Vascular Specialist–March 2021

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Vol.17 No.03 MARCH 2021

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GUEST EDITORIAL RAMPED-UP BENEFITS OF PRODUCTIVITY

PRESIDENTIAL ADDRESSES OF GRIT AND MEETINGS IN THE PANDEMIC AGE

ACADEMIA COVID-19 STRIKES PRACTICE HARD

Outpatient centers like OBLs have lately come under heavy scrutiny in light of new evidence highlighting outlier utilization rates. Last month, the practice patterns of vascular surgery’s so-called 1% entered the crosshairs. But there is a much larger story behind the OBL– a less expensive, easily deployable venue for providing appropriate care

BY BRYAN KAY

Outpatient labs are not necessarily the financial windfall they are often claimed to be, and represent significant value as an appropriate setting for care, argue four private practice vascular surgeons in a detailed defense of the OBL.

BY DENNIS GABLE, MD, DANIEL T. MCDEVITT, MD, ROBERT MOLNAR, MD, AND PATRICK RYAN, MD See page 8–9

PAD

SET: There’s an app for that

BY BETH BALES

CALL IT TIMING ON SEVERAL fronts, each part coming together for the benefit of patients with peripheral arterial disease (PAD).

Included in the mix was an interest on the part of the Society for Vascular Surgery (SVS) to utilize technology to improve patient health and outcomes. Also percolating was an idea for an app to incentivize and monitor exercise therapy with the goal of delaying or preventing the need for intervention. And then there was the desire to be able to detect failing interventions in time to reintervene for better outcomes.

It’s all led down a long and winding road to the SVS Supervised Exercise Therapy (SET) app, announced last year and now in pilot testing. The hope is that by the Vascular Annual Meeting (VAM) in August, SVS SET will be more widely available for SVS members and other physicians to prescribe.

The app is geared to help PAD patients manage their disease at home through supervised exercise— considered the gold standard in the initial and longitudinal management of PAD—plus coaching and education. SVS is spearheading the app and therapy in partnership with Cell-Ed, a remote learning See page 9

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GUEST EDITORIAL

Ramped-up productivity incentives and a deadly down slope

BY BHAGWAN SATIANI, MD

THE HEALTHCARE SYSTEM ALWAYS CONDUCTS A and technical genius in a non-violent manner. I wrote “root cause” analysis when a medical error occurs. It looks several years ago about misaligned incentives between for a systemic problem to address in order to prevent a hospitals and physicians. Hospitals are increasingly being recurrence. Although multidimensional, we have failed remunerated by fixed payment models with an incentive to address one of the root causes of physician burnout: to limit services and procedures. Yet, physicians are an inability to act consistent with our own personal or incentivized by employers to increase productivity by professional ethical values, which is fertile ground for generating more work relative value units (wRVUs). So, moral distress. not only are incentives in opposite directions, but they I have written here about the moral distress that comes create moral conflicts for physicians who are torn between with caring for patients with COVID-19, and how it providing appropriate care or focusing on increasing leads to burnout. However, moral distress pre-existed the productivity to the benefit of themselves and employers. virus. I believe that in this era of change in institutional A recent study published in Health Affairs surmises employment of physicians, the heavy emphasis on that “wasted spending now comfortably exceeds $1 productivity incentives to increase mutual reimbursement trillion annually” in the is a factor in causing moral distress and increasing burnout United States. While in physicians. it is unclear is Financial incentives have always been a source of what “wasteful” conflict of interest in medicine. Even among staff model represents; institutions or other employers offering a fixed salary, even half of productivity is monitored. Physician employment by that number hospitals continues to increase each year. Hospitals provide is clearly physician wellness programs, wellness officers, resilience iniquitous. The training, ethical counseling, team-based care, and other pressure to useful techniques to blunt the significant emotional and produce for the physical consequences of burnout. We await empirical private practice outcomes of these interventions. Simon G. Talbot, MD, or hospital and Wendy Dean, MD, accurately state in a STAT article: employer may “Physicians are smart, tough, durable, resourceful people. create perverse If there was a way to MacGyver themselves out of this incentives and situation by working harder, smarter, or differently, they may also provide would have done it already.” For my younger justification for the few colleagues, MacGyver was a fictional TV character in the 1980s who was a genius at “fixing” things using engineering Bhagwan Satiani

VASCULAR SPECIALIST Medical Editor Malachi Sheahan III, MD Associate Medical Editors Bernadette Aulivola, MD, O. William Brown, MD, Elliot L. Chaikof, MD, PhD, Carlo Dall’Olmo, MD, Alan M. Dietzek, MD, RPVI, FACS, Professor Hans-Henning Eckstein, MD, John F. Eidt, MD, Robert Fitridge, MD, Dennis R. Gable, MD, Linda Harris, MD, Krishna Jain, MD, Larry Kraiss, MD, Joann Lohr, MD, James McKinsey, MD, Joseph Mills, MD, Erica L. Mitchell, MD, MEd, FACS, Leila Mureebe, MD, Frank Pomposelli, MD, David Rigberg, MD, Clifford Sales, MD, Bhagwan Satiani, MD, Larry Scher, MD, Marc Schermerhorn, MD, Murray L. Shames, MD, Niten Singh, MD, Frank J. Veith, MD, Robert Eugene Zierler, MD Resident/Fellow Editor Laura Marie Drudi, MD Executive Director SVS Kenneth M. Slaw, PhD Director of Membership, Marketing and Communications Angela Taylor Managing Editor SVS Beth Bales

2 • Vascular Specialist

with a flawed moral compass to perform “non-beneficial” work. A recent survey published in the Annals of Surgery

by Christopher J. Zimmermann, MD, et al targeted 5,200 surgeons using the revised Moral Distress Scale, a validated instrument for measuring moral distress in clinicians. More than half (58%) noted they are sometimes or often asked to perform non-beneficial surgery, while 77% said they performed at least one non-beneficial operation per year.

Academic surgeons are now suffering from the same disease of “productivitis.” In interviews with 30 surgical chairs, consensus indicated that academic health systems were supporting business goals instead of academic goals.

In many institutions, the power of governance has shifted away from demoralized academic leaders to corporate figures. Shrinking reimbursements are a part of but not the only reason for the demands for more productivity. Business leaders wish to expand programs and build new brick-and-mortar edifices. The encumbrance ultimately falls on physicians by opening pathways that allow them to increase their compensation through incentivized clinical productivity. This, of course, brings in more revenue for health systems to fund programs. The resulting time and effort devoted to more wRVUs then deemphasizes the other two missions of teaching and research—particularly clinical research.

I have been consistent in my view that excessive reliance on wRVU generation tied to compensation is a slippery slope. One of the chief causes of physician attrition is a conflict of values with employers due to our inability to act in harmony with our own ethical values. Beneficence may become secondary to personal or institutional interests.

Multiply potentially millions of such behaviors and we can surmise how this can lead to deep cynicism and loss of faith in the profession itself. We must always ask ourselves: How does this benefit the patient? Anything that does not benefit the patient may lead to something far deadlier than a slippery slope.

Bhagwan Satiani is professor emeritus in the division of vascular diseases and surgery in the College of Medicine at The Ohio State University.

He is an associate medical editor of Vascular Specialist.

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March 2021

CONFERENCE WATCH

First vascular meeting with attendees postvirus gains approving glances

don’t want to cut another person off.

It’s hard to direct those sort of things when you’re moderating because, again, it’s harder to cut somebody off without sounding like you’re being obstreperous.

Whereas if you’re having a conversation with somebody, it sounds like you’re interjecting; it doesn't sound like you’re interrupting. Those are subtle things, but that’s what having us all in the same room—doing the moderating—allows.”

Compromise

BY BRYAN KAY

The first major conference in the vascular surgery universe to incorporate an in-person element as part of a hybrid format has been hailed a success, portending what attendees might expect from the 2021 Vascular Annual Meeting (VAM) set for San Diego in August should it proceed in a similar fashion.

T

he Southern Association for Vascular Surgery (SAVS) annual meeting took place at the end of January in Scottsdale, Arizona, with about 40 people physically present in the room and many more tuning in digitally.

SAVS president Gilbert R. Upchurch Jr., MD, who was present in the flesh to deliver a presidential address focused on the importance of “grit” in vascular surgery (see page 10), told Vascular Specialist the meeting had stayed true to its tradition of good science while maintaining pandemic-era social protocols.

“We were the first meeting to get together—it was clearly scaled down,” Upchurch explained. “The Southern Vascular prides itself on really good science, but also really good social and family interaction. The science was great.

Given the constraints, we tried to keep six feet apart; there were only 40 people there; it was hard, but I would say, in general, it was successful.”

Most scientific presentations were delivered remotely in a recorded format.

Most of the designated discussants for the talks, too, were not present in person.

As a result, much of the discussion and questions from the audience saw presenters provide answers via phone link.

“The rule of thumb was, if you were not going to be present as a discussant, you had to have your remarks recorded,” Upchurch continued. “Not only did that make people stay within a certain timeframe, it made people condense and stay focused on the task of discussing the paper. For the most part, it also helped keep the meeting on track, which I thought was really important.”

The ultimate goal of the meeting—to generate new knowledge to help practicing vascular surgeons—was achieved, said Upchurch. “I think we delivered on that.

March 2021

“It's good to have interaction with people who do the same thing as you, because you realize you're not alone”—Benjamin J. Pearce That can be done through this format. A number of my partners who were back in Florida said they learned a lot from watching the hybrid meeting.”

Virtual format SAVS secretary-treasurer William D. Jordan Jr., MD, noted the relatively low numbers present in the room compared to the 2020 attendance—about 25% of its usual in-person turnout. Yet, he described how the meeting had managed to replicate the robust, discussant-led question-andanswer to-and-fro that occurs at the end of scientific presentations for which SAVS is renowned. “While we have looked at the virtual format—and people are used to looking at the collage of different participants—[for us] it still was missing some of the personal, collaborative element,” Jordan said.

