Vascular Specialist–January 2024

In this issue: 2G uest editorial How the best leaders ensure psychological safety at work

8A ortic Research Consortium F/BEVAR risk factors and one-year mortality

4 L imb salvage Personalized postoperative anticoagulation needed to curb lower-limb amputations, European meeting hears

JANUARY 2024 Volume 20 Number 1

THE OFFICIAL NEWSPAPER OF THE

13 DFUs Updated PAD guidelines for diabetic foot ulcers www.vascularspecialistonline.com

REIMBURSEMENT

Coding:

THE UTILITY OF RENAL STENTING IN HEMODIALYSIS PATIENTS: ONE IN FIVE FOUND TO COME OFF DIALYSIS AFTER BEING STENTED

Increasing complexity and lost RVUs— a drop in the ocean?

By Bryan Kay A FIFTH OF PATIENTS AMONG a chronic kidney disease (CKD) cohort on hemodialysis—a rare subset pulled from a large repository of national data— were able to come off the treatment following renal artery stenting, a team of researchers from the University of Texas (UT) Southwestern Medical Center in Dallas has found.

The findings—set to be presented at the Southern Association for Vascular Surgery (SAVS) 2024 annual meeting in Scottsdale, Arizona (Jan. 24–27)—have been hailed as being potentially the best evidence available in the field of renal stenting for decades to come, among a patient population so few in number that a randomized controlled trial (RCT) would almost never be viable, senior investigator and vascular surgeon J. Gregory

See page 7

A vascular surgery team at Audie L. Murphy VA Medical Center in San Antonio, Texas, uncovers “staggeringly low” numbers of correctly coded billing for three commonly performed vascular procedures, raising concerns over cases with more complex coding.

By Bryan Kay

N

ot long after becoming chief of vascular surgery at Audie L. Murphy Memorial Veterans Hospital—one of the larger of the Veterans Affairs institutions in the U.S.—in the past year, Alissa Hart, MD, started to look at her team’s productivity, and identified a problem. Despite carrying out a brisk load of complex vascular cases for a VA setting like hers, there appeared to be a problem in terms of the level of relative work value units (RVUs) being captured by the center’s coding service. So she went “down the rabbit hole.” What she found astounded her.

“Only 42% were coded correctly, so the majority weren’t coded correctly,” Hart tells Vascular Specialist. “These are simple cases. The TCARs [transcarotid artery revascularizations] were actually coded pretty correct-

See page 3

SVS POINTS TO 2023 ACHIEVEMENTS, CHALLENGES IN COMING YEAR

By Marlén Gomez The Society for Vascular Surgery (SVS) reflects on a year marked by notable achievements on multiple fronts. In a communication to members in mid-December, Executive Director, Kenneth M. Slaw, PhD, underscored the organization’s growth, collaborative endeavors and key milestones attained in 2023.

“Our members’ dedication and collaborative efforts across various councils, committees

See page 6

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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 | Professor HansHenning Eckstein, MD | 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 Christopher Audu, MD Executive Director SVS Kenneth M. Slaw, PhD Manager of Marketing Kristin Spencer Communications Specialist Marlén Gomez

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Vascular Specialist | January 2024

GUEST EDITORIAL How the best leaders ensure psychological safety at work

By Bhagwan Satiani, MD

M

y limited understanding of psychological safety is when people feel safe expressing differing opinions, and thoughts in the workplace. Amy Edmondson, a pioneer in this area, defines it as “the belief that the environment is safe for interpersonal risk-taking.”1 Although psychological safety must be part of every organizational culture, it is critical for high-performing teams. Cues and actions to enable this behavior and impact organizational culture are the responsibility of the leader. High-innovation companies thrive on emotional energy compared to healthcare, where a high-safety environment—such as a hospital, for instance— relies on psychological safety. However, healthcare is also a combination of research, innovation and caring for human beings. This requires leadership to share their aspirations and push for a healthy balance of both.

Why is psychological safety important in the workplace?

Because it is key for people to perform optimally. A McKinsey & Company survey confirms that 89% of employees corroborate that their ability to voice their thoughts and feel safe is essential in the workplace.

Gallup has calculated that doubling the percentage of employees who believe their opinion in the workplace counts from 30% to 60% resulted in a 27% reduction in turnover, a 40% reduction in safety incidents, and a 12% increase in productivity. Not surprisingly, it is also one of the strongest predictors of team performance.

While the lack of such safety for employed physicians can be seen in any scenario, I have been most exposed to it in the academic environment. To assume that the impact of lack of such safety must only be on junior faculty or trainees is erroneous. Surprisingly, even senior tenured professors have expressed fear of speaking the truth in public, and often in meetings. I once had a chair express his fear of speaking out in front of a dean several years ago to me thus: “If anyone says anything to the contrary at a meeting, the dean will cut your b***s out.” Imagine how junior faculty must have felt. One can only assume that expressing an opinion counter to the leader in such an environment could result in ill-treatment in the form of compensation, further career advancement, recommendations and discretionally awarded titles. If senior professors are reluctant to speak up, newly hired or junior faculty will not risk their careers, leading to fear of speaking, a “yes” culture and stunted productivity.

Most of us have encountered leaders who may be successful at soliciting ideas and driving change but lacking in spotting cues at meetings where no one feels free to disagree. Rather than psychological safety, there is a culture of silence. What makes employees feel safe and engaged at work and in teams? Some have described four progressing stages of feeling safe at work: safety to be included, to

“Emotions must be controlled. Focus on the error itself and how to avoid it in the future”

Bhagwan Satiani

learn, to contribute and, finally, to feel safe in challenging the status quo.2 William Kahn, an expert on employee engagement in the context of psychological safety, has identified three conditions for optimum engagement: “feeling safe, meaningfulness and having access to the right energy and resources.” There are consequences of a culture where there is lack of such safety. Research shows that this culture leads to an 85% rate of project failure.

Edmondson has offered an interesting two-by-two grid or matrix with performance standards (apathy and anxiety) on the x axis and psychological safety on the y axis (comfort and learning).1 She advocates for leaders to attempt to push people into the right upper quadrant or the learning zone. Learning, innovation, and productivity will proceed with psychological safety, she counsels.

However, she warns that this one item is only a part of a range of leadership behaviors that accelerates highperformance teams. The obvious goal is for all team members to be in harmony with each other, able to speak and share ideas towards a common purpose, without fear of appearing inane or fearing reprisal. It is the leader’s job to remove any risk associated with speaking out.

So, how should leaders advance a “speak up” culture in order to enable psychological safety?

First, the leader must remember their role in a team.

It is to facilitate, empower others, be a catalyst and model the desired behavior. This means having the awareness to be cognizant of the thoughts and feelings of others. Silence does not equal agreement. Then, asking themselves if the silence is a pattern or a “oneoff ” behavior? Solutions for each are different. Are team members actively engaged in making eye contact with you and others? If you sense hesitation, encouragement with a self-deprecating anecdote of some kind may work.

Or better still, mention one of your own shortcomings. If you are truly self-aware you know what they are or have heard it said about you.

Second, if the leader senses silence during a discussion, ask for advice, not feedback. This is sometimes called the “feed-forward” technique. Feedback is often understood as either an “ask,” or after a decision has been made and interpreted as being judgemental. Using the word “advice” puts the onus on the other person, as well as being heard as being for the future rather than the past. A safe way to elicit advice is to admit that you are still pondering over the issue and that you are probably missing critical pieces of the matter. Not hearing people with a different mindset, leaders may be missing these pieces at a huge cost.

Ron Carucci, co-founder and managing partner at Navalent, mentions two national disasters as examples where “employee voices” were not given importance because their opinions were either not solicited or ignored. These were the Challenger space shuttle in 1985 and the Columbia shuttle in 2003. Give people room to brainstorm out loud. Even if someone presents ideas or suggestions that lack substance, listen and understand the thought first, show empathy, and offer a counter idea, improving on their own statement by asking if they had considered it. People will generally remember what was decided at the meeting. It follows that if a certain position is accepted at a team meeting, progress must be reported at the next meeting.

Third, every team needs a naysayer(s) or a contrarian.

continued on page 3

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FROM THE COVER CODING: INCREASING COMPLEXITY AND LOST RVUs–A DROP IN THE OCEAN? continued from page 1 ly, but the other two— EVARs [endovascular aneurysm repairs] and fenestrated EVARs (FEVARs)? This isn’t even a pedal access atherectomy with stent placement, or something along those lines.

“What I realized, when we looked at this in general, I went back and started trying to re-code my own cases, and there was a point where we did five EVARs in a month—which is pretty good for a VA—and only two of them were coded with a code that had RVUs attached to them.”

Based on her initial discovery, Hart and colleagues—including presenting author Luke Perry, DO, a first-year vascular surgery fellow at UT San Antonio—carried out a retrospective study of the total number of cases, those coded correctly, total number of RVUs, and the number of RVUs actually captured for TCARs, EVARs and FEVARs carried out at their center across a five-year period. The data are set to be presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting ( Jan. 24–27) in Scottsdale, Arizona.

Total RVUs completed were 1,764.42 but only 1,196.82 were captured, SAVS 2024 will hear.

“When I started looking at this, and looking at our productivity numbers, I thought, ‘How is this possible?’” Hart recalls. “We’re doing atherectomy cases, doing TCARs, EVARs and FEVARs, and all these things that a tertiary-level center would do at a VA. I was quite proud of our department.

So having just come from private practice, where I had started to get more familiar with how outpatient-based labs code, and how many RVUs you can get out of a single procedure, I started looking at the way our coding was coming back from our centralized coders. That led me down a rabbit hole

where I started to realize that, not just the VA but other organizations as well, are using coders that are primarily used as outpatient coders to code surgical packages. For vascular surgery, in addition to complex coding, you also have all these modifiers that really increase your RVUs. If a coder is not really sure how to do that properly, we’re doing all this work and we’re not getting the productivity value out of that, or the bonus value for our surgeons. We’re constantly being told you’re not productive enough and our system is trying to find ways for us to cut costs, when the reality is, if they would spend the time and put the energy into coding, then they could justify our existence as is—and probably provide us with more resources.”

With Hart being on the younger side— 34, she reveals—on becoming a chief all of sudden she realized she hadn’t really been prepared, either in her residency or during a stint in private practice, how to improve productivity or, for instance, justify the salaries of new hires.

There is also a vascular identity within hospital systems as well as resource allocation dimension to consider. “Vascular surgery should get the resources that it needs based on the services it provides,” Hart says. “Some of our cases, we are back-up for cardiology, or we are back-up for interventional radiology when they have access complications.

“To make sure vascular surgery gets the recognition and the resources that it deserves to provide both surgical back-up and radiological assistance to so many different departments is really important.”

