Vascular Specialist–December 2020

3 INTERVIEW SVS president Ronald L. Dalman, MD, reflects on year of adversity and positive change

Vol.16 No.12 DECEMBER 2020

Featured in this issue:

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FROM THE EDITOR COPING WITH LOSS DURING COVID-19

DIABETIC FOOT WOUNDS PATIENT-CENTERED MEASURE 'TOO STRICT'

NEW TECH SVS LAUNCHES TRIO OF APPS FOR CLTI

COMMUNITY PRACTICE

OBL Community surgeons discuss surviving private practice in office-based labs

BY BRYAN KAY

vascular practice as they ran through topics from how to start an OBL and how to make one a success.

“One question that remains is whether OBLs are a necessity to survive?” moderator Philip Paty, MD, a vascular surgeon at Vascular Health Partners of Community Care Physicians in Queensbury, New York, told attendees listening in on a special community surgeons session and panel. “Regardless, in the United States nearly 70% of vascular procedures are performed in an outpatient setting. Market share analysis data show that the OBL market size was $8.5 billion in 2019 and is expected to have a compound annual growth rate of 9% from 2020 to 2027. On the other hand, the hospital industry is expected to grow at an annualized rate of 3%, and it is the outpatient

Vascular Specialist 9400 W. Higgins Road, Suite 315 Rosemont, IL 60018

OUTPATIENT SETTINGS LIKE office-based laboratories (OBLs) have attracted increased scrutiny in recent times amid efforts to shine greater light on appropriateness in care. During the COVID-19 pandemic, they have been among some of the hardest-hit private vascular surgery practices as the virus wrought havoc on healthcare delivery and economic vitality across the U.S. They also encompass a major portion of the Society for Vascular Surgery (SVS) membership ranks: The vast majority of SVS members are associated with practices that include outpatient care options such as OBLs and ambulatory surgery centers.

But just how crucial a setting are OBLs to the vascular surgery universe?

The recently concluded virtual annual meeting of the Eastern Vascular Society (Oct. 7–Nov.18) sought to provide an answer for this fundamental sector of

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FROM THE EDITOR

Present imperfect

BY MALACHI SHEAHAN III, MD

ON THE MORNING OF NOV. 9, I RECEIVED a phone call from my sister. My father had been found unresponsive in his Manhattan apartment and was being taken to the hospital. Ok, I told her, call me when you know which one. I was rattled but optimistic. They don’t take dead people to the hospital. I knew vascular surgeons at most of the major New York City medical centers. Hopefully, they would bring him to one of them. I have relied on this network before when I couldn’t be there in person for my family. Minutes later, my sister called back. She couldn’t speak. He was gone.

When we spoke again, she was at his apartment with the medical examiner. My father was in good health at 75 years old. He went to the gym daily and was not on any medications. He had just gone to sleep and never woke up. I had already canceled my clinic and made preparations to fly up to NYC, but, as I spoke with my sister, one thing became clear. I wasn’t going anywhere.

In the NYC of November 2020, there are no wakes, no funerals. I couldn’t even get into his apartment to go through his things. Since my mother had died years earlier, his place would be locked by the police until his will was certified—a process which could take weeks.

I slowly realized I would not see him again. There would be no embalming since there was no wake. He was to be cremated that evening. “I can take a picture of him?” my sister offered helpfully. “Yes, ok,” I said, before: “Wait, no. Do NOT do that!” Walking around with a picture of my father’s body on my phone was not going to help this situation.

My sister found his “will.” It appears my father, ever the pragmatist, had simply copied my mother’s, crossed her name off, and replaced it with his own. Good thing we were not dividing up the Vanderbilt fortune. He had also left some handwritten instructions, prepared years earlier. These were composed in the manner of a parent who was used to getting disobeyed. Amid his fiscally and legally dubious instructions on closing his retirement accounts, there were directions to bury him next to our

VASCULAR SPECIALIST 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 Hans-Henning 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 Laura Drudi, MD Executive Director SVS Kenneth M. Slaw, PhD Director of Membership, Marketing and Communications Angela Taylor Managing Editor SVS Beth Bales

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mother. The phrasing suggested he expected us to grab a couple of shovels and get it done ourselves.

With no opportunity for closure, I didn’t know what to do. I just went back to work. Guilt came in waves. When did we last speak? I checked my phone: Halloween. Not terrible, but not great. I try to stay in frequent contact, but, as you all know, sometimes the days just bleed. We had seen each other very little this year. Before the pandemic, my father would visit frequently, delighting in spending time with his grandchildren. Although having only female siblings and raising just my sister and me, I think my father was woefully unprepared for the violence and property damage that comes with watching three boys. He had planned to attend the Vascular Annual Meeting this year in Toronto to help mind our children. He wouldn’t have even complained when he found out a few other vascular surgeons would be dropping off their kids as well.

As it disrupts travel and gatherings, the pandemic also interferes with our pathways of communication. After the first wave of condolences from our extended family, people I didn’t know started to reach out, looking for their friend. There were a lot of them; my father was the mayor of everywhere. Since we have the same unusual name, I was easily found on Google. Calls kept coming into my office with a similar story: I’m looking for your father; he hasn’t called me back in a few days. My emails exploded with inquiries about my father and a swarm of fervent EPIC suspension notifications since I had dared not to open my inbox for 12 hours.

There are losses more objectively tragic than a 75-year-old father, such as a child or spouse. At 51 years old, I am still clinging desperately to the “gone too soon” demographic. Regardless, there is something indescribably disorienting about a parent’s death. It’s like losing a limb. You wake up one morning, get out of bed, then BAM, your face hits the floor. Where the #$%^ is my leg? It’s been there my entire life. There is a feeling of being erased. Your early memories become fragile, as

you are now their sole caretaker. For my children, this is their first real experience with losing a loved one. One day they had a grandfather, then I told them they didn’t.

They have no context in which to mourn.

Psychologists place great emphasis on the object permanence milestone, but object impermanence is the more brutal lesson. My experience is now familiar and commonplace. Hundreds of thousands of Americans have lost a parent during the pandemic. Our usual methods of closure have been stripped from us. People are dying in isolation, and the ones they leave behind must often grieve alone. Our failure to control the pandemic has had profound psychological consequences beyond the endless death toll. Our country has risen to similar challenges before, and I believe it will again if we learn from the mistakes we made this year. To accomplish this, we must create a complete account of the costs we have endured.

Malachi Sheahan III is the Claude C. Craighead Jr. professor and chair in the division of vascular and endovascular surgery at Louisiana State University Health Sciences Center in New Orleans. He is the medical editor of Vascular Specialist.

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DECEMBER 2020

INTERVIEW

President Dalman reflects on year of adversity—and positive change

BY BRYAN KAY

The last nine months took away much. The Vascular Annual Meeting (VAM) was canceled. The Vascular Research Initiatives Conference (VRIC) suffered a similar fate—its content latterly resuscitated in virtual form last month. The traditional Society for Vascular Surgery (SVS) presidential handover, too, followed an unorthodox route.

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ut if there have been sources of comfort on which to draw despite the challenges posed by COVID-19, for president Ronald L. Dalman, MD, recipient of the SVS baton amid the pandemic, it might be in the coalescence of ongoing SVS work on the identity of vascular surgery and broader cultural currents. This presented an opportunity for SVS introspection and to take a fresh look at what its role as a membership group should be. So much has happened in these months. And much of it has been viewed as positive change.

He might be the least traveled SVS president in the history of the Society.

Yet, the story of his first six months at the helm might be understood as a narrative of great distance covered.

It kicked off at SVS ONLINE. Dalman announced his presidency in the guise of the E. Stanley Crawford Critical Issues Forum. The intention was clear: Vascular surgery faces existential challenges. So themes of branding, the valuation of vascular surgery and its absence as a standalone specialty in national healthcare league tables took center stage. As 2020 draws to a close, Dalman is starting to see his presidential agenda and longer-term SVS priorities gain traction.

“We’re telling our story: who we are, what our role is in healthcare,” he tells Vascular Specialist. “I mean, we know that, largely. But so many of our colleagues and peers both inside and outside of our profession don’t. And all of this helps to internally validate the sense of belonging and purpose and ambition with our members by pursuing this particular agenda. Oddly enough, even though there is no travel this year—I have to be the least traveled SVS president since the dawn of the jet age—the silver lining in this cloud is it has really helped us focus internally: how the organization can be structured, how we can deliver on our responsibilities to our members, how we make everybody feel as though they have a significant opportunity within

DECEMBER 2020

SVS to build their career and realize their ambitions. I think it’s actually turned out to be a good opportunity for that because there are so many other things that would traditionally be expected during a presidential year. So that internal focus, that restructuring and extending the promise that we think the SVS holds for all of its members to the entire membership, has been really worthwhile.

We hope to optimize this within the next six months.”