“And while we had presentations that were on the screen, the fact that we had some actual presence I think helped with that discussion. That’s one of the things that makes the Southern such an interesting meeting and so well-attended.

People like the interchange between the people who are present. We were able to have an element of that discussion, and so we were able to rejuvenate some of that concern. Specifically, we had

the moderators live, and even though there were some discussants that were prerecorded, almost always we had someone from the audience stand up and add another question.”

Benjamin J. Pearce, MD, associate professor of vascular surgery and endovascular therapy at the University of Alabama at Birmingham, was a moderator during both the postgraduate program session and scientific sessions.

Having experienced a series of fully virtual meetings over the course of the last year, he feels the hybrid format proved a superior offering.

“Sometimes you need to seamlessly whisper, give each other hand signals, or write notes back and forth,” he said. “That way, you can keep the discussion going, keep it on time. When you’re doing it on a virtual platform, you can send chat—but that’s always distracting. You’re trying to watch what the person is saying, the chatbox pops up so you’ve got to open a keyboard. At least the hybrid allows for a much more fluid meeting.”

Like it is with radio shows or TV news programs, Pearce added, the goal was to avoid dead air. “With the virtual format, knowing when you should interject is not intuitive. It’s very hard if you’re a panelist to know when to interject because you

SAVS immediate past president W. Charles Sternbergh, MD—who also attended the meeting in person—was variously a panelist, discussant and audience member.

Those involved in managing the meeting had done a “tremendous job” blending the virtual and in-person elements, with about 80% of the talks digitally delivered, he said.

He emphasized the success of the postpresentation phone link to authors for questions from designated discussants and audience members, many of whom tuned in digitally and texted in questions.

“Despite the fact most of the presenters were not there physically, there was still the ability to have a good, lively interchange of ideas around the talks.”

For Sternbergh, the hybrid format was a step in the right direction. “Is this as good as having everyone there in person?

Certainly not,” he added. “There are intangibles that you lose from not having everybody present. But I thought it was a great compromise to be able to get things going in terms of having a meeting.”

For Pearce, what regional and national societies do best is provide camaraderie for members, bring widely distributed surgeons together in one spot to share ideas. To perform that function best, he said, the in-person meeting is necessary.

“We all go out and work in silos in a relatively small specialty compared to a lot of others. I’m lucky that I’m in a pretty big group, but a lot are in a group of one or two. They might not see another vascular surgeon in the entire week or month. It’s good to have interaction with people who do the same thing as you, because you realize you’re not alone. I think offering the hybrid for those who can’t travel in the future is probably a great thing to be able to do, but I also don’t think we should ever replace the goal of getting back to being together. Some of that is personality. Not everybody needs that sort of interaction.

But those of us who are social creatures certainly do.”

Survey Jordan, meanwhile, revealed preliminary data gathered from a survey SAVS sent out to attendees to ascertain their vaccination status. As of mid-February, all of the respondents had replied to say they had either had both doses of the vaccine, or they had previously contracted COVID-19 and had developed antibodies, he said.

“We surveyed and asked if there had been any COVID-19 illness since the meeting, and so far there has been none.

So that’s something else to consider.” vascularspecialistonline.com • 3

VASCULAR PRACTICE

Virtual VSB Certifying Exam ‘a huge success’

BY BRYAN KAY

The virtually administered Vascular Surgery Certifying Exam (CE) has been declared "a huge success" by members of the Vascular Surgery Board (VSB). The VSB recently entered somewhat uncharted waters by conducting the image-heavy CE for remote test takers but recorded just one incomplete test, Board members revealed.

GILBERT R. UPCHURCH, MD, CHAIR OF THE VSB, revealed that 168 out of a total of 169 candidates successfully completed the virtual exam process, which was conducted over a two-day period and involved 56 volunteer examiners and 33 proctors.

“The American Board of Surgery [ABS] had done previous Certifying Exams virtually, but we were the first group to use images, because vascular surgery is so image-conscious and image-dependent,” Upchurch said.

“So, we developed the ability to use CAT [computerized axial tomography] scans, ultrasounds, pictures of patients, etc. That was a huge success. Every one of our clinical scenarios, or testing scenarios, had an image or multiple images. I think the way we did that, and the way we handled that, on the Vascular Surgery Board made for a completely successful Certifying Exam.”

After COVID-19 led to the cancellation of the vascular CE last spring, a backlog of trainees waiting to take the exam developed. The General Surgery Certifying Exam

‘Vascular surgery is an integral part of a complete healthcare system’ A new Society for Vascular Surgery (SVS) report highlights both the critical skills vascular surgeons provide to a healthcare system and the specialty’s benefit to an institution’s bottom line.

“THE VALUE OF THE MODERN vascular surgeon to the healthcare system: A report from the Society for Vascular Surgery Valuation Work Group” was published in the February issue of the Journal of Vascular Surgery. Vascular surgeons provide a unique mix of medical, open surgical and endovascular skills, and fulfill a vital role in the continuum of care of vascular patients, the report stated.

They are also critical to a safe operating room (OR) environment and often provide intraoperative consultations to surgeons of almost every surgical specialty, reported the authors, who were led by Richard Powell, MD, chief of the section of vascular surgery at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.

The skills of vascular surgeons are needed in many nonsurgical situations, 4 • Vascular Specialist

was offered virtually by the ABS in October 2020. This was a large undertaking, with 306 candidates and 70 examiners, according to Board members.

The experience was a technical success, but the vascular exam presented new challenges. All of the scenarios contained images, which the candidate would view during the process of the exam.

The images needed to be imbedded in the electronic exam without prematurely revealing the diagnosis.

“Our vision was to make it identical to the in-person or face-to-face examination,” said Thomas S. Huber, MD, a member of the VSB. “That’s exactly how it worked out.

We did need to incorporate a host and a proctor with the examiners in each of the virtual sessions to facilitate the exam process and for security reasons, and that, quite frankly, worked out famously. This was a total team effort from the VSB, staff, and our volunteer examiners.

The whole group did an excellent job.”

All candidates and examiners took part in an introductory session beforehand to prepare for the exam, added Huber. The VSB members and their staff were “well-coordinated” in administering the content of the test, room assignments and monitoring, he said.

Meanwhile, Upchurch said the VSB aims to have cleared the backlog of test takers by this summer.

“Hopefully by the middle of the summer, we’ll be caught up with all the finishing vascular surgeons and have them Board-certified,” Upchurch explained. “We have a Qualifying Exam in April, and then another Certifying Exam for July or August, and then we’ll be caught up from COVID time—we’ll be back in real time.”

168/169

candidates successfully completed the virtual exam process

Certifying Exam: The image-heavy test took place over a twoday period, involving 56 volutnteer examiners and 33 proctors

too: For example, as experts in wound care, they are frequently the de facto lowerextremity wound care physicians.

“Vascular surgery is an integral part of a complete healthcare system,” according to Powell. “A multitude of specialties require vascular surgery assistance to perform complex procedures; but because vascular surgery is a relatively small specialty, the role and importance of the vascular surgeon in the healthcare system may be underestimated.”

Powell added: “The attributes of the vascular surgery practice are frequently invisible to hospital administration.”

The SVS Valuation Work Group evaluated the role of the modern vascular surgeon, vascular service line revenue, vascular surgeon contribution in different healthcare models, and how to hire and retain a vascular surgeon.

“The particular niche of vascular surgeons is the ability to combine both open and endovascular therapy into hybrid procedures that can take advantage of the unique opportunities that endovascular and open surgery provide,” the report stated.

Without the presence of vascular surgeons on standby, some hospitals may decide it is not safe to offer certain interventions, the authors added. The Valuation Work Group found the financial impact of having vascular surgeons “substantial.”—Beth Bales and Bryan Kay SOURCE: DOI.ORG/10.1016/J. JVS.2020.05.056 March 2021

LOWER EXTREMITY

FDA advisory panel recommends against premarket approval of Lutonix 014 DCB for BTK use

BY JOCELYN HUDSON

A Food and Drug Administration (FDA) advisory panel has recommended against premarket approval of BD’s Lutonix 014 drug-coated balloon (DCB) for use in below-the-knee (BTK) arteries. In a meeting on Feb. 17, the majority of the FDA Circulatory System Devices Panel concluded that the device was likely safe in BTK arteries, but not effective. The benefit-risk ratio also did not appear favorable for the Lutonix 014 DCB, it claimed.

PRIOR TO THE MEETING, THE FDA released an Executive Summary of the premarket approval application for the Lutonix 014 for the treatment of patients with critical limb ischemia (CLI) who have obstructive de novo or non-stented restenotic lesions in native popliteal, tibial and peroneal arteries up to 320mm in length and 2–4mm in diameter.

In the document, they detail results of the Lutonix BTK investigational device exemption (IDE) pivotal study on which they based their conclusions. This was a prospective, multicenter, 2:1 randomized controlled trial comparing the Lutonix 014

6 • Vascular Specialist

DCB (test group) to PTA (control group) for the treatment of BTK arteries. The study was terminated after enrolling 507 of the prespecified 840 vessels.

The FDA summarized the outcomes of the study: “The Lutonix 014 DCB met the non-inferiority primary safety endpoint at 30 days. The primary effectiveness endpoint results did not reach statistical significance, although a 10.5% improvement was noted at six months. However, a durable benefit was not seen at later time points, with the KM [Kaplan-Meier] curves converging at 12 months and primary effectiveness event rates favoring the PTA group thereafter.”

