Vascular Specialist–May 2024

Page 1

2 Guest Editorial Aortas, open surgical skills and gratitude

8 Vascular training

APDVS says goodbye to two longtime leaders during annual spring meeting

15 VAM 2024

‘I’m a big fan of firsts’: National DEI speaker set for new meeting staple

17 Leadership SVS figures host international session to tackle cross-specialty dialogue

www.vascularspecialistonline.com

Questions linger: BASIL-3 does not find for drug-eluting technologies in CLTI

In the UK National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA)-funded BASIL-3 randomized 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 hypothesized 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) willingness-topay threshold. DES, on the other hand, is potentially cost-effective at this threshold.

Andrew Bradbury, MD, professor of vascular surgery at the University of Birmingham in Solihull, England, and the BASIL-3 team of triallists shared this and other key findings during the 2024 Charing Cross (CX) International Symposium in London (April 23–25), addressing the question of which endovascular strategy is best in the femoropopliteal segment.

The investigators presented—for the first time—results of this 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 said.

University of Birmingham statistician Catherine Moakes, MS, reported clinical results of BASIL-3. Between Jan. 29, 2016, and Aug. 26, 2021, the trial enrolled 481 patients, with 160 randomized to plain balloon angioplasty with or without bare metal stent, 161 to DCB with or without bare metal stent, and 160 to DES.

See page 5

‘WE NEED TO CONTINUE TO BE DELIBERATE’: DEDICATED SOCIETY FOR WOMEN VASCULAR SURGEONS FORMED

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

See page 5

SVS UNVEILS TWO WOMEN VASCULAR SURGEON 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.

“This is an exciting year,” said SVS Nominating Committee Chair Ronald L. Dalman, MD,

See page 8

THE OFFICIAL NEWSPAPER OF THE ascularV pecialists CHANGE SERVICE REQUESTED 9400 W. Higgins Road, Suite 315 Rosemont, IL 60018 MAY 2024 Volume 20 Number 5 PRESORTED STANDARD MAIL U.S. POSTAGE PAID IM
this issue:
In
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Medical Editor Malachi Sheahan III, MD

Associate Medical Editors

Bernadette Aulivola, MD | O. William Brown, MD | Elliot L. Chaikof, MD, PhD

| Carlo Dall’Olmo, MD | Alan M. Dietzek MD, RPVI, FACS | John F. Eidt, MD | Robert Fitridge, MD | Dennis R. Gable, MD | Linda Harris, MD | Krishna Jain, MD | Larry Kraiss, MD | Joann Lohr, MD

| James McKinsey, MD | Joseph Mills, MD | Erica L. Mitchell, MD, MEd, FACS

| Leila Mureebe, MD | Frank Pomposelli, MD | David Rigberg, MD | Clifford Sales, MD | Bhagwan Satiani, MD | Larry Scher, MD | Marc Schermerhorn, MD | Murray L. Shames, MD | Niten Singh, MD | Frank J. Veith, MD | Robert Eugene Zierler, MD

Resident/Fellow Editor

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Executive Director SVS

Kenneth M. Slaw, PhD

Executive Director SVS Foundation

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Vascular Specialist is the official newspaper of the Society for Vascular Surgery and provides the vascular specialist with timely and relevant news and commentary about clinical developments and about the impact of healthcare policy. Content for Vascular Specialist is provided by BIBA News. Content for the news from SVS is provided by the Society for Vascular Surgery. The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or the Publisher. The Society for Vascular Surgery and BIBA News will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services, or the quality or endorsement of advertised products or services, mentioned herein. | The Society for Vascular Surgery headquarters is located at 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018. | POSTMASTER: Send changes of address (with old mailing label) to Vascular Specialist, Subscription Services, 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018. |

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GUEST EDITORIAL

UK-COMPASS: Aortas, open surgical skills and gratitude

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 <10 mm, and/or complex necks unsuitable for onlabel 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-

Erica Leith Mitchell

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 highoperative-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.