Uncertainty Member practice concerns are front and center. “We have received a lot of communication from our members about their challenges with their practices, some of which predated the pandemic, but others which have occurred since and been amplified by some of the consequences of the pandemic,” Dalman continues. “More than anything else, our membership is looking for us in the SVS to help them navigate uncertainty, to work more effectively within their local medical environment, their health system, work with their health system leadership, colleagues, peers, and support the specialty to try to get a better sense of what vascular surgeons do, what our contributions are.

All of those questions have been thrown into sharper relief by the events of the last nine months or so. I think, in retrospect, the Crawford Forum was well positioned to at least start to answer some of those questions. The branding toolkit is part of that; we have a couple of our members on the Executive Board who are in community practice

who have really embraced the tools of the branding toolkit to leverage their practice with their peers and local environments.”

Other issues, too, brought the SVS closer to cultural shifts in wider public life. The furor around the controversial paper on the social media activity of young vascular surgeons published in the Journal of Vascular Surgery is a case in point. Dalman pinpoints what those shifting sands meant as the SVS moved to make changes.

“We have made major changes in the structure in the Journal of Vascular Surgery, for example, to try to make it more representative of our membership and include individuals who clearly are qualified but have not been included in the internal processes of the journal,” he explains. “We’ve also created new committees and governance-level structures. We’ve done a lot to level the playing field in terms of access to leadership and success within SVS. But I think it is incumbent upon us now to demonstrate to the membership that these changes are impactful and will make a significant difference.”

Down the road into 2021, the SVS is currently scheduled to host an inperson VAM in San Diego in June. But with COVID-19 again surging—yet the prospect of widely available vaccination leading to hopes of a return to normal life—the return of physical conferences remains difficult to nail down on the calendar. Looking back over 2020 and SVS ONLINE, the digital replacement for VAM, Dalman sees a successful event pulled off amid trying circumstances. In many respects, he views SVS ONLINE as having led the way in producing highquality scientific and educational content as conferences hastily re-purposed their agendas for digital platforms.

But there were deficits, he admits, shortcomings perhaps only in-person meetings can replicate.

“We’ve done a good job of bringing our content online and trying to maintain the educational agenda that we typically provide,” Dalman says. “The content at SVS ONLINE was outstanding and served our members well in terms of keeping them up-to-date with what’s new and changing in vascular surgery.

And [in early November], we had the VRIC conference, which resuscitated the abstracts from the meeting that was supposed to happen in the spring.

That had an excellent attendance and interactive discussion. That responsibility and access to programming and content has been moving along reasonably well in the absence of in-person meetings.

“What hasn’t happened is the ability to connect with your fellow members, and benchmark yourself versus what everybody else is doing—to use a wellused phrase: ‘to get the rest of the story’ behind what you might read in a manuscript. That’s where I think the virtual educational platforms have not really been able to replicate the in-person experience.”

Bringing the community back together remains the aim, but the prospect of a hybrid meeting or another fully digital conference can’t be ruled out. “VAM has been the heart and soul of our organization since it first started in 1947—poignantly enough, we were going to begin this year the celebrations of the 75th anniversary of the SVS,” added Dalman. “We will do everything we can to have an in-person meeting but there is a reasonable probability we won’t be able to have it, though it’s too early to say right now. If it’s possible, we will do it.”

“Extending the promise that we think the SVS holds for all of its members to the entire membership has been really worthwhile”— Ronald L. Dalman

vascularspecialistonline.com • 3

COMMUNITY PRACTICE

COVER STORY

OBL: Community surgeons discuss surviving private practice in officebased labs Continued from page 1

services within the hospitals that are forecasted to experience the most growth, approximating 8%.”

When compared to in-hospital settings, Paty added, procedures in OBLs “not only reduce the overall cost of vascular procedures to the healthcare system but are also reported to result in better patient and healthcare provider experience and satisfaction.”

The increasing presence of OBLs was something acknowledged by Kim Hodgson, MD, the immediate past president of the SVS, in an October interview with Vascular Specialist as he discussed appropriateness in care and the specter of practice outliers both among members of other specialties carrying out vascular procedures and vascular specialists themselves.

Suitability Which recalls a key question posed

by Paty to the panel of community surgeons: What should and shouldn’t be done in the OBL setting?

Jonathan Levinson, MD, a partner in the Cardiovascular Care Group in Springfield, New Jersey, and a member of the panel, provided an answer.

“It’s really those patients that, No. 1,

are nursing home patients that require attendants to be with them, that can’t communicate with us,” he said.

“So they have to be somewhat walkie-talkie patients. With regards to the patients that have multiple comorbidities that are out of control, such as significant renal insufficiency, with our lower-extremity revascularization cases, those are ones that would be better suited to optimize in the hospital.”

Yet, complications are an omnipresent consideration. The specter of planning in the face of a disaster in the OBL bears description. Clifford Sales, MD, managing partner of the Cardiovascular Care Group, another panelist, points first to the need for Advanced Cardiovascular Life Support (ACLS) certification. “And really ACLS-certified, not just going on the course—you’ve got to know what you’re doing,” he said. “Our patients are sick as hell, as everyone knows.

Two days ago, we had a patient come into the office—not even the suite—who coded in the exam room.”

Often, Sales highlighted, tending to nonpatients in the vicinity is an important function. “We run a drill a couple of times a year where one person goes outside to flag down and wait for the ambulance,” he explains. “Another person takes care of the waiting room, and another person takes care of the people in the pre-op and post-op area. All the medical stuff goes on at the bedside, obviously. You’ve got at

BY BRYAN KAY

A research team in Dallas demonstrated the successful operation of transcarotid artery revascularization (TCAR) in a community practice setting, reporting results in line with large-scale TCAR trials. mong the 279 TCAR procedures the investigators analyzed, they found a major adverse cardiac event rate of 2.5%, a stroke rate of 1.1%, and a 0.7% mortality rate. This

4 • Vascular Specialist

Philip Paty

Complications

Study: The ‘successful’ operation of TCAR in a community practice

A

Jonathan Levinson

Clifford Sales

Michael Schwartz

Sean Wengerter

least two or three people, a doc and two nurses, an X-ray tech. Just having that drill, even though it’s a verbal drill, [is important].”

Finances Elsewhere on the panel, Michael Schwartz, MD, a partner at Rockland Thoracic & Vascular Associates in Pomona, New York, ran through some financial realities.

“In an OBL, you’re basically getting one payment for every procedure,” he said. “You want to do what’s best for the

compares favorably with the rates found in the multicenter ROADSTER and CREST trials, the researchers reported. In the case of ROADSTER 2, the equivalent major rates were 1.7% for major adverse cardiac events, 1.4% for strokes and 0.2% for deaths.

The results were presented at the virtual annual meeting of the Texas Society for Vascular and Endovascular Surgery (TSVES), held Nov. 6–7, by Ashlee Vinyard, MD, a vascular surgery fellow at Baylor University Medical Center in Dallas. The research team included Texas Vascular Associates partner William Shutze, MD, chair of the Society for Vascular Surgery (SVS) Clinical Practice Council.

“This report demonstrates that a TCAR program can be successfully launched in a community setting with results comparable to the large-scale TCAR trials and nationwide registries”— Ashlee Vinyard et al

patient, but at the end of the day, using a bunch of balloons and stents, you’re losing money—and that’s not the goal.

The goal is to take care of the patients, and then do well financially. To that end, we really don’t monitor each doctor individually; we don’t have protocols, either. But what we do is audit everyone occasionally, just to see if there are any outliers.”

Back at the baseline, the idea of an OBL dimension to medical training was put to the last remaining panel member, Sean Wengerter, MD, also of Rockland Thoracic & Vascular Associates. “It’s hard to add another thing like contract negotiations [but] I think OBL would be great,” he said. “Looking at the numbers presented here—the number of OBLs, the percentage of cases that are done of vascular cases in them, and the good patient care that I’ve experienced being able to give in the OBL setting—I think the key is good training, good case selection, good case management, good skillset.”

As for the OBL overall direction of travel? Moderator Paty produced a snapshot in his session introduction.

“The rising trend of endovascular procedures coupled with the increasing prevalence of vascular disease, favorable outcomes in OBLs, patient preference, physician autonomy and ownership, and substantial reductions in the overall healthcare cost for procedures done in OBLs, are responsible for driving the increased demands for office-based procedures. Its longevity will center on our ability to prioritize patient safety and outcomes,” he said.

The researchers set out to produce data to help fill a void of reported TCAR experience from the communitybased practice environment.

They retrospectively reviewed 281 patients undergoing TCAR from December 2016 to February of this year. The subtraction of two conversions left 279 cases in the study.

Association between 30-day major adverse cardiac events and continuous variables were evaluated.

High-risk anatomic factors included an age of 75 or greater (135), high lesion (103), hostile neck (50), postcarotid endarterectomy restenosis (32), bilateral stenosis requiring treatment (14), spine immobility (12), laryngeal nerve palsy (10), tandem stenosis (5) and contralateral occlusion (1). The researchers reported that 50.5% were asymptomatic.