The next step in this line of study will see Hart and colleagues delve deeper into their more complex endovascular cases in order to ascertain the extent of incorrect coding

issues. “We’re trying to find out what that looks like now because one of the other issues that I’ve found in my department in my particular system is that we don’t get RVUs associated with reading vascular labs,” she explains. “What I’ve learned in the complexity of the bureaucracy in the federal government, your [productivity] scores are only as good as the data put in.”

So now Hart’s team will look to incorporate that data with their operating room coding in order to determine what is being missed—“not just with vascular lab readings, but also on the radiological interpretation, ultrasound guidance, all those things for those CPT

“When I started looking at this, and looking at our productivity numbers, I thought, ‘How is this possible?’”

ALISSA HART

[Current Procedural Ter minolog y] code modifiers, and see how many RVUs we’re losing.”

SVS announces on-demand coding courses are now available

To expand coding educational resources, the Society for Vascular Surgery (SVS) and long-term partner KarenZupko and Associates Inc. (KZA), a consulting and education firm, plans to release a series of on-demand courses quarterly that will examine the intricacies of coding for vascular surgery. The first course launched in December 2023.

Each fall, the SVS hosts an in-person Coding and Reimbursement Workshop, but the need for additional resources was clear, stated SVS Advocacy Council Chair, Megan Tracci, MD. “Coding is a critical part of running a successful practice for all vascular surgeons and we’re in need of resources, but they’re scarce,” she explained. “The SVS is working to ensure our members have access to the information they need.”

The first course focuses on surgical modifiers in vascular surgery. Modifiers tell the payor what happened in surgery and, more importantly, how they impact on reimbursements. The course dives into the most common modifiers and how they are used accurately in vascular surgery scenarios. New courses will drop throughout 2024.

The courses will provide American Academy of Professional Coders continuing education credits. Vascular surgery professionals and their office staff can access the first on-demand course by visiting vascular.org/codinginquiries.— Kristin Spencer

GUEST EDITORIAL continued from page 2 Sometimes uncomfortable? Yes. A facial expression or other tic may indicate disagreement but sometimes not.

Ask for other viewpoints. To make a point, express a contrary view yourself to lead the discussion off. This allows others the freedom to express divergent opinions.

Fourth, there is a risk that some team members may see the “safe” environment as a license to say whatever they want. Or, while all ideas may be welcome, many do not fit with the goals, mission, or task for the limited time at a team meeting. Remember, there is an “opportunity cost” associated with ideas/projects that do not sync with the goals and objectives of the team. Time and resources wasted on an unworthy project is time lost from a worthwhile one. After listening, gently steer the discussion away and remind everyone that although the idea was good, we can consider this for another time.

Fifth, while I have seen good and bad leaders in a team environment, successful ones have two qualities that stand out. Calmness and confidence when their status or opinion is challenged. They do not get aggravated when the status quo is contested, and especially if team

comportment or performance is deteriorating. Certainly, most team members will make errors. Give team members the freedom to fail as part of the team. Indeed, bring them up as learning opportunities, and avoid finger pointing. Emotions must be controlled. Focus on the error itself and how to avoid it in the future. This is where the fundamental pillar of leadership—self-awareness and knowledge of one’s own triggers—is so important for emotional regulation.

Finally, consider a few steps that clearly demonstrate a team leader’s positive energy. People are loathe to report a problem with culture they see as incompatible with organizational values. The leader must encourage conversation about toxic behaviors in a secluded setting if necessary. Be generous with compliments. And please do not ask for advice from team members as you are close to walking out the door. I have seen this repeatedly.

As I see it, providing psychological safety should be a part of all syllabi associated with developing physician leaders. Part of my learning has come from my own mistakes and being associated with our leadership

program where I have watched groups go through the training, particularly during the team sessions. Although, data from McKinsey points to several other skills predictive of positive leadership, training in open dialogue skills, sponsorship, situational humility, and consultative behaviors (as in suggestion one and two) are especially important.3 McKinsey also reports that only 28% of leaders develop skills necessary to create psychological safety in team settings. We can do a whole lot better than that, right?

References 1. https://amycedmondson.com/psychological-safety%e2%89%a0-anything-goes/ 2. https://www.leaderfactor.com/post/why-are-some-leadersafraid-of-psychological-safety) 3. https://www.mckinsey.com/featured-insights/mckinseyexplainers/what-is-psychological-safety BHAGWAN SATIANI is a Vascular Specialist associate medical editor.

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Vascular Specialist | January 2024

LIMB SALVAGE

PERSONALIZED POSTOPERATIVE ANTICOAGULATION NEEDED TO CURB LOWER-LIMB AMPUTATIONS

By Jocelyn Hudson Anahita Dua

“W

e’re going to see more and more amputations if we don’t figure out the right post-procedure thromboprophylaxis regime ASAP,” Anahita Dua, MD, warned during a lecture on innovative approaches to preventing amputation at the Vascular Society of Great Britain and Ireland’s (VSGBI) annual scientific meeting (Nov. 22–24, 2023).

Diabetes is a significant and growing problem for the vascular community, the associate professor of surgery at Harvard Medical School and vascular surgeon at Massachusetts General Hospital in Boston began. She explained to the audience: “Because our diabetic drugs are doing their job, and the way we take care of these patients is getting better, they are living longer, so we are seeing more of these patients.”

At the Dublin, Ireland, meeting, Dua noted that this rise in prevalence will be accompanied by a parallel increase in the number of associated complications, specifically “complications we, as a society, may not have dealt with before.”

She highlighted one that is a particular cause for concern: the microvascular dissemination of the foot. And, to make matters worse, “we have nothing to help these ‘no-option’ patients,” she said.

Dua’s talk—titled “Going out on a limb to save a life and a limb”—first focused on deep venous arterialization (DVA)—a new technique that, according to the presenter, “is kind of taking the world by storm.”

“There are going to be a couple of guys in the audience who are going to turn to their friend and say ‘we did this in the 80s.’ No, you didn’t—I promise. You did some version of something that was called this in the 80s, but things have changed because technology and medicine have changed,” she said.

So, this is not a new concept, the presenter stressed, noting, in fact, that there are reports of attempts from 1881.

Following a “big breakthrough” in the 1970s, the technique fell out of favor “because it didn’t really work in the way it was meant to.” There were various reasons for this, according to Dua. “We

were plagued by a lack of technology, lack of buy-in and lack of patients.”

The presenter highlighted some data on the new and improved iteration of this technique, first mentioning the PROMISE II trial, for which she was an investigator.

While amputation-free survival was the primary endpoint, Dua focused on the limb salvage rate, which was 76% in patients who otherwise may have had no other option but an amputation.

This is where the presenter turned the audience’s attention to another study— CLariTI—designed to illuminate the “realworld” amputation rate in the U.S. The presenter reported that, in this study of 180 patients at 22 sites across the country, up to 73% who underwent an amputation

“We are undertreating women, even though we think we’re treating them the same. Because of course our studies have not included that many women, so we haven’t seen this” ANAHITA DUA did not have a diagnostic angiogram, while 54% had no revascularization attempts.

“We need to make sure that, across the country, all of these patients are getting the same level of care,” Dua stressed.

The presenter continued that in patients who were told they had no conventional options for salvage and/or had undergone two failed attempts at revascularization, the limb salvage rate was 48% at one year—so, “about a coin toss,” as Dua put it. The pooled results from PROMISE I and PROMISE II, however—which the presenter reiterated focused on DVA— revealed a higher limb salvage rate of 73%.

“I really think that that is the future,

or the only thing we have, frankly, right now, for patients that are coming in with microvascular dissemination of the foot and no other options,” Dua opined.

Anticoagulation: ‘One size fits all doesn’t work’

Despite the progress made for these patients technique-wise, Dua told the audience that the issue of postoperative anticoagulation is hindering outcomes.

“What do we do immediately after we’ve done this amazing, futuristic surgery?” she asked. “We put them on ‘one-sizefits-all’ thromboprophylaxis because we have little idea what we’re doing.” The result is suboptimal outcomes with up to 20% of patients needing reintervention

from stenosis or thrombosis in the first six months post-procedure.

Dua advocated moving away from a “one-size-fits-all” approach, talking through some of the work she is currently conducting on this in her lab at Massachusetts General Hospital.

She noted that, based on her research, a patient’s platelets need to be inhibited by 30% to get a reasonable decrease in thrombosis. In order to get to this number, she explained, every patient will take different medications. “What we should be doing is testing the blood, determining whether or not you hit a particular level, and then treating accordingly,” she said.

The presenter mentioned, for example, that men and women require different treatment. “We are undertreating women, even though we think we’re treating them the same. Because of course our studies have not included that many women, so we haven’t seen this.” The answer? “We need to personalize it,” according to Dua. The presenter noted that the task now is to translate the data into practice. In this regard, Dua referenced an ongoing trial she is conducting called TEG-MED. Dua and her team have formed an anticoagulation algorithm based on the 30% figure highlighted in their previous research.

“The future for these patients is very bright,” Dua said in her concluding remarks. “We’re figuring out the coagulation story, we’re starting to understand that there are patients that can be helped with deep venous arterialization and we’re accepting this new technology, and I really feel that—over time—we don’t have to even say we’re going out on a limb to save a limb, because it’s just going to become our standard of care.”

IN THE NEWS: BREAKING DOWN BARRIERS In a recent New York Times article, Dua shed light on the dire consequences of delayed treatment for peripheral arterial disease (PAD) and the urgent need for a standardized approach to its management. The catalyst for her article lies in the preventable amputation of a woman in her 60s, underlining the critical need for routine monitoring and early intervention.

Dua explains her motivation in writing for a mainstream audience as akin to experiencing the frustration of cleaning up a polluted stream. Despite best efforts, the water remains contaminated because the source of the pollution was upstream, so there is little that can be done to change the water downstream, and the source of the issue is beyond their control.

Dua underscores the manageable nature of PAD, affecting millions of Americans, through lifestyle changes and routine monitoring. However, she points to stark disparities in healthcare access, particularly among Black Americans, resulting in delayed treatment and a heightened risk of amputation.

“We’re sitting here in front of this buffet of drugs and therapies and innovative techniques, but these are end-stage partial solutions and we do not even know how to best use combinations of them,” Due told Vascular Specialist. “We need to

figure out what the right combination is for these patients so that they do well in the long run. We may have two patients with the same lesion in a lower-leg artery, but based on their co-morbidities, genetics and surgical history may need very different interventions. We have to stop treating the lesions and start treating the people. And to do that we must put time and effort into figuring out what is the best standardized approach to diagnosis and treatment or this problem will worsen.”

Through her selection as one of the Presidential Leadership Scholars of 2023, a program in partnership with the Bush (both), Clinton and Johnson presidential centers, she emphasizes the need for societal awareness of PAD. She suggests that linking Medicare payments to angiogram proof for elective amputations could be a decisive step to reduce racial disparities and standardize care to some extent, drawing parallels to the success seen in cancer care.