A member of the BD Lutonix family of drug-coated balloons

The FDA did not find any safety concerns with the device for this indication from the data provided: “To date, the FDA has not noted any safety concerns associated with the use of the Lutonix 014 DCB that would be expected to exceed those of current standard-of-care with nondrug-containing devices. While a safety signal for increased mortality was noted for the use of paclitaxel-coated devices in the superficial femoral artery, this trend was not evidenced in the current study in the BTK anatomy.”

However, they express concern regarding effectiveness: “A modest benefit in regard to the primary effectiveness endpoint compared to PTA can be seen

at six months, but a reversed outcome was noted at 12 months and beyond.

Both prespecified and post hoc secondary endpoint effectiveness evaluations did not demonstrate a clear benefit of the Lutonix 014 DCB versus PTA.” “Overall, the study was terminated early and did not meet the prespecified hypothesis test success criteria. It remains unclear whether the effectiveness differences at six months are clinically meaningful, and that the benefits of the paclitaxel-coated Lutonix DCB outweigh the risks compared to treatment with an uncoated balloon for treatment of atherosclerotic lesions below the knee,” they conclude.

March 2021

COMMENTARY

COVER STORY

In praise of the office-based interventional lab

BY DENNIS GABLE, MD, DANIEL T. MCDEVITT, MD, ROBERT MOLNAR, MD, AND PATRICK RYAN, MD

Vascular surgery has undergone dramatic changes over the last 30 years. What was once a traditional open surgical discipline has now become a hybrid specialty that involves open surgery and endovascular techniques. As vascular surgeons became more adept at endovascular interventions, the venue in which to do these procedures became more important. Initially, most interventions were done in the operating room (OR), where we were most familiar with the conduct of that environment. But it did not take long to realize that there were fundamental limitations in imaging equipment and personnel expertise.

A

s time progressed, many cases began to migrate down to the cardiac catheterization lab. This created other issues, as we were now in competition with cardiologists for the limited resources of the lab. In many institutions, the cardiology service line created a tremendous financial windfall, which was hard to ignore. This meant that vascular surgeons were not the most “favored nation,” and oftentimes our cases were pushed to later times in the day, if they were being done at all.

Also, during this time, the number of older patients increased substantially as baby boomers began to age up into the prime years of cardiovascular disease. This resulted in a higher caseload. The advent of and progression in development of newer endovascular techniques and devices meant that even older patients were candidates for intervention, as well as many patients who previously had few endovascular options. Over time, these changes created a tremendous volume of procedures that needed to be done.

At an institutional level, there was a contemporaneous increase in consolidation, and an overall net reduction in available procedure rooms. With an increasing number of cases and no place to do them, something had to give.

It became clear that most endovascular cases could be done on an outpatient basis.

With development of effective femoral artery closure devices, recovery times were brief after endovascular interventions.

This led to the realization that these cases could be done in a different venue than the hospital—such as an ambulatory surgery center or even in an office.

In 2008, the Centers for Medicare & Medicaid Services (CMS) recognized that endovascular procedures could be done in an office setting (site of service 11) at a significant savings compared to hospitalbased procedures. Available data supported the idea that procedures done in an office were as effective as those done in the hospital and did not compromise patient 8 • Vascular Specialist

safety. Since then, CMS has routinely reaffirmed the appropriateness of covering these procedures in the office setting.

The number of office-based intervention centers has grown steadily through the years to now exceed more than 500 in the U.S. Most procedures done at officebased laboratories (OBLs) are dialysis access maintenance, lower-extremity interventions, venous interventions, and other minor vascular procedures. These cases are done using local anesthetics and, often, moderate sedation. Patients are sent home the same day.

From a patient’s perspective, these outpatient units are very well received.

Most do not want to go to the hospital because they are generally dissatisfied with the experience there. Everything from parking to getting to the procedural unit can be distressingly complicated.

Interactions with hospital personnel are often confusing and unsatisfying. Waiting times are long as complex pre-procedure protocols are followed. Patients may have to wait an unexpected period of time for other physicians to finish their cases prior to their own case starting. This inefficiency has only been aggravated by delays over the last year caused by COVID-19 and the inability of hospitals to maintain elective schedules for outpatient procedures during this time.

Improvement In contrast, OBLs offer a much more patient-centric experience. The number of personnel that a patient interacts with is relatively limited. The venue is limited in size and not confusing to navigate. In some locations, you can park right outside the door. The procedure waiting time is usually short, as the OBL is more adept at predicting how long cases will take.

The office staff, who are familiar with the patient, surgeon and case conduct, knows better when to schedule patients based on the planned procedures for the day. The protocols can be streamlined and shortened since there are no competing service lines.

Vascular surgeons, too, have found the OBL to be a substantial improvement over the hospital setting. A significant portion of a surgeon’s time at the hospital is spent waiting for things to happen prior to the case commencing. This may be a result of elaborate pre-procedure protocols, multiple stakeholders participating in the process, delays in accessing the room secondary to cases that may overrun scheduled times, and a general delay since often vascular cases are not the priority for the catheterization lab. Generally, the lab decides what equipment will be available for the surgeon to use as many physicians

setting. The revenue generated solely from doing hospital-based cases is not adequate to provide reasonable compensation and cover increasing overhead costs for most independent (and even some employed) physicians.

For many vascular surgeons, the more expedient solution is to become employed by the hospital.

While this may be a practical solution to protect income, there are significant impositions on the surgeon’s time that can be frustrating, in addition to the loss of some autonomy that comes with the employment model.

Gable and colleagues are responding to this article published in last month's Vascular Specialist

“ While many patients may require open surgical procedures, endovascular interventions are safe and effective in salvaging limbs when done with appropriate indications. The OBL allows a less expensive, easily deployable venue for providing appropriate care to patients in a very satisfying setting”­ may request the same equipment at the same time. Additionally, specialty items may not be available due to the vagaries of hospital value committees and the consensus of those running the lab.

In the OBL, the surgeon has complete discretion over the timing of the case, the equipment to be used, and the circumstances under which the case will proceed. Using a consistent team of personnel, many of the inefficiencies of working with people who do not normally participate in the care of your patients are eliminated.

Financial gains from the outpatient lab have been a longstanding point of concern and discussion by some.

From a financial perspective, with the continuous and repetitive decrease in payment for peripheral vascular procedures overall by the payors, and the increase in costs of rent, supplies and staffing, it has become more difficult for a surgeon to make a living doing only open and endovascular procedures in a pure hospital

Surgeon income When working in an OBL, any excess margin goes directly to the financial benefit of the practice. Margin is defined as an excess of income over expenses. The expenses involved in an outpatient lab are not insignificant. When the reimbursement for an outpatient procedure is considered, keep in mind that a substantial portion of that cost is absorbed by both direct and indirect costs of owning and maintaining an OBL. In general, it is financially better to do these procedures in an OBL as compared to a hospital from a surgeon income perspective. However, it is not necessarily the windfall it appears to be.

When these cases are done at the hospital, the total cost of the procedure is higher to the payor. There is excess margin that the hospital keeps on these procedures. Therefore, there is no net savings to the system based on doing these procedures at the hospital, and the only difference is that the surgeon does March 2021

not benefit from the additional income compared to the overhead spent. The costs of rent supplies and staffing that are troublesome for private practice physicians (privately employed model) are covered in the employed model in part by the same technical fees paid to the hospital that are argued as a “windfall” for the outpatient labs.

What does this mean as a practical matter? Most of us continue to maintain hospital privileges and to take emergency room call. Without the additional benefit of our outpatient labs, we would not be able to afford the luxury of dealing with the hospital without having to be employed by the hospital. We genuinely care what goes on with our patients, and if there are any issues, we want to be able to address them ourselves in the hospital.

Resources As is true for all professionals, we are in the business of using our time and expertise to help our patients and to earn a living.

Our expertise has no practical expiration date, but our time does. Traditional open surgical procedures, particularly those that involve revascularization of the lower extremities, are time- and labor-intensive procedures. There simply are not enough vascular surgeons—nor OR time—to address all the limbs that are in jeopardy.

While many patients may require (and benefit from) open surgical procedures, endovascular interventions are safe and effective in salvaging limbs when done with appropriate indications. The OBL allows a less expensive, easily deployable venue for providing appropriate care to patients in a very satisfying setting for the patient and the provider.

The Society for Vascular Surgery (SVS) recognizes the value of the outpatient lab as an appropriate setting for vascular patient care.

Although some of the SVS members in a current employed model are prohibited from participating in the OBL, many SVS members who have busy inpatient practices with excellent quality outcomes also participate in an outpatient lab for reasons outlined. In 2018, the Section on Outpatient and Office Vascular Care (SOOVC) was created by the SVS to address increasing member support of this particular venue.

This year there will be several initiatives related to OBLs, including how to decide if this is right for your practice. We encourage all SVS members to join the SOOVC to stay abreast of new developments and have a better understanding of what these labs may provide for our practices.

Dennis Gable, Daniel T. McDevitt, Robert Molnar and Patrick Ryan are private practice vascular surgeons who operate office-based labs in Dallas, Atlanta, Flint, Michigan, and Nashville, respectively.

March 2021

SET: There's an app for that Continued from page 1

and telehealth company. After more than a year in development the therapy is now in pilot testing at 13 sites across the country. Physicians prescribe the therapy and patients complete it from their home using their mobile phones.

Cell-Ed provides live health and wellness coaching, and education on behavioral risk factors such as smoking.

The program calls for walks five days a week (with a minimum of three) for up to 60 minutes for 12 weeks. The app works on any mobile device, even “nofeature” phones.

SET app genesis Approximately two years ago, SVS leadership figures were discussing ways to better communicate and solidify the longitudinal and comprehensive approach vascular surgeons take in caring for patients with vascular disease—the journey of managing vascular disease often starts with medical management prior to any surgical interventions.