The study revealed a total of seven perioperative events from the cohort (three strokes, two myocardial infarctions and two deaths). Mean procedure time was 50.46 minutes.

ROADSTER 1 reported 73.6 minutes, the researchers said.

Additionally, they reported that preoperative imaging with ultrasound only was safe without increasing the risk of major events.

“This report demonstrates that a TCAR program can be successfully launched in a community setting with results comparable to the large-scale TCAR trials and nationwide registries,” they concluded. “In our experience, performing the procedure under local anesthesia increases the risk of [major adverse cardiac events] but duplex ultrasound was found to be safe for preoperative imaging and case planning.”

DECEMBER 2020

VETERANS AFFAIRS

The benefits of an academic research career in the VA

BY SHIPRA ARYA, MD

Every year a number of graduating vascular trainees look for jobs in academic surgery to develop a career as a surgeon-scientist in basic, translational or health services research. The current era of productivitybased compensation and competing demands in clinical, teaching, research and administrative responsibilities pose significant challenges to that career path.

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ut the United States Department of Veterans Affairs—the VA—provides a supportive environment like no other in academic surgery with protected time, dedicated resources and funding for research.

VA research has three overarching strategic priorities: increasing veterans’ access to high-quality clinical trials, increasing the real-world impact of VA research and putting VA data to work for veterans.1 The VA Office of Research and Development (ORD) consists of four research services.2 The Biomedical Laboratory Research & Development Service (BLR&D) supports preclinical research on animals, tissues and biological specimens from humans to further understanding of health and disease from a molecular, genomic and physiologic standpoint.

Clinical Science Research & Development Service (CSR&D) encompasses all human volunteer research and clinical trials to study new treatments and improve clinical practice. Within this division, the Cooperative Studies Program (CSP) conducts large multicenter clinical trials.

Health Services Research & Development Service (HSR&D) sponsors research to study quality, access to care, cost and outcomes to improve healthcare delivery for veterans.

Unlike the National Institutes of Health (NIH), the VA will support research on cost effectiveness of therapies and budget impact analyses for programmatic evaluation. And Rehabilitation Research & Development Service (RR&D) focuses on innovative research to restore function and decrease disability in veterans.

Each division has multiple centers of excellence nationwide that can be excellent resources for new and existing surgeoninvestigators as they set up labs and secure funding.

The core research funding award mechanisms for surgeons are the Career Development Awards (CDAs) and the VA Merit Review Awards. These federally sponsored grants provide substantial salary support, ensuring protected time for research, and are awarded exclusively to investigators with VA appointments.

The CDA program is intended to attract, develop and retain talented researchers to the VA.3 Candidates must be United States citizens. The CDA-1 is akin to a postdoctoral award and offered only by RR&D. The CDA-2 is the main award mechanism for junior surgical

6 • Vascular Specialist

faculty. It is offered by all four services and provides three Computing Infrastructure (VINCI) platform.4 to five years of salary for research funds under appropriate The VA Surgical Quality Improvement Program mentorship within the VA. This is a considerably higher (VASQIP) database captures cardiac and noncardiac level of research support than NIH K awards. It is ideal to surgeries at all VA facilities. This was the first national have at least one mentor who is VA-Merit funded. surgical registry and was the template used to develop the While applicants needn’t be VA-appointed, they do need private-sector American College of Surgeons-NSQIP. The a VA appointment to be funded. Surgeons can receive up VASQIP data has many advantages, as data can be linked to to 75% of salary support. They must also contribute 1/8 center information and CDW data to answer hypotheses or 2/8 full-time equivalents to clinical service. CDA awards that are not possible through ACS-NSQIP.5 come with full VA indirect cost payments, thereby strongly The Million Veteran Program (MVP) is the largest incentivizing local VAs to support them. biobank in the world, collecting genomic information on Merit Review grants are similar to independent research a million veterans. This program provides another unique parent R01s. Funding generally is for two-to-four years and exciting opportunity for VA investigators interested in and investigators need to be at least 5/8 in studying genetic influence on health terms of their VA appointment. The budget is and disease.6 approximately $1.2 million for four years for VA Clinical Assessment, Reporting and most services and $1.5 million for studies with Tracking System for Cath Labs (CART) collects multi-site exemptions. information for all invasive cardiac procedures There are multiple other pilot awards or performed by cardiologists at VA medical focused Request For Applications (RFAs) sent centers. The program maintains an independent out each year, typically oriented around VA research and publications committee that strategic priorities and new efforts. reviews proposals from VA investigators on a The VA’s many rich data sources can be used semi-annual basis.7 by vascular surgical investigators for a variety Shipra Arya VA investigators and the VA CSP have of research and operational projects to build always contributed to important trials in their research programs. vascular surgery, influencing the management of vascular The VA Corporate Data Warehouse (CDW) is a large disease.8–11 Two very important vascular clinical trials have repository of veteran data nationwide, including diagnoses, numerous VA sites and VA investigators as site principal procedures, pharmacy, orders, labs, microbiology, investigators (PIs). physiologic measurements and text documents. Data can The sites are recruiting veterans to answer research be queried and analyzed using the VA Informatics and questions that will influence management of chronic limb

The ability to care for veterans and perform impactful research that improves both veterans’ lives and those of vascular patients at large is a calling and a privilege. threatening ischemia (CLTI) and carotid disease for many years to come. The trials are BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia)12 and CREST-2 (Carotid revascularization and medical management for asymptomatic carotid stenosis trial).13 A number of VA vascular surgeons are PIs of active large national trials, including Panos Kougias, MD, on the TOP (Transfusion trigger after operations in high cardiac risk patients) trial, comparing liberal vs. restrictive transfusion strategies for high cardiovascular risk patients undergoing surgery;14 and Philip Goodney, MD, for PROVE-AAA (Preferences for open vs. endovascular repair of abdominal aortic aneurysm) to test if a decision aid can better align patients’ preferences and their treatment type for AAA.15 The ability to care for veterans and perform impactful research that improves both veterans’ lives and those of vascular patients at large is a calling and a privilege.

As the largest nationalized healthcare system in the U.S., the VA will continue to be an important part of training and career development for surgeon-scientists. (The references for this article can be accessed at vsweb.org/VA1220references.)

Shipra Arya is a member of the SVS VA Surgeons Committee.

DECEMBER 2020

AORTA

Active stent-graft fixation below the renal arteries may have least effect on aortic neck degeneration, study finds

BY BRYAN KAY

Stent grafts with active fixation below the renal arteries as well as oversizing by less than 10% seem to have the least effect on aortic neck degeneration over time, according to a research team who conducted a retrospective review of all endovascular aneurysm repairs (EVARs) for abdominal aortic aneurysms (AAAs) carried out at their parent institution over a 10-year period.

A REVIEW OF THREE TYPES OF graft fixation—infrarenal active, suprarenal active and suprarenal passive—showed that the suprarenal active fixation method led to greater diameter in both suprarenal and infrarenal aortic neck measurements.

Additionally, graft oversizing greater than 15%, and grafts larger than 28mm, also led to larger increases in suprarenal neck measurements. At four years, the change in aortic neck diameter was statistically significant among those with oversizing greater than 15% compared to two other groups: those with oversizing between 10–15% and those with less than 10%.

The results were part of a study led by Carlos F. Bechara, co-director of Loyola

University’s Center for Aortic disease in Maywood, Illinois, that looked into the effect of stent-graft active fixation and oversizing on aortic neck degeneration after EVAR. Lillian Malach, BS, a fourthyear medical student at Loyola, delivered the findings during the Midwestern Vascular Surgical Society (MVSS) annual meeting (Sept. 9–12).

Aortic neck degeneration post-EVAR has been implicated in the long-term development of endoleaks and subsequent reintervention, Malach explained.

“Optimal endograft sizing is a vital aspect of successful repair; however, outside of manufacturer recommendations, there really is no consensus regarding the

F-BEVAR performed on women shows ‘lower’ level of technical success

BY BRYAN KAY

Fenestrated-branched endovascular aneurysm repair (F-BEVAR) for thoracoabdominal aneurysm (TAAAs) carried out on women “demonstrate metrics of increased complexity and have a lower level of technical success, particularly among patients with higher extent aneurysms,” a research team in Seattle found.

“COMPARED WITH MEN, WOMEN HAD SIMILAR 30-day mortality and one-year outcomes, with the exception of an increased rate of sac expansion,” the investigators said. “These data demonstrate that F-BEVAR is safe and effective among women and men,

DECEMBER 2020

optimal oversizing of a graft.”

A total of 400 patients who underwent EVAR at Loyola between 2006 and 2015 were analyzed, from which 154 Lillian Malach were included after exclusions.

The team measured the largest aortic diameter on axial images 1cm above and below the renal arteries.

Change in suprarenal and infrarenal aortic measurements were evaluated by calculating the millimeter difference from each scan compared with the scan obtained preoperatively.

