist. “In certain contexts, U.S. News will use the shorthand Heart & Vascular to refer to Cardiology, Heart & Vascular Surgery.”

Recognition has long been sought for vascular surgery as a separate specialty within the rankings.

In 2020, the question of its inclusion was raised by then incoming SVS President Ronald L. Dalman, MD, and given a prominent spot in that year’s E. Stanley Crawford Critical Issues Forum, which took place during SVS ONLINE, the COVID-enforced digital replacement for VAM 2020. Dalman invited Harder to be part of the forum panel.

“One of the challenges for our members in the U.S. at the current time is the U.S. News & World Report rankings do not recognize vascular surgery as a separate specialty,” Dalman told Vascular Specialist at the time. “They have cardiology, cardiac surgery, neurological surgery, general surgery.”

“This move recognizes vascular surgery as an important specialty,” said SVS Executive Director Kenneth M. Slaw, PhD. “The SVS worked with U.S. News to enact this change, and as we move forward, we will continue to engage with the publication to offer suggestions to help with continued improvement of the rankings in the newly named domain.”

Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair

By
Jocelyn Hudson
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0
Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair
Human Acellular Vessel
Humacyte
Human Acellular Vessel

Humacyte today announced completion of enrollment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company’s Human Acellular Vessel (HAV) in vascular trauma repair.

A press release details that the HAV is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries. The HAV has the potential to assist healthcare professionals in saving life and limb in some of the most difficult circumstances. The results from the Phase II/III vascular trauma trial are intended to support a BLA filing with the US Food and Drug Administration (FDA), planned for the fourth quarter 2023.

The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level I trauma centers in the U.S. and Israel. The primary efficacy assessment will be based on a 30-day HAV patency (presence of blood flow) in patients who have vascular trauma of the extremity, as compared to historic benchmarks reported in literature. Humacyte, the clinical trial sites, and contracted service providers are preparing for locking of the trial database in order to report the V005 results. The company currently expects to complete these activities and report top-line results from the trial before the end of the third quarter 2023.

“We believe that the HAV could revolutionize the ability of surgeons to save the lives and limbs of patients suffering vascular injuries, not only in civilian settings, but also in more challenging environments like the battlefield,” said Laura Niklason, CEO of Humacyte. “The completion of the target enrollment in Humacyte’s Phase II/III vascular trauma trial is expected to enable BLA submission, and is another important landmark moment for our groundbreaking science. Our regenerative medicine technologies create dramatic new therapies—with the potential to provide treatment options for patients facing loss of life or limb for whom current therapies are either inadequate or not available.”

Humacyte’s HAV is a universally implantable, bioengineered human artery that is designed to overcome the challenges associated with traumatic injuries, the company states. It is available to the surgeon immediately, and eliminates the need to harvest and repurpose a vein. Because it is available off the shelf, the HAV can ultimately save valuable time and potentially reduce complications like amputations and tissue loss. Because the HAV is comprised of the same tissue that makes up natural human vessels, it has the potential to repopulate with the patient’s own cells. Clinical results suggest that the HAV is highly infection resistant and therefore is well suited for treating the contaminated wounds created by major traumatic injuries. Importantly, the HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, providing thousands of vessels for treating injured patients.

The V005 study is intended to support Humacyte’s BLA filing with the FDA for treatment of extremity vascular trauma when a synthetic graft is not indicated and when an autologous vein is not feasible. The completion of V005 enrollment comes on the heels of Humacyte receiving the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for the HAV in vascular trauma in May 2023. The RMAT designation allows for close collaboration between Humacyte and the FDA, and increases the chance for a priority review of a BLA after it is filed. At the time of V005 target enrollment, a total of 68 patients had received the HAV in the V005 trial, of which 51 had vascular trauma of the extremity and comprise the primary efficacy analysis.

In addition to the V005 trial, Humacyte notes that the HAV is also being used in Ukraine under a humanitarian aid program that has treated 19 vascular trauma patients in the ongoing war, demonstrating a high rate of favorable outcomes in treating some of the most difficult and infection-prone vascular injuries. The data from the Ukraine humanitarian program will be included in the BLA filing with the FDA. The HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma, arteriovenous access for hemodialysis, and peripheral arterial disease.

Humacyte advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair

By
Jocelyn Hudson
-
0
Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair
Human Acellular Vessel
Humacyte
Human Acellular Vessel

Humacyte today announced completion of enrolment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company’s Human Acellular Vessel (HAV) in vascular trauma repair.

A press release details that the HAV is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries. The HAV has the potential to assist healthcare professionals in saving life and limb in some of the most difficult circumstances. The results from the Phase II/III vascular trauma trial are intended to support a BLA filing with the US Food and Drug Administration (FDA), planned for the fourth quarter 2023.

The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level I trauma centres in the USA and Israel. The primary efficacy assessment will be based on a 30-day HAV patency (presence of blood flow) in patients who have vascular trauma of the extremity, as compared to historic benchmarks reported in literature. Humacyte, the clinical trial sites, and contracted service providers are preparing for locking of the trial database in order to report the V005 results. The company currently expects to complete these activities and report top-line results from the trial before the end of the third quarter 2023.

“We believe that the HAV could revolutionise the ability of surgeons to save the lives and limbs of patients suffering vascular injuries, not only in civilian settings, but also in more challenging environments like the battlefield,” said Laura Niklason, CEO of Humacyte. “The completion of the target enrolment in Humacyte’s Phase II/III vascular trauma trial is expected to enable BLA submission, and is another important landmark moment for our groundbreaking science. Our regenerative medicine technologies create dramatic new therapies—with the potential to provide treatment options for patients facing loss of life or limb for whom current therapies are either inadequate or not available.”

Humacyte’s HAV is a universally implantable, bioengineered human artery that is designed to overcome the challenges associated with traumatic injuries, the company states. It is available to the surgeon immediately, and eliminates the need to harvest and repurpose a vein. Because it is available off the shelf, the HAV can ultimately save valuable time and potentially reduce complications like amputations and tissue loss. Because the HAV is comprised of the same tissue that makes up natural human vessels, it has the potential to repopulate with the patient’s own cells. Clinical results suggest that the HAV is highly infection resistant and therefore is well suited for treating the contaminated wounds created by major traumatic injuries. Importantly, the HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, providing thousands of vessels for treating injured patients.

The V005 study is intended to support Humacyte’s BLA filing with the FDA for treatment of extremity vascular trauma when a synthetic graft is not indicated and when an autologous vein is not feasible. The completion of V005 enrolment comes on the heels of Humacyte receiving the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for the HAV in vascular trauma in May 2023. The RMAT designation allows for close collaboration between Humacyte and the FDA, and increases the chance for a priority review of a BLA after it is filed. At the time of V005 target enrolment, a total of 68 patients had received the HAV in the V005 trial, of which 51 had vascular trauma of the extremity and comprise the primary efficacy analysis.

In addition to the V005 trial, Humacyte notes that the HAV is also being used in Ukraine under a humanitarian aid programme that has treated 19 vascular trauma patients in the ongoing war, demonstrating a high rate of favourable outcomes in treating some of the most difficult and infection-prone vascular injuries. The data from the Ukraine humanitarian program will be included in the BLA filing with the FDA. The HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma, arteriovenous access for haemodialysis, and peripheral arterial disease.

Humacyte advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

SVS Foundation adds two surgeons to board of directors

By
Bryan Kay
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0
SVS Foundation adds two surgeons to board of directors
Bernadette Aulivola and Vikram Kashyap

The Society for Vascular Surgery (SVS) Foundation has announced the appointment of Bernadette Aulivola, MD, and Vikram Kashyap, MD, to its board of directors. Both will serve two-year terms and, with the board’s collective knowledge and experience, will further bolster the Foundation’s ongoing success in driving advancements and impacting the field of vascular surgery.

Assuming the position of board chair is Michael C. Dalsing, MD, SVS immediate past president. Joining him are SVS officers Joseph Mills, MD (president); Treasurer Thomas Forbes, MD; President-elect Matthew Eagleton, MD; and SVS Research Council Chair Raul Guzman, MD. Other board members include Ulka Sachdev, MD, Peter Nelson, MD, Geetha Jeyabalan, MD, and Anil Hingorani, MD.

An SVS Foundation press release notes that Aulivola, a vascular surgeon, professor and director of the Division of Vascular Surgery and Endovascular Therapy at Loyola University Medical Center in Maywood, Illinois, brings a wealth of experience in diagnosing and treating vascular diseases. She has made significant contributions to the field, particularly in venous disease and aortic aneurysms, and her research endeavors have resulted in numerous publications in medical journals.

Kashyap is a vascular surgeon and the Frederik Meijer chair of the Meijer Heart and Vascular Institute, as well as the vice president for Cardiovascular Health at Corewell Health in Grand Rapids, Michigan. With several decades of experience, Kashyap has co-authored more than 200 articles and book chapters, focusing on research areas such as atherosclerosis, thrombosis and cerebrovascular disease.

The Golden Larva syndrome: Is it real?

By
Bhagwan Satiani
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2
The Golden Larva syndrome: Is it real?
Bhagwan Satiani
Failure is part of the process that leads to success. Occasional failures may sting but we must recognize the adage that failure is a “bruise, not a tattoo.”

I knew a mid-career faculty member some years ago who was rapidly progressing up the leadership ladder until they were not. There were no apparent personal or health issues, or any other roadblocks, but gradually, over a period of six to 12 months, the brakes went on. There were some inexplicable decisions, beyond just humility or caution, which made me wonder if professional advancement was even a priority. 

My experience with a few underachieving physicians has been more in the academic sphere than the private-practice world. Although there were some private practitioners who wished to climb the administrative ladder, most were focused on patient care, some academic work, and activities outside work. 

Academic physicians have specific targets, such as promotion, climbing the administrative ladder, and moving up the national and international specialty society hierarchy. These steps are linked with financial rewards and professional recognition. The behavior of underachieving, resulting in a failure to advance, is seen in many professions, including sports and business, and is said to be part of the “Golden Larva syndrome.” 

Robert F. Kennedy is supposed to have said, “Only those who dare to fail greatly can ever achieve greatly.” In a business, entrepreneurial and leadership context, failing is part of the process that leads to success. Famous founders of companies like Google and Apple are cited. New, successful writers are a good example. They ask themselves, “Can I succeed again?” And fear failure. 

Similarly, the fearful leader may freeze and be unable to make any decisions. Carried to an extreme, an irrational fear of failure or atychiphobia occurs often in perfectionists. Fear of failure can sometimes be crippling. Paulo Coelho, the writer, is reputed to have said: “There is only one thing that makes a dream impossible to achieve: the fear of failure.” If enough self-doubt creeps in, most will either not attempt a “stretch” goal, or, if they do, they make it known that their expectations are low. 

Self-doubt is common before we develop enough self-awareness and discover our own capabilities. However, achievements are not always under our control. In my case, I know that there were some events beyond my control, such as timing, bias, or cultural upbringing, where boasting about accomplishments was considered gauche. My deliberate choice of family time versus work and travel was also a factor. It was never a fear of failure. Later, there were health issues that would have prevented me from being competitive and successful, but I wonder if there was, at times, a touch of the Golden Larva syndrome. 

The behavioral hodgepodge of underachievement, negative thinking, sometimes self-sabotage, fear of failing, or even fear of success, falls under the Golden Larva syndrome. Educator and psychoanalyst Manfred Kets de Vries describes one extreme when there is self-sabotage as being akin to a caterpillar that does not fulfill its potential, and therefore fails to flourish into a butterfly.1 People possess the promise of a bright future, but get in their own way and hinder their ability to thrive. Hence, the term Golden Larva syndrome. This includes manifestations such as imposter syndrome and Peter Pan syndrome. 

Imposter syndrome is the most well-known and was first described in 1978 by psychologists Pauline Rose Clance and Suzanne Imes in professional women.2 They initially described women as feeling like frauds and lacking confidence, but later determined that the syndrome occurred in both sexes equally. People with imposter syndrome doubt their abilities, don’t like attention, feel unworthy or less deserving of any success, and give credit to factors other than themselves. Success may also be avoided because one feels unfit or fearful of being under the spotlight in society and taking the place of more deserving people. Some consider this is “success phobia,” part of an ever-increasing number of phobias. There is no joy if and when success does come. Psychologists say that the syndrome is not a medical diagnosis but viewed as “cognitive distortions,” or biased on irrational thoughts and beliefs that we choose to self-reinforce over time.2 

There are some who think that imposter syndrome is an excuse to cover up systemic failures. Ruchika Tulshiyan and Jodi-Ann Burey believe it is a result of bias and exclusion, and that women especially are made to feel that it is a lack of self-confidence that causes them to fail rather than system or organizational issues.3 

Another reason why some may self-sabotage is a reluctance to grow up and take on responsibilities, otherwise known as Peter Pan syndrome. Dan Kiley described this phenomenon in his book, The Peter Pan Syndrome: Men Who Have Never Grown Up. This is also not a medical diagnosis, but a term psychologists use to describe adults, most often males, who decline to shoulder responsibilities and are unable to have healthy personal relationships. In another book, Men Who Never Grow Up, Dan Kiley describes these men as unable to “grow up.” Other traits include a fear of loneliness, a tendency of being self-centered or narcissistic, and impulsive behavior. 

As surgeons, we sometime fail even after performing a “perfect” operation, and although cumulatively these failures take a toll, few of us feel like failures ourselves and stop helping our patients.4 In a clinical context, I know I have had, at one time or another, a fear of failing but in the context of causing harm to patients. We fight through this. We have faith in our training and experience. But the most valuable asset we have are the people around us who believe in us and our abilities, at home and work. 

Given a difficult surgical problem, we have the luxury of leaning on colleagues and members of our society to seek other opinions. I have never had anyone refuse to assist me or decline a call for help when I needed another opinion. Nor have I ever declined to help, including desperate calls from the operating room. This is another reason why we can reach out to members of our society, as extended family, to give our patients the very best care that they deserve. 

Occasional failures do sting, but family, faith, friends, work-related teams and, yes, our colleagues are powerful antidotes. As the poet and writer John Sinclair said: “Failure is a bruise, not a tattoo.” Healers need other healers to take care of each other. We should try this more often. 

References 

  1. De Vries KMFR. Breaking the Cycle of Self-Sabotage: How to Overcome the “Golden Larva Syndrome.” https://knowledge.insead.edu/career/breaking-cycle-self-sabotage-how-overcome-golden-larva-syndrome 
  2. Saymeh A. What is imposter syndrome? Learn what it is and 10 ways to cope. https://www.betterup.com/blog/what-is-imposter-syndrome-and-how-to-avoid-it#:~:text=Imposter%20syndrome%20 is%20the%20condition,phony%22%20and%20doubting%20 their%20abilities 
  3. Tulshyan R, Burey JA. Stop Telling Women They Have Imposter Syndrome. https://hbr.org/2021/02/stop-telling-women-they-have-imposter-syndrome?ref=charterworks.com 

Bhagwan Satiani, MD, is a Vascular Specialist associate medical editor. 

Nectero Medical receives FDA clearance of IND application to initiate Phase II/III clinical trial of Nectero EAST system

By
Jocelyn Hudson
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Nectero Medical receives FDA clearance of IND application to initiate Phase II/III clinical trial of Nectero EAST system

NecteroNectero Medical today announced that the US Food and Drug Administration (FDA) has granted investigational new drug (IND) clearance for the company to initiate a prospective, multicentre, randomised clinical trial (the stAAAble study) to evaluate the safety and efficacy of the Nectero endovascular aneurysm stabilisation treatment (EAST) system in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5–5cm.

