Vascular Specialist–March 2022

16 BIODESIGN Technology Failure is the price of success in medical innovation

Vol.18 No.03 March 2022 Official Publication

Featured in this issue:

www.vascularspecialistonline.com

3

8

18

YOUR SOCIETY SVS creates membership section for women

EARLY CAREER Lessons from the life of Achilles

CORNER STITCH Joining the vascular fold

INSUFFICIENCY

VENOUS STENTING

DEDICATED

Emerging autogenous venous valve formation system sees ‘continual improvement’

vs.

NON-DEDICATED

BY BRYAN KAY

Researchers place venous stenting under the spotlight at AVF 2022

BY JOCELYN HUDSON

VENOUS STENTING WAS A HOT TOPIC ON THE agenda of the recent American Venous Forum (AVF) annual meeting, held this year Feb. 23–26 in Orlando,

BY BRYAN KAY the audience’s attention, researchers Florida.

Catching highlighted a head-to-head study of dedicated versus non-dedicated stents, as well as new subgroup data on the Zilver Vena (Cook Medical) venous selfexpanding stent.

“Iliofemoral venous obstruction when not adequately treated results in chronic debilitating disease and poor quality of life,” said Lillian Tran, MD, of the department of surgery at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, who noted that deep venous stenting is “increasingly preferred” as the mainstay treatment over medical therapy alone.

According to Tran, this move towards stenting necessitates studies comparing the performance of novel, dedicated venous stents with the more traditional, non-

dedicated stents. At AVF, Tran reported the findings of such a head-to-head study at a single center, detailing that the use of dedicated venous stents was associated with a significant reduction in extension into the inferior vena cava (IVC) without reduced early patency rates compared to non-dedicated stents.

The presenter stressed that outcomes after iliac vein stenting rely on multiple technical considerations and stent attributes. “In addition to adequate sizing and consistency in deployment, […] venous stents must

An emerging endovenous valve formation system designed to treat patients with chronic venous insufficiency (CVI) with evidence of deep venous reflux has demonstrated continual improvement since U.S. investigators started performing clinical cases with the device 18 months ago, according to recently presented early data.

The BlueLeaf procedure, currently undergoing clinical research worldwide, has shown a rate of 90% technical success among the first 10 patients treated in the U.S., William Marston, MD, one of the INFINITE-US early feasibility study investigators, told the 2022 annual meeting of the

See page 4

OUR NEW SOLUTION FOR AV FISTULA CREATION Learn more about the Ellipsys system, including important risk information on page 5.

See page 6

The Ellipsys™ Vascular Access System.

UC202115194-01 EN ©2021 Medtronic.

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

CHANGE SERVICE REQUESTED

Presorted Standard U.S. Postage PAID Permit No. 384 Lebanon Jct. KY

GUEST EDITORIAL

The pandemic has been a challenge, but perhaps it imposed some equity

BY LAUREN CRALLE, BS

Years from now when we look back, will we measure time in terms of B.C. and A.C.— Before Covid and After Covid? It’s hard to imagine a time when we will we once again feel comfortable walking hospital halls without a mask. Between businesses converting to work-from-home models and all levels of education adapting to the virtual world, there’s a new normal. As someone with a healthy appreciation for technology, one that at times borders on obsession, I was excited by the prospect of another virtual residency interview season. This would be the second rendition. Kinks would be smoothed, and surely, I could show off my charm and wit via Zoom/Webex/Thalamus. Plus, I was grateful for the chance to save a couple thousand dollars.

B

ut, when I sat and thought about what being virtual meant, ambivalence washed over me. We, as bright-eyed, bushy-tailed medical students, would be choosing our futures via computer screen, not that I had any misconceptions about the power of the inperson interview. Anyone can put on a show for a day and a half, albeit it is easier to do so on Zoom. My cohort of future physicians would be entering three-, five-, sevenyear contracts with hospitals they may have never seen, in states they may have never visited. The five to seven years we spend as vascular surgery residents, the hours we spend with the same people within the same four walls, are longer than some marriages. We were being asked to choose that partnership virtually, limited to computer screens, Google searches, video conferences, and Grubhub deliveries. There wouldn’t be a true resident dinner where we could ask the questions we were too scared to ask on the big day. We could try to ask on the Zoom socials, but there wasn’t that human connection. Usually, one or two applicants might be the ones steering the conversation, popping up on screen more often than others. Occasionally, residents would have questions for each of us, icebreakers.

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 Marie Drudi, MD Executive Director SVS Kenneth M. Slaw, PhD Director of Membership, Marketing and Communications Tara J. Spiess, CAE Managing Editor SVS Beth Bales Marketing & Membership Specialist Anna Vecchio Assistant Marketing & Social Media Manager Kristin Crowe

2 | Vascular Specialist

Other times, we would sit there in awkward silence as the residents joked amongst themselves. Hard to read the room when the room is pixelated.

In a time when masks and nasopharyngeal swabs weren’t barriers to in-person smiles and handshakes, I imagine I would pick a program by looking at how people interact. It worked for medical school.

I chose based on tangibles such as research, community outreach, rank and rigor, but in a tie between two programs, I thought back on culture.

During the tours, who smiled at friends, greeted faculty without

pause, and who made room for the janitor and treated them with respect? I chose right. I have been encouraged to grow and been supported in strife.

Now, we’re being asked to do so behind a screen, without that extra touch. So, I looked at the way people communicated in the main session, how engaged they were in the conversations, who they acknowledged when I asked what they’re most proud of about their institution. For me, it was about the people.

I tried my best to see where I could challenge myself to grow as a person and as a leader, be surrounded by those that support my learning and my inevitable failures, and learn to be an outstanding vascular surgeon. It’s hard without being in the room.

There has been a lot of talk about how to bridge health disparities in the U.S. Overwhelmingly, we need more doctors that look, sound and think like our patients.

Underrepresented students already have enough on their plates with student loans, implicit bias, racial inequality, gender discrimination. We hope to make medical education more accessible, yet we have been asking disadvantaged students to pay out-of-pocket to interview.

To even get the interview, there are biases and barriers. Passing standardized tests is anything but fair, between the cost to merely sit for the exam, the disadvantage for non-native English speakers, and the limitations on persons with disabilities. Having famous mentors and letter writers is a luxury of your institution.

Performing well on rotation is at the mercy of your circumstances. Life happens.

Away rotations

Lauren Cralle

Moreover, beyond the cost of interviews, there’s the “aways.” In a typical year, students do up to five away rotations. Financially, this means covering rent at home, and subletting on the road, paying for food, transportation, and utilities along the way.

Vascular Specialist is the official newspaper of the Society for Vascular Surgery and provides the vascular specialist with timely and relevant news and commentary about clinical developments and about the impact of healthcare policy. Content for Vascular Specialist is provided by BIBA Publishing. Content for the News From SVS is provided by the Society for Vascular Surgery.

POSTMASTER: Send changes of address (with old mailing label) to Vascular Specialist, Subscription Services, 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or the Publisher. The Society for Vascular Surgery and BIBA Publishing will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services, or the quality or endorsement of advertised products or services, mentioned herein.

For missing issue claims, e-mail subscriptions@bibamedical.com.

The Society for Vascular Surgery headquarters is located at 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018.

RECIPIENT: To change your address, e-mail subscriptions@bibamedical.com.

Vascular Specialist (ISSN 1558-0148) is published monthly for the Society for Vascular Surgery by BIBA Publishing.

Printed by Vomela Commercial Group

©Copyright 2022 by the Society for Vascular Surgery

continued on page 3

Published by BIBA Publishing, which is a subsidiary of BIBA Medical Ltd. Publisher Roger Greenhalgh Content Director Urmila Kerslake Managing Editor Bryan Kay bryan@bibamedical.com Editorial contribution Jocelyn Hudson, Will Date, Jamie Bell and Anthony Strzalek Design Terry Hawes Advertising Nicole Schmitz nicole@bibamedical.com Letters to the editor vascularspecialist@vascularsociety.org

BIBA Medical, Europe 526 Fulham Road, London SW6 5NR, United Kingdom BIBA Medical, North America 155 North Wacker Drive – Suite 4250, Chicago, IL 60606, USA

March 2022

YOUR SVS

SVS creates membership section for women

BY BETH BALES

Women make up a growing percentage of vascular surgeons. And they now have a new professional membership home within the Society for Vascular Surgery (SVS)—the SVS Women’s Section.

SVS LEADERSHIP APPROVED THE new membership section in 2021. It is intended as a partnership with the growing women’s vascular surgery membership of SVS and the larger Society to develop a centralized home to discuss specific gender-based issues, support women in practice, research and networking, and organize a grassroots social media campaign to be available to the larger SVS membership.

Goals are to strengthen the communication and collaboration of women in vascular surgery and enhance development and leadership skills that will permit a more robust presence for women who will be able to engage in the SVS, including in leadership roles.

Beyond the benefits available to all SVS members, those joining the new section will enjoy dedicated educational programming at the Vascular Annual Meeting (VAM). A special women’s community section on the online SVSConnect community is coming soon.

Audra Duncan, MD, and Palma Shaw, MD, co-chair this new section.

Its roots go back decades, said Duncan, with women vascular surgeons meeting informally for coffee, lunch or dinner at VAM and other meetings, “back when Palma and I were junior staff.” While acknowledging strong efforts by the SVS to support recruiting women vascular trainees, “there was a gap in the support of practicing women vascular surgeons, and especially those moving into senior and leadership roles. Therefore, although the percentage of women in SVS is constantly increasing, the face of SVS leadership has remained stagnant in terms of diversity.”

A WhatsApp chat for vascular surgeons that began shortly before the pandemic hit also played a part. Amid the isolation, more women surgeons joined and found it an important way to connect informally with other women undergoing the same shared experiences, said Shaw. The chat, plus the

“During the tours, who smiled at friends, greeted faculty without pause, and who made room for the janitor and treated them with respect?”

foot on site, without a single handshake?

Equalizer yes, easy no.

continued from page 2

This practice favors the fiscally fortunate, and pushes others less so into more debt.

That certainly is not helping to bridge disparities in the field. At times, it seems medicine, for all its advances, is stuck in its ways and needs a push in the right direction. Forcing programs to interview virtually and limiting students to one away could be the push we needed.

The virtual interview may be the great equalizer to some degree. My peers have interviewed in Los Angeles, Miami, Chicago, Seattle, when they would have never taken the chance because flights and hotels are expensive.

These peers are brilliant scientists and compassionate leaders who will one day be life-changing physicians. The schools beyond their typical reach would be lucky to train them.

But what about the mental burden of overthinking Zoom lighting and audio quality, of the ever-present risk of technical difficulties and lost internet connections, of choosing a future home without stepping March 2022

VAM gatherings over the years and the Women’s Leadership Dinner held at VAM 2021, served as the basis for formation of the Women’s Section, she said.

One of the first orders of business has been planning the section’s education session at VAM 2022 in Boston.

“Supporting Women Vascular Surgeons: From Recruitment Through Senior Leadership” will cover the needs of the

Audra Duncan

Palma Shaw

“Women have a lot to give back to SVS and we feel like this may be best accomplished when we have a common voice” Audra Duncan

youngest generation of women vascular surgeons; radiation, logistics and wellness for pregnant surgeons; optimal practice partnerships; mentors and sponsors; and how senior women surgeons can create a legacy.

The two-year plan includes promoting involvement; increasing retention of women in vascular surgery; networking and leadership opportunities; programs on female surgeons’ needs; communication via an online network; work-life balance and more.

Both Shaw and Duncan are pleased with how the section is progressing so far, with female surgeons from other countries also expressing interest.

“Women have a lot to give back to SVS and we feel like this may be best accomplished when we have a common voice,” said Duncan.

“Overall, it’s a win-win for both the women members and the SVS.” “We are very grateful to the SVS leadership for supporting this initiative,” said Shaw. “This will help women at many levels achieve their potential and improve work-life satisfaction and wellness for these hard-working, bright and talented women of the SVS.” Section membership is open to any SVS member who identifies as she/her. To apply for section membership, email staff liaison Emily Milkes at emilkes@vascularsociety.org.

Force for good?

At the end of the day, is virtual our new normal? Did we choose correctly? Did we use our technological aptitude for good?

Like any other marriage, we pick residency programs for better or worse. Sitting at the end of the interview season, tired of staring at screens and adjusting lighting, I'm reminded that this is nearly the end of a long journey. Years of schooling and hours spent on resume-building, volunteering, research—all for this. As students, we shadowed, scribed, and nervously followed residents on rounds hoping that we had the right dressings in our white coat pockets. Now, we would be adding MD to our names and, with it, the very real responsibility for patients. While the remainder of our medical education has been relegated to online lectures and our board exams may have been delayed more times than we care to count, we’re ready.

When we walk through the hospital come July, the beginning of the end, I’ll be happy to see where this journey takes us—possibly to a place we would have never seen if not for a microscopic virus forcing our hand. The pandemic has been a challenge, but perhaps it imposed some equity on a process long due for a change.