The suprarenal active fixation demonstrated the greatest change in aortic neck measurement out to four years, Malach said.

“Similar to what we found with the infrarenal aortic neck measurement, the average change in infrarenal aortic neck measurement also demonstrated that the EVAR performed [with a] suprarenal active fixation graft resulted in the greatest change, and we saw an average at four years of 5.31mm change for the suprarenal

“Optimal endograft sizing is a vital aspect of successful repair”— Lillian Malach

but that further efforts to improve outcome parity between the sexes are indicated.”

The findings were part of study on sex-related outcomes after F-BEVAR and presented at the Pacific Northwest Vascular Society (PNWVS) virtual annual meeting (Oct. 29–30) by Natasha Edman, MA, a medical student from the division of vascular surgery at the University of Washington School of Medicine. The researchers approached the study by referencing prior inquiries demonstrating women are less likely to be eligible for F-BEVAR due to anatomic barriers.

“Few data are available to determine whether their outcomes differ from those of men,” Edman told attendees. “Women are known to experience higher mortality after infrarenal and thoracic aortic aneurysm repair but it is unknown whether the same is true for women with TAAA.” Edman and colleagues aimed to describe sexrelated outcomes after F-BEVAR for TAAA. They studied 886 patients with extent IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective physician-sponsored investigational device exemption studies—part of the U.S. Fenestrated and Branched Aortic Research Consortium— from 2007–2019 using either a

plus active, and 2.8mm for the graft with infrarenal plus active fixation.”

Meanwhile, the effect of oversizing on suprarenal and infrarenal aortic neck showed that at four years, the greaterthan-15% group had a statistically larger neck diameter compared to the less-than10%-oversizing group: 3.26mm for <15% compared to a 0.41mm average change for >10%.

“Similarly, with the infrarenal neck measurement, the less than 10% group were statistically smaller than either of the other two groups at four years,” continued Malach. “We saw an average of 3.01mm in the less than 10% group compared to 5.95mm and 5.05mm in the other two groups.”

The researchers further concluded that increased degeneration may lead to increased rates of endoleaks, reintervention and aneurysm-related mortality—seen previously in the literature.

“These findings may influence device selection and degree of oversizing when performing EVARs,” Malach added.

“In general, these findings may provide additional information for surgeons to make the best decision when evaluating patients for AAA, whether with EVAR or open repair.

“And, [the study] also emphasizes the importance of long-term follow-up surveillance.

“In future, we’re hoping to categorize the clinical significance of suprarenal and infrarenal degeneration, evaluate the endoleak and reintervention rates based on the factors that we looked at in this study, and evaluate iliac sizing to see if they have significant degeneration over time.”

Cook Medical patient-specific device or an off-the-shelf Cook Zenith t-Branch. Of the cohort, 288 (33%) were women. They found that women had more extensive aneurysms and higher prevalence of diabetes, but lower prevalence of coronary artery disease and prior EVAR. Women had longer operating room times, lower technical success, and longer length of stay. Women and men had similar 30-day mortality (2.4% vs. 1.7%) and early outcomes, though spinal cord injury was more common in women, the researchers found. “At one year, there were no differences between women and men in freedom from type 1 or 3 endoleak (91.4% vs. 92.0%; p=0.64), reintervention (81.7% vs. 85.3%; p=0.10), branch vessel instability (87.5% vs. 89.2%; p=0.31), and survival (89.6% vs. 91.7%; p= 0.26).”

Women also had a higher incidence of postoperative sac expansion (12% vs 6.5%; p=0.006). Multivariable modeling adjusting for age, aneurysm extent, aneurysm size, urgent procedure and renal function showed that patient sex was not an independent predictor of survival (hazard ratio 0.83, confidence interval 0.50–1.37; p=0.46).

“Thirty-day adverse events and one-year outcomes were broadly similar between women and men undergoing F-BEVAR,” Edman told the PNWVS attendees.

12% vs 6.5%

Women had a higher incidence of postoperative sac expansion (12% vs 6.5%)

vascularspecialistonline.com • 7

PAD

Clinical success measure after revascularization for diabetic foot wounds may be ‘too strict’

BY BRYAN KAY

PATIENT-CENTERED CLINICAL success after lower-extremity revascularization for people with diabetic foot wounds was achieved among 63% of patients in a new analysis—but researchers suggest the measure on which the study was based may define clinical success too strictly given the high rates of limb salvage they saw in the high-risk population involved. The data was revealed by Sarah Deery, MD, a fellow in the division of vascular surgery and endovascular therapy at The Johns Hopkins Hospital in Baltimore, during a session on peripheral arterial disease (PAD) at the Eastern Vascular Society (EVS) virtual annual meeting (Oct. 7–Nov.18).

Deery et al set out to assess clinical success based on patient-centered outcome measures—described by Spence Taylor, MD, and colleagues in a 2007

8 • Vascular Specialist

paper published in the Journal of the American College of Surgeons— following lowerextremity bypass or peripheral vascular intervention for tissue loss in patients from her institution’s multidisciplinary diabetic limb preservation service.

First, Deery referenced the traditional markers of success following lower-extremity revascularization for chronic limbthreatening ischemia (CLTI) with ulcer or gangrene: amputation-free survival, limb salvage, and primary and secondary patency. “However, these may not fully capture success from a patient’s perspective,” she noted.

Taylor et al defined a new measure of clinical success after lower-extremity revascularization for tissue loss whereby a case was only considered a success if a patient maintains intervention patency to

the point of wound healing, has limb preservation at one year, maintains ambulatory status for one year, and survives at least six months.

“Among their population of 677 patients undergoing open and endovascular intervention for tissue loss, only 40% achieved clinical success by their definition,” Deery said.

“Patency to the point of wound healing was the most discriminatory component, with 43.6% of intervention patency to the point of healing. This was driven more by low rates of wound healing at 44% than by intervention patency, which was 73% throughout the study period.”

Deery and colleagues accessed a prospectively maintained database for all patients who presented to the multidisciplinary service at The Johns Hopkins Hospital. They looked at all patients since inception who had at least one year of follow-up, including only those

“Our traditional markers of success at one year were quite high and consistent with our prior reports”—Sarah Deery

with ulcer or gangrene. They analyzed 154 interventions. “Our traditional markers of success at one year were quite high and consistent with our prior reports. Oneyear survival was 91%, amputation-free survival was 83%, and limb salvage 91%, with no differences in outcomes following endovascular or open intervention,” she said. “When evaluating our patientcentered outcomes, intervention patency to wound healing was 72%, limb preservation was 90% at one year, 90% maintained their ambulatory status at one year, and survival at six months was 97%.

“This leads to an overall clinical success of 63%, which is higher than the 40% reported by Taylor and colleagues but is lower than any of the traditional markers of success. The number is driven down primarily by the lower rates of intervention patency to wound healing.”

Concluding, Deery said: “Despite these seemingly low values, 90% of patients had limb preservation at one year and had maintained their ambulatory status. So perhaps this particular measure of clinical success is too strict of a definition given the overall high rates of limb salvage seen in this highrisk population.”

Sarah Deery

DECEMBER 2020

NEWS FROM SVS

VAM 2021 taking shape, schedule changes to expand programming

Andres Schanzer

BY BETH BALES

Though many individual components will remain the same, the 2021 Vascular Annual Meeting (VAM) will have a different look and feel.

“THE MEETING HAS BEEN reorganized. We’re creating an expanded version of VAM that will take place Wednesday morning through Saturday evening,” said Andres Schanzer, MD. He and Matthew Eagleton, MD, co-chair the Society for Vascular Surgery (SVS) Program Committee, which oversees VAM educational and scientific programming.

Previous meetings have featured a Wednesday composed primarily of postgraduate and international sessions, and workshops. Plenty of attendees who didn’t arrive until Thursday, which featured the formal opening ceremony and the first scientific sessions, thus missed these presentations, said Schanzer.

For 2021, Wednesday sessions have been spread out and integrated throughout the meeting, he said. And the opening ceremony will take place at 7:45 a.m., Wednesday, to officially kick off VAM 2021. “Wednesday is becoming the new Thursday, featuring key meeting highlights such as the von Liebig Forum, Kim Hodgson’s honorary address and the Crawford Critical Issues Forum, to name just a few,” he said.

VAM

by the numbers

125 to 130 Average number of exhibitors 10 • Vascular Specialist

In another departure, all mornings will feature sessions—typically key addresses and plenaries—free from competing demands with no concurrent sessions.

Early-morning breakfast sessions, from 6:30 to 8 a.m., will be an exception. Afternoons will include simultaneous programming, not to exceed three sessions at a time.

“Attendees have told us that there is too much going on at any given time,” said Schanzer. “They were frustrated by negotiating the challenge of multiple offerings, because they couldn’t attend important sessions that they wanted to be a part of. So, for 2021, the bulk of scientific content and special addresses will be presented without competition.”

