Vascular Specialist@VAM–July/August Review Edition

2 202 AR NG THE CUL EETI ON VAS UAL M EDITI ANNREVIEW

In this issue:

8N ew VAM lecture 20 Pictured Frank J. Veith speaks VAM through on advent of VAM limb the lens: salvage lectureship A gallery of snaps from the 10 C orner Stitch meeting floor A letter to incoming vascular interns 27 Vascular mapping Tool to evaluate 12 V ascular trauma vessel suitability ‘Lesion vision’ author for fistula creation responds to criticism assessed

JULY/AUGUST 2022 Volume 18 Number 07/08

THE OFFICIAL NEWSPAPER OF THE

DEI INITIATIVES IN VASCULAR SURGERY: HOW ARE WE DOING?

www.vascularspecialistonline.com

COMMENT& ANALYSIS

By Imani E. McElroy, MD, and Carla C. Moreira, MD THE 2022 VASCULAR ANNUAL Meeting (VAM) has been touted as the most diverse to date. As attendees ourselves, we can attest to the increased representation among attendees, presenters and moderators.

A dedicated session, named “Building diversity and equitable systems in vascular surgery,” should have been the perfect setting for the membership and leadership to showcase its stated commitment to diversity, equity and inclusion (DEI) initiatives.

However, the shockingly low attendance by members and leaders at this session left us feeling like we had witnessed a fumble at the one-yard line. This less-than-optimal outcome was met by notable

See page 10

‘STEPTEMBER’ ASKS SURGEONS TO WALK THE WALK Most American adults take an average of 5,000 steps per day.

In fact, this simple act—getting out and moving—can be the key to prevention and treatment of many chronic diseases of the cardiovascular system (writes Beth Bales).

The Society for Vascular Surgery (SVS) hopes to step up, so to speak, that 5,000-step number with

DIVERSITY

GAINS MOMENTUM AT JVS The addition of a diversity, equity and inclusion (DEI) editor at the Journal of Vascular Surgery (JVS) was found to be associated with more diversified publications and perspectives—including a significant increase in the number of women involved in the peer-review process—in a new analysis led by researchers from the University of Florida. By Bryan Kay

RESULTS FROM THE STUDY were hailed by outgoing JVS group editor-in-chief Peter Gloviczki, MD, as a sign of the progress made at the Society for Vascular Surgery (SVS) journals since the DEI editor, Ulka Sachdev-Ost, MD, was appointed nearly two years ago—but also of the opportunity for further improvement in diversity, equity and inclusion that still remains.

The DEI editorial role was created in the wake of the “Medbikini” controversy in which JVS published a since-retracted paper entitled “Prevalence of unprofessional social media content among young vascular surgeons.”

Findings from this new study, “The measurable impact of a diversity, equity and inclusion editor on diversifying content and perspectives represented in the Journal of Vascular Surgery (JVS),” were presented by M. Libby Weaver, MD, during the 2022 Vascular Annual Meeting (VAM) in Boston ( June 15–18). Weaver is a vascular fellow at the University of Florida School of Medicine in Gainesville, Florida, who is about to become a vascular surgeon at the University of Virginia.

Weaver and colleagues set out to measure the impact of Sachdev-Ost’s role on the presence of DEI topics and women authorship over a period stretching from a year prior to Sachdev-Ost’s appointment through May of this year.

“Women and minorities remain underrepresented in academic vascular surgery, and this persists in

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Medical Editor Malachi Sheahan III, MD Associate Medical Editors Bernadette Aulivola, MD | O. William Brown, MD | Elliot L. Chaikof, MD, PhD | Carlo Dall’Olmo, MD | Alan M. Dietzek MD, RPVI, FACS | Professor HansHenning Eckstein, MD | John F. Eidt, MD | Robert Fitridge, MD | Dennis R. Gable, MD | Linda Harris, MD | Krishna Jain, MD | Larry Kraiss, MD | Joann Lohr, MD | James McKinsey, MD | Joseph Mills, MD | Erica L. Mitchell, MD, MEd, FACS | Leila Mureebe, MD | Frank Pomposelli, MD | David Rigberg, MD | Clifford Sales, MD | Bhagwan Satiani, MD | Larry Scher, MD | Marc Schermerhorn, MD | Murray L. Shames, MD | Niten Singh, MD | Frank J. Veith, MD | Robert Eugene Zierler, MD Resident/Fellow Editor Christopher Audu, MD Executive Director SVS Kenneth M. Slaw, PhD Managing Editor SVS Beth Bales Marketing & Membership Specialist Amber Dunlop Marketing & Social Media Manager Kristin Crowe

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, Clare Tierney, Anthony Strzalek, Aaron Kudhail and Adam Pearce 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

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. | 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. | The Society for Vascular Surgery headquarters is located at 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018. | POSTMASTER: Send changes of address (with old mailing label) to Vascular Specialist, Subscription Services, 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018. | RECIPIENT: To change your address, e-mail subscriptions@bibamedical.com | For missing issue claims, 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

Vascular Specialist | July/August 2022

GUEST EDITORIAL Tying healthcare waste and spending to productivity incentives

By Bhagwan Satiani, MD

A

74-year-old woman was recently hospitalized for a pulmonary embolus from acute deep vein thrombosis (DVT) of the mildly edematous left lower leg. She had previous DVT in the same leg 10 years ago, wore stockings and was active.

She had no family history or evidence of underlying hematologic, or other risk factors. Her son sent me the video, pre- and post-thrombectomy, performed by her cardiologist. It showed non-occlusive bilateral lower-lobe embolization. While I was not privy to many details, her hemodynamic parameters did not appear to me to warrant catheter thrombectomy. She was also advised (I was present as a friend) that she next needed venous thrombectomy of the left leg to “prevent post-thrombotic consequences.” Her next appointment, four weeks hence, was for inferior vena cava (IVC) filter removal. She did well and was discharged on daily apixaban. Was all of this necessary?

Another recent example is that of a vascular surgeon who mandates a full duplex lower-extremity (LE) arterial study, along with a full physiologic LE arterial study, on all patients with possible arterial complaints.

As far as I know, only a few folks who follow the literature on guidelines would question similar decisions—they do not because they wish to keep their heads down, possibly because there is no “quality” issue.

Just like retrospective calculation of deaths from medical “errors,” there is a lot of variation, with even experts disagreeing on what test or procedure is warranted. Unwarranted variation in care is that which “cannot be explained “We can debate on the basis of illness, medical evidence, or patient preferabout the amount of low-value or ence, but is accounted for by the willingness and ability of unnecessary care doctors to offer treatment.”1 and waste, but in It is estimated that waste or low value (in my opinmany cases most of us know it ion, no-value care) in the clinical sense represents about 5.4–24.6% of all healthcare spending in the U.S.2 The largest when we see it” percentage of this has been attributed to administrative complexity (7%) and pricing failure (6.1–6.3%). Although half of the waste has not been related to physicians, we do not get off easy. Overtreatment (2–2.7%), care delivery (2.7–4.4%), fraud and abuse (1.6–2.2%) and care coordination (0.7-2.1%) are to varying degrees part of our responsibility.2 Retrospectively labeling a clinical decision to treat is many times a judgment call. But, assigning a profit motive to that decision taints all of us. In a survey of 2,106 physicians from the American Medical Association (AMA) Physician Masterfile, a median of 20.6% of healthcare in the U.S. was seen as unnecessary.3 This included prescription medications (22%), tests (24.9%) and procedures (11.1%). Physicians surveyed estimated that 36% of tests and procedures were unnecessary. Over 70% of them believed that profit was a motivator to perform unnecessary procedures (and I assume tests). Medical specialists were 42.4% Bhagwan of the sample. Granted, the study Satiani had limitations, including the fact that most respondents were not in

surgical practice and may not have had enough surgical expertise.

Profit implies revenue left over after all expenses are paid to allow paying physician salaries. But if 70% of a group of physicians perceive a profit “motive,” suggesting a conflict of interest in their fiduciary role, is there any practice model that does not create such a conflict? Even the Veterans Affairs (VA) or the foundation physician employment models have conflicts. These can be financial (profit, bonus), productivity targets, promotions, hospital budgets or other incentives that are beneficial to the physician in some way. Every test, patient visit or procedure has represented a financial conflict to varying degrees for decades. However, the work relative value unit (wRVU) compensation model in recent employment agreements creates an ethical challenge for the most principled surgeon. I have written previously about the misalignment of incentives in physician employment by hospitals.4 Employment contracts tie base and bonus compensation to wRVUs and may therefore drive up the volume of services and national healthcare spending, some of which could be wasteful. This occurs at the same time as hospitals are publicly participating in accountable care organizations (ACOs), a shift to “value-based” payments assumed to be cooperating in controlling healthcare spending.

Employer hospitals incentivize maximal physician productivity and stay profitable to service the community, plan future expansion, pay for new technologies, and cover the regulatory and liability onslaught. However, compensating physicians based on pure productivity incentives goes against their responsibility of controlling wasteful spending at the front end. Instead, hospitals are mostly concentrating at the backend by monitoring quality of care, encouraging compliance with national guidelines and specialty self-monitoring. They are correct that physicians do not wish hospitals to interfere with their clinical autonomy. The problem remains that unnecessary care may be done safely, and, since there is considerable grey in guidelines, the amount of wasteful spending goes undetected or ignored. So, is this a stalemate?

The “choosing wisely” initiative has had very limited impact on unnecessary spending. Meanwhile, eliminating all unnecessary care is unlikely, partly because in many cases honest people will differ on the indications of procedures/tests. Several strategies would help, such as better education of trainees and referring physicians with clear guidelines, easier access to outside electronic health records to avoid duplication, and better monitoring of vascular care for appropriateness rather than just quality of care. Rather than pure (100%) productivity, some institutions use formulas to encourage teamwork and reduce competition within the hospital to combat low-value care. As an example, compensation may then be based on the financial performance of the individual (60%), unit (20%), department (10%) and hospital (10%). Self-employed practitioners can come up with a similar model. Quality of care and outcome targets can also be worked into the formula.

For our specialty, barring emergencies or urgent cases, elective procedures can be presented to the practice or division group prior to interventions. For non-elective cases, the indications can be listed and presented to the group after the fact.

For non-interventional procedures such as the vascular lab, we should take responsibility for educating folks about

continued on page 4

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Vascular Specialist | July/August 2022

FROM THE COVER: DIVERSITY GAINS DETECTED IN SVS JOURNALS PEER-REVIEW PROCESS the editorial peer-review process, and may contribute to publication bias,” she told VAM 2022.

Authorship and content examination were stratified into three periods: November 2019–October 2020, or the period prior to the creation of the DEI editor’s role; November 2020–October 2021, the period afterward; and September 2021–May 2022, a period incorporating the average 47-week lag time from submission to publication in JVS. The researchers found that editorial, guideline, and non-primary research articles dedicated to DEI topics increased from zero before to four by May 2022. “The proportion of these articles on any topic with women as first or senior authors more than doubled from 24% to 53%,” said Weaver. Invited commentaries and discussions were “significantly increasingly” written by women as the study period progressed—from 19% to 40% (p=0.02).

“There were 56 research studies and systematic reviews on DEI-related topics published during the entire study period—the majority of which were patient-centered,” Weaver explained. “The proportion of research studies dedicated to DEI topics initially decreased but then significantly increased to 7% [5.4% pre; 3.1% post; p=0.04] when taking into consideration the lag in publication time for a total of 23 thus far in the nine-month lag period.”

Clinical research and systematic review manuscripts on DEI topics were nearly twice as likely to have women as first or senior authors (71.4%) compared to non-DEI specific manuscripts (37.5%; p<0.001), the investigators discovered. They also recorded an increase in the number of women reviewers from 31 of 191 (16.2%) to 51 of 245 (20.8%; p=0.22), and of women distinguished reviewers from three of 107 (2.8%) to 16 of 73 (21.9%; p<0.001).

“The addition of a DEI editor to the JVS is associated with diversification of publications and perspectives represented in the journal,” Weaver told VAM 2022 attendees.

“Women in particular contribute significantly to the scientific literature focused on underrepresented patient populations and diversifying the vascular surgery workforce.

There was also a significant increase in women invited to

GUEST EDITORIAL

continued from page 1

“I think that carefully selected trainees can provide very thoughtful reviews, and that might be a way to quickly diversify your pool and add to it a little bit” M. LIBBY WEAVER perform peer reviews during the study period. Ongoing efforts are necessary to continue to improve diversification of subject matter and perspective in the vascular surgery literature, and reduce publication bias.”

Commenting at the close of Weaver’s presentation, Gloviczki explained how the JVS leadership came to the decision two years ago to tackle the diversity issue by creating a dedicated editorial role. “This is a deficiency of

the peer-review process and the editorial process at the journal, and we made, as you beautifully demonstrated, significant changes,” he said.

Yet women, he continued, remain just 15% of the JVS reviewer pool. “We have 706 reviewers of the JVS, and only 104 are women.” The number is twice as high as before 2020, but the journals “desperately” need more, Gloviczki said.

“We try to send every paper to a woman or underrepresented minority reviewer, but they are overwhelmed, and they cannot really be reviewers of all the papers.”

Elsewhere, Gilbert Upchurch Jr., MD, chair of the University of Florida Department of Surgery, asked whether Weaver and colleagues had detected impactful journals in the wider scientific literature “that actually blind to race and gender when sending reviews out” as a potential alternative to the paucity of female reviewers.

“I do know of a paper in the scientific literature—that is not specific to the surgical literature—that demonstrated that, when the assigning editors are women, they are more likely to assign peer reviews to women,” Weaver answered. “And the alternative is true, so I worry that it would actually potentially cause the opposite problem.”

Weaver suggested that a solution may lie in diversifying the editorial board as well as the contingent of assigning editors.

Session moderator Ellen Dillavou, MD, the medical director and division chief of vascular surgery at the WakeMed Hospital System in Raleigh, North Carolina, said the discussion offered an opportunity to encourage younger members of the vascular surgery community, or those who might not think they qualify, to sign up to review and help swell the ranks. “Proportionally, by age, we are a much more diverse group the younger we are,” Dillavou added.

Weaver pointed out that one of the qualifications needed to become a JVS reviewer is Board-eligibility, challenging the journals to take another look at this requirement.

“I think that carefully selected trainees can provide very thoughtful reviews, and that might be a way to quickly diversify your pool and add to it a little bit.”

TYING HEALTHCARE WASTE AND SPENDING TO PRODUCTIVITY INCENTIVES continued from page 2

appropriateness and sharing national guidelines, even if other physicians are requesting tests. As medical director of such a lab, ours was probably one of the few departments to decline repeated and inappropriate carotid or venous scans. The sonographers were aware of my criteria for initial or repeat testing.

If residents, physician assistants or nurse practitioners who ordered them disagreed with sonographers, they were told to have the attending text or call me if they still wanted the tests. A common example was venous scans of all four limbs for a suspected pulmonary embolus, or a repeat venous scan for major axial lower extremity DVT within a week or two after diagnosis.

In many cases, it was obvious that the attending was unaware that the test was requested, and I rarely got contacted. This

was not popular, but I did my best to educate.5,6 Again, the lack of “growth” may sometimes cause a problem with hospital administration, so a clear explanation is needed ahead of time. Waste results from “failures of care delivery, failures of care coordination, overtreatment, pricing failures, administrative complexity, and fraud and abuse.”1 We can debate the amount of low-value or unnecessary care and waste, but, in many cases, most of us know it when we see it.

My point is that, even if there is no physical harm, profligate spending justifies a concerted effort to tighten our approach and come up with innovative ways to monitor unnecessary care before our clinical autonomy becomes a dream. I am not suggesting that any—or many—of us are providing low-value care, but the percep-

tion is out there. Regardless of the exact percentage of waste we have control over, and whether employed by hospitals or not, it is our obligation to be true to our patients, model our behavior for our students and residents, and sleep well at night.

References 1. Wennberg JE. Time to tackle unwarranted variations in practice. BMJ. 2011; 342:d1513 2. The Role of clinical waste in excess US health spending. https://www.healthaffairs. org/do/10.1377/hpb20220506.432025/full/ 3. Lyu H, Xu T, Brotman D et al. Overtreatment in the United States. PLoS ONE 12(9): e0181970. https://doi.org/10.1371/journal. pone.0181970 4. Satiani B. Physician incentives may not be aligned with their health system employer.

What is a physician to do?

Surgery. 2012; 152(5):923–6 5. Mouawad NJ, Go MR, Haurani MJ, Moseley M, Satiani B. Elimination of medically unnecessary duplex venous scanning based upon an established algorithm can result in significant cost savings under Medicare for the institution and the taxpayer. Accepted for publication. Journal of Vascular Surgery.

Venous and Lym Dis 2015; 3:107–12 6. Yoo T, Agrawal R, Braithwaite S, Satiani B, Haurani JH. Four extremity venous duplex ultrasonography for suspected deep venous thrombosis is an anachronism.”

Journal of Vascular Surgery: Venous and Lym Dis 2019; 7:325–32

BHAGWAN SATIANI is professor emeritus in the division of vascular diseases and surgery in the College of Medicine at The Ohio State University, Columbus, Ohio.

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Vascular Specialist | July/August 2022

CLINICAL PRACTICE

CLTI: Translating guidelines into practice

By Beth Bales CLINICAL PRACTICE GUIDELINES (CPG) ARE integral to helping achieve optimal patient care. The Society for Vascular Surgery (SVS) clinical guidelines are evidence-based and the recommendations assist physicians in clinical decision-making in their daily practices.

The challenge for practicing physicians “is to determine how these recommendations apply to our own patients,” said John White, MD, who will moderate the first roundtable.

Thus, the SVS has developed three instructional webinars on the guidelines for patients with chronic limb-threatening ischemia (CLTI). The webinars are “devoted to informing you how to apply the guidelines to the care of your patients, the limb and anatomy,” he said.

The free webinars will be held monthly in August, September and October, and cover “Translating guidelines into practice: Global Vascular Guidelines on the management of patients with CLTI.” These webinars are based on the published guidelines, developed by the SVS, the European Society for Vascular Surgery (ESVS) and the World Federation of Vascular Societies (WFVS). See the guidelines at vsweb.org/GlobalCLTI. The first session will be moderated by White and will be held from 6–7:30 p.m. Central Daylight Time on Monday, Aug. 15. It will focus on overall medical care of CLTI patients, including the current state of optimal medical management; recent developments in anti-thrombotic, anti-hypertensive and lipid-lowering management; and best ways to help patients quit smoking.

The session will feature internationally recognized speakers in peripheral arterial disease (PAD), a chief cause of CLTI and limb loss. The speakers include: Sonia Anand, MD, professor of medicine and epidemiology at McMaster

University in Hamilton, Canada; Joshua A. Beckman, MD, professor of medicine at Vanderbilt University in Nashville, Tennessee; Marc Bonaca, MD, executive director of vascular research at the University of Colorado School of Medicine; and Jonathan Golledge, MChir, professor of medicine at James Cook University in Townsville, Australia.

They will use one sample patient to design treatment strategies and demonstrate how to put the global vascular care guidelines into practice.

Attendees will fill out short surveys before and after the session, and a follow-up survey 60 days later, to determine if the guidelines have been easy to put into daily clinical practice. All participants will receive the guidelines, implementation tools, printed guideline pocket guide and relevant references, and a link to the SVS Interactive Practice Guidelines app.

The remaining two webinars will be Monday, Sept. 12, with “Diagnosis and staging of the limb,” moderated by Joseph Mills, MD; and Monday, Oct. 10, on “Revascularization,” moderated by Michael Conte, MD, who was the U.S. editor for the Global Vascular Guidelines.

CLTI is an important clinical issue and treatments are being studied in the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) trial.

“These three webinars will be coming at an important time as we all anticipate the upcoming results of the BEST-CLI 2 and 3 trials in the next several months,” said Conte.

The SVS urges all members to participate in this important learning opportunity. Learn more, find recommended readings and register at vascular.org/CLTIroundtables.

“These three webinars will be coming at an important time as we all anticipate the upcoming results of the BEST-CLI 2 and 3 trials in the next several months” MICHAEL CONTE

RUC

SVS LOOKS TO MAINTAIN AMA HOUSE OF DELEGATES REPRESENTATION TO MAINTAIN ITS SEAT IN THE AMERICAN Medical Association (AMA) House of Delegates— and, importantly, to be able to provide information that impacts physician reimbursement—20% of Society for Vascular Surgery (SVS) members must also maintain active membership at the AMA. The SVS is currently 60 members short of meeting this required threshold and has until Sept. 1 to meet the metric.

If the SVS loses its seat within the AMA House of Delegates, the impact will be significant, as the SVS also would lose its representation on the RVS (Relative Value Scale) Update Committee (RUC).

The RUC is the main advisory body to the Centers for Medicare and Medicaid Services (CMS) on relative values for new and revised Current Procedural Technology (CPT) codes, said SVS member Nicolas Mouawad, MD. The RUC includes 32 physicians and more than 300 other representatives in each sector of medicine, including primary care and specialists.

Mouawad, the SVS delegate to the AMA, said he understands that many members may have negative feelings about the AMA. However, the organization manages the RUC, which provides critical input to CMS on procedural codes and relative values on both physician work and direct practice expenses, which then drive both positive and negative trends in reimbursement, he added. Thus, “it is crucial that SVS is represented at the RUC.” Actively engaging with the AMA also provides various benefits beyond the House of Delegates and CPT/RUC activities. Though the AMA deadline is September, SVS leaders hope to reach the membership threshold before then. “Please join the AMA and notify SVS by emailing membership@vascularsociety.org when your membership is confirmed. That will let us know when we reach the number needed to keep our seat,” Mouawad said.—Beth Bales

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Indications: The Endurant™ II/Endurant™ IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX™ EndoAnchor™ system when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (≥ 4 mm and < 10 mm) infrarenal necks (see Neck length definition below). The Endurant II stent graft system aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/IIs stent graft system is indicated for use in patients with the following characteristics: • Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories • Proximal neck length of • ≥ 10 mm; or • ≥ 4 mm and < 10 mm when used in conjunction with the Heli-FX EndoAnchor system (bifurcated stent graft only) Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter. • Infrarenal neck angulation of ≤ 60° • Aortic neck diameters with a range of 19 to 32 mm • Distal fixation length(s) of ≥ 15 mm • Iliac diameters with a range of 8 to 25 mm • Morphology suitable for aneurysm repair Contraindications: The Endurant II/Endurant IIs stent graft system is contraindicated in: • patients who have a condition that threatens to infect the graft • patients with known sensitivities or allergies to the device materials When used with the Heli-FX EndoAnchor system, the Endurant II/IIs stent graft system is also contraindicated in: • patients with known sensitivities to the EndoAnchor implant materials. For contraindications regarding ancillary devices used with the Endurant II/Endurant IIs stent graft system, refer to the Instructions for Use provided with the device.

Warnings and Precautions: • The long-term safety and effectiveness of the Endurant II/Endurant IIs stent graft system has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the health and the performance of the implanted endovascular stent graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft), or less than the recommended number of EndoAnchor implants when used in short proximal necks (≥ 4 mm and < 10 mm), should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. • Patients experiencing reduced blood flow through the graft limb, aneurysm expansion, and persistent endoleaks may be required to undergo secondary interventions or surgical procedures. • The Endurant II/Endurant IIs stent graft system is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. • Renal complications may occur: 1) From an excess use of contrast agents. 2) As a result of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent graft should be aligned immediately below the lower-most renal arterial origin. • Studies indicate that the danger of micro-embolization increases with increased procedure duration. • The safety and effectiveness of the Endurant II/ Endurant IIs stent graft system has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details.

MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Endurant II/Endurant IIs stent graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional MRI safety information, please refer to the product Instructions for Use. Adverse Events: Potential adverse events include (arranged in alphabetical order): amputation; anesthetic complications and subsequent attendant problems (e.g., aspiration), aneurysm enlargement; aneurysm rupture and death; aortic damage, including perforation, dissection, bleeding, rupture and death; arterial or venous thrombosis and/or pseudoaneurysm; arteriovenous fistula; bleeding, hematoma or coagulopathy; bowel complications (e.g., ileus, transient ischemia, infarction, necrosis); cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension); claudication (e.g., buttock, lower limb); death; edema; EndoAnchor system (for infrarenal EVAR procedures using the Heli-FX EndoAnchor system): partial deployment, inaccurate deployment, fracture, dislodgement, embolization, stent graft damage, modelling balloon damage); embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, femoral-femoral artery thrombosis, fistula, incontinence, hematuria, infection); hepatic failure; impotence; infection of the aneurysm, device access site, including abscess formation, transient fever and pain; lymphatic complications and subsequent attendant problems (e.g., lymph fistula); neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis); occlusion of device or native vessel; pulmonary complications and subsequent attendant problems; renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft twisting and/ or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow; surgical conversion to open repair; vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection; vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death); vessel damage; wound complications and subsequent attendant problems (e.g., dehiscence, infection, hematoma, seroma, cellulitis). Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events.

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

medtronic.com/aortic UC202210505 EN © 2021 Medtronic. All rights reserved. Medtronic, and Medtronic logo are trademarks of Medtronic. ™ *Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

For distribution in the USA only. 11/2021

7

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THIS ADVERTORIAL IS SPONSORED BY ACHL

DIGGING DEEP INTO DOACS FOR PAD POST-REVASCULARIZATION IN FIGHT TO STAVE OFF AMPUTATION “It’s really sad—but it’s true: In the PAD [peripheral arterial disease] space, we’re really behind. We’re behind in our understanding of the physiology, the anatomy to some extent, the way the disease permeates through the leg.”

T

hose are the words of Anahita Dua, MBChB, an assistant professor of surgery at Massachusetts General Hospital in Boston, as she discusses the fight against amputation in PAD patients who have been revascularized. She is speaking alongside Kush Desai, MD, associate professor of radiology at Northwestern University Feinberg School of Medicine in Chicago, and Christian T. Ruff, MD, director of general cardiology at Brigham and Women’s Hospital in Boston, as the trio of vascular specialists consider the use of direct oral anticoagulants (DOACs) for the treatment of PAD post-revascularization, and novel data that can be used to mitigate the risk of thrombosis, in a new multi-part CME activity entitled, “Beyond the Procedure: Evolving the Current Standard of Care for Patients with PAD.” Calling upon emerging data on DOAC use among PAD patients, the panel of experts survey the current PAD guidelines and the pivotal COMPASS trial, the latter of which looked at the benefit of low-dose rivaroxaban plus aspirin as compared with aspirin alone in those patients with chronic vascular disease.

In part one, “Digging Deeper Into DOACs for PAD,” Ruff delves into guidelines from both the vascular and cardiology worlds as he introduces the subject matter. For patients with symptomatic PAD, he says, if a patient has recently also had a coronary stent placed or acute coronary syndrome, they will likely benefit from dual antiplatelet therapy (DAPT). More broadly, Ruff adds, this is where a strategy of aspirin and clopidogrel, or aspirin plus rivaroxaban, can be considered.

“There is some equipoise here with either DAPT or low-dose rivaroxaban plus aspirin to reduce adverse cardiovascular events,” he explains. “It is important to remind the audience there are no clinical trial data comparing DAPT as a strategy to the low-dose rivaroxaban and aspirin strategy.”

Ruff points out more intensive strategies are favored in patients with high ischemic risk and those with “overt” atherosclerotic disease or diabetes, for example. “Anytime you’re using combination antithrombotic therapy, patient selection is critical because obviously we want to reduce ischemic and thrombotic events—but it will always come at the cost of an excess in bleeding,” he says.

WHO GETS RIVAROXABAN?

Dua asks her fellow panelists more specifically how specialists determine which patients receive a strategy that includes rivaroxaban. Ruff summarizes his thought process by asking, “Is this a patient who is at high risk in the acute period, do they have disease in multiple beds?

“And, if they do,” he says, “I’m going to be more intensive—particularly, the dual pathway strategy is good for preventing MACE [major adverse cardiac events] in general, but also limb events— and use it in my patient. But I’m definitely much more thoughtful in the chronic setting, or in patients who maybe just have single-bed disease, maybe just PAD.” In part two of the CME activity, Dua points out the only level 1A evidence specialists have to call upon in the guidelines to support the way in which they treat PAD patients post-revascularization is to give them “monotherapy with aspirin, whether that be in an endovascular situation” or in a surgical setting. Yet, treatment strategies carried out are “all over the board,” she says, which “is problematic because it is not data-driven.”

Dua highlights the importance of recognizing that in the endovascular space specialists have used DAPT, typically with aspirin and clopidogrel, which amounts to “weak” level 2C evidence, she says.

DOACS AFTER REVASCULARIZATION

Dua then introduces the VOYAGER PAD trial, which looked at more than 6,500 PAD patients who had undergone successful revascularization and who, within the 10 days afterwards, were randomized to a regimen of either rivaroxaban plus aspirin, or a placebo plus aspirin. Pointing to the trial’s primary efficacy outcome, Dua says the most important takeaway “is that, if you’re giving patients rivaroxaban plus aspirin versus aspirin alone, patients have less of a need to treat, less of a need to reintervene, and there is an absolute risk reduction in the primary outcomes.”

The trial was successful in demonstrating

this among the patient cohort. VOYAGER’s main point was to make sure that giving rivaroxaban plus aspirin would result in a reduction in thrombotic and ischemic events

Left to right: Anahita Dua, Kush Desai and Christian T. Ruff

“If you’re giving a patient rivaroxaban plus aspirin versus aspirin alone, patients have less of a need to treat, less of a need to reintervene, and there is an absolute risk reduction in the primary outcomes” ANAHITA DUA “and simultaneously not increase the bleeding profile,” she adds, leading the Food and Drug Administration (FDA) to expand the approval for rivaroxaban plus aspirin to include patients who received lower-extremity revascularization for symptomatic PAD. The panel goes on to ponder the implications of the VOYAGER trial data for practice. “One thing that this underscores is how difficult this is, and the investigators are to be applauded,” says Desai. The data are particularly important for those patients who have had to undergo a revascularization. Among other patients, such as those being managed for lifestyle modification, “we probably err on the side of

being more conservative than with an intense therapy, unless they have significant polyvascular disease.”

Ruff says the question is a good one: “What’s an optimal strategy, DAPT or aspirin plus low-dose rivaroxaban? I don’t think we know the answer to that question,” he says. “So, if I have a patient that requires DAPT, say for their coronary disease, that might be what I choose for that patient. If the patient doesn’t require DAPT, and they need a more intensive regimen, and they’ve just had peripheral revascularization, then this might be an appealing strategy, particularly if their bleeding risk is reasonable.”

CASE STUDIES

Part three of the CME activity hones in on three sample PAD patients who are potential candidates for a rivaroxaban plus aspirin treatment strategy. Ruff, Desai and Dua introduce the cases and discuss application of data previously outlined during the activity.

They include one patient who presents with polyvascular disease and symptomatic PAD; another who has undergone endovascular revascularization for lower-extremity PAD, has a 50-year smoking history and is a diabetic; and a third with non-healing wounds, chronic limb-threatening ischemia and coronary artery disease who was already on warfarin for a history of atrial fibrillation.

In discussion, Dua points toward the “new frontier” posed by increasing issues specialists are seeing in the microvasculature. Patients are living longer, are more complex, and they have more chronic kidney disease, she says.

By 2045, Dua adds, “we’re talking about thousands of patients who are going to be affected.”

In all three case studies, concludes Desai, “you can make a case that a dual-pathway approach makes sense in all those patients, whereas before we were a little bit in the hinterlands trying to figure out what’s the right thing to do.”

Visit https://www.achlcme.org/pad-patient-care-svs and learn about mitigating thrombosis risks to stop amputation post-PAD revascularization. Supported by an educational grant from Janssen Scientific Affairs, LLC.

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Vascular Specialist | July/August 2022

INTERVIEW Limb salvage in focus: New VAM lectureship, born of a pioneering spirit, thrills honoree

he continues, and so it is vascular surgeons who should lead the limb salvage charge going forward. “Now, of course [limb salvage] surgery has been accepted around the world, and, even more importantly, we were among the first to do percutaneous angioplasties in association sometimes with a bypass,” Veith elaborates. “But now the treatment has largely become interventional—I’d say 75–80% of limb salvage procedures are done endovascularly—and the field has exploded. Now the other interventional specialists, like interventional cardiology and intervenBy Bryan Kay tional radiology, are becoming strong advocates of limb salvage.”

Despite being progenitors of the procedure, Veith says, in t all started around the late 1970s, early 1980s. Back then, recalls many communities vascular surgery is gradually losing out to Frank J. Veith, MD, the notion of aggressively pursuing limb these other specialties. “I think the SVS putting emphasis on these salvage in a gangrenous foot or toe went against the grain of procedures, some of which are going to require open vascular current thinking. What Veith and his colleagues were undertak- surgery, many of which will be done interventionally by vascular ing represented “very distal bypasses,” and, at the time, what he surgeons, I think is going to go a long way to maintaining vascuwas doing seemed to amount to virtual heresy, he muses. No lar surgery’s leadership in this area.” one else seemed to accept the legitimacy of the surgeries. Yet Placing a focus on limb salvage might also help attract up-andthey worked, says the vascular surgery luminary, former Society coming vascular trainees and surgeons to a largely unglamorous for Vascular Surgery (SVS) president, and current chairman area of the specialty, Veith adds. “We think that this lectureship will promote progress by vascular surgeons in the of the internationally renowned VEITHsymposium. sometimes-unpopular field of lower-extremity “Everybody thought, if you had a gangrenous revascularization. Right now, everybody is foot, toe or any kind of ischemic lesion of the interested in fenestrated and branched endofoot that was due to atherosclerosis below the groin, that the right treatment was an amputagrafts and treating big, complex aneurysms. tion,” Veith tells Vascular Specialist. “We were That is an important field, and the advances amongst the first to start advocating aggressive are really quite dramatic. But the less glamorlimb salvage. We were able to save, I guess, ous field of treating patients with limb-threatmore than 90% of the patients that presentening ischemia, I think, is extremely important ed with limb-threatening ischemia, to save for vascular surgery to maintain a leadership their leg.” position in.”

For medical students, trainees and emerging Veith was speaking shortly after the occasion of a surgeons who might be viewing the broad swathe new Vascular Annual Meeting (VAM) named lectureship being announced by the SVS—in his honor—that of vascular surgery with a curious eye, Veith has a Frank J. Veith will focus on peripheral arterial disease (PAD) and, in succinct message. “Sometimes it’s best, if you want particular, limb salvage. Coined the Frank J. Veith Lecture, the to achieve leadership in a specialty, to go into a field that is not maiden talk is set to take place next year at VAM 2023 in National primarily popular,” he says. “In other words, don’t try and reHarbor, Maryland ( June 14–17). place all of the extremely skillful vascular surgeons doing these The focus of the lecture, Veith says, bears particular impor- complex aneurysm repairs endovascularly—go into a field that tance for the SVS amid the currently crowded field of physicians is maybe a little less glamorous and sub-specialize in it, and you from other specialties involved in the treatment of PAD. It was may achieve prominence more quickly than you might if you vascular surgeons who originated the treatment for limb salvage, went with the crowd.”

I

CMS SVS ADDRESSES PAIR OF CRITICAL PAYMENT-RELATED PROPOSED RULES In July, the Centers for Medicare and Medicaid Services (CMS) released two critical paymentrelated proposed rules for CY2023—the highly anticipated Medicare Physician Fee Schedule (MPFS) Proposed Rule followed by the Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule.

Of note, in the MPFS, CMS is proposing to cut the Medicare conversion factor—the basic starting point for calculating Medicare payments—by approximately 4.5% for CY2023. In addition, payment reductions for many vascular surgeons are compounded by the second year of CMS’ phasedin implementation of its clinical labor pricing update, which was finalized in the CY2022 MPFS Final Rule.

“This year’s proposed rule is yet another example of how the current payment system fails to support physicians and the patients they serve,” said Matthew J. Sideman, MD, chair of the Society for Vascular Surgery (SVS) Advocacy Council.

“These significant year-over-year payment cuts will most certainly jeopardize patient access to critical vascular healthcare. Congress must begin work in earnest to avert these cuts and establish a new payment system that will provide stability for both physicians and patients.”

In the OPPS rule, CMS is proposing to update payment rates by 2.7% for hospitals that meet applicable quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.1%, reduced by a 0.4 percentage point for the productivity adjustment.

The SVS is analyzing both rules and will submit extensive comments to CMS. SVS members should be prepared to engage in these ongoing advocacy efforts through the remainder of the year, said Sideman.—Megan Marcinko

FROM THE COVER: ‘STEPTEMBER’ ASKS SURGEONS TO WALK THE WALK continued from page 1

➽

a major initiative aimed squarely at promoting the health benefits of walking. The STEPtember Vascular Health Challenge takes place during September, National Peripheral Arterial Disease (PAD) Awareness Month.

During STEPtember, vascular surgeons will not only talk the talk but walk the walk, competing in teams whose members each pledge to walk at least 60 miles during the month. The 60 miles represent the 60,000 miles of blood vessels in the human body.

STEPtember is not just a fundraiser but an opportunity for vascular surgeons across the country and the world to engage with their communities and spread the word about the importance of vascular health.

STEPtember also will raise awareness about vascular disease, and what a vascular surgeon is and what they do. The SVS Public and Professional Outreach SubCommittee is spearheading the project.

“As vascular surgeons, we put patient health and outcomes above everything else, and ‘STEPtember’ is a tangible way to demonstrate that commitment,” said Benjamin Pearce, MD, committee chair.

After all, vascular surgeons focus a great deal of time to mitigate the effects and causes of vascular disease without surgery, said committee member Alan Dietzek, MD. “There’s no more beautiful message than surgeons doing their best to keep their patients out of surgery,” agreed Pearce.

“It all links back to our motto, ‘Surgery is only part of our story.’” Pearce himself is a big advocate of walking, eschewing golf carts while partaking in a favorite activity.

“I’ve been an adamant walker for years on the golf course,” he said. He estimates a golfer can log nearly 2,000 more steps in nine holes when walking versus riding in a cart. Dietzek said the No. 1 complaint his older patients give, when asked how aging affects their lives, is “I can’t walk the golf course anymore.”

Pearce, Dietzek and the other committee members want to link the SVS and walking.

“When you think of smoking cessation, you think of the American Lung Association,” said Pearce. “I want people to automatically think of SVS when they think about walking for health.”

Walking affects many aspects of

cardiovascular health, from PAD to hypertension to slowing the growth of abdominal aortic aneurysms (AAAs). The SVS has created lists of factoids on the benefits of walking that SVS members can download and give to patients. One such infographic is the “Steps for Vascular Health” poster, tying the health benefits of various numbers of steps.

PPO Committee members will be among

“It all links back to our motto, ‘Surgery is only part of our story’” BENJAMIN PEARCE the first to form their “STEPtember” walking teams. The idea is straightforward.

Individuals sign up on the Charity Footprints website, at vascular.org/ STEPtember, and pair their personal fitness devices, such as a Fitbit or Apple Watch, to the site, download the Charity Footprints

application on smartphones, or log in manually on the website. SVS members will join their respective regional team, and community participants can start their own team or join an existing one. Then, between Sept. 1 and 30, participants get walking, logging the steps, and transferring them to the website. Walkers can seek donors for an overall amount or a per-step contribution. All proceeds will go to the SVS Foundation, which will use the monies generated to assist vascular patients with exercise therapy. In addition, proceeds will help create additional public education materials about vascular health and support further development of the SVS Supervised Exercise Therapy (SET) app.

Committee members also are thinking creatively about how to undertake the challenge. Pearce is hoping to walk with his team on a Grand Prix racetrack in his home state of Alabama. Dietzek wants to involve the world of professional golf. “Think of an area in your community that would provide an inspiring way to finish the challenge,” urged Pearce. “It could be the track around the high school football stadium, or a riverwalk, or a well-known park.”

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RISK INFORMATION Caution: Federal (USA) law restricts the use of the system by or on the order of a physician.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

INDICATIONS FOR USE The AURYON Atherectomy System is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).

References: 1. Rundback J, Chandra P, Brodmann M, et al. Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-LaserTM IDE study.

Catheter Cardiovasc Interv. 2019;94(7):1010-1017. 2. Shammas NW, Chandra P, Brodmann M, et al. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-LaserTM , a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: results of the EX-PAD-03 trial. Cardiovas Revasc Med. 2020;21(1):86-92.

3. Auryon. Instructions for use. AngioDynamics; 2020.

AngioDynamics, the AngioDynamics logo, Auryon, and the Auryon logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2020 AngioDynamics, Inc. US/PA/AD/405 Rev 01 9/2020

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Vascular Specialist | July/August 2022

COMMENT&ANALYSIS CORNER STITCH

A LETTER TO NEW VASCULAR INTERNS

By Kirthi Bellamkonda, MD

EVERY INTERN STARTING VASCULAR SURGERY this year is incredibly talented and soon to be a member of a tight-knit, supportive, and fiercely passionate group of surgeons. I remember being on the cusp of my first day a year ago, having spent the interview season talking the talk, yet wondering whether I could walk the walk. In surgery there is really no “trial run” to internship—most sub-internships are focused on operating room (OR) time, and interviews on non-clinical achievements. So I’m hoping to pass on some of the lessons I learned this year.

There will be many false alarm pages. Don’t let complacency creep in. We like to find patterns in everything. After seeing five pages about postop pain in five different patients, all benign, it’s natural to assume the same on the sixth. That is when you will miss a graft thrombosis, a compartment syndrome, a hematoma, or an infection. The pager will “cry wolf ” most of the time, but the safest intern always assumes the wolf is really there and acts accordingly.

Know how (and where) everyone on your team does their job

There are many things in your day-to-day that happen in the background of your awareness—but if you are responsible for making sure it gets done, then you should also know how

to do it. I have had to program an intravenous (IV) My personal efficiency tips: Medical issues should pump, dig through central supply for an obscure dressalways be addressed face-to-face with patients, but ing, and sign for unlabeled specimens in the lab buildthe operator can always help you call an inpatient for ing. Pay attention not just to what other physicians do, quick questions about rides home or pharmacies to but what the support staff do. Ask your techs to show save time. If you have access to a mobile app/orders you how to work the ultrasounds. Ask the critical for your electronic medical record (EMR), use it. I care nurses to show you how to pass meds in a code. always knock out (at least) one task while walking Kirthi Ask physical therapy how to safely mobilize a patient. Bellamkonda somewhere. It also sends me push notifications for Know how to spike an IV. Drive a bed with someone all important lab results. Organize your EMR tabs to from transport. And, when you have a few spare minutes, chart round in the fewest clicks. find dialysis, magnetic resonance imaging (MRI), computed tomography (CT), hyperbaric, pathology, pharmacy, central You are never truly alone stores, instrument reprocessing—you should be able to find In the clinical world, being on call without an in-house senior your patients and your tools at any point in the day. can seem lonely. But most life-threatening overnight inpatient issues are medical in nature, and you will have in-house Experience and knowledge are not critical care and senior medicine trainees. interchangeable Although not part of their job, our in-house trauma, carBeing present and caring for patients is a critical part of train- diology, and anesthesia trainees have reinforced that they ing, but that alone will not get you to the level of knowledge would always help an intern finding themselves all alone in needed. As hard as it is, carve out time to read Rutherford an emergent situation, no questions asked. It is always better and do Vascular Education and Self-Assessment Program to call for help than to demonstrate your independence at the (VESAP) questions, even during intern year. expense of safety. And finally, a few practical points: Always hold pressure for longer than you think you need to after a Efficiency comes from observing efficient groin puncture, take Step 3 before you forget how to read colleagues often a fetal heart tracing. ICU is a good time, and buy the best Everyone in medicine develops a system for looking through own-specialty private disability insurance you can afford. a chart and managing workflow, and it’s easy to become atThe learning curve is steep, but your knowledge this year will tached to the first thing your first senior shows you in your grow exponentially without you even realizing it. Don’t forget first block. I would encourage you to keep watching co-in- to step back and take time for yourself on days off. Good luck! terns and seniors do “basic” things, even after you know how to do all the usual intern tasks. There will always be KIRTHI BELLAMKONDA is a vascular resident at Dartmouthsomeone who has found a new shortcut or an automation. Hitchcock Medical Center in Lebanon, New Hampshire.

FROM THE COVER: DEI INITIATIVES IN VASCULAR SURGERY: HOW ARE WE DOING? expressions of frustration and disappointment by the few attendees who were present. Quickly, these sentiments were being echoed and amplified on social media platforms. The Society for Vascular Surgery (SVS) Executive Board responded to the smoldering controversy with a written statement posted on the official SVS website with a brief statement vowing continued efforts to prioritize DEI principles and accelerate change while acknowledging organizational shortcomings.1 Certainly, scheduling so many competing events had a significant impact.

Empty seats and sparsely attended sessions notwithstanding, what lessons should the SVS and those of us working on DEI-focused initiatives take away from these events? Does lack of attendance equate with lack of interest in DEI? More importantly, what is the current state of DEI efforts in vascular surgery? Are vascular surgeons appropriately interested, engaged, and equipped with the knowledge and skills to combat health inequities? Do current and future vascular surgeons understand how paramount DEI interventions are to building a diverse workforce more mindful of the barriers our most vulnerable patients face?

We don’t ask these questions to be

hyperbolic. Rather, we ask in the hope of eliciting thoughtful and frank, at times painful, discussions about the root cause of many of these complex issues and our roles in addressing them. Broadly speaking, DEI has been seen as the panacea to increase diversity and inclusion in our workforce, address bias in the clinical learning environment, and eliminate health inequities and disparities.2-3 Each of the objectives are pillars of DEI that exist in their separate but interconnected domains. The SVS has adopted these same principles in its bylaws and efforts to change the organizational culture of vascular surgery. As SVS members, we are all tasked with the work to advance “excellence and innovation in vascular health through education, advocacy, research and public awareness.” As such, advancing DEI initiatives is in keeping with our mission as vascular surgeons.

However, in its current iteration, we’ve treated DEI as a secondary outcome, whereas it should be treated as a primary outcome. So how, then, do we make this transition to appropriately position DEI efforts within our day-to-day practice? We propose that adopting instruments and metrics to capture and analyze patients’ social determinants of health (SDoH) in clinical care, research, and quality improve-

continued from page 1

ment initiatives is a concrete first step that individual and organizations can take today.

It has been well documented that patients with low-income levels, and racial and ethnic minorities, have worse outcomes with amputations and are more likely to undergo fewer revascularization attempts prior to intervention.4-5 SDoH provides a good mechanism to interrogate the reasons behind these disparate outcomes and help provide evidence-based, patient-centered comprehensive vascular care. Also, integrating these datapoints into our root-cause analysis during peer-review conferences can serve as teaching moments for our trainees and quality improvement opportunities.

Vascular surgery finds itself at the intersection of SDoH, patient outcomes and a perilous healthcare system. This presents challenges but also opportunities. We are privileged to take care of simultaneously the most diverse, disenfranchised and comorbid populations in our society. As this population ages and the health gap widens, it is more important than ever that we put the correct emphasis on DEI interventions.

References 1. https://vascular.org/news-advocacy/articles-press-releases/prioritizing-dei-principles. Accessed June 22, 2022

2. Aulivola B, Mitchell EL, Rowe VL, et al.

Ensuring equity, diversity, and inclusion in the Society for Vascular Surgery: A report of the Society for Vascular Surgery Task Force on Equity, Diversity, and Inclusion. J Vasc Surg. 2021 Mar;73(3):745–756.e6. doi: 10.1016/j.jvs.2020.11.049 3. Dalman RL, Murphy SA, AbuRahma AF, et al. The Society for Vascular Surgery Executive Board response to the Diversity, Equity and Inclusion Taskforce Report. J Vasc Surg. 2021;73(3):757–761. doi:10.1016/J. JVS.2020.11.048 4. Fanaroff AC, Yang L, Nathan AS, et al.