Dua’s article received a positive reception among her peers and the medical community due to its list of resources and action items. She thanked the NYT for a platform that affords broad outreach. “Many would agree: my patient did not have to die this way,” said Dua.—Marlén Gomez

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Vascular Specialist | January 2024

FROM THE COVER SVS POINTS TO 2023 ACHIEVEMENTS continued from page 1

YEAR IN REVIEW Vascular Specialist’s top stories of 2023

➽

Here are the trending articles from across Vascular Specialist last year.

and departments have propelled us forward.

2023 stands out as a year of significant achievements that our members can take pride in,” said Slaw. “As we look forward to 2024, the SVS remains steadfast in its commitment to championing quality and safety in patient care, the best science in the field, and advancing vascular surgery through meaningful collaboration, innovation, and, as a specialty, by letting the world know how special our members are as vascular surgeons.”

SVS takes to the Hill  Over 50 SVS leaders and staff participated in a Hill visit before the 2023 Vascular Annual Meeting (VAM) in Washington, D.C.  SVS members engaged with over 100 Congress representatives to advocate for immediate changes to Medicare payment policies, which led to initiatives to consider legislation, including a “Clinical Labor Bill”  The SVS plans to host an advocacy skillbuilding conference in 2025

on Outpatient and Office Vascular Care (SOOVC) developed the Handbook on Outpatient Vascular Care, released at the end of 2023.

“Each month of the year brings new ideas, energy and opportunities, as well as new challenges and threats that make strategy and change a universal constant for the SVS,” said Slaw.

The pace of change has accelerated and has become its unique challenge. SVS leadership commits to continue evolving the Society to address new opportunities and challenges.”

Joseph L. Mills

Rolling with the changes  SVS membership reached a total of 6,400 diverse members  SVS Affiliate membership, encompassing over 500 vascular physician assistants, nurse practitioners, and advanced care providers, played a substantial role in shaping the future of vascular care delivery B ylaw changes were ratified, concluding a multi-year journey to update SVS bylaws, explicitly focusing on modifying the composition of the Executive Board  During the 2023 Executive Board retreat in July, significant resources were committed to augmenting and accelerating branding efforts initiated in 2021, with the refreshed branding set to be unveiled in 2024

Quality improvement goes national  The SVS successfully initiated the Vascular Verification Program with the American College of Surgeons, demonstrating Kenneth M. achievement in both inpatient and Slaw outpatient standards programs  The SVS Patient Safety Organization (PSO)/ Vascular Quality Initiative (VQI) surpassed 1,000 Advancements in education subscribing practice sites and recorded over 1 million  T he SVS achieved its highest attendance at the procedures in the VQI database Vascular Research Initiatives Conference (VRIC), with  The VQI introduced the Smoking Cessation National over 130 registrants Quality Initiative, highlighting the SVS’ commitment  T he organization completed its second Complex to addressing critical public health issues associated Peripheral Vascular Intervention Skills Course with vascular care and ongoing improvements in the Coding and  The SVS/PSO Fellowship in Training program was Reimbursement Workshop launched as part of ongoing efforts to enhance  T he SVS launched virtual coding courses in professional development and education December  SVS mobilized dozens of member letters expressing  T he sixth edition of the Vascular Education and concern for patient safety relative to the Centers Self-Assessment Program (VESAP6) is set to launch for Medicare & Medicaid Services (CMS) national in Spring 2024. A new audio supplement/companion coverage determination (NCD) rule that will expand for VESAP6 will be piloted, allowing learners to listen carotid stenting. The SVS is on record with CMS, to case discussions expressing its concerns, and has offered solutions to  T he launch of the fifth journal in the Journal of minimize potential harm Vascular Surgery portfolio, Journal of Vascular Surgery-Vascular Insights, showcased open-access Health reporters contacted the SVS numerous times, publishing models seeking comment and guidance regarding stories featuring poor patient outcomes.

The 2023 “Great Gatsby” Gala proved to be a “The role of clinical practice guidelines, appropriate resounding success, raising more than $200,000 to use criteria (AUC), greater understanding of health and support the future of vascular health. The Vascular practice economics, and focus on substantial challenges Health Step Challenge increased participation from last and flaws in current CMS payment/incentive policies year, with participants collectively walking 44,000 miles were all subjects of discussion,” said Slaw and raised more than $100,000.

“The SVS plans to strengthen its communications “As the year concludes, I encourage you join us in infrastructure as it anticipates more frequent and 2024 for the ‘Night at the Museum’ Gala at Chicago’s continued contact with media professionals in 2024 Museum of Science and Industry,” said Slaw. and beyond.”

SVS member volunteers have pressed forward to sculpt the future with numerous new task forces in 2023, Translation to transformation including Pediatric Vascular Care, Patient Engagement, in clinical practice Innovation in Vascular Care, Clinical Trials and a  The launch of the inaugural “Translating Guidelines proposed new Section for Senior Members. into Practice” webinar attracted hundreds of SVS SVS President Joseph L. Mills, MD, addressed members. The course covered the translation of achievements the Society will target in the new year. global chronic limb-threatening ischemia (CLTI) “2024 will bring about a new set of challenges for guidelines, Best Endovascular vs. Best Surgical our Society to overcome,” he said.

Therapy in Patients with Critical Limb Ischemia “The SVS reaffirms its unyielding commitment to (BEST-CLI) results and updated varicose veins clinical advancing excellence and innovation in vascular health practice guidelines through education, advocacy, research and public  The SVS secured a $100,000 educational grant from awareness. Together, we will continue to emphasize the Council of Medical Specialty Societies (CMSS) to quality and patient safety, push boundaries, foster support ongoing translational efforts innovative solutions, and empower our members with the knowledge and resources needed to excel in the  The SVS initiated a national compensation study and dynamic field of vascular surgery. program for vascular surgery in response to member “Our collective dedication will be the driving force queries to address gaps in credible data behind the sustained success of the SVS and will continue to impact the evolving landscape of vascular Emphasizing its ongoing commitment to office and healthcare favorably.” outpatient care in the community, the SVS Section

1. Coding: New CPT codes for percutaneous arteriovenous fistula creation Back in February, Sunita Srivastava, MD, and David Han, MD, worked through the 2023 Current Procedural Terminology (CPT) code set and the two new codes governing arteriovenous (AV) fistula creation in the upper extremity.

2. SVS responds to New York Times article on overuse of vascular interventions In July, SVS President Jospeh Mills, MD, penned a response to the swirling coverage in the mainstream media of inappropriateness in vascular care.

3. Likes, dislikes and reposts: The new age of the vascular surgery influencer Early in the year, Jean Bismuth, MD, and Jonathan Cardella, MD, tackled the thorny topic of vascular surgeons’ use of social media.

4. From the editor: Sex, lies, and carotid stents In our October issue, Malachi Sheahan III, MD, Vascular Specialist medical editor, entered the debate around the Centers for Medicare & Medicaid Services (CMS) decision to expand coverage for carotid artery stenting. He dealt, in part, with the issue of practitioner competence in the treatment of asymptomatic carotid disease.

5. Surmodics provides regulatory update related to FDA premarket approval application for SurVeil Surmodics announced in January how it had received a letter from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drugcoated balloon (DCB). In the letter, the FDA indicated that the application was not currently approvable. The device was later approved in July.

6. Robotic surgery: ‘We’ve missed the boat on this,’ says Houston vascular chief In April, we interviewed Alan Lumsden, MD the Walter W. Fondren III Presidential Distinguished Chair at Houston Methodist’s DeBakey Heart & Vascular Center in Houston, Texas, on an emerging program at Houston Methodist that aimed to help prod those practicing in the vascular surgical space deeper into the field of robotic surgery.

7. Letter to the editor: The vascular influencer W. Michael Park, MD, from University Hospitals in Cleveland, Ohio, responded to the earlier editorial penned by Jean Bismuth, MD, and Jonathan Cardella, MD, focused on social media use by vascular surgeons. “The voices of nonacademic surgeons are given a platform to broadly share their experience,” he retorted in his piece. “If legitimately good people are dissuaded from participating, only the cheap suits will remain.”

8. Vascular surgery added as named specialty to influential national hospital rankings In July, it emerged that U.S. News & World Report was about to rename the specialty formerly known as “Cardiology & Heart Surgery” to include vascular surgery in its national rankings of the best hospitals in the country.

9. Envision, private equity and patient care: Substituted values 2.0 Back at the start of the year, Arthur E. Palamara, MD, a vascular surgeon in Hollywood, Florida, crafted a commentary on the specter of private equity in healthcare.

10. CMS confirms broadened Medicare coverage of carotid artery stenting in final decision In October, we reported on the final CMS decision to approve the coverage expansion for carotid stenting. National Coverage Determination (NCD) 20.7 essentially confirmed the expansion outlined in a July proposed decision memo.

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FROM THE COVER EXPLORING THE UTILITY OF RENAL STENTING IN HEMODIALYSIS PATIENTS: ONE IN FIVE FOUND TO COME OFF DIALYSIS AFTER BEING STENTED continued from page 1

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Modrall, MD, a professor of surgery at UT Southwestern Medical School, told Vascular Specialist ahead of SAVS 2024.

“I have worked in the area of renal artery stenting for a number of years, but we have always focused on patients who had CKD and were not yet on dialysis,” Modrall explained.

When working on a larger study, using the TriNetX clinical database, he realized an opportunity had presented itself because of the repository’s sheer size. “It has a very large number of patients who were already on dialysis when they got stented,” said Modrall. “I realized that this presented a unique opportunity to address something that the literature is completely lacking.”

Among 173 patients who met inclusion criteria, Modrall and colleagues show that 33 (19.1%) were rescued from dialysis after stenting and were categorized as responders. At 30–90 days post-stenting, the median eGFR (estimated glomerular filtration rate) for responders was 51.6 ml/ min/1.73 m2 and remained stable over a median follow-up of 1.1 years. Survival was superior for responders, compared to nonresponders, they found.

“We looked at patients who were on recent dialysis or current dialysis at the time of the renal artery stenting,” Modrall explained. “We defined recent stenting as within 60 days. The goal was to avoid inclusion of patients who maybe had dialysis six months ago but were no longer on it.

“Many of us in this field have had the sense there may be a small subset who can come off dialysis if stented at the right time but we have never had any data to guide us in patient selection, so, by and large, providers have just decided if patients are already on dialysis then they’re not going to stent that patient.

“What we found was that there is a subset that will come off dialysis—it’s about 19% of stenting patients came off in this cohort.”

Modrall and his team established that there were three basic predictors: duration of pre-stenting dialysis <79.5 days, diabetes and smoking. Two were dominant, he said.

“Diabetes was a negative predictor.”