LAUREN CRALLE is a medical student who will graduate in the Class of 2022 from University of Massachusetts Medical School. vascularspecialistonline.com | 3

VENOUS STENTING

COVER STORY

Dedicated vs. non-dedicated continued from page 1

establish a balance between radial force, flexibility and crush resistance,” she informed the audience. Tran detailed that dedicated, nitinol-based stents have been developed to meet these requirements and are now on the market in the U.S. and Europe. Four of these stents have been approved by the Food and Drug Administration (FDA) for venous indications, the presenter relayed, noting, however, the fact that the Vici (Boston Scientific) and Venovo (BD) stents were recalled last year.

Outcomes data from investigational device exemption (IDE) trials of the four dedicated venous stents have demonstrated excellent patency rates, Tran communicated.

However, she highlighted that head-to-head, comparative performance data against the more traditional Wallstent (Boston Scientific) and other non-dedicated stents are limited.

Tran et al therefore performed a retrospective review of all patients who underwent iliofemoral venous stenting for acute thrombotic, post-thrombotic and non-thrombotic indications at their institution between 2014 and 2021, grouping patients based on the use of novel, dedicated venous stents versus non-dedicated stents during their treatment.

The team measured 30-day stent failure and one-year patency rates as primary outcomes, Tran detailed, adding that secondary outcomes included stent sizing and extension.

A total of 135 patients (186 limbs) were treated in the study, Tran told AVF attendees, specifying that 63 limbs were treated using novel dedicated stents, while 123 were treated using the traditional Wallstent or another nondedicated stent.

The team noted no preference in stent type in treating acute thrombotic or post-thrombotic lesions at their institution, but they did observe that dedicated venous stents were more likely to be used in nonthrombotic lesions.

Addressing the AVF audience, Tran reported that fewer stents were deployed per limb with the use of novel dedicated venous stents. In addition, she revealed that one patient had a stent fracture without thrombosis, and that there were no cases of deployment failure or stent migration in either group.

Additionally, larger size was observed in limbs using the Wallstent alone compared to dedicated venous stents and proximal stent extension into the IVC greater than 50% was significantly reduced with the use of novel venous stents compared to the non-dedicated devices, Tran detailed.

The presenter relayed some further key outcomes

Database analysis findings ‘matched precisely’ with reported reasons for venous stent recalls

BY BRYAN KAY

A RECENT ANALYSIS OF THE recalled Venovo and Vici venous stents—initiated last year—characterized “significant differences” between reported device and patient issues, and subsequent interventions for the two systems, with findings ultimately matching the reasons given for the recall at the time.

4 | Vascular Specialist

from the study: “Overall, dedicated venous stent use was not significantly associated with differences in early stent patency rates, nor was it a predictor of 30-day stent failure using a logistic regression analysis.”

In addition, she reported that primary patency rates remain comparable between novel venous stents and nondedicated stents at one year. On subgroup analysis, the researchers did not see any differences between the nondedicated and dedicated stents in either 30-day or one-year stent patency rates.

Tran acknowledged some limitations of the group’s study, including its retrospective nature, small sample size, short follow-up and no concurrent measurement of clinical improvement.

“In our experience, we found a significant reduction in extension into the IVC, total number of stents deployed and mean stent diameter with the use of novel, dedicated

Zilver Vena

Wallstent

“We found a significant reduction in extension into the IVC [with the use of dedicated venous stents]” Lillian Tran venous stents compared to Wallstents alone,” Tran concluded. In addition, she recapped that there were no significant differences in early outcomes between the two stent types.

Also highlighted at AVF were new data on one of the dedicated venous stents. In a presentation on three-year subgroup outcomes from the VIVO clinical study, Anthony Comerota, MD, of the Inova Heart and Vascular Institute in Falls Church, Virginia, summarized that the latest results “continue to support the safety and effectiveness” of the Zilver Vena venous self-expanding stent, designed to treat patients with symptomatic iliofemoral venous outflow obstruction. The aim of the subgroup analysis was to report on three-year patency, clinical improvement and stent integrity in a “real-world” population, including patients with post-thrombotic syndrome (PTS; 43%); those with acute deep vein thrombosis (aDVT; 24%); and

A team of researchers from the Virginia Commonwealth University School of Medicine in Richmond, Virginia, tapped the Food and Drug Administration (FDA) MAUDE database for all adverse event reports related to the recalls. Delivering the results at the 2022 winter annual meeting of the Vascular and Endovascular Surgery Society (VESS) in Snowmass, Colorado ( Jan. 27–30), Yuchi Ma, BS, a Virginia Commonwealth University second-year medical student, informed attendees the team had found 341 reports for the Venovo stent (BD) and 50 for the Vici (Boston Scientific). The former was recorded as having activation failure (289 events, or 85%) as its predominant device-related issue, while the Vici saw 24 events, or 48%,

patients with non-thrombotic iliac vein lesions (NIVLs; 33%). Looking at patient demographics, Comerota highlighted that the PTS patients had particularly long lesions with a mean length of 12.5cm, double the mean of the lesions in the NIVL group.

Comerota also noted that 54% of the PTS patients had the stent traversed below the inguinal ligament. The figures were 24% in the aDVT group and 10% among the NIVL patients. In addition, he informed the AVF audience that almost 40% of the PTS patients had a complete occlusion of their iliac venous system, “really putting them at a much higher risk for failure.” This compared to 21% of the aDVT patients.

Comerota revealed an overall three-year patency rate of 90%, averaging out rates of 100%, 84% and 86% in the NIVL, aDVT and PTS groups, respectively. Looking at three-year freedom from clinically-driven reintervention data, the presenter reported an overall rate of 93–94%, with a 100% rate for NIVL patients, 92% in the aDVT group and 87% among the PTS patients.

The venous clinical severity score (VCSS) was shown to be “significantly improved” at one month and that observation remained at three years’ follow-up, the presenter relayed, noting that the rates were exactly the same for each of the three groups.

In addition, a “marked improvement” in the ClinicalEtiological-Anatomical-Pathophysiological (CEAP) classification was evident in each of the three groups. “Of course, we recognize that the aDVT patients may have a bit more clinical improvement for obvious reasons—their presentation was acute and it was acutely relieved,” said Comerota. In addition, the speaker noted improvement in the venous disability score (VDS) in each of the three groups.

A “very important issue” in venous stenting is quality of life, Comerota remarked, noting a sustained improvement from one month to three months overall, and when the data are broken down into the three subgroups, a significant improvement at one month and out to threeyear follow-up.

Finally, core lab analysis of the 79 stents that were extended below the inguinal ligament demonstrated that there was no evidence of stent fracture in any of the three groups at one-, two- and three-year follow-up, Comerota communicated.

The presenter concluded: “The results through three years continue to support the safety and efficacy of the Zilver Vena venous stent. High rates of patency by ultrasound and freedom from clinically-driven reintervention were seen, clinical improvement after stent placement was demonstrated by markedly improved VCSS, VDS, improvement of the CEAP and, most importantly, improved quality of life.” In addition, he reiterated that there was no evidence of stent fracture in those patients with stents extending below the inguinal ligament.

registered as related to stent migration.

Fracture, meanwhile, made up a significant proportion of reported issues for both (7% of the Venovo and 16% for the Vici).

“For both venous stent systems, the majority of the cases experienced no clinical symptoms or consequences,” Ma told VESS, but the Venovo “did seem to show a significantly higher percentage.”

Subsequent interventions performed included ballooning, stent extraction, utilization of a new device, and stenting over the previous stent, all of which were reported in higher percentages in the Vici.

The research team—completed by Michael F. Amendola, MD, divisional vascular chief at Virginia Commonwealth, Kedar S. Lavingia, MD, assistant professor

of surgery, and James M. Dittman, BS, a senior medical student—conceded their findings were limited by either under- or overreporting given the MAUDE database does not capture all procedures performed using the two stent systems. In a later interview with Vascular Specialist, Dittman elaborated: “The MAUDE database hasn’t been extensively used by the vascular community to characterize devices prior to these adverse events ... [This] was an ideal exercise for us to see the power of MAUDE in determining whether or not those were the signals we actually saw in the adverse events that were reported.”

Ma added, “The findings that we saw in the database matched precisely with reasons why these stents were recalled.”

March 2022

TRANSFORM YOUR AV FISTULA CREATION Ellipsys™ Vascular Access System

91.6

%

cumulative patency at two years1

18+

peer-reviewed publications2

3,000+ HIGH successful endoAVF procedures2

technical success, maturation, and cannulation rates1,3,4

INSUFFICIENCY

COVER STORY

Emerging autogenous venous valve formation system sees ‘continual improvement’ continued from page 1

American Venous Forum (AVF) in Orlando, Florida (Feb. 23–26).

These data are part of a total of 30 patients treated at sites worldwide, demonstrating a 93% technical success rate of forming at least one valve, said Marston, who disclosed a consultancy relationship with InterVene, the company behind the BlueLeaf device.

Enrolled patients, classed as C5–6 on the CEAP (Clinical-Etiological-AnatomicalPathophysiological) classification of disease severity, all had significant deep vein reflux in two main segments between the knee and the common femoral vein, adequate inflow and no acute deep vein thrombosis (aDVT), Marston, the vascular surgery division chief at the University of North Carolina at Chapel Hill, explained.

Thus far, all subjects in the study have had a maximum of two valves formed using the device—most performed on the right leg and all monocuspid valves (Food and Drug Administration [FDA] approval has now been granted to form bicuspid valves, Marston informed attendees). The patient pool has

a mean age of 59, presented with a venous clinical severity score (VCSS) of 15, and 70% had a previous history of DVT (six on the ipsilateral limb).

Marston told AVF attendees how the U.S. investigators had achieved success in nine out of the 10 patients, with the mean number of leaflets formed standing at 1.7. He further noted how procedure time was currently decreasing, explaining how the system requires a period of adjustment as physicians adapt to patient and equipment positioning.

Marston pointed out two minor device deficiencies that did not lead to any complications.

In terms of VCSS among the first six subjects with follow-up out to 12 weeks, investigators saw a mean decrease of 2.3, he said, though he cautioned the earlystage nature of the data. Marston reported no major adverse events, one partial valve pocket thrombosis at one day and one partial distal intraluminal thrombosis. Both were asymptomatic and no longer seen after 30-day duplex follow-up, he added.

The process behind the development of the BlueLeaf system—which gained FDA Breakthrough Device designation late last year—”has been under evolution such that we’re just starting to do bicuspid valves and, in fact, we are scheduled to do the first one in the U.S. next week,” Marston said. “The device we are using today is quite different from the one we used 18 months ago.”

The system involves retrograde access; a high-pressure balloon expanded to force the deck of the device up against the vein wall; an advanced needle that enters the vein wall

References 1 Beathard GA, Litchfield T, Jennings WC. Two-year cumulative patency of endovascular arteriovenous fistula. J Vasc Access. May 2020;21(3):350-356.

2 Data on file at Medtronic.

3 Hull JE, Jennings WC, Cooper RI, Waheed U, Schaefer ME, Narayan R. The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access.

J Vasc Interv Radiol. February 2018;29(2):149-158.e5.

4 Shahverdyan R. Comparison of Surgical (sAVF) and Percutaneous (pAVF) Arteriovenous Fistulae Presented at LINC. January 2021.

Brief Statement Indications The Ellipsys™ system is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0 mm and less than 1.5 mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

Contraindications The Ellipsys™ system is contraindicated for use in patients with target vessels that are < 2 mm in diameter.

The Ellipsys™ System is contraindicated for use in patients who have a distance between the target artery and vein > 1.5 mm.

Warnings § The Ellipsys™ system has only been studied for the creation of an AV fistula using the proximal radial artery and the adjacent perforating vein. It has not been studied in subjects who are candidates for surgical fistula creation at other locations, including sites distal to this location. § The Ellipsys™ system is not intended to treat patients with significant vascular disease or calcification in the target vessels. § The Ellipsys™ system has only been studied in subjects who had a patent palmar arch and no evidence of ulnar artery insufficiency. § Use only with the Ellipsys™ Power Controller, Model No. AMI-1001. § The Ellipsys™ Catheter has been designed to be used with the 6 F Terumo Glidesheath Slender™*. If using a different sheath, verify the catheter can be advanced through the sheath without resistance prior to use. § Use ultrasound imaging to ensure proper placement of the catheter tip in the artery before retracting the sheath, since once the distal tip of the catheter has been advanced into the artery, it cannot be easily removed without creation of the anastomosis. If the distal tip is advanced into the artery at an improper location, complete the procedure and remove the catheter as indicated in the directions for use. It is recommended that a follow-up evaluation of the patient is performed using appropriate clinical standards of care for surgical fistulae to determine if any clinically significant flow develops that require further clinical action.