Geographic and socioeconomic disparities in major lower extremity amputation rates in metropolitan areas. J Am Heart Assoc. 2021;10(17):21456. doi:10.1161/ JAHA.121.021456 5. Gober L, Bui A, Ruddy JM. Racial and gender disparity in achieving optimal medical therapy for inpatients with peripheral artery disease. Ann Vasc Med Res. 2020;7(4).

Accessed July 19, 2022. /pmc/articles/ PMC7877491/

IMANI E. MCELROY is a resident at Massachusetts General Hospital in Boston.

CARLA C. MOREIRA is an associate program director at Alpert Medical School of Brown University in Providence, Rhode Island.

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CAROTID INTERVENTIONS

A brilliant plan to increase vascular surgeons’ income—and decrease the incidence of stroke!

By Russell Samson, MD I HAVE COME UP WITH A BRILLIANT plan that will decrease the incidence of stroke nationwide, provide an excellent source of income for vascular surgeons, and reduce vascular surgeons’ stress and burnout. My concept is based on two recent trends in the management of patients at risk for carotid territory stroke.

First, medical management is now so advanced that it can prevent almost all strokes in asymptomatic patients. Therefore, prophylactic carotid endarterectomy or carotid stenting is now inappropriate and unnecessary, except, possibly, in patients with truly critical stenosis in the >90% range.

Second, according to a paper presented at the 2022 Vascular Annual Meeting (VAM), if surgery is performed, follow-up duplex scanning is unnecessary, since most patients will not develop a subsequent stroke, nor will

they develop significant restenosis that requires revision. Thus, vascular surgeons face diminished income since they will not be performing large numbers of prophylactic carotid procedures, nor subsequent follow-up duplex scans.

My profoundly elegant concept is simple.

Vascular surgeons must immediately stop performing highly-stressful carotid endarterectomy or stent procedures in asymptomatic patients. However, if high-grade stenosis is detected, they must continue to do six-monthly carotid duplex scans ad infinitum, just in case a truly critical stenosis is ultimately encountered. Since the reimbursement for a carotid endarterectomy is usually around $900, whereas the reimbursement for a duplex scan is approximately $150, equipoise in reimbursement will be achieved after just three years.

Vascular surgeons must immediately stop performing highlystressful carotid endarterectomy or stent procedures in asymptomatic patients

Thereafter, since the patient is unlikely to have a stroke, and therefore will likely live a long time, the vascular surgeon will make a stress-free $300 a year with onRussell Samson going testing. Rather than having to waste time going to the hospital, sit around waiting for anesthesia to see the patient and put them to sleep, worry that the patient will wake up strokefree, and speak to the family and write the op note etc., they can now relax at the beach drinking a piña colada while they read the duplex scans on their laptop.

Further, they will no longer need to pay the exorbitant malpractice fees that are associated with the risk of carotid endarterectomy-related stroke, nerve injury and death.

Concomitantly, the national incidence of stroke will fall precipitously, and everyone will be happy!

RUSSELL SAMSON is a vascular surgeon at Sarasota Vascular Specialists in Sarasota, Florida. He is a 2020 recipient of the SVS Excellence in Community Practice Award and a former medical editor of Vascular Specialist.

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12

Vascular Specialist | July/August 2022

COMMENT&ANALYSIS LESION VISION

Confessions of a dual-trained, dualpracticing vasculartrauma surgeon

By Joseph DuBose, MD LIKE MOST OF THE OTHER READERS OF Vascular Specialist, I look forward to perusing each release for not just useful information but also insightful editorials that frame ongoing issues in thoughtful and entertaining ways.

I personally find that I am rarely disappointed in what I find in this newspaper in this regard, and the recent article by our medical editor, Dr. Malachi Sheahan III, titled “A modest proposal: Let’s eat the trauma surgeons” was no exception.

It left me with many things to think about… including how I would season the half of my body that Dr. Sheahan satirically suggested I should cannabilize.

Let me explain. I am a dual-trained trauma and vascular surgeon who continues to fight to maintain a balanced practice in both fields. For six years after completing a surgical critical care/trauma two-year fellowship, I worked as an academic military trauma surgeon. I confess I am one of those slightly deranged individuals who actually enjoys the struggle of creating order from chaos at times when most sane individuals would probably rather be in bed. For me clinically, there is simply nothing like the adrenaline and reward that can be found trying to save a trauma victim from bleeding to death at midnight on a Saturday.

Ask any busy trauma surgeon what their most interesting recent case was and I would be willing to bet some vascular injury is a common response. I relished these challenges perhaps more than most of my trauma colleagues. It was not hard to appreciate, however, that I had some gaps in my training that limited my ability to care for many of these challenges. Endovascular technologies were already emerging as effective solutions to vascular injuries at some anatomical locations and improving outcomes as they did so. In the open surgical realm, I found it challenging to find avenues by which I could consistently maintain my skillsets in exposure, control and repair of blood vessels. More military deployments or trauma call were not going to fix these deficiencies very efficiently.

And so, with the support of my military leadership and some respected trauma mentors, I self-demoted from mid-level trauma attending to vascular fellow. It was at times a humbling experience. But now, seven years into a dual practice, I can honestly say that I have found the clinical niche that I find most personally rewarding. I take as much trauma call as any of my trauma partners, and also have a busy vascular practice treating the full spectrum of elective and emergent vascular disease. It makes for a very busy workload for sure, but an advanced vascular skillset has empowered me to be clinically happy in my interest area—and even to expand into areas that one would not typically associate with traditional vascular or trauma surgery practice. For example, my current vascular group performs the majority of the solid organ and hemorrhage control embolization interventions for our trauma program.

Despite my contentment with my dual practice, I must confess it often presents me with interesting dilemmas. I do sometimes find myself asking existential questions related to my professional identity. Am I a trauma surgeon with a passion for vascular injury? Or, rather, am I a vascular surgeon with an interest in vascular trauma? The answer is some-

times complex and dependent upon the context. When my two training background split personalities converge in the deciding of how to manage a complex vascular injury, the real quandaries can begin. In these moments, all the debates regarding the future of vascular trauma and optimal vascular injury treatment in the endovascular era, that rage across the “Twittersphere,” become my internal dialogue.

In attempting to make sense of these often dueling perspectives, I worked with a group of vascular and trauma surgeons as lead author on an editorial called “Beyond the crossroads: Who will be the caretakers of vascular injury management?” for Annals of Surgery. The intent was to outline the challenges all stakeholders face as changes in technology, training and trauma center organization influence the ongoing evolution in vascular injury care. It was my attempt to highlight for consideration the potential potholes on this road that both vascular and trauma surgeons must travel together. As one who will readily “nerd out” about vascular trauma, this publication was a way of giving voice to the debating portions of my overly trained mind.

The response? Well, let’s just say it was not necessarily warmly received in all sectors. Many trauma surgeons criticized me for suggesting they are no longer capable of caring for vascular injury in the era of endovascular technologies.

Some vascular colleagues perceived that I was implying they fail to understand the nuances of vascular injury management in the context of the severely injured trauma patient.

My well-intentioned highlight of potential present and future challenges had backfired to some degree. The article left me best known in some circles as the evil spirit who coined the term “lesion vision,” thereby arming some of my fellow trauma surgeons with a war cry against further encroachment of vascular surgeons into their cherished vascular injury excitement.

“Open vascular repair skills will almost certainly continue to be required for vascular trauma management, but no one has the ability to develop and maintain this skillset like the modern vascular surgeon” By way of apology, I offer as backstory that the first time I ever used “lesion vision” was in presenting one of my own morbidities where I had clearly let focus sharpen too narrowly on the hybrid operating room (OR) screen, and missed important changing physiology of a bleeding trauma patient under my own care. As such, if I coined the term in later self-deprecation at our M&M meeting, then I am also the first documented victim of this malady. As I genuflect remorsefully in your collective directions, I hope that you will forgive me and let me return from the outcast lunch table at the annual vascular community picnic.

It is also my fervent hope that you will help me make room at that table for others like me. When I started down this pathway of dual training, I could count on one hand the individuals that I knew of working as true dual-practicing vascular and trauma surgeons in the U.S. Now, however, this

pathway seems to be making some small gains, and our numbers are growing. At present, these individuals seem to cluster at major high-volume trauma centers around the U.S. Baltimore, Denver and Austin all harbor collections of dual-practicing vascular/trauma surgeons. A more substantial number of dual-trained surgeons primarily practice more exclusively in vascular surgery but serve as exceptional ambassadors to vascular injury care, and outstanding resources to their trauma partners at their trauma centers. At least monthly, I get a call from a surgical resident or trauma fellow to talk about the benefits of pursuing dual training in the context of changes in vascular injury care. It may not be a massive movement, but it does seem to be a potential “thing.”

The question remains, however: Is there a real role for this sort of a training pathway? There is clearly a need for more vascular surgeons to support trauma, as has been discussed on the pages of this periodical very effectively. No rational individual would argue that vascular surgeons are not an absolutely necessary part of the endovascular advancement of vascular injury care. The days of open blunt aortic repair have given way to thoracic endovascular aneurysm repair (TEVAR). Other anatomic locations are following suit. Only the vascular community is uniquely positioned to effectively guide this evolution. Open vascular repair skills will almost certainly continue to be required for vascular trauma management, but no one has the ability to develop and maintain this skillset like the modern vascular surgeon. The role of the vascular surgeon in trauma is secured for those that are interested in incorporating it into their practice.

But there is also a clear and present interest among trauma surgeons in remaining engaged in vascular injury care. In a recent survey of both vascular and trauma surgeons, it was noted that, despite significant interest in vascular injury by practicing trauma surgeons, most feel unprepared to do so.

The most commonly cited reasons for this discomfort were inability to maintain the skillset and unfamiliarity with techniques. Can my own unique breed of dual-trained surgeons, and the numerous vascular surgeons who are also interested in trauma, be of service in this regard? Can we, in the least, do a better job of educating the next generation of trauma trainees in the capabilities we have to offer that might augment the care of the most challenging of the patients they are called upon to care for? I hope the answer is “Yes”… or I will have to figure out yet another new career plan.

In my own vision of a future utopia, I can see a time when there may be at least one dual-practicing trauma and vascular surgeon at most of the leading trauma centers in the U.S. In this ideal world, these individuals could serve as ambassadors between their vascular and trauma divisions. They will be valuable in improving the knowledge base and skillset of their trauma colleagues and their trainees, and finding ways to empower trauma surgeons to engage actively and productively in the vascular injury care evolution. They will also free their vascular partners to focus their energies more actively on the unique vascular practice models they are passionate about—be they aortic, peripheral, cerebrovascular or venous in nature. They might be “odd ducks” like myself, but they have the potential to be valuable resources to both disciplines they have pursued. And in this utopian future, no one will remember what “lesion vision” means.

JOSEPH DUBOSE is a professor of surgery in the University of Texas at Austin’s Dell Medical School in Austin, Texas.

Are your patients with CAD really stable?

Consider XARELTO®.

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XARELTO® is the ONLY DOAC indicated in combination with aspirin* to significantly reduce the risk of major CV events† in patients with CAD1-8 XARELTO® (2.5 mg BID)

ASPIRIN

(75 mg-100 mg QD) Tablets not shown to actual size.

Arterial Thrombus

*XARELTO® 2.5 mg twice daily + aspirin 75 mg to 100 mg once daily; †Major cardiovascular events include CV death, MI, and stroke.

BID = twice daily; DOAC = direct oral anticoagulant; CAD = coronary artery disease; CV = cardiovascular; MI = myocardial infarction; QD = once per day.

INDICATION XARELTO®, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease (CAD).

IMPORTANT SAFETY INFORMATION result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

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Use of indwelling epidural catheters

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Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants, see Drug Interactions

Premature discontinuation of any oral anticoagulant, including XARELTO®, increases the risk of thrombotic events. If anticoagulation with XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

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A history of traumatic or repeated epidural or spinal punctures

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A history of spinal deformity or spinal surgery

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Optimal timing between the administration of XARELTO® and neuraxial procedures is not known

B. Spinal/epidural hematoma

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

A. Premature discontinuation of XARELTO® increases the risk of thrombotic events

Epidural or spinal hematomas have occurred in patients treated with XARELTO® who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

CONTRAINDICATIONS • •

Active pathological bleeding Severe hypersensitivity reaction to XARELTO® (eg, anaphylactic reactions)

WARNINGS AND PRECAUTIONS •

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Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including XARELTO®, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO® to warfarin in clinical trials in atrial fibrillation patients. If XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

Risk of Bleeding: XARELTO® increases the risk of bleeding and can cause serious or fatal bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue in patients with active pathological hemorrhage.

– An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not dialyzable.

– Concomitant use of other drugs that impair hemostasis increases risk of bleeding.

These include aspirin, P2Y12 platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, NSAIDs, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs).

– Risk of Hemorrhage in Acutely Ill Medical Patients at High Risk of Bleeding: Acutely ill medical patients with the following conditions are at increased risk of bleeding with the use of XARELTO® for primary VTE prophylaxis: history of bronchiectasis, pulmonary cavitation, or pulmonary hemorrhage; active cancer (ie, undergoing acute, in-hospital cancer treatment); active gastroduodenal ulcer or history of bleeding in the three months prior to treatment; or dual antiplatelet therapy. XARELTO® is not for use for primary VTE prophylaxis in these hospitalized, acutely ill medical patients at high risk of bleeding.

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Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. To reduce the potential risk of bleeding associated with concurrent use of XARELTO® and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of XARELTO®. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of XARELTO® is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known. An indwelling epidural or intrathecal catheter should not be removed before at least 2 half-lives have elapsed (ie, 18 hours in young patients aged 20 to 45 years and 26 hours in elderly patients aged 60 to 76 years), after the last administration of XARELTO®. The next dose should not be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of XARELTO® for 24 hours. Monitor frequently to detect signs or symptoms of neurological impairment, such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), or bowel and/or bladder dysfunction. Instruct patients to immediately report any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.

Use in Patients with Renal Impairment: – Nonvalvular Atrial Fibrillation: Periodically assess renal function as clinically indicated (ie, more frequently in situations in which renal function may decline) and adjust therapy accordingly. Consider dose adjustment or discontinuation in patients who develop acute renal failure while on XARELTO®. Clinical efficacy and safety studies with XARELTO® did not enroll patients with CrCl <30 mL/min or end-stage renal disease (ESRD) on dialysis.

Please read additional Important Safety Information on the following pages and read accompanying Brief Summary of full Prescribing Information, including Boxed WARNINGS for XARELTO®.

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Use in Patients with Renal Impairment (cont’d): – Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE: In patients with CrCl <30 mL/ min, rivaroxaban exposure and pharmacodynamic effects are increased compared to patients with normal renal function. There are limited clinical data in patients with CrCl 15 to <30 mL/min; therefore, observe closely and promptly evaluate any signs or symptoms of blood loss in these patients. There are no clinical data in patients with CrCl <15 mL/min (including patients on dialysis); therefore, avoid the use of XARELTO® in these patients. Discontinue XARELTO® in patients who develop acute renal failure while on treatment.

– Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: In patients with CrCl <30 mL/min, rivaroxaban exposure and pharmacodynamic effects are increased compared to patients with normal renal function. There are limited clinical data in patients with CrCl 15 to <30 mL/min; therefore, observe closely and promptly evaluate signs or symptoms of blood loss in these patients. There are no clinical data in patients with CrCl <15 mL/min (including patients on dialysis); therefore, avoid the use of XARELTO® in these patients. Discontinue XARELTO® in patients who develop acute renal failure while on treatment.

– Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding: In patients with CrCl <30 mL/min, rivaroxaban exposure and pharmacodynamic effects are increased compared to patients with normal renal function. There are limited clinical data in patients with CrCl 15 to <30 mL/min; therefore, observe closely and promptly evaluate any signs or symptoms of blood loss in these patients. There are no clinical data in patients with CrCl <15 mL/min (including patients on dialysis); therefore, avoid the use of XARELTO® in these patients. Discontinue XARELTO® in patients who develop acute renal failure while on treatment.

– Reduction of Risk of Major Cardiovascular Events in Patients with CAD and Reduction of Risk of Major Thrombotic Vascular Events in Patients with PAD, Including Patients after Recent Lower Extremity Revascularization Due to Symptomatic PAD: For patients with CrCl <15 mL/min, no data are available, and limited data are available for patients with a CrCl of 15 to 30 mL/min. In patients with CrCl <30 mL/min, a dose of 2.5 mg XARELTO® twice daily is expected to give an exposure similar to that in patients with moderate renal impairment (CrCl 30 to <50 mL/min), whose efficacy and safety outcomes were similar to those with preserved renal function. Clinical efficacy and safety studies with XARELTO® did not enroll patients with end-stage renal disease (ESRD) on dialysis.

– Pediatric Patients: There are limited clinical data in pediatric patients 1 year or older with moderate or severe renal impairment (eGFR <50 mL/min/1.73 m2); therefore, avoid use of XARELTO® in these patients.

There are no clinical data in pediatric patients younger than 1 year with serum creatinine results above 97.5th percentile; therefore, avoid the use of XARELTO® in these patients.

Use in Patients with Hepatic Impairment: No clinical data are available for adult patients with severe hepatic impairment. Avoid use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy, since drug exposure and bleeding risk may be increased. No clinical data are available in pediatric patients with hepatic impairment.

Use with P-gp and Strong CYP3A Inhibitors or Inducers: Avoid concomitant use of XARELTO® with known combined P-gp and strong CYP3A inhibitors or inducers.

Risk of Pregnancy-Related Hemorrhage: In pregnant women, XARELTO® should be used only if the potential benefit justifies the potential risk to the mother and fetus. XARELTO® dosing in pregnancy has not been studied. The anticoagulant effect of XARELTO® cannot be monitored with standard laboratory testing. Promptly evaluate signs or symptoms suggesting blood loss (eg, a drop in hemoglobin and/or hematocrit, hypotension, or fetal distress).

Patients with Prosthetic Heart Valves: Use of XARELTO® is not recommended in patients who have had transcatheter aortic valve replacement (TAVR), based on the results of the GALILEO study, which reported higher rates of death and bleeding in patients randomized to XARELTO® compared to those randomized to an antiplatelet regimen. Safety and efficacy of XARELTO® have not been studied in patients with other prosthetic heart valves or other valve procedures. Use of XARELTO® is not recommended in patients with prosthetic heart valves.

Acute PE in Hemodynamically Unstable Patients/Patients Who Require Thrombolysis or Pulmonary Embolectomy: Initiation of XARELTO® is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.

Increased Risk of Thrombosis in Patients with Antiphospholipid Syndrome: Directacting oral anticoagulants (DOACs), including XARELTO®, are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS). For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.

DRUG INTERACTIONS • • • • •

Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase risk of bleeding.

Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase risk of thromboembolic events.

XARELTO® should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A inhibitors (eg, erythromycin) unless the potential benefit justifies the potential risk.

Coadministration of enoxaparin, warfarin, aspirin, clopidogrel, and chronic NSAID use may increase risk of bleeding.

Avoid concurrent use of XARELTO® with other anticoagulants due to increased bleeding risk, unless benefit outweighs risk. Promptly evaluate signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs.

USE IN SPECIFIC POPULATIONS •

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Pregnancy: The limited available data on XARELTO® in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use XARELTO® with caution in pregnant patients because of the potential for pregnancy-related hemorrhage and/or emergent delivery. The anticoagulant effect of XARELTO® cannot be reliably monitored with standard laboratory testing. Consider the benefits and risks of XARELTO® for the mother and possible risks to the fetus when prescribing to a pregnant woman.

– Fetal/Neonatal adverse reactions: Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate.

– Labor or delivery: The risk of bleeding should be balanced with the risk of thrombotic events when considering use in this setting.

– There are no adequate or well-controlled studies of XARELTO® in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage.

Lactation: Rivaroxaban has been detected in human milk. There are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production.

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for XARELTO® and any potential adverse effects on the breastfed infant from XARELTO® or from the underlying maternal condition.

Females and Males of Reproductive Potential: Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants, including XARELTO®, should be assessed in females of reproductive potential and those with abnormal uterine bleeding.

Pediatric Use: XARELTO® was not studied and therefore dosing cannot be reliably determined or recommended in children less than 6 months who were less than 37 weeks of gestation at birth, had less than 10 days of oral feeding, or had a body weight of less than 2.6 kg.

Clinical studies that evaluated safety, efficacy, and pharmacokinetic/pharmacodynamic data support the use of XARELTO® 10-mg, 15-mg, and 20-mg tablets in pediatric patients.

For the XARELTO® 2.5-mg tablets, there are no safety, efficacy, and pharmacokinetic/ pharmacodynamic data to support the use in pediatric patients. Therefore, XARELTO® 2.5-mg tablets are not recommended for use in pediatric patients.

Although not all adverse reactions identified in the adult population have been observed in clinical trials of children and adolescent patients, the same warnings and precautions for adults should be considered for children and adolescents.

Geriatric Use: In clinical trials the efficacy of XARELTO® in the elderly (65 years or older) was similar to that seen in patients younger than 65 years. Both thrombotic and bleeding event rates were higher in these older patients.

OVERDOSAGE •

Overdose of XARELTO® may lead to hemorrhage. Discontinue XARELTO® and initiate appropriate therapy if bleeding complications associated with overdosage occur. An agent to reverse the anti-factor Xa activity of rivaroxaban is available.

ADVERSE REACTIONS • •

Most common adverse reactions in adult patients with XARELTO® were bleeding complications.

Most common adverse reactions in pediatric patients were bleeding, cough, vomiting, and gastroenteritis.

cp-62551v9

IMPORTANT SAFETY INFORMATION (cont’d) WARNINGS AND PRECAUTIONS (cont’d)

Please read accompanying Brief Summary of full Prescribing Information, including Boxed WARNINGS for XARELTO®.

References: 1. XARELTO® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. Bevyxxa® [prescribing information]. South San Francisco, CA: Portola Pharmaceuticals. Inc; 2020. 3. Eliquis® [prescribing information]. Princeton, NJ and New York, NY: Bristol-Myers Squibb Company and Pfizer Inc.; 2021. 4. Bevyxxa® (betrixaban)—Notice of Permanent Discontinuance of Manufacturing in April 2020: Portola Pharmaceuticals, Inc. 5. Pradaxa® [prescribing information]. Ridgefield, CT: Boehringer lngelheim Pharmaceuticals, Inc.; 2021. 6. Savaysa® [prescribing information]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2021. 7. Eikelboom JW, Connolly SJ, Bosch J, et al; COMPASS Investigators. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017;377[14):1319-1330. 8. Online supplement to: Eikelboom JW, Connolly SJ, Bosch J. et al; COMPASS Investigators. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl Med. 2017 ;377[14]: 1319-1330.

XARELTO® is licensed from Bayer HealthCare AG, 51368 Leverkusen, Germany. © Janssen Pharmaceuticals, Inc. 2022 07/22 cp-327420v1

Janssen Pharmaceuticals, Inc.

Brief Summary of Prescribing Information for XARELTO® (rivaroxaban) XARELTO (rivaroxaban) tablets, for oral use XARELTO (rivaroxaban) for oral suspension See package insert for Full Prescribing Information WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3, 2.4) in Full Prescribing Information, Warnings and Precautions, and Clinical Studies (14.1) in Full Prescribing Information].

B. Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or spinal surgery • optimal timing between the administration of XARELTO and neuraxial procedures is not known [see Warnings and Precautions and Adverse Reactions].

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions].

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions].

INDICATIONS AND USAGE Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation XARELTO is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1) in Full Prescribing Information].

Treatment of Deep Vein Thrombosis XARELTO is indicated for the treatment of deep vein thrombosis (DVT).

Treatment of Pulmonary Embolism XARELTO is indicated for the treatment of pulmonary embolism (PE).