“We believe the Nectero EAST system has the potential to address a significant unmet clinical need and improve outcomes in AAA patients who currently have no proven treatment options. Nectero EAST aims to be the first therapy to stabilise growth of small- to mid-sized AAAs,” commented Jack Springer, president and chief executive officer of Nectero Medical. “The IND clearance and initiation of a landmark pivotal study reflect our continuing commitment to bringing transformative therapies to improve the lives of patients with aneurysmal disease.”

The Nectero EAST system is a single-use, endovascular system for the treatment of infrarenal AAAs and is comprised of a dual-balloon delivery catheter and stabiliser mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and potentially reduce the risk of further degradation. A press release details that the procedure does not require any specialised tools or training, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions.

“I am really encouraged by the initial data of the Nectero EAST system to potentially slow the growth of AAA and thereby minimise the likelihood of rupture and/or need for major intervention,” commented Dan Clair (Vanderbilt University Medical Center, Nashville, USA), co-principal investigator for the stAAAble study. “If proven safe and efficacious at stabilising AAA growth, the Nectero EAST system has the potential to transform the lives of thousands of patients with aneurysmal disease.  We are honoured to be one of the centre to participate in this groundbreaking study that is likely to have a pronounced impact on the future management of AAA patients.”

The IND submission was supported by a prospective, first-in-human study of 21 patients treated outside the USA. Early Phase I clinical results were recently published in the Journal of Vascular Surgery and showed that a single, localised PGG administration to patients with small- to medium-sized infrarenal AAAs was safe and demonstrated the potential to slow the growth of AAA. The stAAAble study will be conducted largely in the USA and is expected to initiate enrolment in the next few months.

Endologix announces first patients treated with the Detour system

By
Bryan Kay
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0
Endologix announces first patients treated with the Detour system

Endologix has shared in a press release that the first patients underwent percutaneous transmural arterial bypass (PTAB) using the Detour system since Food and Drug Administration (FDA) approval of the system was granted.

PTAB with the Detour system treats complex peripheral arterial disease (PAD), enabling physicians to bypass lesions in the superficial femoral artery by using stents routed through the femoral vein to restore blood flow to the leg. This approach is effective for patients with long lesions (20–46cm in length), those that have already undergone failed endovascular procedures, or those that may be suboptimal candidates for open surgical bypass, the company states.

For the rollout, Endologix collaborated with two healthcare systems known for clinical excellence. PTAB using the Detour system was first performed at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and at Salinas Valley Health Medical Center.

SVS coding workshop coming in October

By
Beth Bales
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0
SVS coding workshop coming in October

The SVS’ 2023 Coding and Reimbursement Workshop will help participants learn about accurate coding and reimbursement for vascular surgery. The intensive two-day program will review essential topics such as recent Current Procedural Terminology (CPT) code and Medicare changes. 

An optional workshop on evaluation and management (E/M) codes is being offered to provide participants with a deeper understanding of E/M codes, which are crucial for accurately documenting patient encounters and determining appropriate reimbursement. 

The optional workshop will be held from 8 a.m. to 12 p.m. on Oct. 16. The main course will be conducted from 1 to 5 p.m. on Oct. 16 and from 7:30 a.m. to 4:30 p.m. on Oct. 17. 

Both the CPVI Skills Course and the Coding and Reimbursement Workshop will be held at the OLC Education & Conference Center, 9400 W. Higgins Road, Rosemont, Illinois. Visit vascular.org/coding23. 

Crawford panel looks at opportunities to plug and extend vascular surgery workforce pipeline

By
Bryan Kay
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Crawford panel looks at opportunities to plug and extend vascular surgery workforce pipeline
The 2023 Crawford panel

This year’s E. Stanley Crawford Critical Issues Forum zeroed in on the pipeline of sources feeding the vascular surgery ranks. Incoming SVS President Joseph Mills, MD, assembled an expert panel to look at many of the key issues at the heart of efforts to address workforce-related concerns. 

The panel captured three main areas of focus: the root sources of future vascular surgeons, the existing workforce, and the distribution of that workforce. Lee Kirksey, MD, from the Cleveland Clinic in Ohio, looked at outreach to high school and college students and Malachi Sheahan III, MD, from Louisiana State University in New Orleans, dealt with efforts to attract medical students and residents in training. Dawn M. Coleman, MD, from Duke University Medical Center in Durham, North Carolina, addressed vascular surgeon wellness, followed by Laura Marie Drudi, MD, from Centre Hospitalier de l’Universite de Montreal in Canada, on burnout solutions. The panel was rounded out by former SVS President Michel S. Makaroun, MD, on workforce supply or maldistribution, and Peter R. Nelson, MD, from the University of Oklahoma in Tulsa, on measures to improve the workforce crisis. 

Lee Kirksey on the early years… 

“Not everyone is capable of, or wants, to be a physician. I know it’s hard for us in this room to believe that, but not everyone wants to be a physician or vascular surgeon. However, there is a broad range of healthcare ecosystem jobs that provide family-sustaining wages and opportunities for a rewarding career. Much investigation is needed to better understand the student- and family-perceived barriers in pursuing health science careers. We think we know, but when we talk to parents we actually are probably missing the point. And in every community, whether it is urban, indigenous American, rural, White, Black or brown, there are motivated caregivers and communities whom we serve, and they hold surgeons in such high regard, they are waiting for us to take a leadership role in galvanizing the resources and continuing to address the important issue of shaping a multi-dimensional, diverse healthcare workforce.” 

Malachi Sheahan III on medical education and training… 

“It is time to establish ourselves as the expert on vascular disease at the medical school level. If we don’t, there are other specialties very interested. In a [2016] editorial by the leaders of the American Heart Association and the American College of Cardiology, they say they need an American Board of Internal Medicine-certified specialty focused on patients with peripheral arterial disease [PAD] because their care has been undermined. So if we don’t establish ourselves as the expert, other people will.” 

Dawn M. Coleman on surgeon wellness… 

“Physician burnout is a public health crisis. Frankly, it is a workforce crisis for us. It is a chronic condition in which your perceived demands outweigh perceived resources. There are staggering personal and professional repercussions of physician burnout. In 2019, burnout was reclassified as an occupational phenomenon by the ICD-11 classification of diseases. And there are also staggering personal and professional ramifications that are associated with work-related stress—which is a precursor for burnout—that have really impressive medical sequelae, including cognitive dysfunction, increased risk of heart disease, type-2 diabetes, fertility challenges, sleep disruptions, insomnia, isolation, etc. Moral distress matters, which can intersect with burnout, and I am positive all of us feel this at some point.” 

Laura Marie Drudi on burnout solutions… 

“Addressing physician burnout and well-being requires a multi-level, multi-pronged approach that involves both individual and organizational factors. Although burnout is rooted in the environment and systems in which we work, I do believe we have to first turn inwards to fill our own cup before we serve others. For those of you who are experiencing burnout and feel isolated, you’re not alone. Through support, connection and engagement, I am confident we will make progress in this space together.” 

Michel S. Makaroun on workforce supply… 

“In the last three years, approximately 170 vascular certificates have been issued every year, but we are still far behind the interventional radiologists and interventional cardiologists. So, is the funnel looking a little bit better? It is. We are now producing about 58 new vascular surgeons per year, but it is still inadequate. I will leave with you with this statement from a paper about the county-level maldistribution. ‘Although encouraging vascular surgeons to practice in underserved areas would be an ideal solution, it is not pragmatic.’ Developing alternatives is essential to get new methods of providing vascular care to geographically isolated populations.” 

Peter R. Nelson on prophylactic measures to address the workforce crisis… 

“We really need to work toward regional systems for efficient education, communication and delivery of multidisciplinary team healthcare. Patients want access to vascular healthcare close to home. They don’t want to come to Tulsa or Oklahoma City to get care. Vascular surgeons can and should lead in these efforts by recruiting vascular surgeons to work in these underserved areas with support from the tertiary referral centers—but, more importantly, to think broadly of how we define workforce, empower other physicians who are already in those communities—primary care providers, podiatrists, general surgeons, cardiologists—to feel more comfortable and confident taking care of vascular disease.”

SVS responds to New York Times article on overuse of vascular interventions

By
Joseph Mills
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SVS responds to New York Times article on overuse of vascular interventions
SVS President Joseph Mills
In an official Society response, SVS President Joseph Mills, MD, tackles recent coverage in the mainstream media of inappropriateness in vascular care.

There have been several recently published articles by respected news media outlets highlighting the deeply concerning issue of the overuse of invasive procedures to treat peripheral arterial disease (PAD). The front-page New York Times article (Sunday, July 16, 2023), first-authored by Katie Thomas, serves as the exclamation point. The Society for Vascular Surgery (SVS) appreciates the efforts of the NYT to call attention to the inappropriate use of interventions in an effort to raise patient awareness, promote quality and advocate for safety in the delivery of vascular care.

The SVS has more than a 75-year history of setting the standards of care, quality and safety for patients with PAD. Founded in 1946, and comprising more than 6,000 members, the SVS mission is to advance excellence in vascular healthcare through education, advocacy, research and public awareness. Our mission and code of ethics focus on doing what is best and most appropriate for the care of patients with vascular disease, despite the challenges created by a struggling healthcare delivery system and problematic regulatory/reimbursement policies. We are troubled to see reports of patient harm because of the violation of the fundamental ethos of all physicians and surgeons to “first do no harm.” However, we are also concerned that such articles will cause patients to mistrust the healthcare system and delay seeking appropriate and timely care for limb- and sometimes life-threatening PAD.

It is essential for the public, affected patients and their family members, to understand there is only one primary specialty in medicine comprehensively educated, trained and tested to provide the full spectrum of evidence-based care to vascular patients, ranging from medical management to minimally invasive procedures, to open surgery. That specialty is vascular surgery.  The vast majority of SVS members are vascular surgeons, board-certified by the Vascular Surgery Board (VSB) of the American Board of Surgery (ABS), who practice daily with integrity and are dedicated to appropriate and ethical care. Unfortunately, there are outliers practicing far beyond the pale who stretch ethical boundaries and deviate from the best available science and evidence-base. Within the NYT article, regarding the procedure highlighted, it was noted that “from 2017–2021, about half of Medicare’s atherectomy payments—$1.4 billion—have gone to 200 high-volume providers.”  It should be noted that none of the physicians detailed in this NYT story is a board-certified vascular surgeon or SVS member. As the article also documents, after failed attempts at limb salvage by other practitioners, patients end up in the vascular surgeon’s care only as a last resort, sometimes far too late to save a precious limb.

The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology, are providing high-quality, evidence-based care with safety and the best patient outcomes in mind. Appropriate and safe vascular care can be delivered in both outpatient and hospital settings.

Unfortunately, as in all professions and trades (albeit more disturbing in the healthcare arena), there are outliers who overstep the bounds of ethics, appropriateness and quality, perhaps driven by other motivations, including notoriety or financial gain. This is a complex issue that requires the examination not only of the events detailed in this story, in which several patient experiences with the physicians that provided their care were highlighted, but of the underlying healthcare economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.

The issue of overuse in medical care is not a new one. Scientific, peer-reviewed articles written by SVS members and vascular surgeons were among the first to call attention to potential patient harm resulting from the aggressive overuse of interventions for patients with PAD largely brought about by regulatory and reimbursement coverage decisions that financially incentivized such therapy. These studies documented a dramatic increase in atherectomy procedures primarily performed in an outpatient setting with extremely high-volume users (outliers) more likely to be non-vascular surgeons treating patients early after a diagnosis of claudication. As one example of a highly reimbursed procedure of unproven value, roughly 50% of Medicare reimbursements for atherectomy went to just 200 high-volume providers.

The article also alludes to the potential for the development of improper relationships between industry and healthcare practitioners as one factor that may drive inappropriate use or overuse of drugs and devices for financial gain. A detailed discussion of this issue is not possible here, but there is no doubt that the medical industry of drug and device manufacturers is essential to the provision of healthcare and innovation in therapy. Many widely available and highly useful drugs and devices (stents, endovascular grafts, etc.) have been developed by ethical, scientific collaboration between practicing physicians and surgeons and the healthcare technology industry. As do most other medical societies, the SVS has a policy on conflict of interest and conflicts of commitment.

These ethical principles underpin and guide all we do, not only as a medical organization, but also as individual practitioners. The needs of the patient should always come first; no procedure should be recommended or performed in any patient if it is not primarily and solely for the benefit and best interests of that patient.

The SVS has been the leading national organization in defining quality and safety standards for the provision of comprehensive vascular care, particularly for PAD. There are an estimated 10–12 million people in the U.S. who have PAD, so it is important to educate patients and the public about PAD and how it should be treated. The disease is caused by the build-up of plaque deposits in the walls of arteries due to a combination of risk factors, including diabetes, smoking, hypertension, hyperlipidemia, increased age and genetics. PAD is a broad spectrum of disease; in general, it is a marker for cardiovascular disease and the most common complication to develop in affected patients is not limb loss, but rather heart attacks and stroke. Thus, all patients with PAD should have best medical therapy and control of their risk factors to the extent possible. There are three stages of PAD: asymptomatic, claudication (leg cramping or pain with walking) and chronic limb-threatening ischemia (CLTI=non-healing wound or gangrene).

Only the latter has a significant risk of limb loss, and even in CLTI patients, the risk depends upon the stage of disease. Through the publication of research studies, evidence-based guidelines and appropriate use criteria documents, the SVS has consistently promulgated the principle that the best care for the majority of patients with PAD—particularly those who are asymptomatic—is to promote exercise (walking) and to manage the PAD medically by modifying correctable risk factors such as elevated lipids, diabetes, smoking and hypertension.

PAD is common, particularly in older people, but not all leg pain is directly related to PAD—even in those who have the disease. For example, arthritis, gout, musculoskeletal and spinal problems can all cause leg and foot pain. Even for patients who have pain with walking from PAD, the majority are best treated initially with risk-factor control, walking therapy to promote collaterals, and muscle adaptation to exercise and occasionally medicines specific for vascular leg pain brought on by walking (since fewer than 5% of patients with claudication progress to a limb-threatening PAD stage). Vascular surgeons are uniquely trained and positioned to understand the full context and spectrum of PAD and all of the available treatment options. As such, it has been the position of the SVS that a first intervention for PAD patients—even a “minimally invasive procedure”—should be done only when absolutely necessary, as once completed, it may “accelerate the clock” and speed the progression of vascular disease and its complications.

Invasive procedures for claudication may improve function and quality of life but patients should be selected carefully, and the interventions tailored to be both safe and likely to produce meaningful benefit. The SVS practice guidelines have proposed a threshold of at least two years of likely durability for an intervention performed for claudication. There is a disturbing trend of overly aggressive treatment, with recent studies demonstrating nearly 30% of patients are receiving interventions on below-the-knee arteries, despite no evidence they would benefit and mounting evidence it may accelerate their disease. Moreover, the article highlights the growing frequency of multiple, repeated procedures that is emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous.

There are patients with PAD (perhaps 5–8%) who suffer from or progress to the most advanced PAD stage, that of CLTI. This condition is more prevalent in people with diabetes. Preventing amputation in such patients hinges upon early and accurate diagnosis, followed by an individualized treatment plan targeted to the patient’s risk, goals and stage of disease. Such a plan is best carried out with the involvement of a vascular surgeon, and frequently includes other specialists, such as podiatrists. The SVS spearheaded and published classification systems to assess risk of limb loss, an anatomic staging system and global guidelines for evidence-based care to save limbs and prevent amputations. Although many CLTI patients require intervention, endovascular therapy is only one option, and a good number of patients fare better with surgical bypass. Vascular surgeons are the only specialists trained to offer both options, when needed. Patients deserve to be fully informed when making decisions about invasive treatments.

