Vascular Specialist–January 2023

SOUTHERN VASCULAR

Renal stenting

Study probing which CKD patients would benefit most from renal artery stenting points toward those who experience a more rapid decline in renal function over six months prior to the procedure

By Bryan Kay

It has been a source of great frustration for J. Gregory Modrall, MD, ever since, in 2014, the CORAL (Cardiovascular outcomes in renal atherosclerotic lesions) trial established no benefit from renal artery stenting over medical therapy in patients with chronic kidney disease (CKD). It created, the professor of surgery at the University of Texas (UT) Southwestern Medical School in Dallas told Vascular Specialist, “a state of therapeutic nihilism, if you will, in

See page 4

02 Guest editorial Bhagwan Satiani, MD, looks at a potential ‘shiny new object’

06 Comment & analysis

Christopher Audu, MD, ponders his vascular surgical loves in Corner Stitch

11 JVS

SVS introduces new peer-reviewed title to JVS family

18 3D printing Webinar explores how tech might affect practice

www.vascularspecialistonline.com

SVS FOUNDATION CHANGES NAME OF PROGRAM AIMED AT PROVIDING CARE FOR UNDERSERVED PATIENTS

By Beth Bales

THE SOCIETY FOR VASCULAR Surgery (SVS) Foundation program formerly known as VISTA has a new name. VISTA—an acronym for Vascular Volunteers In Service To All—is now simply Vascular Care for the Underserved™. Its mission, however, remains the same: “to provide outreach, screening and other resources to those who are impacted by lack of access, inadequate resources and/or distance from modern healthcare facilities.”

With many SVS members expressing interest in addressing disparities in care, and building on the Foundation’s successful grant programs for community awareness and prevention, the program provides opportunities for vascular surgeons to make a direct impact on patients. Vascular Care for the Underserved™ focuses particularly on bringing vascular care to underserved populations, such as Black, Native American, and Hispanic patients, and all those who lack access due to low socioeconomic status.

“The new name better reflects what our goal is: to provide programs and resources to those who, for whatever reason, are underserved in terms of healthcare,” said SVS

See page 8

SOCIETY FOR VASCULAR SURGERY MEMBERS are mourning the death of James (Jimmy) S.T. Yao, MD, 88, former SVS president and Lifetime Achievement Award recipient (writes Beth Bales).

Yao, professor emeritus at Northwestern University, died Tuesday, Dec. 20, in Chicago. He had been a very active member of SVS since 1974, holding many roles, including that of president in 1993.

He was born in China and spent most of his formative years in Macau, in Eastern Asia. He returned to China before medical school and, seeing the political turmoil there, went instead

See page 17

GUEST EDITORIAL

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

Director of Marketing &

Communications Bill Maloney

Managing Editor SVS Beth Bales

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, Eva Malpass and Benjamin Roche

Design Terry Hawes

Advertising Nicole Schmitz nicole@bibamedical.com

Letters to the editor vascularspecialist@vascularsociety.org

BIBA Medical, Europe

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By Bhagwan Satiani, MD

Value based payments (VBP), or “volume to value,” was the new buzz word over a decade ago, promising yet another chimera in ways to reimburse physicians and hospitals based upon “value,” instead of fee-for-service (FFS).

VBP models link payment or compensation to healthcare outcomes, infrastructure and quality of care rendered. The value equation states:

Value (V) = Q (quality) + S (service)

C (cost)

The idea was to bend the healthcare cost curve and improve healthcare outcomes. If these models succeeded, we would expect better patient satisfaction, greater efficiency, improved outcomes, and lower cost.

I am reminded of advice for healthcare executives to follow these four points: Do not sell “risk” as a shiny new object; connect value-based care to existing priorities; message should be related to physician day-to-day work, not yours; and be sure to use risk to advance clinician engagement.1 This advice was priceless in retrospect.

The Affordable Care Act (ACA) of 2010 ushered in the “VBP payment modifier,” starting with Medicare’s flagship Shared Savings Program (MSSP), Accountable Care Organizations (ACOs), followed by advanced alternative payment models (APM), the Medicare Access and CHIP Reauthorization Act (MACRA), the Merit-based Incentive Payment System (MIPS), and the list goes on.

since they are used to being reimbursed by the system, and they believe they are being compensated fairly. Although physicians remain split on whether FFS care is best (about 70% favor it), most agree that the time for it has come and gone since they see the waste in the system. They know FFS is more expensive. A survey from Bain & Company of almost 1,000 physicians, along with health system finance and procurement officers, showed that physicians feel helpless to control costs, even though they understand that both cost of clinical care and pharmaceuticals need to come down.3 Physicians feel they are being overruled and “managed” rather than being asked to sit at the table where decisions are made.

Lack of great promise

The lack of strong empirical evidence has also slowed the implementation of value-based care. Physicians are aware of many previous iterations of healthcare reimbursement models and the fact that population-based VBP models have not thus far shown great promise. Furthermore, there are not enough incentives for managing the total cost of care, and not many physicians are willing to take the downside risk with APMs. Physicians are also uncertain about the guiding principles for any new VBP formula. How is value defined and what does it mean? Are clinical-decision support and analytic systems up to date? Is there flexibility in the compensation for surgeons who wish to be compensated for working harder or working less? For surgeons, the quality component means judging the decision to operate or not, the choice of the appropriate procedure for that condition, the technical success or failure, and the ultimate outcome, compared with benchmarks. Since some of these targets are hard to measure, we are left with items like antibiotic guidelines or thromboembolic prevention as examples that have only a modest amount to do with the essence of surgery.

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 2023 by the Society for Vascular Surgery

Currently, four main types of VBP models exist: performance-based payments, bundles, shared savings, and risk and capitation.2

The Department of Health and Human Services (HHS) aspired to convert 30% of FFS Medicare payments to VBP models by the end of 2016, and 50% to make the switch by 2018. Data show that 38.2% of healthcare dollars flowed through some type of VBP model as of 2019.

The success of VBP programs is mixed with many models failing to show a major impact thus far. For a while, ACOs and VBPs showed some early cost reductions, but neither seemed to significantly impact the quality of care. A Deloitte survey of 680 U.S. physician respondents in 2020 showed that nearly all still relied on FFS reimbursement and only one-third said some of their compensation was tied to VBP.2 An AMA analysis in 2018 showed that salary is the most common method (52.5%), followed by productivity (31.8%). Some 33% of surgical specialists were paid strictly on productivity. Why is FFS still the dominant reimbursement method?

Hospitals and physicians strongly prefer FFS

Finally, the timing of payments is complex and may vary, making revenue collection difficult to predict. Take the shared savings programs such as bundled payments. Other than large hospitals and medical groups with resources to hire expert help, most physicians do not have the tools, processes, and the analytic capability to assess risk- or value-based contracts. So, while interest in VBP contracting over the last decade has been a high priority, the reality is that actual implementation has not matched the interest.

While more data is awaited, VBP has had no significant impact on slowing the growth in healthcare costs thus far. The main reason is a consensus on the definition of value and data standards. Second, from a system standpoint, hospitals have difficulty determining the actual internal cost (not charges) and even quality of care at the individual level to plan for an outcomes-based payment model. Patient outcomes are also difficult to match with the standards because of absence of shared platforms.4 Third, incentives are not aligned from the system down to hospitals and medical groups. Finally, the infrastructure—including population and management analytics—is expensive, particularly in the beginning, and negates any savings.

Quality performance measures

There are some bright spots. In an MGMA Stat poll in 2022, 42% of medical groups said quality percontinued on page 4

Has the risk in the value-based payment model been sold as another ‘shiny new object’?

The ‘great resignation,’ traveling nurses, and professional ennui have reduced the number of trained, experienced personnel. New hires are often unacquainted with complex procedures, which increases the chances for unfavorable outcomes

Bhagwan Satiani

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FROM THE COVER: RENAL STENTING: STUDY POINTS TOWARD CKD PATIENTS WHO EXPERIENCE MORE RAPID DECLINE IN RENAL FUNCTION OVER SIX MONTHS PRIOR TO THE PROCEDURE

our specialty on how to manage people with renal artery stenosis, and either hypertension or CKD.” Why? The patients kept coming, he said. And vascular surgeons were left with less certainty regarding how they should treat them, he said.

So Modrall and colleagues set about identifying putative predictors to be able to select patients for renal artery stenting who are most likely to benefit. They dug into the Veterans Affairs Corporate Data Warehouse to find 695 patients who underwent renal stenting between 2000 and 2021, categorizing them as “responders” if eGFR (estimated glomerular filtration rate) at 30 days or greater post-stenting increased 20% compared to pre-stenting. All others were “non-responders.”

The results were stark. Presented at the 2023 Southern Association for Vascular Surgery (SAVS) annual meeting (Jan. 18–21) in Rio Grande, Puerto Rico, they revealed that patients in CKD stages 3b and 4 (eGFR 15-44 mL/min/1.73m2) are the only sub-groups with a significant probability of improved renal function after renal stenting, with the rate of decline of preoperative eGFR over the months prior to stenting a powerful discriminator of patients who are most likely to benefit.