Led by Kim Hodgson, MD, then SVS president, the leaders also wanted to work on initiatives that would use technology to help surgeons in new ways. Why not work on developing an app to monitor PAD patients as part of walking therapy? “We don’t just do interventions,” said Hodgson. “We provide comprehensive care. .”

And so, SVS leadership put out a call for volunteers for a new Health Information Technology Task Force, whose initial focus would be on the development of the SET app. The interest and expertise of SVS members in this arena was significant, said Hodgson.

Judith Lin, MD, professor and chief of vascular surgery at Michigan State University College of Human Medicine was selected to chair the new task force.

Another volunteer was Oliver Aalami, MD, a clinical associate professor of surgery and the director of Biodesign for Digital Health at Stanford University.

He had already been working on the technological aspects of monitoring movement using personal digital technology.

His own frustration with failed interventions was behind his interest.

Patients who came in with occluded stents had noted three months earlier that they couldn’t walk as far as

previously but thought the situation their members to do it.” One possibility would improve. A lightbulb went off. is the telemedicine model, which could “That is where this journey started,” create reimbursement avenues for Aalami said. “Scar formation and providers. “The earliest opportunities neointimal hyperplasia are the most for adoption lie within value-based frequent causes of stent failure and healthcare systems or with providers subsequent difficulty walking, and this who participate in alternative payment forms slowly over time. I wondered, can models such as Medicare Advantage,” we detect patterns of decline in activity said Aalami. and correlate this with early stent failure?

Currently, supervised exercise therapy This could help personalize surveillance must be done in person or it’s not protocols.” reimbursed, explained Sunita Srivastava, SVS leaders approached Aalami MD, assistant professor of surgery at because of his digital health research and Harvard Medical School and chair of suggested a home-based exercise therapy the SVS Coding and Reimbursement program to bolster the utilization for Committee. “The SVS SET app and patients with symptomatic PAD. Months Cell-Ed coaching are really supervising of development followed, led by the HIT but using mobile technology to do so.”

Task Force in concert with Cell-Ed. With this in mind, the SVS is exploring The need for supervised therapy is and expects to be advocating for more there. Surveys show that though 49% of reimbursement of remotely supervised providers said they have referred patients exercise therapy. One example of such for SET, a whopping 98% said they would therapy being successful is in The if they could.

Netherlands, where any patient who Cost and inconvenience hinder wants even to consider intervention for prevalence. Reimbursement requires a PAD must first complete a SET program. hospital-attached setting where providers “In five years, 83% of patients didn’t need are on-site, but land and facility costs put intervention,” said Aalami. that out of reach for many. Moreover, Can it work for the app? By the end reimbursement typically covers the of June, SVS leaders hope to see if facility fee but not the supervision fee. the program has significantly affected Aalami began his work from a passive activity, quality-of-life scores, the technical standpoint. six-minute walk test and, Because typical PAD most importantly, the goals patients are older and patients set for themselves. have financial restraints, A longer-term goal is accessibility was key. to evaluate if a remote A functional program program can delay or of value “had to be prevent intervention. deliverable on the most basic of phones,” he said.

Enrollment Patients who do have The randomized controlled smartphones, on the other trial will start by May. hand, “get all the bells and Sites are currently being whistles,” including steps recruited, including those walked every day, plus with and without in-person activity trends that are exercise therapy programs. predictive of functional Organizers want to see capacity. how in-person programs At the same time, affect the therapy, and Cell-Ed provides the app’s The SVS SET app was if in-person and remote spurred in part by live coaches patients need programs both meet a desire to provide for encouragement and patients’ goals. In parallel individualized care and support in order to change with the randomized avoid interventions their behavior, as well as the controlled trial, other sites education and information to will be able to enroll and learn more about the disease. The HIT offer the program to their PAD patients.

Task Force designed and is conducting Aalami said he believes the SET app the pilot study of the app, which thus far merely scratches the surface in terms seems to be a success, said Task Force of technology and remote monitoring, chair Lin. Coaches report significant data-driven results and the future. The patient enthusiasm and progress.

Vascular Quality Initiative is exploring the possibilities because of the new Obstacles importance on patient-centered and A major obstacle to widespread program patient-reported outcomes. “It all adoption is reimbursement. While the started for me with more personalized SVS has funding for the pilot program monitoring after stent placement—is and an upcoming randomized controlled there a correlation between disease trial, there is much uncertainty as to burden and activity?” he said. what happens down the road.

Hodgson agreed. “It’s still a work in “It can’t be a free program forever,” progress; we’re still seeing where this can said Aalami. “We hope that if payors find go. I think it can go a lot further.” out it’s working, they’ll pay to incentivize And it all starts with walking.

vascularspecialistonline.com • 9

PRESIDENTIAL ADDRESSES

Life during the COVID-19 pandemic: Meetings about meetings and the grit that matters in vascular surgery

BY BRYAN KAY

THE PAST YEAR DURING WHICH THE CONCEPT OF “the meeting” shifted almost entirely into the digital realm has challenged everything from the constitution of the working day to the breadth of collective patience. Or, as Matthew Corriere, MD, at the helm of the Vascular & Endovascular Surgery Society (VESS) 2021 Winter Meeting ( Jan. 21–24), put Matthew the events of a-year-in-meetings: “Usually the VESS Executive Corriere Council meeting happens every month, or every other month, and then it started happening two or three times a week. I found we were actually having meetings about whether we were going to have a meeting, or whether the SVS [Society for Vascular Surgery] was going to have their meeting; and if they didn’t have their meeting, should we have our meeting. It got really, really meta quickly.”

Corriere, rounding out his 2020–2021 term as VESS president, was delivering a presidential address he dubbed “Meetingology.” The winter gathering of VESS, hosted at North American ski resorts, intentionally adds an informal note to proceedings, with attendees and presenters encouraged to dress down—even this year when the pandemic forced remote delivery. Hence, the mock serious rebukes fired the way of suited-and-booted trainees and students who apparently hadn’t received the memo on appropriate attire at the virtual podium.

The VESS presidential address follows a similar tone. So went Corriere’s boutique advisory, from a self-described “meetings connoisseur,” on the hows and whys of good (and better) meetings—and ways to avoid bad ones. Last year, he told the VESS virtual audience, “we started being ambushed and subterfuged with this endless set of meeting requests at the same time as many of us were hauled out of the OR [operating room] and had no idea.” A few years ago, Corriere had set himself a New Year’s resolution to set a weekly time allotment for meetings to four hours. He may have failed thus far, he reflected—but the COVID-19 era offered little indication he would make up ground anytime soon.

“There’s a growing angst about stopping the meeting madness, why your meetings stink, and what we’ve got to do about it,” he said. According to the book, “The Surprising Science of Meetings,” by Steven Rogelberg, PhD, there were 55 million meetings per year pre-pandemic, Corriere pointed out. There are costs to that, he said. In dollar terms, the figure amounts to $1.4 trillion in the United States. That doesn’t include opportunity costs, he said. “If you’re in a meeting, you can’t be doing something productive somewhere else.”

This conjures a term to which he said he relates: “Meeting Recovery Syndrome,” or time spent winding down after a frustrating meeting. In general, bad meetings tend to go along certain lines, Corriere argued. They might have ill-defined goals or lack an appropriate agenda. Key people may be missing.

There might be too many participants. The meetings may suffer from timing issues, or else poor interpersonal dynamics.

He provided 10 tips designed to wrestle good meetings out of groups of people. “Decide why you’re gathering, and if there’s not a good reason, cancel the meeting. Thoughtfully exclude people who do not need to be there,” Corriere said. The meeting environment should serve the purpose. Close the door; host with generous authority; be present; make an agenda with the most important item first; encourage “good controversy”; actively manage the clock.

And, he added, “conduct regular quality assessments.”

"THIS IS WHAT HAPPENS TO YOU WHEN YOU SHOW grit: You end up being elected president of the American College of Surgeons.”

Those were among the words delivered by Gilbert R. Upchurch Jr., MD, in his presidential address at the Southern Association for Vascular Surgery (SAVS) annual meeting in Gilbert R. Scottsdale, Arizona, in late January. He was talking about the Upchurch Jr. singular achievements of Julie Ann Freischlag, MD: vascular surgeon; the first, and to-date only, woman president of the Society for Vascular Surgery (SVS); and, now, the American College of Surgeons president-elect.

Upchurch interviewed Freischlag to help inform the argument he put forth in his address: that “grit matters in vascular surgery.” She figured among a trio of female vascular surgeons with whom he spoke about grit last year as the cultural currents around diversity, equity and inclusion issues shifted. She had told him: “Learning to speak out just by being the only female in the room was an art I learned early. I strengthened my grit as the number of female vascular surgeons increased.”

“Her story is really amazing,” Upchurch added. “I applaud the grit she has shown over time.” Upchurch aimed to use Freischlag’s story to help convince vascular surgeons of every stripe that the characteristic of grit was central in the practice of their specialty. For grit, he had told an audience made up of surgeons both in the room and many more attending virtually, is the antithesis of burnout. “Regardless of our struggles, we’re all obligated to make vascular surgery better for our trainees and future vascular surgeons, as well as our patients,” he said.

Earlier, Upchurch had told attendees he initially looked set to draw lessons on grit from a scene in the 1969 western movie, “True Grit,” starring John Wayne as lawman Rooster Cogburn. In that scenario, Cogburn is seemingly doomed yet resolute as four adversaries are arrayed against him. Yet, upon further examination, Upchurch would find true meaning in the character of the 14-yearold Mattie Ross, played by Kim Darby, who had hired Cogburn to help avenge her father’s murder.