Vascular surgeons have also pioneered tracking patient outcomes. To this end, the SVS established its Patient Safety Organization (PSO) to monitor outcomes of patient care, which now includes 1,007 participating centers, and has collected the outcomes of more than 1 million vascular interventions within its Vascular Quality Initiative (VQI) registries. In addition, in collaboration with the American College of Surgeons, the SVS recently launched it Vascular Verification Program, setting standards of quality across vascular care settings. Vascular surgeons are actively engaged in and leading the effort to promote shared decision-making and patient education around PAD care, including the message that while an abnormal ankle brachial index (ABI)—a noninvasive measure of blood flow to the leg/foot—or the symptom of claudication can be important warning signs, the best therapeutic response is most often best medical therapy, not the “quick fix” of an intervention performed unnecessarily or prematurely.

As reported in another recent article by ProPublica, SVS feels strongly that the public at large and the vascular patient population should be educated and have access to all the resources they need to make the best choices for their care, including being provided with an explanation of the natural history of their condition, the expected outcomes of medical and interventional therapy, and understanding the differences between a variety of types of providers who perform some vascular procedures compared to board-certified vascular surgeons who provide the full spectrum of vascular care.

The SVS will continue to actively promote quality and safety for vascular patient care through its published guidelines, appropriate care documents, PSO-VQI registry and initiatives such as the Vascular Verification Program. All practitioners in vascular practice are encouraged to become familiar with and to utilize them. The SVS will continue to develop these resources and make them available.

The SVS encourages patients to check and verify the credentials of their providers before agreeing to a plan of vascular care. We also encourage second opinions. Finally, in their efforts to cover health news, the SVS urges media professionals to be diligent in presenting healthcare and medical information that is fully balanced, as coverage could lead to patient distrust and delays in necessary care with potentially adverse consequences.

Joseph Mills is president of the SVS. He was writing on behalf of the SVS Executive Board.

The numbers are in: VAM 2023 adds up to another SVS classic

By
Beth Bales
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0
The numbers are in: VAM 2023 adds up to another SVS classic
VAM 2023 by the numbers
Landmark meeting (June 14-17) with nearly 1,400 vascular professionals moves the needle with program innovations, slew of new science and jam-packed agenda. 

With more content presented than ever before, a family-friendly Wednesday night gathering, the inaugural Frank J. Veith Distinguished Lecture, a hugely successful gala and the vascular surgery community more than happy to be together, the 2023 Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM) was heralded as another big success. 

“Overall, it was really well-received,” declared Andres Schanzer, MD, chair of the SVS Program Committee, which oversees the scientific content at the meeting. “People really enjoyed themselves,” he said. 

“The quality and impact of the science was really high. It was diverse across the whole array of vascular surgery procedures and medical management.” 

And, not only was the science and research important, “but I think people really enjoyed the opportunity to connect with colleagues. People are enjoying interacting with each other in a meaningful way around vascular surgery,” Schanzer continued. 

“And most importantly, we are being as inclusive as possible with the hope that our meeting participants look more like the patients we take care of.” 

Some of the highlights of VAM 2023 by the numbers include: 

  • Nearly 2,300 total attendees
  • More than 800 abstracts submitted 
  • Fifty-two abstracts at eight plenaries 
  • Twenty-one educational sessions 
  • Four SVS special section sessions 
  • Hands-on learning for the Physician Assistant Section 
  • Five international sessions 
  • A total of 271 posters 
  • Eleven abstracts presented simultaneously with publication in the Journal of Vascular Surgery 
  • The move of officer voting into VAM’s first few days 

This year’s meeting also included a number of new initiatives and events, which proved quite popular, Schanzer said. 

Attendees enjoyed an opening night, family-friendly SVS Connect@VAM: Building Community party that was open to all, with food, games and activities. With a successful debut, it will return in 2024 and afterwards as an annual event, Schanzer said. 

The inaugural Veith lecture, announced at the close of VAM 2022—which focused on the results of the BEST-CLI trial—drew a healthy crowd, as did several other BEST-CLI-focused content. 

Organizers moved the championship round of the Poster Competition to the plenary room on Saturday morning, leading to a robust audience and more recognition for the 10 finalists. 

Highlighting sessions that included topics related to diversity, equity and inclusion, plus including “invited discussants” for many of those sessions, also was well-received. 

The Program Committee and Postgraduate Education Committee are reviewing the feedback obtained via the VAM 2023 evaluation, Schanzer said. 

“So, if you have not completed the evaluation please do so no later than July 14. It is critical we hear from you so we can continue to meet your educational needs going forward,” he added. 

Second edition of VSITE review text released

By
Bryan Kay
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Second edition of VSITE review text released
The second edition was released at the end of June 2023

The second edition of a hit trainee-created textbook primarily aimed at those taking the Vascular Surgery In-Training Exam (VSITE) has hit the shelves.

The Vascular Surgery Review Book, authored by Thomas Creeden, DO, a resident from the University of Massachusetts in Worcester, Massachusetts, was first released a year ago and quickly saw soaring sales.

The latest edition features updates on technical steps for the majority of routine vascular surgery procedures—including bailout techniques—as well as detailed descriptions and explanations of sizing/designing of custom fenestrated and branched aortic grafts.

Also new are summaries of high-yield societal guidelines, new chapters covering areas such as ascending aortic management and distal lower-extremity bypass, and a section on the recently published results from landmark chronic limb-threatening ischemia (CLTI) trials, BEST-CLI and BASIL-2.

Late last year, as sales soared, Creeden said the textbook had also reached many medical students, vascular surgery interest groups (VSIGs), and even the device industry.

By December, the title had registered as one of the top-selling books on Amazon within the vascular and thoracic surgery category, with copies selling in 14 countries, he detailed.

Creeden’s original driving force was to create a high-yield reference text that would be fundamentally easier and quicker to work through than traditional vascular surgery textbooks when preparing for the VSITE, along with exams like the vascular boards.

SVS seeks volunteers to write position paper

By
Beth Bales
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0
SVS seeks volunteers to write position paper
SVS seeks volunteers for new position paper

Society for Vascular Surgery (SVS) members have until July 31 to apply to serve on a new SVS writing group to develop a position paper on the scope of work of vascular surgery practice in diagnosing and treating vascular disease. Volunteers should have expertise and interest in this topic area.

The paper will address the following:

  • Discussing the vascular surgery service line and the scope of work based on basic core and sub-competencies of a vascular surgeon
  • Defining a vascular surgeon in each category and various positions
  • Setting the upper limits of what is considered appropriate in terms of time utilization and expectations
  • Defining the appropriate and adequate support structure needed to provide 24-hour vascular care at an institution
  • Maximizing the utility and value of healthcare professionals on the team, with focus on developing recommendations for optimizing the role of advanced practice providers (APP)
  • Presenting recommendations on how to deal with workforce shortages to optimize efficiency to prevent burnout

This is a one-year commitment, with volunteers expected to participate in monthly meetings, review papers and help with writing the position paper. After review, the paper will be published in the Journal of Vascular Surgery (JVS).

Those interested in participating should complete the online application—which must include a brief statement (200 words or less) regarding their experience and interest in this topic—and their CV by July 31. Applicants will be requested to fill out relevant conflicts of interest (COI) per the SVS’s COI Policy.

Study finds similar rates of VTE in both flying and non-flying surgical patients

By
Jocelyn Hudson
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Study finds similar rates of VTE in both flying and non-flying surgical patients

air travelUncertainty underlying the magnitude of risk posed by long distance air travel in venous thromboembolism (VTE) patients has created the need for a deeper, systematic dive into the guidelines and resources providers should be turning to when managing their pre-flight VTE patients.

Jessie Shea (Imperial College London, London, U.K.) took to the stage at the recent European Venous Forum (22–24 June, Berlin, Germany) to deliver the findings of a recent systematic review and meta-analysis of VTE risk in surgical patients with recent air travel.

“A number of studies have shown a positive correlation between VTE risk and long-haul air travel, with incidence rates of up to 5% in patients with concurrent risk factors and an estimated 10–30% of patients with VTE dying within 30 days of incidence,” Shea detailed.

With surgical tourism on the rise, Shea explained that patients opting to endure long-distance flights to seek surgical intervention could be lacking the resources necessary to guide safe air travel. In 2017 alone, there were an estimated 1.4 million US medical tourists, creating a significant need for peri-operative travel guidelines to inform patients of potential risk.

To address the potential risk, Shea et al‘s systematic review and meta-analysis was designed by pulling all available literature about VTE risk in surgery when flying versus surgery at home. To conduct the analysis, the study design collected reporting of incidence of VTE in patients undergoing surgical intervention who had recently engaged in air travel versus those who had not.

Shea detailed that limiting factors for the study included risk of detection or recall basis, heterogeneity in thromboprophylaxis applied, variation in flight characteristics and duration, and impact of other associated VTE risk factors in participating patients.

The presenter concluded that the study found similar rates of VTE in both flying and non-flying surgical patients maintained across subgroup analysis of both preoperative and postoperative air travel, air travel greater than four hours in length and surgery associated with high VTE risk.

“The most important thing is to use a full risk assessment to identify each individual patient’s risk and also take into account the length of surgery,” she said in her closing remarks. “Looking at our study, it would suggest that there is no increase for VTE, but obviously our conclusion is limited by the quality of the evidence.”

Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices

By
Jocelyn Hudson
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Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices
FDA has issued new guidance for the use of paclitaxel coated devices in peripheral arterial disease
paclitaxel update issued by FDA
The FDA has issued new guidance for the use of paclitaxel coated devices in peripheral arterial disease

In a letter to healthcare providers dated July 11, 2023, the Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on data and analyses.

This update signals a lowering of the red flag raised in a 2019 letter from the Administration—published in response to a meta-analysis that indicated a late mortality signal—warning that treatment of PAD with paclitaxel-coated balloons and paclitaxel-eluting stents was “potentially associated with increased mortality”. 

Alongside the letter, the US FDA has updated its recommendations for healthcare providers regarding the use of paclitaxel-coated balloons and stents for PAD. As well as removing reference to the possibility of increased mortality with these devices, the amended guidance softens the language around the monitoring of patients who have been treated with paclitaxel-coated stents and balloons, stating that healthcare providers should continue ‘routine’ rather than ‘close’ monitoring of these patients, as had previously been stated. 

The safety of paclitaxel—used in peripheral interventions to prevent restenosis—was called into question by data put forward in 2018 by Konstantinos Katsanos (University of Patras, Patras, Greece) et al that pointed to an increased risk of death at two and five years following the use of paclitaxel-coated balloons and paclitaxel-eluting stents in the femoropopliteal artery. 

The FDA responded, notifying healthcare providers in early 2019 about a late mortality signal in patients treated for PAD in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents. Their most recent update on the topic, prior to that shared on July 11, 2023, was posted in August 2019. 

In its new update, the FDA notes that “additional data from the pivotal randomised controlled trials (RCTs) has become available,” and that the Administration has worked with device manufacturers and external stakeholders to develop the protocol and analysis plan for new data generation. 

The FDA references the fact that device manufacturers collaborated in an updated meta-analysis, which included “additional studies, more complete vital status information, and longer-term follow-up compared to prior studies”. Patient follow-up in these studies ranged from two to five years, the Administration notes, and led it to conclude that the updated RCT meta-analysis “does not indicate that the use of paclitaxel-coated devices is associated with a late mortality signal”. 

Furthermore, the FDA states that it also reviewed additional analyzed of the risk for late mortality, including the SWEDEPAD trial interim analysis, the VOYAGER PAD study, the German BARMER Health Insurance study, the US Veterans Health Administration study and the Medicare SAFE-PAD study. “None of these studies, with mean or median follow-up ranging from 1.7 to 3.5 years, found a risk for late mortality associated with paclitaxel-coated devices,” the FDA communicates, adding that longer-term follow-up in several of these studies is ongoing. 

VESAP5 expires July 14

By
Beth Bales
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VESAP5 expires July 14

The SVS’ fifth edition of the Vascular Education and Self- Assessment Program (VESAP5) expires at 9 a.m. CDT July 14 and with it, the possibility of claiming continuing medical education credits. 

Learners can earn credits and obtain certificates until then. Vascular surgeons and trainees can utilize the online program to prepare for qualifying, certification and recertification exams in vascular surgery and to keep up-to-date in the field. 

The VESAP5 program was released on July 16, 2020. Those who purchase the VESAP5 comprehensive package—now at up to 50% off—before the expiration date will have access to a non-CME version from July 17 of this year through July 17, 2024. 

The educational content will remain accessible even after the CME expiration. Learn more at vascular.org/VESAP5. 

Vascular Specialist–July 2023 VAM Review Edition

By
Bryan Kay
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Vascular Specialist–July 2023 VAM Review Edition

in this issue:

    • The numbers are in: VAM 2023 adds up to another SVS classic 
    • Guest Editorial: The Golden Larva Syndrome: Is it real? asks Bhagwan Satiani, MD
    • Comment & Analysis: Congress considers incremental steps towards Medicare payment reform 
    • Presidential Address: Michael C. Dalsing charts a course from rural America to the vanguard of a revolutionary surgical specialty
    • Vascular Leaders: SVS honors two vascular surgeons with Lifetime Achievement Award 

Review urges development of protocols to reduce hypersensitivity reactions after cyanoacrylate varicose vein treatment

By
Éva Malpass
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Review urges development of protocols to reduce hypersensitivity reactions after cyanoacrylate varicose vein treatment
Eduardo Silva

Despite being considered “generally safe,” cyanoacrylate can cause local reactions in up to 25% of patients, disproportionately affecting women, Asian race and thin patients with a body mass index of <22. This was the conclusion drawn by Eduardo Silva, MD, from Coimbra Hospital and University Center in Coimbra, Portugal, in his presentation at this year’s European Venous Forum (June 22–24) in Berlin, Germany.

Cyanoacrylate, the speaker first noted, has gained popularity in recent years for the treatment of varicose veins, due to its “minimally invasive” procedural nature and its ability to be performed in an outpatient setting. However, concern has grown in parallel to cyanoacrylate’s uptake, since increasing reports of “phlebitis-like reactions” have led some to question its safety.

These kinds of reactions have been later associated with type IV hypersensitivity, Silva explained, observing that symptoms can range from local itching, erythema, pain and swelling—typically resolving within a few days—although “severe” reactions have been reported.

Elaborating further on the typical presentation of this kind of hypersensitivity, Silva emphasized that type IV hypersensitivity often has a delayed onset, developing days to months after exposure to cyanoacrylate. Warning against expecting an immediate reaction, he made clear that “most of these will be between two to three days after the treatment.” Silva explained that these reactions occur in response to antigens produced by the subject to foreign substances that he has previously been exposed to, which, upon new exposure, triggers an “inflammatory cascade mediated by T cells.”

Using this information as the foundation of their study, Silva et al conducted a literature review using Embase and PubMed databases, evaluating the incidence and symptoms of suspected hypersensitivity reactions and their relation with phlebitis-like adverse events following cyanoacrylate varicose vein treatment.

Identifying 17 studies which reported severe complications, they highlighted 1,208 patients that had undergone cyanoacrylate varicose vein treatment, amounting to 1,631 treated veins. In total, 13 veins had to be excised in nine patients. Among these patients, the majority were female (65.8%), with a mean age of 52 years.