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

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-operativerisk ≥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 continued on page 5

2 Vascular Specialist | May 2024

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IMPORTANT SAFETY INFORMATION

JETi™ Hydrodynamic Thrombectomy System

INDICATIONS FOR USE

The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to sub selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

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Table 1. Catheter Fluid Delivery Flow Rate

Fluid Maximum Recommended Fluid Delivery Flow Rate

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Page 2 of 2

GUEST EDITORIAL

Aortas, open surgical skills and gratitude

continued from page 2

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 is professor and chief of vascular and endovascular surgery at the University of Tennessee Health Science Center in Memphis, Tennessee.

FROM THE COVER QUESTIONS LINGER: BASIL-3 DOES NOT FIND FOR DRUG-ELUTING TECHNOLOGIES IN CLTI

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, PhD, a professor of health economics at University of Birmingham, 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 qualityadjusted 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-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 summarized 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 revascularization 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

continued from page 1

these findings were generally consistent over different scenarios and analyses and across different patient subgroups.

Finally, Bradbury 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 randomized 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, an interventional cardiologist in Philadelphia, 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, MD, chief of vascular surgery at the University of California, San Francisco, added that there have now been three BASIL trials, but not one has shown a difference in limb outcomes. “While I recognize 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, MD an interventional radiologist in Auckland, New Zealand, 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.

FROM THE COVER ‘WE NEED TO CONTINUE TO BE DELIBERATE’: DEDICATED SOCIETY FOR WOMEN VASCULAR SURGEONS FORMED

continued from page 1

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.—Jocelyn Hudson

5 www.vascularspecialistonline.com
Michael Conte

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. By Bryan Kay

“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

VARICOSE VEINS

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, partner-

ships 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.

New randomized 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 randomized 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 stripping arms were similarly satisfied postprocedurally, the principal investigators told the 2024 Charing Cross (CX) International Symposium in London, England (April 23–25), in the first-time release of results from the Spectrum Program trials.

Similarly, principal investigators Kathleen Gibson, MD, from Bellevue, Washington, and Manj Gohel, MD from Cambridge, England, reported that in the RCT comparing the VenaSeal system to endothermal ablation, similar patient satisfaction was demonstrated between the two procedures.

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.

Results from the secondary endpoint measure of modified Aberdeen Varicose Vein Questionnaire (AVVQ) at 30 days showed trends in favor 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 (93.1% vs. 93.6%).

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 CEAP (Clinical, Etiological, Anatomical and Pathophysiological) classification 2–5.

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 patientspecific primary endpoints, “it is notable that there were trends towards advantages with VenaSeal, and it performed comparably with our standards of care,” Gibson added.

The Spectrum Program 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 look at time to ulcer healing through 12 months.

“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

“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.” Bryan Kay

“The VenaSeal patients—and all of the patients in general— had good quality-of-life improvements at 30 days”
KATHLEEN GIBSON
6 Vascular Specialist | May 2024
APPROPRIATE CARE
Kathleen Gibson

The Thompson Retractor OneFrame System:

A ‘complete partner’ for aortic aneurysm procedures

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?

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?

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.

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?

How does the Thompson Retractor OneFrame System compare to other forms of retraction in the market?

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?

I started using a very basic exposure, but I saw the capacity for this retractor to

APPROACHES TO AORTIC ANEURYSM SURGERY: BASIC TO MORE COMPLEX

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

7 www.vascularspecialistonline.com
ADVERTORIAL | SPONSORED BY THOMPSON RETRACTOR
Xavier Berard Midline laparotomy transperitoneal approach with suprarenal control Infrarenal AAA, edge of the 11th rib left retroperitoneal minimally invasive approach Thoracoabdominal approach for a type IV TAAA

FROM

THE COVER SVS

UNVEILS TWO WOMEN VASCULAR SURGEON CANDIDATES FOR 2024–25 VICE PRESIDENT

continued from page 1 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 the SVS Industry Relations Advisory Committee.

The selection of Harris and Shaw marks a milestone election for the SVS as whoever is elected will become the second woman to serve as SVS president, the first being Julie Freischlag, MD, in 2014.