Indeed, part of the initial impetus for his talk was the work of Angela Duckworth, PhD, a professor of psychology at the University of Pennsylvania, contained in the book, “Grit: The Power of Passion and Perseverance.” Her work defined grit, Upchurch said—specifically as passion and perseverance for very long-term goals. “I was really excited about giving a talk about John Wayne and True Grit,” he explained. “But it turns out, actually—after one of her TED talks—I had it all wrong. And especially given the issues that we’ve had around diversity, equity and inclusion, I pivoted my entire talk.”

He then proceeded to outline five methods vascular surgeons could use to develop grit: The tools of realistic positivity; of major challenges matching skillsets; of deliberate practice to the order of 10,000 hours in order to achieve mastery; of hard work; of higher meaning and purpose. “Hopefully I’ve convinced you that grit matters in vascular surgery,” Upchurch concluded. With the weapons of the grit toolbox, he said, vascular surgeons can treat the ailments that stalk them: burnout, apathy, implicit bias and indifference.

“We all need a little more Mattie Ross in us.”

“Usually the VESS Executive Council meeting happens every month, or every other month, and then it started happening two or three times a week”—Matthew Corriere

“Regardless of our struggles, we're all obligated to make vascular surgery better for our trainees and future vascular surgeons, as well as our patients”—Gilbert R. Upchurch Jr.

10 • Vascular Specialist

March 2021

LEADERSHIP

Freischlag: ‘Leading when everyone is watching— and when no one knows what to do’

BY BRYAN KAY

The title of this year's Southern Association for Vascular Surgery (SAVS) Jesse E. Thompson, MD, Distinguished Guest Lecture was heralded as “Leading when everyone is watching”—but COVID-19 lent the message Julie Ann Freischlag, MD, was attempting to transmit a certain sharpness.

“I

n parentheses, [leading when everyone is watching] means, actually: When no one knows what to do,” the CEO of Wake Forest Baptist Health system in WinstonSalem, North Carolina, told the recent SAVS annual meeting ( Jan. 27–30) in a virtual version of the lecture, which for the first time ever was delivered by a female surgeon. “And I’ll tell you, the pandemic has challenged us all.”

Freischlag was speaking about the impact on practice and her role helping lead her institution through the roller coaster of events since surgery ground to a halt last March. Learners were pulled

March 2021

off rotations, she recalled. Research was stopped. People had to deal with shifting advice around mask-wearing. Surgery then restarted. Testing for the virus improved.

Then COVID-19 came rip-roaring back in November, December and January, with many more cases, Freischlag continued.

Which is when leaders like her had to figure out how to get people vaccinated.

Yet, the pandemic also provided opportunity. She pointed to the pick-up of telemedicine and the recent success of Vascular Surgery Board exams, having been delivered remotely. “Challenges are gifts, even though sometimes it’s really hard to appreciate the gift we’re

given from COVID-19,” Freischlag said.

“We need to figure out what kind of opportunities come out of these kinds of calamities and disasters,” she added.

Freischlag pointed to data showing that only 47% of people strongly agreed that their employers communicated a clear plan of action for COVID-19. “I think that’s because it’s been so confusing,” she said.

Freischlag outlined a slew of potential leadership remedies. Team together, she said—but in a way that means others will feel compelled to follow. For instance, she highlighted the example of surgeons who shifted their cases to outpatient centers among those making a difference.

Do right by your patients, families and communities, she said: by doing things like helping those suffering from food insecurity, wearing masks and not congregating in large groups.

“Authenticity is really important. I know with my leadership style, you really need to show who you are,” Freischlag said.

“When I was the chair of surgery at Johns Hopkins, I was the only woman chair for 11 years, so my job was to speak out, and say what I felt, so that people could go forward and maybe do things differently in the future. Now, there are a few more women chairs, and a few more diverse chairs.”

On a personal level, Freischlag was the first person randomized to the Moderna

vaccine trial, she recently learned. Indeed, Freischlag prizes taking time to ask people how they can be helped through some of the rigors of the pandemic. In a recent instance, one such exchange had a remarkable ending.

“We have also asked people to start asking, ‘Are you going to take the vaccine?’” Freischlag told the SAVS gathering. “And to have a conversation about how it’s so important, because there are some people who are scared to take it.

I was just at my dentist last week, and my dental hygienist wasn’t going to take the vaccine. So I talked to her a bit about how I was the first patient in the Moderna trial, and how I had my vaccine months ago. At the end of my visit, she said, ‘I think you did more for me than I did for you today.’

She goes, ‘I am going to get my vaccine.’”

Julie Ann Freischlag

vascularspecialistonline.com • 11

TOWN HALLS

Branded! Putting together pieces of vascular identity

BY BRYAN KAY

Two-and-a-half years back, when Kathryn E. Bowser, MD, joined her current institution as a vascular surgeon, a confluence of unfolding events led her to a realization: “A lot of people did not understand what the modern vascular surgeon actually did.”

BOWSER, A HOSPITAL-EMPLOYED SURGEON at ChristianaCare system in Newark, Delaware, was outlining the backdrop to her use of the SVS Branding Toolkit during the latest edition of the Society for Vascular Surgery (SVS) Town Hall series focused on the early impact of the materials.

“We’re a large hospital system and we’re academicaffiliated,” she told the Town Hall panel. “I’d done my general surgery training there as well but I had to be reintroduced as a vascular specialist in a hospital where there were seven other vascular surgeons at the time, six of them having been there over 16 years and much longer. Around the same time, there was a shift towards more of the physicians—the cardiologists, the primary care doctors—also becoming hospital-employed. We were also in this heart and vascular service line—all this was happening at the same time.

“Even though academically we were under the

12 • Vascular Specialist

department of surgery, otherwise we were alongside cardiology and cardiothoracic surgery—but we never quite fit well in either realm. That became even more evident as I was pushing to market myself.”

Those individuals who did not seem to understand what it is vascular surgeons do included not only members of the marketing department, but patients, leadership, referring doctors and even other surgeons, explained Bowser. “It became pretty important to me to [market myself] and it just happened to coincide with the SVS branding efforts.”

As internal marketing efforts confused her with the likes of cardiology, interventional radiology and, in one instance, “women’s heart health,” she found herself steering the conversation back to what it is vascular surgeons actually offer.

The SVS Branding Toolkit—whose features include branding videos and condition-specific fliers—has helped feed Bowser’s own branding work on a bespoke website and her social media output. “What I really like about this is it’s so simple, and it works on what I think of as the grassroots level,” Bowser explained. “It can be just as simple as informing the people you know, the people in your immediate community, about what we do. It’s not just about self-promotion; it’s about elevating our specialty.

So, the more of us who do it in our own communities, the more effective it could be.”

Judith Lin, MD, professor and chief of vascular surgery at Michigan State University College of Human Medicine,

Lansing, Michigan, provided a view from academic practice. Starting a new practice eight months ago in the midst of the COVID-19 pandemic, she confronted the twin challenges of virtual visits and the fact there are few vascular surgeons in Lansing, the Michigan state capital.

“It seemed like the vascular surgery desert because I am the only board-certified vascular surgeon in Lansing, currently,” Lin revealed.

Which begged the question: Who is dealing with vascular disease in the area? “We’ve got the interventional cardiologists, who do a lot of peripheral interventions, either in the OBL [office-based labs] or in the hospital; we have interventional radiologists who also do a lot of peripheral [interventions]; so that’s what most people are thinking— that radiology and cardiology do the vascular [work]. Then there’s cardiovascular surgeons, who do a lot of the bypasses, the endarterectomies, in addition to open heart surgery.”

The Branding Toolkit helped Lin carve out messaging to explain the comprehensive nature of her vascular care. “I think we can enhance a lot of this with social media coverage,” she told the Town Hall.

Meanwhile, William P. Shutze, MD, a partner in Texas Vascular Associates based in Plano, Texas, labelled himself a branding novice by comparison, but an early adopter of the toolkit. He emphasized the need to create a national footprint for vascular surgery. “We really need to get everybody pitching in, trying to brand themselves locally, so we can get a national brand out of this,” he said.

“It seemed like the vascular surgery desert”—Judith Lin

March 2021

YOUR SVS

Key MACRA changes highlighted

BY MOUNIR HAURANI, MD, KAREN WOO, MD, EVAN LIPSITZ, MD, AND JOSE ALMEIDA, MD

The Medicare Access and CHIP Reauthorization Act (MACRA) is in its fifth calendar year, and the Centers for Medicare & Medicaid Services (CMS) continues to publish rule changes annually.

CMS HAS LIMITED THE CHANGES for 2021 Merit-based Incentive Payment System (MIPS) reporting due to the COVID-19 crisis.

The agency also introduced the Alternative Payment Model (APM) Performance Pathway (APP) for 2021 to reduce the burden on clinicians and stakeholders.

Key changes in the relative weight of the four MIPS performance categories— quality, cost, promoting interoperability (PI) and improvement activities (IA)— were made.

These include cost increases from 15 to 20% of the final score and quality decreases from 45 to 40%. The minimum reporting threshold to avoid penalties increases from 45 to 60 points, while the threshold for the exceptional performance category remains at 85 points.

Clinicians not participating at this level in 2021 will experience up to a 9% penalty in their 2023 Medicare reimbursements.

For MIPS APMs reporting traditional MIPS measures, the performance weightings are: quality, 50%; cost, 0%; PI, 30%; and IA, 20%—again with a

minimum threshold of 60 points. Eleven quality measures were removed for 2021, including “All-Cause Hospital Readmission.” Changes to more than 100 existing measures and the addition of two new administrative claims measures were implemented.

Importantly, the PI category retained the “Query of Prescription Drug Monitoring Program,” which is worth 10 points, or one-sixth of the points needed to avoid a penalty. In the IA category, CMS will continue to give credit for COVID-19-related data reporting, but only if entered into a clinical data registry.

Additional COVID-19-specific changes doubled the number of points available for the complex patient bonus—up to 10 points for the 2021 performance year.