Looking closely at less severe reactions to cyanoacrylate treatment, Silva and his team noted 250 patients who had developed some form of adverse reaction after administration, the most common reaction being thrombophlebitis or phlebitis-like reactions (4–25.4%), however he asserted that “most complications were mild and self-limited”.

Building a portfolio of risk factors, the speaker noted that the presence of suprafascial saphenous vein location (<1cm underneath the skin), as well as larger veins (>8mm), were associated with adverse reactions to cyanoacrylate. Although Silva concluded that population characteristics and procedural factors “did not seem to influence the risk of developing hypersensitivity.”

After critically reviewing the literature, Silva concluded his presentation by asking the question: “Who should we test?” He asked if it should it be everyone? Patients with a known acrylate allergy? Or patients at risk of previous exposure? First, he considered patch testing all patients pre-procedure, stating that this “can be very useful to identify patients that might be at risk of developing hypersensitivity,” though he warned that “exposing everyone to [patch testing] may actually be causing first exposure and sensitizing the patient.”

Secondly, revealing a trick question, Silva eliminated patients with a known acrylate allergy completely, stating that these patients “should not be treated [with cyanoacrylate] at all.” Looking at his third option, he concluded that patients at risk of previous exposure should be considered for testing, although “many patients do not know they have been previously exposed,” posing difficulties for healthcare providers.

Providing a clear overview of their findings, Silva conveyed that cyanoacrylate is “a safe treatment,” but discussion needs to address the differences between phlebitis-like reactions and “classic” thrombophlebitis. Finally, he emphasized the importance of “developing protocols to identify and reduce hypersensitivity reactions,” and urged physicians to consider referral to clinical allergists “when in doubt”.

The top 10 most popular Vascular Specialist stories of June 2023

By
Clare Tierney
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The top 10 most popular Vascular Specialist stories of June 2023

Last month, Vascular Specialist garnered readers’ attention with an array of commentary on the BEST-CLI and BASIL-2 trials; the medical editor’s interview with vascular surgery’s ‘living legend’ Frank J. Veith, MD; the news of the death of Past SVS President Kenneth Wayne Johnston; and a report of a Vascular Annual Meeting (VAM) breakfast session on the role of vascular surgeons in the pulmonary embolism (PE) treatment paradigm.

1. More research needed but lithotripsy plus TCAR ‘an answer’ in certain carotid disease patients

Misty Humphries, MD, MAS, associate professor of surgery at UC Davis in Sacramento, California, gives Vascular Specialist the lowdown on recent findings that intravascular lithotripsy (IVL) may be able to expand transcarotid artery revascularization (TCAR) into patients with traditionally prohibitive calcific disease.

2. ‘Nobody believed us’: Vascular giant on overcoming skeptics

Malachi Sheahan III, MD, Vascular Specialist’s medical editor, speaks to living legend and limb-salvage pioneer Frank J. Veith, MD, on the contents of his hard-hitting new book, The Medical Jungle: A Pioneering Surgeon’s Battle to Revolutionize Vascular Care and Challenge the Medical Mafia, ahead of the inaugural named lecture established in his honor taking place at last month’s VAM.

3. BEST-CLI investigators implore a move beyond endo vs. open ‘battle’ in the name of scientific advance

The principal investigators behind the BEST-CLI trial struck a conciliatory tone during the inaugural Frank J. Veith Distinguished Lecture at VAM 2023 in which they laid bare the blood, sweat and tears shed on their journey to complete the landmark study.

4. SVS mourns death of Past President Kenneth Wayne Johnston

The Society for Vascular Surgery (SVS) mourns the death of Kenneth Wayne Johnston, an SVS member, former president and recipient in 2009 of the SVS’ highest honor, the Lifetime Achievement Award.

5. Novel drug candidate for slowing AAA growth demonstrates safety in humans

According to Stephen Cheng, MBBS, MS, chair of the Department of Surgery at the University of Hong Kong, the first-in-human study findings suggesting that the local delivery of a glucose-derived compound in small- and medium-sized AAAs is safe merit further evaluations within randomized controlled trials.

6. BASIL-2 and BEST-CLI: A tale of two limb trials

Michael S. Conte, MD, is chair in Vascular Surgery at the University of California San Francisco (UCSF), and he weighs in on some of the key questions surrounding the BASIL-2 and BEST-CLI trials.

7. Crawford panel focuses on challenges of vascular workforce crisis

This year’s VAM E. Stanley Crawford Critical Issues Forum looked at ways to address the pipeline of sources feeding the vascular surgery pool of talent, yielded an illuminating perspective on the looming workforce crisis currently occupying leaders in the field.

8. VQI@VAM: Social media helps promote safe technique, study finds

A social media campaign promoting educational videos proved efficient and cost-effective, and similar campaigns will be useful for quality improvement projects directed toward medical trainees.

9. The essential ‘need’ for vascular surgeons in PE treatment paradigm

Vascular surgeons who are SVS members from pulmonary embolism response teams (PERTs) or busy PE programs from six large hospitals and systems discussed advances in care and the role that vascular surgeons play in the current PE landscape at a breakfast session at VAM last month.

10. Special VAM session underscores ‘complementary’ nature of open and endovascular strategies in CLTI patients

A dedicated session at VAM 2023 saw speakers and delegates gather to debate, analyse and consider the implementation of the BEST-CLI and BASIL-2 randomized-controlled trials (RCTs). There was general agreement that the strategies are complementary, and that “picking the right thing for the right patient at the right time” should take precedence.

Surmodics receives FDA approval for the SurVeil drug-coated balloon

By
Bryan Kay
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Surmodics receives FDA approval for the SurVeil drug-coated balloon
Kenneth Rosenfield

Surmodics has announced the receipt of Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB).

A company press release notes that the SurVeil DCB may now be marketed and sold in the U.S. to physicians for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (≤180mm in length) in femoral and popliteal arteries having reference vessel diameters of 4mm to 7mm. The SurVeil DCB received CE mark certification in the European Union in June 2020.

“I am excited that the Surveil DCB will be available to treat patients in the USA,” said Kenneth Rosenfield, MD, an interventional cardiologist at Massachusetts General Hospital in Boston, co-principal investigator of the TRANSCEND clinical trial.

“The Surveil DCB is the next generation DCB as established by results from the TRANSCEND trial which is the only head-to-head pivotal study that has been conducted versus the market-leading DCB. The Surveil DCB successfully demonstrated non-inferior safety and effectiveness at two years post-treatment with a substantially lower drug dose.”

FDA approves study of ZFEN+ for treatment of aortic aneurysms

By
Bryan Kay
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FDA approves study of ZFEN+ for treatment of aortic aneurysms
Photo by Dwight C. Andrews/McGovern Medical School at UTHealth Office of Communications Dr. Gustavo Oderich - CV Surgery
Gustavo Oderich

The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+).

The clinical study will assess the safety and effectiveness of the ZFEN+ in combination with the Bentley InnoMed BeGraft balloon-expandable fenestrated endovascular aortic repair (FEVAR) bridging stent graft system (BeGraft) for the endovascular treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

The ZFEN+ is predicated on the commercially available Zenith fenestrated abdominal aortic aneurysm (AAA) endovascular graft, but extends the proximal margin of aneurysmal disease that can be treated endovascularly to include patients with more complex aortic disease. For patients with complex aortic disease, the only currently established treatment option is open surgical repair.

The ZFEN+ clinical study is a prospective, multicenter, single-arm study that will include sites in the U.S. and Europe. At this time, the FDA has approved enrollment of the first 30 patients. Ultimately, Cook intends to enroll 102 patients in the pivotal study. The primary safety endpoint is a composite measure of device technical success and procedural safety within 30 days. Likewise, the primary effectiveness endpoint is a composite measure of freedom from aneurysm-related mortality and freedom from clinically significant reintervention through 12 months post procedure. A composite measure is a group of variables collected during the clinical study and analyzed.

“The ZFEN+ endovascular graft will meet a significant need for our patients,” said Gustavo Oderich, MD from the University of Texas Health Science Center at Houston in Houston, Texas, who is the global principal investigator of the study.

“There are not many options to treat complex aortic aneurysms other than open repair or off-label use of devices. Even long after off-the-shelf devices become available, the ZFEN+ will offer a tailored approach specific to the patient anatomy. The ZFEN+ clinical study will provide a benchmark for safety and effectiveness of a less invasive option to treat complex abdominal aortic aneurysms.”

VAM 2023 attendees have their say on the impact of BEST-CLI and BASIL-2 trials

By
Will Date
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VAM 2023 attendees have their say on the impact of BEST-CLI and BASIL-2 trials

As the vascular community continues to unpack the key learnings from two of the biggest trials to date in chronic limb threatening ischemia—BEST-CLI and BASIL-2—attendees of the 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17) told Vascular Specialist how they see the two landmark trials shaping practice in years to come.

SVS mourns death of Past President Kenneth Wayne Johnston

By
BIBA Publishing
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SVS mourns death of Past President Kenneth Wayne Johnston
Kenneth Wayne Johnston

The Society for Vascular Surgery (SVS) mourns the death of Kenneth Wayne Johnston, an SVS member, former president and recipient in 2009 of the SVS’ highest honor, the Lifetime Achievement Award. 

Barry Rubin, MD, chair and program medical director for the Peter Munk Cardiac Centre for the University Health Network in Toronto, writing with other colleagues, called Johnston “one of Canada’s preeminent and gifted academic surgeons … Dr. Johnston was a visionary leader, educator, researcher and tireless advocate for vascular surgery who cared for his patients with kindness and compassion. His surgical skills were outstanding and always carefully applied and he was a patient teacher of clinical skills to a large cohort of residents and fellows. Dr. Johnston’s work ethic was legendary, and he led by example, always contributing, learning and exploring new areas of research to apply to patients with vascular disease. He continuously questioned current dogma and used the scientific approach to develop new diagnostics and therapies and instilled this quest in the trainees who were privileged to work with him. Dr. Johnston set very high standards for himself and strove each day to meet them – we and many others were deeply influenced by watching Dr. Johnston reach those standards and are much better today because of it.”

In the U.S., Johnston played a critical role in brokering the merger of the two American vascular societies to become the SVS, overcoming strong resistance to the merger at the time. He served as vice president and then president, in 2008, leading the development of SVS’ first strategic plan. He received SVS’ Lifetime Achievement Award in 2009, to recognize his outstanding and sustained contributions to the profession of vascular surgery and to Society itself. He is the only Canadian to ever have received this most prestigious award. He was also Vascular Specialist‘s first-ever medical editor.

Said SVS Treasurer and colleague of Johnston, Thomas Forbes, MD: “Wayne was the penultimate vascular surgeon, scholar, leader and educator. More importantly he was a loving family man and trusted mentor, colleague and friend. We all looked to him for his sage advice and wisdom. He will be sorely missed but we’ll all try to continue his legacy, locally, nationally and internationally.”

Johnston was a pioneer and driving force in the establishment of the Canadian Society for Vascular Surgery 40 years ago and served as both its secretary and president. Today, the Society is internationally recognized and is Canada’s most important forum for supporting professional education, research and standards of care related to the prevention, diagnosis and treatment of vascular conditions, said Rubin.

At the University of Toronto, Johnston established the Division of Vascular Surgery and was its inaugural chair, a position he held for more than 20 years. As a teacher and mentor, he established the first vascular surgery training program in Canada and trained a generation of vascular surgeons, many of whom he inspired to go on to have distinguished careers in academic and community medicine. A strong proponent of multidisciplinary approaches to research, he supervised 43 masters and doctoral-level engineers.

Johnston played a major role in setting the standards for accreditation of training in vascular surgery that were adopted by the Royal College of Physicians and Surgeons of Canada. He co-edited the seventh and eight editions of Rutherford’s Vascular Surgery, the standard, definitive medical reference text for a range of health professionals including vascular surgeons, interventionalists and vascular medicine specialists worldwide, and was the first and only Canadian to do so. For seven years he was editor- in-chief of SVS’ peer-reviewed scientific journal, the Journal of Vascular Surgery, and was the first Canadian to be honored with this responsibility.

As a clinical scientist, Johnston’s research greatly improved the care of patients with vascular disease, and his vascular research lab was one of the first in North America. His impact on the understanding and treatment of patients with vascular disease was unparalleled. Dr. Johnston published seminal papers detailing the results of the world’s first major prospective study of patients that established the role of balloon angioplasty of the arteries of the legs in treating patients with impaired circulation, preventing disabling pain and amputations. His research changed the way that patients with blocked arteries are treated and this procedure is now recognized internationally as the treatment of choice.

In the late 1980s and early 1990s, Johnston led the first and largest Canadian-based multicenter study of abdominal aortic aneurysms in the world. The study results had a significant impact on the selection and treatment of patients with abdominal aortic aneurysms and continue to be used to identify patients at increased risk of major surgery who would benefit from new and less invasive approaches. Remarkably, Johnston had 34 years of continuous funding from the Canadian Institute for Health Research for his research into the development and use of ultrasound.

In 2018, Johnston was invested as a Member of the Order of Canada, one of the country’s highest civilian honors. “Dr. Johnston left an indelible mark on us, and we are privileged to have known, been trained by and worked with him for so many years. He will truly be missed,” said Rubin.

Johnston is survived by his wife Liz Cain, his daughter Andrea (Andrew) and son Matthew (Paloma) and grandchildren Mercer, Maren, Myles and Piers. Wayne was predeceased by his wife of almost 50 years, Dr. Jean Turley.

His funeral will be July 5 in Toronto. Memorial contributions may be made to to the Princess Margaret Cancer Foundation or to the Dr. K. Wayne Johnston Memorial Fund.

Risk of cancer-related VTE recurrence ‘significantly lower’ using NOACs compared with low molecular weight heparin

By
Éva Malpass
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Risk of cancer-related VTE recurrence ‘significantly lower’ using NOACs compared with low molecular weight heparin
Female nurse assisting patient undergoing renal dialysis in hospital room

Delivering results and recommendations from a systematic review and meta-analysis of novel oral anticoagulants (NOACs) versus low molecular weight heparin (LMWH) in the prevention of venous thromboembolism (VTE) recurrence in cancer patients, Patricia Noreen Bueno, MD, from St Luke’s Medical Center in Quezon City, Philippines, asserted that the risk was “significantly lower” when using NOACs, but “careful consideration” must be employed when choosing an anticoagulant.  

Presenting on the first morning of this year’s European Venous Forum (June 22–24) in Berlin, Germany, Bueno began by situating their chosen field of study, highlighting the prevalence of VTE as a common complication in cancer patients, and its association with higher morbidity and mortality.  

“Traditionally,” she noted “LMWH has been the standard [preventive measure] in this population, however NOACs or oral anticoagulants have emerged as a potential alternative due to their convenience and ease-of-use.”  

In their analysis, Bueno and her team looked at randomized controlled trials (RCTs) that included NOACs in patients with cancer-associated VTE, defining their primary outcome as VTE recurrence. To do so, they initiated a comprehensive search of clinical trials available on PubMed, Cochrane, Google Scholar and Gray literature, using RevMan 5.4 to perform their critical appraisal.  

Identifying eight RCTs including 4,741 patients—2,408 who received NOACs and 2,337 who received LMWH—Bueno et al specify that NOACs were administered orally, while LMWH were required to be administered subcutaneously by a healthcare professional.  

“Our analysis showed that risk of cancer-associated VTE recurrence was significantly lower in patients treated with NOACs, compared with LMWH [risk ratio 0.64; 95% confidence interval 0.52–0.80; p<0.0001; I2%],” Bueno said, however making clear that the safety of NOACs is not significantly superior to that of LMWH. Adding to their results, Bueno also noted that all-cause mortality showed no statistical difference between the two groups.  