Reduction in the Risk of Recurrence of Deep Vein Thrombosis and/or Pulmonary Embolism XARELTO is indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.

Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery.

Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding XARELTO is indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding [see Warnings and Precautions and Clinical Studies (14.5) in Full Prescribing Information].

Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) XARELTO, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease.

Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD XARELTO, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients XARELTO is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.

Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure XARELTO is indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.

CONTRAINDICATIONS XARELTO is contraindicated in patients with: • active pathological bleeding [see Warnings and Precautions] • severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions) [see Adverse Reactions] WARNINGS AND PRECAUTIONS Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including XARELTO, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO to warfarin in clinical trials in atrial fibrillation patients. If XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3, 2.4) and Clinical Studies (14.1) in Full Prescribing Information].

Risk of Bleeding XARELTO increases the risk of bleeding and can cause serious or fatal bleeding. In deciding whether to prescribe XARELTO to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding.

Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.

Discontinue XARELTO in patients with active pathological hemorrhage. The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.

Concomitant use of other drugs that impair hemostasis increases the risk of bleeding. These include aspirin, P2Y12 platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions], selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors.

Concomitant use of drugs that are known combined P-gp and strong CYP3A inhibitors increases rivaroxaban exposure and may increase bleeding risk [see Drug Interactions].

XARELTO® (rivaroxaban) Risk of Hemorrhage in Acutely Ill Medical Patients at High Risk of Bleeding Acutely ill medical patients with the following conditions are at increased risk of bleeding with the use of XARELTO for primary VTE prophylaxis: history of bronchiectasis, pulmonary cavitation, or pulmonary hemorrhage, active cancer (i.e., undergoing acute, in-hospital cancer treatment), active gastroduodenal ulcer in the three months prior to treatment, history of bleeding in the three months prior to treatment, or dual antiplatelet therapy. XARELTO is not for use for primary VTE prophylaxis in these hospitalized, acutely ill medical patients at high risk of bleeding.

Reversal of Anticoagulant Effect An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not dialyzable [see Clinical Pharmacology (12.3) in Full Prescribing Information].

Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.

Spinal/Epidural Anesthesia or Puncture When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis [see Boxed Warning].

To reduce the potential risk of bleeding associated with the concurrent use of XARELTO and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of XARELTO [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of XARELTO is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.

An indwelling epidural or intrathecal catheter should not be removed before at least 2 half-lives have elapsed (i.e., 18 hours in young patients aged 20 to 45 years and 26 hours in elderly patients aged 60 to 76 years), after the last administration of XARELTO [see Clinical Pharmacology (12.3) in Full Prescribing Information]. The next XARELTO dose should not be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of XARELTO for 24 hours.

Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/ analgesia or lumbar puncture, monitor frequently to detect any signs or symptoms of neurological impairment, such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), bowel and/or bladder dysfunction. Instruct patients to immediately report if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.

Use in Patients with Renal Impairment Nonvalvular Atrial Fibrillation Periodically assess renal function as clinically indicated (i.e., more frequently in situations in which renal function may decline) and adjust therapy accordingly [see Dosage and Administration (2.1) in Full Prescribing Information]. Consider dose adjustment or discontinuation of XARELTO in patients who develop acute renal failure while on XARELTO [see Use in Specific Populations].

Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE In patients with CrCl <30 mL/min, rivaroxaban exposure and pharmacodynamic effects are increased compared to patients with normal renal function. There are limited clinical data in patients with CrCl 15 to <30 mL/min; therefore, observe closely and promptly evaluate any signs or symptoms of blood loss in these patients. There are no clinical data in patients with CrCl <15 mL/min (including patients on dialysis); therefore, avoid the use of XARELTO in these patients.

Discontinue XARELTO in patients who develop acute renal failure while on treatment [see Use in Specific Populations].

Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery In patients with CrCl <30 mL/min, rivaroxaban exposure and pharmacodynamic effects are increased compared to patients with normal renal function. There are limited clinical data in patients with CrCl 15 to <30 mL/min; therefore, observe closely and promptly evaluate any signs or symptoms of blood loss in these patients. There are no clinical data in patients with CrCl <15 mL/min (including patients on dialysis); therefore, avoid the use of XARELTO in these patients.

Discontinue XARELTO in patients who develop acute renal failure while on treatment [see Use in Specific Populations].

Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding In patients with CrCl <30 mL/min, rivaroxaban exposure and pharmacodynamic effects are increased compared to patients with normal renal function. There are limited clinical data in patients with CrCl 15 to <30 mL/min; therefore, observe closely and promptly evaluate any signs or symptoms of blood loss in these patients. There are no clinical data in patients with CrCl <15 mL/min (including patients on dialysis); therefore, avoid the use of XARELTO in these patients.

Discontinue XARELTO in patients who develop acute renal failure while on treatment [see Use in Specific Populations].

Pediatric Patients There are limited clinical data in pediatric patients 1 year or older with moderate or severe renal impairment (eGFR <50 mL/min/1.73 m2); therefore, avoid the use of XARELTO in these patients.

There are no clinical data in pediatric patients younger than 1 year with serum creatinine results above 97.5th percentile; therefore, avoid the use of XARELTO in these patients [see Dosage and Administration (2.2) in Full Prescribing Information and Use in Specific Populations].

Use in Patients with Hepatic Impairment No clinical data are available for adult patients with severe hepatic impairment.

Avoid use of XARELTO in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy since drug exposure and bleeding risk may be increased [see Use in Specific Populations].

No clinical data are available in pediatric patients with hepatic impairment.

Use with P-gp and Strong CYP3A Inhibitors or Inducers Avoid concomitant use of XARELTO with known combined P-gp and strong CYP3A inhibitors [see Drug Interactions].

Avoid concomitant use of XARELTO with drugs that are known combined P-gp and strong CYP3A inducers [see Drug Interactions].

Risk of Pregnancy-Related Hemorrhage In pregnant women, XARELTO should be used only if the potential benefit justifies the potential risk to the mother and fetus. XARELTO dosing in pregnancy has not been studied. The anticoagulant effect of XARELTO cannot be monitored with standard laboratory testing. Promptly evaluate any signs or symptoms suggesting blood loss (e.g., a drop in hemoglobin and/or hematocrit, hypotension, or fetal distress) [see Warnings and Precautions and Use in Specific Populations].

Patients with Prosthetic Heart Valves On the basis of the GALILEO study, use of XARELTO is not recommended in patients who have had transcatheter aortic valve replacement (TAVR) because patients randomized to XARELTO experienced higher rates of death and bleeding compared to those randomized to an anti-platelet regimen. The safety and efficacy of XARELTO have not been studied in patients with other prosthetic heart valves or other valve procedures. Use of XARELTO is not recommended in patients with prosthetic heart valves.

XARELTO® (rivaroxaban)

XARELTO® (rivaroxaban)

Acute PE in Hemodynamically Unstable Patients or Patients Who Require Thrombolysis or Pulmonary Embolectomy Initiation of XARELTO is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.

Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome Direct-acting oral anticoagulants (DOACs), including XARELTO, are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS). For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.

ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed in other sections of the labeling: • Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation [see Boxed Warning and Warnings and Precautions] • Bleeding Risk [see Warnings and Precautions] • Spinal/Epidural Hematoma [see Boxed Warning and Warnings and Precautions]

Treatment of Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) EINSTEIN DVT and EINSTEIN PE Studies In the pooled analysis of the EINSTEIN DVT and EINSTEIN PE clinical studies, the most frequent adverse reactions leading to permanent drug discontinuation were bleeding events, with XARELTO vs. enoxaparin/ Vitamin K antagonist (VKA) incidence rates of 1.7% vs. 1.5%, respectively. The mean duration of treatment was 208 days for XARELTO-treated patients and 204 days for enoxaparin/VKA-treated patients.

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

During clinical development for the approved indications, 34,947 adult patients were exposed to XARELTO. Hemorrhage The most common adverse reactions with XARELTO were bleeding complications [see Warnings and Precautions].

Nonvalvular Atrial Fibrillation In the ROCKET AF trial, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 4.3% for XARELTO vs. 3.1% for warfarin. The incidence of discontinuations for non-bleeding adverse events was similar in both treatment groups.

Table 1 shows the number of patients experiencing various types of bleeding events in the ROCKET AF trial.

Table 1: Bleeding Events in ROCKET AF*- On Treatment Plus 2 Days Parameter Major Bleeding†

XARELTO N=7111 n (%/year) 395 (3.6)

Warfarin N=7125 n (%/year) 386 (3.5)

XARELTO vs. Warfarin HR (95% CI) 1.04 (0.90, 1.20)

55 (0.5) 84 (0.7) 0.67 (0.47, 0.93) Intracranial Hemorrhage (ICH)‡ 36 (0.3) 58 (0.5) 0.63 (0.42, 0.96) Hemorrhagic Stroke§ Other ICH 19 (0.2) 26 (0.2) 0.74 (0.41, 1.34) Gastrointestinal (GI)¶ 221 (2.0) 140 (1.2) 1.61 (1.30, 1.99) 27 (0.2) 55 (0.5) 0.50 (0.31, 0.79) Fatal Bleeding# ICH 24 (0.2) 42 (0.4) 0.58 (0.35, 0.96) Non-intracranial 3 (0.0) 13 (0.1) 0.23 (0.07, 0.82) Abbreviations: HR = Hazard Ratio, CI = Confidence interval, CRNM = Clinically Relevant Non-Major. * Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment. † Defined as clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome. ‡ Intracranial bleeding events included intraparenchymal, intraventricular, subdural, subarachnoid and/or epidural hematoma. § Hemorrhagic stroke in this table specifically refers to non-traumatic intraparenchymal and/or intraventricular hematoma in patients on treatment plus 2 days. ¶ Gastrointestinal bleeding events included upper GI, lower GI, and rectal bleeding. # Fatal bleeding is adjudicated death with the primary cause of death from bleeding.

Figure 1 shows the risk of major bleeding events across major subgroups.

Figure 1: Risk of Major Bleeding Events by Baseline Characteristics in ROCKET AF – On Treatment Plus 2 Days

Table 2 shows the number of patients experiencing major bleeding events in the pooled analysis of the EINSTEIN DVT and EINSTEIN PE studies.

Table 2: Bleeding Events* in the Pooled Analysis of EINSTEIN DVT and EINSTEIN PE Studies Enoxaparin/ VKA† XARELTO† N=4130 N=4116 Parameter n (%) n (%) Major bleeding event 40 (1.0) 72 (1.7) Fatal bleeding 3 (<0.1) 8 (0.2) Intracranial 2 (<0.1) 4 (<0.1) Non-fatal critical organ bleeding 10 (0.2) 29 (0.7) Intracranial‡ 3 (<0.1) 10 (0.2) 1 (<0.1) 8 (0.2) Retroperitoneal‡ Intraocular‡ 3 (<0.1) 2 (<0.1) 0 4 (<0.1) Intra-articular‡ 27 (0.7) 37 (0.9) Non-fatal non-critical organ bleeding§ Decrease in Hb ≥ 2 g/dL 28 (0.7) 42 (1.0) Transfusion of ≥2 units of whole blood or packed red blood cells 18 (0.4) 25 (0.6) Clinically relevant non-major bleeding 357 (8.6) 357 (8.7) Any bleeding 1169 (28.3) 1153 (28.0) * Bleeding event occurred after randomization and up to 2 days after the last dose of study drug. Although a patient may have had 2 or more events, the patient is counted only once in a category. † Treatment schedule in EINSTEIN DVT and EINSTEIN PE studies: XARELTO 15 mg twice daily for 3 weeks followed by 20 mg once daily; enoxaparin/VKA [enoxaparin: 1 mg/kg twice daily, VKA: individually titrated doses to achieve a target INR of 2.5 (range: 2.0-3.0)] ‡ Treatment-emergent major bleeding events with at least >2 subjects in any pooled treatment group § Major bleeding which is not fatal or in a critical organ, but resulting in a decrease in Hb ≥ 2 g/dL and/or transfusion of ≥ 2 units of whole blood or packed red blood cells Reduction in the Risk of Recurrence of DVT and/or PE EINSTEIN CHOICE Study In the EINSTEIN CHOICE clinical study, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 1% for XARELTO 10 mg, 2% for XARELTO 20 mg, and 1% for acetylsalicylic acid (aspirin) 100 mg. The mean duration of treatment was 293 days for XARELTO 10 mg-treated patients and 286 days for aspirin 100 mg-treated patients.

Table 3 shows the number of patients experiencing bleeding events in the EINSTEIN CHOICE study.

Table 3: Bleeding Events* in EINSTEIN CHOICE Acetylsalicylic Acid XARELTO† (aspirin)† 100 mg 10 mg N=1127 N=1131 n (%) n (%) Parameter Major bleeding event 5 (0.4) 3 (0.3) Fatal bleeding 0 1 (<0.1) Non-fatal critical organ bleeding 2 (0.2) 1 (<0.1) Non-fatal non-critical organ bleeding‡ 3 (0.3) 1 (<0.1) Clinically relevant non-major (CRNM) bleeding§ 22 (2.0) 20 (1.8) Any bleeding 151 (13.4) 138 (12.2) * Bleeding event occurred after the first dose and up to 2 days after the last dose of study drug. Although a patient may have had 2 or more events, the patient is counted only once in a category. † Treatment schedule: XARELTO 10 mg once daily or aspirin 100 mg once daily. ‡ Major bleeding which is not fatal or in a critical organ, but resulting in a decrease in Hb ≥ 2 g/dL and/or transfusion of ≥ 2 units of whole blood or packed red blood cells. § Bleeding which was clinically overt, did not meet the criteria for major bleeding, but was associated with medical intervention, unscheduled contact with a physician, temporary cessation of treatment, discomfort for the patient, or impairment of activities of daily life.

In the EINSTEIN CHOICE study, there was an increased incidence of bleeding, including major and CRNM bleeding in the XARELTO 20 mg group compared to the XARELTO 10 mg or aspirin 100 mg groups.

Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery In the RECORD clinical trials, the overall incidence rate of adverse reactions leading to permanent treatment discontinuation was 3.7% with XARELTO. The rates of major bleeding events and any bleeding events observed in patients in the RECORD clinical trials are shown in Table 4.

Table 4: Bleeding Events* in Patients Undergoing Hip or Knee Replacement Surgeries (RECORD 1-3) Total treated patients

Note: The figure above presents effects in various subgroups all of which are baseline characteristics and all of which were pre-specified (diabetic status was not pre-specified in the subgroup but was a criterion for the CHADS2 score). The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be over-interpreted.

Major bleeding event Fatal bleeding Bleeding into a critical organ Bleeding that required re-operation Extra-surgical site bleeding requiring transfusion of >2 units of whole blood or packed cells Any bleeding event‡

XARELTO 10 mg

Enoxaparin†

N=4487 n (%) 14 (0.3) 1 (<0.1) 2 (<0.1) 7 (0.2) 4 (0.1)

N=4524 n (%) 9 (0.2) 0 3 (0.1) 5 (0.1) 1 (<0.1)

261 (5.8)

251 (5.6)

XARELTO® (rivaroxaban)

XARELTO® (rivaroxaban)

Table 4: Bleeding Events* in Patients Undergoing Hip or Knee Replacement Surgeries (RECORD 1-3) (continued)

Defined as i) fatal bleeding, or ii) symptomatic bleeding in a critical area or organ, such as intraarticular, intramuscular with compartment syndrome, intraspinal, intracranial, intraocular, respiratory, pericardial, liver, pancreas, retroperitoneal, adrenal gland or kidney; or iii) bleeding into the surgical site requiring reoperation, or iv) bleeding leading to hospitalization.

CI: confidence interval; HR: hazard ratio; ISTH: International Society on Thrombosis and Hemostasis

Hip Surgery Studies Major bleeding event Fatal bleeding Bleeding into a critical organ Bleeding that required re-operation Extra-surgical site bleeding requiring transfusion of >2 units of whole blood or packed cells Any bleeding event‡ Knee Surgery Study

XARELTO 10 mg N=3281 n (%) 7 (0.2) 1 (<0.1) 1 (<0.1) 2 (0.1) 3 (0.1)

Enoxaparin† N=3298 n (%) 3 (0.1) 0 1 (<0.1) 1 (<0.1) 1 (<0.1)

201 (6.1) N=1206 n (%) 7 (0.6) 0 1 (0.1) 5 (0.4) 1 (0.1)

191 (5.8) N=1226 n (%) 6 (0.5) 0 2 (0.2) 4 (0.3) 0

Major bleeding event Fatal bleeding Bleeding into a critical organ Bleeding that required re-operation Extra-surgical site bleeding requiring transfusion of >2 units of whole blood or packed cells 60 (5.0) 60 (4.9) Any bleeding event‡ * Bleeding events occurring any time following the first dose of double-blind study medication (which may have been prior to administration of active drug) until two days after the last dose of double-blind study medication. Patients may have more than one event. † Includes the placebo-controlled period for RECORD 2, enoxaparin dosing was 40 mg once daily (RECORD 1-3) ‡ Includes major bleeding events Following XARELTO treatment, the majority of major bleeding complications (≥60%) occurred during the first week after surgery.

Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding In the MAGELLAN study, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events. Cases of pulmonary hemorrhage and pulmonary hemorrhage with bronchiectasis were observed. Patients with bronchiectasis/pulmonary cavitation, active cancer (i.e., undergoing acute, in-hospital cancer treatment), dual antiplatelet therapy or active gastroduodenal ulcer or any bleeding in the previous three months all had an excess of bleeding with XARELTO compared with enoxaparin/placebo and are excluded from all MAGELLAN data presented in Table 5. The incidence of bleeding leading to drug discontinuation was 2.5% for XARELTO vs. 1.4% for enoxaparin/placebo.

Table 5 shows the number of patients experiencing various types of bleeding events in the MAGELLAN study.

Table 5: Bleeding Events in MAGELLAN* Study–Safety Analysis Set - On Treatment Plus 2 Days Enoxaparin 40 mg / XARELTO 10 mg MAGELLAN Study¶ placebo N=3218 N=3229 n (%) n (%) Major bleeding‡† 22 (0.7) 15 (0.5) Critical site bleeding 7 (0.2) 4 (0.1) 3 (<0.1) 1 (<0.1) Fatal bleeding§ Clinically relevant non-major bleeding events (CRNM) 93 (2.9) 34 (1.1) * Patients at high risk of bleeding (i.e. bronchiectasis/pulmonary cavitation, active cancer, dual antiplatelet therapy or active gastroduodenal ulcer or any bleeding in the previous three months) were excluded. † Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment. ‡ Defined as clinically overt bleeding associated with a drop in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome. § Fatal bleeding is adjudicated death with the primary cause of death from bleeding. ¶ Patients received either XARELTO or placebo once daily for 35 ±4 days starting in hospital and continuing post hospital discharge or received enoxaparin or placebo once daily for 10 ±4 days in the hospital.

Reduction of Risk of Major Cardiovascular Events in Patients with CAD In the COMPASS trial overall, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 2.7% for XARELTO 2.5 mg twice daily vs. 1.2% for placebo on background therapy for all patients with aspirin 100 mg once daily. The incidences of important bleeding events in the CAD and PAD populations in COMPASS were similar.

Table 6 shows the number of patients experiencing various types of major bleeding events in the COMPASS trial.

Table 6: Major Bleeding Events in COMPASS - On Treatment Plus 2 Days*

Parameter Modified ISTH Major Bleeding‡ - Fatal bleeding event Intracranial hemorrhage (ICH) Non-intracranial - Symptomatic bleeding in critical organ (non-fatal) - ICH (fatal and non-fatal) Hemorrhagic Stroke Other ICH - Bleeding into the surgical site requiring reoperation (non-fatal, not in critical organ) - Bleeding leading to hospitalization (non-fatal, not in critical organ, not requiring reoperation) Major GI bleeding

XARELTO† N=9134 n (%/year) 263 (1.6) 12 (<0.1) 6 (<0.1) 6 (<0.1) 58 (0.3) 23 (0.1) 18 (0.1) 6 (<0.1) 7 (<0.1)

Placebo† N=9107 n (%/year) 144 (0.9) 8 (<0.1) 3 (<0.1) 5 (<0.1) 43 (0.3) 21 (0.1) 13 (<0.1) 9 (<0.1) 6 (<0.1)

XARELTO vs.

Placebo HR (95 % CI) 1.8 (1.5, 2.3) 1.5 (0.6, 3.7) 2.0 (0.5, 8.0) 1.2 (0.4, 4.0) 1.4 (0.9, 2.0) 1.1 (0.6, 2.0) 1.4 (0.7, 2.8) 0.7 (0.2, 1.9) 1.2 (0.4, 3.5)

188 (1.1)

91 (0.5)

2.1 (1.6, 2.7)

117 (0.7)

49 (0.3)

2.4 (1.7, 3.4)

* Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment in the safety analysis set in COMPASS patients. † Treatment schedule: XARELTO 2.5 mg twice daily or placebo. All patients received background therapy with aspirin 100 mg once daily.

‡

Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD The incidence of premature permanent discontinuation due to bleeding events for XARELTO 2.5 mg twice daily vs. placebo on background therapy with aspirin 100 mg once daily in VOYAGER was 4.1% vs. 1.6% and in COMPASS PAD was 2.7% vs. 1.3%, respectively.

Table 7 shows the number of patients experiencing various types of TIMI (Thrombolysis in Myocardial Infarction) major bleeding events in the VOYAGER trial. The most common site of bleeding was gastrointestinal.

Table 7: Major Bleeding Events* in VOYAGER- On Treatment Plus 2 Days

Parameter TIMI Major Bleeding (CABG/non-CABG) Fatal bleeding Intracranial bleeding Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or drop in hematocrit of ≥15%

XARELTO† Placebo† N=3256 N=3248 n (%) Event rate n (%) Event rate %/year %/year 62 (1.9) 0.96 44 (1.4) 0.67 6 (0.2) 0.09 6 (0.2) 0.09 13 (0.4) 0.20 17 (0.5) 0.26 46 (1.4) 0.71 24 (0.7) 0.36

XARELTO vs.

Placebo HR (95 % CI) 1.4 (1.0, 2.1) 1.0 (0.3, 3.2) 0.8 (0.4, 1.6) 1.9 (1.2, 3.2)

* Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. † Treatment schedule: XARELTO 2.5 mg twice daily or placebo. All patients received background therapy with aspirin 100 mg once daily.

CABG: Coronary artery bypass graft; CI: confidence interval; HR: hazard ratio; TIMI: Thrombolysis in Myocardial Infarction Bleeding Criteria Other Adverse Reactions Non-hemorrhagic adverse reactions reported in ≥1% of XARELTO-treated patients in the EINSTEIN DVT and EINSTEIN PE studies are shown in Table 8.

Table 8: Other Adverse Reactions* Reported by ≥1% of XARELTO-Treated Patients in EINSTEIN DVT and EINSTEIN PE Studies Body System Adverse Reaction XARELTO 20 mg Enoxaparin/VKA EINSTEIN DVT Study N=1718 N=1711 n (%) n (%) Gastrointestinal disorders Abdominal pain 46 (2.7) 25 (1.5) General disorders and administration site conditions Fatigue 24 (1.4) 15 (0.9) Musculoskeletal and connective tissue disorders Back pain 50 (2.9) 31 (1.8) Muscle spasm 23 (1.3) 13 (0.8) Nervous system disorders Dizziness 38 (2.2) 22 (1.3) Psychiatric disorders Anxiety 24 (1.4) 11 (0.6) Depression 20 (1.2) 10 (0.6) Insomnia 28 (1.6) 18 (1.1) XARELTO 20 mg Enoxaparin/VKA EINSTEIN PE Study N=2412 N=2405 n (%) n (%) Skin and subcutaneous tissue disorders Pruritus 53 (2.2) 27 (1.1) * Adverse reaction with Relative Risk >1.5 for XARELTO versus comparator Non-hemorrhagic adverse reactions reported in ≥1% of XARELTO-treated patients in RECORD 1-3 studies are shown in Table 9.