“Both of those are helpful to clinicians because we can then look at the patient’s history of where their renal function is currently when we see them in the office, and where it’s been for the last six–nine months,” Modrall explained, “and we can make a much more educated estimation of the probability of improved renal function when we stent them.

“By the same token, on the flip side of that is, if a patient has, for instance, very flat renal function over six or nine months prior to stenting, we can tell the patient that the probability of improved renal function is so low that it doesn’t

even merit the treatment. That’s a huge help to clinicians.”

The third—and negative—predictor, the research team uncovered in the study, is diabetes, Modrall continued. “This turned out to be an interesting finding that we have now seen in two successive studies with different datasets,” he said. “What that tells us is that, probably, with many patients with diabetes, their kidney is probably already too injured to benefit from stenting. While we’re not saying you shouldn’t stent those patients, we certainly would say you should be very circumspect and careful about choosing patients for stenting if they have diabetes.” Importantly, Modrall pointed out, the predictors highlighted in the study are “putative,” or “candidate predictors,” that have not been validated in a prospective series. “The next step

is to take the data from this study, combine it with two of our prior studies, and in doing so we will have close to 1,800 patients with renal artery stents,” he said. “That represents the single largest dataset of renal artery stenting patients in existence to my knowledge.”

Modrall and his team hope to then leverage the enlarged dataset to create an outcome prediction tool that clinicians could use in practice. He envisages a desktop- or phonebased application into which a patient’s parameters could be inputted in order to establish a probability of improved renal function. “We’re not there yet; we don’t with 100% certainty know that that would be feasible,” Modrall conceded. “But that is the goal, and that is where we are beginning to work currently.”

Modrall believes the study also showcased the “unique partnership” between an academic institution, UT Southwestern, and a Veterans Affairs facility, the Dallas VA Medical Center, where he also holds an appointment. “This really benefits both facilities, both institutions and all of their patient populations,” he added.

formance measures are included in physician compensation plans.5 In another survey, two-thirds of physicians have linked to VBP, and over half believe it improves quality and trims costs.6

Ironically, 69% are not using proper technology to identify at-risk patients, and 72% are not linking to medical and social data. So, in 2022, while the vast majority believe the end of FFS is here, 60% of FFS is either not linked or somewhat linked to value and quality, another 27% are APM models based on FFS, and 15% on population-based payments.

Some bundled payment and ACO programs have succeeded, but most do not have the resources, time, or administrative or financial experience to take a higher risk proposition.

The Centers for Medicare & Medicaid Services (CMS) estimates that since 2015, savings increased tenfold to more than $4 billion in 2020. It is also true that VBP programs may have done better with permember-per month premiums during the COVID-19 pandemic than the unreliable FFS programs.

After the last decade of experimentation, physicians want empirical evidence that evolving models of patient care management, compensation, and policies work.3 As Bain & Company maintain, without

sound evidence, high quality of care will remain elusive, and unengaged physicians will remain on the sidelines. If physicians readily admit that FFS is expensive, their involvement at the grassroots to help lead the change is imperative. They should be part of agreements on guiding principles, transparency, equity across specialties, and adjust for personal choices for individuals consistent with the hospital’s financial and quality goals.2

Some analysts believe the current VBP models are simply FFS “lite.” Goldsmith comments that MedPAC has called the VBP movement a disappointment.7 He also states that hospitals have not recovered the billions of dollars into these models. Moody’s data for 2020 showed that the median percentage of risk-based payment of total hospital revenues is 1.1%, down 0.5% from 2018.

Furthermore, clinicians have spent countless non-reimbursable hours debating and documenting these quality measures. The impact of horizontal and vertical mergers of hospitals, physicians and insurers on VBP is unknown.

The physician dilemma has been well stated by Berenson and Kaye who comment that “practical reality is that CMS, despite heroic efforts, cannot accurately measure any physician’s overall value, now

continued from page 2

or in the foreseeable future,” concluding, “yet the medical profession has been remarkably quiet as this flawed approach proceeds.”8

And proceed it has. Some experts claim that COVID-19 has hastened the move to VBP, that private equity firms are betting on innovation and newer models of care, and that healthcare plans and payers are leading the way.9 The future remains clouded.

My questions are: how is it going to be different this time, and are many physicians involved?

References

1. Dailey E. Win physician buy-in for value-based care. https://www.advisory.com/ Topics/Population-Health-ROI/2021/03/ Win-physician-buy-in-for-value-basedcare?elq_cid=331978&&utm_source=member_db&utm_medium=email&utm_campaign=2022Feb21&utm_content=member_headline_amembertest_x_x_x_x&elqTrackId=c8c9302bfc774ca39512e3ed46a97ed3&elq=299a4efffe7b44a8ba38cfc6b3510c96&elqaid=91515&elqat=1&elqCampaignId=45683&elqcst=272&elqcsid=5949.

2. https://www2.deloitte.com/us/en/pages/ life-sciences-and-health-care/articles/valuebased-care-payment-models.html.

3. https://www.bain.com/insights/front-line-ofhealthcare-report-2017/

4. DeLone M. If value-based contracts succeed…we might not need them anymore. Deloitte. https://www2.deloitte.com/us/ en/pages/life-sciences-and-health-care/ articles/health-care-current-october22-2019. html?id=us:2em:3na:hcc:awa:abt:102219&ctr=cta&sfid=0033000000ZUOnhAAH#1

5. https://www.mgma.com/practice-resources/ revenue-cycle/shifting-to-value-amid-pandemic-and-staffing-chall

6. https://innovaccer.com/resources/industry-reports/the-state-and-science-of-valuebased-care

7. Goldsmith J. Commentary in https:// www.healthaffairs.org/do/10.1377/forefront.20220125.362333/

8. Berenson RA, Kaye RK. Grading a Physician’s Value—The Misapplication of Performance Measurement. N Engl J Med 2013 Nov 28;369(22):2079-81. doi: 10.1056/ NEJMp1312287.

9. Jacob A, Guthrie F. Accelerating value-based care: Why health plans now hold the keys | Viewpoint. https://www. chiefhealthcareexecutive.com/view/accelerating-value-based-care-why-health-plansnow-hold-the-keys-viewpoint

BHAGWAN SATIANI is a Vascular Specialist associate medical editor .

GUEST EDITORIAL HAS THE RISK IN THE VALUE-BASED PAYMENT MODEL BEEN SOLD AS ANOTHER ‘SHINY NEW OBJECT’?

“If a patient has, for instance, very flat renal function over six or nine months prior to stenting, we can tell the patient that the probability of improved renal function is so low that doesn’t even merit treatment”

J. GREGORY MODRALL

J. Gregory Modrall

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COMMENT& ANALYSIS CORNER STITCH

Back to basics:

about vascular surgery

By Christopher Audu, MD

RECENTLY, AFTER COMPLETING A DIFFICULT open aortic operation with my attending, a bright M3 asked me “Why vascular surgery?” The question didn’t catch me off guard, as I always have a ready answer, and we had just finished a pretty awesome operation. Also, it was enlightening to hear how my attending stumbled upon vascular surgery. We finished that operation, and, thankfully, the patient did well. Nevertheless, in the weeks since, my mind has wandered back to this simple question. It’s one I’ve had to answer many times over, starting from my interview days years ago. I wanted to share some of my answers in the hopes that it’ll inspire others to consider vascular surgery.

Vascular pathophysiology

The thought of intervening on arterial and venous pathology (all over the body, no less!) was strongly appealing to me. There is no other field of medicine that is able to do what we do operatively and clinically. We share the treatment of some vascular beds with other specialties, but none of them are able to provide the true comprehensive vascular care that a vascular surgeon can provide.

That niche and the unique pathophysiology mean that we interact with almost every other specialty in medicine. Since most disease processes require vascular perfusion, it

References

also means that vascular surgeons are often called upon to assist colleagues in unique ways.

Vascular pathophysiology is, at the same time, intriguing, complex, personalized and nuanced enough to keep us intellectually stimulated and engaged. No two operations as a vascular surgeon are the same.

The patient population

The vascular surgical population spans the extremes. On the one hand, vascular surgery patients are some of the sickest in the hospital. This means that, by default, we care for the marginalized, disenfranchised and most ill of patients with multi-system failure. Our patients frequently require ICU-level care, requiring us to have a strong working knowledge of critical care.

On the other hand, vascular surgery patients can be young, healthy athletes with thoracic outlet syndrome or popliteal entrapment, or they can be venous patients with varicose veins requiring outpatient intervention. I don’t like amputations, but as my training journey has progressed, I’ve come to see this intervention as less of a failure, but something that may help the patient achieve the goals of their lives after efforts at revascularization have not been successful.

The vascular surgical community

My first visit to the Vascular Annual Meeting (VAM) was in 2015, when it was in Boston. I remember walking away from that meeting feeling like I had finally found the group of physicians that I could fit into.