Those two dominant variables within the cohort alone “predicted 83–84% of the outcomes accurately,” Modrall continued.

“So, we think that’s pretty solid data that suggest that we should be looking especially at those two variables in choosing the patients for stenting.”

With no RCT ever likely to be carried out in this subset of patients because the number who were stented in any given institution while already on dialysis are so few up to now, the data from his SAVS paper “might be the best we have for decades,” reflected Modrall.

“I personally wouldn’t stent every patient who was recently on dialysis, had renal artery stenting and was not a diabetic, because we have got to look at other factors like long-term survival, ability to tolerate the procedures, etc., but I think that is a good starting place and a lot more than we had

before this study began,” Modrall added.

“It’s always going to be a difficult decision and it’s something that should be made in conjunction with a nephrologist, the patient and after looking at life expectancy and the patient’s ability to tolerate the procedure.

With good education, the patient should J. GREGORY MODRALL be very active in making that decision.

The chances are not high, one in five, but if we can take you off dialysis, it will have a huge impact on your life going forward.” the time. “That represents the single largest The ongoing larger study on which dataset of renal artery stenting patients in Modrall and colleagues are working existence to my knowledge.” revealed that patients in CKD stages 3b and Modrall and his team explained how they 4 (eGFR 15-44 mL/min/1.73m2) are the only had hoped to leverage the enlarged dataset sub-groups with a significant probability of to create an outcome prediction tool that improved renal function after renal stenting, clinicians can use in practice. He envisaged with the rate of decline of preoperative a desktop- or phone-based application eGFR over the months prior to stenting a into which a patient’s parameters could be powerful discriminator of patients who are input in order to establish a probability of most likely to benefit. improved renal function.

Those results, delivered during SAVS 2023 “It turns there are variables that we in Rio Grande, Puerto Rico, last January, bore haven’t defined,” he said prior to SAVS 2024. the ultimate aim of creating a prediction “The predictive capacity is better than we tool. At the time, Modrall pointed out that have now, but it is not as high as I’d like to the predictors highlighted were “putative,” see it. We are continuing to work on that. or “candidate predictors,” that have not “If I cannot get to a predictive capacity been validated in a prospective series. “The with this database that I think is sufficient, next step is to take the data from this study, the next step would be to take a machinecombine it with two of our prior studies, learning approach to try to identify and in doing so we will have close to 1,800 variables that maybe we haven’t even patients with renal artery stents,” he said at considered before.”

“We think that’s pretty solid data that suggest that we should be looking especially at those two variables”

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Vascular Specialist | January 2024

COMPLEX AORTA

U.S. Aortic Research Consortium maps out F/BEVAR preoperative risk factors for one-year mortality in complex AAAs, TAAAs

By Bryan Kay A SERIES OF PREOPERATIVE RISK FACTORS —including currently smoking, chronic kidney disease (CKD), congestive heart failure (CHF), aneurysm size greater than 7cm, more advanced age (75 or over), Crawford extent I–III thoracoabdominal aortic aneurysms (TAAAs), known chronic obstructive pulmonary disease (COPD), and anemia at baseline—were found to be predictive of one-year mortality among patients undergoing fenestrated and branched endovascular aneurysm repair (F/BEVAR) for complex AAAs and TAAAs with custom-made devices.

That is the key finding from one of the latest papers to come out of the U.S. Aortic Research Consortium (U.S. ARC) of investigational device exemption (IDE) trials set to be presented at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona ( Jan. 24–27).

The 10-center, more than 3,000-patient research conglomerate aims to use the data generated to create a risk stratification calculator to help inform a preoperative decision-making process that balances risk of aneurysm rupture if no intervention takes place, and mortality risk at one year if the disease is operated upon, Adam Beck, MD, a U.S. ARC investigator and vascular surgery division director at the University of Alabama at Birmingham in Birmingham, Alabama, told Vascular Specialist ahead of the SAVS 2024 meeting.

“The typical discussion when we are in clinic talking to patients about whether or when they should repair their aneurysm always focuses on the risk of rupture,” he said.

“And that risk of rupture is usually put into the context of annual rupture risk. We did this project because we wanted to give a counterpoint to that risk of rupture.

That was the idea behind this one-year mortality risk. So, you can say, ‘This is the risk of doing nothing, and here is the risk of doing something,’ in the setting of the patient’s overall state of health and quality of life.”

Operative mortality can be very low—from 1–2%— depending on the extent of the aneurysm and complexity of the repair, Beck observed. “But the mortality when you go out to a year can be much higher than that. So,

something is happening to these patients after they get repaired. It’s not rupture of their aneurysm. Many of them are dying of their other medical comorbidities.”

The U.S. ARC researchers looked at the full range of preoperatively available risk factors—gender, race, age, coronary disease, CHF, emphysema, cerebrovascular disease, diabetes, renal disease, hypertension, as well as both smoking and preoperative functional status. They were stratified by Crawford extent of their aneurysm: one complex AAA (juxtarenal/suprarenal) and two separate TAAA groups—one comprising Crawford type IV and V and the other the particularly high-risk extent I–III group, Beck explained.

“The things that we found that were predictive of oneyear mortality in a multivariable Cox regression was if they were a current smoker, if they had CKD, CHF, a very large aneurysm (greater than 7cm), more advanced age (75-plus), extent I–III TAAAs, patients with known COPD, and those who were anemic at baseline,” he said.

“The aneurysm size is a tough one. That one always falls out in an analysis like this: the bigger your aneurysm, the higher your risk of one-year mortality. It’s an interesting thing because the bigger your aneurysm, the more likely we are to offer you a repair—even in the setting of higher-risk patients, because we’re weighing that risk-benefit with rupture.”

During SAVS 2024, the research team will break down what the risk looks like in their predictive model by increasing risk factors. The risk calculator the U.S. ARC

“Risk of rupture is usually put into the context of annual rupture risk. We did this project because we wanted to give a counterpoint to that risk of rupture” ADAM BECK

TRAINING

SVS LAUNCHES VESAP6 PRESALES IN JANUARY WITH DISCOUNT

By Kristin Spencer THE SVS IS SET TO LAUNCH THE sixth edition of the Vascular Education and Self-Assessment Program (VESAP6) in April.

The highly anticipated review resource became available for pre-sales Jan. 10, which will continue through March 26, allowing

users access upon launch. VESAP is a digital aid for vascular surgeons in preparing for qualifying, certification and recertification examinations and to remain current in the specialty of vascular surgery and endovascular therapy.

investigators hope to generate would enable individual patient data to be plugged in to gauge their one-year mortality risk.

“Hopefully this could be something that will allow you to discuss with the patient in clinic and say, ‘Here is your risk of rupture, and here is your Adam Beck risk of mortality at one year. I think that it makes sense to proceed with your repair.’ Or you could say, ‘It really doesn’t make sense at your current size for us to put you at the risk of the operation,’” explained Beck. “This could also help you with your discussions about smoking cessation. If we could show patients on our phones apps and say, ‘This is your risk of mortality at a year with you being a current smoker. If I take this risk factor out, here is your risk factor at one year, and it will be a sizable difference.’ I think that will really help that discussion with the patient and our clinical decision-making.”

Further down the road, U.S. ARC is set to continue building on its body of work with additional analyses in areas such as target-vessel outcomes based on type of stent graft used, the impact of aortic aneurysm sac behavior after repair, the impact of renal insufficiency on outcomes, and the impact of endoleaks on mortality.

The group has also recently completed a pilot study for a randomized controlled trial (RCT) for prophylactic spinal drains in patients with extent I–III TAAAs. The latter particularly excites Beck owing to his longstanding interest in preventing spinal cord ischemia as a complication of complex aortic aneurysm repairs.

Another recent development saw U.S. ARC include aortic arch procedures in its registry. “A few of the centers are capturing data for their endovascular aortic arch reconstructions,” Beck noted. “This is still in its infancy, but we’ll have some consortium data to publish in the next year or two, once we have more patients.”

Despite being only about six years old, U.S. ARC is having a big impact on evolving the arena of complex repair of TAAAs and AAAs, Beck said. “In our group, we have each changed our practices based on our publications,” leading to quality improvement, he added.

“I’m biased because of my personal academic interests, but I think if we can actually get a [large, nationwide] RCT going for spinal cord ischemia, that would be one of the biggest contributions that we could make to the aortic surgery world. It will take a few years to enroll the number of patients we will need, so successfully initiating the trial may be one of our next big landmarks.”

Vascular and general surgery residents and fellows consistently report the utility of the program in their preparation for the Vascular Surgery In-Training Examination (VSITE) and American Board of Surgery In-Training Examination (ABSITE).

VESAP6 will come with over 600 questions, accompanied by detailed discussions and references.

The resource can be used in learning mode, where users can review the correct answers, rationale and references; and exam mode, where the user will complete entire modules without seeing the answers, rationale or references, in hopes of passing with

a score of 75% or higher to earn Continuing Medical Education Credit (CME).

VESAP6 has been allocated 97.5 CME credits. Pre-sales for VESAP6 will open with a 10% discount available on all individual purchases. Additionally, SVS members who take advantage of the presale will be entered into a lottery for complimentary registration for VAM 2024.

Visit vascular.org/VESAP to access more information on the resource.

NEW!

NEW!

DFUs

VLUs

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Vascular Specialist | January 2024

COMMENT&ANALYSIS VASCULAR PRACTICE

Redemption through perseverance

By Arthur E. Palamara, MD IN THE LATE 1970S, A NEUROSURGEON at New York’s St. Luke’s Hospital operated on a beautiful, young, rising soprano who studied opera at a major New York conservatory. She was delightful, full of the joy of living, and orphaned at an early age to raise her teenage brother. Having already overcome significant adversity, her only impediment to a blossoming career and a happy life was a brain tumor. The tumor appeared benign, and its resection was considered routine. The neurosurgeon was top notch, capable and clinically at the top of his game. There was not much that could go wrong.

But as happens in the arcane realm of neurosurgery, things went terribly wrong. After the skull was opened and the surgeon began to remove the tumor, the brain increased in size and poured out of the brain cavity. The surgeon was devastated. He and the anesthesiologist performed all of the maneuvers to shrink it back to size. It was of no use. More and more brain fungated from the skull. In a fit of absolute frustration, the surgeon gathered a fistful of brain tissue and disgustedly threw it against the wall. Despondent and defeated, the neurosurgeon turned to the resident assisting him and said: “She will not live. Close the skull as best you can.” Overwhelmed by a crushing sense of helplessness, he rushed hurriedly from the room.

It was my night to take care of patients and the neurosurgeon came to me. In a voice filled with anguish and despair, he bared his instruction. “Arthur, she may live a couple of days, but she will not survive. It would be best if you allowed her to die. There is no point in prolonging her suffering.”