Table 9: Other Adverse Drug Reactions* Reported by ≥1% of XARELTO-Treated Patients in RECORD 1-3 Studies XARELTO 10 mg Enoxaparin† Body System N=4524 N=4487 Adverse Reaction n (%) n (%) Injury, poisoning and procedural complications Wound secretion 125 (2.8) 89 (2.0) Musculoskeletal and connective tissue disorders Pain in extremity 74 (1.7) 55 (1.2) Muscle spasm 52 (1.2) 32 (0.7) Nervous system disorders Syncope 55 (1.2) 32 (0.7) Skin and subcutaneous tissue disorders Pruritus 96 (2.1) 79 (1.8) Blister 63 (1.4) 40 (0.9) * Adverse reaction occurring any time following the first dose of double-blind medication, which may have been prior to administration of active drug, until two days after the last dose of double-blind study medication † Includes the placebo-controlled period of RECORD 2, enoxaparin dosing was 40 mg once daily (RECORD 1-3)

XARELTO® (rivaroxaban)

XARELTO® (rivaroxaban)

Pediatric Patients Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients The safety assessment is based on data from the EINSTEIN Junior Phase 3 study in 491 patients from birth to less than 18 years of age. Patients were randomized 2:1 to receive body weight-adjusted doses of XARELTO or comparator (unfractionated heparin, low molecular weight heparin, fondaparinux or VKA).

Discontinuation due to bleeding events occurred in 6 (1.8%) patients in the XARELTO group and 3 (1.9%) patients in the comparator group.

Table 10 shows the number of patients experiencing bleeding events in the EINSTEIN Junior study.

In female patients who had experienced menarche, ages 12 to <18 years of age, menorrhagia occurred in 23 (27%) female patients in the XARELTO group and 5 (10%) female patients in the comparator group.

Table 10: Bleeding Events in EINSTEIN Junior Study – Safety Analysis Set - Main Treatment Period*

Postmarketing Experience The following adverse reactions have been identified during post-approval use of XARELTO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: agranulocytosis, thrombocytopenia Hepatobiliary disorders: jaundice, cholestasis, hepatitis (including hepatocellular injury) Immune system disorders: hypersensitivity, anaphylactic reaction, anaphylactic shock, angioedema Nervous system disorders: hemiparesis Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS)

XARELTO† N=329 n (%)

Parameter

Comparator Group‡ N=162 n (%)

0

2 (1.2)

10 (3.0)

1 (0.6)

Trivial bleeding

113 (34.3)

44 (27.2)

Any bleeding

119 (36.2)

45 (27.8)

Major bleeding§ Clinically relevant non-major bleeding¶

These events occurred after randomization until 3 months of treatment (1 month for patients <2 years with central venous catheter-related VTE (CVC-VTE). Patients may have more than one event. † Treatment schedule: body weight-adjusted doses of XARELTO; randomized 2:1 (XARELTO: Comparator). ‡ Unfractionated heparin (UFH), low molecular weight heparin (LMWH), fondaparinux or VKA. § Defined as clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome. ¶ Defined as clinically overt bleeding, which did not meet the criteria for major bleeding, but was associated with medical intervention, unscheduled contact with a physician, temporary cessation of treatment, discomfort for the patient, or impairment of activities of daily life.

Non-bleeding adverse reactions reported in ≥5% of XARELTO-treated patients are shown in Table 11. *

Table 11: Other Adverse Reactions* Reported in XARELTO-Treated Patients by ≥5% in EINSTEIN Junior Study XARELTO N=329 n (%)

Adverse Reaction

* †

Comparator Group N=162 n (%)

Pain in extremity

23 (7)

7 (4.3)

Fatigue†

23 (7)

7 (4.3)

Adverse reaction with Relative Risk >1.5 for XARELTO versus comparator.

The following terms were combined: fatigue, asthenia.

A clinically relevant adverse reaction in XARELTO-treated patients was vomiting (10.6% in the XARELTO group vs 8% in the comparator group).

Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease (CHD) after the Fontan Procedure The data below are based on Part B of the UNIVERSE study which was designed to evaluate the safety and efficacy of XARELTO for thromboprophylaxis in 98 children with CHD after the Fontan procedure who took at least one dose of study drug. Patients in Part B were randomized 2:1 to receive either body weightadjusted doses of XARELTO or aspirin (approximately 5 mg/kg).

Discontinuation due to bleeding events occurred in 1 (1.6%) patient in the XARELTO group and no patients in the aspirin group.

Table 12 shows the number of patients experiencing bleeding events in the UNIVERSE study.

Table 12: Bleeding Events in UNIVERSE Study - Safety Analysis Set - On Treatment Plus 2 Days XARELTO* N=64 n (%)

Parameter Major Bleeding† Epistaxis leading to transfusion

†

§

1 (1.6)

0

1 (1.6)

0

4 (6.3)

3 (8.8)

Trivial bleeding

21 (32.8)

12 (35.3)

Any bleeding

23 (35.9)

14 (41.2)

Clinically relevant non-major (CRNM) bleeding§

*

Aspirin* N=34 n (%)

Treatment schedule: body weight-adjusted doses of XARELTO or aspirin (approximately 5 mg/kg); randomized 2:1 (XARELTO: Aspirin).

Defined as clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, a transfusion of the equivalent of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome.

Defined as clinically overt bleeding, which did not meet the criteria for major bleeding, but was associated with medical intervention, unscheduled contact with a physician, temporary cessation of treatment, discomfort for the patient, or impairment of activities of daily life.

Non-bleeding adverse reactions reported in ≥5% of XARELTO-treated patients are shown in Table 13.

Table 13: Other Adverse Reactions* Reported by ≥5% of XARELTO-Treated Patients in UNIVERSE Study (Part B) XARELTO N=64 n (%)

Aspirin N=34 n (%)

Cough

10 (15.6)

3 (8.8)

Vomiting

9 (14.1)

3 (8.8)

Gastroenteritis†

8 (12.5)

1 (2.9)

Rash†

6 (9.4)

2 (5.9)

Adverse Reaction

* †

Adverse reaction with Relative Risk >1.5 for XARELTO versus aspirin.

The following terms were combined: Gastroenteritis: gastroenteritis, gastroenteritis viral Rash: rash, rash maculo-papular, viral rash

DRUG INTERACTIONS General Inhibition and Induction Properties Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters. Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events.

Drugs that Inhibit Cytochrome P450 3A Enzymes and Drug Transport Systems Interaction with Combined P-gp and Strong CYP3A Inhibitors Avoid concomitant administration of XARELTO with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir) [see Warnings and Precautions and Clinical Pharmacology (12.3) in Full Prescribing Information].

Although clarithromycin is a combined P-gp and strong CYP3A inhibitor, pharmacokinetic data suggests that no precautions are necessary with concomitant administration with XARELTO as the change in exposure is unlikely to affect the bleeding risk [see Clinical Pharmacology (12.3) in Full Prescribing Information].

Interaction with Combined P-gp and Moderate CYP3A Inhibitors in Patients with Renal Impairment XARELTO should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A inhibitors (e.g., erythromycin) unless the potential benefit justifies the potential risk [see Warnings and Precautions and Clinical Pharmacology (12.3) in Full Prescribing Information].

Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort) [see Warnings and Precautions and Clinical Pharmacology (12.3) in Full Prescribing Information].

Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology (12.3) in Full Prescribing Information].

Avoid concurrent use of XARELTO with other anticoagulants due to increased bleeding risk unless benefit outweighs risk. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs [see Warnings and Precautions].

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary The limited available data on XARELTO in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use XARELTO with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of XARELTO cannot be reliably monitored with standard laboratory testing. Consider the benefits and risks of XARELTO for the mother and possible risks to the fetus when prescribing XARELTO to a pregnant woman [see Warnings and Precautions].

Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications including pre-eclampsia. Maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption and early and late pregnancy loss.

Fetal/Neonatal Adverse Reactions Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate.

Labor or Delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery [see Warnings and Precautions]. The risk of bleeding should be balanced with the risk of thrombotic events when considering the use of XARELTO in this setting.

Data Human Data There are no adequate or well-controlled studies of XARELTO in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associated risk for major birth defects or miscarriage. In an in vitro placenta perfusion model, unbound rivaroxaban was rapidly transferred across the human placenta.

Animal Data Rivaroxaban crosses the placenta in animals. Rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis. This dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the highest recommended human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg during the period of organogenesis. This dose corresponds to about 14 times the human exposure of unbound drug. In rats, peripartal maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day).

Lactation Risk Summary Rivaroxaban has been detected in human milk. There are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production. Rivaroxaban and/or its metabolites were present in the milk of rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XARELTO and any potential adverse effects on the breastfed infant from XARELTO or from the underlying maternal condition (see Data).

XARELTO® (rivaroxaban)

XARELTO® (rivaroxaban)

Data Animal Data Following a single oral administration of 3 mg/kg of radioactive [14C]-rivaroxaban to lactating rats between Day 8 to 10 postpartum, the concentration of total radioactivity was determined in milk samples collected up to 32 hours post-dose. The estimated amount of radioactivity excreted with milk within 32 hours after administration was 2.1% of the maternal dose.

Reduction of Risk of Major Cardiovascular Events in Patients with CAD and Reduction of Risk of Major Thrombotic Vascular Events in Patients with PAD, Including Patients After Recent Lower Extremity Revascularization due to Symptomatic PAD Patients with Chronic Kidney Disease not on Dialysis Patients with a CrCl <15 mL/min at screening were excluded from COMPASS and VOYAGER, and limited data are available for patients with a CrCl of 15 to 30 mL/min. In patients with CrCl <30 mL/min, a dose of 2.5 mg XARELTO twice daily is expected to give an exposure similar to that in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Clinical Pharmacology (12.3) in Full Prescribing Information], whose efficacy and safety outcomes were similar to those with preserved renal function.

Females and Males of Reproductive Potential Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician.

The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including XARELTO should be assessed in females of reproductive potential and those with abnormal uterine bleeding.

Pediatric Use The safety and effectiveness of XARELTO have been established in pediatric patients from birth to less than 18 years for the treatment of VTE and the reduction in risk of recurrent VTE. Use of XARELTO is supported in these age groups by evidence from adequate and well-controlled studies of XARELTO in adults with additional pharmacokinetic, safety and efficacy data from a multicenter, prospective, openlabel, active-controlled randomized study in 500 pediatric patients from birth to less than 18 years of age.

XARELTO was not studied and therefore dosing cannot be reliably determined or recommended in children less than 6 months who were less than 37 weeks of gestation at birth; had less than 10 days of oral feeding, or had a body weight of less than 2.6 kg [see Dosage and Administration (2.2) in Full Prescribing Information, Adverse Reactions, Clinical Pharmacology (12.3) and Clinical Studies (14.8) in Full Prescribing Information].

The safety and effectiveness of XARELTO have been established for use in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure. Use of XARELTO is supported in these age groups by evidence from adequate and well-controlled studies of XARELTO in adults with additional data from a multicenter, prospective, open-label, active controlled study in 112 pediatric patients to evaluate the single- and multiple-dose pharmacokinetic properties of XARELTO and the safety and efficacy of XARELTO when used for thromboprophylaxis for 12 months in children with single ventricle physiology who had the Fontan procedure [see Dosage and Administration (2.2) in Full Prescribing Information, Adverse Reactions, Clinical Pharmacology (12.3) and Clinical Studies (14.9) in Full Prescribing Information].

Clinical studies that evaluated safety, efficacy, pharmacokinetic and pharmacodynamic data support the use of XARELTO 10 mg, 15 mg, and 20 mg tablets in pediatric patients. For the XARELTO 2.5 mg tablets, there are no safety, efficacy, pharmacokinetic and pharmacodynamic data to support the use in pediatric patients. Therefore, XARELTO 2.5 mg tablets are not recommended for use in pediatric patients.

Although not all adverse reactions identified in the adult population have been observed in clinical trials of children and adolescent patients, the same warnings and precautions for adults should be considered for children and adolescents.

Geriatric Use Of the total number of adult patients in clinical trials for the approved indications of XARELTO (N=64,943 patients), 64 percent were 65 years and over, with 27 percent 75 years and over. In clinical trials the efficacy of XARELTO in the elderly (65 years or older) was similar to that seen in patients younger than 65 years. Both thrombotic and bleeding event rates were higher in these older patients [see Clinical Pharmacology (12.3) and Clinical Studies (14) in Full Prescribing Information].

Renal Impairment In pharmacokinetic studies, compared to healthy adult subjects with normal creatinine clearance, rivaroxaban exposure increased by approximately 44 to 64% in adult subjects with renal impairment.

Increases in pharmacodynamic effects were also observed [see Clinical Pharmacology (12.3) in Full Prescribing Information].

Nonvalvular Atrial Fibrillation Patients with Chronic Kidney Disease not on Dialysis In the ROCKET AF trial, patients with CrCl 30 to 50 mL/min were administered XARELTO 15 mg once daily resulting in serum concentrations of rivaroxaban and clinical outcomes similar to those in patients with better renal function administered XARELTO 20 mg once daily. Patients with CrCl <30 mL/min were not studied, but administration of XARELTO 15 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment [see Clinical Pharmacology (12.3) in Full Prescribing Information].

Patients with End-Stage Renal Disease on Dialysis Clinical efficacy and safety studies with XARELTO did not enroll patients with end-stage renal disease (ESRD) on dialysis. In patients with ESRD maintained on intermittent hemodialysis, administration of XARELTO 15 mg once daily will result in concentrations of rivaroxaban and pharmacodynamic activity similar to those observed in the ROCKET AF study [see Clinical Pharmacology (12.2, 12.3) in Full Prescribing Information]. It is not known whether these concentrations will lead to similar stroke reduction and bleeding risk in patients with ESRD on dialysis as was seen in ROCKET AF. Treatment of DVT and/or PE and Reduction in the Risk of Recurrence of DVT and/or PE In the EINSTEIN trials, patients with CrCl values <30 mL/min at screening were excluded from the studies, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 15 to <30 mL/min. Avoid the use of XARELTO in patients with CrCl <15 mL/min.

Prophylaxis of DVT Following Hip or Knee Replacement Surgery The combined analysis of the RECORD 1-3 clinical efficacy studies did not show an increase in bleeding risk for patients with CrCl 30 to 50 mL/min and reported a possible increase in total venous thromboemboli in this population. In the RECORD 1-3 trials, patients with CrCl values <30 mL/min at screening were excluded from the studies, but administration of XARELTO 10 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 15 to <30 mL/min. Avoid the use of XARELTO in patients with CrCl <15 mL/min.

Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding Patients with CrCl values <30 mL/min at screening were excluded from the MAGELLAN study. In patients with CrCl <30 mL/min a dose of XARELTO 10 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Observe closely and promptly evaluate any signs or symptoms of blood loss in patients with CrCl 15 to <30 mL/min. Avoid use of XARELTO in patients with CrCl <15 mL/min.

Patients with End-Stage Renal Disease on Dialysis No clinical outcome data is available for the use of XARELTO with aspirin in patients with ESRD on dialysis since these patients were not enrolled in COMPASS or VOYAGER. In patients with ESRD maintained on intermittent hemodialysis, administration of XARELTO 2.5 mg twice daily will result in concentrations of rivaroxaban and pharmacodynamic activity similar to those observed in moderate renal impaired patients in the COMPASS study [see Clinical Pharmacology (12.2, 12.3) in Full Prescribing Information]. It is not known whether these concentrations will lead to similar CV risk reduction and bleeding risk in patients with ESRD on dialysis as was seen in COMPASS. Pediatric Use No dosage adjustment is required in patients 1 year of age or older with mild renal impairment (eGFR 50 to ≤ 80 mL/min/1.73 m2). There are limited clinical data in pediatric patients 1 year or older with moderate or severe renal impairment (eGFR <50 mL/min/1.73 m2); therefore, avoid the use of XARELTO in these patients.

There are no clinical data in pediatric patients younger than 1 year with serum creatinine results above 97.5th percentile; therefore, avoid the use of XARELTO in these patients [see Dosage and Administration (2.2) in Full Prescribing Information].

Hepatic Impairment In a pharmacokinetic study, compared to healthy adult subjects with normal liver function, AUC increases of 127% were observed in adult subjects with moderate hepatic impairment (Child-Pugh B).

The safety or PK of XARELTO in patients with severe hepatic impairment (Child-Pugh C) has not been evaluated [see Clinical Pharmacology (12.3) in Full Prescribing Information].

Avoid the use of XARELTO in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy.

No clinical data are available in pediatric patients with hepatic impairment.

OVERDOSAGE Overdose of XARELTO may lead to hemorrhage. Discontinue XARELTO and initiate appropriate therapy if bleeding complications associated with overdosage occur. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. The use of activated charcoal to reduce absorption in case of XARELTO overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not dialyzable [see Warnings and Precautions and Clinical Pharmacology (12.3) in Full Prescribing Information]. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products. An agent to reverse the anti-factor Xa activity of rivaroxaban is available.

Active Ingredient Made in Germany Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Licensed from: Bayer HealthCare AG 51368 Leverkusen, Germany © 2011-2021 Janssen Pharmaceutical Companies cp-62545v11

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VAM THROUGH THE LENS »

Vascular Specialist | July/August 2022

www.vascularspecialistonline.com

Between the latest research and education, Presidential Address, keynote speeches, lectures, honors and—of course—camaraderie and fun, the four days of the 2022 Vascular Annual Meeting (VAM) in Boston flew by.

This VAM gallery captures some of the highlights.

“People were really excited to gather together and hear about the latest science and innovation in the field” ANDRES SCHANZER

VAM presented opportunities for old friends to visit while they also could learn the latest in vascular disease prevention and treatment. On page 20, Enrico Asher (left) and Peter Lawrence catch up; in the center and at the bottom, Jonathan Bath and Rana Afifi make a point. At left, outgoing JVS Editor-in-Chief Peter Gloviczki honors Christopher Audu with an award. On page 21, clockwise from top left, Program Committee Chair Andres Schanzer, speaks to the crowd.

Immediate Past President Ali AbuRahma (left) passes the gavel—and the SVS reins—to President Michael C. Dalsing. Avianne Bunnell (left) and Bernadette Aulivola pause during the Women’s Leadership Dinner. Panelists answer questions from the audience during a session dedicated to office-based labs. Society for Vascular Nursing (SVN) President-elect Kristin Alix (left) and Board Director Karen Hanrahan kick off the SVN 40th Annual Conference with the keynote address, and Samantha Minc takes to the podium during the Crawford Forum Photography by Martin Allred/ Nationwide Photographers

21

22

Vascular Specialist | July/August 2022

AWARDS

SVS, journals present annual list of gongs The Society for Vascular Surgery (SVS) and the Journal of Vascular Surgery (JVS) group presented a slew of awards and honors at the SVS Annual Business Meeting during VAM 2022. JVS publications include flagship title JVS itself, JVS: Venous and Lymphatic Disorders (JVS-VL); JVS: Cases, Innovations and Techniques (JVS-CIT); and JVS-Vascular Science (JVS-VS).

JVS CERTIFICATE OF RECOGNITION TO EDITORIAL LEADERSHIP

Ruth Bush, MD, JVS-VL editor and nonJVS-VL reviews; Keith Calligaro, MD, JVS editor and non-JVS reviews; Alan Dardik, MD, JVS-VS editor; Audra Duncan, MD, JVS reviews; Cynthia Shortell, MD, JVSVL reviews, clinical research; Bernardo Mendes, MD, JVS, JVS-VL, JVS-CIT, vascular image, videos; Gregory Moneta, MD, JVS-VL, clinical research

JVS INTERNS

Christopher Audu, MD, University of Michigan; Anand Brahmandam, MBBS, Yale University; Elizabeth Chou, MD, Massachusetts General Hospital; Shernaz Dossabhoy, MD, Stanford University; Laura Marie Drudi, MD, University of Montreal; Jessica Mayor, MD, Baylor College of Medicine; Akiko Tanaka, MD, University of Texas Health Science Center at Houston

JVS-VS, 2021 MOST VIEWED ARTICLE AWARD

Luca Saba, MD, and coauthors, University of Cagliari (Italy); “Review of imaging biomarkers for the vulnerable carotid plaque”

JVS-CIT, MOST VIEWED ARTICLE AWARD

Joshua I. Ng, BSE, and coauthors, Thomas Jefferson University Hospital, Philadelphia; “Giant abdominal aortic aneurysms”

JVS-VL, 2021 MOST HIGHLY CITED ARTICLE AWARD

Fedor Lurie, MD, and coauthors, Jobst Vascular Institute, Toledo, Ohio; “The 2020 update of the CEAP [Clinical, Etiological,

Anatomical, and Pathophysiological] classification system and reporting standards”

JVS, 2021 MOST HIGHLY CITED ARTICLE AWARD

Michael S. Conte, MD, and coauthors, University of California, San Francisco; “Global vascular guidelines on the management of CLTI”

JVS-VS, 2021 BEST NEW REVIEWER AWARD: Christopher Audu, MD, University of Michigan

JVS-VL, 2021 BEST NEW REVIEWER AWARD: Naiem Nassiri, MD, Yale University

JVS, 2021 BEST NEW REVIEWER AWARD Bernadette Aulivola, MD, Loyola University Medical Center, Maywood, Illinois

JVS-VS, 2021 BEST REVIEWER AWARD

Haidi Hu, MD, the First Hospital of China Medical University

JVS-VL, 2021 BEST REVIEWER AWARD

WINNERS OF INTERNATIONAL CONTESTS NAMED Across the VAM program, a number of competitions took place, including within the international program.

International Poster Contest

First place: Paula Pinto Rodríguez, medical student from Bogota, Colombia (additional author: Oscar Moreno Rocha, MD); “Chronic venous disease progressionassociated biomarkers” Second place: Gloria Kim, MD, vascular resident in Michigan; “Defining physical resilience among patients with vascular disease— flipping risk evaluation to an ‘opt-in’ perspective” Third place: Sujin Lee, MD, vascular resident, Boston; “Clinical utility of peripheral calcium scoring in evaluating peripheral arterial disease severity”

contributions to the SVS over a 20-year career •R uth Bush, MD, as outgoing chair of the Document Oversight Committee •V enita Chandra, MD, outgoing chair of what originally was the Young Surgeons Committee and for forming the Young Surgeons Section •P eter Henke, MD, outgoing chair of the Publications Committee Amy Reed, •D an McDevitt, MD, outgoing recipient of a chair of the Community Practice Presidential Section Citation •A my Reed, MD, inaugural and outgoing chair of the Communications Committee and secretary of SVS •W illiam Shutze, MD, outgoing chair of the Clinical Practice Council

International Fast Talk

First place: Charles DeCarlo, MD, vascular resident, Boston; “Outcomes of acute aortic syndrome due to penetrating aortic ulcer and intramural hematoma in the endovascular era” Second place: Emiliano Chisci, MD, surgeon, Florence, Italy; “The open repair of an infrarenal aortic aneurysm is superior to endovascular repair even in case of sac shrinkage at 15-year follow-up”

International Young Surgeons Competition

Dasha Savage, medical student, Stanford University School of Medicine, California; “Using a supervised learning algorithm to predict postoperative treatment failure in patients with cardiovascular disease via passive monitoring”

Lois A. Killewich, MD, University of Texas Health Science, San Antonio

SVS, SVS FOUNDATION PRESENT AWARDS DURING VAM

JVS, 2021 BEST REVIEWER AWARD

At the Annual Business Meeting, individuals received awards and recognition from both the SVS and SVS Foundation.

Lewis B. Schwartz, MD, Advocate Lutheran General Hospital, Park Ridge, Illinois

JVS EDITOR OF THE YEAR AWARD

Presidential Citations

Excellence in Community Practice Award

For sustained contributions to their patients and community, as well as exemplary professional practice and leadership.