At that time, I had visited national meetings for other specialties, but vascular was the only one that checked all my boxes for what I was looking for in a career. Since then, I’ve attended many other vascular-specific meetings like the Vascular and Endovascular Surgical Society (VESS) meeting, the Pacific Northwest Endovascular Conference (PNEC), the Vascular Research Initiatives Confer-

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.

Precautions

ence (VRIC) and I’m looking forward to some more this year. At each meeting, I’m impressed by how tight and small a community vascular is. But, more importantly, my initial impression of the field as a welcoming, innovative, research-embracing, and collegial field has not diminished.

Research and mentorship

On that note, in 2015, I walked among the posters specifically looking to see what the breadth of research was in the field, and if I could fit in. I was pleasantly surprised at the number of high-quality scientific projects that were being pursued.

This discovery was very exciting because I knew that no matter what I decided to pursue in training or beyond, I knew I could find a mentor who had walked the road I sought to travel. Perhaps this was the biggest factor that drew me in to the field. And as a resident, the mentorship and sponsorship I’ve received have honestly kept me going.

The X factor

Okay, no, not the television show. Rather, the concept that there is just something indescribable about vascular surgery that just makes it cool. Maybe it’s the numerous endovascular devices we get to use, or it’s that we use fine needles and Castroviejo drivers to operate, or we respond to emergencies day or night, or it’s because we have the best operating room playlists; there’s just something about vascular surgery that makes it suave.

These were some of the answers I gave my M3 student. She was very good, and I hope she considers vascular. To that end, in 2023 at Corner Stitch we hope to cover a broad range of topics and, ultimately, help others see why vascular surgery is the best specialty!

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.

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 medtronic.com/AVdata

CHRISTOPHER AUDU is the Vascular Specialist resident/fellows editor.

All the things I love

IN.PACT™ AV Drug-Coated Balloon (DCB)

First & only

The first and only DCB with superior, sustained results at 36 months for AV fistula lesions versus PTA.1,2

Separate trials evaluating target lesion primary patency for IN.PACT AV DCB at 36 months and Lutonix™* DCB at 24 months.†

36-month results

vs. PTA at 36 months

vs. PTA at 36 months

26.9%

2.5% vs. PTA at 24 months

months

*Third-party brands are trademarks of their respective owners.

p = 0.087

0.087

24.4%

24.4%

43.1%

43.1% Standard

28.6%

28.6%

†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.

DISPARITIES

SVS Foundation board approves latest pilot programs to help underserved

By Beth Bales

THE SVS FOUNDATION HAS AWARDED GRANTS to two Society for Vascular Surgery (SVS) members to help them serve the underserved.

They are: Julia Glaser, MD, who is set to conduct two health fairs to screen attendees for vascular diseases (abdominal aortic aneurysms [AAAs], carotid disease and peripheral arterial disease [PAD]), as well as for PAD risk factors. She also will conduct a qualitative study to determine factors that cause patients with critical limb ischemia to delay seeking care.

And Tammy Nguyen, MD, who will look to address the limited access to preventative diabetes care and treatment for diabetic foot ulcers (DFUs) via mobile outreach clinics.

Julia Glaser

Glaser—an assistant professor of clinical surgery at Penn Medicine—works in Philadelphia, the United States’ seventh most populated city and one with a large high-poverty area, a high rate of diabetes and a disproportionately high rate of amputations.

“I see patients when amputation was all we could do for them,” she said. “And we wish we’d seen them six months earlier.”

She believes the city’s PAD burden is likely due to multiple factors in two main categories: lack of education and barriers to receiving care. Thus, her project includes both the health fairs and the qualitative research study to identify the barriers that prevent patients from seeking care earlier in the disease process.

“We want to raise awareness and see patients earlier, so we have something to talk about besides amputation,” she said.

The two health fairs would be held in early spring and late summer. Glaser anticipates each will reach 150 to 200 people, and will be held at churches in the west and southwestern Philadelphia areas. Multiple stations will screen individuals for vascular disease and for vascular disease risk factors, and offer information on hypertension, diabetes, PAD, AAAs, carotid disease and smoking cessation. Specialists in cardiology, vascular surgery, podiatry and primary care will be available.

The fair will include:

◆ AAA screening

◆ A quick carotid screening

◆ Ankle-brachial index

◆ Blood pressure reading

◆ A point-of-care hemoglobin A1c Patients will receive the results, as

well as care guidance, and will be encouraged to share the results with a primary care physician (including volunteers mailing the results at the fair). Information on primary care providers also will be provided.

The qualitative study will help Glaser get “a full picture of the reasons patients do not present to care in a timely manner,” she said. “I make a lot of assumptions about why people don’t seek care but what if I’m wrong? Maybe the truth is not that people don’t know they need care, but they can’t make appointments because they don’t have transportation. Maybe they’re afraid because a relative also had a similar slowly darkening toe or non-healing wound who ended up in the hospital for months, with sequential amputations before succumbing to heart disease.”

Study findings will help her make changes for the second fair, she said. “If a big problem is transportation, we’ll figure out ways to get people to me. We can have pamphlets outlining the transportation system. If smoking is an issue, we can have information on smoking cessation. We want to find out what’s preventing people from getting help.”

She said there is little existing literature on some of these delays in seeking care. She hopes her study will uncover the factors that may be missed in more traditional questionnaires written by healthcare professionals.

Glaser’s ultimate goal with her project? “I hope to put myself out of business.”

Tammy Nguyen

A major complication of poorly controlled diabetes is a DFU, which can lead to lower-extremity amputation. According to Nguyen, “Diabetes disproportionately affects more than 500,000 people suffering from homelessness or housing insecurities in the United States.”

FROM THE COVER:

continued from page 1

Foundation Chair Peter Lawrence, MD.

“That’s the aim of our pilot programs, which will bring healthcare to people in need, particularly those with diabetes, and the homeless.”

The program is being implemented through a phased approach, with two new programs recently approved. Three existing projects are “Disparities in Access to Care for Limb Salvage: The Oklahoma Project,” headed by Kelly Kempe, MD; “A Patient-Centered Approach to Reduce Diabetes-Related Lower Extremity Amputations among Underrepresented Minorities,” from Jospeh Mills, MD; and a project from Misty Humphries, MD, named “Targeted Outreach in Vascular Deserts to Improve Outcomes for Chronic Limb-Threatening Ischemia.”

“Lack of appropriate care leads to limb loss, stroke, death and other serious issues,” said Lawrence.

“And many of these situations are avoidable—if we can just get patients appropriate care. That is what this program strives to address.”

existing care to that population.

As Nguyen outlines, “By providing access to multidisciplinary diabetic foot care in a forum that is familiar and accepted by our focus population, this allows us to bridge any distrust these marginalized communities may have with the medical profession. We are essentially meeting them where they are.”

For example, at one event in the parking lot at the YMCA, a homeless man stood by, watching the mobile diabetic foot screening community outreach clinic for several hours, Nguyen related. Many volunteers asked him to register, but he refused, preferring to observe. At the end of the clinic, as volunteers packed up, he finally approached them and asked to be evaluated. He eventually told the volunteers of his prior bad experiences with doctors who, he said, “gave him meds he didn’t need and wouldn’t listen to him.” He told the volunteers he had a different view of them, calling them “good people who were just there to help,” said Nguyen.

“This interaction gave me insight into the psyche of the population we are trying to serve. Some people suffering from homelessness or housing insecurities may have had negative experiences with healthcare and are afraid or wary to seek help, even though they know where to go. Our presence in the community helps break down that barrier,” she said.

The homeless and housing-insecure population has a critical need for comprehensive care to prevent, diagnose and treat diabetic foot wounds because of the limited access to healthcare facilities either due to financial or transportation issues, or perceived barriers to care, she said.

“Diabetic foot ulcers and non-healing wounds that lead to amputation have a profound effect on the homeless, impacting their ability to walk, maintain independence, and work,” she said.

“The goal of our project is to impact and empower the homeless and housing-insecure population through preventative education and providing a welcoming healthcare venue that encourages diabetic foot care access and treatment.

“Patients understand the severe ramifications of an amputation and that they don’t want that happening to them. To prevent amputation, it’s our role as vascular surgeons to be better educators and help people advocate for themselves.”

The project is a pioneering approach to community outreach that is tailor-fit to address the unique needs of a disadvantaged community by improving access to multidisciplinary diabetic foot care in collaboration with local community facilities that already provide

The mobile diabetic foot screening community outreach clinics combine essential features of two different establishments, she said: “The multidisciplinary resources of large academic hospitals (UMass Medical Center) with the accessibility of established community centers. By combining these two establishments over the past two years, UMass Medical Center and local trusted community centers, we have been able to successfully create mobile diabetic foot screening community outreach clinics.”

The Vascular Care for the Underserved™ project will build on the experience of the previous five clinics. Each clinic provides not only core diabetic foot services, including vascular surgery, vascular non-invasive studies, diabetes, and podiatry, but also dermatology, ophthalmology, addiction behavioral health, and even COVID-19 vaccinations to an average of 40–50 homeless and housing-insecure participants at each event.