An hour later, the patient arrived in the recovery room. Not culpable of any misdeed, her heart and lungs functioned perfectly. Her brain had betrayed her. I, in my innocence, could not let her die. I found I could not neglect her in her hour of need. I meticulously cared for her throughout the night with the concern of a shepherd guarding his injured lamb. I was too inexperienced and naive to do otherwise.

Persistence

For the next month, she became my charge.

Her brother came in daily, cried, stayed for a while, and left. I performed every aspect of her care that required correction.

While her body stayed perfectly intact, she remained in a deep coma. Every morning I would jab a large needle into her left femoral vein and withdraw blood to be sampled. Every afternoon I would make whatever adjustments were necessary. My patient and I endured the ridicule of more

sanguine colleagues who laughed—but did not interfere—with this ritual. I admit that without her active mental interaction, I began to think of her as a “thing” devoid of human qualities.

After more than a month, the neurosurgeon decided to try an operation, a ventricular-atrial shunt, to relieve the pressure in her brain. Since I was her de facto guardian, he allowed me—under his tutelage—to perform the entire operation. I drilled a hole into her skull, inserted a long needle into the right lateral ventricle, and was rewarded with the presence of clear, white fluid. The needle was connected to a thin plastic tube inserted into a vein in her neck. Perhaps futile, perhaps extravagant, the operation was at the very least, an attempt to remedy a catastrophe. Sometimes the human condition demands an act of expiation.

The next morning, to our utter surprise, the patient woke up. She actually sat up in bed, talked to us and ate solid food. Because of her youth, her recovery was rapid. Her sole disability was dyslexia. Everything she attempted to read was backwards. Given the immensity of the alternatives, dyslexia was a small price to pay and no great impediment; her memory was sharp.

Six months later, on a Sunday afternoon, I was invited to her recital at Juilliard. She gave a concert where she sang beautifully.

She possessed a superb, operatic voice, with great control, range and command. Her brother, her only relative, was in attendance.

To me, it was a triumph of perseverance over adversity. Medically, it was probably a miracle. At the reception following her concert, I summoned up the courage to ask her: “Did you feel any of those needles that I stuck into your groin?”

“Yes,” was her response, “and they hurt like hell.” Some 45 years later, and still mindful of this acknowledgment, I never dehumanize a patient.

simply imposing our biases on a defenseless human being? Our response says more about societal values than it does about a legislative or legal maelstrom.

This moral dilemma is even more conflicting today over the subject of abortion. There is little doubt that both sides are sincere in their belief, while the gulf remains irreproachable.

Part of my training took place at Harlem Hospital in New York. Back in the 1970s, Harlem was part of the Columbia Presbyterian system. As interns, we did a one-month rotation on the vascular ward. In those days, vascular surgery at a large city hospital was largely an amputation service. While revascularization was sometimes attempted, it was rarely successful, which led to a number of multilevel amputations.

The huge floor was comprised of large rooms, each of which housed eight African American patients. They were all poor, all alone, and all suffering withered limbs with varying levels of amputations. Wounds would be dressed daily. Healing was slow and their hospitalizations were long. These patients were uniformly cheerful and bore their lot in life with grace and good humor.

After dinner, they would go out on a balcony to smoke, then return to their room to watch—and good naturedly argue over—the Yankees or Mets game on a beat-up television with rabbit ears. After retiring for the night, they would repeat the same sequence the following day.

One afternoon after making rounds and frustrated by any lack of progress of any of the patients, I made a statement to the

I’m not sure that my reverence for the profession is shared by private equity firms that increasingly dominate our medical landscape

The world of vascular surgery

Terri Schiavo was famously a patient in a vegetative state confined to a nursing home in Tampa 18 years ago. She was in a coma for 10 years. She was unable to meaningfully interact with her environment. We really don’t know what Terri Schiavo could perceive.

My patient was in a coma for only a month. Yet Terri’s condition demanded answers as to a timeless question: what is life? More profoundly: how do we respond to individuals who don’t conform to our definition of life? Do we have the right to terminate a life that we don’t find meaningful? Or are we

Arthur E. Palamara

group: “I would rather be dead than live like those patients.”

Our African American attending turned to me with a calm, unemotional voice and said: “Doctor, these patients may not be a White, young doctor from New Jersey with aspirations of becoming a great surgeon, but they have achieved something you don’t yet have. They enjoy a roof over their head, three meals a day, entertainment, and emotional support for each other. Their expectations may not be yours, but they have found contentment.”

In a slightly more forceful voice, he added: “You do not have the right to impose your values on them.”

Our medical landscape

Some people are slow learners. Some years ago, an elderly, very ill patient presented with a contained ruptured abdominal aortic aneurysm (AAA) and acute cholecystitis. It is an understatement to say he was sick and septic. In true Crawfordian fashion, I repaired the aneurysm, closed the retroperitoneum, covered it with omentum, then removed the bulging, necrotic gallbladder. I drained everything. He hung on for several weeks in the intensive care unit (ICU) experiencing multiple complications. He was returned to surgery several times, but the details have been forgotten.

Finally, one Saturday morning, he was again declining, some other problem having cropped up that could benefit from operative intervention. His overly supportive family was at his bedside.

As I explained the alternatives, his daughter with whom I enjoyed a very good relationship said: “Whatever you think is best, doctor. We trust you.”

“We can try. Although he is very ill and may not survive,” I responded.

I walked towards the nurse’s station to book the case with the operating room. His hospital course replayed itself in my mind as I slowly acknowledged that he was not going to survive. I abruptly stopped. Retracing my steps, I re-entered the room.

The family looked at me expectantly. “I think I am operating for myself, not for your father’s benefit,” I explained. It is time to let him go. They cried and hugged me.

The story about the opera singer is true.

The book is called Seizure. It was made into a television movie starring Leonard Nimoy.

As a doctor, I have fought death and illness for too many years to concede even one patient. Unfortunately, I’m not sure that my reverence for the profession is shared by private equity firms that increasingly dominate our medical landscape.

Perhaps I am still imposing my values on others.

ARTHUR E. PALAMARA is a vascular surgeon practicing in Hollywood, Florida, for 44 years. He is active in county, state and national medical organizations.

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CORNER STITCH

BEYOND ‘DO BETTER’: NEW YEAR REFLECTIONS FROM A VASCULAR SURGERY TRAINEE

By Shernaz Dossabhoy, MD

T

he new year is a time for reflection. It is also an opportunity to rededicate, or if needed, reinvent ourselves. Vascular surgery training is long, at least five to seven years for most of us. Most of our reflection happens as we progress from one academic year to the next, and often our self-feedback loop is stuck on do better, go faster, publish more. In the midst of surgical training, we regularly internalize our failures but often fail to savor our victories. This year, I’m trying something new. In business, SWOT (strengths, weaknesses, opportunities and threats) analysis is the gold standard to evaluate performance, reprioritize and reallocate resources, and set future goals. As a current second-year research resident, soon to start year six of seven of vascular surgery training, I’m sharing my own SWOT with you.

Strengths

Leadership, organization, communication: After a recent busy call weekend (during research time, we cover one shift per month as the acting “chief ” resident), operating all night and then rounding on 25 new patients, my attending texted

me: “Great work this weekend, chief! You’ll do well when you come back given your natural attention to detail. Thank you for your help.”

Weaknesses

I have many. First, the Vascular Surgery In-Training Examination (VSITE). Each year, I am determined to do all the Vascular Education and Self-Assessment Program (VESAP) and Vascular Surgery Surgical Council on Resident Education (VSCORE) questions, review Anki flashcards, and score higher than just average on the in-service exam, but to no avail. This year, I’m buddying up with a friend in the general surgery program, and we’ve scheduled weekly study sessions on zoom for accountability. I’m also using Dr. Thomas Creeden’s The Vascular Surgery Review Book. Second, lower extremity distal bypass and upper extremity thoracic outlet syndrome exposures. No matter how many times I review the anatomy, it doesn’t click for me. This year, I am using the Complete Anatomy 3D human body atlas app while I read.

Third, taking on too many projects. Research time has been a

blessing in many ways, but it is also an easy time to over-commit to seemingly disparate research and writing projects and lose sight of what you actually set out to accomplish during the two years.

Opportunities

Anatomy and simulation courses and training. With the continued concerns regarding open surgical training volume, doubling down on program-initiated, regional, or national courses seems like a no-brainer.

This past fall, our program had its first cadaver lab where we worked in teams of senior/junior trainees to cover all the major vascular dissections. I also attended the Midwestern Vascular Surgical Society (MVSS) simulation course, which covered everything from lower extremity bypass to ruptured endovascular aneurysm repair (EVAR), and ZFEN (Zenith Fenestrated AAA endovascular graft) to transcarotid artery revascularization (TCAR). Other courses on my list to attend are the Louisiana State University Fundamentals of Vascular Surgery Symposium, Top Gun skills competition at the Society for Clinical Vascular Surgery (SCVS) annual meeting, Houston Methodist open aortic training course, and the Weill Cornell Big Apple Bootcamp skills course.

Threats

Burnout and letting self-care fall to the bottom of my list.

While I don’t think I have personally experienced burnout, I know that making sure to schedule yoga classes, meal prep,

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CORNER STITCH BEYOND ‘DO BETTER’: NEW YEAR REFLECTIONS FROM A VASCULAR SURGERY TRAINEE continued from page 11 and family time on my calendar (just like all my other work commitments), makes me feel better and more whole. If you are clinical right now, this is hard. But even just fitting in a 15-minute high-intensity interval training video with my coffee in the morning before heading to the hospital, or after getting home from a long day before dinner, can shift my mood entirely.

This year, rather than resolutions, I would encourage you to write out your SWOT analysis and maybe even share it with someone else. Hearing a co-resident’s struggles, and then sharing your own, is a powerful way to connect and combat burnout. Don’t let one bad day, week, or month define you. Vascular surgery also doesn’t define you, but it’s a large part of who we are, who we have chosen to become. It is also a path of continuous evolution.

Just when you’ve mastered one skillset, it’s time to feel uncomfortable again. This holds true through every transition, from intern to second year, second to third year, third year to research time, and research years back to the last two clinical chief years.

So, as I get close to starting up “Heartbreak Hill” with just a little more than two years left in training, I am reminding myself of why I chose and love vascular surgery: our patients have complex disease requiring our creativity and resilience, and yet they accept the redo-redo-redo procedure and remain grateful. We have lifelong relationships with our patients, and we are still the only surgical specialty I know to receive holiday cards and gift baskets from our patients and their families. We are the firefighters of the hospital, the service other surgeons call when they need help. We foster a culture of innovation and research. We are a close-knit community of approximately 3,000 vascular surgeons, who all seem to know each other, somehow.

SHERNAZ DOSSABHOY is a vascular surgery resident at Stanford University in Palo Alto, California.