The SVS held a virtual Town Hall on May 1 to allow SVS members a chance to ask the candidates questions about their vision for the future of the SVS. All members were invited and encouraged to attend to help inform their voting decisions.

Numerous other opportunities to share information about the candidates are also available.

Online voting will open for Early Active, Active and Senior SVS members in good standing on Monday, June 3, and will last through 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 two candidates, visit vascular.org/2024Candidates.— Kristin Spencer

“They 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”
RONALD L. DALMAN

APDVS APDVS says goodbye to two long-term leaders during spring meeting

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

GOVERNANCE SVS APPROVES FY 2024–2025 BUDGET, SETS PRIORITIES

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

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 fouryear term as APDVS secretarytreasurer as the honor of a lifetime.

During the four years of Lee’s leadership, two as presidentelect 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

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 SelfAssessment 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.

“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”
KENNETH M. SLAW
8 Vascular Specialist | May 2024
Dawn Coleman, Jason Lee and Malachi Sheahan III Linda Harris Palma Shaw

Lightning Bolt 7 ‘stands alone’ in aspiration thrombectomy for acute limb ischemia

“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.”

“I think there’s going to be more and more endovascularfirst, and the era of just pure open ALI treatment is probably going to be gone in the next couple of years”
MARTYN KNOWLES

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 “mak-

acts 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,

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.”

Martyn Knowles

“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.”

From 2015 onwards, Knowles employed thrombectomy more and more often, initially utilizing it in “easier” cases but—following device improvements, including

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

ing 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 inter-

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.”

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.

9 www.vascularspecialistonline.com
ADVERTORIAL | SPONSORED BY PENUMBRA, INC.
Martyn Knowles is a consultant for Penumbra, Inc.

COMMENT& ANALYSIS

MENTORING CORNER STITCH

Rethinking failure as a vascular trainee

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

AMA

The Physician Practice Information (PPI) Survey, a new national study, is underway. The PPI survey is collecting representative data on practice expense and hours spent in direct patient care. This data will be collected at the specialty level and shared with the Center for Medicare & Medicaid Services (CMS) to update the Medicare Economic Index (MEI) and the Resource-Based Relative Value Scale (RBRVS). The study, led by the American

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”

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.

CHRISTOPHER AUDU, MD, is the Vascular Specialist resident/fellow editor.

WHAT DO WE DO WHEN MENTORS BECOME HARDER TO FIND? STEP IN THE SVS MENTOR MATCH

PROGRAM

EARLY-CAREER VASCULAR SURGEONS and vascular trainees often cite mentorship as one of the most important factors in choosing a career and making it successful. I know that each of my mentors from medical school into practice has made a lasting and measurable impact on my clinical approach, technical skill and the ability to navigate career hurdles. But what do we do when mentors become so much harder to find?

Edward Gifford

Whether we are looking to develop a skill that doesn’t exist in our practice, or we need an outside perspective on a new career opportunity, the chances are that many of our colleagues and peers have been down these sorts of roads before, and likely have even mentored others among us on similar issues.

Medical Association (AMA) and supported by 173 healthcare organizations, including the Society for Vascular Surgery (SVS), aims to better understand the costs faced by today’s physician practices. The study data will be used to support physician payment advocacy efforts with members of Congress and CMS.

The Medicare Physician Fee Schedule, maintained by CMS and used by many other payors, relies on 2006 cost information to develop practice expense relative values, the MEI and resulting physician payments.

As the U.S. economy and healthcare system have undergone substantial changes since that time, including inflation, the widespread adoption of electronic health records and other information technology systems, practice expense payments no longer accurately reflect the relative resources that are typically required to provide physician services.

The AMA contracted with Mathematica, an independent research company, to conduct the PPI Survey. Physician practices will be selected randomly to collect their confidential responses, and individual data will be kept private. The study will

rely on financial experts in practices to complete an online financial information survey. The number of direct patient care hours is a critical component of the Medicare payment methodology. Therefore, individual physicians will receive a short patient care hours survey either directly from their practice or Mathematica. The input from physician practices and individual physicians that are randomly selected to participate in this study is critical. Each participating practice will receive an individualized report.