BlueLeaf endovenous valve formation

“The cusps we are forming today are much better than they were a year ago” William Marston and hydrodissects a flap; and then a nitinol dissector advanced into the flap, expanding and deepening the formation to create a valve cusp. Improvements made to the latest generation of the device means the valve cusp formed has more depth and a deeper capture of blood after creation, Marston elaborated. Additionally, “the device balloon has been strengthened to help puncture post-thrombotic veins, as most of the patients enrolled are post-thrombotic.”

Marston drew attention to one of the study cases with one year of follow-up to demonstrate the BlueLeaf system’s evolution.

The 53-year-old male patient, who had two monocuspid valves created, showed no DVT through 365 days of follow-up and a VCSS improvement from a baseline of 9 to

6. Marston noted how the valve cusp still showed some motion at one year compared to initial formation. “We’d like to see more but this was with a very early version of the device,” he said. “The cusps are now deeper and wider and hopefully will move better at 365 days than we see here. But this patient did have a well-preserved improvement in VCSS.” Concluding, Marston told the AVF meeting the BlueLeaf procedure “is technically feasible,” capable of forming valve cusps and under “continual improvement.” “The cusps we are forming today are much better than they were a year ago,” he said, pointing to an “exciting” future as study investigators progress into bicuspid valve formation and the hope of greater luminal coverage.

Precautions § This product is sterilized by ethylene oxide gas. § Additional procedures are expected to be required to increase and direct blood flow into the AVF target outflow vein and to maintain patency of the AVF. Care should be taken to proactively plan for any fistula maturation procedures when using the device. § In the Ellipsys™ study, 99% of subjects required balloon dilatation (PTA) to increase flow to the optimal access vessel and 62% of subjects required embolization coil placement in competing veins to direct blood flow to the optimal access vessel. Prior to the procedure, care should be taken to assess the optimal access vessel for maturation, the additional procedures that may be required to successfully achieve maturation, and appropriate patient follow-up. Please refer to the “Arteriovenous Fistula (AVF) Maturation” section of the labeling for guidance about fistula flow, embolization coil placement, and other procedures to assist fistula maturation and maintenance. § The Ellipsys™ System is intended to only be used by physicians trained in ultrasound guided percutaneous endovascular interventional techniques using appropriate clinical standards for care for fistula maintenance and maturation including balloon dilatation and coil embolization. § Precautions to prevent or reduce acute or longer-term clotting potential should be considered. Physician experience and discretion will determine the appropriate anticoagulant/antiplatelet therapy for each patient using appropriate clinical standards of care.

Potential Adverse Events Potential complications that may be associated with creation and maintenance of an arteriovenous fistula include, but may not be limited to, the following: § Total occlusion, partial occlusion or stenosis of the anastomosis or adjacent outflow vein § Stenosis of the central AVF outflow requiring treatment per the treatment center’s standard of care § Failure to achieve fistula maturation § Incomplete vessel ligation when using embolization coil to direct flow § Steal Syndrome § Hematoma § Infection or other complications § Need for vessel superficialization or other maturation assistance procedures.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device.

medtronic.com/ellipsys UC202201743 EN ©2021 Medtronic.

Medtronic and the Medtronic logo are trademarks of Medtronic.

All other brands are trademarks of a Medtronic company.

For distribution in the USA only. 06/2021

6 | Vascular Specialist

March 2022

ANNUAL MEETING

Tickets selling briskly for Gala: ‘Cheers to 75 Years’

BY BETH BALES

More than 410 people have made their intentions to raise a glass to toast the SVS’ quartercentury of helping vascular patients during the Vascular Annual Meeting (VAM) in Boston this summer.

THEY HAVE ALREADY PURCHASED scores of tables and tickets for the SVS Foundation’s “Cheers for 75 Years” Gala on Friday evening, June 17.

Festivities begin at 6:30 p.m. at the Sheraton Boston Hotel, the VAM headquarters hotel. The evening will kick off with a reception, followed by dinner, entertainment, the live auction, raise the paddle event and dancing. Dress is semiformal/black-tie optional.

All proceeds benefit the SVS Foundation for its research, public education, awareness and other programs to improve patient and vascular care.

Tickets are $500 a person or $5,000 a table. The Foundation is offering Platinum and Gold table packages as well, with just two and six, respectively, still available as of press time in early March.

The Silver table package was sold out.

In response to a social media post about purchasing tickets, a group from the University of Texas tweeted, “We’ve got our table! Get yours and support (the) SVS Foundation! Looking forward to seeing our #VascTwitter friends in Boston at VAM2022.” The Division of Vascular and Endovascular Surgery at University of Massachusetts Medical School was quick to respond. “We’ll be there next to you, U of T Vascular, with our table.

It is critically important to support [the] SVS Foundation. The ROI [return on investment] can be seen all around us, locally, regionally, nationally. Lead the science, lead the field.”

The most recent Gala, held in 2019, was a huge success, selling out in just a few weeks. Organizers believe the 2022 event will bring colleagues together to celebrate in a big way. In fact, Gala Committee CoChair Matthew Eagleton, MD, was first out the gate to purchase a table.

Purchase tickets at vascular.org/Gala22tickets.

“We’ll be there next to you, U of T Vascular, with our table. It is critically important to support [the] SVS Foundation”

BY BETH BALES

REGISTRATION AND HOUSING WILL OPEN BY MIDMarch for the Society for Vascular Surgery (SVS) 2022 Vascular Annual Meeting (VAM).

This year’s premiere educational event for all vascular professionals is set for June 15–18 at the Hynes Convention Center in Boston. Visit vascular.org/VAM22Hotels for information on hotel accommodations. The headquarters hotel is the Sheraton Boston Hotel, which is directly accessible to the Hynes Convention Center.

For 2021, VAM organizers noted that “Wednesday is the new Thursday,” as a number of events that formerly took place on Thursday moved to Wednesday. Wednesday is still the new Thursday, because those events—the Opening Ceremony, the William J. von Liebig Forum, the E. Stanley Crawford Critical Issues Forum and the first plenaries—remain firmly in place on the Wednesday schedule.

“This was very well-received last year and continues to allow us to reduce scheduling conflicts,” said SVS Program Committee Chair Andres Schanzer, MD. The committee determines much of the scheduling and programming for the meeting, along with the SVS Postgraduate Education Committee, which handles sessions such as concurrent, breakfast, “Ask the Expert” and special sessions, and postgraduate education courses.

Also returning is the livestreaming registration option, with even more content going out via the virtual medium. This will allow those who cannot attend in person to view nearly 20 sessions as they unfold. For 2022, most international livestreamed sessions have been moved to early morning, to permit those overseas to watch at a more reasonable time of day. In addition, an entire afternoon of livestreamed content will now accompany the morning content, allowing viewers to login all day long.

VAM 2022 encompasses four full days of education, networking and learning, and two days of exhibits from industry throughout the vascular world. Topics range from hard science to discussion of diversity issues, the vascular surgery workforce, quality care and improvement, an update on the SVS Foundation VISTA (Vascular Volunteers in Service to All) program and much more. Reviews of recently published SVS guidelines will close each plenary session. “We aim to cover a broad variety of topics that will be of interest to our diverse members, from emerging trends to highlighting particular vascular conditions and treatments, to situations our members face frequently, such as dialysis access, thoracic outlet syndrome and chronic limb-threatening ischemia,” said Schanzer. “This meeting will have important content for all SVS members.”

See the “Schedule at a Glance” at vascular.org/SAG22.

What’s coming up at VAM? What’s going on at breakfast, concurrent and “Ask the Expert” sessions? What are the topics of the three postgraduate education courses? See the titles below for just a portion of the educational offers at the Vascular Annual Meeting (details are subject to change).

Registration for VAM 2022 set to open by mid-March

● Clinical Trials: What You Need to Know ● Secrets to Choosing and Optimizing a Practice that

will Support Your Wellness and Career Longevity

CONCURRENT Ali AbuRahma

● There’s a Zebra in the Room: Aberrant Vascular

Pathologies and Current Management Strategies ● “Endovation”—Endovascular Innovation for Urgent

and Emergency Complex Aortic Disorders ● Progressing and Sustaining our Vascular Surgery Workforce

into the Future through Innovation in Surgical Education

ASK THE EXPERTS

● Improving Vascular Care in

● Proximal DVT ● Cost-Effectiveness in Vascular Surgery ● Community Research Partnerships

● Thoracic Outlet Syndrome ● The Failing and Failed EVAR ● Building Diversity and Equitable Systems in

Underserved Communities

and Interventions ● My Worst Cases ● Quality Improvement: Using a Data-Driven Approach

Vascular Surgery

POSTGRADUATE EDUCATION

to Improve Care and the Bottom Line

BREAKFAST ● Surgical Approach to the Lumbar Spine ● Physician-led Prosthetic Care Produces Improved Amputee

Outcomes ●P revention and Management of Infection in Vascular Surgery ● Creation and Maintenance of a Comprehensive Dialysis Access

Center: Lessons Learned from Vascular Leaders at all Levels

March 2022

● Management of Vascular Trauma: Exploring Consensus in the

Who, Where and How Amidst Subspecialized Training and Practice ● Updated Guidelines and Unresolved Controversies in Carotid Disease ● Toe and Flow Rounds—Working Towards a Comprehensive Approach to the Management of Chronic Limb-Threatening Ischemia

For information on VAM 2022, visit vascular.org/VAM.

Wanted: Fun, wherever it may be

Whether it’s an offering of artwork, tickets to pro basketball or football games, a cabin in the woods or a cottage on the beach, the surgeons overseeing the SVS Foundation Gala want to hear from you.

The SVS Foundation “Cheers to 75 Years” Gala will feature both live and silent auctions, a big part of the fun of the event. While the live auction is restricted to participants, anyone with an internet connection can place bids and up the ante in the silent auction, starting a few weeks before the June 17 event.

Notifications will let participants know when someone has topped the bid on a particular offering. While all contributions are welcome, of special interest are sporting events and skyboxes, sports memorabilia, travel and timeshares, food, entertainment, wine and high-end liquors, artwork, activities such as golf, as well as chef classes, jewelry and educational experiences.—Beth Bales

For information on auction items and to donate, email Catherine Lampi at SVSFoundation@vascularsociety.org.

For information on the gala, visit vascular.org/Gala22Tickets.

vascularspecialistonline.com | 7

EARLY CAREER

Life of Achilles: Turning weakness into bursts of innovation, creativity

BY BRYAN KAY

Themes rooted in the life of Achilles, the heroic figure from Greek mythology, and the concept of “emotional stamina” underpinned the message delivered from the presidential podium during the 2022 winter annual meeting of the Vascular and Endovascular Surgery Society (VESS).

T

he specter of Achilles has loomed large over the life and times of the man behind the message.

In recent years, Jason Lee, MD, the immediate past president of VESS and an active sportsman, has suffered two ruptures of his Achilles tendon. Taking inspiration from the legend of Achilles’ exertions during the Trojan War, Lee drew on both the warrior and leadership characteristics Greek mythology bestows on Homer’s central hero of the Iliad to illustrate character traits redolent of progress and recovery during the 2022 VESS Presidential Address.

“His swiftness was what made him a great warrior,” Lee told the VESS gathering in Snowmass, Colorado ( Jan. 27–30). “The ability to get in and out of trouble quickly, to make quick decisions and move swiftly.” But demigod Achilles also had human traits, he continued, including deep loyalty to family and friends. Perhaps like a lot of young vascular trainees, Lee suggested, he began as slightly angry and impulsive. “But perhaps like most of our trainees who have gone on to be wonderful junior faculty and senior faculty, he adapted.”

Achilles progressed through a well-described leadership improvement as he rose through the ranks, Lee explained.

Battle after battle, or “surgery after surgery,” he said, Achilles was undefeated—“even though the larger war that we all stage every day at the hospital was perhaps at a stalemate.”

His eventual retreat from war, subsequent return to the fray and ultimate death were tied up in conflict with

SVS creates new membership opportunity for young surgeons

BY KRISTIN CROWE

SURGEONS WITHIN THEIR FIRST 10 years of practice now have a dedicated home within the Society for Vascular Surgery (SVS). In December 2021, the SVS Executive Board approved the Young Surgeons Section (YSS) as a new membership Section. After the recruitment and building of a strong charter membership, the YSS has officially launched.