The changes have been in the works for approximately five years, he said.

“There were several motivating factors.

We wanted to be able to include more scientific content and materials for an increasingly diversified

membership.

Thursday to Saturday just wasn’t enough. This way, we can share the information and content we want to share without members being forced to make a choice between

important content.”

The committee further hopes to schedule the afternoon events in tracks, based not only on content areas, but also practice types. “We want people with different interests to be able to focus on the tracks they’re excited about,” Schanzer said. “We don’t want to have all the dialysis access sessions at the same time, nor content all geared to community practitioners at the same time.”

The structural changes minimize competing demands with multiple sessions held concurrently, he said.

As is usual, the SVS president, Ronald L. Dalman, MD, will give his Presidential Address—typically a meeting highlight—on Friday morning. The meeting will offer a second presidential highlight, a keynote address on Wednesday morning from immediate past president Kim Hodgson, MD. COVID-19, and the resultant cancellation of VAM 2020, prevented him from delivering his address.

Other sessions of interest for 2021 include a COVID-19 plenary session, a COVID-19 invited session focusing on other aspects of the disease, such as policy and infectious disease control, and a new plenary session on diversity, equity and inclusion.

“Attendees have told us that there is too much going on at any given time”— Andres Schanzer

2 6 Plenaries

Scientific sessions

AVERAGE PROFESSIONAL ATTENDANCE (2016-19):

1,731 2

Meeting-wide receptions

1

Aortic summit

Changes at a glance IN THE MORNINGS, THERE will be no competing programming.

In the afternoons; and there will be no more than three sessions at any one time, separated into tracks of topics and practice types. The opening ceremony, the William J. von Liebig Forum and the E. Stanley Crawford Critical Issues Forum all will be held Wednesday. Postgraduate courses and VESS sessions will be held throughout the meeting, instead of Wednesday.

VAM 2021 details: June 2 to 5

San Diego Convention Center, San Diego, California Plenaries: June 2 to 5 Exhibit Hall: June 3 to 4 The Society for Vascular Nursing, the Vascular Quality Initiative and the Society for Vascular Ultrasound all will hold their meetings in conjunction with the SVS. *SVS continues to plan full speed ahead for an in-person, high-impact meeting where colleagues can once again connect and learn from each other. The Society hopes it won’t be necessary, but, if it is, will be ready to convert the meeting to an innovative and engaging virtual format.

The protection and safety of attendees remains top priority.

Breakfast sessions planned:

3 industry/ 6 SVS

3

Annual meetings to be held in conjunction with VAM: (Society for Vascular Nursing, Society for Vascular Ultrasound and Vascular Quality Initiative) DECEMBER 2020

MEMBERSHIP

SVS member named to AMA RUC

BY BETH BALES

The American Medical Association's Board of Trustees has named Society for Vascular Surgery (SVS) longtime coding expert and member Robert M. Zwolak, MD, as the AMA alternative representative to the organization’s RVS Update Committee (RUC), and alternative vice chair.

T

he RUC is a unique multispecialty committee dedicated to describing the resources required to provide physician services, which the Centers for Medicare & Medicaid Services (CMS) considers in developing Relative Value Units (RVUs).

“Dr. Zwolak brings great skill and experience to the RUC process and is the ideal individual to represent the needs of vascular surgeons in this role,” said SVS president Ronald L. Dalman, MD. “This is another of his many substantive contributions to the work and mission of the SVS.” Matthew Sideman, MD, chair of the SVS Policy and Advocacy Council, has worked with Zwolak on these

DECEMBER 2020

issues for 15 years. “The SVS is a small Sideman, added, “I have had the society without a permanent seat on the tremendous good fortune to learn the committee. We should be extremely proud RUC from Dr. Zwolak. I have worked side to have one of our own selected for this by side with him for the past 15 years. His leadership position,” Sideman said. knowledge of the committee, its processes, Representatives from nearly 40 national and its history are unequaled. His selection medical specialty societies endorsed as alternate vice chair is a recognition of his Zwolak’s nomination. This was based on years of service.” his “long-standing experience and invaluable Zwolak said, “I hold profound respect for contribution to the RUC process in several the accomplishments of the RUC in shaping capacities for over 20 years. ... Dr. Zwolak’s the relative value world in which we all live, experience with the resource-based Robert M. Zwolak and I believe deeply in the fundamental relative value scale [RBRVS] is concept that healthcare professionals can extraordinary, bar none.” work as a team to appropriately assess Zwolak, a former SVS president, is chief of the these values.” Zwolak’s three-year term will begin in surgical service for the Manchester Department of March 2021.

Veterans Affairs Medical Center in Manchester, New Hampshire, and for the White River Junction VA Medical Dues and membership information Center in White River Junction, Vermont.

Did you pay your 2021 SVS dues? As next year begins, those who did not could see a lapse in their benefits.

Graduated Candidates in year four of their “graduated candidate” membership must transition to Active membership.

Those who did not apply for such membership by Dec. 1 this year could also see their benefits interrupted.

SVS has many new and thriving initiatives, including the just-debuted Branding Toolkit to help members promote their expertise with referring physicians; the active community on SVSConnect; wellness and leadership initiatives; a Mentor Match program; and many more benefits.

Additionally, members also receive the Journal of Vascular Surgery publications. All of this is open only to members. Email membership@vascularsociety.org.

"The SVS is a small society without a permanent seat on the committee. We should be extremely proud to have one of our own selected for this leadership position"— Matthew Sideman

vascularspecialistonline.com • 11

CONGRESS

The power of groups: Invest in the SVS PAC

BY MARK A. SMITH, MD, AND JANICE HONG, MD

Humans are social animals, and, over time, they have found that their best times are spent in groups. We have just celebrated Thanksgiving, spending time with our most important group, our family, reflecting on our present life situation and giving thanks.

And more holidays are to come.

AS PHYSICIANS, VASCULAR SURGEONS BELONG to many groups besides family: They also are part of practices, hospital medical staffs, operating room teams, ambulatory centers, medical associations and specialty societies.

For most vascular surgeons, the Society for Vascular Surgery (SVS) plays a major group role, with continuing education and networking identified as important activities. Many do not realize that the SVS does so much more. We would like to focus on SVS’ role in representing and influencing the governmental determination of our compensation levels.

Many busy vascular surgeons struggle to remain informed regarding deliberations in Washington, D.C. Currently, the assignment of Medicare dollars to the procedural facet of our multilevel patient care responsibilities is in arbitration. We find it disconcerting that “Medicare budget neutrality” was proposed in 2019 and seamlessly executed without much fanfare. This most current development mandates fiduciary changes set to take place Jan. 1, 2021, and they are not trivial—7% reimbursement cuts.

More specifically, every procedure we perform, from the most basic vascular access to the extraordinarily complex and emergent ruptured abdominal aortic aneurysm repair, would have its associated fee reduced by that much. That’s a very painful pre-tax bite. This inequity is compounded by the zero growth in work

relative value unit (wRVU) conversion in addition to absolutely no consideration for inflation over the past several decades. Not only have vascular surgeons failed to receive a raise in more than 20 years, the stated actions will be salary cuts for those of us who provide services to Medicare patients—and private payers often follow Medicare’s lead. In order to neutralize a net negative contribution margin from the low-intensity

We cannot overstate the importance of a unified voice from our Society, explaining this complex interplay to politicians and demanding equitable reimbursement for what we do.

Fund hope with the SVS Foundation

BY BETH BALES

A gift to the SVS Foundation funds not just things—patient education fliers, research awards and community awareness projects—but also hope for a better future.

H

ope that screenings identify people at risk for a ruptured abdominal aortic aneurysm.

That research uncovers the mechanisms in diabetes progression, leading to better treatments. And, that amputations will be prevented.

It is hope, in part, that motivates surgeon-scientists and their research.

“The results are not necessarily immediate,” said vascular surgeon Katherine Gallagher, MD, mentor to several young surgeon-scientists. These emerging professionals have received SVS Foundation research grants, as she herself has done.

12 • Vascular Specialist

But by starting students down the research path, SVS Foundation grants, importantly, spur students’ “interest and desire, and give them an opportunity and forum to get involved in research.”

And that research, she said, can advance treatments for vascular disease and impact patient care.

Some of her past mentees are now

outpatient fields, the high-risk, high-exposure service lines such as ours are now open season to the budget hawks in Washington, D.C. The effect of this change in cash flow is most obvious in private practice (revenue-minus-expenses arrangements). But, even fully employed vascular surgeons will ultimately feel this as their contractual RVU conversion factors come under scrutiny at each institution. Failure to appropriately remunerate those taking the biggest risks clinically and investing the lion’s share of their youth to perfect this highly sophisticated craft will erode our ability to care for the patients we love.

Additionally, administration now dominates the healthcare landscape. Over the past three decades middle management has ballooned. Today, physicians are in the rear of most executive-level discussions at most institutions. At the same time, professional fees are used as markers and cash-on-hand assets for the ultimate determination of physician pay. As such, the 7% cut reduces our individual service line profitability.