Clinicians with practices affected by COVID-19 can petition for re-weighting of the performance categories.

CMS waived the requirement that Accountable Care Organizations (ACOs) perform Consumer Assessment

Channeling SVS messaging across diffuse mediums

Committees

BY BETH BALES

In order to recognize the diverse ways members interact and consume information, a new Society for Vascular Surgery (SVS) Communications Committee, replete with three subcommittees, has been formed.

The move is designed to allow the SVS to coordinate and expand the ways in which it communicates to its members and the world.

Subcommittees

T

he three subcommittees include the existing Public and Professional Outreach Committee led

by Joseph Mills, MD; Social Media, led by Meryl Logan, MD; and Website Development, directed

by Paul Crisostomo, MD. The SVS secretary, currently Amy Reed, MD, will chair the overall Communications Committee. It will focus on high-level communications strategy and help manage and integrate communications across all of the SVS, including print and digital publications, social media, the SVS website and SVSConnect, said Reed.

The expansion is a result both of continued growth of the Society and creation of new communications vehicles born out of the COVID-19 pandemic, a time when member communications took on increased importance.

“We had to focus on and communicate with members quickly on many important topics, seemingly all at once,” said Reed. “We experienced the sudden halt to elective surgeries, which affected members’ livelihoods; government response and assistance; cancellation of the 2020 Vascular Annual Meeting, and much more.”

To keep members informed of rapidly changing news, in late March 2020 the SVS began publishing the biweekly Pulse electronic newsletter every week, frequently with a March 2021

lead-off note from thenpresident Kim Hodgson, Magazines MD. SVS leadership met weekly to consider important topics that needed to be addressed, how to ease members’ concerns and to make suggestions for augmenting communications. Pulse has resumed its biweekly schedule but the need to integrate communications has not disappeared, said Ronald L. Dalman, MD, SVS president.

“We have a host of ways to reach our members, and need all of them to reach a diverse population of members who all communicate via slightly different manners,” he said.

Other vehicles include the bi-monthly DC Update newsletter, the monthly Vascular Trainee;

of Healthcare Providers and Systems (CAHPS) surveys. CMS finalized their plan to phase in quality reporting for ACOs to meet the “Shared Savings Program” quality performance standards.

The expectation is by the 2023 performance year, ACOs achieve a quality performance score greater than or equal to the 40th percentile across all MIPS quality performance category scores.

Finally, a new reporting pathway, MIPS Value Pathway (MVP), will be adopted in 2022. It is intended to be specialty-specific and will place more emphasis on patientreported outcomes.

For a more in-depth view of this topic, read a full-length version of this article at vsweb.org/MACRAchanges2021.

Mounir Haurani, Karen Woo (chair), Evan Lipsitz and Jose Almeida are members of the Performance Measures Committee.

biweekly Future Vascular Surgeons; occasional and potentially monthly SVS Foundation communications; eblasts; Vascular Specialist; Journal of Vascular Surgery publications and the new Audible Bleeding podcast.

The committees’ charges include overseeing the continued dissemination of the branding campaign; work with the Podcasts PPO Committee on strategic development around news and media, rapid response and crisis communication; work to develop strategies to reach medical students and residents; strategic oversight of increased social media e-newsletters engagement and new website development; to provide Town Halls consultation to SVS staff developing communications content via all channels; and developing media materials on items of interest across the Society, the medical community, and to consumers.

Among the members of the Communications Committee are the editors and hosts of Audible Bleeding (Sharif Ellozy, MD); Vascular Specialist (Malachi Sheahan III, MD); Town Halls (Kim Hodgson, MD); VAM Program (Matthew Eagleton, MD) and Membership (Afshin Molkara, MD) committees; the Diversity, Equity and Inclusion associate editor for the Journal of Vascular Surgery (Ulka Sachdev-Ost, MD); and the Coalition for Optimization of Vascular Surgery Trainees and Students (Chelsea Dorsey, MD). vascularspecialistonline.com • 13

ACADEMIA

COVID-19 pandemic led to ‘severe’ financial loss for academic vascular surgery division

BY BRYAN KAY

The initial stages of the COVID-19 pandemic resulted in threemonth sustained decreases in operative and outpatient clinical volume as well as a “severe” financial loss for a U.S. academic vascular surgery division, researchers from a prominent health system in an early epicenter reveal.

B

oth clinical volume and profit margins “returned to prepandemic values in month four” of the pandemic, a trend that has been sustained through the early part of 2021, said first-named author Clayton J. Brinster, MD, associate program director of the vascular surgery fellowship training program at Ochsner Health in New Orleans.

Brinster delivered the findings during a rapid-fire presentation session at the 2021 Southern Association for Vascular Surgery (SAVS) annual meeting, held in a hybrid format from Scottsdale, Arizona ( Jan. 27– 30). He was part of a research team led by senior author W. Charles Sternbergh III, MD, professor and chief of vascular and endovascular surgery at Ochsner.

Brinster outlined the still-evolving widespread financial impact of the pandemic on the U.S. healthcare system.

He said the Coronavirus Aid, Relief and Economic Security (CARES) Act was signed into law in March 2020 to help offset losses—but was based “only on an estimated total financial loss of 7–15%.”

A total of $323 billion was expected to be lost through October 2020, yet just $175 billion in healthcare relief had been allocated, Brinster pointed out.

He drew attention to data showing the quarterly average of national healthcare system operating margins from 2018 through the fourth quarter last year: The CARES Act did offset the “rapidity and severity of losses” in the second quarter but “the severe losses are not only ongoing but they’re progressing into the fourth quarter.”

He added, “The bottom line is that most healthcare systems already function at a slim-to-negative financial margin, and CARES Act relief funds have helped hospitals and healthcare systems—but they represent only a fraction of the losses incurred so far.”

So Brinster et al set out to examine the continuing evolution and impact of pandemic-induced financial changes within their academic vascular surgery division at Ochsner.

Operating room (OR), catheterization laboratory, vascular lab and outpatient

14 • Vascular Specialist

clinic volumes were reviewed. Financial returns and margins, insurance payor mix and relative value unit (RVU) generation were recorded, with the respective trends analyzed.

Two intervals were established for comparison, Brinster explained—the first a pre-COVID interval of 14 months including January 2019 through February 2020, the second a COVID cohort with data from March to November 2020.

“When we look at procedure volume through the early pandemic, it predictably decreases sharply an average of -31% per month over the first three months of the pandemic. This, of course, is due to major restrictions on elective cases and other features limiting patient interaction during those months,” Brinster said.

“When we trend our own cath lab volume in our division through the end of the year, we see a rebound toward the pre-COVID values in the threemonth cohorts examined in 2020.

“When we look at the RVU pandemic trends, we see, of course, another sharp downturn in those three early pandemic months of 32% per month, but actually overages of 13% and 8% respectively in the following months.

“Perhaps the most accurate estimation of financial generation and health of a division is, in fact, the hospital margin generated by the division.

This is basically an estimate of total professional revenue on an in- and outpatient basis. We see sharp down trends of 52% in the

negative from March, April and May of 2020, but a rebound to within 1% of pre-COVID values for the next two threemonth cohorts, which is encouraging.”

Turning to recovery, Brinster revealed the projected overage requirements that would be needed to achieve financial equipoise in light of the financial loss incurred earlier in 2020: Based on simple extrapolation modeling, he explained that “aggressive margin overages of 10% per month for 15–16 months would be required to make up for that three-month deficit of 2020.”

Furthermore, a less aggressive “but still very challenging” 5% per month overage would be required for 31–32 months to make up for the financial loss during the early part of the pandemic, Brinster said.

Concluding, Brinster said: “The early pandemic resulted in a three-month sustained divisional loss that was severe.

Clinical volume and profit margins returned to pre-pandemic values in month four of the pandemic, and that has been sustained through the early part of 2021. We saw the CARES Act supplementation grossly underestimates the acute and long-term financial need, and aggressive monthly overages and salutary return would take years to achieve financial equipoise without supplementation.”

$

‘Unanticipated’ Leading questions of the findings, rapid-fire session moderator Benjamin J. Pearce, MD, associate professor of vascular surgery and endovascular therapy at the University of Alabama at Birmingham, drew reference to further research presented by Ochsner researchers earlier at SAVS 2021 that detailed “unanticipated” major decreases in cases of acute stroke, interventions for acute stroke, and telestroke consults at a comprehensive stroke referral center in a pandemic epicenter—namely Ochsner and New Orleans.

Pearce asked: “You bounced right back, but you have done an overage of cases, looking at your case volumes—so where are those cases that didn’t get done during your downtime?”

That’s a question the team at Ochsner is attempting to answer, Brinster responded. “As you mentioned—and alluded to our stroke abstract—it’s all theoretical and based on assumption of changed behaviors due to the pandemic, with people afraid to come into the hospital, elderly populations not being checked on, a lot of noise in terms of communication to patients about when they should, or if they should, be coming in for follow-up.

“No one has any clear answers, but in terms of targeted strategy from the business end of things, it seems to be a four-pronged approach. One of those approaches is the supplementation of normal clinic approaches with an investment in telehealth to maintain an outreach in terms of new referrals, maintain relationships with primary MDs, renew prescriptions, etc. That’s not really an answer to where did they go, but how to capture them moving forward.”

William Shutze, MD, a vascular surgeon and partner at Dallas- and Planobased Texas Vascular Associates, probed Brinster on how the loss incurred during the fallow period would be achieved from a process point of view. “If your goal is to make up your loss during this free period of time with overages going down the road, there’s going to have to be adjustments made within the processes,” he said.

“You’re going to have to expand OR capacity and clinic capacity, and those are two barriers that aren’t easily changed in a large system. So is there a plan at Ochsner to attack this problem by adjustment in processes as well?”