Your practice may receive an email from ppisurvey@mathematica-mpr.com and a USPS mail packet from Mathematica that contains a link to the survey as well as supporting information. Speak with your practice management colleagues to determine if they have received these communications and ask them to complete this important survey.

For more information about the survey, visit vascular.org/PPIsurvey.

DAVID HAN is the SVS Coding Committee chair.

The SVS Connect platform now gives all Society for Vascular Surgery (SVS) members the ability to search for and reach out to fellow vascular surgeons for virtual mentoring and advice.

From former SVS presidents to department chairs, mentors have signed up to help early-career surgeons, residents, fellows and seasoned career professionals with guidance and support.

Whether a member is looking to start a successful career in private practice or to get more involved in clinical research, the SVS Mentor Match program likely has someone who’s willing to lend a hand—or at least give some advice. Interested mentees and mentors can head to vascular.org/MentorMatch to learn more about the initiative.

Past mentees headed to the Vascular Annual Meeting (VAM) in June who remember the impact a mentor had are encouraged to sign up to be an in-person mentor to a medical student or vascular surgery resident.

Imparting knowledge is a great way to pay it forward and keep the mentorship going. Visit vascular.org/VAM24mentor to sign up.

EDWARD GIFFORD is a vascular surgeon at Hartford HealthCare in Hartford, Connecticut.

10 Vascular Specialist | May 2024
SURVEY AIMS TO HELP HEALTHCARE ORGANIZATIONS ADVOCATE FOR MEDICARE PHYSICIAN PAYMENT SYSTEM UPDATES CONGRESS

Why we keep asking you for money GOVERNMENT GRAND ROUNDS

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

POLL

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.

The role of deep venous arterialization comes under scrutiny

“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 multicentrer PROMISE UK trial. He reported that TADV using the LimFlow system in no-option CLTI patients resulted in a 67% amputa-

tion-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.

“The key question is what gets our patients into daily life with full ambulation sooner”
THOMAS ZELLER

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.’”

Jocelyn Hudson

11 www.vascularspecialistonline.com
ANAHITA DUA is a member of the SVS PAC Steering Committee. Anahita Dua
38TH ANNUAL MEETING FOR SPONSORSHIP OR MEETING INFORMATION PLEASE CONTACT PEYTEN BOUTWELL AT: PEYTEN@WELLASSEMBLED.COM | 503-804-1820 EVENTS.EASTERNVASCULAR.ORG THE CHARLESTON PLACE 205 MEETING ST. CHARLESTON, SC 29401

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 was 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 treatment 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.

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.

The fourth abstract, presented by Sermsathana sawadi, 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

“Historically, foams have been considered statistical collections of bubbles. This paradigm leads to the perception that you can interact with one bubble without changing the rest of the arrangement”
CABRERA GARCIA-OLMEDO

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

“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 last 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 (Sun Scientific), that looks to solve venous leg ulcer issues.

The AeroCare device is measurable 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 with 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, 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 venous leg ulcers.

Articles from May 2024—all of them from flagship title JVS —are:

• “Prospective evaluation of upper extremity access and total transfemoral approach during fenestrated and branched endovascular repair”: vascular. org/JVS-eval-May2024OA

• “A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoralpopliteal artery” (Editor’s

Choice): vascular.org/JVS-registryMay2024OA

• “Reported pain at work is a risk factor for vascular surgery trainee burnout”

(Audible Bleeding): vascular.org/JVS-painMay2024OA

• “Percutaneous thrombectomy for acute limb ischemia is associated with equivalent limb and mortality outcomes compared to open thrombectomy”: vascular.org/JVS-ALI-May2024OA

13

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

“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”
EDITH TZENG

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

Tackling inequities in venous care

DURING THE 2024 AMERICAN VENOUS FORUM (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.”—Brian McHugh

14 Vascular Specialist | May 2024
PAD
DISPARITIES

VAM 2024

‘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).

I t 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

VASCULAR NURSING

SVN CELEBRATES NATIONAL NURSES WEEK

THE SOCIETY FOR VASCULAR Nursing (SVN) highlighted the key role played by dedicated vascular nurses in the delivery of high-quality vascular care ahead of National Nurses Week (May 6–12).