MAINSTREAM MEDIA DIG DEEPER INTO ATHERECTOMY USE FURTHER REPORTS ON THE USE OF atherectomy in the U.S. appeared in ProPublica toward the end of 2023.

The nonprofit investigative news outlet shared three articles in its latest round of investigations digging into Medicare claims data.

The main article reports on a new analysis of Medicare claims by a team from across both ProPublica and CareSet, a health analytics group.

The investigation found that atherectomies “were performed on about 30,000 patients who had questionable need for them.”—Jocelyn Hudson

DFUs

INTERNATIONAL COLLABORATION UNVEILS UPDATED PAD GUIDELINES IN DIABETIC FOOT ULCERS

By Marlén Gomez

THE INTERNATIONAL WORKING Group on the Diabetic Foot (IWGDF), the European Society for Vascular Surgery (ESVS) and the Society for Vascular Surgery (SVS) have jointly released updated guidelines for the diagnosis, prognosis and management of peripheral arterial disease (PAD) in individuals with diabetes mellitus and a foot ulcer.

The guidelines were developed using GRADE (Grading of Recommendations, Assessment, Development and Evaluations) methodology and were supported by several systematic reviews organized by Vivienne Chuter, MD, professor of podiatry at the University of Newcastle, Australia. The aim is to provide consistent, multidisciplinary and inter-societal recommendations applicable to clinicians everywhere.

SVS President Joseph Mills, MD, affiliated with Baylor College of Medicine in Houston, who co-chaired the writing committee along with Rob Fitridge, MD, of the University of Adelaide, Australia (IWGDF) and Rob Hinchliffe, MD, of the University of Bristol, England (ESVS), shed light on the significant developments.

“This collaboration, with extensive input from multiple specialties, represents a crit-

ical step forward in addressing diabetes-related foot complications across the globe,” Mills said.

Building upon the 2019 IWGDF guideline, the updated guidelines cover a spectrum of crucial aspects of diabetic foot care. The writing committee, consisting of 18 experts from various disciplines, including vascular surgery, angiology, interventional radiology, vascular medicine, endocrinology, epidemiology and podiatry, worked collaboratively to develop recommendations that span the entire continuum of care.

The guidelines were Guidelines jointly published in the Jour- cover nal of Vascular Surgery, the European Journal of Vascular and Endovascular Surgery and Diabetes/Metabolism Research and Reviews.

The guidelines include five critical recommendations for diagnosing PAD in individuals with diabetes, both with and without a foot ulcer or gangrene. Additionally, the guidelines offer five recommendations for prognosis, aiding in estimating the likeli-

hood of healing and amputation outcomes in those with diabetes and a foot ulcer or gangrene.

A comprehensive set of 15 recommendations focuses on PAD treatment, prioritizing individuals for revascularization, selecting appropriate procedures and post-surgical care. The writing committee, conscious of potential gaps in current evidence, also highlighted key research questions for further exploration.

Mills stressed the importance of these guidelines in improving patient care and reducing the burden of diabetes-related foot complications. “By becoming familiar with and following these recommendations, healthcare professionals can enhance their ability to provide better care to individuals with diabetes, ultimately improving outcomes,” he said.

Mills indicated that the international, multidisciplinary approach to developing these guidelines reflects a concerted effort to address the diverse needs of patients with diabetes around the world.

“As healthcare professionals begin to implement these updated recommendations, we hope to substantially diminish the burden of diabetes-related foot complications, reduce preventable, major limb amputations and improve outcomes for individuals worldwide,” said Mills.

OBL SOOVC releases handbook for outpatient care

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he SVS Sub-Section on Outpatient and Office Vascular Care (SOOVC) has released the anticipated Office-Based Lab (OBL) Handbook to guide practitioners and aid with safety and cost-effectiveness, as well as expand patients’ access to care.

Anil Hingorani, MD, chair of SOOVC, emphasized the increasing prominence of outpatient vascular care, constituting over 50% of lower extremity angioplasties. The handbook aims to fill the existing resource void, offering guidance on starting and maintaining office-based labs (OBLs) and ambulatory surgery centers (ASCs), catering to new practitioners and those with established practices.

“We don’t have many resources for how to manage this and develop and maintain these new types of practice models. This handbook is a resource meant to help a new practitioner or even a practitioner who already has an up-and-running OBL or ASC and assist them in maintaining these new paradigms,” said Hingorani.

He highlighted the dynamic nature of the handbook, describing it as a live document that will evolve as the field progresses. This adaptability, made possible by its online format, enables timely updates and additions. Three new chapters have already been added since the initial version, reflecting the field’s rapid evolution. The handbook will have both an online and a print version for accessibility, with the online version available now.

The handbook covers crucial topics for practitioners, including finance, research, anesthesia, equipment and accreditation. Hingorani said the chapters, designed to be concise and focused, feature formats such as bullet points, regular text, pictures and charts that are easy to understand.

Addressing the timeline of the handbook’s creation, Hingorani mentioned that the process began about a year ago, with authors

submitting chapters within a relatively short timeframe, facilitated by their familiarity with the subject matter. The SVS team played a crucial role in the editing process, ensuring the quality of the content.

Hingorani mentioned the challenges practitioners face in the evolving field of outpatient vascular care, mainly focusing on financial considerations, regulations, and ensuring patient safety and quality care.“We want to make certain that these OBLs are financially solvent, and a lot of planning is done before you put the shovel in the ground,” said Hingorani. “Quite frankly, you want to ensure you have a financial plan. Fortunately, this handbook has chapters written by experts who know how to develop those. In medicine, we don’t train our trainees how to do that.”

The handbook authors continuously contribute and provide updates to ensure the handbook remains a comprehensive and up-to-date resource.

Regarding the future of the handbook, Hingorani mentioned the possibility of turning chapters into podcasts, leveraging the growing popularity of audio-based content. The aim is to make the content more accessible for practitioners.

“This is an important contribution and advancement to the field that many of our practitioners are getting increasingly involved with, but more importantly for our patients, it’s quite important because they prefer an effective environment to perform these procedures.”

For more, visit vascular.org/SOOVC.— Anil Hingorani (top) Marlén Gomez and OBL handbook

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AAA

The Aneurisk founders are in the front row (seated from left to right): Nathan Liang, David Vorp and Timothy Chung.

The Aneurisk team (standing left to right) are Pete Gueldner a PhD student, lead software developer Chris Niles, and Micah Guffey, director of operations

University of Pittsburgh awards $100,000 grant to SVS member for AI-based healthcare project

By Marlén Gomez LAST OCTOBER, THE UNIVERSITY OF Pittsburgh’s Clinical and Translational Sciences Institute hosted its 10th Pitt Innovation Challenge (PinCh), providing a total of $550,000 in prizes, with the top-three winners each receiving a $100,000 grand prize. PinCh 2023 announced that SVS member Nathan Liang, MD, and his co-founders Timothy Chung, PhD, and David Vorp, PhD, were awarded $100,000 for developing Aneurisk, an artificial intelligence (AI)-based tool designed to assess the risk and prognosis of patients with abdominal aortic aneurysms (AAAs).

The grand prize teams presented their proposals to a panel of judges at the Petersen Events Center, where six finalist teams and 10 “elevator pitch” finalists showcased their ideas to address critical health issues. The Aneurisk technology aims to reduce adverse patient outcomes and surveillance costs by providing clinicians with a tool to project growth and likely outcomes upon diagnosis.

With their collective backgrounds in clinical medicine, biostatistics, biomechanics, artificial intelligence and machine learning, the team collaborated to utilize a retrospective dataset from UPMC to develop a machine-learning model that predicts patient outcomes after approximately five years.

“The results of our prototype algorithm got us really excited,” said Liang, a vascular surgeon at the University of Pittsburgh Medical Center (UPMC) and assistant professor of surgery and bioengineering at the University of Pittsburgh.

“There is a potential opportunity to use our technology for treating or, at the very least, understanding these aortic aneurysms better. It became clear that this was a technology that could become something, and that’s where we were encouraged by the Pitt Innovation Institute to spin out a startup company.”

Aneurisk focuses on utilizing AI to assess the risk of AAA patients. The patent-pending technology has the potential to revolutionize the field by providing a preliminary prediction of aneurysm behavior, offering clinicians valuable insights

COULD METFORMIN BE FIRST-EVER MEDICAL TREATMENT THAT IS EFFECTIVE AT MANAGING ANEURYSM DISEASE?

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here is a global interest in assessing whether metformin, which has a long track record of safety and efficacy, is relatively inexpensive and is taken by millions of people every day for type-2 diabetes, has an effect on the progression of abdominal aortic aneurysms (AAAs).

The LIMIT trial, a prospective randomized, level one, placebo-controlled, blinded trial, sponsored by the National Institutes of Health (NIH), is designed to investigate whether metformin significantly prevents the enlargement of existing AAAs in non-diabetic people.

“It is difficult to make an asymptomatic patient better. And so, you want a treatment that is not going to be very arduous, and not be very high risk. [It should be] relatively inexpensive, [and] easy to take, and metformin checks all those boxes,” explains Ronald L. Dalman, MD, from Stanford University in Stanford, California, at the 2023 VEITHsymposium in New York City (Nov. 14–18), who invites the U.S. vascular community to get involved in the trial.

“If metformin works in this application, it may also work in secondary treatment

for treatment decisions, said Liang. Work on the technology goes back over five years and led to the recent incorporation of the company in February 2023. Since they started working together, the team has received more than $1 million in funding for research and development.

Chung highlighted the importance of engaging with potential end-users during the development phase. The team spent six weeks contacting vascular surgeons across the country and other potential customers to gauge interest and refine their hypothesis and technology approach. The team expressed their gratitude for the responses received from SVS members who took the time to speak about common pain points in managing patients with AAAs. “We have developed AI tools to accelerate image-based analyses, all while modeling clinical outcomes. Acceleration is critically important in offering point-of-care solutions for identifying which patients are at higher risk,” said Chung.

“The power of the machine-learning approach we are taking is that the prediction algorithm will be trained using many types of data and will determine which types and which specific parameters are critical in forecasting future aortic aneurysm enlargement or even eventual outcomes.

We now know that biomechanics—specifically the balance between wall stress and strength—is important in considering the current risk of aneurysm rupture, but what other factors—and combinations of factors—can predict future rupture accurately now? What groups of parameters can predict future growth or time to critical size for the aneurysm?

When fully constructed and clinically validated, Aneurisk will be able to do this on a patient-specific basis,” explained Vorp.

The Aneurisk team is now seeking additional funding to transition their technology from a proof-of-concept to a practical tool clinicians can use for patients. “I’ve been doing this long enough to know that many people promise a lot, but not everyone follows through. We’re trying to ensure that we’re offering something that meets the needs of patients and our fellow vascular surgeons,” said Liang.