The Young Surgeons Section’s mission is to foster and accelerate the learning and career development of SVS members within their first 10 years in clinical practice. Charter members plan to achieve this mission by establishing an engaging and interactive forum that will enhance SVS efforts in education, advocacy, quality

8 | Vascular Specialist

higher leadership, a failing plan B, as well as vengeance and loyalty. Crucially, the arrow that would claim his life— Achilles’ heel— Lee informed his audience, is shrouded in much mystery and debate. But for Lee, the key to the answer, and the inherent lesson, may lie in scholarly literature that focuses on the warrior’s “imperfect” vulnerability. “Despite whatever armor we put on,” he said, “all of us have that vulnerability, and embracing it perhaps is the best way to adapt to the day-to-day issues we come up with,” he related. Those Achilles ruptures Lee himself suffered in the last half decade offered up personal trajectories of progress and recovery: “Armed with a continued desire to compete, and even after a second rupture a year later,” the Stanford vascular chief and competitive tennis player told VESS, “[it was] back to the OR [operating room], back to

Despite whatever armor we put on, all of us have that vulnerability, and embracing it perhaps is the best way to adapt to the day-today issues we come up with” Jason Lee

practice, ethics, research, diversity, equity and inclusion, and member value—with specific focus and attention to the needs of members in their earlier career stages.

Chelsea Dorsey, MD, an associate professor of surgery at the University of Chicago, is serving as the first section chair and leads the YSS Steering Committee, composed of 12 members.

The idea for the section developed within the former SVS Young Surgeons Committee, led by Venita Chandra, MD, and focused on the needs of SVS members in their first 10 years of clinical practice.

Chandra and Dorsey, along with the members of the former committee, were instrumental in developing the YSS. “I am incredibly excited and humbled to chair the newly formed Young Surgeons Section of the SVS,” said Dorsey.

“It has already become abundantly clear that there is a significant amount of interest and enthusiasm from our earlycareer vascular surgeons to get involved, improve the overall experience for younger members of the SVS and provide additional resources to this demographic.”

the tennis courts—it turns out these bilateral Achilles ruptures happen with some frequency: and we’re back to everything. This was [about] overcoming the inability to recover physically, and then realizing the emotional recovery necessary for it.”

Lee asked VESS attendees to consider their own Achilles ruptures, and to consider lessons to be derived from the warrior’s legend. Fierce devotion to protect as well as sponsor the next generation. A warrior’s mentality of battle strategy and teamwork, as in the OR and clinics.

Loyalty and dedication to causes and movements.

Recognizing strengths can be weak points, and vice versa.

That it’s okay to be vulnerable. That leftfield ideas can change history. To remember to respect those who came before. Just as he had when faced with those ruptures, “climb the mountain, and then do it again.” And weather the storm in the spirit of “emotional stamina.”

Back during VESS 2016, Lee could be seen wheeling around the conference venue on a scooter having incurred the first of those Achilles ruptures. Back then, it soon dawned on him the significance of the moment, he told Vascular Specialist a few days after giving the 2022 VESS Presidential Address. “It was compelling the idea of how indestructible we all like to think we are in trying to put on a strong vascular surgery face for our patients, for our colleagues, for our trainees,” he said.

“But we actually all need to have a lot of self-introspection about our own vulnerabilities. Rather than think of those things as weaknesses, we should actually embrace when we’re in those times and turn them into moments of change, innovation and creativity—and make good of them.”

The YSS is planning a session for the 2022 Vascular Annual Meeting (VAM) in Boston that will focus on many of the career and practice development issues that arise for these early-career vascular surgeons. This will be the first of many educational opportunities developed and hosted by the section, and members should stay tuned for more details.

“Early signs indicate that there is a plethora of opportunities for the YSS to collaborate with other arms of the society to further the mission laid out by our section and the Society as a whole,” said Dorsey.

“I believe our Section’s members recognize our role as the future of our field and take that responsibility quite seriously. We are not only poised to dig into the practice and career-development

Jason Lee

needs of this group, but we also have our eye on ensuring the SVS understands the priorities of our section’s constituents. We are just getting started, but in my opinion the sky is the limit for the YSS.” Section members must be an SVS member in good standing and be within their first 10 years of practice in order to participate. SVS Active, Candidate and International members are all eligible to apply. For more information, email kcrowe@vascularsociety.org.

The YSS Steering Committee also includes Rana Afifi, MD, Edward Arous, MD, Saideep Bose, MD, Nathan Droz, MD, Laura Marie Drudi, MD, Edward Gifford, MD, Michael McNally, MD, Nicolas Mouawad, MD, Leigh Ann O’Banion, MD, Carlos Pineda, MD, and Christine Shokrzadeh, MD.

“Early signs indicate that there is a plethora of opportunities for the YSS to collaborate with other arms of the society to further the mission laid out by our section and the Society as a whole” Chelsea Dorsey

March 2022

PAD

Potential ‘new paradigm’ in treatment of long occlusive lesions emerges

BY SARAH CROFT

Vascular surgeon Lewis Schwartz, MD, has had an interest in biomedical engineering since very early in his career. So his involvement in the early-stage Efemoral vascular scaffold system marks a significant milestone in a mission to save legs and provide better care for patients with peripheral arterial disease (PAD).

SCHWARTZ, A CLINICAL PROFESSOR OF SURGERY at University of Illinois College of Medicine in Park Ridge, Illinois, is one of the co-founders behind the novel, balloon-expandable, resorbable, drug-eluting device, which late last year saw results from a study in domestic farm swine delivered at the annual meeting of the Midwestern Vascular Surgical Society (MVSS) in Chicago.

The pre-clinical trial showed that “long, mobile, peripheral arteries can be successfully treated with multiple, short, balloon-expandable, bioresorbable scaffolds,” presenting author Rym El Khoury, MD, told MVSS attendees.

El Khoury—formerly a general surgery resident at University of Illinois Metropolitan Group Hospitals in Chicago and now a vascular surgery fellow at the University of California San Francisco (UCSF)—explained how the results were drawn from a total of 38 resorbable scaffolds implanted in eight iliofemoral arteries of four female swine. Configurations, she said, consisted of two scaffolds in two arteries, four scaffolds in another two arteries, six scaffolds in three arteries, and eight scaffolds in one. The total arterial scaffolded length ranged from 32–97mm.

The Efemoral system, or EVSS, being developed under the auspices of Efemoral Medical, has been heralded as a “new paradigm” in the treatment of long-segment lesions with a device made up of multiple, short scaffolds. “The EVSS is directed to the long, occlusive, atherosclerotic lesions typical of the human peripheral arterial tree and was designed to become the first absorbable stent with widespread clinical viability,” reflects Schwartz in an interview with Vascular Specialist.

It seeks to succeed where previous bioresorbable scaffolds have suffered pitfalls in five ways, he continues.

“By targeting the unmet clinical needs of peripheral vascular intervention, as opposed to coronary intervention; by exhibiting the radial force typical of balloon-expandable metal stents, as opposed to self-expanding nitinol stents; by employing a co-polymer to enhance strength and ductility; by formulating the scaffold to degrade within the first two years, as opposed to the four years typical of historical absorbable stents; and by serially mounting multiple, independent scaffolds over the device length in order to mitigate fracture and facilitate the treatment of long lesions.”

Schwartz details how the design of radial strength is exhibited “like a freight train negotiating a tight bend in the tracks, the individual scaffolds maintain the arterial 10 | Vascular Specialist

lumen with high radial force while the inter-scaffold spaces are free to bend and compress during limb movement.

“As such, the EVSS can readily treat the short lesions of the femoropopliteal arteries that have been traditionally enrolled in clinical trials of peripheral vascular intervention; in addition, simply by loading more scaffolds onto longer angioplasty balloons, the EVSS can be easily adapted for the treatment of long femoropopliteal lesions heretofore inaccessible using currently available technology,” Schwartz says.

‘Preserved structural integrity’ El Khoury elaborates further on the results presented at the MVSS in Chicago. “Angiographic and optical coherence tomography (OCT) images were obtained of the hindlimb in natural extension and exaggerated flexion showed that native porcine iliofemoral arteries significantly deformed with passive hindlimb flexion as expected (bending 110±20° and compression 20±14%) while preserving their mean luminal diameter even with extreme deformation (4.7±0.4mm vs. 5.0±0.2mm in extension vs. flexion; p=0.16),” she tells Vascular Specialist.

“Following EVSS implantation, supra-physiologic flexion created similar patterns of deformation in the treated artery (bending 113±19° and compression 15±15%) while mean luminal diameter remained stable without kinks or occlusion (4.7±0.7mm vs. 4.7±0.5mm in extension vs. flexion; p=0.80). Arterial deformation was borne by shortening of the inter-scaffold spaces (2.2±08mm vs.

1.9±0.7mm in extension vs. flexion; p<0.01) as well as the

Lewis Schwartz

Rym El Khoury

“The EVSS is directed to the long, occlusive, atherosclerotic lesions typical of the human peripheral arterial tree and was designed to become the first absorbable stent with widespread clinical viability” Lewis Schwartz

Efemoral vascular scaffold system

scaffolds themselves (10.7±1.4 vs. 9.9±1.1mm in extension vs. flexion; p<0.01). OCT and 3D micro-computed tomography (micro-CT) imaging confirmed consistent wall apposition and preserved structural integrity in all scaffolds,” El Khoury further explained.

The first-in-human EFEMORAL I trial, meanwhile, is a prospective, single-arm, open-labeled, multicenter, clinical investigation enrolling patients with an arterial diameter of ≥5.5mm and ≤6.5mm, and lesion length ≤90mm receiving a single EVSS, Schwartz details. Its purpose is to evaluate safety and performance of the sirolimus-eluting EVSS in patients with symptomatic peripheral arterial occlusive disease from stenosis or occlusion of the femoropopliteal or external iliac artery. The principal investigator is Andrew Holden, MDChB, director of interventional radiology at Auckland City Hospital, Auckland, New Zealand. The

trial has a primary safety endpoint of freedom from major adverse events at 30 days and a primary efficacy endpoint of freedom from binary restenosis at 12 months.

Also of note, Schwartz explains, is that the EVSS was originally formulated with paclitaxel as the antiproliferative agent of choice. However, after the 2018 meta-analysis by Konstantinos Katsanos, MD, et al suggested the drug “carries an increased risk of late mortality […] Efemoral felt it prudent to abandon the cytotoxic drug paclitaxel in favor of the cytostatic drug sirolimus.”

Schwartz reiterates his drive to tackle “the unmet clinical need for effective lower-extremity revascularization.” With the historical strategy of open surgical bypass, he says, some “14–44% of long bypass leg incisions become infected and up to 69% of patients are re-hospitalized in the first year, with excessive mortality and morbidity.” Yet, while “the current paradigms” of endovascular therapy—such as employing balloon dilatation and dilatation with specialty balloons coated with antiproliferative drugs—are generally effective in treating short lesions, Schwartz continues, “the results of endovascular intervention in the long, chronic occlusions observed in critically ischemic patients remain dismal.”

Combating leg amputation Schwartz says the EVSS design and development have been informed by a long career that has included early training in biomedical engineering, general and vascular surgery, a decade of academic basic and clinical investigation, and a decade of designing and developing biomedical device intravascular strategies, in addition to “a tragic but lifelong experience of leg amputation.”

Improvements in the treatment of PAD over the last near half century “have been quantum” but failure, including extremity amputation, “remains commonplace,” he says. “We can do better.” For now, Schwartz adds, the device holds promise. “Assuming consistent demonstration of the safety and efficacy of the EVSS in pre-clinical and clinical investigations, the device could potentially become commercially available in the U.S. as early as 2027.”

FDA approves increased enrollment in atherectomy clinical trial RA MEDICAL SYSTEMS, A COMPANY FOCUSED ON developing the excimer laser system to treat vascular diseases, has announced that enrollment has reached 95 subjects in the pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy device for the treatment of peripheral arterial disease (PAD).

The company also announces approval from the Food and Drug Administration (FDA) to increase subject enrollment from 100 subjects to 125 subjects.

DABRA has been cleared by the FDA for crossing chronic total occlusions (CTOs) in patients with symptomatic infrainguinal lower-extremity vascular disease and has an intended use for ablating a channel in occlusive peripheral vascular disease.

The open-label pivotal atherectomy clinical trial can enroll subjects with symptoms of PAD (Rutherford Class 2–5) at up to 10 sites. Outcome measures include safety, acute technical success as well as clinical success. The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA, and before any adjunctive treatment.

The trial’s safety and clinical success endpoints are major adverse events at 30 days post-procedure and incidence of primary target lesion revascularization at six months.— Anthony Strzalek

March 2022

VENOUS DISEASE

VenoValve improvement ‘maintained’ for 2.5 years without adverse events

Sebastian Cifuentes at AVF 2022

BY BRYAN KAY

Envveno Medical announced positive 30-month data from the firstin-human trial of the VenoValve bioprosthetic potential venous valve replacement during the 2022 American Venous Forum (AVF) annual meeting held in Orlando, Florida (Feb. 23–26).

THE RESULTS SHOWED THAT VenoValve recipients—now an average of 30 months post-VenoValve implantation— continue to benefit from the device and have experienced no relapses of severe chronic venous insufficiency (CVI), no recurrences of venous ulcers, and no material adverse safety events, the company reported. Average improvement in reflux was 55%; likewise, average improvement in venous clinical severity score (VCSS) was 61%; and the same

measure in visual analog scale (VAS) was 81%. All of these datapoints were as compared to pre-VenoValve levels for the eight first-in-human patients who agreed to be followed, including one patient now three years post-implantation.