In addition to expanding the mobile diabetic foot screening community outreach clinics, the new project will also focus on identifying the specific barriers to care, how to systematically address these barriers, and provide follow-up care to the homeless and housing-insecure population identified.

In addition to this award, Nguyen also received the 2022 Vascular Cures Wylie Scholar Award and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) K08 grant, which also will focus on non-healing DFUs. For that project, she will research how diabetes affects the immune system and how that, in turn, affects wound-healing.

“I make a lot of assumptions about why people don’t seek care but what if I’m wrong? Maybe the truth is not that people don’t know they need care, but they can’t make appointments because they don’t have transportation…”

JULIA GLASER

Julia Glaser

Tammy Nguyen

SVS FOUNDATION CHANGES NAME OF PROGRAM AIMED AT PROVIDING CARE FOR UNDERSERVED PATIENTS

The Aortic Disease Program at Tampa General Hospital’s Heart & Vascular Institute is no stranger to the challenges of complex care. Situated in the population center of Tampa, Florida, in the nation’s third most populous state, the tertiary referral center stands poised to meet the flow of incoming cases that show increasing degrees of complexity.

The times could not be more apt for the team’s collaborative approach. Tampa General Hospital performs a large volume of fenestrated endovascular aneurysm repairs (FEVARs) for abdominal aortic aneurysms (AAAs) compared to many other centers, and confronts a familiar problem, says Dean Arnaoutakis, MD, the medical director of the Tampa General Hospital Aortic Disease Program. The combination of a large elderly population with increased implementation of EVAR over the past decade has given rise to the increasingly common patient popping up across the country, who presents with aneurysm sac growth, despite prior EVAR.

“We’ve done over 100 FEVARs in the last year,” observes Arnaoutakis, also an associate professor of surgery at the University of South Florida. “And about a third of that volume is for patients who have had failed prior EVARs, typically from a type I endoleak. So, we are amounting a rather robust experience and program of salvaging old EVARs by putting in custom fenestrated endograft to obtain more appropriate proximal aortic seal.”

This facility for endovascular salvage for prior failed EVARs is the result of a well of experience navigating the specific anatomic nuances and pathology of these complex cases. Though these EVAR revisions are

showing up all across the U.S., Arnaoutakis sees a higher overall number owing to being at one of the region’s largest tertiary referral centers, in addition to the large elderly population in the area, many of whom are former or active smokers, and thus more likely to have had an EVAR implanted in the first place.

Besides revisions linked to EVARs originally performed outside of instructions for use (IFU) parameters, Ar naoutakis also points to the volume of cases he carries out related to older itera tions of aortic stent grafts.

“Previously published stud ies indicate that compliance with EVAR implantation guidelines is poor, with up to 40–60% implanted off-label,” he says, which “will naturally lead to that device failing over time. I think we are seeing more of these cases now.

“In addition, we’re seeing a lot of first-generation devices, which are more than 10 to 15 years old, fail. We have learned over time that these earlier generation devices have either design or material imperfections. These issues are driving the high rate of failed EVARs in our practice.”

Arnaoutakis himself has been working to help find ways of dealing with these types of cases. One is a physician-sponsored investigational device exemption (PS-IDE) he gained earlier this year from the Food and Drug Administration (FDA) to evaluate

the efficacy of fenestrated and branched EVARs using physician-modified endografts (PMEGs) in a clinical trial setting.

“There were many reasons to apply for a PS-IDE to do F/BEVAR with PMEGs. The number of patients I encountered with failed prior EVAR who would not tolerate an open explant was certainly a driving factor as the current FDA-approved fenestrated device is typically not usable in this setting due to constraints with the device design. These patients often require a four-vessel fenestrated device with complete relining of the prior endograft, a device which is currently not commercially available,” he explains.

Increasing complexity, of course, comes with the inherent dangers posed by exposure to higher doses of radiation. In order to mitigate the effects, team members carrying out these procedures have access to zero-gravity, lead-based suits designed to decrease the amount of radiation to which they are exposed— which is “considerable” in the context of 100-plus FEVARs per year, Arnaoutakis points out. Similarly, the team uses cloud-based fusion imaging technology, which also helps reduce radiation exposure and speeds up procedural times, to make them more efficient and safe, he adds.

Arnaoutakis and the multidisciplinary Tampa General Hospital aortic team are

well positioned to deal with the incoming volume of these complex cases. “As our fenestrated endovascular aortic program has become more sophisticated, our overall practice has evolved such that we can salvage these failed endografts, which is decreasing our number of open explant operations. Our preliminary data suggests that this evolution in our practice has improved our patient outcomes,” he says.

That multidisciplinary team—previously led by Murray Shames, MD, now Tampa General Hospital’s chief of staff and the Richard G. Connar Endowed Professor and chair of surgery at the University of South Florida—includes key members from vascular surgery and interventional radiology.

“We have a wonderful relationship with our interventional radiologists here

who we often do these operations in conjunction with,” notes Arnaoutakis. “We each have a slightly different skillset, and, when combined, it really promotes our procedure technical success and improves patient outcomes.”

“ We are amounting a rather robust experience and program of salvaging old EVARs by putting in custom fenestrated endograft to obtain more appropriate proximal aortic seal”

ADVERTORIAL | THIS ADVERTORIAL IS SPONSORED BY TAMPA GENERAL HOSPITAL

Dean Arnaoutakis

Murray Shames

How a multidisciplinary team meets the complex challenges of fixing failed EVARs

2022 WAS AN AMAZING YEAR FOR SVS

By Beth Bales

DESPITE ANY NUMBER OF CHALLENGES, the Society for Vascular Surgery had a hugely successful 2022 and looks forward to a bright 2023.

Executive Director Kenneth M. Slaw, PhD, outlined a number of firsts for the Society, including:

◆ Publishing the first appropriate use criteria (AUC) to cover treatment of claudication

◆ Creating popular roundtable webinars on putting SVS guidelines into practice

◆ Holding the first hands-on training course, the Complex Peripheral Vascular Intervention Skills (CPVI) course

◆ Creating a new structure for the Journal of Vascular Surgery publications

◆ Conceiving and running the successful, first-ever Vascular Health Step Challenge, in which participants pledged to walk at least 60 miles during September—Peripheral Arterial Disease (PAD) Awareness Month—to highlight PAD and raise money for public awareness and other initiatives

The year also included the conclusion of the year-long celebration of the Society’s 75th anniversary, which kicked off in San Diego in August 2021, during the 2021 Vascular Annual Meeting (VAM).

Festivities ended in June 2022, with the “Cheers to 75 Years” Gala, which kept the crowd dancing and—not at all incidentally—netted the SVS Foundation more than $200,000 for programs and initiatives.

ADVOCACY

Growing the specialty and adding new voices, through:

◆ Adding membership sections for women and young surgeons

◆ Including sessions at VAM 2022 for all five special membership sections.

◆ Holding a summit on diversity, equity and inclusion (DEI)

◆ Adding a fourth pillar, for DEI initiatives, to the SVS Foundation

◆ Creating a portal for recruitment into vascular surgery, choosevascular.com, through COVERS (Coalition for Optimization of Vascular Surgery Trainees and Students), a coalition comprised of the Association of Program Directors of Vascular Surgery (APDVS), Society for Clinical Vascular Surgery (SCVS), SVS and the Vascular and Endovascular Surgery Society (VESS)

“Applying DEI awareness and principles is a culture-change journey, and we are well on the way to finding new balance,” said Slaw.

“Through changes in governance committees like the Executive Board, Strategic Board, appointments, and the Nominating Committee, greater DEI awareness is influencing the way we work and what we do.”

Advocacy in Washington to support patients and surgeons through:

◆ Holding the first Payment Reform Summit, bringing together people for two days of discussions on setting a new direction and alternative for government policies that affect vascular surgery

◆ Bringing aboard our new advocacy director and legislative assistant

◆ Organizing two separate “Weeks of Action,” urging member engagement with lawmakers in efforts to change policy on physician payment and reimbursement

“Great challenges remain with addressing payment policy, and it is looking more and more like the current system offers no acceptable path forward, so alternative, creative solutions need to be brought front and center,” Slaw said.

Expanding the SVS quality footprint in the United States and globally via:

◆ Establishing the Patient Safety Organization’s Vascular Quality Initiative as a premier provider of real-world evidence across medicine, government, and industry

◆ Expanding the Society’s work with the International Consortium of Vascular Registries

◆ Establishing SVS as the administrative home of the World Federation of Vascular Societies (WFVS)

“Quality patient care is central to the SVS mission, and the SVS must establish itself as the epicenter and driver of quality,” Slaw noted. He went on to add his personal thanks to the SVS leaders and volunteers, and staff, who together “achieved great progress in the face of many significant challenges.”

President Michael C. Dalsing, MD, said it has been his privilege to lead the organization as president for the past six months. “I am really looking forward to the next six as we prepare for the Vascular Annual Meeting in National Harbor,” he said.