•D aniel McDevitt, MD •R obert Molnar, MD •A rthur Palamara, MD The Society for Vascular Surgery also welcomed its newest members designated as Distinguished Fellows: Kwame Amankwah, MD, Donald Baril, MD, Luke Brewster, MD, Manuel Doblas, MD, Nasim Hedayati, MD, Kakra Hughes, MD, Peter Rossi, MD, Jessica Simons, MD, and Margaret Tracci, MD. The Midwestern Vascular Surgery Society received the SVS PAC Regional Society Award, which recognizes the highest percentage of a regional society membership contributing to the SVS Political Action Committee.

Mentored Patient-Oriented Research Career Development Award (K-23) Award

Samantha Minc, MD, West Virginia University School of Medicine, Morgantown, West Virginia,

Clinical Research Seed Grant

James Iannuzzi, MD, University of California, San Francisco

Fred Weaver, MD, University of Southern California, Los Angeles

Immediate Past President Ali AbuRahma, MD, presented several people with Presidential Citations for meritorious service.

• Patricia Burton, for substantial

Resident Research Award

The finalists—victorious after the initial round of 120 posters—presented and discussed their work in a rapid-paced session.

The winners and their posters were, in first place ($1,500), Ben Li (PC214), of the University of Toronto, with “Urinary fatty acid biding protein 3 has diagnostic and prognostic value in peripheral artery disease”; in second place ($1,000), Allen Li

(PC008), from the University of Ottawa, with “Development of an artificial intelligence tool for intraoperative guidance during endovascular aneurysm repair”; and, in third place ($500), Kirsten Dansey (PC140), of Beth Israel Deaconess Medical Center in Boston, who presented “Two-dimensional versus three-dimensional registration for image-fusion technology.”

SVS President Michael Dalsing, MD, and SVS Program Committee Chair Andres Schanzer, MD, led questions and discussions following presentations by the finalists. Matthew Corriere, MD, moderated.

Attendees used Audience Response System devices to score each presentation. All 10 finalists received $300 for reaching the final round.—Beth Bales

Christopher Audu, MD, University of Michigan Medical Center (mentor, Katherine Gallagher, MD)

GRASSROOTS

POSTER CONTEST WINNERS ANNOUNCED AND THEN THERE WERE THREE: With audience members scoring the presentations, three winners were selected from among 10 finalists in the final round of the VAM 2022 Poster Competition.

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IN.PACT AV DCB IN.PACT AV DCB

43.1% 43.1% Standard PTA Standard PTA

Log-rank p < 0.001 at Log-rank p <and 0.001 at 6, 7, 12, 24, 36 months 6, 7, 12, 24, and 36 months 0 0

1 1

3 3

6 6

7 7

9 9

12 12

18 18

Months Months

24 24

28.6% 28.6% 30 30

36 36

30 30

36 36

Lutonix DCB Lutonix DCB

26.9% 26.9% Standard PTA Standard PTA

Log-rank p = 0.087 Log-rank p = 0.087 0 0

1 1

3 3

6 6

7 7

9 9

12 12

24.4% 24.4%

18 18

24 24

Months Months Third-party brands are trademarks of their respective owners. † Primary patency endpoints are defined differently; results are from different studies and may vary in a head-to-head comparison; charts are for illustration purposes only. ‡ IN.PACT AV Access Trial: Target Lesion Primary Patency Rate was defined as freedom from clinically driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 36 months (1,080 days) post-procedure. § Lutonix AV Clinical Trial: Target Lesion Primary Patency was defined as freedom from clinically driven reintervention of the target lesion or access thrombosis measured through 24 months. *

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GALA

75 SVS FOUNDATION’S 2022 PARTY DECLARED A SMASH HIT 14.5 14.5

Guests who% couldn’t stop dancing vs. PTA at% prompted organizers to keep the festivities vs.months PTA at 36 36 months going, with music extended until midnight, at the Society for Vascular Surgery (SVS) Foundation’s “Cheers to 75 Years” Gala, writes Beth Bales.

T

he Gala was June 17, during the 2022 Vascular Annual Meeting (VAM) in Boston. The sold-out event generated more than $200,000 for the SVS Foundation and marked the culmination of the year-long celebration of the founding of the SVS. The amount raised was twice what organizers thought would be the stretch goal.

“I could not be happier with the way it turned out,” said a beaming Ronald L. Dalman, MD, chair of the 2022 Gala Committee and SVS president from 2020–2021.

This year’s success % would not have been possible without %of the 2019 crew, led by Cynthia Shortell, the incredible work vs. PTA at MD, and Benjamin vs.

PTA at 24 monthsW. Starnes, MD, he emphasized.

“They the way for this year and gave us a huge run24 paved months ning start. We got a sense of what worked and what didn’t, and we could laser in on our goal.”

The 2019 Gala established an expectation and helped prompt people to be generous in not only purchasing tickets but also contributing to the auctions, Dalman said.

And noting that the 2020 annual meeting was canceled and COVID-19 concerns nixed the gala in 2021, “We also had two additional years of pent-up demand,” he added.

Then-SVS President Michel Makaroun, MD, provided the inspiration in 2019, wanting a dinner-dance that would bring vascular professionals together to celebrate the specialty and each other.

Under the co-leadership of Shortell and Starnes, the 2019 Gala sold out in weeks and—as was the case this year—had attendees dancing until the DJ turned off the tunes.

Hits with the crowd included the video of a patient whose life has been changed via treatment by two SVS vascular surgeons able to increase care thanks to two SVS Founda-

2.5 2.5

tion programs. “People loved seeing how two Foundation programs worked together to benefit a patient,” said Dalman.

The 360-degree live photo booth and caricature artists in operation during the reception also proved a hit, as did popular entertainment, the SVS’ own Acoustic Shadows group, performing separately but together from around the country in a pre-recorded video. The talented musicians were Katherine Bowser, MD, Pat Geraghty, MD, Steve Henao, MD, and David Rigberg, MD. “I think there will be serious consideration of an in-person performance for next year,” said Dalman.

Some auction highlights included the top donated item for the live auction—a stay in Peter and Karen Lawrence’s home in the Hamptons in New York—which fetched $8,000.

This is the first time the Lawrences have ever allowed this use of their home, said Dalman.

“People loved seeing how two Foundation programs worked together to benefit a patient” RONALD L. DALMAN

Gala revellers partake in the SVS Foundation festivities, including auctions, during VAM 2022 in Boston

Top consignment items for the live auction involved two trips to South Africa ($26,000); for the silent auction, donation of sessions with 14 SVS members and staff, $4,200.

The gala is of great importance not only to the SVS Foundation, which benefits from the proceeds generated, but also the Society itself, Dalman said.

The event celebrates, as Makaroun intended, the entire specialty and all SVS members, while it supports the mission and work of the SVS Foundation, said Dalman.

“It allows everyone to participate and support the Foundation, all at the same time.”

Venita Chandra, MD, and an as-yet unnamed colleague will co-chair the 2023 Gala. As for Dalman, “I’m looking forward to next year!”

Read more about the Foundation, its mission and activities at vascular.org/ SVSfoundation.

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Vascular Specialist | July/August 2022

VASCULAR PRACTICE

Integrity, innovation and leadership mark out 2022 SVS community practice awardee recipients

By Beth Bales

O

ne has been described as a “man of honesty and integrity.”

Another introduced endovascular aneurysm repair (EVAR) and endovascular surgery to the south side of Atlanta.

And “a true leader in vascular surgery” and “the real deal” were comments used to characterize the third surgeon, all of whom were recipients of the 2022 Society for Vascular Surgery (SVS) Excellence in Community Practice Award at VAM 2022 in June. They are Daniel McDevitt, MD, Robert Molnar, MD, and Arthur Palamara, MD. For more than 20 years, Daniel McDevitt has practiced in a challenging area where a high proportion of patients have cardiovascular disease. He deliberately chose to locate in this area “to make a difference and help the community,” said one of his colleagues.

His accomplishments include bringing endovascular techniques to the area, plus developing an outpatient interventional lab for his practice, with the inclusion of interventional radiologists; it is the only multispecialty outpatient lab in the Atlanta region. He was a charter member of the Outpatient Endovascular and lnterventional Society.

McDevitt worked to revive the Atlanta Vascular Surgical Society and later to merge the membership as a chapter of the new Georgia Vascular Society, and participates in location and regional vascular activities. A colleague reports that not only does McDevitt advocate for quality of care, but he also has led efforts to understand and react to government regulations that impact vascular surgery.

McDevitt has served as chief of surgery, chair of the medical staff and secretary of the Board of Directors at Southern Regional Medical Center. He was medical director of the SRMC Cardio-Vascular Services for six years and medical director of the SRMC Vascular Lab for 16 years.

McDevitt also attends medical fairs to provide free services to those who cannot afford care and assures that no matter the circumstances, patients receive the best care possible no matter the circumstances. “His fellow physicians consider him one of the leaders of the medical community, and many turn to him for the care of family members as well as their patients,” said a colleague.

He is a past president of the Georgia Vascular Society, dedicated to the mentoring and education of young vascular surgeons. Outside the medical arena, he also is active in the arts.

“The body of his work over the past 25 years of continuous practice in this community represents a high bar of service and achievement deserving of recognition,” a colleague said.

McDevitt credited past presidents, particularly Immediate Past President Ali AbuRahma, MD, plus SVS Executive

Director Kenneth Slaw, PhD, in accepting Two of the awardees, the award. “They have been a great inspi- Daniel ration,” he said.

McDevitt Meanwhile, Robert Molnar and his (middle left) and Robert career “exemplify the highest standards Molnar (middle and quality the award stands for,” said right), receive awards at a colleague. Molnar joined the Michigan their VAM 2022 Vascular Center in July 1998 and immediately impacted patient treatment options. He helped lead the transition from open surgical techniques to interventional treatments then transforming the vascular field.

Quality and compassionate patient care has long been a calling card for him, as has been vascular education and training. Under his leadership the Michigan Vascular Center was granted a two-year fellowship for two vascular fellows a year. This was “a significant accomplishment for a private practice group,” said a colleague. All its graduating fellows thus far have passed their Board exams. Molnar was instrumental in founding the Michigan Vascular Research

“Despite being predominantly in solo practice, [Arthur Palamara] has also devoted himself to patient care outside of the realm of vascular surgery” Center and participated in multiple clinical trials, including more than 75 industry-based trials. “In addition to leading his group into the future of vascular interventional care, he [saw the] importance of creating and managing the Michigan Vascular Center’s outpatient diagnostic and interventional laboratories. He is currently working with the SVS to create certification guidelines for such sites throughout the country,” as part of the SVS-American College of Surgeons Vascular Center Verification and Quality Improvement Program, a colleague said.

Molnar performed one of the first endovascular abdominal aortic aneurysm (AAA) implants using the Ancure/EVT (in 1988), and participated in the initial Medtronic and Endologix AAA stent trials. In 2001, he traveled to Italy to learn carotid stenting from Fausto Castriota, MD, and Alberto Cremonese, MD, at the time Europe’s premier stenting team.

Molnar was part of the team performing the first

carotid stent implant in Michigan in 2002. “He was a visionary,” said a colleague.

Elsewhere, Molnar was involved in his group’s efforts to establish the first practice-owned office-based laboratory (OBL) in Michigan, with a second center added eight years later. He has been an advocate for this outpatient practice model and helped many others in their OBL efforts. In fact, in the early years after establishing the OBL, surgeons from around the country visited the center to help establish similar facilities in their practice locations.

The Michigan Vascular Center was the first OBL accredited by the SVS Task Force on Vascular Verification in 2022.

Molnar’s expertise was recognized by his appointment to an OBL subcommittee in 2017, as well as being named chair of the SVS Section on Outpatient and Office Vascular Care (SOOVC). He currently serves on the SVS Executive Board, SVS Payment Reform Task Force, the Vascular Quality Initiative (VQI) Patient Safety Organization (PSO), and is the chair of the SVS Clinical Practice Section.

Molnar is currently the chairman of the Department of Surgery at McLaren-Flint, a large tertiary care medical center in mid-Michigan, as well as its director of surgical education.

He has served as a longtime associate program director for the Sparrow/Michigan State University-sponsored general surgery residency, and in 2013 helped his group establish one of the first Accreditation Council for Graduate Medical Education (ACGME)-­accredited private practice-based vascular fellowships in the country. He is also a clinical professor of surgery at Michigan State University.

“This isn’t really an individual award,” Molnar said. “I have to recognize my group and the culture that was established by its founding members.”

And, finally, with more than 50 years of experience, Arthur Palamara was described by a calleague as having “excelled in numerous leadership positions within his hospital and has received multiple awards of recognition.” These include: president of the Broward County Medical Society, the South Florida Society for Vascular Surgery and the Florida Vascular Society; vice president of the Florida Medical Association; Florida delegate to the American Medical Association; member of the NAACP since 1994; chair of the United Way Campaign-Health Care Professional Committee; member of the board of directors of the Broward Project for the Homeless; and member of the American Committee for the Shaare Zedek Medical Center-Jerusalem Israel, in addition to other honors.

Palamara “has been one of the primary vascular surgeons on Florida’s east coast,” said a colleague. “Even now, after so many years in practice, he tirelessly continues to provide excellent surgical care to his community. Despite being predominantly in solo practice, he has also devoted himself to patient care outside of the realm of vascular surgery. He has been a major player in the Florida Medical Association and in local and state politics specifically with the view to improving the health of all patients in our state.”

Palamara has been involved in legislative issues that affect patient health and particularly engaged in patient safety, handgun reform and elderly care, serving on medical and government committees to further these goals. As a researcher, he has presented his clinical research in peer-reviewed vascular journals and Florida Vascular Society sessions. Palamara has also been a voluntary associate professor of surgery at the University of Miami since 1998. He has constantly set the bar at the highest level, said a colleague. Remarked another, “Dr. Palamara is extraordinarily well-respected by his peers, yet he remains a humble servant to his patients and community.”

The “is the highest recognition I have ever received,” said Palamara, who could not attend VAM due to his attendance at an AmerArthur ican Medical Association (AMA) Palamara House of Delegates meeting.

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FISTULA CREATION

INTRAOPERATIVE VASCULAR MAPPING DURING HEMODIALYSIS ACCESS ‘SHOULD BE INCORPORATED INTO ROUTINE PRACTICE’

Intraoperative ultrasonographic venous mapping is a useful tool to evaluate vessel suitability for arteriovenous fistula (AVF) creation, Yana Etkin, MD, associate professor of surgery at the Zucker School of Medicine at Hofstra/Northwell in Lake Success, New York, concluded at the 2022 Vascular Annual Meeting (VAM) in Boston (June 15–18). According to the presenter, the technique may increase the rate of distal fistula creation and lower that of graft replacement, and therefore “should be incorporated into routine clinical practice,” reports Jocelyn Hudson.

ETKIN AND COLLEAGUES NOTE IN the abstract of their study that there is currently no consensus on how best to evaluate the suitability of vessels for AVF creation.

They write that use of preoperative sonographic vascular mapping performed by a vascular imaging facility is common, despite a lack of evidence on AVF outcomes. Their goal was to evaluate the utility of intraoperative vascular mapping performed by the operating surgeon during access creation.

The research team performed a retrospective study of 239 AVFs that were

created at their center between 2019 and 2021, Etkin informed the VAM audience.

The team only included patients who had intraoperative and preoperative vein measurements recorded. The presenter detailed that the operating surgeon performed intraoperative measurements and that the certified vascular lab carried out preoperative measurements.

Etkin noted that site selection for fistula creation was based on a distal-to-proximal and superficial vein-first approach. This meant that the team considered radioce-

phalic fistulas first followed by based on intraoperative mapping, brachiocephalic and then bramaturation rates were similar, at chiobasilic fistulas, the presenter 84% as compared to 88% in the rest explained. Veins with a diameter of the cohort. of at least 2mm on intraoperative Etkin noted that there were mapping were used for fistula creseveral limitations to the study, Yana Etkin ation. noting the small number of The investigators compared intraopera- patients included. tive measurements of the veins used for fisIn discussion that followed Etkin’s pretula creation to preoperative measurements sentation, one audience member expressed of the veins in the same anatomic location, their “surprise” that type of anesthesia did the presenter explained. She added that not appear to affect AVF creation in the the researchers reviewed the preoperative study. “This is something we are looking mapping and analyzed which hemodialysis at,” replied Etkin. “It might be sedation.” access would have been created if intraop- However, she stressed that the team needs erative mapping was not performed. to collect data from more patients in order The presenter reported at VAM that, on to carry out such an analysis. Another VAM average, intraoperative vein measurements delegate asked whether preoperative vein were about 1mm larger than preoperative mapping might correlate better if it is pervein diameters (3.6mm vs. 2.5mm), and that formed well after the time of dialysis, stressthis was consistent in all anatomic sites, in- ing that the patients could be dehydrated cluding forearm cephalic vein, upper arm when they come in for mapping. “That is cephalic vein and basilic vein. The team also the question that is almost impossible to anfound that anesthesia type did not signifi- swer,” the presenter replied. “We always opcantly affect intraoperative measurements. erate the day after dialysis, but preoperative In patients who had regional anesthesia, mapping might have been done on the day the mean intraoperative vein diameter was of dialysis, when the patient is dehydrated.” about 3.6mm, compared to 3.4mm in paThere was widespread agreement with tients who had local anesthesia.

Etkin’s conclusions among the VAM auWhen looking at preoperative mapping dience, with one delegate likening the alone, Etkin revealed that 71% of patients research to a consensus statement. This would have the same access created. Ten prompted the presenter to question why percent of patients would require a more the guidelines do not yet endorse the intraproximal fistula created utilizing superficial operative mapping as a standard of care. veins, 13% would have fistulas created using “That is why we wanted to put these data deep veins, and 6% would require a graft, out there, to see if there is interest in addthe presenter added. In this subset of 70 ing the recommendation of intraoperative patients who had a different access created mapping into national guidelines.”

The Society for Vascular Surgery Foundation (SVSF), a champion of vascular research and disease prevention led by national experts in vascular care, is challenging you to join in the movement to get moving!

The STEPtember Vascular Health Challenge is a virtual walking fundraiser set for all September. Sign up to get started, and invite your colleagues, friends and family to join your team. Participants’ goal is to walk 60 miles in September (PAD Awareness Month!) to represent the 60,000 miles of blood vessels in the human body.

Registration Now Open!

Vascular.org/STEPtember

Each participant will receive a T-shirt, fundraising webpage to highlight practice community, and personal testimony. The top walkers and fundraisers will receive prizes.

Game on!

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It was a great use of my time. Intensive learning!

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DISPARITIES Female sex is associated with reintervention and mortality following elective EVAR, new research finds

By Jocelyn Hudson WOMEN ARE MORE LIKELY TO DIE within five years of having elective surgery to repair an abdominal aortic aneurysm (AAA) or need repeat surgery, according to a recent study.

Writing in the Journal of Vascular Surgery, Taylor Corsi, BS, a medical student at Rutgers University, Piscataway, New Jersey, and colleagues said the disparity between men and women who undergo the surgery needs to be addressed by including women in early aortic aneurysm screening, as well as incorporating more women in clinical trials of aortic medical devices.

The data were originally presented at the 2021 annual meeting of the Eastern Vascular Society (EVS) in Charleston, South Carolina. An update was delivered at the 2022 Society for Clinical Vascular Surgery (SCVS) Annual Symposium held

in Las Vegas in March. “Despite as a higher rate of reintervention the fact that men are more likely to within those years. be diagnosed with and to die from “Our question was, knowing AAA, women are still under-repreall these things that we do, do sented in many clinical trials for the men and women have different aortic devices used in minimally outcomes—even though they are Taylor Corsi invasive aortic aneurysm repair,” being operated on by the same said William Beckerman, MD, a surgeon, at the same hospital with vascular surgeon at Robert Wood Johnson the same devices?” Beckerman said. “The University Hospital, New Brunswick, New answer to that was ‘yes.’ Men and women Jersey, who led the study. do differently after surgery. Our data “As men and women are known to have suggest factors beyond patient age and different aortic anatomy, this study highbaseline health risk likely contribute to lights the need for an increased focus on, greater surgical morbidity and mortality and inclusion of, women in aortic device for females following elective EVAR.” creation and subsequent trial enrollment.”

Researchers conducted a retrospective chart review of 273 patients—75% of them male and 25% female—who underwent endovascular aneurysm repair (EVAR) from 2011 to 2020 at a tertiary medical centre. The idea was to learn how many patients survived five years beyond the surgery and how many needed reintervention. The females were older, and were more likely to have chronic obstructive pulmonary disease, require home oxygen therapy or dialysis.

Despite some variations in morbidities, the differences in survival and reintervention were statistically significant, the reWILLIAM BECKERMAN searchers found. Females had significantly lower survival rates at five years as well

PAD

FEMALE SEX IS ASSOCIATED WITH ADDITIONAL TREATMENTS FOLLOWING SURGERY FOR INTERMITTENT CLAUDICATION, STUDY SHOWS

A

new U.S. study has found that female sex is associated with more reinterventions after surgical treatment for intermittent claudication. Additionally, guideline-directed medical therapy, including aspirin and statin use, was used less frequently among female compared with male patients in both the preoperative and postoperative settings.

“Based on these findings, we recommend that vascular interventionists treating female patients with intermittent claudication increase their efforts to maximize medical therapy and discuss with their patients the differences in intervention durability based on patient sex,” explained first author Scott R. Levin, MD, a general surgery resident from Boston University School of Medicine and Boston Medical Center.

The researchers conducted a retrospective analysis of patients undergoing vascular interventions for intermittent claudication in more than 800 academic and non-academic centers in North America from 2010–20.

Among the 64,752 peripheral vascular interventions, 38% were performed in female patients. Out of the 9,314 infrainguinal bypasses and 3,227 suprainguinal bypasses, 30% and 37% were per-

“As men and women are known to have different aortic anatomy, this study highlights the need for an in-creased focus on, and inclusion of, women in aortic device creation”

formed in females, respectively. Female compared with male sex was associated with increased reinterventions after peripheral vascular interventions, infrainguinal bypasses and suprainguinal bypasses at one year.

Additionally, they found that regardless of patient sex, one-year amputation rates were higher than expected compared to medical management (smoking cessation, aspirin and statin therapy, a walking program) alone prompting Levin to recommend that surgeons attempt an adequate period of medical therapy prior to offering invasive interventions for intermittent claudication.

According to the researchers, increasing medical options, particularly for an elective vascular procedure, is essential and an area for immediate improvement.

“However, this is only one factor that may mitigate the disparity in reintervention rates by patient sex. Future prospective analysis is warranted to assess the reasons for the type of intervention offered, as well as for suboptimal medical therapy, treatment failures, and need for reintervention among female patients,” said Levin.

These findings appear online in the Annals of Vascular Surgery journal.—Jocelyn Hudson

“Future prospective analysis is warranted to assess the reasons for the type of intervention offered, as well as for suboptimal medical therapy, treatment failures, and need for reintervention among female patients” SCOTT R. LEVIN

AMPUTATION VQI ANALYSIS LINKS HIGH LEVELS OF NEIGHBORHOOD DEPRIVATION TO MORE SEVERE PAD PATIENTS CATEGORIZED AS LIVING in neighborhoods with high levels of disadvantage under the Area Deprivation Index (ADI) measure of community adversity have more advanced peripheral arterial disease (PAD) and lower rates of revascularization versus amputation, a new retrospective analysis of Vascular Quality Initiative (VQI) data demonstrates.

The study, led by senior author Marc Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston, showed patients residing in the most disadvantaged zip codes were less likely to present with claudication, more likely to report rest pain, and less likely to undergo a revascularization for their PAD than those who live in areas classed as having the lowest levels of deprivation.

The ADI is composed of five quintiles, with the 5th the most deprived.

Adjusted analysis showed patients in the 5th ADI quintile being twice as likely to undergo intervention for rest pain rather than claudication, and 40% less likely to undergo revascularization compared to those in the first quintile, according to the analysis.

The data were presented at the VAM 2022 in Boston ( June 15–18) by Lucas Mota, MD, a Beth Israel Deaconess general surgery resident.