The data were presented by Sebastian Cifuentes, MD, until recently a vascular surgery research fellow at Fundacion Santa Fe-Universidad de los Andes in Bogota, Colombia, and part of a research team led by principal investigator Jorge Ulloa, MD,

Six-month CLOUT data indicate ClotTriever can effectively remove full spectrum of thrombus

of the same institution. Cifuentes told AVF 2022 delegates that patients implanted with the VenoValve demonstrated that improvement was “maintained” out to 2.5 years without the occurrence of adverse events, with no recurrence in C5 patients and no new ulcers on the ipsilateral side in C6 patients based on the CEAP (ClinicalEtiological-Anatomical-Pathophysiological) classification of disease severity.

(Inari Medical) for all chronicity subgroups, Dexter said.

No patients required adjunctive thrombolytics. Adjuvant angioplasty was used in 73% (acute: 70%; subacute: 68%; chronic: 84%) and stents in 47% (acute: 46%; subacute: 42%; chronic: 50%) of cases.

Complete or near-complete thrombus removal was achieved in 85% (acute: 90%; subacute 81%; chronic: 84%) of limbs, including 51% (acute: 54%; subacute: 49%; chronic: 49%) with 100% thrombus removal. The postSix-month outcomes from the ongoing thrombectomy median hospital stay was one day for all subgroups. At six months, 90% (acute: 86%; subacute: CLOUT registry demonstrate the safety 89%; chronic: 96%) of the treated limbs had flow present, and effectiveness of the ClotTriever and 90% (acute: 84%; subacute: 90%; chronic: 91%) were thrombectomy system in a real-world compressible. Any PTS at six months was about 20% in the deep vein thrombosis (DVT) population acute, 25% in the subacute and 30% in the chronic arms. regardless of clot chronicity level, the 2022 “Statistically, this has a p value of 0.5—we’ll see how that holds out in another two years when we have finished annual meeting of the American Venous enrollment of 500 patients,” Dexter said. On the other Forum (AVF) in Orlando, Florida (Feb. 23– hand, moderate-to-severe PTS, “was remarkably low at 26) heard.

5% in the acute arm, and about 10% in the subacute and NORFOLK, VIRGINIA-BASED VASCULAR chronic arms.” surgeon David Dexter, MD, was delivering the latest Major adverse and serious adverse events “were similar subgroup analysis update from the prospective, multicenter and also rare,” Dexter added. “All-cause mortality was three study on behalf of the CLOUT registry investigators patients throughout the first 250.” Furthermore, in terms based on the first 250 patients enrolled at 24 sites, telling of venous clinical severity score (VCSS) numbers, at 30 attendees, “We were able to meet the performance goal of days and six months they were “nicely low” at 3 and 2 for greater than 75% in all three [chronicity] groups.” Dexter, the acute group, 4 and 3 among subacute patients, and 4 of Eastern Virginia Medical School and Sentara Vascular and 4 in the chronic subset, Dexter pointed out. Pain score Specialists, explained, “We numbers were “essentially zero had remarkably low deviceacross the board.” The same related serious adverse events was true when measuring at one month. And our rates quality of life, he said. of post-thrombotic syndrome “The average quality of % % % Acute Subacute Chronic [PTS]—including moderate life went back to the patient’s to severe—at six months were baseline regardless of the similarly low.” chronicity believed to be in the The data from the registry clot for acute, subacute “We were able to meet show 33% of the 250 patients and chronic.” the performance goal of included with acute thrombus, The CLOUT registry’s followgreater than 75% in all three 35% with subacute and 32% up out to two years is ongoing. with chronic clot. Almost all Total enrollment of 500 patients [chronicity] groups” procedures were single session, at up to 50 sites has the David Dexter with an average of four passes intention of probing using the ClotTriever device all-comers.—Bryan Kay

90

March 2022

81

84

The VenoValve is currently being evaluated in the SAVVE (surgical antireflux venous valve endoprosthesis) U.S. pivotal trial, with a primary safety endpoint of absence of material adverse safety events in 26% or less of the patients at one month post-implantation, and a primary effectiveness endpoint of improvement in reflux of at least 30% measured at six months.

Houston, we have a dialysis access problem ...

BY URMILA KERSLAKE

THE CONCEPT OF DEDICATED VASCULAR access centers fuels a turbocharged Texan tussle with Karl Illig, MD, of Flow Vascular Center in Houston, taking on Eric Peden, MD, an associate professor of cardiovascular surgery at Houston Methodist Hospital, in a no-holds-barred debate on how best to deliver longitudinal patient care. The question is: who will patients call with “Houston, we have a (dialysis access) problem”?

Illig tips his hat at renowned vascular access educator John Ross, MD, and “his greatest contribution”—the creation of the concept of the total dialysis access provider and total dialysis access center. And Illig is an unapologetic advocate for similar comprehensive dialysis access centers as the model to deliver the best patient care. In a presentation titled “Dialysis access in the 21st century: A call to arms,” Illig is categorical about his message to renal care physicians providing dialysis services: “You do it wrong—patients die early.

You do it right—quality and quantity of life significantly improve.”

Peden’s riposte is that the most beneficial aspect to practicing in a hospital system is that you can provide truly comprehensive care. “No matter how sick the person, no matter what their other medical troubles are, there are additional resources available at the hospital setting that are simply not available at some outpatient settings,” he states.

Peden acknowledges that freestanding centers offer a variety of advantages for what he terms “garden variety” vascular access care. “In other scenarios, when things are more complicated ... then care really cannot be provided safely at the access center.

Heaven forbid there are complications—those really need to be managed in a hospital,” he adds.

A full-length feature on the Illig-Peden debate is available by visiting vascularspecialistonline.com. vascularspecialistonline.com | 11

APPROPRIATE USE

Increased market competition linked to higher odds of revascularization among asymptomatic patients with moderate carotid stenosis

BY BRYAN KAY

A vascular surgery research team with a growing reputation for its work investigating appropriateness in care in the peripheral vascular bed recently uncovered an association between increased regional market competition among proceduralists and higher odds of revascularization being carried out for moderate- versus high-grade asymptomatic carotid stenosis. The investigators detected no similar impact among symptomatic patients, leading Rebecca Sorber, MD, a general surgery resident at The Johns Hopkins University School of Medicine in Baltimore, and colleagues to conclude that a more competitive marketplace, or more physicians in a given region offering such carotid procedures, “may influence more aggressive behavior” when treating asymptomatic carotid disease patients who may otherwise be good candidates for surveillance.

S

enior author Caitlin W. Hicks, MD, associate professor of surgery at Johns Hopkins, told Vascular Specialist in an interview: “We do a lot of really important procedures and a lot of great care for patients but I also think we do too many procedures, or things that are not necessarily in patients’ best interests.”

This latest project probing the contentious space of asymptomatic carotid intervention through the lens of market competition follows a body of work on atherectomy practice patterns and the appropriateness of its use, and was recently presented at the 2022 winter annual meeting of the Vascular and Endovascular Surgery Society (VESS), held in Snowmass, Colorado ( Jan. 27–30).

“This one is a unique take on [that type of work], and it looks at the regional market competition characteristic, which is an interesting way to understand market influences, perhaps, in practice patterns,” Hicks explained.

To arrive at their findings, Sorber, Hicks and colleagues plumbed the Vascular Quality Initiative (VQI) database for all patients undergoing first-time carotid revascularization for carotid artery stenosis of 50–99% between 2016–2020, stratifying them by symptomatology and degree of stenosis (moderate: 50–<80%; high grade: ≥80%). They then used 10 U.S. Health and Human Services (HHS) designated regions to measure competition amongst physicians, ultimately looking at nearly 150,000 patients.

Diabetes: Impact of local medicolegal landscapes on costs MORE LITIGIOUS U.S. STATES did not see decreased amputation rates over those where the medicolegal environment was less adverse, according to an analysis of Medicare data exploring the association between the realities of local medical-legal landscapes and diabetes-related care costs.

A team of researchers from the Mayo Clinic Arizona in Phoenix and UMass Memorial Health in Worcester, Massachusetts, found that across U.S. states, a 1% increase in lawsuits per 100 physicians was associated with a greater than 10% increase in riskadjusted standardized per-capita costs.

12 | Vascular Specialist

Competition by region was overall “quite high,” Sorber told VESS, which she said reflected the large number of proceduralists offering carotid revascularization in the U.S. The most competitive was the Great Lakes/ Chicago region, with the least competitive Caitlin W. identified as Denver/Rocky Mountains.

Hicks Sorber revealed how a 10-point decrease in the Herfindahl-Hirschman Index (the measure the research team used to calculate physician market competition)— which corresponded to increased competition—was associated with an odds ratio of 1.02 increased likelihood of revascularization in moderate grade asymptomatic carotid stenosis versus those with high grade (95% confidence interval [CI] 1.01–1.03). “As expected, an

“At a minimum, there is room for improvement in ensuring patients with asymptomatic carotid stenosis and symptomatic stenosis are on best medical therapy prior to revascularization” Rebecca Sorber

An adverse medicolegal environment is “independently associated” with high healthcare costs, but doesn’t necessarily result in improved outcomes, they concluded. Per-capita spending on diabetes ranged from $15,799 in states with infrequent and lower malpractice payouts compared to $18,838 on average in states with higher and more frequent settlements (p<0.05). Diabetic patients in states with adverse medicolegal environments had more procedures, imaging tests, and readmissions (p<0.05), Austin Pierce, MD, a general surgery resident from the Mayo Clinic, told the 2022 VESS winter annual meeting as the findings were presented for the first time. On multivariate analysis, amputation rates were associated with increased spending, co-morbidity prevalence,

and race, but not medicolegal factors.

“An adverse medicolegal environment is pretty clearly associated with higher healthcare spending, driven through greater intensity of service utilization,” senior study author Andrew J. Meltzer, MD, Mayo Clinic Arizona vascular chair, told Vascular Specialist.

“The one thing that we can certainly measure in terms of outcomes based on available data, that’s relevant with our population in particular, would be amputation rates … this higher intensity of testing and higher spending does not correlate with any improvement in outcomes; it really simply reflects the external pressures that are placed upon those taking care of patients in an environment that is overly litigious.”—Bryan Kay

identical analysis in symptomatic patients showed no significant association between competition and revascularization threshold,” she told VESS. Furthermore, in-hospital outcomes showed that the moderate grade asymptomatic patients had a significantly higher likelihood of stroke and stroke-death following revascularization compared to their high-grade asymptomatic patients counterparts, Sorber added. “Again, an identical analysis among symptomatic patients did not demonstrate this relationship, instead showing a slightly increased risk of mortality for high-grade patients.” Multivariable analysis demonstrated that moderate grade revascularization was independently associated with the composite adverse outcome of stroke-death among asymptomatic patients, Sorber added.

Sitting alongside Hicks later, Sorber detailed how much of her mentor’s work has focused on disease processes that have clearer guidelines of what physicians should be carrying out. In those cases, she said, “we can really make judgments on whether what people are doing is appropriate,” she said. “With asymptomatic carotid disease, we don’t necessarily have that—a lot of the new trials are still in progress. So, this is the right time to do this project and look at this data, but it’s a difficult time to contextualize the results.” The bottom line though, Sorber told Vascular Specialist, is that the project uncovered data showing physicians surrounded by a lot more competitors who are also treating carotid disease were “more likely to offer an operation to somebody with a lower percentage Rebecca of stenosis.” That was consistent with Sorber results derived from other analyses of surgical behavior in more competitive markets, she said.

Summing up the group’s findings during VESS, Sorber pointed to “the small but significant increases in adverse perioperative outcomes demonstrated for moderate-grade asymptomatic patients” as highlighting a need for “critical reflection” about factors motivating decisions to offer revascularization to asymptomatic patients with less than 80% stenosis. “At a minimum,” she said “there is room for improvement in ensuring patients with asymptomatic carotid stenosis and symptomatic stenosis are on best medical therapy prior to revascularization” as the carotid space awaits results from trials such as CREST-2.

Medtronic issues voluntary recall for TurboHawk Plus directional atherectomy system On Feb. 7, Medtronic issued a notice emphasizing that the same warnings and precautions issued for the HawkOne directional atherectomy system in a recent voluntary recall also apply for the company’s TurboHawk Plus 6Fr system due to design similarities. The company said this is not a new issue.

“There is no product retrieval or disposal requested at this time,” Medtronic communicated in a news alert, which detailed that approximately 800 devices are impacted by this recall.

“Additionally, there are no actions required for patients treated with the TurboHawk Plus 6Fr or any Medtronic directional atherectomy devices,” the Medtronic alert continued.

Medtronic advised that there have been zero reports of tip damage and zero reports of injury or death on the TurboHawk Plus device.—Jocelyn Hudson

March 2022

IN.PACT™ Admiral™ drug-coated balloon (DCB)

Tested. Trusted.