After looking back, he added, he is also looking ahead. “The year 2023 will be even better! My hope is we will continue to work together to advance the specialty, improve patient care, and have even ‘more voices’ drive our efforts and be a unified force for our members. The Strategic Board of Directors meets in January with a fresh Member Survey to guide our planning … game on!”

SVS ends 2022 with latest ‘Week of Action’ to prevent Medicare payment reductions

The Society for Vascular Surgery (SVS) issued its thanks to December “Week of Action” participants.

ONCE AGAIN, SVS MEMBERS SHOWED

incredible support for the Society’s advocacy efforts by engaging in the week’s various activities and continuing to amplify the specialty’s collective voice on Capitol Hill, according to the SVS.

During the Week of Action, members were asked to join in a year-end push to prevent significant Medicare payment cuts by urging Congress to take action to address the critical issue before the end of its session.

More than 700 messages were sent asking for the inclusion of new funds in year-end legislation for the explicit purpose of increasing the non-facility/office-based practice expense relative value units (RVUs) negatively impacted by the clinical labor update policy

PAYMENT CUTS

New SVS series zeroes in on government’s impact on vascular surgery

STARTING NEXT MONTH, THE Society for Vascular Surgery (SVS) will begin a series of articles focusing on how the actions of Congress and regulatory agencies affect vascular surgeons and the patients they serve, and importantly, how sustained advocacy engagement is important for all SVS members.

“Government Grand Rounds” will strive to frame the importance of engaging in advocacy initiatives from a variety of perspectives.

“Advocacy” continues to rank high among SVS member priorities, and yet many members remain unsure how to support SVS advocacyrelated programs, what activities are available and how to measure success along the way.

The “Government Grand Rounds” series seeks to answer some of these questions and move the SVS closer to its goal of establishing a strong culture of engagement across our entire membership. —Beth Bales

CONGRESS FAILS TO #STOPTHEFULLCUT

DESPITE INTENSE PRESSURE from the entire healthcare provider community, Congress failed to include provisions in its year-end legislative package to fully prevent Medicare payment cuts that took effect Jan. 1.

from the Centers for Medicare & Medicaid Services (CMS).

These messages also included a parallel push to offer relief from the underlying fee schedule conversion factor adjustment, as provided in legislation introduced by Reps. Ami Bera, MD, and Larry Bucshon, MD (H.R. 8800). In tandem, advancement of these policies would help provide critical stability for vascular surgeons and ensure a positive foundation for ongoing deliberations regarding systemic reforms to Medicare physician reimbursement.

700

10,000 MESSAGES SOCIAL MEDIA VIEWS

Sending these messages wasn’t the only way members helped advocate during the

Week of Action. Members also helped raise the profile of vascular surgery by promoting the specialty’s key issues on social media.

Across all networks, more than 10,000 social media impressions, or “views,” were garnered.

The SVS Advocacy Council thanked all those who took part for remaining engaged and determined to advocate for the vascular surgical specialty. “With the start of the 118th Congress, there is much work to be done, and the Council looks forward to continuing to facilitate opportunities for SVS members to engage in advocacy,” Council staff said.—Beth Bales

The package—negotiated by congressional leadership—includes adjustments for the Medicare Conversion Factor (CF) for both 2023 (+2.5%) and 2024 (+1.25%) and postpones statutory “Pay Go” requirements to provide relief from an additional 4% reduction. After accounting for these adjustments, both physician and non-physician clinicians should anticipate an across-the-board reduction of approximately 2% in Medicare payments for calendar year 2023, depending on services provided and any 2023 Relative Value Units (RVU) changes to those procedures. Additional reductions relating to year two of the clinical labor update policy transition will also apply, with a variable impact depending on practice type.

The Society for Vascular Surgery (SVS) expressed disappointment that lawmakers are allowing any payment reductions to remain in place, a sentiment shared across the provider community. —Beth

Bales

Michael C. Dalsing Kenneth M. Slaw

SVS UNVEILS LATEST ADDITION TO JVS FAMILY OF PUBLICATIONS

By Beth Bales

THE YEAR 2023 PROMISES TO BE ONE OF change for the Journal of Vascular Surgery (JVS) family of publications, including the introduction of a fifth journal.

JVS-Vascular Insights (JVS-VI) launched this month as an online-only, open-access (non-subscription) title. This model is similar to that of JVS-Cases Innovations and Techniques (JVS-CIT) and JVS-Vascular Science (JVS-VS). The second journal, JVS: Venous and Lymphatic Disorders, (JVS:VL) remains a subscription-based publication.

Launching the new publication, said Executive Editor Ronald Dalman, MD, “reflects the shared vision of the Society for Vascular Surgery (SVS) and Elsevier to further enhance the relevance of the JVS portfolio for today’s vascular specialist.”

Insights will not focus on particular topics, such as vascular disease, veins, hard sciences, or technology and innovation and cases. Instead, editors would like qualitative, hypothesis-generating, and background research (trial planning) manuscripts; review articles; single-center quality improvement projects; practice management, business and ethics topics; as well as commentaries and historical vignettes.

Manuscripts now featured in the JVS “Education Corner” will be transitioned to JVS-VI later this year, and case-by-case, targeted manuscripts are being redirected from the other journals to JVS-VI

Dalman said a finer focus will evolve over time, but he said it is already clear that the new title’s dedicated education forum will provide for a “far more robust consideration” of the topic than was possible previously because of space limitations.

“Perhaps most importantly, however, our hope is that JVS-VI will engage new constituencies within vascu-

lar surgery, including the SVS Community Practice Section, to contribute those members’ insights and best practices into the lexicon of contemporary vascular care,” said Dalman.

“As the SVS/American College of Surgeons Vascular Center Verification and Quality Improvement Program (VCVQIP) begins its rollout later this year, JVS-VI will be an ideal forum to consider the effectiveness and impact of this partnership.”

Dalman will lead JVS-VI through the initial launch period, with active support from the editorial leadership of the other four journals.

Late last year, it was announced that JVS:VL was going green. From this month, the publication is published exclusively online.

“Society for Vascular Surgery [SVS] members, and millions of people throughout the United States and the world, are concerned about the environmental impact of the choices we make,” said JVS:VL editor-in-chief Ruth L. Bush, MD, explained of the decision to cease print publications of the journal.

“[JVS-VI] reflects the shared vision of the Society for Vascular Surgery (SVS) and Elsevier to further enhance the relevance of the JVS portfolio for today’s vascular specialist”

Timeline of JVS publications

2013: JVS-Venous and Lymphatic Disorders, (jvsvenous.org) dedicated to venous disease, launches

2015: JVS-Cases, Innovations and Techniques (jvscit.org) begins online publication.

2020: JVS-Vascular Science (jvsvs.org) is added to the roster

January 2023: JVS-Vascular Insights is introduced

EVOLUTION

Further changes in store for 2023

THE PLANNED CHANGES FOR 2023 FOR THE JOURNAL OF Vascular Surgery publications continue the momentum that began in mid2022. As former Editor-in-Chief Peter Gloviczki, MD, and Senior Editor Peter Lawrence, MD, ended their six-year run as editors of all publications, a restructuring took place. Ronald Dalman, MD, was named executive editor to oversee all things JVS and to enhance brand identity for the publications.

Separate editors also were appointed to lead each journal: Thomas Forbes, MD, editor-in-chief of JVS; Ruth Bush, MD, and Matthew Smeds, MD, editors-in-chief of JVS: Venous and Lymphatic Disorders (JVS:VL) and JVS-Cases, Innovations and Techniques (JVS-CIT), respectively; and Alan Dardik, MD, from editor to editor-in-chief of JVS-Vascular Science (JVS-VS).

Other changes and additions planned for this year include:

◆ Focus on author experience as a priority for all JVS journals, including expectation of a less-than-30-day interval from submission to first decision

◆ Updated editorial board lineups for each JVS specialty journal

◆ Adoption of new guidelines for aspiring editorial board (EB) members, with defined and transparent metrics for EB selection and further leadership opportunities going forward

◆ A social medial editor for each journal, with assistance from SVS JVS-assigned staff

◆ Expansion of Audible Bleeding podcasts highlighting Editors’ Choice of the month articles, featuring editorial team interviews of selected authors to get the “story behind the story.” Selected articles will rotate between portfolio journals each month

◆ The official transition in January of JVS:VL from print to digital. The switch to digital-only reduces not only costs but also its environmental footprint

◆ A virtual special issue on peripheral arterial disease (PAD) in JVS-VS guest edited by Alan Daugherty, PhD, and David Vorp, PhD

◆ JVS-CIT’s inaugural “Virtual Special Issue” on new developments in treating PAD. Frank Arko, MD, of the Sanger Heart and Vascular Institute, will guest-edit the issue, which editors hope to have online in the spring. An additional special issue is planned for later in the year.