“National Nurses Week is a time to acknowledge the remarkable efforts of our vascular nursing community,” said Kristen Alix, RN, the 2023–2024 SVN president. “Vascular nurses play a crucial role in improving patient outcomes and enhancing the quality of vascular care delivery.”

The SVN celebrates the work of vascular nurses year-round, staging everything from educational seminars to

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.”

tory 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.

“There has to be acknowledgement of the patient as an individual, just as there needs to be confidence in the physician”

Foster says primary diversity, equity and inclusion (DEI) challenges stem from a reactionary rather than anticipa-

networking opportunities. The Society extends quarterly virtual roundtable discussions as a complimentary benefit to members, with a session slated for May 15 focused on “Connective Tissue Disorders, Vascular Disease and Genetic Testing.” Heather Perne, NP-C, from the University of Toledo in Toledo, Ohio, will be the guest speaker (visit vascular.org/SVNroundtables).

May is also the month of the nurse: starting with National Nurses Day on May 6, National Nurses Week then extends into the week beyond, with the entire month recognized as National Nurses Month.

Alix said the role of vascular nurses remains paramount in delivering highquality care to patients with vascular conditions.

“I joined as a novice bedside nurse, only expecting to glean knowledge of the vascular patient,” she commented.

“There was that and so much more.

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.

SVN gives the ability to network with national nursing leaders, provides expert content and encourages individual professional growth.

“I never thought I would lecture nationally, serve on a Board of Directors, or add to vascular education and research.

“It is so much more than a society; it is a network of friends with a shared passion.”

The 42nd SVN Annual Conference runs concurrently with VAM 2024 in Chicago. To learn more, visit vascular.org/ SVN24.— Gomez

SVS FOUNDATION

‘A

Night at the Museum’ Gala

ALL ARE INVITED TO JOIN THE SVS Foundation for an evening honoring science at the “Night at the Museum—A Celebration of Science” Gala on Friday, June 21, at Chicago’s Museum of Science and Industry. Funds raised from the Gala will support the SVS Foundation’s investment in vascular disease research.

Gala Co-Chair Leigh Ann O’Banion, MD, said, “Supporting the Foundation’s investment in research helps support new and returning opportunities for vascular surgery professionals each year.”

Ticket and table purchases include complimentary round-trip transportation from the Marriott Marquis to the Museum of Science and Industry and admission to the Museum of Science and Industry, and more.

No on-site tickets will be available. Visit vascular.org/Gala2024 to make purchases.

15 www.vascularspecialistonline.com
Karith Foster will take to the VAM 2024 podium in Chicago Kristen Alix
‘What if we could translate the most durable Dacron repair into a minimally invasive approach?’

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

“For the last 10 years, there was no interest in the robot. For the last two years, there has been an incredibly high interest”
CHARUDATTA BAVARE

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 certi fied 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.

16 Vascular Specialist | May 2024
INTERVIEW

‘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).

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.”

SOCIETY BRIEFS

VQI spring regional meetings underway

THE SPRING 2024 VASCULAR Quality Initiative (VQI) regional meetings have begun.

VQI members are encouraged to attend their most local meeting to review their region’s data report, learn about how medical centers perform various procedures, receive a cross-regional comparison and more. Staff from the SVS Patient Safety Organization (PSO) will review VQI initiatives and go over data registry updates.

Members looking for their region’s meeting date or unsure of how to RSVP are encouraged to visit vascular.org/VQIregional

After arriving at the link, members should click their respective region area and scroll to “biannual meeting information.”

If the meeting has not already passed, a red hyperlink will be available to access the invitation and RSVP for the meeting.

Contact svspso@svspso.org for more information

“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”

PRADEEP MISTRY

SVS FOUNDATION AWARD

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.

17 www.vascularspecialistonline.com
Compiled by Marlén Gomez and Kristin Spencer Kevin Mangum
LEADERSHIP

IVC 2024: When are lymphedema pumps the answer?