The IN.PACT Admiral DCB remains the market-leading DCB, backed by five years of efficacy data,1 even in complex lesions.2

Highest

patency benefit through 3 years†1

Lowest

CD-TLR rates through 5 years1

Most

publications for a DCB‡

5

years of data1

Discover the data at Medtronic.com/5yearDCB

AAA

Study ‘supports’ SVS open abdominal aortic anuerysm volume recommendations A MULTICENTER, RETROSPECTIVE DATABASE ANALYSIS SUGGESTS improved open abdominal aortic aneurysm (AAA) outcomes when surgeon volume is greater than seven cases yearly and performed in hospitals with a 30-day mortality rate less than 5%.

The Society for Vascular Surgery (SVS) published updated practice guidelines in 2018 that recommended open AAA repair be limited to centers that meet a case volume threshold and outcome target. Specifically, they state open AAA repair should be conducted in centers that have a mortality rate of less than 5% and that perform at least 10 open repairs per year. The study, which queried records from 2000–2014, involved 7,594 patients treated by 542 surgeons at 137 hospitals. The annual open AAA repair case volume averaged 12.9 (median seven) for the hospitals, and five (median three) for the surgeons. Overall, 4,000 cases were performed in centers meeting the SVS criteria versus 3,594 cases performed in centers that did not. Comparing outcomes between the groups, the researchers noted significant differences in centers meeting criteria (one-year mortality 9.2%; 30-day mortality 3.5%) and not meeting criteria (one-year mortality 13.6%; 30-day mortality 6.9%).

Of note, complication rates between the groups were similar—except the rate of pulmonary complications, which was significantly lower in centers meeting the SVS criteria. “These data showed a positive correlation between the 2018 SVS AAA guidelines and outcomes for elective open AAA repair within the SPARCS dataset,” said senior author Adam Doyle, an associate professor of vascular surgery at University of Rochester Medical Center, Rochester, New York.

Doyle suggested: “This supports centralizing elective open AAA operations to higher-volume surgeons at high-quality centers. This may have educational value for trainees as high-volume surgeons tend to practice at teaching hospitals.”

The study was published in the February issue of the Journal of Vascular Surgery (JVS).—Jocelyn Hudson

† ‡

Primary patency not assessed after three years.

Data and additional comparative data on file with Medtronic.

Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. 5-year results from the IN.PACT SFA Trial. Circ Cardiovasc Interv.

June 2019;12(6):e007702.

2 Gunnar Tepe. 5-year results from the IN.PACT Global Study Prespecified Cohorts: ISR, CTO and Long Lesions. Presented at VIVA, 2021.

1

Brief Statement IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter Indications for Use: The IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm.

Contraindications: The IN.PACT Admiral DCB is contraindicated for use in: • Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries • Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system • Patients with known allergies or sensitivities to paclitaxel • Women who are breastfeeding, pregnant, or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

Warnings: • A signal for increased risk of late mortality has been identified following the use of paclitaxel-coated balloons and paclitaxel- eluting stents for femoropoliteal arterial disease beginning approximately 2–3 years post-treatment compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel-coated device exposure. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients. • Use the product prior to the Use-by Date specified on the package. • Contents are supplied sterile. Do not use the product if the inner packaging is damaged or opened. • Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution). • Do not move the guidewire during inflation of the IN.PACT Admiral DCB. • Do not exceed the rated burst pressure (RBP).

The RBP is 14 atm (1419 kPa) for all balloons except the 200 and 250 mm balloons. For the 200 and 250 mm balloons the RBP is 11 atm (1115 kPa). The RBP is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection.

Perioperative care in open aortic surgery: SVS and ERAS Society issue consensus statement The Society for Vascular Surgery (SVS) and the Stockholm, Sweden-based Enhanced Recovery after Surgery (ERAS) Society have released a consensus statement intended to help address perioperative challenges faced by vascular surgery patients.

THE ERAS PATHWAYS HAVE PROVEN beneficial for a number of surgical specialties, and the application of these pathways will be important to address the needs of patients undergoing open aortic operations, according to a press release.

With the goal of delivering highquality perioperative care and accelerating recovery, this consensus statement is intended to help address the many perioperative challenges faced by vascular surgery patients, who are often older, frailer and have more comorbidities than the average surgical patient. The document focuses on both transabdominal and retroperitoneal approaches—including

supraceliac, suprarenal and infrarenal clamp sites—for aortic aneurysm and aortoiliac occlusive disease operations.

Katharine McGinigle, MD, chair of the SVS writing group, stated, “The ERAS Writing Group and I are thrilled to share this consensus statement for perioperative best practices for open aortic surgery, and really believe that our patients have much to gain. Each of these recommendations are really nothing new on their own, but it is the collection of them that makes the group of recommendations novel.

They emphasize the coordination and timing of care across disciplines to reduce unnecessary care variation and to give our patients the best chances of an improved convalescence.”—Beth Bales To read this consensus statement, visit Visit vascular.org/ERASstatement.

• The safety and effectiveness of using multiple IN.PACT Admiral DCBs with a total drug dosage exceeding 34,854 μg of paclitaxel in a patient has not been clinically evaluated.

Precautions: • This product should only be used by physicians trained in percutaneous transluminal angioplasty (PTA). • This product is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. • Assess risks and benefits before treating patients with a history of severe reaction to contrast agents. • The safety and effectiveness of the IN.PACT Admiral DCB used in conjunction with other drug-eluting stents or drug-coated balloons in the same procedure or following treatment failure has not been evaluated. • The extent of the patient’s exposure to the drug coating is directly related to the number of balloons used. Refer to the Instructions for Use (IFU) for details regarding the use of multiple balloons and paclitaxel content. • The use of this product carries the risks associated with percutaneous transluminal angioplasty, including thrombosis, vascular complications, and/or bleeding events.

• Vessel preparation using only pre-dilatation was studied in the clinical study. Other methods of vessel preparation, such as atherectomy, have not been studied clinically with IN.PACT Admiral DCB. • This product is not intended for the expansion or delivery of a stent.

Potential Adverse Effects: The potential adverse effects (e.g., complications) associated with the use of the device are: abrupt vessel closure; access site pain; allergic reaction to contrast medium, antiplatelet therapy, or catheter system components (materials, drugs, and excipients); amputation/loss of limb; arrhythmias; arterial aneurysm; arterial thrombosis; arteriovenous (AV) fistula; death; dissection; embolization; fever; hematoma; hemorrhage; hypotension/hypertension; inflammation; ischemia or infarction of tissue/ organ; local infection at access site; local or distal embolic events; perforation or rupture of the artery; pseudoaneurysm; renal insufficiency or failure; restenosis of the dilated artery; sepsis or systemic infection; shock; stroke; systemic embolization; vessel spasms or recoil; vessel trauma which requires surgical repair. Potential complications of peripheral balloon catheterization include, but are not limited to the following: balloon rupture; detachment of a component of the balloon and/ or catheter system; failure of the balloon to perform as intended; failure to cross the lesion. Although systemic effects are not anticipated, potential adverse events that may be unique to the paclitaxel drug coating include, but are not limited to: allergic/immunologic reaction; alopecia; anemia; gastrointestinal symptoms; hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia); hepatic enzyme changes; histologic changes in vessel wall, including inflammation, cellular damage, or necrosis; myalgia/arthralgia; myelosuppression; peripheral neuropathy. Refer to the Physician’s Desk Reference for more information on the potential adverse effects observed with paclitaxel. There may be other potential adverse effects that are unforeseen at this time. Please reference appropriate product Instructions for Use for a detailed list of indications, warnings, precautions, and potential adverse effects. This content is available electronically at manuals.medtronic.com.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

UC202210984 EN ©2021 Medtronic. All rights reserved. Medtronic, Medtronic logo, and Engineering the extraordinary are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. For distribution in the USA only. 12/2021

14 | Vascular Specialist

March 2022

VASCULAR PRACTICE

Medicare Quality Payment Program changes for 2022 In November 2021, the Centers for Medicare & Medicaid Services (CMS) published the 2022 Medicare Physician Fee Schedule (MPFS) final rule, which includes the final policies for the 2022 performance year of the Quality Payment Program (QPP). The rule affects the traditional Merit-Based Incentive Payment System (MIPS), MIPS Value Pathways (MVPs), the APM Performance Pathway (APP), Advanced APMs and the Medicare Shared Savings Program (Shared Savings Program). Here are highlights from the 2022 QPP rule and a link to additional resources.

MIPS-ELIGIBLE CLINICIANS: THE RULE REVISES the definition of a MIPS-eligible clinician to include social workers and certified nurse midwives.

MIPS Performance Category Weight Changes: By law, the Quality and Cost performance categories must be equally weighted at 30% beginning with the 2022 performance period. The weights for the Promoting Interoperability (25%) and Improvement Activities (15%) categories remain the same as 2021. The rule updates and redistributes the performance category weights for small-practice clinicians. For them, the Promoting Interoperability (PI) category will be automatically reweighted/eliminated without having to apply. If no PI data is reported, the other categories are reweighted as follows: Quality (40%), Improvement Activities (30%) and Cost (30%). But if a small practice reports PI data, the category will be scored, and the normal weights will apply.

VRIC registration now open

BY BETH BALES

REGISTRATION HAS OPENED FOR THE Society for Vascular Surgery’s 2022 Vascular Research Initiatives Conference (VRIC), set for May 11 in Seattle. The conference, with a theme of translational immunology and cardiovascular disease, focuses on basic and translational vascular research and features abstract presentations followed by lively, thoughtful and useful discussions; a poster exhibit; a translational panel on a particular aspect of vascular biology; and the Alexander W. Clowes Distinguished Lecture.

This year’s panel will be led by Katey Rayner, PhD, and Nicholas Leeper, MD. They will discuss the role of the immune system in cardiovascular disease and ways to target these pathways, said Katherine Gallagher, MD, chair of the SVS Basic and Translational Research Committee, which plans and runs VRIC. Both professors, she said, are well-versed and highly regarded for their work in immunology and cardiovascular disease. The coronavirus has upended some prior conceptions of immunology, leading to increased recognition of the “role of the immune system and how important it is, particularly in our cardiovascular realm,” said Gallagher. The panel is expected to discuss new treatments for vascular disease that specifically target the immune system.

Leeper runs the Leeper Laboratory at Stanford University, which studies the vascular biology of atherosclerosis and aneurysm disease, particularly in the molecular mechanisms involved and developing new translational therapies to fight disease.

Rayner is director of the Cardiometabolic March 2022

Minimum Performance Threshold and Payment Adjustments: CMS has finalized a minimum performance threshold of 75 MIPS points in 2022 (up from 60 MIPS points in 2021). For this year, clinicians will need to achieve a final MIPS score of at least 75 points to avoid any MIPS penalty. An additional performance threshold of 89 points is established for exceptional performance. The 2022 performance year is the last year for an additional MIPS adjustment for exceptional performance.

As specified by law, the maximum payment adjustments for 2022 is set at plus/minus 9% and will be applied towards a clinician’s 2024 Medicare Part B payments for covered services. This means a MIPS-eligible clinician who does not participate in MIPS in 2022 will receive a negative payment adjustment of -9% in 2024.

CMS Web Interface: The CMS Web Interface is extended as a collection type and submission type in

microRNA Laboratory at the University of Ottawa Heart Institute and an assistant professor in the department of biochemistry, microbiology and immunology at the University of Ottawa.

Kathleen A. Martin, PhD, will present the Clowes Lecture. The lecture is named for the late SVS member Alexander Clowes, MD, a renowned mentor and surgeon-scientist who demonstrated an exceptional commitment to research in vascular disease and who played a critical role in VRIC. The lecture isn’t intended as just paying homage to Clowes, said Larry Kraiss, MD, at the time of the first lecture in 2017. “It is so we can still inspire today’s young scientists to follow his path.”

Martin is professor of medicine and pharmacology at Yale University School of Medicine and co-director of the Yale Cardiovascular Research Center. Also part of VRIC will be honoring and hearing presentations from Bao-Ncog H. Nguyen, MD, and Jean Marie Ruddy, MD, recipients of the SVS Foundation Mentored Clinical Scientist Research Career Development Award; and four sessions on abstracts involving: ● Arterial remodeling and discovery science for venous disease ● Atherosclerosis and the role of the immune system ● Aortopathies and novel vascular devices ● Vascular regeneration, stem cells and woundhealing To maximize time as well as travel dollars, VRIC is held the day before and in the same venue as the American Heart Association’s Vascular Discovery: From Genes to Medicine Scientific Sessions. That conference will be held May 12–14 and will offer CME credit.