In addition, through a series of not-so-transparent calculations, these cuts will ultimately result in the further dependence of the physician on his/her place of employment and reduction in leverage at all the negotiating tables. Tracking this back to our most sacred mission, it eliminates our ability to advocate for the care our patients need.

Nurturing a new service line or any other dollarintensive undertaking should be a patient-first equation. Such proposals now are misdirected, with hospital administration fed first. Doctors are at the bottom of the food chain, and as our real earnings are cut by the governmental pig from which we suckle, our ability to implement the latest and greatest are undermined.

The SVS PAC is our voice to our governmental representatives who make these decisions. Through SVS, we have group power. We cannot overstate the importance of a unified voice from our Society, explaining this complex interplay to politicians and demanding equitable reimbursement. So, during this holiday season, we urge all members of the SVS family to remember to give thanks to our Society for all it contributes to our individual and collective welfare.

We are measured by our actions. So: please contribute generously to your SVS PAC (vsweb.org/PAC).

independent surgeon-scientists working in translational research, and others are headed that way. “They’ve touched vascular surgery, certainly, in different ways. I think all of them will have an impact on our specialty, on our patients, our research and in different arenas.”

She is proud of each and every one.

“They’re going to change the world.”

Please help them keep change going.

Please invest in hope. Please give to the SVS Foundation at vsweb.org/GIVE.

“They’re going to change the world” —Katherine Gallagher

Smile while you shop The holidays and end-of-year festivities are upon us. The pandemic has made many people leery of their favorite brick-

and-mortar stores, turning to the online world in search of that perfect gift for everyone, from the newspaper delivery person to Tess, the family dog.

For those of you who shop online on Amazon, please remember to smile first. Shopping that starts at www.smile. amazon.com turns that gift for Aunt Mary into a donation for the SVS Foundation.

For those who have designated the SVS Foundation as its “smile” organization, the retail giant donates 0.5% of every eligible purchase to it. For example, an SVS member purchases toys, games, electronics and a dog chew for a total of $551.71, resulting in $2.76 in donations.

Multiply that $2.76 by 500 similar shopping trips and, suddenly, the SVS Foundation will receive nearly $1,380. Multiply that $2.76 by comparable shopping of just 2,500 members and nearly $7,000 flows into the SVS Foundation’s coffers. It pays to smile!

Please do so at www.smile.amazon.com.

Future vascular patients will thank you.

DECEMBER 2020

NEWS FROM SVS

Audible Bleeding now flows through SVS

BY BETH BALES

The Society for Vascular Surgery would like to welcome the popular Audible Bleeding podcast into its communications family.

SVS HAS REACHED AND EXECUTED an agreement with Audible Bleeding that will navigate the popular podcast series to the Society.

The podcasts, currently presented biweekly, are intended as a resource for trainees and practicing vascular surgeons, especially early-career surgeons. The initiative serves as a resource for the vascular surgery community and launched in November 2018.

The Audible Bleeding team started with the 2019–2020 co-fellows in the vascular surgery fellowship program at New YorkPresbyterian Hospital—Adam Johnson, MD, Kevin Kniery, MD, Matthew Smith, MD, and Nicole Rich, MD—under the

mentorship of program director Sharif Ellozy, MD. “The podcasts have been a labor of love for us and it’s grown organically,” said Johnson, currently a second-year vascular surgery fellow.

The group brought on the newest fellows, Jacob Schwarzman, MD, and Adham Elmously, MD, and increased the types of episodes to include interviews with leaders in the field; board reviews and collaborations with the SVS Young Surgeons Committee; “Editor’s Choice” from the Journal of Vascular Surgery publications; and another podcast, Behind the Knife.

Episodes also have included Frank Veith, MD, on the past, present and future of vascular surgery; Gilbert Upchurch, MD, on mentorship, millennials and modern vascular surgery; Ronald L. Dalman, MD, on implicit bias in the workplace; and many other SVS members and leaders (see vsweb.org/AudibleEpisodes).

“The Society for Vascular Surgery has always been involved in terms of members being interviewed,” said Ellozy, associate professor of surgery at Weill Cornell Medicine in New York. With a formal commitment and partnership in place, he and the team hope even more members will not only become listeners but also share their specialty’s stories. SVS staff will help with production, marketing and coordination to help bring the podcasts to a larger audience.

Sharif Ellozy

“There’s a role for anyone at any point in their career”— Adam Johnson “There’s a role for anyone at any point in their career,” said Johnson. More seasoned surgeons are sought as topic experts, and trainees are needed to develop questions

and perform interviews. “We want people engaged. We want to build on the already vibrant vascular surgery community.”

That includes broadening the scope to include sessions geared toward those members in community practice and those emphasizing the history of vascular surgery. In fact, Audible Bleeding soon will feature podcasts of the videos created by the SVS History Work Group covering the three eras of vascular surgery.

Topics frequently emerge from current events or remarks made on Twitter or SVSConnect, and suggestions from listeners are also welcome.

Look out for updates on how to become engaged with the podcast in SVS’ weekly e-newsletter Pulse, in Vascular Specialist and on the SVS website.

“We’re excited to bring Audible Bleeding within the SVS family,” said Ellozy. “It opens the podcast up to more people, generating not only new excitement but also helping to create new topics and potentially new participants. This is a winwin for everyone, especially our listeners.”

“I couldn’t agree more,” noted Kenneth M. Slaw, PhD, SVS executive director.“The principals at Audible Bleeding should be very proud of what they have accomplished, and as SVS seeks to expand its communications enterprise and infrastructure, adding the talent and reach of Audible Bleeding podcasts is a perfect fit. We are delighted to help Audible Bleeding continue to flourish.”

Apply for research awards

BY BETH BALES

Applications for three Society for Vascular Surgery (SVS) Foundation awards are coming up early in the new year.

T

he Resident Research Award ( Jan. 13, 2021) is open to surgical and vascular surgery trainees. This prestigious award carries with it the opportunity to present at the Vascular Annual Meeting (VAM) in June 2021. The award provides special recognition of original scientific work by trainees that has yet to be published in manuscript form. The winner also receives $5,000.

The Vascular Research Initiatives Conference (VRIC) Trainee Award ( January 2021) sees recipients present their research at the annual VRIC, which will be held in May 2021. Top-scoring abstracts are considered; recipients also receive complimentary registration to VRIC and to the American Heart Association’s Vascular Discovery Scientific Sessions as well as $1,000 for conference travel (non-local attendees only).

The Student Research Fellowship award (Feb. 1, 2021) aims to stimulate laboratory and clinical vascular research by undergraduate college students and medical students registered at universities in the United States and Canada.

Learn more and find applications at vsweb.org/Awards.

14 • Vascular Specialist

DECEMBER 2020

TECHNOLOGY

Society launches mobile apps for staging of CLTI

BY BETH BALES

The Society for Vascular Surgery (SVS) has launched three new mobile apps to help guide surgeons in the treatment and management of chronic limb-threatening ischemia (CLTI).

T

he apps help facilitate translating the Global Vascular Guidelines1,2 on managing CLTI. These guidelines highlight the importance of individualized clinical decision-making based on the assessment of patient risk, limb severity and anatomic pattern of disease (PLAN). PLAN provides an organized framework for provider-patient discussions as well as outcomes assessment and evidence-based practice.

The three new apps, available on its interactive practice guideline (iPG) mobile platform, allow for real-time estimation of patient risk (Vascular Quality Initiative [VQI] CLTI Mortality Prediction Model), severity of limb threat (SVS Threatened Limb Classification [WIfI] staging system), and anatomic complexity of disease (Global Limb Anatomic Staging System [GLASS]). The calculators are simple to use and meant for everyday practice settings.

The VQI CLTI Mortality Prediction Model was developed from a cohort of 38,470 unique patients who underwent infrainguinal revascularization (open or endovascular) for CLTI and had data available in the VQI registry.3 Using baseline patient demographics, comorbidity, ambulatory status and medication use, this model estimates both 30-day (peri-procedural) and twoyear patient survival. Risk groups are summarized as low (>97% 30-day and >70% two-year survival), medium

DECEMBER 2020

(95–97% 30-day, 50–70% two-year survival), or high (<95% 30-day or <50% two-year survival).

The SVS Threatened Limb Classification [WIfI] calculator uses the consensus scheme for estimating risk of major amputation that has since been validated across multiple institutional studies and registries.4 The target population for WIfI staging is any patient referred for possible CLTI, excluding those with purely venous or traumatic wounds, acute limb ischemia, embolic or non-atherosclerotic disease. Wound, ischemia and infection are each graded on a 0–3 scale.

The combination of grades is then grouped into four clinical stages based on estimated one-year risk for major amputation. WIfI staging is recommended for all patients at initial presentation and over time to monitor response to interventions or disease progression.