Brinster said conversations are ongoing around rolling forecasts, revenue and costs to tackle the issue.

“Within service lines, I think they are taking a careful, very lean perspective on what can make more money and what’s losing money; however, there have been no concrete changes in our vascular surgery division.”

March 2021

AORTA

EVAR improves one-year survival in octogenarians with AAAs, study finds

BY BRYAN KAY

Endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) in those aged 80-plus decreases one-year mortality rates compared to non-operative management, researchers at the University of Texas (UT) Southwestern Medical Center in Dallas found.

WORKING FROM A COHORT OF 11,829 PATIENTS who met study criteria, Mitri Khoury, MD, a general surgery resident at the institution, et al found that while the predicted one-year mortality rate without EVAR was 14.6%, the actual rate was “significantly higher” with EVAR at 10.6% (p<0.001). The overall rate of major adverse cardiac events (MACE)—the study’s secondary outcome—was 4.4%. The findings were delivered at the Southern Association for Vascular Surgery (SAVS) annual meeting held in Scottsdale, Arizona ( Jan 27–30).

The research team carried out a retrospective review of

March 2021

the Vascular Quality Initiative (VQI) database of EVARs “As previous studies have shown, predicted one-year for AAA completed from 2003–2020. The cohort had a rupture risk based solely on diameter may not necessarily median age of 84, with 76.2% male. Some 4,681, or 39.6%, be completely accurate.” of the patients had an aortic diameter of less than 5.5cm.

Khoury further noted that the VQI dataset did not have Another 10.6% had a diameter of 7cm or greater. a variable that allowed the researchers to determine if Khoury and colleagues used the Gagne Index to patients have metastatic cancer, “which is worth a total of calculate the predicted one-year mortality from untreated five points in the calculation of the Gagne Index and can AAA. This involved a validated co-morbidity score lead to a large underestimation of a patient’s oneplus one-year aneurysm-related mortality year survival. without repair—one-year aortic rupture risk “However, patients with metastatic based on aneurysm diameter x 0.85. cancer would likely only represent a very Patients with a Gagne Index of 0–3 small cohort in the study focused on had significantly lower actual one-year elective EVARs in elderly patients, and mortality rates with EVAR compared would not have a significant effect on the to that predicted without repair, but the overall results.” researchers found no significant benefit Providing context, Khoury later told of EVAR for patients with a Gagne Vascular Specialist: “The relative Index of 4 or more. That was benefit of EVAR versus also the case with patients continued surveillance in who had a AAA size of less the elderly is currently than 5.5cm, “so preference unknown. Nonoperative should be given to elderly management of AAAs patients with lower Gagne carries a substantial risk of Indices and larger AAAs,” rupture and subsequent Khoury et al discovered. death in the elderly since One-year survival for the majority of AAA patients was then regressed on ruptures occur in patients Octogenarian EVAR a subset of variables, he said. Age, 75 years of age or older. To survival coronary artery disease, increasing AAA further complicate decision-making, diameter, increasing Gagne Index and MACE life expectancy decreases with advancing were independent predictors of mortality in the elderly, age, which may nullify the benefit of EVAR. Thus, it is the investigators found. By way of contrast, Khoury told currently unknown whether offering repair to those of SAVS, body mass index, as well as aspirin and statin use advanced age improves overall mortality. The purpose of were associated with improved survival. this study was to quantify the impact of EVAR on one-year He noted several limitations, starting with the “inherent mortality in the elderly by comparing the actual one-year biases” of a retrospective study. “In addition, we do not mortality after EVAR to the predicted one-year mortality have specifics regarding the aneurysm anatomy,” he added. without repair.”

One-year mortality rate among elderly with AAA

Predicted (without EVAR):

14.6%

Actual (with EVAR):

10.6%

vascularspecialistonline.com • 15

CONTROVERSIES

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In memoriam: Aspiring vascular surgeon Noor Gul Shah, 29

BY RAE ROKOSH, MD, AND BENJAMIN WADOWSKI, MD

Noor Gul Shah, MD, who passed away in October last year aged 29, was a remarkable fourth-year resident in general surgery at NYU Langone Health in New York City. Born and raised in Cherry Hill, New Jersey, she attended her home state’s Rutgers University for her collegiate studies, graduating from Rutgers’ Robert Wood Johnson School of Medicine in New Brunswick in 2017 as a member of the Alpha Omega Alpha honors society. Like many of us, during her schooling she found joy in the operating room, dedicating herself to the surgeon’s path. As a junior resident, Noor—with her tireless work ethic and distinctive verve—quickly proved to be a talented clinician and avid learner. As she progressed through to her fourth year of residency, she returned again and again to vascular surgery for its challenges and hardearned rewards. She fell in love with its breadth of techniques, its freedom from anatomic boundaries, and its demand for constant innovation and evolution. Even before applying for fellowship, Noor dove into the field with all of her characteristic zeal, pursuing research with the goal of improving outcomes for her patients.

NOOR’S PASSION FOR SURGERY become a treasured colleague. This was met in equal measure with memoriam is not a recounting of a her charisma and zest for life. long and glorious career. The loss of A self-possessed and brilliant Noor is far more difficult to put into young woman, she was prone to words because we are left with only laughter, quick with a joke, and a shadow of what would have been. had a lightness of heart that could We mourn her passing for the sake lift a room. It’s no surprise then that of a generation of surgeons who may people would flock to her when seeking Noor Gul Shah have trained under her eye, the scientific a confidante or a sympathetic ear. And insights that remain obscured, and she reciprocated with a fierce loyalty to those the countless patients deprived of her empathy fortunate enough to be a part of her circle, which and mastery. Most importantly, we mourn was ever-growing. Noor cherished her family with her family whose pain we cannot begin to and friends, with an affection matched by her comprehend. insatiable thirst for adventure. She found her In her personal statement for vascular soulmate in her late husband Mohammad—their fellowship, Noor closed by reflecting on how love for each other was infectious, and together inspirational her mother had been in her pursuits: they explored the world.

“After witnessing my mother raise five children on It’s possible that many of you would have her own, I learned that an unwavering work ethic met Noor during the most recent fellowship can tear down the highest of barriers.” As Noor’s application cycle. You would have interviewed mother was her personal source of strength a confident, remarkable young surgeon with in forging on toward a career as an academic boundless promise. You might have chatted vascular surgeon, Noor will remain an inspiration with her over dinner about her aspirations: She to all of us as we carry on this tradition in her dreamed of opening a hospital in Pakistan in the stead­­—she was driven to be a true luminary in name of her late father, Hamraz Shah, to provide the field. This is for Noor, in her loving memory. free surgical care to those in need. You would She will be deeply missed but never forgotten. have marveled at her accomplishments and heard stories from around the globe, including her service rotations through San Francisco, Pakistan Rae Rokosh and Benjamin Wadowski wrote this and Sierra Leone to help those less fortunate. tribute on behalf of all of Or you may simply have sat by her on a bus or Noor's colleagues at NYU Langone train, struck by the friendliness and warmth of Health's Department of Surgery. a beautiful stranger who might someday have

“After witnessing my mother raise five children on her own, I learned that an unwavering work ethic can tear down the highest of barriers”­­—Noor Gul Shah March 2021

Pioneering Duke vascular surgeon Richard McCann dies Richard McCann, MD, a vascular surgeon who reinvented his skills after the endovascular revolution in the 1990s and implanted the first endograft for an abdominal aortic aneurysm (AAA) at Duke University in Durham, North Carolina, has died.

BORN IN PORTLAND, MAINE, in 1948, McCann gained his medical degree from New York's Cornell University in 1974.

That was also the year he joined Duke as an intern—the start of a nearly five-decade career at the institution that saw him rise to become a professor of surgery.

“During his tenure at Duke, Dr. McCann became recognized as a superb surgeon in every domain,” the Duke University Richard McCann School of Medicine recorded in a memorial.

“Technically, he mastered the anatomical exposure of vascular structures in all areas of the body with exceptional technical speed and efficiency. No vascular emergency was beyond his capability, and no patient or colleague was ever left without his immediate support to save both life and limb.”

Additionally, Duke highlighted how McCann had pioneered complex aortic surgery, using an array of both open and endovascular techniques—“demonstrating his surgical creativity and technical mastery.”

McCann also mastered the art of renal transplantation and participated in the first liver transplant at Duke.

He was also active academically. McCann published more than 150 articles covering nearly every topic in vascular surgery. He served as the first chief of vascular surgery at Duke and the first program director of the institution’s vascular surgery fellowship program.

McCann was honored as a Duke Surgery Master Surgeon in 2016, which the institution said was an acknowledgment of his outstanding clinical judgment in addition to the provision of the highest level of clinical care for the most vulnerable and disadvantaged patients who passed through its doors.

“As a man of few words, he made every spoken word important.

Beyond Duke, as an ambassador and humanitarian, he donated his medical and surgical talent to care for patients in Saudi Arabia, Vietnam and, most notably, Haiti,” the Duke memorial added. “Duke Surgery, thousands of patients and hundreds of surgical trainees have benefited from Dr. McCann’s tireless efforts and surgical excellence.”—Bryan Kay

Respected surgeon Melvin H. Sher

Melvin H. Sher, MD, of Framingham, Massachusetts, died Jan. 28, 2021. He was 89. A former U.S. navy surgeon, Sher served aboard the aircraft carrier USS Forrestal. He is credited with introducing vascular surgery to the Framingham area, where he established a private practice. Sher retired from active surgical practice in 2001.—Beth Bales and Bryan Kay

vascularspecialistonline.com • 17

NEWS BRIEFS

Despite it being a year unlike any other, the increased generosity of the SVS Foundation donors allowed for the mission work to continue as planned.