“We have developed AI tools to accelerate image-based analyses, all while modeling clinical outcomes. Acceleration is critically important in offering point-of-care solutions for identifying which patients are at higher risk” TIMOTHY CHUNG

after [a] patient has had endografting to reduce the need for secondary procedures for endoleaks, for graft migration, or aneurysm enlargement. It could be [used] in a variety of applications both as a de novo treatment, as well as an adjunctive treatment following surgery. Here is something that could be a complement to surgical management, both before, during or after surgical intervention,” adds Dalman, who is the Walter C. and Elsa R. Chidester professor and vice chair of surgery for clinical affairs at Stanford Medicine. He is also the inaugural executive editor for the Journal of Vascular Surgery suite of publications.

There is some evidence available, albeit not without its limitations, to support the use of metformin in AAA management.

A systematic review and meta-analysis

of drug repurposing for the treatment of AAA—published online ahead of print the week following VEITH 2023 in the European Journal of Vascular and Endovascular Surgery (EJVES)—indicates that metformin and statins “may provide some effect in slowing AAA progression.”

Authors led by Joachim Sejr Skovbo Kristensen, from Odense University Hospital and the University of Southern Denmark in Odense, Denmark, do acknowledge, however, that “no definitive evidence was found for any of the [12] investigated drugs in this study.”

They posit that publication bias “may have influenced the positive findings,” and go on to stress that “further research is needed to identify effective medical treatments for AAA progression.”— Urmila Kerslake and Jocelyn Hudson

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SOCIETY BRIEFS

Compiled by Marlén Gomez and Kristin Spencer

SVS seeks volunteers for open committee slots The SVS is accepting applications for vice chairs and volunteers. SVS members in good standing can apply for up to two committee positions and serve for a oneyear appointment term renewable for a maximum of three years based on evaluation of performance.

This call for committee members comes with new eligibility terms for committee members and vice chairs. Any Early-Active SVS member in good standing can apply to serve.

In November, membership votes made the change official. The Appointments Committee and Executive Board have expanded the pool of eligible vice chairs to include anyone who has served on a committee within the past six years.

Once the application window closes, the SVS Appointments Committee will review all SVS committees, their leadership and assembled applications, analysing for gaps in knowledge, experience, practice type and diversity. Recommendations that come out of this process will be presented to the SVS Executive Board for approval.

Eligible SVS members can apply for open positions from mid-January until late March.

For questions about eligibility, email governance@vascularsociety.org.

GIVING TUESDAY BRINGS IN FIVE-FIGURE SUM THE SVS FOUNDATION CELEBRATED ANOTHER PHILANTHROPIC success through its Giving Tuesday efforts, raising $20,000 in funds. Presenting sponsor W. L. Gore and Associates doubled the final funds through their match, further magnifying the donations. As a result, Giving Tuesday raised a total of $40,000 for vascular health.

SVS Foundation Chair Michael C. Dalsing, MD, said this day is a beacon of hope and charity, aligning with the true spirit of the holiday season. Notably, this season’s celebration extended to the Foundation’s “Celebration of Science” campaign, transforming into a months-long commemoration in honor of the Foundation’s mission.

“Anytime we have an infusion of funds to this level, it allows us to be more innovative and supportive of existing research grants and potentially to address new research opportunities,” said Dalsing. “It allows us to promote the health of our patients and gives us an opportunity to benefit them in an exponential manner by virtue of cutting-edge research.”

Giving Tuesday messaging, a Celebration of Science campaign component, was spread across multiple media outlets from the Foundation Board of Directors, sharing messages on reasons to donate to the Foundation. Dalsing even braved the social media world to spread the message to his colleagues.

Palma Shaw, MD, chair of the Industry Relations Advisory Committee, praised the donors for their generosity, expressing that the dedication exhibited by supporters on Giving Tuesday had been inspiring. Her goal within her role is to strengthen the relationship between the SVS and industry partners.

Donors can visit vascular.org/ GivingTuesday to learn how to join the celebration and support the Foundation’s ongoing work.

Mentor Match available for all SVS members The SVS has expanded its Mentor Match program, which is now available to all SVS members in good standing. The program aims to connect vascular surgery professionals with experienced mentors who can help them achieve goals.

Mentor Match began in 2019 and was open to medical students and general surgery residents. The program allowed for future vascular surgeons to request a mentor who could provide guidance on their impending career. Between 2019 and 2023, over 200 individuals took advantage of the free program.

The Society’s Membership Section leaders initiated the expansion of the program when they inquired about mentorship opportunities for their Section members in late 2023.

In addition to allowing all members to become mentees, the Society will also enable more members to become mentors.

Interested members can visit SVSconnect.vascular.org to learn more and sign up.

CLINICAL&DEVICENEWS First patient treated in ARISE II study of ascending stent graft GORE HAS ANNOUNCED THE FIRST PATIENT IMPLANTATION OF THE company’s ascending stent graft in the ARISE II trial, describing it as an exciting step in the development of treatments for pathologies involving the ascending aorta using endovascular repair rather than traditional open surgery.

On Dec. 1, national principal investigator Eric Roselli, MD, a cardiac surgeon at the Cleveland Clinic in Cleveland, Ohio, performed the case alongside fellow study investigators: cardiac surgeon Patrick Vargo, MD, and vascular surgeon Frank Caputo, MD. The patient was identified as a candidate for the trial after presenting with a fusiform aneurysm of the ascending aorta and aortic arch.

ARISE II is the first multicenter pivotal study approved by the Food and Drug Administration (FDA) investigating the use of a minimally invasive endovascular device to treat the ascending aorta. The trial investigates the treatment of isolated lesions as well as chronic and residual type A dissections involving the ascending aorta. The Gore ascending stent graft is designed for investigational use in combination with the Gore Tag thoracic branch endoprosthesis.

“The treatment of the ascending aorta has long been a ‘final frontier’ in endovascular surgery. ARISE II is a significant step forward as we search for minimally invasive options that can be offered to higher risk patients,” said Roselli.

The ARISE II study will investigate how an endovascular stent graft, delivered via catheter, may be used to line the diseased portion of the ascending aorta as a potential alternative to open surgical repair. Endovascular technologies have been applied to other regions of the aorta to reduce the risk of complications and recovery times, but no endovascular device is currently approved for the ascending aorta. “Our patient is recovering well. Having a minimally invasive alternative would be a significant advancement for patients not suitable for open surgery,” said Caputo.—Bryan Kay

Humacyte submits Biologics License Application to FDA for Human Acellular Vessel HUMACYTE ANNOUNCED THE submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.

A press release detailed that the BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial, as well as from the treatment of wartime injuries in Ukraine.

The HAV was observed to have higher rates of patency, and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.

The HAV, a bioengineered tissue, is under investigation as an infection-resistant, universally implantable conduit for use in vascular repair.

“Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons and to improve outcomes and reduce complications for patients,” the Humacyte press release reads.

“The HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, which are expected to have the capacity to provide thousands of vessels for treating patients in need.”

Humacyte claims that the HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, also including arteriovenous access for hemodialysis and peripheral arterial disease, in addition to vascular trauma repair.

The company advises that the HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.—Jocelyn Hudson

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Vascular Specialist | January 2024

PAD Serration angioplasty associated with reduced recoil in infrapopliteal arteries compared with plain balloon angioplasty By Éva Malpass

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study comparing the extent of early infrapopliteal recoil after serration and plain balloon angioplasty has found the former produces “substantially less” arterial recoil in the treatment of these lesions and has demonstrated “technical feasibility” in measuring early recoil using standard angiography.

The investigation, led by Venita Chandra, MD, of Stanford University in Stanford, California, as well as Michael Lichtenberg, MD, and Stefan Stahlhoff, MD, of Arnsberg Clinic in Arnsberg, Germany, was driven by the rising prevalence of peripheral arterial disease (PAD), and the rapidly developing arsenal of balloon devices imbued with new technologies, which are aimed at providing more effective treatment options. Recoil following balloon angioplasty of tibial arteries is a known mechanism of lumen loss in this patient population and is considered to be a contributing factor in early failure or later restenosis.

The findings were published online in the Journal of Endovascular Therapy in early December.

The Serranator (Cagent Vascular) balloon, which is designed to provide a controlled lumen gain while minimizing vessel injury when performing percutaneous transluminal angioplasty for PAD, was compared to plain balloon angioplasty. Chandra and colleagues—including first author Arash Fereydooni, MD, a Stanford vascular surgery resident—aimed to assess the ability to define and measure post-angioplasty recoil in infrapopliteal arteries, as well as to compare the two devices’ effect on recoil.

The multicenter, sequential comparative study enrolled patients with lesions of the infrapopliteal arteries who underwent alternating plain balloon angioplasty or serration angioplasty with the Serranator device.

Capturing angiographic imaging pre-, immediately postand 15-minutes following angioplasty, the study core lab measured and analyzed vessel recoil, final diameter stenosis and dissection grade.

A total of 36 patients were enrolled, with 39

infrapopliteal lesions treated. There were no significant differences concerning demographics or lesion characteristics between the Serranator (n=20) and plain balloon angioplasty (n=19) groups. Arterial recoil, defined as greater than 10% lumen loss at 15 minutes, occurred in 25% of Serranator-treated lesions compared to 64% in the plain balloon angioplasty group. The investigators also report that clinically relevant recoil, defined as greater than 30% lumen loss at 15 minutes, was present in only 10% of patients who underwent serration and in 53% of patients after plain balloon angioplasty.

The authors note that, although their study was undertaken to test the feasibility of measuring early arterial recoil, they were able to compare the performance of a serration balloon against plain balloons in a prospective, randomized fashion.

Fereydooni et al conclude that, to their knowledge, theirs is the “first demonstration” of a head-to-head core lab adjudicated angiographic outcome assessment of infrapopliteal artery

“It would be of interest to obtain three-dimensional data using intravascular ultrasound (IVUS) to better characterize changes in area and lesion morphology with serration angioplasty” ARASH FEREYDOONI ET AL

SCAI, SIR, SVS JOINTLY PUBLISH PROCEEDINGS FROM MULTISPECIALTY PERIPHERAL IVUS ROUNDTABLE PROCEEDINGS FROM AN EXPERT consensus roundtable that discussed the benefits of intravascular ultrasound (IVUS) in lower extremity revascularization procedures have been released in the Journal of the Society for Cardiovascular Angiography & Interventions, Journal of Vascular and Interventional Radiology and Journal of Vascular SurgeryVascular Insights.

The roundtable focused on the current challenges in diagnosing and treating lower extremity revascularization, knowledge and data gaps, and the potential role of IVUS in addressing these challenges. Experts shared their insights and experiences from the fields of interventional cardiology, interventional radiology and vascular surgery. The expert consensus meeting was convened by SCAI

and co-sponsored by the American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), Society of Interventional Radiology (SIR), Society for Vascular Medicine (SVM) and Society for Vascular Surgery (SVS).