The Global Limb Anatomic Staging System [GLASS] calculator allows the treating vascular specialist to estimate the complexity of infrainguinal arterial disease from an angiogram. A high-quality study including the ankle and foot is required. The treating physician first decides on the preferred Target Artery Path (TAP), which is the primary infrapopliteal artery selected for establishing inline flow for the case at hand. Grades are then defined for the femoropopliteal and infrapopliteal segments based on lesion location, length and severity.

These grades are then combined into three overall GLASS stages for the limb that correspond to low-, intermediate- and high-complexity disease. These disease patterns are expected to correlate with both immediate technical success and one-year limb-based patency for an endovascular approach.

“Broad dissemination and use of these calculators will increase the quality of patient and provider discussions about prognosis and treatment, provide opportunity for validation and future refinement of the tools, and promote evidence-based care for patients with this challenging disease,” said Michael Conte, MD, SVS editor for the global guidelines.

The apps are currently available at the App Store for those with Apple products.

References for this article may be found at vsweb.org/ CLTIAppReferences.

vascularspecialistonline.com • 15

LOWER EXTREMITY

Rivaroxaban plus aspirin in CLTI patients undergoing revascularization to lower extremity 'reduced' risk of adverse outcomes at three years

BY BRYAN KAY

In one of the latest sub-analyses from the VOYAGER PAD trial, investigators found that rivaroxaban plus aspirin versus aspirin alone in the high-risk population of patients with chronic limb-threating ischemia (CLTI) undergoing lower-extremity revascularization reduced the risk of a first major adverse limb or cardiovascular event as well as unplanned revascularization at three years.

THE DATA WAS PRESENTED BY Marc Bonaca, MD, a cardiologist at the University of Colorado Anschutz School of Medicine, at the American Heart Association’s virtual Scientific Sessions 2020, which were held from Nov. 13–17.

More than one in four of CLTI patients will experience a first major adverse limb or cardiovascular event and 23% will require an unplanned revascularization at three years, Bonaca told attendees.

Rivaroxaban 2.5mg twice daily plus aspirin

versus aspirin alone reduced the risk of these outcomes consistently in those with and without CLTI, he said.

“However, due to their risk profile, the absolute benefits are particularly important in those with [CLTI],” Bonaca revealed.

A total of 6,564 were randomized to rivaroxaban 2.5mg twice daily or placebo on a background of 100mg aspirin.

The indication for lower-extremity revascularization was collected at randomization, the authors noted.

The primary endpoint was a composite of acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke Marc Bonaca or cardiovascular death. Unplanned index limb revascularization was a prespecified secondary outcome.

Of the total, some 1,533 patients underwent revascularization for CLTI. Patients with CLTI versus those without had a higher rate of the primary endpoint at three years (26.9% vs. 17.8%).

The benefit of rivaroxaban was consistent in those with CLTI (hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.69–1.05) and without (HR 0.86, 95% CI 0.74–0.99). Unplanned index limb revascularization was significantly reduced in those with CLTI (HR 0.78; p=0.0376). Bleeding was increased with no heterogeneity based on CLTI. The researchers concluded: “Patients with CLI [critical limb ischemia], now CLTI, one of the most severe manifestations of PAD, represent an extreme risk population characterized by high rates of recurrent procedures and adverse events of the limb, heart and brain. Lower-extremity revascularization is recommended in CLI to minimize/ prevent tissue loss; however, the risk of complications appears particularly high in

Analysis finds no mortality and improved limb outcomes in drugcoated device cohort

BY JOCELYN HUDSON

Given the absence of a safety signal in data from the VOYAGER PAD trial, a new analysis examined the potential benefit of drug-coated device versus non-drug-coated device treatment for reducing limb outcomes.

C

onnie Hess, MD, an associate professor of cardiology at the University of Colorado in Aurora, presented the most recent findings in a late-breaking data session at this year’s Vascular Interventional Advances conference (VIVA 2020) held Nov. 6–8 virtually, reporting no excess mortality and improved limb outcomes with drugcoated device use in peripheral arterial disease (PAD).

Hess noted that patency remains a challenge, and that drug-coated devices are associated with a reduction in clinically-driven unplanned index limb revascularization.

However, she relayed that rivaroxaban 2.5mg twice daily plus aspirin reduces this risk, in addition to reducing major adverse events of the heart, limb, and brain, irrespective of device type. “These observations suggest that a ‘pharmaco-invasive’ approach combining innovative devices with effective medical therapy may optimize outcomes in PAD,” she told the VIVA audience.

16 • Vascular Specialist

the post-intervention setting.”

Despite the extreme risk profile, Bonaca and colleagues said, there are few adjunctive medical therapies that have shown benefit in CLTI patients both overall “and particularly after intervention.”

The researchers added: “Rivaroxaban 2.5mg twice daily with aspirin should be considered as adjunctive therapy after lower-extremity revascularization for CLI to reduce adverse events of the heart, limb and brain as well as the need for repeat revascularization.”

“Patients with CLI, now CLTI, one of the most severe manifestations of PAD, represent an extreme risk population characterized by high rates of recurrent procedures and adverse events of the limb, heart and brain”— Marc Bonaca et al

The co-primary outcomes for this analysis were unplanned index limb revascularization and major adverse limb events, defined as acute limb ischemia or major amputation of vascular cause. As drug-coated use was not randomized, inverse probability treatment weighting was used to account for known confounders.

Hess detailed that use of a drug-coated device was associated with a significant 16% reduction in relative risk of clinically-driven unplanned index limb revascularization (hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.76– 0.92) but was not associated with a reduction in major adverse limb events (HR 1.08, 95% CI 0.9–1.3).

Use of a drug-coated device was associated with a significant 16% reduction in relative risk of clinically-driven unplanned index limb revascularization

16% reduction

DECEMBER 2020

Intravascular lithotripsy superior to PTA in acute procedural success out to 30 days

BY JOCELYN HUDSON

THE DISRUPT PAD III RANDOMIZED controlled trial (RCT) provides the largest levelone evidence for the treatment of heavily calcified femoropopliteal arteries, noted William Gray, MD, an interventional cardiologist at Main Line Health, Philadelphia, during the second and final late-breaking data session at this year’s Vascular Interventional Advances conference (VIVA 2020) held Nov. 6–8 virtually.

Gray reported that Shockwave’s intravascular lithotripsy (IVL) was superior to percutaneous transluminal angioplasty (PTA) in acute procedural success out to 30 days.

DECEMBER 2020

In addition, Gray informed the VIVA audience that IVL demonstrated atraumatic treatment, characterized by a reduction in percentage diameter stenosis prior to drug-coated balloon or stent placement, lower maximum inflation pressure, reduction in frequency and severity of dissections, and lower post-dilatation and stent implantation rate.

He stressed that these RCT outcomes are similar to the PAD III registry in multiple vessel beds, highlighting the consistency of IVL treatment in complex anatomy.

Endovascular treatment of calcified peripheral artery lesions may be associated with suboptimal vessel expansion, increased complication risk, and reduced long-term patency.

Single-arm studies have reported promising results with IVL in the presence of moderate and severe calcium, yet comparative evidence from randomized

The primary effectiveness endpoint of procedural success was significantly greater in the intravascular lithotripsy group of patients

trials is lacking. The purpose of this study is to compare acute outcomes in patients receiving vessel preparation with IVL or PTA prior to drugcoated balloon (DCB) treatment for peripheral arterial disease (PAD) in calcified femoropopliteal arteries.

The DISRUPT PAD III RCT enrolled PAD patients with moderate and severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA. The primary effectiveness endpoint was procedural success, defined as core-lab adjudicated residual stenosis ≤30% without flow-limiting dissection prior to DCB or stenting. Secondary endpoints evaluated at 30 days included major adverse events and clinically-driven target lesion revascularization (CD-TLR).

Gray detailed that in patients receiving IVL (n=153) or PTA (n=153), the primary effectiveness endpoint of procedural success was significantly greater in the IVL group (65.8% vs. 50.4%, p=0.007).

Post-treatment balloon dilatation (measured prior to DCB) residual diameter stenosis (27.3±11.5% vs.

30.5±13.9%, p=0.04), freedom from any dissection (81.5% vs.67.7%, p=0.009), flow-limiting dissection (1.4% vs. 6.8%, p=0.03), and provisional stent placement (4.6% vs. 18.3%, p<0.001) were also significantly lower in the IVL group.

Secondary outcomes, including rates of major adverse events and CD-TLR at 30 days, were comparable between groups.

vascularspecialistonline.com • 17

CONFERENCE DIGEST

Frailty still strongly linked to mortality after AAA EVAR

Foot vein arterialization study shows 77.8% limb salvage rate Foot vein arterialization (FVA) is a safe procedure with good early graft patency and a limb salvage rate of 77.8%, Qi Yan, MD, and colleagues found during a retrospective review of patients treated between 2019–2020.