WHEN THE FOUNDATION’S FISCAL and donated to the Foundation that year began, April 1, 2020, the pandemic provides so much impact to the Society had only recently started to cause and on patient care. To help increase worldwide shutdowns and major the Foundation’s visibility, four SVS disruptions in elective surgeries, deeply members generously spearheaded a impacting the lives of Society for Vascular very successful year-end Matching Gift surgery members and their practices.

Challenge, resulting in nearly $12,000 Amid so much havoc, the Foundation in donations from new donors. This Board of Directors took a pause in fundsurpassed the goal of the $10,000 raising and marketing. Directors took in matching funds. Donations went advantage of the hiatus to to the Greatest Need review the awards program Fund and the Awareness given the overall situation. and Prevention Fund for With travel at a virtual community health initiatives.

■ Fund-raising, standstill, Foundation The Society also marketing paused awards that required it notched a jump in the ■ 2020 awards paused, were deferred and other percentage of members then distributed as the who contributed to the awards paused until later result of strong fiscal in the fiscal year. Through Foundation, from 17 to stewardship strong fiscal stewardship 21%. Boosting that member and member support and member support, the support percentage further ■ 2021 award Foundation was able to is a major goal for the next applications distribute all budgeted fiscal year. As the fiscal year being accepted awards and is accepting winds to an end, COVID-19 ■ 2020 Gala canceled; applications for this year’s vaccines are providing hope, 72% of ticketgrants. elective surgeries have purchasers donate to COVID-19 resulted in resumed, and Foundation the Foundation the cancellation of the leaders anticipate ■ Matching Gift highly anticipated second celebrating the Foundation Challenge nets nearly annual SVS Foundation mission in person at the $12,000 new-donor “Vascular Spectacular” proper time. donations Gala. Ticket-purchasers To learn more about ■ Percentage of SVS received refunds, of the SVS Foundation and members donating course, and since April, its work to impact patient increases from 72% of those purchasers care, visit vsweb.org/ 17 to 21% have turned right around SVSFoundation.—Beth Bales

Year in review

Celebrating surgeons on March 30 THE SOCIETY FOR VASCULAR Surgery (SVS) Foundation recognizes and thanks all SVS surgeons and physicians on National Doctors’ Day, which falls on March 30.

This annual observance began in 1933 in Winder, Georgia, when Eudora Brown Almond, wife of Charles B. Almond, MD, wanted to have a day to honor physicians.

The day honors the work and dedication provided by doctors to their patients and communities.

Although celebrated informally since then, President George W. Bush signed a resolution in 1990 to make the day an officially recognized observance day in the United States.

March 30 marks the anniversary of a doctor using general anesthesia in surgery for the first time. It was on that day in 1842, in Jefferson, Georgia, Crawford

18 • Vascular Specialist

Long used ether to anesthetize a patient, named James Venable, and then removed a tumor from his neck without the patient feeling any pain. Thus, Long is now viewed as the pioneer of surgical anesthesia by means of the inhalation of ether.

By 1958, a resolution commemorating Doctors’ Day was adopted by the U.S. House of Representatives.

The SVS celebrates that medical advance and all others, and thanks, in particular, vascular surgeons throughout the world who spend so much time and energy mastering the subspecialty and saving lives everywhere.—Beth Bales

VESAP5 mobile app now available The mobile app for the fifth edition Vascular Educational Self-Assessment Program (VESAP5)—for both Android and Apple operating systems— is now available. Apple users need to visit the App Store, while Android users should visit Google Play (play.Google.com).

THE COMPANION APPLICATION allows users to access VESAP5 off-line and sync their progress once online again.

This user-friendly feature lets users access and use the program in nearly any environment, such as the operating room

or during air travel. VESAP5 incorporate a highly secure authentication system that protects every user’s name, password and personal data.

The fifth version of VESAP builds on the strong foundation of earlier versions, offering updated questions across all modules, from cerebrovascular and renal/ mesenteric to vascular laboratory and vascular medicine.

The modules and their content parallel the published subject areas for VSCORE (the vascular surgery component of the Surgical Council on Resident Education) curriculum.

VESAP5 includes a lab module that can be purchased separately.

The VESAP5 program was introduced in July 2020 at a 25% discount due to the financial difficulties caused by the COVID-19 pandemic. Regular pricing resumes April 1.

To save 25%, purchase VESAP5 by March 31. Visit vsweb.org/VESAP.—Beth Bales

New officers named to office-based lab section New officers are in place with the SVS Section on Outpatient and Office Vascular Care (SOOVC) Executive Committee.

NEW OFFICERS ARE IN PLACE WITH THE SVS SECTION ON SOOVC Executive Committee. They are Robert Molnar, MD, chair; Clifford Sales, MD, vice chair; and members Ruosu An, MD, Ellen Derrick, MD, Anil Hingorani, MD, Jacqueline Majors, MD, and Bradley Thomas, MD. SVS created the section in 2019 for clinicians who work in outpatient and officebased vascular care centers. It serves as a forum where members can advance the care of patients in outpatient settings through enhancing SVS efforts in education, advocacy, quality practice, ethics and research.

Activities have included a special breakfast section on outpatient facilities at the 2019 Vascular Annual Meeting and a question-and-answer session on SVSConnect.

All SVS members in good standing who are interested in outpatient and office vascular care may apply for membership in the section. Hospital and practice administrators may join as Affiliate members. Email soovc@vascularsociety.org.— Beth Bales

Spotlight SVS member James L. Cox, MD, received the 2020 Jacobson Innovation Award of the American College of Surgeons on Feb. 5. The international surgical award honors living surgeons who have been innovators of a new development or technique in any field of surgery. Cox is best known for the Cox maze procedure, which treats atrial fibrillation surgically.—Beth Bales

March 2021

Credit: Yulia Novik/iStock/Getty Images Plus

Foundation work continues during year of challenges

USPSTF reaffirms 2014 recommendation for asymptomatic carotid stenosis

BY BRYAN KAY

The United States Preventive Services Task Force (USPSTF) has recommended against screening for asymptomatic carotid artery stenosis in the general adult population—a reaffirmation of the 2014 D recommendation.

THE USPSTF STATEMENT CAME IN A RECOMMENDATION STATEMENT recently published in the Journal of the American Medical Association (JAMA). The document was written by Alex H. Krist, MD, a professor of family medicine and population health at Virginia Commonwealth University in Richmond, Virginia, and colleagues.

“This recommendation statement is a reaffirmation of the 2014 D recommendation for screening for asymptomatic carotid artery stenosis,” the USPSTF members write in JAMA. “The USPSTF issued the D recommendation based on evidence that the harms of screening for carotid artery stenosis in asymptomatic adults outweigh the benefits. The USPSTF found no new substantial evidence that could change its recommendation and therefore reaffirms its recommendation.”

To arrive at the updated recommendation, the USPSTF commissioned a reaffirmation evidence review to identify new and substantial evidence sufficient enough to change the prior recommendation, the authors explain.

“The reaffirmation update focused on the targeted key questions on the potential benefits and harms of screening and interventions, including revascularization procedures designed to improve carotid artery blood flow, in persons with asymptomatic carotid artery stenosis.”

The recommendation applies to adults who do not have a history of transient ischemic attack, stroke, or other neurologic signs or symptoms referable to the carotid arteries, Krist and colleagues write.

The USPSTF does not recommend screening adults without these signs or symptoms, they comment. In terms of treatment for patients with asymptomatic disease, “the harms of surgical interventions compared with appropriate medical therapy appear to outweigh the benefits,” the authors point out.

However, the authors acknowledge that more research is needed in order to evaluate “the benefits and harms of screening for asymptomatic carotid artery stenosis in the general adult population.”

They explain that such investigation would include trials with long-term follow-up (>5 years) that compare carotid endarterectomy (CEA) or carotid artery angioplasty and stenting (CAS) plus contemporary best medical therapy with best medical therapy alone, including completion of ongoing trials.

Veterans study: No evidence of increased risk of death with use of PCDs out to three years A study of more than 10,000 U.S. veterans with peripheral arterial disease (PAD) undergoing endovascular interventions in the femoropopliteal segment found that rates of two- and three-year all-cause mortality were similar among patients undergoing revascularization with a paclitaxel-coated device (PCD) and those who were treated with an uncoated device.

Veterans Health Administration (VHA) data contained in the VA Corporate Data Warehouse as well as the National Death Index. The researchers conclude: “In this large, contemporary cohort of patients undergoing femoropopliteal [peripheral vascular interventions] within the VHA, there was no evidence of an associated increased risk of long-term, all-cause mortality among patients treated with PCDs when compared with those treated with non-PCDs. Cause-specific mortality rates were similar between both cohorts.”

Additionally, the study highlights the “vast possibilities” of using the VHA Corporate Data Warehouse with the National Death Index for future postmarket safety surveillance of PAD devices, they remark.—Bryan Kay

THE FINDINGS, RECENTLY PUBLISHED in the Journal of the American Heart Association (JAHA), were derived from

Postmarket study of sirolimus-eluting balloon enrolls first patient MedAlliance has announced enrollment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon Selution SLR for the treatment of patients with peripheral arterial disease (PAD). Selution SLR is a novel sirolimus-eluting balloon that provides a controlled, sustained release of the drug, similar to that of a drug-eluting stent (DES).

THE OBJECTIVE OF THE STUDY IS to collect real-world safety, efficacy, health economics and patient reported qualityof-life data in over 700 patients with PAD treated with Selution SLR. It is a singlearm, all-comers study including all lower-

March 2021

limb indications and will cover at least 50 sites in Europe, Asia and South America.

Patients will be followed-up at 30 days, six months, then every year out to five years, with a primary endpoint of target lesion revascularization at 12 months.—Bryan Kay

vascularspecialistonline.com • 19