◆ The introduction of “How I Do It” articles in JVS-CIT, highlighting the work of surgeons known to excel at particular procedures

◆ JVS-CIT articles taking a different focus, including “Cases in Leadership,” written by graduates of the SVS Leadership Development Program

“We’re excited about what we’re introducing this year,” said Dalman. “Our editors have lots of ideas on how to increase engagement and make our journals even more relevant to our members and others in the vascular surgery specialty.”

Beth Bales

NEW

January’s free-access papers in JVS, JVS:VL

JVS

1. “Statin therapy is associated with improved perioperative outcomes and long-term mortality following carotid revascularization in the Vascular Quality Initiative (VQI),” with a visual abstract. Visit vascular.org/JVS-StatinTherapyJan23

2. “Understanding radiation exposure and improving safety for vascular surgery trainees,” which is set to be featured on an episode of the Audible Bleeding podcast. Visit vascular.org/

JVSRadiationSafetyJan23

3. “Endovascular navigation with Fiber Optic RealShape (FORS) technology,” with a visual abstract. Visit vascular.org/ JVS-FORStechnologyJan23.

4. Variability of antiplatelet response in patients with peripheral artery disease,” Editor’s Choice, with a visual abstract and CME credit possible. Visit vascular.org/ JVS-AntiplateletTherapyandPAD

5. “Racial disparities in presentation and outcomes for endovascular abdominal

aortic aneurysm repair,” with visual abstract). Visit vascular.org/JVS-RacialDisparitiesAAAJan23

JVS:VL

1. “Excellent results seen in both transaxillary and infraclavicular approach to first rib resection in patients with subclavian vein thrombosis,” Editor’s Choice. Visit vascular.org/JVSVL-VTOSJan23

2. “Criteria to predict mid-term outcome after stenting of chronic iliac

vein obstructions (PROMISE trial),” CME credit available. Visit vascular.org/ JVSVL-PROMISEJan23.

3. “Identification of lymph vessels using an indocyanine green (ICG) camera-integrated operative microscope for lymphovenous anastomosis in the treatment of secondary lymphedema.” Visit vascular.org/JVSVL-MappingLVAJan23

4. “Pathologic characteristics of human venous in-stent stenosis and stent occlusion.” Visit vascular.org/JVSVL-StenosisPathologicFeatures

JVS-Vascular Insights JVS-VI

January 1984: Journal of Vascular Surgery (JVS) (jvscsurg.org) begins publication

Get FIT: Applications for Quality Fellowship in Training program open

The Fellowship in Training (FIT) from the Society for Vascular Surgery’s Vascular Quality Initiative (SVS VQI), introduces residents and fellows in vascular-focused programs to the SVS Patient Safety Organization (PSO). FIT debuted just a year ago, in January 2022, with 16 inaugural trainees and 16 VQI mentors.

The program lasts 12 to 18 months and is designed to foster an understanding of quality processes and metrics among the trainees through mentorship in the VQI. FIT is offered in collaboration with the Association of Program Directors in Vascular Surgery (APDVS), American College of Cardiology and Society for Vascular Medicine.

VQI aims to raise the bar for vascular care, quality improvement and patient outcomes. Currently, 968 centers participate in the VQI’s 14 registries, and more than 1 million procedures have been captured. Vascular surgeons, cardiologists, radiologists and other

CASES

By Beth Bales

specialists who perform vascular procedures participate in registry data collection.

FIT is open to people completing medical residencies or fellowships in any vascular disease-focused specialty (vascular surgery, cardiology, radiology or vascular medicine).

The trainees work closely with their mentors on participation in regional biannual meetings and review of comparative VQI data, including center-level quality improvement processes.

They are part of the quality improvement process, plus work in quality charter development and research initiatives using VQI data.

“This is an incredible opportunity for those who are invested in quality improvement and safety in vascular surgery,” said Gary Lemmon, MD. “Data—collecting it and sharing it—is at the heart of everything we do, and FIT participants learn how this all impacts patient care and outcomes.”

Participants can:

Prioritizing “entertaining and informative” sessions, the 29th Annual Pennsylvania Hospital Vascular Symposium and the 3rd Annual Pennsylvania Hospital/University of Pennsylvania Non-invasive Vascular Laboratory Symposium (April 21–22) in Philadelphia returns, providing the latest open surgical and endovascular management of vascular disease. Discussing this year’s meeting, Keith Calligaro, MD, chair and director, tells Eva Malpass the program will center around “brief” seven-minute presentations and subsequent case appraisal, aimed at sparking debate and audience discussion to aid information sharing and learning.

“It is a pretty unique conference,” Calligaro explains, “during each session we have around four or five speakers, but very brief talks and after that we present cases and say: ‘What would you do?’”

The program seeks to encompass all areas of vascular surgery, including evolving fields such as increasing endovascular management of thoracoabdominal aortic aneurysms (TAAAs). Among other aspects of the program highlighted by Calligaro is the predominant theme of emerging techniques and technologies, including the role of artificial intelligence (AI). Leveling the playing-field, the meeting gives all participants the opportunity to share their methodology. Calligaro recalled a particular case he put to Bruce Perler, MD, who was chief of vascular surgery at Johns Hopkins: “I went up to him and asked ‘What would you do? […] He kept hedging, and I said you’ve got to make up your mind and say what you’re going to do. I thought he kept dodging my questions, and he finally said in an exasperated tone of voice, ‘whoa, whoa, whoa, I feel like I’m taking my vascular boards again!’”

Calligaro commented on how the structure of the meeting has “evolved,” recalling the first 10 years, when the meetings were primarily devoted to one topic, such as aortic aneurysms or carotid disease. Following a more varied format over the next 20 years, he gathered feedback revealing the value audience members gained from active dialogue on a wider breadth of case presentations. Utilizing this back-and-forth as “reinforcement” for the core presentations, Calligaro now walks among the audience spotting dozing audience members and asking about their approach—“just to keep everyone on their toes.”

“Every year we have three of the most famous vascular surgeons in the country present ‘My worst case with a bad outcome—they happen to me too’ during the second morning of the meeting,” he said. “I ask them not to present a tough case and the ending is how great you are. The ending should be that they are human and something didn’t go right, even for these experts. I think that’s the teaching point for the trainees.”

Calligaro’s approach aims to bring humor to education, providing a unique twist to keep attendees engaged. Setting sights on April, Calligaro added that by “addressing controversial topics of interest” to vascular surgeons, reinforced by “lively, educational and fun” debate, he expects the meeting to be a success.

◆ Gain knowledge/understanding of a PSO and its strengths and limitations on data sharing

◆ Gain familiarity with mechanics of data entry into the VQI website, including abstraction requirements, variable definitions and inclusion/exclusion criteria for registry data

◆ Learn the value of data review via regional group meetings, big-data analysis of VQI@VAM and how this cannot be done locally at a center or single institution

◆ Develop enthusiasm for participation in regional and national meetings as 1)

potential for career networking, and 2) improving process of care back to center level

◆ Learn the value and mechanics in implementing a Research Allocations Committee (RAC) proposal and use of metadata via claims linkage such as Medicare

◆ Experience career advancement—again through networking capability, volunteer participation in steering committees/research/presentations and the value of mentoring from experienced vascular surgeons

The first group of trainees will have the opportunity to present their work in June during VQI@VAM, the VQI annual meeting held in conjunction with the SVS Vascular Annual Meeting (VAM). These participants also will be competing for one of five coveted Jack L. Cronenwett Scholarships, worth up to $10,000 each, to continue their research and/or work more closely with committees and staff on VQI initiatives. The scholarship is named for Jack L. Cronenwett, MD, vascular surgeon, educator and the VQI registry’s co-founder.

More information is available at vascular. org/VQIFIT

“Data—collecting it and sharing it—is at the heart of everything we do, and FIT participants learn how this all impacts patient care and outcomes”

GARY LEMMON

‘Unique’ vascular meeting set to update surgeons, prioritize audience debate

VASCULAR

ACCOLADES

It’s awards season at SVS as well as Hollywood

By Beth Bales

It’s not quite the Hollywood version, but January kicks off “Awards Season” at the Society for Vascular Surgery (SVS) and the SVS Foundation, with deadlines in February and March for many honors.

In many cases, the awards represent not only a nod to the past and present, but also the future. With some deadlines having already passed early in the year, submission time is in full swing.

“In the case of our career-long awards, such as the SVS Lifetime Achievement Award and the Medal for Innovation Award, we honor those who have contributed over the course

of decades—not only to our Society but also to our specialty,” said SVS President Michael Dalsing, MD. “We also have our student, resident and trainee awards, and research awards which recognize the work of those working to affect the future, to forward new treatments to impact the course of vascular disease and affect our patients lives for the better.”

Feb. 1

◆ SVS Foundation Student Research Fellowship: The award supports undergrad-

uate and medical students at universities in the United States and Canada who are conducting laboratory or clinical vascular research projects

SVS Excellence in Community Practice Award, honoring members who have exhibited outstanding leadership within their communities as a practicing vascular surgeon, including those who practice in outpatient-based facilities

March 1

Applications are due March 1 for several gongs, including some of the Society’s most prestigious honors.