Yan et al, of the University of Texas Health Science Center at San Antonio, studied the last-resort procedure in chronic limbthreatening ischemia (CLTI) patients out of revascularization options, presenting their data at the Texas Society for Vascular and Endovascular Surgery (TSVES) virtual annual meeting (Nov. 6–7).

In addition to the 77.8% limb salvage rate, they found an average time to healing of some 146 days—which was “significantly higher” than that of the 50% in medical management, the researchers reported—Bryan Kay

DETOUR system: ‘Excellent’ functional improvement in complex PAD cohort During a late-breaking data session at this year’s Vascular Interventional Advances virtual annual meeting (VIVA 2020) staged Nov 6–8, Ehrin Armstrong, MD, a professor of cardiology at the University of Colorado, Denver, presented two-year outcomes from the DETOUR I trial for percutaneous femoropopliteal bypass.

He reported a 96% clinical success rate, with 83% of patients at Rutherford class 0 at two years, which “shows excellent functional improvement in a patient population facing severely debilitating PAD [peripheral arterial disease].”The DETOUR I trial was designed to evaluate the safety and effectiveness of the Detour system for percutaneous femoropopliteal bypass, which recently received Food and Drug Administration breakthrough device designation.—Jocelyn Hudson

RCT finds increased wound closure, high-quality healing using mVASC Treatment with the mVASC microvascular tissue graft product (MicroVascular Tissues) results in superior wound closure compared to standard-of-care alone, finds the first randomized controlled trial using microvascular elements to treat microvascular dysfunction.

Presented at the Symposium on Advanced Wound Care (SAWC) Fall 2020 meeting, held virtually Nov. 4–6, the HIFLO trial investigators, led by plastic surgeon Lisa Gould, MD, concluded that the higher percentage of closed ulcers, faster time to healing, increased blood flow, and improved sensation with mVASC “may mitigate some of the risk factors associated with diabetic foot ulcer complications (such as infection, reoccurrence, and amputation),” though say that additional studies should be performed. HIFLO was a level 1, prospective, single-blind, randomized clinical trial conducted at six U.S. sites.

It assessed outcomes in 100 patients with Wagner grade 1 and 2 neuropathic diabetic foot ulcers. Patients were randomized 1:1 to standard of care or mVASC plus standard of care.—Suzie Marshall

18 • Vascular Specialist

An analysis of the Vascular Quality Initiative (VQI) endovascular aneurysm repair (EVAR) registry for elective abdominal aortic aneurysms (AAAs) revealed that frailty continues to be highly correlated with mortality after the procedure among those aged 80 and over.

Researchers from the Mayo Clinic in Rochester, Minnesota, found EVAR to be safe in low-frailty octogenarians—but among their high-frailty contemporaries the risk of rupture should be high prior to the consideration of elective repair.

The data was presented by Lily E. Johnston, MD, a vascular surgery fellow at the institution, during the virtual annual meeting of the Midwestern Vascular Surgical Society (MVSS) Sept. 9–12. Johnston noted that octogenarians comprise nearly 20% of elective AAA repairs in a recent series, bearing increased perioperative and one-year mortality. “We know that treatment of aneurysmal disease must be evaluated in the context of overall life expectancy versus risk of rupture,” she said. “Frailty is strongly associated with perioperative and long-term mortality after EVAR in octogenarians.”

The research team aimed to assess how frailty impacts outcomes among patients of advanced age undergoing elective endovascular AAA repair.

Frailty scores were calculated using the modified frailty index, with low-, moderate-, and high-risk groups created on the basis of the 0–25th, 26th–75th, and 76th–99th percentile distributions of the score. Primary outcomes were 30day and one-year mortality.

The frailty index was calculated for a total 8,462 over the age of 80 who underwent repair. Scores ranged from 26 to 56 with a median of 31. Patients with a score less than 30 were classed as low frailty, 30-34 moderate, and 35 or over high. There was no difference noted across groups in intraoperative complications or early reoperation, Johnston said. “However, significant differences across groups were noted in postoperative complications, in which 10% of high frailty patients had complications such as hematoma, myocardial infarction, stroke and others, versus 7.7% and 7% of moderate and low frailty patients, respectively.”

Furthermore, 30-day mortality was 2.7% in the high frailty group versus 1.1% and 0.8% in the moderate and low frailty groups. Meanwhile, one-year mortality was 13.6% among the the high frailty patients, 6.8% in the moderate group, and 4% in the low frailty class. Concluding, Johnston told the MVSS gathering: “In low frailty individuals, EVAR is safe. However, for high-frailty patients, the risk of rupture should be high prior to considering elective repair given the significantly worse postoperative outcomes.”—Bryan Kay

NESVS outgoing president makes diversity pitch

told the Sept. 11–12 gathering. “We should reach out to students before they have a career path. We should identify and mentor those from underrepresented groups at all levels. I’m not suggesting promotion of someone who doesn’t have the tools to During the virtual annual succeed but rather to help them to develop the skills to succeed, and then advocate meeting of the New England for them.

Society for Vascular Surgery “We should embrace diversity at all (NESVS), outgoing president levels—in our practices, in our hospitals, Marc L. Schermerhorn, MD, and in our patients. We can all learn called for the NESVS to follow about our patients, try to understand their culture, learn to communicate better. the lead of the Society for We should be asking Vascular Surgery (SVS) by questions to make sure creating a diversity task force. our message is coming Schermerhorn devoted his presidential across. We may need address to the issue of diversity, equity to ask our patients how and inclusion, outlining an effort he said they’d prefer to learn would ultimately enable vascular surgery about vascular disease. We to recruit more women and need to educate minorities into the specialty ourselves Marc L. and improve patient care. and adapt Schermerhorn “Each of us can contribute ourselves.”— to this effort,” Schermerhorn Bryan Kay DECEMBER 2020

IMAGING

Study findings support SVS practice guidelines for surveillance of small AAAs

BY BRYAN KAY

The low rate of events that occur in small abdominal aortic aneurysms (AAAs) supports the continuance of ultrasound surveillance every three years for those that measure between 3–3.9 cm and every year for those 4–4.9cm, researchers found.

INVESTIGATORS AT THE Cleveland Clinic, Ohio, carried out a retrospective analysis of 5,945 ultrasounds covering 1,581 patients to arrive at the conclusion.

Explaining how the findings support the Society for Vascular Surgery (SVS) clinical practice guidelines on ultrasound surveillance for small AAAs, research team member Jarrad Rowse, MD, said, “If someone has a 3.5cm aneurysm, yearly surveillance is probably a little bit more stringent than is needed based on the freedom from repair indication and freedom from growth.”

He was presenting data from the study during the annual meeting of the Midwestern Vascular Surgical Society (MVSS) staged virtually Sept. 9–12.

The SVS guidelines currently state that

DECEMBER 2020

aneurysms in the 3–3.9cm range should be observed at three-year intervals, while those 4–4.9cm should be monitored at one-year intervals, Rowse said. Rowse and colleagues set out to determine whether the guidelines fit with clinical practice and identify patients who may be at elevated risk for aneurysm growth.

Patients (average age 73, 349 of whom were female) with more than two AAAs and a baseline aneurysm size of less than 5cm were included in the Cleveland Clinic series drawn from 2008–2018. Groups were created for comparison using size criteria according to the SVS guidelines.

Overall growth rates were also compared under three classes: precipitant, expected, and no growth. Rowse said the study showed 68% of the patients showed no growth, 21% expected growth, and 10%

had precipitant growth, while 34, or 2.2%, met repair indications during follow-up (average follow-up was 27.8 months).

Males were found to be more likely to be identified with a larger aneurysm (4–4.9cm), and more likely to have hypertension and chronic kidney disease.

Rowse further stated that the larger the aneurysm at baseline, the more likely patients were to demonstrate precipitant growth. They were also more likely to reach repair indications, he said.

“Using Cox univariate hazard ratios to identify freedom from growth at two years,

10%

precipitant growth

22% weexpected growth

68%

of the patients showed no growth

we found that aneurysms that were less than 4cm were relatively free from precipitant growth as well as essentially any growth, whereas larger aneurysms again demonstrated more growth,” Rowse said.

In terms of freedom from repair, the research team found that at two years, the larger the aneurysm, the more likely the relevant patient was to meet the criteria for repair.

“The reason we looked at two years was based on our follow-up as well as a benchmark to delineate the one and three years from the guidelines,” Rowse explained. Furthermore, the team found that males were more likely to have precipitant growth, a larger aneurysm size, larger growth rate, and maximum growth rate. Concluding, Rowse added: “In our series, female gender had less precipitant growth than previously reported, and metformin again showed that it may abrogate aneurysmal growth. There continues to be this subset of patients that do exhibit more precipitant growth of their small aneurysms; however, we were not able to further classify them, and I think those are the patients that we should focus some of our further studies on to identify which patients need more close surveillance.”

vascularspecialistonline.com • 19