Showing consistency with prior meta-analyses performed in this area, Bueno conveyed that their review “[reflects] the benefits of NOACs’ pharmacokinetics and pharmacodynamics, including their short half-life, rapid onset/offset of action, and few drug-drug interactions”.  

As an offshoot to their current study, Bueno then moved on to give detail to two subanalyses they performed using the present patient population, first looking at risk of major bleeding based on location of cancer and use of either NOACs or LMWH, and secondly, looking at the type of NOAC used, namely apixaban, rivaroxaban or edoxaban.  

Elucidating the results of the former subanalysis, Bueno et al defined groups by gastrointestinal (GI) and non-GI location of cancer, finding no statistical significance between groups when using NOACs or LMWH. She continued, however, stating that in GI studies they found “an increased risk of major bleeding when [patients were] treated with NOACs.” This, she posited, may be due to cancer location and the presence of other pathologies such as ulceration, and “highlights the importance of closely monitoring symptoms and signs of bleeding in patients with GI malignancies while undergoing treatment with anticoagulants.” 

Concerning the latter subanalysis, Bueno gave a brief review of available NOACs and their attributed risk factors—overall emphasizing the “careful consideration” that must be maintained by clinicians when choosing an appropriate anticoagulant—particularly for patients with pre-existing bleeding risk factors.  

Overall, Bueno and her team observed that anticoagulation therapy with NOACs is “effective and safe” in preventing cancer-associated VTE recurrence. Although they acknowledge that the current preference is LMWH for patients with GI malignancies who have a high risk of bleeding, they hope that their review may “aid clinicians” in their decision-making and spur further clinical trials.

Vascular Verification Program registers first four hospitals in US—including UCSF

By
Bryan Kay
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0
Vascular Verification Program registers first four hospitals in US—including UCSF
Michael S. Conte

UC San Francisco Medical Center (UCSF) is among the first four hospitals in the U.S. to be verified as part of the American College of Surgeons’ (ACS) Vascular Verification Program (Vascular-VP), a quality program recently launched in partnership with the Society for Vascular Surgery (SVS).

To receive verification as a “Comprehensive Inpatient Vascular Program,” UCSF demonstrated a commitment to improving outcomes and care for patients receiving vascular surgical and interventional care in an inpatient setting.

Vascular-VP leverages the strengths and expertise of the ACS and SVS to provide an evidence-driven, standardized pathway for instituting and growing a quality improvement and clinical care infrastructure within a hospital’s vascular program.

“The Vascular Verification Program helps strengthen a hospital’s safety and continuous improvement culture to enhance patient outcomes with greater reliability and standardization of care. As one of the first hospitals to receive this verification, UCSF Health has shown its commitment to providing the highest quality care for vascular patients,” said Clifford Y. Ko, MD, director of the ACS Division of Research and Optimal Patient Care.

To become verified, UCSF Health met the standards outlined in the Optimal Resources for Vascular Surgery and Interventional Care (2023 Inpatient Standards), which addresses elements of vascular surgical and interventional care and quality. These standards span from the outpatient clinic to the operating rooms, recovery areas, intensive care units, laboratories and interventional suites.

“We are proud to partner with the ACS and the SVS in this important new program, which exemplifies the culture of surgical quality improvement that drive us every day in our operating rooms, clinics, and wards,” said Julie Ann Sosa, MD, chair of the Department of Surgery at UCSF.

“Modern care of vascular patients requires teamwork and expertise. This designation recognizes the deep commitment of our leadership, faculty, and staff to optimal care of the vascular patient through all phases of their care,” added Michael S. Conte, MD, co-director of the Heart and Vascular Center and chief of vascular and endovascular surgery at UCSF.

As a Vascular-VP verified hospital, UCSF Medical Center also becomes an ACS Surgical Quality Partner. Being a Surgical Quality Partner signifies a hospital’s dedication to consistently improving procedures and approaches, while maintaining a critical eye on process at every step. The Surgical Quality Partner designation lets patients know UCSF Health is dedicated to quality and relentless self-improvement and has been verified or accredited by the ACS. Patients can trust that the care they receive at Surgical Quality Partner hospitals adheres to the most rigorous standards in surgical quality. UCSF Health is an ACS Surgical Quality Partner by participating in Vascular-VP.

“We welcome UCSF Health into the ACS Quality Programs. They have shown their commitment to delivering the highest quality care, evaluating that care in a rigorous fashion, and dedicating themselves to continuous improvement,” said ACS Executive Director  and CEO Patricia L. Turner, MD.

Assessing the needs of young vascular patients

By
Beth Bales
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0
Assessing the needs of young vascular patients
Dawn Coleman
vascular
Dawn Coleman

In the past 18 months, a joint taskforce studying the needs of pediatric vascular patients has made great strides, conducting a needs assessment, identifying top priorities and planning resources for surgeons of these young patients. The next step: a meeting this month for interested members from both the Society for Vascular Surgery (SVS) and the American Pediatric Surgical Association (APSA). SVS members Dawn Coleman, MD, and John White, MD, co-lead for the SVS; Regan Williams, MD, and David Rothstein, MD, co-lead for APSA.

The meeting titled the Pediatric Vascular Surgery Development Group was held on Thursday June 15, 2023 at the Gaylord National Resort and Convention Center, with interested SVS members at­tending live during the SVS Vascular Annual Meeting (VAM) and APSA members attending virtually. All four co-leaders anticipate the group will hereafter begin to meet quarterly.

It’s the first-of-its-kind get-together at an annual meeting to gather both vascular and pediatric surgeons. Since its formation in late 2021, the task force has conduct­ed a thorough needs assessment and prioritized four pillars of critical care: blunt and penetrating vascular trauma, iatrogen­ic trauma, hemodialysis access and ECMO (extracorporeal membrane oxygenation) life support.

Trauma isn’t the No. 1 issue in pediatric vascular patients, but it is one of the most common and, importantly, it’s often a time-sensitive challenge, according to Coleman. “Delays in care can compromise the long-term and functional outcomes of children, in addition to immediate life and limb threat,” she said. “Thus, it’s a high-impact focus for our team.”

Many more invasive procedures on the heart and kidneys occur now than 10 and 20 years ago, said White. “Patients will have complications from these procedures, and we need to be prepared to address them.” ECMO has been used more frequently with children recently, especially during COVID-19, but also for the wide variety of respiratory dis­orders children acquire. “Its usefulness in children has been proven and it requires vascular cannulation. So we, again, need to explore best techniques,” White added.

Williams and Rothstein said the task force grew out of several themes. For one, general surgery residents (and con­sequently graduating pediatric surgery fellows) have progres­sively less and less exposure to vascular surgery, particularly open surgery. As a result, practicing pediatric surgeons, es­pecially early-career ones, have little experience in vascular surgery operations. Additionally, vascular surgery diseases are rare in pediatric surgery but opportunities for collabora­tion with vascular surgeons abound. “The best care for our pediatric patients is often provided in a collaborative fashion and we can improve this collaboration by defining areas of common ground, breaking down administrative barriers and measuring our outcomes,” they said.

In the works are supplements from each organization’s journals that will include a set of descriptive disease-specific articles and access to a physician toolkit. Task force members want to accelerate developing best practices for these critical domains already identified and eventually expand into other areas and engage stakeholders from other disciplines.

New analysis probes BEST-CLI trial against real-world setting data

By
Jocelyn Hudson
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1
New analysis probes BEST-CLI trial against real-world setting data

SCAIA new analysis of chronic limb-threatening ischemia (CLTI) treatment outcomes was presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Ses­sions (May 18–20) in Phoenix.

Since the initial results of the BEST-CLI trial found surgery superior to endovascular revascularization, questions have lingered. The new analysis, led by Eric Secemsky, MD, sought to analyze a broader clinical population via the Medicare population. The endpoint used for the patient group was a composite of major adverse limb events (MALE) and death.

A total of 66,153 patients were included—10,125 autologous grafts, 7,867 non-autologous and 48,161 endovascular. Compared to BEST-CLI cohort 1, patients were older, more often female and had a greater burden of comorbidities. Endovascular operators were less likely to be surgeons (55.9% vs. 73% in BEST-CLI) and more likely to be interventional cardi­ologists (25.5% vs. 13.0%). The risk of death or MALE was higher with surgery (56.6% autologous vs. 42.6% BEST-CLI cohort 1; 51.6% non-au­tologous vs. 42.8% BEST-CLI cohort 2) but similar with endovascular. Of those receiving endovascular treatment, major interventions occurred less frequently compared to the trial (10% real-world vs. 23.5% cohort 1; 8.6% real-world vs. 25.6% cohort 2).

Primary patency after venous stenting best in NIVL patients, study finds

By
Jocelyn Hudson
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0
Primary patency after venous stenting best in NIVL patients, study finds

A recent study concludes that non-thrombotic iliac vein lesion (NIVL) patients have better primary patency after venous stenting than patients with venous thrombotic disorders. Olivier Espitia, MD, from CHU de Nantes in Nantes, France, and col­leagues report this main finding from a multicenter cohort study in the European Journal of Vascular and Endovascular Surgery (EJVES).

The authors detail that it was their aim to assess primary stent patency predictive factors in three groups of patients with history of lower limb vein thrombosis: NIVL, acute deep vein thrombosis (aDVT) and post-thrombotic syndrome (PTS).

The investigators included consecutive patients from January 2014 to December 2020 from seven hospitals. The team reported the anticoagulant and antiplatelet therapy strategies employed after venous stenting and compared these between the three patient groups. In their results, Espitia et al state that the study included 377 patients in total, comprising 134 in the NIVL group, 55 in the aDVT group and 188 PTS patients, and that medi­an follow-up was 28.2 months.

The authors report in EJVES that primary paten­cy was statistically significantly higher in the NIVL group (99.3%) compared with the PTS group (68.6%; p<0.001) and the aDVT group (83.6%; p=0.002). In addition, the researchers note that PTS patients received a statistically significantly greater number of stents and had more stents below the inguinal ligament.

Finally, Espitia et al report that discontinuation of antiplatelet therapy at the last assessment was 83.6% for NIVL, 100% for aDVT, and 95.7% for the PTS group (p<0.001). Discontinuation of anticoagulation therapy was 93.2% for NIVL, 25% for aDVT, and 70.3% for the PTS group (p<0.001). “The only predictor of worse primary patency in the aDVT group was long-term anticoagulation before stenting,” they write.

Bias and the silver bullet: Gender partiality seen within AI algorithms for AAA identification

By
Éva Malpass
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0
Bias and the silver bullet: Gender partiality seen within AI algorithms for AAA identification
Sharon Kiang
AI
Sharon Kiang

Artificial intelligence (AI) has become a central focus within various spheres, from commerce to medicine—including applications in patient care. Sharon Kiang, MD, talks to Vascular Specialist about the specter of bias and how a “hybrid” approach between AI and human specialty may be the best solution going forward.

Sharon Kiang, MD, considers it the “silver bullet” clinical perception of AI. In the Loma Linda University School of Med­icine associate professor’s reckoning, it’s no mere nebulous metaphor but the underpin­nings of her latest research into disease pre­diction models, and the gendered biases they found within their foundational algorithms.

“Originally, we weren’t looking at bias. We were just looking to see if the aortic model, using machine learning and AI algorithms, could predict and understand the progres­sion of disease and, if possible, therefore pre­dict outcomes,” Kiang tells Vascular Specialist. Operating on the assertion that human error and a “human-bound limitation of resourc­es” confound patient care today, Kiang’s team believe that AI could alleviate a portion of manual “yearly factors,” which can take up significant time.

Kiang has not long since finished present­ing some of her latest findings at the 2023 Women’s Vascular Summit (April 28–29) in Buffalo, New York, where she extrapolated on the advent of AI’s more frequent deploy­ment, and the greater ease with which its limitations can be seen. “We started reading about how bias is unintentionally put into algorithms, and so went to look at our own data to see if there are biases there,” she says. Kiang selected gender as their specified bias variable, in part because disparities within post-intervention clinical outcomes in fe­male aneurysm patients have already been reported. “We wanted to see if our machine was able to fix that and equalize its ability to learn,” Kiang explains.

Kiang told the Women’s Vascular Summit about how she and col­leagues investigated gendered bias in convolutional neural networks, or deep learning, for abdominal aor­tic aneurysm (AAA). Their findings revealed that the machine was un­able to overcome this bias and could not identify aneurysms in females as it could in males. “This may be that female aortas are smaller,” Kiang notes, so limiting the ma­chine’s accuracy. Offering further explana­tion, she stated that their data may have also been “flawed,” creating bias in the algorithm, or that it may not accurately represent “the question being asked of the machine.”

Although she hypothesized that a perfect algorithm could theoretically be designed— blinded to race, gender, financial, and geo­graphical disparities, so in essence a “blinded unicorn algorithm”—Kiang states that ques­tions arise about whether this would make it a “useful” algorithm at all. Where the “bal­ance” lies, she continues, is in a realistic AI architecture that can support these variables in a “representative” and “fair” way.

But, time is of the essence. “AI moves fast” Kiang asserts, observing that her growing body of research is developing closely along­side that of organizations with predomi­nantly financial motives, who are keen to “keep pushing.” Apart from a brief diversion to comment on the novel and rapid devel­opment of ChatGPT—“Dude, we haven’t even discussed the ethical implications of [ChatGPT], right?”—Kiang’s viewpoint remains focused on the positive change AI can effect in the care of humans globally. “It sounds Ivory Tower-ish, but my mind is cen­tered on the benefit to populations—not just at a specialty level, or even at a hospital level, but at a national, global level,” Kiang says.

AI does not come without limitations, Ki­ang makes clear; however, apprehension has most commonly been “driven by fear.” “On a superficial level people suggest that they will be out of a job, and I be­lieve that’s unfounded,” she says, high­lighting the only legitimate fear might be for support staff whose job could be performed more efficiently by AI. “I’m not here to say we should not advance technology so that people can be less efficient in the care that they provide pa­tients. But neither am I saying we should build Skynet and drive the human race out of need,” she adds.

A “hybrid” approach between AI and human specialty may be the best solution, Kiang proposes, a “human understanding of relationships” filling the gaps where AI is most lacking. But a “critical mass” of peo­ple who believe in the positive function of AI is needed, she continues. “If you don’t have that buy-in, you will have a lopsided relationship that isn’t truly a hybrid model. In this case, you will have executive bean-count­ers who don’t know anything about boots-to-the-ground patient care, leaning on AI predictions. I can see that as a problem mov­ing forward.”

Kiang describes her experience of the complex contemporary reception to AI, de­tailing how audiences are becoming more “receptive” to her ongoing AI research com­pared with previous years.

“We are hitting while the iron is hot right now, and it’s very hot,” she says. Kiang be­lieves people are now more “open-minded, or are being forced to be.” Emphasizing the importance of “clean” messaging when pre­senting research on this technology, Kiang says she aims to continue demonstrating the realistic clinical applications of AI that have the potential to better patient care in the future.

Advocacy exists to serve: Surgeons, patients and our mission

By
Margaret C. Tracci
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Advocacy exists to serve: Surgeons, patients and our mission
Margaret C. Tracci
advocacy
Margaret C. Tracci

One of the most gratifying aspects of working to advocate for surgeons is that, at its heart, this is completely trans­parent and is done simply to serve. Serve what? To serve surgeons, by supporting their ability to flourish in practice, pushing back against the seemingly endless accumulation of regulatory and other encumbrances, and focusing a light on surgeon well-being.