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.” —–Brian McHugh

“I want to be very careful separating out where there is evidence and where there isn’t, and where there is opinion”
BRAJESH LAL

CHOOSING THE RIGHT VENOUS STENT FOR THE RIGHT SITUATION

PATRICK MUCK, MD, FROM CINNCINATTI, 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.”—Brian McHugh

The ISWVS is a newly established organization founded in 2023 with a mission to promote fellowship, equality, and excellence in vascular surgery. We are dedicated to improving healthcare access, innovating vascular solutions for women and minority populations, and supporting women vascular surgeons and aspiring professionals Join us in our mission for a healthier, more equitable future in vascular surge ry.

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VENOUS STENTING

CLINICAL&DEVICENEWS

BEST-CLI and the BASIL trials: Motion sees audience move in favor of endovascular therapy over bypass

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

Abbott’s Esprit BTK scaffold system given FDA approval for CLTI treatment

ABBOTT HAS announced that the Food and Drug Administration (FDA) granted approval for the Esprit BTK everolimuseluting 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 has been designed to keep arteries open and deliver a drug (everolimus) designed to support vessel healing prior to then completely dissolving.

Prosthetic valve implantation shows ‘vast’ improvements in deep chronic venous insufficiency

DAVID DEXTER, MD, FROM NORFOLK, Virginia, presented podium-first efficacy

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.”

“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.”

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.

results from the Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) trial at the 2024 Charing Cross (CX) International Symposium (April 23–25) in London, England, assessing the surgically implanted VenoValve.

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.

Penumbra announces FDA clearance of Lightning Flash 2 for the treatment of PE

PENUMBRA HAS ANNOUNCED THAT the Food and Drug Administration (FDA) cleared the launch of Lightning Flash 2, the next-generation computer-assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary embolism (PE), a company press release stated.

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.”

GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*

Consult Instructions for Use eifu.goremedical.com

INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts. CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available.

*As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS Heparin Surface. Products listed may not be available in all markets. GORE, Together, improving life, VIABAHN and designs are trademarks of W. L. Gore & Associates.  © 2021 W. L. Gore & Associates, Inc. 21373436-EN DECEMBER 2021

19 www.vascularspecialistonline.com
21373436-EN-VSX-Indications-Ad.indd 1 12/8/21 11:10 AM
01: 4.5” x 5.625” Esprit BTK

GORE® VIABAHN®

Endoprosthesis with Heparin Bioactive Surface*

5-YEAR PATENCY IN COMPLEX, REAL-WORLD SFA LESIONS.

The VIABAHN® Device demonstrated durable clinical outcomes in challenging superficial femoral artery (SFA) disease.

Gore Japan Post-Market Clinical Study1

* As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.

Complex patient population2

▪ 24 cm average lesion length

▪ 70% chronic total occlusions

▪ 27% critical limb-threatening ischemia

▪ 48% TASC II D lesions

1. Iida O. 5-year outcomes of the Gore® Viabahn® Endoprosthesis for the treatment of complex femoropopliteal lesions in a Japanese population. Presented at the 21st Annual Vascular InterVentional Advances (VIVA); October 30, 2023–November 2, 2023; Las Vegas, NV.

2. Iida O, Ohki T, Soga Y, et al. Twelve-month outcomes from the Japanese post-market surveillance study of the Viabahn Endoprosthesis as treatment for symptomatic peripheral arterial disease in the superficial femoral arteries. Journal of Endovascular Therapy 2022;29(6):855-865.

W. L. Gore & Associates, Inc. Flagstaff, Arizona 86004 goremedical.com

Please see accompanying prescribing information in this journal.

Products listed may not be available in all markets.

GORE, Together, improving life, VIABAHN and designs are trademarks of W. L. Gore & Associates.

© 2023 W. L. Gore & Associates, Inc. 231095897-EN NOVEMBER 2023

100 80 60 40 20 0 0 12 24 36 48 60 Time after index procedure (Months) Patency (%) Primary patency Secondary patency Primary assisted patency 62.4% 74.1% 82.3% 309 234 188 140 103 309 244 203 152 111 309 218 166 119 89 N at risk at start of interval
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