SVS Awards include:

The Lifetime Achievement Award, one of the highest honors SVS bestows on a member. This award, presented at the Vascular Annual Meeting, recognizes an individual’s outstanding and sustained contributions to the profession and SVS, and their exemplary professional practice and leadership. The 2022 recipient was Jonathan B. Towne, MD

◆ Medal for Innovation in Vascular Surgery, honoring an individual whose contribution has had a transformative impact on the practice or science of vascular surgery. The most recent recipient was venous surgery pioneer Robert Kistner, MD, in 2019

SVS Foundation Awards include clinical Research Seed Grants, providing $25,000 in direct support for pilot clinical projects that could potentially become larger studies funded by industry or government sources.

A patient-oriented topic is encouraged. Recent recipients are:

◆ James C. Iannuzzi, MD, studying “Prehabilitation using a digital app in elective inpatient vascular surgery” (2022) and, from 2021

◆ Cassius Iyad Ochoa Chaar, MD, “Genetic variants associations with premature peripheral arterial disease,” and

◆ Katharine McGinigle, MD, “Using precision medicine to define adaptive treatment strategies for patients with chronic limb-threatening ischemia”

Starting this year, SVS has added service to the Society as an important component of its SVS Distinguished Fellow process. Nominations and applications also are due March

1 for this honor, which goes to Active, International or Senior vascular surgeon members who have made substantial contributions in two of the three categories of research, service and education. Visit vascular.org/DistinguishedFellows for more information.

For award information visit vascular. org/SVSAwards or vascular.org/ SVSFoundationAwards

L i m i t e d - t i m e 2 5 % d i s c o u n t !

5 t h E d i t i o n o f t h e V a s c u l a r

E d u c a t i o n a l S e l f - A s s e s s m e n t

P r o g r a m ( V E S A P ) :

1 3 t o p i c a r e a s

V E S A P 5 V a s c u l a r L a b ( s e p a r a t e p u r c h a s e )

4 m o d u l e s f o r d i a g n o s t i c s &

i m a g i n g

C o n t e n t a n d q u e s t i o n s b a s e d o n

c u r r e n t p r a c t i c e , t r e n d s a n d g u i d e l i n e s

T o p i c s t h a t a l i g n w i t h V S C O R E

L e a r n i n g & e x a m m o d e s

C o m p a n i o n a p p f o r o f f - l i n e u s e

P e r f e c t f o r :

Q u a l i f y i n g ,

c e r t i f i c a t i o n &

r e c e r t i f i c a t i o n

e x a m p r e p

A B S I T E & V S I T E e x a m p r e p

S a t i s f y i n g

C M E / M O C

r e q u i r e m e n t s

R P V I c e r t i f i c a t i o n

S t a y i n g c u r r e n t

w i t h t h e s p e c i a l t y

“We honor those who have contributed over the course of decades— not only to our Society, but to our specialty”

MICHAEL DALSING

FROM THE COVER: OBITUARY: SVS MOURNS PASSING OF FORMER PRESIDENT continued from page 1

ing loyalty, and devotion to family will be remembered by all of those have worked and trained with him,” said Pearce. Tributes began coming in quickly. “He was one of my vascular heroes as a trainee and early-career surgeon,” said William Shutze, MD, now SVS secretary.

“It was my extreme good fortune to have trained under Dr. James S.T. Yao (Jimmy) in the early 1980s,” said SVS President Michael Dalsing, MD. “Jimmy was an exceptionally skilled vascular surgeon who also had the ability and willingness to train others. He was not afraid to innovate on the spot if it meant that his patient would do better— his care was always patient-centered. It was truly a joy to watch him operate and to mimic his skills in some small way. Jimmy expected remarkable things from himself and from you—measure to improve, ‘do it once, do it right and you don’t have to do it again,’ improve others by adding to the literature, and no ‘tomatoes’ meaning hematomas.

“But with all his success he never forgot who he was— truthful, dedicated, humble and intellectually fearless.

Dr. James S.T. Yao has been my longest and unfailing teacher, mentor and sponsor during my career, and I will greatly miss him. We have all lost a friend and colleague who is irreplaceable—one of a kind.”

“Jim was a giant in our vascular surgery specialty and as one of our past presidents,” said past president Ali AbuRahma, MD. “God bless him; our hearts are with his family.”

“What a great man—he will long be remembered,” said President-Elect Joseph Mills, MD, adding that on a personal level, Yao was always kind and supportive to Mills early in his career.

Quoting Maya Angelou’s poem, “When Great Trees Fall,” Mills said of Yao, “In the forest of vascular surgery, he was

FOUNDERS PAPER

PLANNED AND UNPLANNED VASCULAR ASSISTS FOUND TO IMPROVE OUTCOMES

An award-winning paper presented at the 2023 Southern Association for Vascular Surgery (SAVS) annual meeting in Rio Grande, Puerto Rico, established an association between vascular involvement in non-vascular-led cases where vascular expertise was required and improved patient outcomes (writes Bryan Kay).

EMMA ROONEY, MD, A VASCULAR SURGERY fellow at Emory University in Atlanta, collected SAVS’ prestigious Founders Award for the work on the first day of the meeting (Jan. 18–21). The study showed vascular involvement improved outcomes in cases where that participation was both planned and unplanned

The retrospective analysis carried out by Rooney and colleagues looked at 245 patients treated at three non-trauma hospitals who had vascular surgery involvement in their cases led by a non-vascular surgeon.

“Our initial interpretation was that we had improved outcomes in the planned cases because they did have favorable outcomes intraoperatively and postoperatively,” Rooney told SAVS attendees. However, upon further interpretation, Rooney said the analysis uncovered equivalent mortality in cases classed as unplanned, suggesting the specialty’s “high ability” to deal with complications.

In memoriam

JULIUS H. JACOBSON II, Julius H. Jacobson II, MD, 95, Dec. 4, 2022, who practiced vascular surgery at the Icahn School of Medicine at Mount Sinai in New York City for 54 years, 35 of those years as chief of vascular surgery. He is called the “father of microsurgery” for having developed the first microscope to allow the surgeon and first assistant to view a magnified operative field simultaneously, according to his obituary. He was showcased in a Society for Vascular Surgery History Project video, a series of interviews of outstanding leaders (visit vascular.org/JacobsonVideo). He also funded an annual research conference for the SVS, now known as the SVS Vascular Research Initiatives Conference (VRIC).

James S.T. Yao being interviewed in a video history series

SOCIETY BRIEFS

Compiled by Beth Bales and Kristin Crowe

SVS WEBINAR ON 3D PRINTING SHOWCASES HOW TECHNOLOGY COULD AFFECT CURRENT AND FUTURE PRACTICE

THE RECORDING OF THE SOCIETY FOR VASCULAR

Surgery (SVS) webinar on three-dimensional (3D) printing in vascular surgery is now available on the SVS website.

The SVS Health Information Technology Committee (HIT) held the webinar, “3D Printing for Vascular Imaging,” in December 2022. Committee Chair Judith Lin, MD, and member Dan Kassavin, MD, co-moderated the webinar. Nick Carruthers, MD, Stacy Fisher, MD, Jeffrey Hirsch, MD, and Nicholas Osborne, MD, presented various aspects of 3D printing and its uses.

“Three-dimensional imaging is becoming an essential tool in the workplace, including in medicine,” said Lin.

Carruthers began the webinar with an overview on the use of 3D as well as a demonstration of how to “create a model from a CT scan and then print it mainly using consumer-grade printers and materials available to almost anybody.”

Osborne demonstrated, in-depth, how to use the technology for complex aneurysm planning and practice for actual surgery. His conclusions are that such printing in these cases has value in planning, in education for residents, explaining details to patients, and operating room back-table customization.

Fischer and Hirsch related how using 3D printing to make surgery safer for Fischer’s congenital heart disease patients led to requests from vascular surgeons to similarly help with aneurysm repair. The two also discussed which kind of imaging has led to the most success in 3D modeling; software; future directions, including personalized medicine with 3D models as part of a patient’s records; education; consultation with other providers; and more.

Sean Lyden, MD, is now chief medical consultant for VESTECK and has joined the VESTECK Scientific Advisory Board. VESTECK is an early-stage medical device company focused on the aortic repair and structural heart markets. Lyden chairs the Society for Vascular Surgery (SVS) Government Relations Committee and sits on the SVS Advocacy Council, and the Political Action Committee (PAC) Steering and Postgraduate Education committees.

Louis Kozloff, MD, a former varsity swimmer at the University of Pennsylvania, with his wife, endowed a swimming and diving head coaching position to the university. Kozloff is a vascular surgeon in North Bethesda, Maryland, and a professor of surgery at the George Washington University Medical Center. He and wife, Rene, both are Penn graduates.

Thomas Maldonado, MD, has been named chief medical officer for Koya Medical, which is developing treatments for lymphedema and venous diseases.

‘GATSBY’ GALA TICKETS ON SALE BEGINNING JAN. 20

BOOK YOUR TRIP TO THE Roaring Twenties early, and save some money, perhaps for auction items.