To serve our patients, by advocating for the highest quality care and tackling impediments to access. To serve our mission, by raising public and patient awareness of the role of vascular surgery and highlighting the importance of research, care innovation and the healthy growth of the vascular surgeon workforce.

Over the years, the Society for Vascular Surgery (SVS) has built a robust infrastructure to serve its members through advocacy, supported by both surgeon volunteers on its com­mittees and councils and by an expert professional staff, based both in Rosemont, Illinois, and Washington, D.C. The Policy and Advocacy Council works closely with policy and ad­vocacy staff to facilitate communication and coordination among its member committees, across councils, with the Strategic Board.

The Council’s committees include: Government Relations, which takes the lead on federal legislative and regulatory issues; Coding, which plays a critical role through the Amer­ican Medical Association’s Relative Value Scale (RVS) Update Committee (RUC) and beyond in the valuation and reim­bursement of vascular services; the PAC Steering Commit­tee, which raises and disburses funds to support all advocacy efforts; the VA Vascular Surgeons Committee, representing the unique position and perspective of the U.S. Department of Veterans Affairs (VA) surgeons and veterans; and the Per­formance Measures Committee, doing duty across councils to ensure alignment.

What does coordination and collaboration of advocacy across the SVS mean? This means that the policy and pri­orities of the entire society are drawn from the expertise of the councils and committees and the values of our vascular surgeon members. The Clinical Practice Council, for ex­ample, has helped define our advocacy agenda through the recommendations developed by the Wellness Committee, the insight into the impact of current payment policies of­fered by the Section on Outpatient and Office Vascular Care (SOOVC), and the initial work of the Population Health Task Force. Once policy and priorities are set, the SVS continues to serve through its three advocacy pillars: grassroots, political and legislative advocacy.

Our professional staff is continually working to move our priorities forward in D.C. And as Andrew Kenney wrote a few months ago, this operation is infinitely stronger with the support of surgeons engaging our legislators through in-per­son meetings, letters, calls, and social media in a grassroots campaign. So when you think of advocacy, know that SVS advocacy truly exists to serve. To get involved, reach out at advocacy@vascularsociety.org.

Margaret C. Tracci is the chair of the SVS Advocacy Council.

Changing gears: A guide to cruising back to the operating room

By
Kenneth Tran
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Changing gears: A guide to cruising back to the operating room
Kenneth Tran

For surgeons-in-training, professional development time (colloquially known as “the research years”) is a welcome break from the rigors of surgical residency. A time to rest, reflect, and embark on new growth opportunities. A reprieve from the 6:00 a.m. (or earlier) morning rounds, mid­dle of the night calls from the emergency department, and discerning gaze from our attendings. However, inevitably, the time comes to get back into clinical gear to fin­ish the job that you started (residency). Cue the nervous jitters and sweaty palms. This is a universal feeling nearly all of us have felt before returning to patient care after a long hiatus. Rest assured, the first three years of your surgical training have prepared you well for your return—but there are a few things you can do to make the transition back as smooth as possible.

Trip down memory lane

Like all things in surgery, the devil is in the de­tail. While the basics of clinical care, such as determining operative candidacy or periop­erative management, are likely old hat, little things will certainly have escaped your mem­ory. This is especially true in the operating room (OR). Which side of the anastomosis is easier to sew first for a below-knee bypass? What sheath size does this device need again? How does attending X like their cases draped and positioned? Revisiting old case logs and surgical notes from years past may be helpful to jog your memory of these minute details. This is also a good time to dust off the old anatomy and operative technique textbooks. Like riding a bicycle, technically performing both open and endovascular cases “comes back fast.” However, a few afternoons of deliberate practice with a set of Castrovie­jos, 6-0 Prolene, some expired PTFE grafts and your favorite Spotify playlist is a nice way to get back into the swing. Likewise, for endovascular cases in particular, a proac­tive visit to the endovascular device storage room to get re-acquainted with the names of commonly used wires, catheters and sheaths is beneficial.

Showing your age

One of the joys of vascular surgery is the sheer pace of innovation in our field, with a never-ending stream of new devices and techniques to master. Coming back from research, I found myself encountering new acronyms that I had never heard of before. What is a DVA exactly? Is the TBE the same as TAMBE? Seemingly overnight, TCAR be­came a widely adopted procedure that I was now expected to be facile with. A quick meet­ing with your friendly neighborhood device representatives is helpful in this regard. They often can share with you the newest updated endograft configuration booklets, which are invaluable for case planning. A few months prior to starting back, you may also find it useful to listen in on your division’s weekly case conferences to get a grasp on current clinical algorithms. For example, our vascu­lar lab and limb salvage program had adopt­ed pedal acceleration time as a new surrogate marker for foot perfusion, which may affect which patients are offered intervention.

It’s all about the team

Returning from research years often coin­cides with transitioning from being a junior to senior resident. In your new role, man­aging a cadre of interns, junior residents and advanced practice providers becomes supremely important. Cases need to be appropriately and fairly assigned, consults evaluated and staffed efficiently, and patient concerns and dispositions thoroughly ad­dressed. These tasks cannot be performed without a well-functioning team. I personal­ly found team management was one of the most difficult aspects of my final years of residency. This aspect of training was sel­dom discussed, nor do we often have formal education or coaching to improve our “soft skills”—which are arguably right up there with gaining operative skill in order to be an effective surgeon. If they can spare the time, grabbing coffee to chat with the cur­rent chief residents on service is immensely helpful in this regard. Your colleagues can give you a primer on any new workflow changes, service logistics or other aspects of patient care that have changed since you were last on service. Leaning into your new role as chief resident is a daunting task, but is without a doubt a rewarding and beneficial experience as you embark on your journey to independent practice.

The week before you start

One of my friends told me that he channeled his nerves into preparation. For him, that meant rounding with the team a few days before he was to start running the service. This helped get him back into the wake-up schedule, and he got to know the patient on service and their plan. He was also able to pick the mind of the chief resident he was taking over from. He got to meet the support staff. He also cites the benefit of knowing the operative schedule so that he could prep for the cases. Finally, he says he went down to the hybrid room on a quiet afternoon and reminded himself of “what the buttons did.”

The first month back is going to be stress­ful. There’s just no way around it, but I hope this column helps someone make that tran­sition back a little smoother.

Kenneth Tran is a vascular surgery resident at Stanford University, California.

Physical pain a risk factor for vascular surgery trainee burnout, survey reveals

By
Jocelyn Hudson
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0
Physical pain a risk factor for vascular surgery trainee burnout, survey reveals

burnoutA recent survey has indicated that physical pain is “prevalent” among vascular sur­gery trainees and represents a risk fac­tor for burnout. Eric Pillado, MD, MBA, a vascular surgery resident at Northwestern University Feinberg School of Medicine in Chicago, shared this conclusion during the second SVS-VESS Scien­tific Session at this year’s Vascular Annual Meeting (VAM). 

Pillado detailed that 527 trainees completed a confidential, voluntary survey, administered after the Vascular Surgery In-Training Examination (VSITE), representing an 82.2% response rate. He revealed that 38% reported moderate-to-severe discomfort/pain after a full day of working, among whom 73.6% reported using ergonomic adjustments and 67% over-the-counter medications. Pillado also communicated that more women tended to report moderate-to-severe pain than men (44.3% vs. 34.5%, p<0.01).

After adjusting for gender, training level, race/ethnicity, mistreatment, and lack of operative autonomy—which the authors describe in their abstract as a proxy for loss of meaning in work— moderate-to-severe pain (odds ratio [OR] 2.52, 95% confidence interval [CI] 1.48–4.26) and using physiotherapy as pain management (OR 3.06, 95% CI 1.02–9.14) were determined to be risk factors for burnout.

In light of these findings, the presenter suggested in his conclusion that programs “should provide ergonomic education and adjuncts, such as posture awareness and microbreaks during surgery, early and throughout training”.

Pillado presented this work on behalf of senior author Dawn M. Coleman, MD, chief of the division of vascular and endovascular surgery at Duke University Medical Center in Durham, North Carolina, and the Vascular Surgery SECOND trial steering committee.

The Big Interview: Pioneering surgeon recounts career as new VAM lectureship is birthed

By
Adam Pearce
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The Big Interview: Pioneering surgeon recounts career as new VAM lectureship is birthed

Vascular Specialist medical editor Malachi Sheahan III, MD, sits down with Frank J. Veith, MD,  to discuss his new book, The Medical Jungle, ahead of the maiden named Vascular Annual Meeting (VAM) lecture created in the former SVS President’s honor. The Frank J. Veith Distinguished Lecture took place last week, and was focused on BEST-CLI. Here, they talk through his career highlights, including his journey as a limb-salvage pioneer.

VAM attendees chime in on BEST-CLI and BASIL-2

By
Will Date
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VAM attendees chime in on BEST-CLI and BASIL-2

VS@VAM journalist Will Date and videographer Jean-Philippe Bensoussan caught some VAM 2023 foot traffic outside the BEST-CLI and BASIL-2: Debate, Analysis and Implementation session last week to get their take on the two trials and how it has impacted their practice.

William Shutze

First up, SVS President and vascular surgeon William Shutze, MD with Texas Vascular Associates in Plano, says he is staying a familiar course.

“These are two really amazing, important trials that just came out this year that have profoundly affected the care of vascular patients. And it’s very exciting that the results have been published.

“At the same time, even though the overarching conclusions appear to be different, the way that I have interpreted these trials is it’s reinforced a lot of my own personal biases in the care of vascular patients. “I strongly favor bypass surgery for patients that are healthy and have a good quality vein. However, for patients that fall outside of those parameters, it demonstrate the superiority of endovascular techniques and limb salvage.”

Nicolas Mouawad

Nicolas Mouawad, MD, chief of vascular and endovascular surgery at McLaren Bay Region in Bay City, Michigan, says the two trials offer much food for thought.

“The long-awaited BEST-CLI and then BASIL-2, which I saw when they gave the information at Charing Cross,. I must say it really has confirmed and validated my current practice. We want to keep [intervention] as minimally invasive as possible, but if you have single-segment great saphenous vein in complex patients with CLTI, then I generally would offer a bypass.

“BEST-CLI is really an opportunity to compare best surgical therapy versus endovascular care. However, with BASIL-2 coming out, this has given us a little bit of a different perspective from what we saw in BEST-CLI. Unfortunately, I think it keeps the waters a little bit muddied, but for me in my current practice, it really just validates what I currently do.”

Lee Kirksey

Lee Kirksey, MD, vice chair of vascular surgery at Cleveland Clinic in Cleveland, Ohio, peripheral arterial disease (PAD) care is about offering the most appropriate care for the individual patient.

“What BASIL-2 as well as BEST-CLI really highlight is the importance of looking at this heterogeneous group of patients with PAD in a more granular fashion. We know that systemic risk of the operation, the patient’s anatomic complexity, the lesion complexity—all of these things should influence and impact how we manage the patients.

“I really look at BEST-CLI and BASIL-2 as highlighting the importance that we need to tailor therapy to the patient in front of us, using all the best available grading classifications, the GLASS scale for anatomic complexity, the WIfI scale in terms of the patient presentation, and then select the appropriate therapy. Really, it endorses the need for team based care so that we have expertise within endovascular therapy, expertise within open surgical bypass. Sometimes there will be some hybrid component of those therapies and we offer the most appropriate therapy for that patient in front of us.

Vincent Rowe

For University of California Los Angeles (UCLA) chief of vascular surgery Vincent Rowe, MD, a BEST-CLI site investigator, diagnosis and screening come to the fore.

“For me, the most important lesson was the outcome the outcome of the patients. I knew that patients with lower extremity disease had a high rate of mortality at four to five years. I didn’t realize it was this high— and even in those treated with endovascular therapy. So that was shocking to me. And I believe it means we’re going to need to try to diagnose these patients earlier. I think we should start screening these patients. I think it will save lives. And then I also believe that it will really help us be able to combat that low survival rate.

“To know that a patient that I operate on either with a stent or a bypass has a low probability of being there in follow up at five years makes me work even harder because, even though they may not be there in five years, I want them there with their leg until they close their eyes.”

Frailty status beats WIfI score as mortality predictor in all-comer CLTI study

By
Jocelyn Hudson
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Frailty status beats WIfI score as mortality predictor in all-comer CLTI study
WIfI score
John Houghton

A study presented during Plenary Session 3 at last week’s Vascular Annual Meeting (VAM), concluded that the Wound, Ischemia, and Foot Infection (WIfI) stage is predictive of major amputation at one-year follow-up in patients with chronic limb-threatening ischemia (CLTI), while frailty status is a better predictor of mortality. The researchers also found that, at baseline, WIfI classification is associated with both frailty and disability but not quality of life (QoL).

Submitting and presenting author John Houghton, MD, a National Institute for Health and Care Research (NIHR) academic clinical lecturer at the University of Leicester in Leicester, England, opened his talk by noting that the WIfI classification system has been widely adopted in CLTI management; however validation has predominantly been among patients undergoing revascularization. The present study, therefore, aimed to investigate the association of WIfI stage with baseline frailty, disability, and QoL, in addition to one-year major amputation and survival, in all-comers with CLTI.

Outlining the study methods, Houghton noted that the research team performed a single-center prospective cohort study of patients aged ≥18 with CLTI, who were enrolled in the study between May 2019 and March 2022. He noted that frailty, disability and QoL assessments were performed at baseline, with an interim analysis of one year outcomes performed in January 2023.

The presenter continued that amputation incidence was calculated for WIfI stages, and individual WIfI score combinations with ≥5 patients, and presented as percentages with 95% confidence intervals (CI).

Houghton, who presented this study on behalf of senior author Rob Sayers, professor of vascular surgery at the University of Leicester, and colleagues, detailed that a total of 432 patients were included in the research. He shared that 52 patients (12%) classified as WIfI stage 1, 112 (25.7%) stage 2, 107 (24.8%) stage 3, and 93 (21.5%) stage 4. There were 69 patients (16%) who had incomplete WIfI scores.

Sharing key results with the VAM audience, Houghton reported that increasing WIfI stage was associated with increasing prevalence and severity of frailty (p=0.003), and greater disability (p<0.001). He added that QoL scores, however, were similar for each WIfI stage.><0.001). He added that QoL scores, however, were similar for each WIfI stage.

In addition, the presenter revealed that major amputation incidence at one-year follow-up was 2% (95% CI, 0–11) for WIfI stage 1, 7% (95% CI, 4–14) for stage 2, 8% (95% CI, 4–15) for stage 3, 20% (95% CI, 13–30) for stage 4, and 16% (95% CI, 9–27) in those patients with incomplete WIfI scores. It was specified that amputation incidence for individual WIfI scores was largely consistent with stage classification.

Houghton further reported that increasing WIfI stage was independently associated with one-year major amputation (sub-distribution hazard ratio [SHR], 1.99; 95% CI, 1.33–2.97, p=0.001), and was also associated with one-year mortality (HR, 1.31; 95% CI, 1.03–1.67; p=0.029). Frailty (clinical frailty score ≥5; HR, 2.18; 95% CI, 1.26–3.76; p=0.005) and non-operative management (HR, 4.42; 95% CI, 2.63–7.41; p<0.001), the presenter stated, were found to be the strongest predictors of mortality at one year.><0.001), the presenter stated, were found to be the strongest predictors of mortality at one year.

“These results from the Leg ischemia management collaboration (LIMb) study provide further validation of the utility of the WIfI score in classifying patients with CLTI by risk of major amputation at one year,” Houghton told VS@VAM ahead of his presentation.