The research included nearly 80,000 patients who received open and endovascular infrainguinal revascularization or amputation from 2003–2020. The investigators established that 5th quintile patients were younger, with a mean age of 65, and more likely to be Black, have comorbidities, be former smokers or current smokers, and be uninsured.

Mota said the ADI was selected as a better measure of the underlying social determinants of health related to neighborhood conditions rather than simply a focus on individual factors such as race, income and insurance status. “Attention needs to be given to understanding neighborhood factors that are contributing to these disparities in order to identify community-level targets for improvement,” Mota told VAM Lucas 2022.— Mota Bryan Kay

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VS@VAM ROUND-UP The facts

Initial feedback showed attendees enjoyed both the expanded lineup that offered sessions on all four days as well as the expanded live-streaming options, he said.

Participants also liked the balance of clinical and non-clinical sessions, an important objective in planning, said PGEC Chair William Robinson, MD. He added that in official feedback received by mid-July, the positive response was between 90 and 100% across the board on whether the content presented was relevant to attendee educational needs and practice.

“People felt there were engaging sessions with high levels of speaker/presenter expertise,” he said.

In addition, planners received very strong feedback from the sessions attendees that featured more audience interaction in innovative formats. Attendees also liked the number and diversity of those presenting sessions.

“We were trying to get some diversity across career stages, demographics and practice settings,” said Robinson. of them remote “Beyond presenting quality content that was top-notch, quite a few members said that this VAM felt very warm and welcoming, that they truly felt this was their professional home,” said SVS Executive Director With cutting-edge science, practice management topics and Kenneth M. Slaw, PhD. “It was a great experience targeted educational sessions—not to mention receptions, plenary sessions and a great meeting, and dinners and the SVS Foundation Gala—the Society for it was wonderful to see so Vascular Surgery’s 2022 Vascular Annual Meeting has been many members come away happy and fulfilled. And now declared a big success. we work to consider how to make ’23 even better.”

Planning has, of course, IT FEATURED: “People were really excited to already begun for the 2023 ◆ More than 1,540 attendees, including gather together and hear about meeting, to be held June 131 who attended remotely and livethe latest science and innovation 14–17 at the Gaylord Nastreamed the sessions in the field,” said SVS Program tional Resort & Convenabstracts ◆ Eight plenary sessions featuring more Committee Chair Andres Schanzer, tion Center in National than 60 abstracts of the latest clinical MD, who helps plan programming Harbor, Maryland, outside research for VAM with the Postgraduate EduWashington, D.C. ◆ The E. Stanley Crawford Critical Issues cation Committee (PGEC). “They also This year’s success started Forum focused on disparities in were really happy to be together with with excellent session provascular care others in the field.” posals nearly a year ago, ◆ Five sessions aimed directly at the followed by refinement membership sections for physician and development in coassistants, young surgeons, women, operation with the PGEC, raised for the community practitioners and those in said Robinson.

SVS Foundation outpatient-based settings That process is now ◆ Six SVS breakfast, five “Ask the Expert,” underway for VAM 2023. and seven concurrent sessions, three “Starting with good topics is postgraduate education courses, and key,” Robinson said. five international sessions ◆ A sold-out “Cheers to 75 Years” gala that Attendees can review most sessions from WILLIAM ROBINSON netted more than $200,000 for the VAM 2022 at the Online Planner, at SVS Foundation vascular.org/Planner22.

1,540

VAM 2022 A BIG SUCCESS

131 8

>60

“We were trying to get some diversity across career stages, demographics and practice settings”

$200k

Compiled by Beth Bales and Kristin Crowe

PROPOSALS SOUGHT FOR VAM 2023 Members are still raving about the 2022 Vascular Annual Meeting (VAM) even while organizers seek topics for educational sessions for the 2023 edition.

Proposals are due at 3 p.m.

Central Time on Wednesday, Aug. 24.

“As vascular surgeons, we know what issues we come up against frequently—such as dialysis access, particular vascular conditions, practice management problems.

I’m asking members to think about what they need to know more about, or what solutions they may have devised to help with patient treatments or other topics,” said William Robinson, MD, who chairs the Postgraduate Education Committee, which organizes VAM educational content for breakfast, concurrent, “Ask the Expert” and special membership section sessions, plus postgraduate education courses.

Sessions could also address complications and how to deal with them successfully, tips for younger surgeons in their first few years of practice and other targeted topics, he said. “If you’ve ever been at VAM and wondered, ‘why don’t they address this,’ now is the time to write out those thoughts and send them in,” he said.

VAM 2023 is June 14–17 at the Gaylord National Resort & Convention Center in National Harbor, Maryland, outside Washington, D.C., with educational programming to be held all four days of the conference. The Exhibit Hall will be open June 15 and 16, and the SVS Gala, benefiting the SVS Foundation, will be the evening of Friday, June 16.

RAFFLE WINNERS ANNOUNCED Three SVS members were the lucky winners of the Exhibit Hall raffles at VAM 2022.

David Patrick Ebertz, MD, a surgical resident in Cleveland Heights, Ohio, was present and won the $500 Amazon gift card at the draw held during the Opening Reception on the Thursday of VAM. Ravi Narendra Ambani, MD, who recently completed his training and also of Cleveland Heights, and Guillermo A. Escobar, MD, of Atlanta, were the winners of the $250 Amazon gift cards.

Their names were drawn on the Friday of VAM during Exhibit Hall hours.

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Vascular Specialist | July/August 2022

RADIATION

PIONEERING CENTER REPORTS ‘MODERATE’ SUCCESS RATE WITH FIBER OPTIC REALSHAPE TECHNOLOGY IN FIRST 50 PATIENTS

By Bryan Kay

VASCULAR SURGEONS FROM THE medical center that pioneered use of the radiation-lowering Fiber Optic RealShape (FORS) imaging modality reported a 62% technical success rate using the first-generation of the technology across the first 50 procedures performed.

The data were reported at VAM 2022 by Giuseppe Panuccio, MD, from University Heart and Vascular Center Hamburg in Germany, who told those gathered his team’s work with the system represented “moderate success cannulating aortic branch vessels and a high potential in reducing radiation exposure.”

The cases involved—mostly branched and fenestrated endovascular aneurysm repairs (B/FEVARs) all performed by three operators—were carried out between February 2020 and February 2021 in Hamburg using the FORS guidewire and a pair of

FORS catheters (with technical success with conventional catheter the FORS catheter compatibility). A was 18% (p<0.001), total of 186 tasks Panuccio revealed. were included in Successful 62% rate of the study.

FORS task cathtechnical success, Challenges eterization was with 38% of the related to vessel associated with a cases abandoned catheterization, significant threeincluding stefold radiation exnosis >50% and posure reduction angulation >45º, (dose area product were assessed, as 12.5 vs. 4.4 cGycm2, were the time required p<0.001). for each catheterization Further, success ranged as well as radiation exposure. from 81% at the superior Panuccio reported no FORS-remesenteric artery to 42% at the lated complications as he delivered celiac trunk. the data showing a 62% rate of Panuccio said the operators also technical success, with 38% of the encountered “some problems” cases abandoned. with branches (success rate of “What was really impressive 52%), angulation (33%), and stenowas that when FORS was sucsis greater than 50% (17%). cessful, the amount of radiation “The reduced success rate Giuseppe Panuccio required for catheterization was observed in challenging anatomy really minimal,” he said. appears related to the limited “You have to consider that inside of the availability of FORS catheter shapes and radiation needed for catheterization, we its device properties,” Panuccio and his consider also the angiography that was co-authors concluded. performed before the catheterization.”

“Iterative FORS improvements are Reduced technical success was associatunderway to address these limitations with ed with cannulation of renal arteries, vessel the hopes of increasing success.” angulation, and vessel stenosis, he told Panuccio said the researchers expect VAM 2022. Catheterization tasks through visualization improvements when using a branch of a complex aortic endograft conventional catheters to be forthcoming. frequently required a non-FORS catheter— Further evaluation is ongoing through a

38%

References 1 Holden A. The IN.PACT AV Access Study: Results through 36 Months. Presented at Charing Cross 2022.

2 Trerotola SO, Saad TF, Roy-Chaudhury P; Lutonix AV Clinical Trial Investigators. The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis. J Vasc Interv Radiol.

January 2020;31(1):1-14.e5.

Brief Statement IN.PACT™ AV Drug-coated PTA Balloon Catheter Indications for Use The IN.PACT™ AV Paclitaxel-coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.

Contraindications The IN.PACT AV DCB is contraindicated for use in the following anatomy and patient types: • 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 femoropopliteal 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. Inadequate information is available to evaluate the potential mortality risk associated with the use of paclitaxel-coated devices for the treatment of other diseases/conditions, including this device indicated for use in arteriovenous dialysis fistulae.

Physicians should discuss this late mortality signal and the benefits and risks of available treatment options for their specific disease/ condition 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 AV DCB. • Do not exceed the rated burst pressure (RBP). 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.

• The safety of using multiple IN.PACT AV DCBs with a total drug dosage exceeding 15,105 μgpaclitaxel has not been evaluated clinically.

62%

FORS multicenter registry, which includes nine transatlantic centers and more than 350 enrolled patients.

Gustavo Oderich, MD, moderating the session in which Panuccio was presenting, commented on the “changing paradigm” the technology and associated data represented, and also asked Panuccio how many of the tasks he and his colleagues could not complete were down to not having the proper wire or catheter versus an inability to see other landmarks.

“One of the main limitations was the material properties—but also how we learn how to use it,” Panuccio said. “You have to completely re-set how you use the wire and with which catheter is the best combination. Material properties have to be developed, improved.”

“The reduced success rate observed in challenging anatomy appears related to the limited availability of FORS catheter shapes and its device properties” GIUSEPPE PANUCCIO

Precautions This product should only be used by physicians trained in percutaneous transluminal angioplasty (PTA).

• Assess risks and benefits before treating patients with a history of severe reaction to contrast agents. Identify allergic reactions to contrast media and antiplatelet therapy before treatment and consider alternatives for appropriate management prior to the procedure.

• This product is not intended for the expansion or delivery of a stent.

• Do not use the IN.PACT AV DCB for pre-dilatation or for post-dilatation.

• This product is designed for single patient use only. Do not reuse, reprocess, or resterilizethis product. Reuse, reprocessing, or resterilizationmay 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.

• The use of this product carries the risks associated with percutaneous transluminal angioplasty, including thrombosis, vascular complications, and/or bleeding events.

• The safety and effectiveness of the IN.PACT AV DCB used in conjunction with other drug-eluting stents or drug-coated balloons in the same procedure 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.

• Appropriate vessel preparation, as determined by the physician to achieve residual stenosis of ≤ 30%, is required prior to use of the IN.PACT AV DCB. Vessel preparation of the target lesion using high-pressure PTA for pre-dilatation was studied in the IN.PACT AV Access clinical study. Other methods of vessel preparation, such as atherectomy, have not been studied clinically with IN.PACT AV DCB. •

Potential Adverse Effects Potential adverse effects which may be associated with balloon catheterization may include, but are not limited to, the following: abrupt vessel closure, allergic reaction, arrhythmias, arterial or venous aneurysm, arterial or venous thrombosis,death, dissection, embolization, hematoma, hemorrhage, hypotension/hypertension, infection, ischemia or infarction of tissue/organ, loss of permanent access, pain, perforation or rupture of the artery or vein, pseudoaneurysm, restenosis of the dilated vessel, shock, stroke, vessel spasms, or recoil.

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. These complications may result in adverse effects.

Although systemic effects are not anticipated, potential adverse effects not captured above that may be unique to the paclitaxel drug coating include, but are not limited to, the following: 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 Physicians’ 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 Usefor a detailed list of indications, warnings, precautions, and potential adverse effects. This content is available electronically at www.manuals.medtronic.com.

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

P

medtronic.com/AVdata

UC202216301 EN ©2022 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. 05/2022

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INTERVIEW Engaging with primary care providers ‘critically important’ to improving AAA screening Matthew Mell, MD, has spent a lot of time looking into issues around screening for abdominal aortic aneurysms (AAAs). The problem, says the chief of vascular surgery at University of California Davis in Sacramento, California, is a difficult one to shake: “In the U.S., we under-screen,” he tells Bryan Kay. MELL LOOKS AT SOME OF THE studies that have come out of the Kaiser Permanente healthcare system in Southern California—a fully integrated health maintenance organization (HMO), or closed system—as instructive. There, physicians were able to use an electronic health record to help increase AAA screening rates to “a very high” 50–80%.

But in non-HMO, or open, systems like his own institution, no one had attempted to find out if such an approach might help boost screening rates, he tells Vascular Specialist.

Mell and colleagues recently sought to fill that void in the literature against a backdrop of more than 70% of Medicare beneficiaries not being enrolled in a fully integrated HMO and AAA screening poorly utilized by Medicare at-risk populations.

Mell et al established that primary care providers (PCPs) are “key to optimizing AAA screening rates” and that “out-ofnetwork patients are particularly vulnerable due to a lack of a PCP.” To improve screening rates, at-risk patients need a PCP, and PCPs need both knowledge of U.S. Preventive Services Taskforce (USPSTF) recommendations and active partnership with vascular surgeons to increase patient

buy-in, the research team suggested.

“We looked at both in-network and out-of-network patients—in other words, patients who had their primary care provider within our system and without, or who got their care within our system or their care outside, and what we found was that patients who got the care in our system were much more likely to have a PCP,” Mell explains. “We found that patients who had a PCP were far more likely to accept screening when we offered it to them. I will say, though, that the screening rate was still low. Our patients who have PCPs, I think, had around a 35 or 36% acceptance rate, which was low compared with closed healthcare systems.”

The UC Davis findings— presented earlier this year during the 2022 Vascular and Endovascular Surgery Society (VESS) winter annual meeting in Snowmass, Colorado, by medical student Angela Matthew Aguirre, BS—showed Mell that of 1,073 eligible patients, review of med-

ical records and calls confirmed previous imaging in 46%. Among the remaining 578, in-network patients (n=117, or 20%) were more likely to have a PCP (95% vs.

53%, p<.001). Successful contact was more likely for patients with a PCP (odds ratio, 2.36; 95% confidence interval 1.62– 3.45; p<.001). Of those offered screening, 31.9% accepted. The most common reason for declining was deference to a PCP (58%). On multivariate analysis, having a PCP remained the strongest predictor of screening.

“We concluded with this study that engaging the PCP, both at the individual level and, perhaps, at a system level, is going to be really, critically important to improving screening rates for patients who are at risk and eligible,” Mell says.

Locally, Mell and colleagues have set up educational meetings between their group and primary care to elucidate who is eligible for screening, how to receive it and clear up misconceptions among patients over who pays for screening. “In Europe and in other systems, healthcare systems that are nationalized, patients are used to getting a piece of mail from the healthcare system saying, ‘You’re eligible for this screening test,’ and they go and do it. We have don’t have that, and I think it is clear that a much more personalized approach is really the only way to be effective.”

“We found that patients who had a PCP were far more likely to accept screening when we offered it to them” MATTHEW MELL

NEW DATA SUGGEST PATIENTS AT AAA REPAIR THRESHOLDS CAN BE SAFELY DEFERRED Data from the PROVE-AAA cluster-randomized trial (Preferences for open versus endovascular repair of abdominal aortic aneurysm) of a novel decision aid to assist veterans deciding between their options demonstrated that surgeons can safely defer AAA repair in patients with a 5cmplus aneurysm diameter “for a moderate time.”

Mark Eid, MD, a general surgery resident at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and colleagues from the PROVE-AAA research team looked at 235 patients enrolled across 23 Veterans Affairs (VA) medical centers—109 at 11 control sites and 126 at 12 intervention sites who were either provided with their usual preoperative care or a decision aid before meeting with their surgeon. The full cohort were then given a series of surveys to assess their preferences, ultimately making the decision to either undergo surgery or active surveillance. “Among the study participants who deferred surgery, 23 were in the decision aid arm, while 17 were in the control arm who received their usual care,” Eid said as he presented results from the study at VAM 2022. In the decision aid group, 13% of veterans chose to defer their care— compared to 15% among those who received their usual care. “The vast majority of those who deferred were still awaiting surgery, primarily due to OR shutdowns at the beginning of the COVID-19 pandemic,” Eid revealed, also showing that more veterans in the decision aid group chose to refuse surgery compared to those who got usual care. “At the end of our surveillance period in the summer of 2020, no veterans had suffered aneurysm death or rupture.”

PROVE-AAA showed that approximately 20% of veterans with a AAA meeting Society for Vascular Surgery criteria for repair were deferred, and that this contingent were similarly satisfied to those who had surgery, Eid concluded. “At least in the short term, our data suggest that even patients at or slightly above the repair thresholds can safely consider their choice about proceeding with their aneurysm.”—Bryan Kay

CODING Maximize reimbursement: Learn latest in coding at SVS workshop

W

hen it comes to coding, information gaps can lead to revenue gaps. Proper coding and documentation are integral to receiving appropriate reimbursement for vascular procedures.

And coding for these procedures can be tricky, with many nuances. The Society for Vascular Surgery’s 2022 Coding and Reimbursement Workshop will help surgeons decode the terminology of global surgical packages, how Medicare values services, surgical modifiers, Current Procedural Terminology (CPT) codes, documentation, audit risks and more.

Learning correct coding can help a surgeon’s bottom line.

The workshop teaches surgeons (and/or their staff ) what they need to know to make certain they receive all the reimbursement to which they are entitled, said course director Sean Roddy, MD. The workshop and half-day optional workshop for Evaluation and Management (E&M) coding will be Oct. 1–2.

The optional half-day workshop will be from 8 a.m.–12 p.m.

Oct. 1, with the full-day workshop from 1–3:30 p.m. Oct. 1 and from 7:30 a.m.–4:30 p.m. Oct 2. Both will be at the OLC Education and Conference Center in the SVS Headquar-

ters office, 9400 W. Higgins Road in Rosemont, Illinois, just minutes from Chicago’s O’Hare International Airport.

“Coding and reimbursement are two totally different concepts,” said Roddy. “Coding is how you report what you do. Reimbursement is how you get paid.”

The course teaches surgeons and their coding staff how to code and, just as importantly, how to document accurately to maximize their appropriate reimbursement. “I always say we don’t want our members leaving money on the table. The government will be only too happy to keep it,” said Roddy.

He stressed two practicalities of correct coding and documentation: It’s generally accepted that correct coding lessens a surgeon’s audit risk. “We try to teach the proper way for appropriate coding to avoid an audit,” he explained.

If a surgeon is denied the first time around, “the chances of

a claim getting paid eventually go down precipitously and a surgeon has to pay the staff to re-work it.” It’s just best to do it right the first time around, he said.

Important changes for 2023 include Medicare payment modifications, new guidelines for E&M coding and change in the Medicare Physician Fee Schedule.

The content level is intermediate to advanced and is appropriate for all career levels, from vascular trainees to surgeons.

SVS members receive discounted pricing. Early-bird pricing is available through Sept. 1, and the adjacent Hampton Inn and Suites has discounted room rates when rooms are booked before Sept. 2.—Beth Bales See agendas for both workshops, learn more and register at vascular.org/Coding22.

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PEER REVIEW

Overseeing a period of progress, change at helm of SVS journals Departing JVS editors Peter Gloviczki, MD, and Peter Lawrence, MD— known affectionately as “the two Peters”—talk to Beth Bales about their time atop the journals—and handing the titles over to new leadership.

A

s their terms were about to end, Gloviczki and Lawrence—editor-in-chief and senior editor, respectively, of the Journal of Vascular Surgery family of publications— began reflecting on their time at the helm and the changes to which they’ve borne witness and helped usher in along the way.

Together, the two Peters have overseen a number of changes and accomplishments.

Fundamentally, they say, they are proud of the work they’ve done. Yet, the most vivid emotion, they both say, is “how honored we both are to have been the editors of the JVS journals” after taking over from former editors Anton Sidawy, MD, and Bruce Perler, MD. “We have considerably transformed our editorial policies, increased the diversity of our editorial boards and included more than 25% more women and underrepresented minorities,” they said in a farewell message of sorts in the journals’ June issues that reflects upon their six years as editors. Their terms ended at the end of June.

The list of accomplishments is extensive.

To wit, the journals now are part of a complete JVS portfolio that encompasses a wide range of communications vehicles, with the additions reflecting the changing landscape of media and information platforms. The portfolio includes monthly “Editors’ Choice” videos; press releases; article highlights; visual abstracts; the increasingly popular JVS journal clubs; an internship program; now ending its first year; the continuing medical education (CME) program; Audible Bleeding podcasts; and a major increase in all social media activities. Both men praised the staff, authors and reviewers for the success of the publications. They quoted Apple Computer co-founder Steve Jobs, who once said “Great things are always done by a team of people.”

Today, JVS has an all-time high impact factor of 4.860, and the PlumX metrics, reflecting social media impact, has seen a major increase. JVS-Venous and Lymphatic Disorders (JVS-VL), meanwhile, published in partnership with the American Venous Forum (AVF), has become the leading international print and online journal on the prevention, investigation and management of venous disease. It has an impact factor of 4.190, the highest among vein and lymphatic journals. It too has enjoyed an increase in PlumX Metrics.

A COMPLEMENTARY DUO

“I think we had a vision of what we wanted to achieve,” said Gloviczki, of he and

not simply emphasizing clinical research of the type typically presented at the Vascular Annual Meeting.

“If we wanted to stay a society on the cutting edge, we could not marginalize basic research, which is critical to vascular surgery.

So we initiated JVS-Vascular Science—and got a renowned basic research scientist to be editor [Alan Dardik, MD],” said Lawrence.

They also oversaw creation of four separate websites for submission to each journal, plus separation of the editorial boards.

The two emphasized an international presence, attending meetings around the world regularly and spreading the word about the journals. They invited surgeons in other countries to be part of the editorial boards and sought international guidance on certain clinical practice guidelines. Today, more than 50% of submissions come from outside the U.S.

Lawrence, who applied as a team to oversee the journals.

At the time, the two had known each other well for more than a decade, with a common history. Both had connections with Leslie and Susan Gonda, vascular benefactors who contributed generously to Mayo Clinic, institutional home of Gloviczki, as well as to the University of California Los Angeles, where Lawrence is director of the CONFRONTING UCLA Gonda Vascular CONTROVERSY, Center.

EMBRACING CHANGE “We had known Their ter ms also each about 15 years might be remembered before we started our for the international terms as editors,” said attention and scrutiny Gloviczki. “I thought over publication of an we would do very well article in JVS on social together as a pair of media and professioneditors of the journal.” alism on the part of Said Lawrence of vascular surgeons and their time in leaderprofessionals. ship: “He was the drivTo protest some ing force, but he and I content of the article, walked together.” women in medicine Chief among their the world over began aims was to maintain publishing—on social the journals’ excel- The Journal of Vascular Surgery family media, of course— of peer-review titles lence, and to also grow photos of themselves them and broaden their in swimwear, refuting scope to cover additional key areas of vascu- the idea that clothing and competence are lar disease management. somehow linked.

“We knew our specialty was—and is— To Gloviczki, it was a point of major transbecoming more diverse. More women are formation and had positive results. After regoing into it; there is more ethnic, racial and tracting the article, issuing an apology and cultural diversity,” said Lawrence. writing an editor’s statement on the issue, “And we knew vascular surgeons were not the journals took immediate steps to imall doing the same operations. We had been prove the review process and increase the about arterial surgery—carotid, aneurysmal, diversity of the editorial boards. or bypasses and distal arterial disease. But ve“It was obvious we were way behind in nous was evolving. To keep the involvement diversity, equity and inclusion [DEI],” said of members as the field changed, we needed Gloviczki, with the SVS already having a task to change as a journal. We needed to sepa- force on the topic ready to release its findrate the types of papers being published.” ings. JVS added an associate editor focused For example, increasingly more papers on DEI issues, Ulka Sachdev-Ost, MD. And were being submitted to JVS that belonged, with approximately 60 special contributors, instead, to JVS-VL, said the surgeons. And the JVS published a special supplement in August journal first known as Case Reports and then 2021 on the importance of DEI in the review Cases and Innovative Techniques, was renamed process and the academic field in general.