Early-bird ticket sales for the Society for Vascular Surgery (SVS) Foundation’s “Great Gatsby Gala,” to be held at the 2023 Vascular Annual Meeting (VAM), begin Jan. 20. Tables of 10 will be available for $5,000, $7,500 and $12,000.

This year’s Gala will transport attendees to the 1920s and the Jazz Age, the setting for the classic F. Scott Fitzgerald tale of mysterious millionaire Jay Gatsby. The “Gatsby Gala” will be held the evening of June 16 and will include the Surgeon Speakeasy Cocktail Reception, dinner, entertainment, live and silent auctions, and dancing. All proceeds will benefit the SVS Foundation and its efforts to fund the future of vascular health.

“3D printing has become the largest instructive technology shift since the internet,” Lin said at the webinar’s conclusion. “It’s fascinating to see where technology will take us in the future and definitely something we look forward to.”

The panelists’ information could “affect your current and future practices,” she told webinar participants, and the information presented during discussion could help surgeons take better care of their patients via various innovations. “Our next step is to strive for improvements in vascular care using these modern technologies,” she said. “Let’s innovate.”

To view the recording visit vascular.org/3DprintingRecording.

New CPT Codes for percutaneous arteriovenous fistula creation

By Sunita Srivastava, MD, and David Han, MD

FOR THE 2023 CURRENT

Procedural Terminology (CPT) code set, two new codes (36836 and 36837) have been added that describe percutaneous arteriovenous (AV) fistula creation in the upper extremity. The most significant material difference between these two procedures is that one approach requires two catheters from two different percutaneous access sites, one in the vein and one in the artery that are then approximated using magnets. The other technique requires a single percutaneous access that connects the artery and the vein under ultrasound guidance and then uses mechanical capture for approximation.

Both codes include all vascular access, angiography, imaging guidance, radiologic supervision and interpretation, and blood flow redirection or maturation techniques—for example, transluminal balloon angioplasty or coil emboliza-

tion—that are performed for fistula creation. Prior to 2023, there were only open surgical codes available for reporting an AV fistula, requiring a surgical cutdown to expose the artery and vein, vein dissection, ligation of venous branches, arteriotomy, and suturing of the vein to the arteriotomy. The coding descriptions for the open access procedures (36818, 36819, 36820, 36821) also include completion ultrasound and completion contrast angiography, if performed.

New codes 36836 and 36837 will have a 0-day global assignment, which means that any services or procedures performed on a day other than the date of the procedure may be separately reported. Surgeons also should keep in mind that percutaneous AV fistula creation in any location other than the upper extremity should be reported with code 37799, Unlisted procedure, vascular surgery.

Individual ticket sales will start at $500, beginning Jan. 20. This year, the Foundation is pleased to make a limited number of tickets available for young surgeons. “All of us involved in planning the Gala know that our young surgeons would probably find it hard to swing a $500 ticket,” said Gala Co-Chair Leigh Ann O’Banion, MD. “But as the future of the specialty and our Society, we want them to participate in this celebration of all things vascular.”

Besides general sales, the SVS is offering a number of sponsorship opportunities and table ticket levels.

For more information, visit vascular. org/2023gala.

Membership clears bylaws changes

THE SOCIETY FOR VASCULAR Surgery voting membership voted to approve proposed changes to the bylaws that will change the composition of the Society’s Nominating Committee.

A minimum of 150 votes is required to establish quorum and this was exceeded with 284 votes registered. A two-thirds majority of those voting is required for bylaws passage, and this was exceeded with 77.5% support.

Members voted in favor of three revisions to Article X of the SVS bylaws.

The committee’s size will remain the same, at seven members, but expand the diversity of perspective.

The changes affect the process for nominating SVS officers for 2023–24, which begins this month. The chair of the 2023 Nominating Committee is Kim Hodgson, MD.

Scenes from 3D printing webinar

ESVS AAA guidelines alert recommends

‘enhanced surveillance’ in patients treated with Nellix device

IN A NEWLY RELEASED “FOCUSED UPDATE” TO their 2019 recommendations, the European Society for Vascular Surgery (ESVS) abdominal aortic aneurysm (AAA) guidelines writing committee has published advice on the surveillance and management of patients treated with the Nellix endovascular aneurysm sealing (EVAS) system (Endologix).

The committee advises that all patients in whom a Nellix device has been implanted “should be identified, properly informed and enrolled in enhanced surveillance.” If device failure is detected, it states that “early elective device explant should be considered in surgically fit patients.”

The alert, authored by Jon Boyle, MD, from Cambridge University Hospitals NHS Trust and University of Cambridge in Cambridge, England, et al was published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

Boyle and colleagues note that they performed a scoping review of risk for late serious aortic-related adverse events in patients treated with EVAS for AAA based on a literature

search in PubMed up to Dec. 7, 2022. Following synthesis of the available evidence, the writing committee agreed on recommendations graded according to the European Society of Cardiology (ESC) grading system.

“EVAS has a very high incidence of late endograft migration resulting in proximal type 1 endoleak with risk of rupture, requiring open conversion with device implant,” the authors write, detailing their key finding from the review. They add that the reported mortality for elective explantation varies between 0% and 14%, while acute conversion for rupture has a “very dismal prognosis” with 67–75% mortality.

The authors detail that ESVS guidelines are renewed every five years or so, and that ESVS focused updates are issued “to convey important new data that have emerged in between the publication of the full guidelines, that affect patient safety or impact decision-making or management of the patients.”

In their 2019 guidelines on the management of abdominal aortoiliac artery aneurysms, the writing committee recommended that “conceptual new technologies, such as [EVAS], should only be used within studies approved by research ethics committees and with informed consent, until properly evaluated.”

In May of last year, Endologix ended

production of the Nellix EVAS system, based on reportedly higher rates of leaks around the device’s implantation, endograft migration and aneurysm sac enlargement. The guideline committee recognized, however, that there was no clear guidance on surveillance and management of patients who have already undergone AAA repair with an EVAS device. It was for this reason that the ESVS AAA guidelines writing committee initiated a literature review on the topic. “The current accumulated knowledge suggests that patients treated with EVAS for AAA may be at high risk for serious aortic-related adverse events, which justified an updated guidance on the surveillance and management of patients already treated with EVAS,” they write in the new paper.

Commenting on the timing of the alert, the committee note that they decided it was important to publish before the fully updated guidelines will be available in 2024, “to highlight the issues with EVAS failure, to promote patient safety and to encourage clinicians to identify all patients in whom a Nellix device has been implanted.”

MEDTRONIC HAS ANNOUNCED THE first patient enrollment in the ADVANCE trial, a head-to-head randomized controlled trial of two aortic stent graft systems, the Medtronic Endurant II/IIs system and Gore Excluder AAA device family systems.

The ADVANCE trial is a global, postmarket, prospective, interventional, multicenter study that will enroll a minimum of 550 patients at up to 50 centers globally. Patients will be randomized to receive endovascular aneurysm repair (EVAR) with either the Endurant family or Excluder family grafts, and will be followed at one month, one year, and annually through five years. The first patient in the ADVANCE trial was enrolled by the team led by Ray Workman, MD, at Novant Health Forsyth Medical Center in Winston-Salem, North Carolina.

“Through the ADVANCE trial, we are working to deepen our evidence of sac regression as a key indicator of long-term EVAR patient outcomes,” said Hence Verhagen, MD, professor of vascular surgery at Erasmus Medical Center in Rotterdam, the Netherlands, and co-principal investigator of the trial. “Our hope is that the findings will allow physicians to make evidence-based clinical decisions to improve long-term patient outcomes.”

The ADVANCE trial aims to further the understanding of sac regression by robust evaluation of CT imaging utilizing an independent core lab through five years. The trial will provide a comparison of aneurysm sac regression outcomes between the Medtronic Endurant II/IIs stent grafts and the GORE Excluder AAA stent grafts with additional evidence to analyze risk factors related to aneurysms that fail to regress. The trial will also compare other key clinical outcomes between the two stent grafts, including endoleaks, migration, secondary interventions, mortality, and renal complications.

“We are pleased to announce the first patient enrolled in the ADVANCE trial,” said Marc Schermerhorn, MD, chief of vascular and endovascular surgery, Beth Israel Deaconess Medical Center in Boston, and co-principal investigator of the trial. “This milestone underscores the commitment to rigorous study of the long-term data around the durability of the Endurant system for patients in need of EVAR. The results of the trial aim to demonstrate contemporary outcomes and our overarching goal to deliver superior aortic patient care through robust and rigorous clinical data.”

The ADVANCE trial draws on clinical data showing that one-year sac regression is an early indicator of improved long-term survival. The outcomes were consistent with the eight-year results from the ENGAGE OUS Registry, published in January 2022, which demonstrated the long-term clinical safety and effectiveness of the Endurant Stent Graft System.

Compiled by Jocelyn Hudson and Bryan Kay

Medtronic announces first enrollment in head-tohead global randomized trial evaluating durability of EVAR

Nellix device