“These data are particularly useful as all not all patients presenting with CLTI require, or are suitable for, revascularization but most of the published data on the WIfI score come from patients undergoing intervention. The LIMb patient cohort is a representative sample of CLTI patients and nearly 25% of patients included were initially managed conservatively. The finding that both frailty and disability were associated with increased WIfI stage highlights both the vulnerability of this patient population and the potential benefits of successful revascularization, but the lack of association of WIfI score with quality of life is counter-intuitive and warrants further exploration.”

SVS diversity celebration at VAM 2023

By
Beth Bales
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SVS diversity celebration at VAM 2023
Doctors and medical staff wearing surgical masks, they are standing together, coronavirus prevention concept

The Society for Vascular Surgery celebrates all of its members at the inaugural Celebration of Diversity Reception at the Vascular Annual Meeting (VAM) 2023.

In previous years, many specific groups held smaller receptions while at VAM, including young surgeons, women and many others, including alumni groups. For this year, SVS organizers decided to instead combine many into one.

“In the past, the Women’s Networking Reception was held as an extension of the ‘Women’s Committee,’ a designation that preceded the current Women’s Section,” said Audra Duncan, MD, one of the founding members and current chair of the Women’s Section.

“The reception became so popular, that it was typically difficult to enter the packed room at the venue. So, the reception evolved into larger and larger rooms, and the invite list became broader to capture the wide audience that was interested in attending,” she said.

“It is breath-taking to see the large audience at this reception compared to the handful of us in a room 20 years ago, and to know we are gathering with so many other VAM members.”

Optimizing the clinical environment: ‘Mitigating Barriers to Inclusion and Advancement in Academic Surgery’ presented at VAM 2023

By
Beth Bales
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Optimizing the clinical environment: ‘Mitigating Barriers to Inclusion and Advancement in Academic Surgery’ presented at VAM 2023
Raghu L. Motaganahalli

America’s face is changing, becoming more diverse and with more women and immigrants in the country, medicine and the vascular surgery specialty.

Raghu L. Motaganahalli, MD, of the Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, presented both the barriers and pathways to success in “Mitigating Barriers to Inclusion and Advancement in Academic Surgery: International Medical Graduate (IMG) Perspective. His presentation was part of an educational session on “Optimizing the Clinical Environment: Learning & Practicing with Intent and Inclusion” Thursday afternoon at the Vascular Annual Meeting (VAM) 2023 last week.

“I am an immigrant vascular surgeon and believe we add value to our specialty,” he said straightforwardly, at the start of his presentation. The US includes more than 2.8 million foreign-born healthcare workers from a wide range of countries. Top countries of birth are the Philippines, Mexico, India, Jamaica and Haiti.

In 2021, US-born doctors represented 60.1% of residents and fellows in ACGME-accredited programs; DOs made up 16.9% and international medical graduates made up nearly 23%. IMGs in 2021 represented 17.5% of the vascular surgery workforce.

Some challenges in getting hired include concerns about standardized training, including school reputation and accreditation; perceived language and cultural barriers and visa requirements, he said.

Both systemic intervention and individual actions can help mitigate exclusion. IMGs who want to advance in academics should “choose the right environment, surround yourself with people who want you to succeed and supplement your environment with the necessary resources to succeed.”

SVS honors two with Lifetime Achievement Award

By
Beth Bales
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SVS honors two with Lifetime Achievement Award
Left to right: Julie Freischlag, Michael C. Dalsing, Enrico Ascher
SVS
Left to right: Julie Freischlag, Michael C. Dalsing, Enrico Ascher

The Society for Vascular Surgery (SVS) honored two surgeons—instead of the traditional one—with its highest honors, the Lifetime Achievement Award at the Vascular Annual Meeting (VAM) last week.

It’s only the third time the Society has done so in the award’s history, said Michael C. Dalsing, MD. He presented the honorees: Enrico Ascher, MD, professor of surgery at NYU Langone School of Medicine, and Julie Freischlag, MD, formerly dean of Wake Forest University School of Medicine and now chief academic officer of Advocate Health. Freischlag was SVS’ first—and still only—woman president.

Both Ascher and Freischlag are “exceptionally deserving of this prestigious distinction,” said Dalsing. SVS will profile the two recipients in the July issue Vascular Specialist.

‘Vigilant’ surveillance and low threshold for further interventions ‘crucial’ following rescue of prior EVAR with PMEG

By
Jocelyn Hudson
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0
‘Vigilant’ surveillance and low threshold for further interventions ‘crucial’ following rescue of prior EVAR with PMEG
PMEG
Senior author Marc L. Schermerhorn

The findings of a recent study on reinterventions and sac dynamics after fenestrated endovascular aneurysm repair (FEVAR) with a physician-modified endograft (PMEG) for index aneurysm repair and following prior EVAR led researchers to conclude that “vigilant” surveillance and a low threshold for further interventions are “crucial.” The finding relates to PMEG for rescue of prior EVAR with loss of proximal seal.

Nicholas J. Swerdlow, MD, a vascular surgery fellow at Beth Israel Deaconess Medical Center in Boston, shared these findings during Plenary Session 4 last week at the 2023 Vascular Annual Meeting (VAM) on behalf of senior author Marc L. Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center, and colleagues.

Swerdlow et al note in their study abstract that, while the high frequency of reinterventions after FEVAR with a PMEG has been well-studied, the impact of prior EVAR on reinterventions and sac behaviour following these procedures remains unknown. In the present study, therefore, the researchers analyzed three-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal.

The investigators analyzed 122 consecutive FEVARs with PMEGs at a tertiary care center that was submitted to the Food and Drug Administration (FDA) in support of an investigational device exemption (IDE) trial. They excluded patients with aortic dissection, type I–III thoracoabdominal aneurysms, non-elective procedures and prior aortic surgery other than EVAR, for a final cohort of 92 patients.

Patients were divided into those who underwent PMEG for index aneurysm repair (index-PMEG) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (rescue-PMEG).

Swerdlow shared with the audience that, of the 92 patients included in the analysis, 55 (60%) underwent index-PMEG and 37 (40%) underwent rescue-PMEG. He added that rescue-PMEG patients were older—78 years (interquartile range [IQR] 75–83) vs. 73 years (69–78), p<0.001. Otherwise, there were no statistically significant differences in baseline demographics and procedural characteristics p<0.001. Otherwise, there were no statistically significant differences in baseline demographics and procedural characteristics.

The presenter reported that perioperative mortality was 1.8% for index-PMEG and 2.7% for rescue-PMEG (p=0.8) and that, at three years, overall survival was 83% for index-PMEG and 72% for rescue-PMEG (p=0.08).

In addition, he noted that freedom from reintervention was significantly higher for index-PMEG than rescue-PMEG, specifically 79% vs. 45% at three years (p<0.001).

Swerdlow then shared sac dynamic findings. He revealed that, at three years following index-PMEG, aneurysm diameter was stable in 58% of patients and decreased in 42% of patients, with no cases of sac expansion.

At three years following rescue-PMEG, however, he noted that aneurysm diameter was stable in 31% of patients, decreased in 31% of patients and increased in 38% of patients (p=0.05).

The presenter stated in his conclusion that FEVAR with PMEGs for index aortic repair and rescue of prior EVAR with loss of proximal seal are “two distinctly different entities.” He summarized that, following FEVAR with a PMEG for index aneurysm repair, less than a quarter of patients had undergone reintervention at three years and sac expansion was “rare.”

At three years following PMEG rescue of prior EVAR with loss of proximal seal, however, it was observed that over half of patients had undergone reintervention and over a third had ongoing sac expansion, which led Swerdlow to underscore the importance of “vigilant” surveillance and a low threshold for further interventions in this group of patients.

Ahead of Swerdlow’s presentation, Schermerhorn shared some thoughts on the study findings with VS@VAM: “I have changed my practice now to reline the entire graft whenever I do a rescue PMEG. I believe that many of these patients have undetected type 3 endoleaks that lead to sac expansion and subsequent loss of the proximal seal.

“Extending the seal proximally fixes the 1a leak but does not address the original cause of sac expansion for the subgroup that had original expansion due to type 2 or 3 endoleak and we need to be alert to this possibility. I have now performed sacotomy on four patients for presumed type 2 endoleak with sac expansion (two of whom had prior rescue PMEG) and found fabric tears that were not detected by [computed tomography angiography], duplex, or angiography.”

Two-year DETOUR2 study results presented at VAM 2023

By
Bryan Kay
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Two-year DETOUR2 study results presented at VAM 2023
Sean Lyden

Endologix has announced the 24-month results of the DETOUR2 study, presented at VAM 2023, the annual meeting of the Society for Vascular Surgery (SVS), by one of the study’s principal investigators, Sean Lyden, MD,  chairman of vascular surgery at the Cleveland Clinic in Cleveland, Ohio.

Percutaneous transmural arterial bypass (PTAB) with the Detour system, recently received premarket approval Approval from the Food and Drug Administration (FDA). The system enables physicians to percutaneously bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein to restore blood flow to the leg. The Detour system is comprised of the Endocross device and Torus stent grafts.

The DETOUR2 study enrolled 202 patients in the U.S. and Europe. The 24-month results from the study indicated that 96% of enrolled patients had chronic total occlusions, with a mean lesion length of 32.7cm. Technical success was achieved in 100% of treated patients and the primary safety endpoint was surpassed with a 30-day major adverse event (MAE) rate of 7%

The freedom from clinically driven target lesion revascularization (CD-TLR) at 24 months was 76.7%, and secondary patency was 82.3%. The freedom from symptomatic deep vein thrombosis (DVT) was 96.5%, and freedom from major lower limb amputation was 98.5% at 24 months.

“The two-year results from the DETOUR2 Study are encouraging and demonstrate PTAB using the Detour system offers good patency rates in long superficial femoral artery (SFA) lesions. As noted in the conclusion of the presentation, the two-year data mimics those of surgical bypass without the need for general anesthesia, long length of stay, and high risk of complications. We look forward to continuing to study the Detour system,” said Lyden.

SVS announces new vice president and treasurer following 2023 election

By
Bryan Kay
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SVS announces new vice president and treasurer following 2023 election
Keith Calligaro and Thomas Forbes

The Society for Vascular Surgery (SVS) has announced the latest additions to its officer roll following the 2023 elections for Society vice president and treasurer. 

Keith Calligaro, MD, of Pennsylvania Hospital and a professor of clinical surgery at the University of Pennsylvania School of Medicine in Philadelphia, was elected vice president for 2023–24, meaning he enters the presidential line of succession to become president in 2025–26.

Thomas Forbes, MD, surgeon-in-chief and James Wallace McCutcheon Chair of the Sprott Department of Surgery at the University Health Network in Toronto, assumes the role of SVS treasurer after winning the electoral contest.

The results were announced during the SVS Annual Business Meeting held at the conclusion of the 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland.

Incoming SVS President Joseph Mills, MD, told members in a Society mailer the election saw a record number cast ballots.

“The election opened in Mid-May, and we left no stone unturned to stress the importance of voting to all voting-eligible members, which resulted in a record turnout with 939 votes (30% of eligible voters),” he wrote. “In the 2022 election, just over 600 voting eligible members voted, resulting in a 50% increase in one year. Thank you to all members who chose to cast their vote.

Mills also thanked the other candidates who ran for the two positions for their candidacies: Kellie Brown, MD, professor of surgery in the Division of Vascular and Endovascular Surgery at the Medical College of Wisconsin in Milwaukee, who ran for vice president; and Palma Shaw, MD, professor of surgery at State University of New York in Syracuse.

“Each of them is a strong leader within the society and their institutions, and I look forward to continuing to work with them within SVS,” Mills commented. “There’s no doubt we will continue to see great things from them.”

Nephrologist insights for vascular surgeons at hemodialysis access session

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Nephrologist insights for vascular surgeons at hemodialysis access session
Female nurse assisting patient undergoing renal dialysis in hospital room

Friday afternoon in Potomac D will see VAM play host to a series of presentations on access for hemodialysis that will offer education on arteriovenous fistulas (AVFs), grafts (AVGs) and maturation—as well as strategies for managing their failure.

The session will be moderated by Maureen Sheehan, MD, of Wake Forest University Medical Center, North Carolina, and Thomas Huber, MD, from the University of Florida in Gainesville, and is titled “Creation and Complications: Current Strategies in Hemodialysis Access.” Split into two sections, the 90-minute program will focus first on access creation, with Vandana Dua Niyyar, MD, President of the American Society of Diagnostic and Interventional Nephrology (ASDIN), offering up an interventional nephrologist’s angle on the creation of dialysis access.

Speaking to VS@VAM, Huber—among those behind the program—said: “The hope was that we could get someone from the outside that could share their perspective. We’ve tasked [Niyyar] with telling us what vascular surgeons need to know from a nephrologist’s perspective.”

Next up will come Theodore Yuo, MD, of the University of Pittsburgh Medical Center, who will explore endovascular AVF (endoAVF), before Libby Weaver from the University of Virginia Health System will talk AVG materials and Yana Etkin, MD, Zucker School of Medicine at Hofstra/Northwell, Long Island, New York, will explore access maturation strategies.

Following a 15-minute panel discussion, the second half of the session will get underway with a talk on the management of failing AVGs and AVFs from Jeffrey J. Siracuse, MD, from the Boston School of Medicine in Boston. Management is the name of the game in this whole second sequence of talks—with management of everything from high-flow AV access the focus of Samuel S. Ahn of TCU & UNTHSC School of Medicine, Fort Worth, to the management of access emergencies rounding out the session in a talk from Huber himself.

Detailing his talk, Huber told VS@VAM that he will turn the spotlight on “aneurysms and pseudoaneurysms that are not recognised and treated definitively.”

‘Excellent’ limb salvage rates for trauma bypass performed by vascular surgeons

By
Will Date
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‘Excellent’ limb salvage rates for trauma bypass performed by vascular surgeons
Clement Darling, MD

Revascularization for extremity trauma can be performed with excellent limb salvage rates, though poor compliance with long-term surveillance raises some cause for concern.

These are among the primary messages presented from a study detailing the experience and outcomes of a rural, level one, trauma center performing upper- or lower-extremity revascularization in trauma patients over a 20-year timespan, in which investigators sought to identify bypass failure modes and surveillance protocols.

Vascular surgery resident Misak Harutyunyan, MD, presented the analysis during this morning’s Plenary Session 7 (8:00–9:30 a.m.) in Potomac A/B, on behalf of the Albany Medical College vascular team, including senior author Jeffrey Hnath, MD, and submitting author R. Clement Darling, MD. The Albany team posits that long-term outcomes in civilian trauma patients requiring upper- or lower-extremity revascularization has been poorly studied, secondary to limitations of certain large databases and the nature of the patients in this specific vascular subset.

Their dataset offers up insights from 223 revascularizations performed between January 2002 and June 2022. Of these patients 161 (72%) had lower and 62 (28%) upper extremities. The Albany team reports an operative mortality rate of 4.5% (n=10), all involving lower-extremity revascularization. Thirty-day non-fatal complications included immediate bypass occlusion in 11 patients (4.9%), wound infection in 7 (3.1%), graft infection in 6 (2.7%), and lymphocele/seroma in 5 patients (2.2%). All major amputations (13, 5.8%) were early and in the lower extremity bypass group, the study’s authors report. Late revisions in the lower- and upper-extremity groups were 14 (8.7%) and 2 (3.2%) respectively.