For more information on VRIC and to register, visit vascular.org/VRIC22. Email questions to education@ vascularsociety.org.

traditional MIPS for registered groups, virtual groups and APM entities with 25 or more clinicians for the 2022 performance year only. The rule finalizes a longer transition for electronic clinical quality measures (eCQMs)/MIPS clinical quality measures (CQMs) reporting for Shared Savings Program Accountable Care Organizations (ACOs) by extending the CMS Web Interface as an option for three years (through the 2024 performance year).

MIPS Value Pathways (MVPs): Clinicians will be able to report MVPs beginning with the 2023 performance year as a new reporting framework to eventually replace the traditional MIPS program. MVPs will be voluntary for the 2023–2027 performance years.—SVS Quality Measures and Performance Committee For more information, visit www.qpp.cms.gov.

FIT trainees announced for quality program Sixteen residents and fellows interested in vascular disease and quality improvement have been selected for the inaugural Vascular Quality Initiative (VQI) mentor-based program, Fellowship in Training (FIT).

THE SOCIETY FOR VASCULAR Surgery Patient Safety Organization (SVS PSO) offers the program, known as SVS VQI FIT. It seeks to foster an understanding of quality processes and metrics among vascular residents and fellows—the “trainees”—through mentorship in the VQI, in collaboration with the Association of Program Directors in Vascular Surgery (APDVS), American College of Cardiology (ACC) and Society for Vascular Medicine.

“We are inspired by the genuine interest in and commitment to quality improvement,” said FIT Chair Garry Lemmon, MD, and Brigitte Smith, MD, co-chair. “We are confident that the VQI FIT Program will further enhance their knowledge and skills to be able to lead and improve the quality of vascular care throughout their careers. Please join us in congratulating this outstanding group of young physicians committed to vascular care!”

With mentors guiding them, the selected will participate in quality improvement and metrics through VQI regional study group

participation and quality assurance opportunities at the local level.

The 12- to 18-month program encourages FIT participants to develop quality charters and improvement projects for presentation at VQI@VAM meetings. Lemmon and Smith also thanked the volunteer faculty and mentors. Not all could be selected, he said, but noted program leaders expect rapid growth in the program. “Your time and expertise are what will truly make the program successful, and we greatly appreciate your commitment to your trainees,” they said. “They are the future of vascular surgery, and the future is bright.”—Beth Bales Contact Betsy Wymer at bwymer@ svspso.org or Lemmon at GLemmon@ svspso.org with questions.

“We are inspired by the genuine interest in and commitment to quality improvement” Garry Lemmon vascularspecialistonline.com | 15

TECHNOLOGY

Failure is the price of success in medical innovation

BY BETH BALES

Know upfront that you’re going to fail.

Repeatedly. Or so it goes. “There is no instant gratification in biodesign,” according to Anahita Dua, MD, a vascular surgeon at Massachusetts General Hospital/Harvard Medical School in Boston, and an innovator for more than 10 years in surgical devices and treatments.

SHE DISCUSSED HOW TO INNOVATE IN VASCULAR surgery in “Surgeon Innovator: Startups, Entrepreneurship and Venture Capital,” a webinar presented in late 2021 by the Society for Vascular Surgery (SVS) Health Information Technology Committee. “Biodesign innovation is driven by a compelling need,” Dua said. It’s also a topic “near and dear to my heart: how to take an idea from inception to market—with practical tips—and some of the pitfalls that can occur.”

She asked rhetorically why anyone should listen to her.

The answer: Those who want to innovate, who have an idea of how to do something better, need to learn—as she has—how to fail. “You have to know why it happened and how you learn from it.” Dua has had several ideas and devices, including a thrombolysis device and a surgical instrument (Dua Dissector), that have achieved varying

degrees of success. “I have a couple of patents here and there,” she said.

“I’ve been through the process. I’ve lost a lot of money.”

The innovation landscape today little resembles “the old days,” such as in the time of vascular surgery pioneer and former SVS President Michael DeBakey, MD, and other innovators. “You can’t take something from a lab anymore and put it into a patient,” Dua said. “Because after that you’re going to jail.”

Know “from Day 1” the target audience for the product. “If you don’t, you’re going to waste a lot of time and money,” she warned, adding that pivoting in the middle can be challenging. It’s not enough for something to be new. It also has to be to the betterment of a need, has to be more cost-effective and something people want, Dua said.

“Just because it’s cool doesn’t mean it flies,” she said, adding, “Pay attention to the value up front.” Start by drawing a sketch. “Draw it out.

It needs to exist even just on paper.”

Once drawn, build a prototype, possibly using engineers who sign non-disclosure agreements. They build the product for you—“do not try to do everything yourself!” Dua advised. Then test. “There will be a thousand naysayers,” she warned.

“Never, ever change your idea to suit

FREQUENT MISTAKES 1. P utting patent before the horse. Never focus on the patent before a complete product evaluation and market analysis; make sure your idea can be patented.

A medical patent lawyer can help walk innovators through the process.

2. Overestimating the market. Do a proper analysis before investing money in anything.

3. Trying to be a one-man/ woman show. “Do not try to do everything yourself! If ever you need collaboration, it’s in the invention space. Go to the local engineering college.

Sign NDAs; don’t give up pieces of your pie but find people you trust and be savvy about it.

4. Spending substantial time and money perfecting a product. “Create the basic prototype and make it pretty later. All you want to know is, ‘does it work?’“ 5. Having an inadequate selling and distribution plan.

a different concept. It doesn’t have to be pretty, it just has to work. Bells and whistles can come later.”

Implement the design and make it into a real product. “Ideally by this point you have a patent in place,” Dua continued. Inventors also should know whether licensing is something they want to consider. “Cost is key,” she said. “Keep the features down and stick with materials and the concept. You are testing whether it’s going to work and if your market really exists. Move out of the doctor mindset of, ‘Is it good for a patient?’

In medical device development ask, ‘Is it good for society?’ If so, then it’s good for patients. Being cost-effective is fundamental to getting to market.”

Ultimately, if the product is a success, “it can change the lives of people even after you die,” said Dua. She illustrated the concept with numbers; between the ages of 35 and 70, if she performs 10 operations a week, she will help 18,200 patients. But, if she invents something that’s used in thousands of global procedures, thousands to millions of patients will be helped. “Innovation has always been part of surgery,” Dua stated. “Ask, ‘How can we make this better?’ We know the problems, so we should be part of providing the solutions. Then identify, invent, implement.

Approach problems methodically and let your mind wander.”

Watch the webinar and learn more at vascular.org/InnovatorWebinar.

THE MOST COMPLETE ONE-DAY ENDOVASCULAR CONFERENCE

MAY 27, 2022 HYATT REGENCY SEATTLE SEATTLE, WA

The 2022 Pacific Northwest Endovascular Conference will offer its signature interactive learning format, 70+ world-class faculty, focused breakout sessions, resident competition and Simulation Summit live in Seattle.

MAY 26, 2022

MAIN SESSIONS • • • • •

Aortic – Modern Management Lower Extremity Venous Physician Practice Technical Pearls, Tips and Debate

9 CME HOURS

CONCURRENT SESSIONS

SIMULATION SUMMIT FOR VASCULAR TRAINEES Scholarship includes: • Registration to Summit & PNEC • Lodging at the Hyatt Regency Seattle • Travel reimbursement (U.S.-based)

• Updates on Vascular Surgery for Advanced Practice Providers • Limb Preservation & Wound Care

CALL FOR ABSTRACTS Submit your abstract today!

Register to attend

PNEC-SEATTLE.ORG 16 | Vascular Specialist

March 2022

NEXT GEN

Training leaders for the future of vascular surgery: The SVS Leadership Development Program This quarter’s leadership column highlights the need to build leaders in vascular surgery and the work of the Society for Vascular Surgery (SVS) Leadership Development Program, now working with its third cohort. Babak Abai, MD, discusses the program, incorporating the thoughts of SVS Executive Director Kenneth M. Slaw, PhD, and Melissa Kirkwood, MD, chair of the SVS Leadership Development Committee and integrally involved in creation of and overseeing the program.

“LEADERS ARE MADE, THEY ARE not born,” said NFL great Vincent Lombardi. For vascular surgeons, training takes the most formidable period of our lives. From that first glimpse of the operating theater as a third-year medical student to the end of our formal training, it is a tour de force lasting a decade of our lives. We train in the art and science of vascular surgery to help our patients by restoring blood flow, preventing stroke, preserving limbs and saving lives.

We are who other surgeons often call when they are in trouble. We are an indispensable part of any hospital system.

An authoritarian approach is often necessary, because of the situations we find ourselves in.

However, when it comes to leading a group of individuals or providing direction to our teams, we are very poorly trained. Some individuals have natural abilities to lead, but most of us flounder with lack of vision and an inability to shore up the troops or we are dealing with unrealistic expectations, burnout and adversity. Research shows that leadership is 30% innate and 70% learned.1 Then how is it that we get no training in this important aspect of human interaction?

There are practically no courses or formal training on leadership during medical education, yet we are expected to create teams and work together to achieve the common good of our patients, hospitals, departments, divisions and trainees.

Vascular surgeons serve a small and vital role in any hospital. We are,

however, dwarfed by other services.

We often compete for resources and sometimes patients with these services.

It is easy to become complacent and feel powerless within this construct.

It is as leaders that we can overcome this. Leadership is not a title or a position within a specific specialty. It is an ideal we should all aspire to regardless of our position. It is important to exercise these skills to achieve a common mission and common good: to grow everyone in the team, to bring all teams together and to accomplish only what can be done as a larger group.

The seeds for the SVS Leadership Development Program were sown three decades ago while Slaw was working with physicians in other medical societies.

He consistently asked physicians about deficits in their knowledge and what was not taught in medical school that would help their careers. Leadership skills surfaced as a very common gap.

While at the American Academy of Pediatrics, Slaw joined and helped form a work group studying the best science around teachable leadership skills, and the structure of other leadership development programs. The result was a customized leadership development program that was well-received and really made a difference in the lives of the physicians, nurses, physician assistants and other professionals who went through it.

When Slaw arrived at the SVS six years ago, he assessed whether vascular surgeons were as much in need of

Letter to a young vascular surgeon

BY ALI IRSHAD, MD

I

want to talk to you again for a little while, Ranier Maria Rilke writes in his eighth letter to a young poet to whom he is giving advice regarding his passion and pursuit for a career in poetry. I would like to take the following lines to reflect on the challenges of a young surgeon navigating the environs of our specialty.

As a vascular surgeon in the nascence of his career, I have found the looming and unpleasant consideration of budget cuts stifling our livelihoods and our ability to care March 2022

leadership development as pediatricians.

The answer appeared to be a resounding “yes.” Slaw approached Grace Wang, MD, and Kirkwood, who were leading the SVS Leadership and Diversity Committee at the time. The committee embraced the challenge by conducting a study of leadership models and skills assessment, interviewing established leaders in vascular surgery and writing about their philosophies and approaches in Vascular Specialist, and by conducting a session at the Vascular Annual Meeting (VAM). This work resulted in the development of the program. The Leadership Development Program is based on The Leadership Challenge model of Kouzes and Posner,2 and is well-developed through years of research. The committee liked this model because it emphasizes the basic, essential leadership skills physicians need.

“The course cuts to the heart of what an exceptional leader is by taking an indepth look at how the most successful leaders model the way,” said Kirkwood.

“Truly effective leaders are trustworthy, honest, transparent, humble, dependable

“Truly effective leaders are trustworthy, honest, transparent, humble, dependable...”

Melissa Kirkwood and focused on the needs of their team members above their own interests.”

The SVS leadership program is in its third year of training a cohort of vascular surgeons to become better future leaders.

The core of the program involves a series of six web-based lectures presented by leaders in vascular surgery. Each is followed by breakout sessions where a smaller group meets and discusses what is learned. These small groups also provide support and camaraderie.

This is where problems are discussed in detail. It provides a venue to build lasting relationships. This year, for the first time, there will be an in-person, two-day leadership workshop in Chicago in April.

The endpoint of all this activity is the leadership development luncheon that is

part of VAM in June in Boston.

I was privileged to be a part of the second cohort and further lucky to be chosen to receive one of four Mastery Grants this past year. As a part of my Mastery Grant project, I have chosen to bring a group of interested individuals from the Leadership Development Program Committee, and create a Leadership and Development Research Subcommittee. We are in the process of recruiting two trainees to receive Leadership Research Scholarship for Trainees. The subcommittee’s initial focus is to evaluate the three cohorts that have finished the program. Our core mission and long-term goals are to evaluate if we are teaching the “right stuff ” in terms of leadership. The Leadership Development Program is part of a vision to improve everyday lives for vascular surgeons at all levels by teaching skills not innate to surgery training. I cannot overstate the value of this course as it has made me think about my own practices within our microcosm of vascular surgery at Thomas Jefferson University and how I can improve myself and the vascular team, as well as the environment around me.

In addition, the friendships and mentorships that are created within the cohort of leadership programs are longlasting and provide a springboard for discussing problems and making changes necessary to lead us into the future of vascular surgery. Learn more about the program at vascular.org/LDP. References 1. D eNeve J-E, Mikhaylov S, Dawes CT, Christakis NA, Fowler JH. Born to lead?