JVS: Cases, Innovations and Techniques.

The year-old internship program was a “We could then expand the range of pa- direct response to the retracted paper, said pers,” said Lawrence. “We could take topics Gloviczki. He and Lawrence charged Sachoriginally published in JVS that concentrated dev-Ost with, among other priorities, trainon innovations in practice management or ing young people on how to become good education and put them in CIT.” reviewers while also emphasizing DEI issues.

Both also felt that there needed to be a The seven interns wrote peer reviews and place in JVS and the SVS itself for papers con- commentaries, attended monthly lectures centrated on basic and translational research, and national vascular meetings, and studied

how to incorporate DEI into research and medical/science journals.

“We took the cream of the crop,” said Gloviczki.” It was a very successful first year of the program, and without a doubt it is going to grow.”

Lawrence also takes pride in the publication’s online Journal Club, led by Paul DiMuzio, MD, and Misty Humphries, MD. The club educates vascular surgical trainees in interpreting high-level clinical and basic science articles, and how to appropriately apply the information to clinical practice and future research.

Both men know they are leaving the “family” in good hands and approve of the restructuring that has been done to add strength and guidance. SVS Past President Ronald L. Dalman, MD, has been named executive editor to oversee the big picture and to enhance brand identify for all things JVS. Thomas Forbes, MD, takes over editorship of JVS, while Ruth Bush, MD, and Matthew Smeds, MD, are the new editors-in-chief of JVS-VL and JVS-CIT, respectively. Dardik has moved from editor to editor-in-chief of JVS-VS. This spreads the workload around, will help to continue differentiation of the journals and will increase involvement of SVS members, especially younger ones, as reviewers, and eventually members of the editorial boards.

“It’s a good idea to have someone at the top overseeing the four journals,” said Gloviczki. “They certainly have a very bright future.”

PASTURES NEW

As for the two editors, who have spent so much of their time overseeing the journals, what’s next?

Lawrence will wind up his tenure at UCLA, where a search is ongoing for his replacement. He has one more year as chair of the SVS Foundation, an organization near and dear to his heart, and may continue with some of the research in which he’s interested.

He also plans to enjoy spending more time with his wife, Susan, and remaining involved in her career as president of the Huntington Library, Art Museum, and Botanical Gardens in San Marino, California. Staying involved will be easy, said Lawrence, as the job includes a house on the grounds where benefits and fundraisers are held.

Gloviczki will keep up with his academic activities, including working on the venous guidelines of the SVS and AVF, and on the fifth edition of the Handbook of Venous and Lymphatic Disorders, first published in 1996.

He is on the Board of Trustees of his alma mater, the Semmelweis University in Budapest, Hungary, and plans to stay in contact with colleagues at Mayo, the SVS and AVF. The short-term goal? “I’m going to take a little vacation. For six years, this has practically been my daily activity. I think it will be a real pleasure,” he said, adding, “My wife can hardly wait!”

REGISTRATION IS OPEN!

FELLOWS COURSE IN VENOUS DISEASE

for Physicians in Training and in Early Career

West Coast VEIN FORUM

TWO COURSES. ONE VENUE. SEPTEMBER 22-24, 2022 THE EDGEWATER HOTEL • SEATTLE, WASHINGTON The FELLOWS COURSE IN VENOUS DISEASE, a unique, non-CME program led by a faculty of experts in the field, features a highly interactive environment and small group hands-on workshops within an informal, collegial atmosphere – making these very popular programs.

This course is ideal for:

• Fellows and residents within the specialty of vascular surgery, interventional radiology, interventional cardiology, vascular medicine, general surgery and associated programs.

• Recent graduates of these programs.

• Practicing physicians who are new to the field of venous.

Scholarships are available for Physicians-in-Training!

The WEST COAST VEIN FORUM, a unique CME program, led by a faculty of experts in the field, is an opportunity for community vein practitioners to have a conversation about challenges and controversies in vein treatment.

• The diverse range of topics and discussions will provide an understanding of the complexities and depth of science needed by anyone treating varicose veins and other venous problems.

• The WCVF offers clinicians providing treatment of venous disease a unique opportunity to expand their basic knowledge in order to provide the highest quality of care in venous disease.

• Faculty lectures and in-depth discussions will focus on practical challenges and controversies in venous disease treatment.

WATCH THIS VIDEO!

VISIT VENOUSFORUM.ORG FOR MORE INFORMATION. VenousForum

venousforum.org

Wes

Vein

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TECHNOLOGY Innovation within the Veterans Health Administration Frederick Beavers, MD, and George Akingba, MD, take a deep dive into how cutting-edge technology is used to provide veterans with better healthcare.

West Coast Vein Forum

IF ONE WERE TO ASK THE AVERAGE CITIZEN where cutting-edge technology is developed, the most probable answer would be “private industry”; think Apple, Tesla, Uber. This lies in the belief that the U.S. government is slow, risk-averse and cumbersome when it comes to innovation efforts. But taking a deep dive into the recent history of innovation in the U.S. would yield a different perception. For example, consider the Defense Advanced Research Projects Agency, known as DARPA. Born out of the realization that the U.S. had fallen behind the Union of Soviet Socialist Republics (USSR) in the Space Race, DARPA was created in 1958 to catch up to Russia and ensure that the U.S. would never lag behind technologically in matters of national security.

A few years later, DARPA expanded its mission. A partnership was formed between the military (Air Force) and academia (Douglas Engelbart and the Stanford Research Institute) to create the framework for modern computers (the oN-Line System). This model of an academia and private-sector partnership would be used repeatedly to innovate, eventually leading to the invention of the internet.

In the 1960s, the Lockheed Corporation In 2020, the Veterans developed Eclipsys, allowing physicians to place Health Administration orders electronically. In 1977, the federal gov(VHA) launched two new ernment laid the groundwork for an electronic programs: VA Ventures and health record (EHR) system with the Computer the Office of Healthcare Assisted System Staff (CASS). CASS was develInnovation and Learning oped at the Veterans Affairs (VA) Medical Center (OHIL). VA Ventures’ at Massachusetts General Hospital and became Frederick Beavers George Akingba mission is to promote the precursor of today’s Veterans Administracollaboration between the tion’s EHR platform, Veterans Health Information System VHA, academia, start-up companies and industry to drive and Technology Architecture (VistA). In short order, the healthcare innovations towards sustainable, high-impact VA allowed unrestricted access to this EHR technology, solutions and to ensure that innovations are delivered providing the private sector the opportunity to expand its initially to military veterans. use. Two decades later, the VA developed and implementDirect patient care technologies include: 3D bioprinted the Computerized Patient Records System (CPRS), the ing, artificial intelligence (AI) and machine learning first clinically usable EHR in the world. imaging, robotics, and augmented and virtual reality. One Patient care has also benefited from government innoproject directly applicable to the surgical community that vation. In 1978, a joint venture between the U.S. Navy and highlights the VA’s push for innovation is Project ConverDARPA led to the technology of Excimer lasers, used for gence. The VA is leveraging a public-private partnership laser eye surgery and arterial atherectomies. In 2006, a between the VA, Verizon, Medivis, Azure and Microsoft joint venture—LUKE—between the VA, DARPA and the to develop a 5G medical campus. The goal is to convert private sector (DEKA Research and Development Corpo2D imaging to 3D-holographic imaging, leading to better ration) led to the development of an electromechanical preparation and planning for surgery. prosthetic upper arm with near-natural control. These Thus, it is shown that the U.S. government, and, by examples are just the tip of the iceberg. extension, the VHA, has recognized that to stand still is to be left behind. The VA has been at the forefront of developing new ways to deliver healthcare to veterans and the general population. Through public-private partnerships, the VA will continue to innovate and look for new, better and more effective ways to provide progressive patient care.

In 1978, a joint venture between the U.S. Navy and DARPA led to the technology of Excimer lasers, used for laser eye surgery and arterial atherectomies

FREDERICK BEAVERS is a member of the SVS VA Vascular Surgeons Committee. GEORGE AKINGBA is a vascular surgeon at the VA Medical Center in Washington, D.C.

QUALITY

PATIENT-REPORTED OUTCOMES IN VASCULAR SURGERY ARE HERE TO STAY Evan Lipsitz, MD, Caitlin W. Hicks, MD, Ashley K. Vavra, MD and Karen Woo, MD discuss bringing PRO data into routine care

I

n 2022, the Centers for Medicare and Medicaid (CMS) is again emphasizing the importance of patient-reported outcomes (PROs) through legislation regarding the Quality Payment Program. In the Merit-based Incentive Payment System (MIPS), the use of PRO tools was designated as a highly weighted Improvement activity.1 The objective of this activity is to incorporate PRO data into routine clinical care, thus increasing patient engagement and health outcomes for all populations. PRO improvement activities require both documentation of promotion of PRO tools and PRO data collection for 2022.

In addition, this year eight of the MIPS Quality Measures involve the use of PROs.2 The measures focus on functional status changes for patients with a range of orthopedic pathologies; one asthma- and one psoriasis-focused quality measure assessing patient-reported disease control; and one primary care measure that captures 11 patient-reported items to assess the broad scope of primary care. Overall,

CMS is increasing its focus on PRO measures in both the quality and improvement spaces, and vascular surgeons need to be aware of and prepared for this shift.

There are a number of PRO measures (PROMs) relevant to vascular disease.

Last year, the Society for Vascular Surgery (SVS) Performance Measures Committee (PMC) identified all available PROMs relevant to vascular surgeons. The PMC also evaluated PROMs perceptions, barriers to implementation and concerns.3 The PMC identified 31 PROMs related to vascular surgery diseases, and three subthemes in knowledge gaps among vascular surgery physicians: lack of awareness of existing PROMs; knowledge of how they are developed and validated; and clarity around how they should be used.

Participating physicians were concerned about the usefulness of PROMs in vascular surgery, barriers to the use and implementation of PROMs, and possible unintended consequences of reporting PROMs. Based

on these findings, the PMC recommended four actions to facilitate the widespread implementation of vascular surgery-related PROMs: develop more vascular surgery-specific PROMs that expand our ability to assess response to treatments for vascular disease; develop recommended best practices for their collection and use; provide education about them; and partner with stakeholders to improve PROM development and implementation.

One of MIPS’ major limitations to date has been the relevance of quality measures to vascular surgery. There are less than a handful of vascular-specific measures recognized by CMS, and two are currently up for potential removal due to a lack of reporting in performance year 2020.

Given the CMS focus on PROs, it may be valuable for the SVS to advocate for PROM development for use in MIPS and, ultimately, MIPS Value Pathways (MVPs).

The SVS PMC is currently tackling this issue, along with the action items around

PROMs noted above.3 In order for PROMs to be effectively applied, SVS members need to better understand and implement these measures moving forward.

References 1. Quality Payment Program. 2022 Improvement Activities: Traditional MIPS. Available at https://qpp.cms.gov/mips/explore-measures?tab=improvementActivities&py=2022 Accessed 7/15/2022.

2. Quality Payment Program. 2022 Quality Measures: Traditional MIPS. Available at https://qpp.cms.gov/mips/explore-measures?tab=qualityMeasures&py=2022.

Accessed 7/15/2022.

3. Hicks CW, Vavra AK, Goldsborough E 3rd, et al. Current status of patient-reported outcome measures in vascular surgery. J Vasc Surg. 2021 Nov;74(5):1693-1706.e1.

EVAN LIPSITZ is PMC chair, CAITLIN HICKS the vice chair, and ASHLEY K. VAVRA a member of the committee. KAREN WOO is past chair.

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SOCIETY BRIEFS SVS SET TO LAUNCH MAIDEN EDITION OF CPVI SKILLS COURSE

FOR YEARS, SAID VIKRAM KASHYAP, MD, fellow Society for Vascular Surgery (SVS) members have asked for a course where they could learn the latest innovations and advanced endovascular techniques for peripheral vascular interventions.

Two outbreaks of COVID-19 have twice delayed the course but now, from Oct. 23–24, surgeons will get what they’ve sought, the Complex Peripheral Vascular Intervention (CPVI) Skills Course to treat their patients with peripheral arterial disease (PAD) and chronic limb-threatening ischemia, known as CLTI. It includes an extensive hands-on program designed by vascular surgeons for vascular surgeons, and will be held at the OLC Ed-

Vascular Specialist | July/August 2022

Compiled by Beth Bales and Kristin Crowe ucation and Conference Center in the SVS Headquarters Building. The site, at 9400 W. Higgins Road, Rosemont, Illinois, is just minutes from O’Hare International Airport in Chicago.

“PAD and CLTI are the biggest clinical areas for vascular surgeons in the United States,” said Kashyap, who is co-directing the course with Patrick Geraghty, MD, and Daniel McDevitt, MD. “Surgeons really need to become familiar with the latest treatments and technology, and we have a world-class faculty providing just that at this course.”

The first day will include didactic and casebased interactive learning. Day two is a “full day of hands-on workshops where participants can really understand the details of doing complex interventions using the latest technologies and innovations,” said McDevitt. Techniques and procedures include: ◆R etrograde tibial and pedal access with cadaver limbs ◆P edal-loop imaging and techniques with cadaver limbs ◆ Deep venous arterialization with cadaver limbs ◆ IVUS with cadaver limbs ◆ Atherectomy devices ◆A spiration/peripheral thrombectomy catheters ◆ Re-entry devices ◆ Closure devices The course also will include a demonstration of a percutaneous deep vein arterialization

Visit the Journal of Vascular Surgery at jvascsur.org.

See the agenda and register before the course sells out at vascular.org/CPVI.

CPVI COURSE PRICING GUIDE CPVI Course Early Bird Pricing (Through Sept. 24)

Regular Pricing (starting Sept. 24)

Member

$995

$1,100

Candidate Member

$800

$895

Non-Member Candidate

$825

$920

Non-Member

$1,695

$1,895

Registration Type

LEADERSHIP PROGRAM APPLICATIONS DUE BY AUG. 15

Journal of Vascular Surgery outlines latest free-access articles now available THE JOURNAL OF VASCULAR Surgery (JVS) has several articles available for open access from its July and August issues through Oct. 1. Among them are: ◆ Center volume and improved outcomes following open abdominal aortic aneurysm (AAA) repair, vsweb.org/AugMedical center 22JVS-AAAVolumeOutcome open AAA repair ◆ Longer follow-up intervals folvolume has been lowing endovascular aneurysm investigated in a repair (EVAR), vsweb.org/Aug- new JVS paper 22JVS-AAAFollowUp ◆ Histologic and morphologic character of pediatric abdominal aortic developmental coarctation and hypoplasia, vsweb.org/Aug22JVS-PediatricNarrowing ◆ Natural history and growth rates of isolated common iliac artery aneurysms (continuing medical education [CME] credit available), vsweb.org/Aug22JVS-CIAA ◆ Appropriate use criteria (AUC) for the management of intermittent claudication, vsweb.org/JVS-ClaudicationAUC

system, which is being evaluated in the U.S. in a pivotal study. Participants will have a unique opportunity to try out the ground-breaking system, said Kashyap.

“This is going to be very exciting. It’s going to give surgeons familiarity and, thus, make them more comfortable with treatment techniques,” Geraghty said. He added that the course will offer education of value to all vascular surgeons, from early-career to seasoned professionals.

Because hands-on learning is such an important part of the course, no live-streaming will be offered.

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LEARN TO BE A LEADER OR ENHANCE YOUR leadership skills—applications to be part of the fourth cohort of the Society for Vascular Surgery Leadership Development Program (LDP) are due Aug. 15.

The year-long, highly interactive learning experience is recommended for those five to 10 years out of training. The aim is to help participants enhance their leadership skills, reach their full potential as leaders, and apply what they learn in the vascular surgery specialty and in their workplaces, communities and lives.

Twenty-five to 30 surgeons will be selected for the program, which runs from Sept. 28 through the 2023 Vascular Annual Meeting, which is June 14–17, 2023.

The selected surgeons will participate in webinars, mentoring and a 1.5-day in-person workshop, plus identify and tackle real-life challenges that leaders in vascular surgery face. Cohort members will practice applying what they learn during the course to such real-life challenges. The LDP is sponsored jointly by the SVS, the Society for Clinical Vascular Surgery and the Vascular and Endovascular Surgery Society. Apply at vascular.org/LDP22.

Volunteer for new SVS Self-Assessment Committee THE SOCIETY FOR VASCULAR Surgery is seeking volunteers for a new Self-Assessment Committee that will oversee products and programs such as the sixth edition of the Vascular Education and Self-Assessment Program (VESAP) to be released in early 2024. After the launch of VESAP6, the committee will explore new formats that align with member needs.

The committee appointment term is one year, which is renewable. The committee structure will consist of two co-chairs who will serve as the VESAP editors-in-chief, and 13 committee members, also VESAP section leads. Applications are due Aug. 19: vascular.org/AssessmentVolunteer.

Prepare for Board Exams at UCLA/SVS Review Course P L A N N I N G T O TA K E T H E upcoming Vascular Surgery Board (VSB) examinations? Prepare for them at the “Seventh Annual UCLA/SVS Symposium: A Comprehensive Review and Update of What’s New in Vascular and Endovascular Surgery.”

The course is coming up quickly. It will be held Aug. 25–28 at the Beverly Hilton in Beverly Hills, California.

This 3.5-day symposium, a joint effort of the Division of Vascular and Endovascular Surgery at the University of California Los Angeles (UCLA) and the Society for Vascular Surgery (SVS), offers an in-depth review of the vascular surgery specialty for those preparing to take their Board examinations.

It also provides the basic didactic education for vascular residents and fellows in training. The course recognizes four major pillars of vascular surgery practice—conventional open operations, catheter-based intervention (endovascular procedures), the medical aspect of patient management, and diagnostic imaging and noninvasive testing.

Learn more and register at vascular.org/ ReviewSymposium22.

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www.vascularspecialistonline.com

CLINICAL& DEVICENEWS Compiled by Jocelyn Hudson, Will Date and Bryan Kay

Terumo Aortic announces first commercial implant of Thoraflex Hybrid in US Following the recent approval by the Thoraflex Food and Drug Administration (FDA) of the Hybrid device Thoraflex Hybrid frozen elephant trunk (FET) device for the treatment of patients with complex aortic arch disease, Terumo Aortic has now announced the first commercial implant of the device in the U.S. The Thoraflex Hybrid is a single-use medical device combining a Gelweave polyester graft with a nitinol self-expanding stent graft. It is indicated for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and repair of the descending thoracic aorta, with or without involvement of the ascending aorta, in cases of aneurysm and/or dissection.

The implant was performed by the principal investigator of the Thoraflex Hybrid study, Joseph Coselli, MD, professor and executive vice chair in the division of cardiothoracic surgery at Baylor College of Medicine in Houston, Texas. “The procedure was very successful, the device performed well, and the patient is making a good recovery,” said Coselli.

“Thoraflex Hybrid is the first device of its kind used in FET repair in the United States, and it will allow U.S. physicians to treat patients who may be at great risk of rupture with a device that brings the primary benefit of requiring a single-stage procedure for those with suitably limited disease instead of two procedures, which has been the conventional pathway in the United States for this group of patients.”

01:The 4.5” x 5.625” Thoraflex Hybrid received FDA approval in 2022.

CYDAR MEDICAL AND KING’S COLLEGE LONDON PARTNER ON RANDOMIZED CONTROLLED TRIAL OF CYDAR EV MAPS Cydar Medical has partnered with King’s College London in London, England, to initiate the ARIA study—a randomized controlled trial to assess the clinical-, technical- and cost-effectiveness of a cloudbased, artificially intelligent image fusion system in comparison to standard treatment to guide endovascular aneurysm repair (EVAR).

“Our central hypothesis is that digital technology—specifically cloud-computing and artificial intelligence (AI)—can be used to assess and learn from large volumes of data to inform clinical decisionmaking, and has the potential to improve the predictability of individual patient outcomes and the consistency of outcomes in the NHS [British National Health Service],” said Rachel Clough, MD, principal investigator and clinical senior lecturer from King’s College London.

The trial will enroll 340 patients at 10 sites across the United Kingdom with a clinical diagnosis of abdominal aortic or thoracoabdominal aortic aneurysm (AAA and TAAA, respectively) suitable for endovascular treatment.

The trial will follow patients for one year and assess the effect of Cydar EV Maps—certified software-as-a-medical device—on clinical-, technical- and costeffectiveness in comparison to standard EVAR treatment used for both standard and complex devices.

The study was initiated with the first patient enrolled at the Liverpool University Hospitals NHS Foundation Trust in Liverpool, England.

GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*

FIRST PATIENT ENROLLED IN WRAPSODY ENDOPROSTHESIS REGISTRY STUDY Merit Medical announced the successful enrollment of the first patient in its WRAP registry in a recent press release. The study will evaluate the clinical benefits associated with the use of the Wrapsody cell-impermeable endoprosthesis in patients receiving hemodialysis who experience stenosis or occlusion of blood vessels required for dialysis.

Dean Huang, MD, a consultant diagnostic and interventional radiologist at King’s College Hospital in London, England, enrolled the first patient in the WRAP Registry. “The patients being treated with the Wrapsody cellimpermeable endoprosthesis have historically had few clinical options,” Huang said. “These patients have typically faced frequent reinterventions to maintain vessel patency, resulting in multiple procedures and hospitalizations.

The WRAP study will add to the growing body of evidence on Wrapsody’s ability to achieve durable outcomes for this vulnerable patient population.”

The WRAP registry study will enroll up to 500 patients with outflow circuit stenosis or occlusion who are receiving hemodialysis at medical facilities throughout Europe, South America, Australia and New Zealand. Clinical outcomes will be evaluated over a two-year period in accordance with its CE Mark.

The Wrapsody is an expandable nitinol stent frame with an external layer of expanded polytetrafluoroethylene (PTFE) and an internal layer of spun PTFE. It is being studied under an investigational device exemption (IDE) in the U.S.

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Consult Instructions for Use eifu.goremedical.com

INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm.

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

Consult Instructions for Use eifu.goremedical.com

INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm – 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.

CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available.

Products listed may not be available in all markets. *As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS Heparin Surface.

Products listed may not be available in all markets.

GORE, Together, improving life, VIABAHN and designs are trademarks of W. L. Gore & Associates. © 2021 W. L. Gore & Associates, Inc. 21373436-EN DECEMBER 2021

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GORE, VBX, VIABAHN and designs are trademarks of W. L. Gore & Associates. © 2021 W. L. Gore & Associates, Inc. 21100151-EN APRIL 2021

COVERED STENTS OFFER PROMISING ADVANTAGES for treating complex iliac occlusive disease

The GORE® VIABAHN® Device family of covered stent grafts gives you the flexibility and conformability to safely and confidently address even the most complex cases.1,2,* HIGHER PATENCY RATES AT THE AORTIC BIFURCATION3

Patency rates

92%

P = .023

92% 78% 62%

Covered stents

Bare metal stents

One-year

Covered stents

Bare metal stents

See all the data

Two-year

Balloon expandable covered iliac kissing stents versus bare metal stents at the aortic bifurcation

* The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis indication includes de novo or restenotic lesions in iliac arteries, including those at the aortic bifurcation. The GORE® VIABAHN® Endoprosthesis indication includes lesions in the iliac arteries only.

1. Piazza M, Squizzato F, Dall’Antonia A, et al. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185.

2. Panneton JM, Bismuth J, Gray BH, Holden A. Three-year follow-up of patients with iliac occlusive disease treated with the Viabahn Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy 2020;27(5):728-736.

3. Sabri SS, Choudhri A, Orgera G, et al. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. Journal of Vascular & Interventional Radiology 2010;21(7):995-1003.

Please see accompanying prescribing information in this journal. Products listed may not be available in all markets.

GORE, Together, improving life, VBX, VIABAHN and designs are trademarks of W. L. Gore & Associates. ©2022 W. L. Gore & Associates, Inc. 22470700-EN JULY 2022

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