Although the study’s authors are set to report that revascularization for extremity trauma can be performed with excellent limb salvage rates, demonstrating long-term durability with low limb loss and bypass revision rates, they also sound a note of caution over poor compliance with long-term surveillance. “The poor compliance with long-term surveillance is concerning and may require adjustment in patient retention protocols,” they will state, adding, however, that “emergent returns for bypass failure are extremely low in our experience.”

Improved fistulas and cost-effectiveness promised in plenary 5 abstract presentation

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Improved fistulas and cost-effectiveness promised in plenary 5 abstract presentation
Ellen Dillavou
Ellen Dillavou, MD

Friday morning’s Plenary Session 5 (8:00–9:30 a.m.) is set to feature new data on an external support device that may deliver more functional arteriovenous fistulas (AVFs) while also offering an improvement in cost-effectiveness. Presenting an abstract on research into the VasQ device will be Ellen D. Dillavou, MD, of WakeMed Hospital in Raleigh, North Carolina.

The study explored the support device’s ability to improve functional success in AVF over a 24-month period. Dillavou is set to deliver “the first complete report of the U.S. pivotal comparative study results”, alongside a cost-effectiveness analysis. Over the study, she will detail, 144 patients were enrolled—90% of them receiving a brachiocephalic and 10% a radiocephalic fistula. Some 782 patients treated by the same surgeons without the VasQ device immediately before enrollment in the trial were identified as a comparative group, with their Medicare claims data utilized for comparison. Statistical comparison was then performed between the groups with regards to primary patency—defined as freedom from intervention—as well as functional success (continuous use for dialysis after 30 days) and post-creation reintervention. Payor cost was taken into consideration alongside each of these outcomes.

“Primary failure of 7.9% for VasQ AVF patients compared favorably to the 22% to 32.2% reported in contemporary U.S. meta-analyses,” the study authors report, while the cumulative patency for the VasQ device of 76.7% (95% confidence interval [CI]: 67.7–83.4%) was found to be “superior to contemporary meta-analyses,” which the authors say report between 53.7% to 63% for standard AVFs. There was a “nearly 50% reduction in access interventions” with the device at six months, which the authors argue led to the annualized cost reduction they found of US$7,764.19 per patient year.

Last hours to bid on Gala Auction items

By
Beth Bales
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Last hours to bid on Gala Auction items

A night of grandeur, reminiscent of the parties hosted by the fictional character Jay Gatsby, awaits attendees on tonight (Friday) at the “Great Gatsby Gala,” benefiting the SVS Foundation.

Gala tickets are sold out, but bidding will continue for everyone regardless of VAM or Gala attendance. More than 50 items are available, including weekend excursion packages. The Gala Silent Auction will close at 8 p.m., allowing individuals from around the globe to participate.

Presidential handover at VAM 2023

By
Beth Bales
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Presidential handover at VAM 2023

The annual business meeting (for members only).

The results of the just completed SVS election of officers (vice president and treasurer) will be announced at the meeting, which will also feature reports from officers and others, presentation of awards and the passing of the gavel—and the SVS presidency—from Michael C. Dalsing, MD, to Joseph Mills, MD. The meeting, from 12–1:45 p.m. Saturday, closes out VAM 2023.

Future research needed to ‘optimize’ use of imaging technologies during aortic procedures

By
Jocelyn Hudson
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Future research needed to ‘optimize’ use of imaging technologies during aortic procedures
Carlos H. Timaran, MD and Francis Caputo, MD
Carlos H. Timaran, MD and Francis Caputo, MD

Imaging technologies in the aortic space will be a key feature of Saturday’s Plenary Session 8 (11:15 a.m. to 12:30 p.m.) in Potomac A/B, with speakers set to share data on Philips’ Fiber Optic RealShape (FORS) technology and Centerline Biomedical’s IntraOperative Positioning System (IOPS).

Valeria Mejia-Martinez, BS, a medical student at the University of Texas Southwestern Medical Center in Dallas, is due to deliver a presentation on target vessel catheterization with FORS using upper extremity versus transfemoral access for fenestrated/branched endovascular aneurysm repair (F/BEVAR).

Mejia-Martinez et al note in their study abstract that traditionally, and due to length constraints, FORS has been used primarily for transfemoral (TF) access, with the purpose of the present study being to report the feasibility and benefits of using FORS during F/BEVAR—including cannulation times of target vessels and radiation measures—comparing upper extremity (UE) versus TF access.

In order to achieve their study objective, the research team conducted a single-center retrospective study with prospectively collected data. They included data from 74 patients who underwent F/BEVAR with FORS guidance for target vessel catheterization during an 11-month period. Among 370 navigation tasks reported, the researchers note that 350 (94.6%) were performed with FORS.

The presenter is due to share at VAM the result that technical success was 90.3% and that mean time required to deem the catheterization as a failure was 8.4±5 minutes. She will also communicate that UE access, steerable sheath, and FORS catheters were used in 54.3%, 17.7% and 13.7% of cases, respectively.

Mejia-Martinez will conclude that F/BEVAR with FORS technology is feasible using both UE and TF access and facilitates artery catheterization with acceptable technical success and potentially reduced radiation. However, she will stress that further experience is required to “optimize the use of FORS during F/BEVAR”.

Speaking to VS@VAM ahead of the presentation, senior author Carlos H. Timaran, MD, MS, professor in the division of vascular and endovascular surgery at the University of Texas Southwestern Medical Center, shares his opinion on what is next for FORS: “Cost, potential use with all imaging platforms and expanded availability of guidewires and catheters are the key steps forward in the development and widespread application of this technology.”

Later in the session, Nicholas G. Hoell, MD, integrated vascular resident at the Cleveland Clinic in Cleveland, will speak on the use of electromagnetic IOPS as a 3D imaging adjunct in EVAR based on the results of a safety and feasibility study.

On behalf of senior author Francis J. Caputo, MD, associate professor and program director at the Cleveland Clinic, Hoell will share the results of a study that aimed to demonstrate the safety and efficacy of the electromagnetic-based IOPS in providing guidance for accurate wire and catheter navigation as an adjunct to fluoroscopy during thoracic endovascular aortic repair (TEVAR), FEVAR and EVAR.

Hoell will detail that 30 patients with aortic aneurysms suitable for TEVAR, FEVAR and EVAR were enrolled across two sites in the U.S. from 2020 to 2022.

He is set to reveal that technical success was achieved in 100% of patients with IOPS providing adjunctive 3D guidance for wire and catheter manipulation during aortic navigation and branch vessel cannulation, with zero serious and non-serious adverse events attributable to the IOPS system at seven-day follow-up.

Hoell will conclude at VAM that the electromagnetic-based IOPS is safe and effective in providing adjunctive 3D guidance for wire and catheter manipulation in infrarenal and fenestrated endovascular abdominal aortic aneurysm repair. She will, however, underline the fact that future research is needed to investigate the potential for IOPS to reduce radiation exposure to patient and operator, reduce contrast usage, and reduce operative time while providing better visualization of complex anatomy.

Caputo told VS@VAM ahead of the presentation: “It is imperative that we find alternative imaging modalities to fluoroscopy. This study is a first step in showing the IOPS is safe and effective as an adjunct to traditional fluoroscopy. Future studies must demonstrate the ability to perform endovascular procedures alone with IOPS as well as the ability to have the tools to navigate tough anatomy.”

Study shows performance on the vascular qualifying examination does not predict performance on the certifying examination

By
Éva Malpass
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Study shows performance on the vascular qualifying examination does not predict performance on the certifying examination
Libby Weaver, MD
Libby Weaver, MD

A national cohort study of vascular trainees taking the Vascular Qualifying Examination (VQE) and the Vascular Certifying Examination (VCE) found performance during the former is “not predictive” of first-time pass achievement in the latter—but, the findings highlight the “[necessary]” identification of trainee competency measures that may predict certification examination failure.

Speaking to VS@VAM ahead of her presentation on Saturday, Libby Weaver, MD, from University of Virginia Health System in Charlottesville explained that their results may have stemmed from the two examinations testing distinct competencies.

Given board certification is associated with better quality of care, and that training programs must demonstrate high rates of first-attempt pass by their graduate candidates to maintain accreditation, Weaver noted this result indicates we must “find a marker to better identify candidates at risk [of failure]”.

In a follow-up study looking at Accreditation Council for Graduate Medical Education (ACGME) Milestone ratings—a means of formative assessment of trainees—Weaver et al convey how these are seen to be a “highly predictive” indication of ability to pass board certification examinations. Specifically, medical knowledge and patient care competencies strongly predict performance on VQE, whereas interpersonal communication skills emerge as strongly predictive of VCE performance. This suggests we are “certifying well-rounded vascular surgeons and maintaining a high-quality standard within our specialty”, Weaver noted.

To this end, Weaver intends on furthering this research against a backdrop of the emerging evidence which has found a correlation between board certification and quality of care.

The current study’s senior author Brigette Smith, MD, University of Utah Health, Salt Lake City, is presently researching how Milestone ratings ultimately predict quality of care, ensuring outcomes in practice are reflective of assessment of trainees. “If we are able to make that connection it would be a huge advancement in surgical education,” Weaver commented.

Novel drug candidate for slowing AAA growth demonstrates safety in humans

By
Jamie Bell
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Novel drug candidate for slowing AAA growth demonstrates safety in humans
Stephen Cheng, MD

The local delivery of a glucose-derived compound in small- and medium-sized abdominal aortic aneurysms (AAAs) has been deemed safe, with “promising” early efficacy data indicating its potential in stabilising or slowing AAA sac growth. According to Stephen Cheng, MBBS, MS, chair of the Department of Surgery at the University of Hong Kong, these first-in-human study findings—which he will present today at VAM 2023 during Plenary session 6 (10–11 a.m.) in Potomac A/B—merit further evaluations within randomized controlled trials.

“The main message is that this is a group of patients where, currently, there are no effective treatments to slow the growth of [abdominal aortic] aneurysms,” Cheng tells VS@VAM. “And, therefore, the idea of using a drug that is delivered only once inside the aneurysm sac sounds attractive— especially if it leaves nothing behind and all the future treatment options are left open.”

The multicenter study in question saw patients with an AAA (diameter <5.5cm) recruited to receive a one-time, local administration of 25ml of 1,2,3,4,6-pentagalloyl glucose (PGG) solution via transfemoral access. The study’s primary endpoints were technical success and safety—determined by the occurrence of major adverse events at 30 days. Cheng et al have reported a 100% rate of technical success, and found that the only safety-related concern was that four of the 21 enrolled patients showed a transient elevation of liver enzyme levels. However, these levels returned to normal within 30 days and triggered no clinical symptoms.

“When we talked to the pharma scientists, who are really looking at the molecular aspects of why these drugs work, the answer was that PGG is largely metabolized in the liver,” Cheng adds. “This is a way that the liver responds to any [raised level] of glucose in the metabolism pathway. That is the explanation that has been given to us, but we have seen no adverse effects in the patients. It will certainly be an area we will be closely monitoring as to how patients behave afterwards but, so far, they are all fine and the one patient who did have a very high enzyme level returned to normal in about a month’s time.” With this being a first-in-human study, Cheng is quick to point out that any conclusions drawn from the results regarding efficacy of the PGG solution in slowing AAA growth are preliminary.

Nevertheless, as per their secondary endpoint of freedom from aneurysm sac enlargement, the researchers report average AAA diameter changes from baseline of 0.2mm, 1.1mm, 2mm and 0.8mm at six, 12, 24 and 36 months, respectively. Follow-up computed tomography angiography (CTA) data further indicated average volume changes of 2.5%, 9.6%, 24.3%, and 11.6%, respectively—and, at 12 months, none of the aneurysms had grown by more than 5mm in diameter, while only three had a volume growth >10%.

Prior studies have indicated that the average rate of AAA sac growth is around 3–3.5mm per year, according to Cheng. He states that this figure was used as a target in the present study, adding that the treatment threshold in Caucasians is an aneurysm diameter of 5.5cm and, “if we can slow the growth by 50% [to about 1.7mm], then we can push back the threshold for intervention from five years to 10 years, and that would bring expected benefits”.

“But, I must reiterate that this is a first-in human study of a relatively small number of patients,” he adds. “The main focus was on patient safety rather than long-term aneurysm sac [growth].”

BEST-CLI investigators implore a move beyond endo vs. open ‘battle’ in the name of scientific advance

By
Bryan Kay
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BEST-CLI investigators implore a move beyond endo vs. open ‘battle’ in the name of scientific advance
Alik Faber, MD and Matthew Menard, MD

The principal investigators behind the BEST-CLI trial struck a conciliatory tone during the inaugural Frank J. Veith Distinguished Lecture yesterday morning in which they laid bare the blood, sweat and tears shed on their journey to complete the landmark study.

The headline findings that emerged out of the trial—that both open and endovascular procedures were equally safe, and that chronic limb-threatening ischemia (CLTI) patients deemed suitable for either approach who had an adequate great saphenous vein experienced better overall clinical outcomes after open bypass surgery—sparked rancor in the interventional and surgical communities.

Yet, Alik Farber, MD, and Matthew Menard, MD, used the maiden Veith Lecture to shine a light down a path toward further advances in end-stage peripheral arterial disease (PAD) care. The pair used the platform to tell the story of their journey in order that others might take the leap of faith they did to tackle “impactful questions in science,” Farber told VAM 2023 attendees.

They first got together to develop the idea for a trial to compare open vs. endo treatment for CLTI in 2007. “It really was the blind leading the just as blind,” quipped Menard. As Farber described, personally he had very little experience in clinical trials at the time. “There was a lot of insecurity,” he said. “Were we really the right people to do this?” he recalled thinking back then.

Upon receiving positive feedback from within the vascular surgery ranks, Farber related, they began the National Institutes of Health (NIH) application portion of their journey.

At first blush, as they prepared to go down the NIH route, they thought vascular surgeons should do the trial owing to the fact they carry out both procedural modalities.

Despite their arguments, the application failed. Yet, they persevered. They responded to the criticisms. Other specialties were included. More funding was secured. Some of that rancor seen in the aftermath of the release of their findings late last year emerged back then over trial design too. But eventually, the specialties united, and they got NIH grant approval.

They had many difficulties along the way. “This trial was extremely difficult to enroll,” said Farber. “There were multiple curveballs.” The Katsanos meta-analysis. COVID-19. Running out of money.

They got there, presenting at the American Heart Association and publishing the results in the New England Journal of Medicine. “We hope our story encourages others to pursue their research ambitions, even in the face of obstacles, self-doubt and judgment of others,” said Farber.

Menard paid tribute to the man for whom the new VAM lecture is named: Frank Veith, MD. “It is impossible to [over]estimate how much of a maverick Frank has been, and the enormity of what he has contributed to the field,” he said. Menard sees a kindred spirit in Veith in the sense of how the limb-salvage pioneer looks at the foot. Menard, too, likes to try the less conventional. “But one thing I haven’t done, and Frank did it a long time ago: he did a prosthetic bypass to the foot,” said Menard. “It worked. Here’s another thing that Frank did: 13 prior failed procedures—he did a bypass from the common iliac artery to the peroneal artery. And it worked.”

Veith was also an endovascular believer before most had cottoned on to its potential, he said. Menard’s point was centered on progress in CLTI made over the decades. That extends to turf battles—endo vs. open. “Hopefully, never more,” he said. “Turf battles in the vascular community have been, and still are distracting, destructive, highly counter-productive and of very little service to our patients. I charge the audience to sincerely bring to their part to fight an entirely new battle: that is to move beyond this 25-year-old paradigm of endo vs. open.”

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