“Improvements in outcomes following peripheral vascular intervention have lagged compared to other endovascular treatments, such as percutaneous coronary intervention.

Both clinical experience and evidence support the greater use of peripheral IVUS to reduce adverse events and extend the patency of our lower extremity revascularization procedures. By gathering experts from different specialties, we aimed to foster collaboration and exchange ideas to improve patient care for peripheral IVUS,” said Eric A. Secemsky,

recoil between a plain balloon and any specialty balloon. Situating their findings among concurrent research, the investigators highlight the consistency of their results with the earlier PRELUDE (Prospective study for the treatment of atherosclerotic lesions using the Serranator device) study conducted by Andrew Holden, MD, from the Auckland Regional Public Health Service in Auckland, New Zealand, which found one- and six-month patency rates to be 100% and 64%, respectively, between the Serranator and plain balloon angioplasty.

Similarly, Fereydooni and colleagues also point to the single-center PRELUDE-BTK follow-on study, which reported an average final residual stenosis of 17% vs. 34% between the groups.

Fereydooni et al contend that a possible explanation for these favorable results may be due to the serration mechanism allowing for “more controlled and predictable delivery of radial force” compared with plain balloons.

Although their findings may add to a body of literature that favors serration angioplasty, Fereydooni and colleagues underline that their small sample size and the “preliminary nature” of their feasibility endpoints “[limit] the analysis power” for comparing serration and plain balloon angioplasty in specific patient anatomy.

Among other limitations, the authors add that the study protocol did not include an assessment of long-term outcomes of early arterial recoil and how this translates to long-term patency between the two devices.

“It would be of interest to obtain threedimensional data using intravascular ultrasound (IVUS) to better characterize changes in area and lesion morphology with SA [serration angioplasty],” they write.

MD, lead author of the proceedings document.

“The roundtable provided a unique opportunity to identify knowledge gaps and discuss how IVUS can enhance our understanding and treatment of peripheral arterial and deep venous pathology.”

During the roundtable, participants highlighted the potential of IVUS in guiding revascularization procedures, such as angioplasty and stenting, to optimize outcomes for patients. They also emphasized the need for further research and evidence to support the integration of IVUS into routine clinical practice.

“Vascular diseases are complex conditions requiring team-based care, research and information sharing to ensure that patients have access to appropriate, quality care for their condition,” said SIR President Alda L. Tam, MD. “Ongoing collaboration among these specialties is paramount to improving outcomes for patients worldwide.”

The roundtable concluded with a commitment to ongoing interdisciplinary collaboration and knowledge sharing among physicians. Participants agreed that treat-

ment standards, formal training programs and global quality metrics are needed to improve patient care.

The considerations and consensus views shared in “Intravascular ultrasound use in peripheral arterial and deep venous interventions: Multidisciplinary expert opinion from SCAI/AVF/AVLS/SIR/SVM/SVS” represent the opinion of the consensus committee members.

The published document identified future directions and needs in the arena of IVUS, including plugging data gaps, reinforcing educational efforts and changing perceptions of IVUS, as well as establishing appropriate use.

“IVUS is an important tool for many aspects of peripheral vascular intervention, but its utilization remains low,” the authors write in an outlook statement at the close of the document.

“Closer interdisciplinary collaboration at all levels will be crucial to ensure continued growth of IVUS utilization by appropriately trained and informed physicians, in a sustainable application of the latest data to patient identification and process optimization with supportive reimbursement.”—Bryan Kay

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BEST-CLI: A YEAR DOWN THE ROAD

By Jocelyn Hudson A DEDICATED SESSION AT THE 2023 VEITHsymposium (Nov. 14–18) in New York City aimed to unpack the ways in which clinical practice and attitudes in the field of chronic limb-threatening ischemia (CLTI) have changed since the BEST-CLI trial was published back in November 2022. The trial’s principal investigators (PIs)—Boston-based vascular surgeons Alik Farber, MD, and Matthew Menard, MD, and interventional cardiologist Kenneth Rosenfield, MD, also of Boston—invited a multidisciplinary panel of opinion leaders from both the U.S. and Europe to share their thoughts and highlight some unanswered questions.

‘We don’t cure these people’

First to comment was vascular surgeon Peter Schneider, MD, from the University of California San Francisco in San Francisco.

“One thing I think is worth calling out is the change over one year,” he began. Schneider recalled that, during a 2022 VEITHsymposium session on BEST-CLI, “everybody was worried in some way” about what was going to happen next. A year later, however, he pointed out that “that’s melted away completely.” This change in opinion, in Schneider’s view, is testament to the leadership of the three PIs. Schneider’s main point was that BEST-CLI has contributed to a recognition that CLTI treatment is “much more complicated” than revascularization alone, predicting that the field is “going to become more like cancer treatment.” He continued: “These people have cancer. It was clear to all of us how sick they are, but now it will be clear to a much broader audience” Vascular surgeon and SVS President Joseph Mills, MD, from Baylor College of Medicine in Houston, expanded on Schneider’s point. “This cancer analogy works really well,” he said. “We don’t cure these people, and what we want to do is try to put them in remission for as long as possible.” Here, Mills advocated the use of endpoints that look at disease-free survival and wound-free period, suggesting they are probably the most useful for assessing long-term outcomes. “We should start looking at what’s better for [patients’] long-term care and not even one- or two-year results, but what happens over the lifespan of that patient,” he said.

Antiproliferative therapy key

Interventional radiologist Robert Lookstein, MD, from Mount Sinai Health System in New York, echoed Schneider’s sentiment that “the discourse [around BEST-CLI] has become more constructive than deconstructive” over the course of the past 12 months, in large part thanks to the trial leadership.

He was keen to stress, however, that it is “obviously concerning” BEST-CLI reached different outcomes to BASIL-2, presented in April 2023. “It should be recognized they’re

studying different populations,” he noted.

Lookstein also highlighted the fact that there were very few women and underrepresented minorities enrolled in these two trials, urging caution with regard to extrapolating the results to these specific demographics.

Lookstein’s pointed to the importance of antiproliferative therapy. He referenced a retrospective analysis presented earlier in the session by vascular surgeon Michael Conte, MD, from the University of California San Francisco, that suggested the endovascular arm of BEST-CLI “would probably have better outcomes” had the endovascular protocol been standardized with the level one evidence available on antiproliferative therapy and the infrainguinal circulation. “We have massive amounts of data [showing] that [antiproliferative therapy] is superior to non-antiproliferative therapy,” he stressed, asking why—against this backdrop of evidence— any vascular specialist would withhold this technology from their patients.

Rosenfield, from Massachusetts General Hospital, pointed out that if he were to place a bare metal stent in a coronary vessel, “that would almost be malpractice nowadays.”

Menard, of Brigham and Women’s Hospital, also picked up on Lookstein’s point, saying that one of the very important current challenges is that of “how to get the best endo[vascular] and the best surgery out there.”

Lookstein added: “I think it behooves all of us to either lobby the guidelines or to speak out.” He mentioned the “profound” data presented by Conte on the impact of antiproliferative therapy on patency. “I firmly believe drug-coated balloons and stents must be considered the standard of care at this point.”

Put the patient first

Vascular surgeon Elizabeth Genovese, MD, from Penn Medicine in Philadelphia, noted the endovascular-first nature of her clinical expertise, which stemmed from the fact that she had worked for five years in the southeast of the U.S., where her patients had been “very medically complex and often poor surgical candidates.”

Once BEST-CLI was published, Genovese stated that she moved to offering a more “patient-first” approach. Now, she relayed, her practice is framed around the question of which patients fall into the BEST-CLI cohort that does well with bypass first compared to an endovascular-first approach. “These are the patients who not only have good vein, but that tend to be on the healthier spectrum of the patient population; these are the patients that I didn’t necessarily see in the first five years of my practice,” Genovese noted.

“But simultaneously, the patients in the open cohort had a fairly high anatomic complexity,” she added, referencing that over 60% of patients had infrapopliteal targets and 51% of the endovascular arm required tibial interventions. “What this study has done for us is made us realize that, in the right patient population, in more complex anatomic patients, bypass first remains still a really good and durable option,” Genovese summarized.

Responding, Rosenfield stressed that “we need to be better about case selection for all of our techniques.”

Alik Farber presents data from BEST-CLI for the first time in November 2022

“I think we need to create the spaces where we can come together and discuss how best to [treat these patients],” he said.

“The single most important thing that I learnt from the trial was the fact that when we had a patient with CLTI come into our facility, we would be forced to look at [the case] together,” Mena-Hurtado added. “We continue that practice up until today, and I think it has made not only our outcomes better, but our patients better.”

‘There’s more work that needs to be done’

“The discourse [around BEST-CLI] has become more constructive than deconstructive” ROBERT LOOKSTEIN

No more silos

Interventional cardiologist Carlos Mena-Hurtado, MD, from Yale School of Medicine in New Haven, Connecticut, remarked that—for him and his institution—BEST-CLI had been “incredibly important” because “it made us come out of silos and it made us understand [...] that CLTI is more than simply just revascularization.” He stressed that, while there is “a lot of work to do,” it 4.5”not x 5.625” is 01: important to put blame on each other.

Vascular surgeon Maarit Venermo, MD, from Helsinki University Hospital in Helsinki, Finland—who noted that her center was the first site outside the U.S. to join the trial—pointed to the “huge number” of future studies in the works, which she believes will inform decisions around which treatment is best for which subgroups of CLTI patients. “Also, there will be a population who don’t benefit from endo[vascular] or surgery,” she added, stressing the importance of taking this into account when making clinical decisions.

Farber, of Boston Medical Center, also encouraged audience members to look ahead to what is next, stressing that BEST-CLI and BASIL-2 are just the start. “No matter what your views are on [BEST-CLI] or BASIL-2 [...], the exciting thing is that we have data coming in this space, which did not have a lot of data [before],” he said. Farber said more work needs to be done, with the “top priority” now to “harmonize” BEST-CLI and BASIL-2 using patient-level data. “It’s an exciting time,” he added.

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

21373436-EN-VSX-Indications-Ad.indd 1

12/8/21 11:10 AM

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.

Complex patient population2

Gore Japan Post-Market Clinical Study1

▪ 24 cm average lesion length

Patency (%)

100

80

82.3% 74.1%

60

62.4% Secondary patency Primary assisted patency Primary patency

40

20

0

N at risk at start of interval

309 309 309

244 234 218

203 188 166

152 140 119

111 103 89

0

12

24

36

48

60

▪ 70% chronic total occlusions ▪ 27% critical limb-threatening ischemia ▪ 48% TASC II D lesions

Time after index procedure (Months) * As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.

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