A twin design and genetic association study of leadership role occupancy.

Leaders Q. 2013;24(1):45–60.

2. Kouzes, J, Posner, B. The Leadership Challenge: How to Make Extraordinary Things Happen in Organizations. 2017 (6th Edition), Jossey-Bass, San Francisco, CA.

BABAK ABAI was part of the 2021 Leadership Development Program. He is an associate professor of surgery and program director of the Vascular Surgery Fellowship Program at Thomas Jefferson University in Philadelphia.

for our patients to be vexing. During our training, for our specialty. These dedicated men and women while we perfected our anastomoses and our spend countless hours speaking with congressmen endovascular techniques, tested our stamina and women, and senators and raising funds to and broadened our knowledge to care for influence policy that affects each of us for years patients, these were not the battles for which to come. They provide a seat at the table for our we were prepared. small and oft understated specialty.

While the efforts such as those of the Society The physician community stands on a precipice: for Vascular Surgery Valuation Work Group to challenge Congress to stop budget cuts that will Ali (Richard Powell, MD, et al) highlight the direct hinder our ability to treat our patients and compensate Irshad and intangible utility of vascular surgeons in the our practices appropriately. healthcare system, the reality is we see our specialty As we start our careers and find our place in this undervalued, overworked and underrepresented in the rewarding profession, let the SVS PAC advance our microcosm of U.S. healthcare. standing and renew our voice.

As a member of the SVS Political Action Committee Find your voice. Donate to the PAC. (PAC) for the past two years, I have had the opportunity to join the ranks of vascular surgeons committed to advocacy ALI IRSHAD is a member of the SVS PAC Steering Committee. vascularspecialistonline.com | 17

COMMENTARY

Corner Stitch Moments suspended in time: Joining the vascular fold

BY LINDSEY OLIVERE, MD

NOON ON MARCH 19, 2021, MARKED the end of an unprecedented year in the world of resident recruiting. Months of virtual interviews, “away” rotations done through a computer screen, and a few short trips to prospective cities amidst rolling waves of lockdowns all culminated in this moment on a friend’s patio in a makeshift Match Day celebration.

Moments after seeing the words “Vascular Surgery—University of Pittsburgh Medical Center” on a letter printed by a friend in an ode to in-person Match Days

of the past, I received an email from my new program coordinator and a flurry of congratulatory messages from colleagues, both within and outside my future home in Pittsburgh.

What many don’t realize, particularly in a world as small as that of vascular surgery, is that opening your Match letter immediately welcomes you into the fold of not only your new training program, but a remarkably innovative and multidisciplinary field.

The weeks from Match Day to June 2021 were a blur of spending precious last moments in Durham, North Carolina, my home of nearly a decade.

Seeing family and friends. Filling out countless onboarding documents. And ultimately moving to Pittsburgh with my partner, who thankfully joined me as a UPMC anesthesia intern. I also had the opportunity to travel to Texas and finally meet friends from the virtual interview trail at a pre-intern bootcamp.

Soon enough, I was at a Pirates game, staring at those incredible yellow bridges spanning the Allegheny River and bracing myself for the moment when I would don my long white coat as an MD. As we enter March 2022 and I reflect on personal and professional growth over the last year, I can’t believe it has only been 12 months since opening that letter. I am still adjusting to life as a surgical resident, but there are a few things I know played a

Worldwide TCAR analysis provides ‘roadmap’ to evaluate future training approaches

pivotal role in easing this transition.

First, the friends made on the interview trail—many of whom I met for the first time in Texas—have remained sources of support throughout the last few months.

It is worthwhile to invest in relationships with individuals who will become lifelong colleagues. Second, I spent time with family and friends before July—it is much harder to find time to get away during residency, particularly if you are training far from home, as well as to have protected time with a partner or spouse before your schedule becomes more hectic. Third, I invested time getting to know my co-residents. The beginning of the year can be overwhelming, but I tried to take advantage of every opportunity I could to spend time with my awesome co-intern, other vascular residents, as well as my new general surgery colleagues, who have all become my primary social network and support here in Pittsburgh.

After a year of virtual interviews, I also took the time to explore my new city after Match Day and find a home

in a neighborhood that would meet my needs as a resident. When time at home is limited, it has made a difference to come home to a place I love living in.

Finally, and perhaps most importantly, I have tried my best to be patient with myself in this transition. When it gets hard to maintain this perspective, I have called upon old mentors, and sought out new ones, to remind me both of how far I’ve come, and how much time still lies ahead to hone skills and explore interests.

Overall, the time from Match Day to the start of intern year can feel overwhelming, and it is normal to fear your first moments alone with a pager.

To all the new future vascular surgeons joining our community in March 2022: enjoy the time that lies ahead, and respect the time it will take to transition to life in residency. In the meantime, I can’t wait to welcome you all into the fold!

LINDSEY OLIVERE is a first-year vascular surgery resident at the University of Pittsburgh Medical Center.

What many don’t realize, particularly in a world as small as that of vascular surgery, is that opening your Match letter immediately welcomes you into the fold of not only your new training program, but a remarkably innovative and multidisciplinary field

Brajesh K. Lal

BY JOCELYN HUDSON

AN ANALYSIS OF THE WORLDWIDE EXPERIENCE OF TRANSCAROTID artery revascularization (TCAR) has produced key objective proficiency metrics and an analytic framework to assess adequate training for the procedure.

“Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases,” Brajesh K. Lal, MBBS, professor of vascular surgery at the University of Maryland, Baltimore, and colleagues concluded in the Journal of Vascular Surgery (JVS). Lal et al analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to traditional in-person training on live cases.

The researchers describe how physicians underwent one of three mandatory training programs. Lal and colleagues compared the adverse event rates between the procedures performed by physicians after undergoing the three modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were non-inferior to proctored training. They communicated that, in the period March 3, 2009, to May 7, 2020, 1,160 physicians underwent proctored (19.1%), cadaver-based (27.4%) and synthetic model-based (53.5%) TCAR training, performing 17,283 TCAR procedures. The proctored physicians treated younger patients and more patients with asymptomatic carotid stenosis and had more prior experience with transfemoral stenting, the researchers specified. They reported that the over 24-hour composite clinical adverse event (1%; 95% confidence interval [CI], 0.8–1.3%) and technical adverse event (6%; 95% CI, 5.4–6.6%) rates did not differ significantly by training mode.

18 | Vascular Specialist

March 2022

NEWS BRIEFS

Medical students reach out to hemodialysis community in times of COVID-19

BY HALLIE BYRD, MS

AS PRESIDENT OF THE Louisiana State University (LSU) Vascular Surgery Interest Group (VSIG), I’ve been eagerly exploring opportunities to engage with community members and uplift them on their journeys to improved health.

As all are acutely aware, COVIDrelated restrictions on medical facilities and medical students alike have made it quite difficult for community involvement in a time when some (e.g., Zoom-based medical students and certain patient populations) could deeply benefit from greater socialization. One group of vascular patients that comes to mind are those receiving hemodialysis; between the dietary restrictions and burden of the treatment regime that such patients must regularly endure, I considered inspirational ways to hearten their recent Valentine’s Day (hello, off limits phosphate-laden chocolate).

So, this Valentine’s Day, with the help of LSU’s Nephrology and Hypertension Interest Group (NHIG), LSU’s VSIG spearheaded a campus-wide drive for hemodialysis and diabetes-friendly candy and cards. These items were

Hallie Byrd tends to a hemodialysis patient during an LSU VSIG outreach event

hand-packaged into individual goodie bags by several interest group members. On Feb. 14, we personally delivered these treats and handwritten cards to many of the 80 patients at our local DaVita Memorial dialysis unit.

While only a small gesture, we could readily see the positive impact it had on the patients in the center.

From the response, it seemed to make their day a little brighter and perhaps their treatment a bit more bearable.

Hopefully, this will serve as a reminder that even small acts of kindness and consideration can impact our patients’ lives and health in a substantial way.

Applications are due by 11:59 p.m.

Central Standard Time on March 25 for the joint American College of Surgeons/Society for Vascular Surgery scholarship to attend a health policy leadership course taking place in June.

The $8,000 ACS/SVS Health Policy Scholarship defrays tuition, travel, housing and food costs to attend the Executive Leadership Program in Health Policy and Management at Brandeis University near Boston from June 5–12.

The course is set to take place in person; a virtual option will be made available should circumstances change.

Since 2004, the Heller School has offered an annual Leadership Program in Health Policy and Management for 30 to 35 physician and surgeon leaders

Peer-reviewed COVID-19 archive grows

HALLIE BYRD is a medical student at LSU Health School of Medicine in New Orleans.

Lesson learned: Entering vascular residency during first wave of pandemic AN INSIGHT INTO THE BENEFITS OF VIRTUAL LEARNING FROM THE perspective of a medical student on the cusp of residency as the early stages of the pandemic played out was delivered during the most recent Society for Vascular Surgery (SVS) virtual Town Hall (Feb. 3).

Tony Nguyen, DO, now a vascular surgery resident at the University of South Florida in Tampa, told those tuned in how he recognized his status as a student was beneficial almost immediately.

“I was a fourth-year medical student during the first round of COVID-19 and part of the first cohort to go through the audition rotation virtually,” he said.

“You have multiple face-to-face sessions with faculty where they teach you vascular surgery, and you have their (mostly) undivided attention as you present on a topic. You can do multiple of these virtual audition interviews with really no cost to the applicant.”

Nguyen pointed to the absence of travel and housing expenses that meant effectively “free face-to-face time with faculty, program directors and chiefs of division” as he navigated the uncharted waters of launching a career in the thick of a pandemic. He said downsides included less time with residents and the inability to fully project personalities, as well as an absence of clinical, hands-on experience. But, he countered, “it seems like a good trade-off as a medical student to get all of this opportunity while not having to wake up at 4:30 a.m,” before adding that the cost burden had landed on the side of institutions and that might be why many had since “fallen off.”—Bryan Kay

March 2022

Apply for health policy program

by March 25

TWO YEARS IN, AN indicator of COVID-19’s continuing presence in the world is the growth of the “COVID-19 Collection” in the pages of the Journal of Vascular Surgery publications. Launched in April 2020, the research has appeared in not just the signature JVS publication (98 papers), but also two of the three companion publications, JVS: Venous and Lymphatic Disorders (43 articles) and JVS: Cases and Innovative Techniques (22 papers).

Some of the most recent papers include an update of the European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on managing acute limb ischemia in light of the pandemic; resolution of acute pulmonary embolism using anticoagulation alone; the resident and fellow experience; and one covering the “drastic increase” in hospital labor costs during the pandemic and how that has led to sustained financial loss for an academic vascular surgery division.—Beth Bales See vsweb.org/CovidCollection.

partially sponsored by the American College of Surgeons and the Thoracic Surgery Foundation.

This intensive one-week program equips health leaders with the knowledge and skills essential for creating innovative and sustainable solutions to improve the quality, cost-effectiveness and efficiency of healthcare service delivery, as well as for participating in healthcare policy and reform.

Program sessions and case studies offer the latest in national health policy and management frameworks.

Sample program topics include health policy in the United States; economics and financing; individual and group decision-making; managing clinics and the care process; effective leadership styles; managing change in complex systems; conflict negotiation; and financial literacy for physician leaders.

—Beth Bales

Learn more about the scholarship at vascular.org/HealthPolicyScholarship.

Nominations due March 31 for community practice award Nominations for the Society for Vascular Surgery‘s prestigious Excellence in Community Practice Award are due March 31.

The honor, formerly known as the Excellence in Community Service Award, is exclusively for those who practice in the community setting, including members in an office-based lab (OBL) setting.

Selection recognizes an individual’s sustained contributions to patients and their community, as well as exemplary professional practice and leadership.

To be considered, applicants must be community practitioners and have been in practice as a vascular surgeon for at least 20 years, been an SVS member for at least five years, and show evidence of impact on vascular care or community health.

—Beth Bales

Learn more at vascular.org/ CommunityServiceAward.

New JVS editorial leadership structure announced The Executive Board of the Society for Vascular Surgery (SVS) recently revealed the new composition of the Journal of Vascular Surgery (JVS) publications‘ senior leadership. The changes are set to take effect on July 1. The editorial structure atop the SVS’ peer-reviewed journals now features editors-in-chief for each of the group’s four titles, overseen by an executive JVS editor. The latter role will be assumed by Ronald L. Dalman, MD. Thomas Forbes, MD, takes over as editor-in-chief of JVS; Ruth L. Bush, MD, heads up JVSVenous and Lymphatic Disorders; Matthew Smeds, MD, takes the reins of JVS-Cases, Innovations & Techniques; and Alan Dardik, MD, leads JVS-Vascular Science.—Bryan Kay

vascularspecialistonline.com | 19