Vascular Specialist–September 2021

17 PAD MONTH Save the date Upcoming skills workshop aims to disseminate latest advances in PAD care

Vol.17 No.09 SEPTEMBER 2021 Official Publication

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FROM THE FLOOR Looking back as in-person VAM makes a return

QUALITY IN CARE SVS reveals future launch of new verification program

GENDER DISPARITIES VAM paper provokes brisk plenary discussion

LATEST SIGNAL: Paclitaxel debate rumbles on after report of increased amputation risk

BY MALACHI SHEAHAN III, MD

THE RECENT REPORT OF AN ELEVATED risk of major amputation among patients treated with paclitaxel-coated balloons (PCBs) in the lower limbs has already seen a mixed reaction from professionals across the vascular specialty. In this special report, we hear from five expert vascular surgeons who discuss the implications of the findings made by interventional radiologist Konstantinos Katsanos, MD, and colleagues.

First, Jessica Simons, MD, Caitlin W. Hicks, MD, and Katharine McGinigle, MD, pore over the meta-analysis in question, commenting on the methodology Katsanos et al pursued, and discussing the reported results. Michael Conte, MD, and Joseph Mills, MD, also weigh in with analysis on the significance of the latest study ahead of results expected from ongoing clinical trials that look at drug-coated balloon usage in peripheral arterial disease (PAD).

➔ PCB paclitaxel

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FROM THE FLOOR

VAM 2021 structural changes prove hit with attendees

BY BETH BALES

It was an epic return: nearly 700 abstracts presented in six plenaries and several other forums; six concurrent sessions; six SVS breakfast sessions; three postgraduate courses; six “Ask the Experts” presentations; more than 1,000 in-person professional attendees; nearly 400 livestreaming registrants; 88 exhibitors in 154 booths; three presidents; two presidential addresses; and three annual meetings held in collaboration with each other.

THAT’S THE 2021 VASCULAR ANNUAL Meeting (VAM) by some of the numbers.

But mere math can’t convey the contagious enthusiasm of participants who had waited more than two years for the chance to reconnect with colleagues and participate in education, networking and fun.

“People were extremely excited to be inperson again,” said Andres Schanzer, MD, cochair, with Matthew Eagleton, MD, of the SVS Program Committee, which oversees educational content at VAM—Schanzer chairs the committee for 2021–22. “I can’t tell you how many people

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

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stopped one of us to tell us how happy they were to be there.”

This year’s meeting featured several important structural changes designed to minimize overlapping sessions and maximize the attendee experience. They included moving several sessions formerly held on Thursday to Wednesday, holding the three postgraduate courses on three different days, scheduling plenary sessions without conflicts, and offering a livestreaming option for those unable to travel.

Member reactions have proved the changes quite popular, said Schanzer. “Our at-home registrants really liked being able to watch the livestreamed sessions via their computers,” he said, adding that those watching remotely especially enjoyed being able to participate in live questions and answers via Zoom.

Spreading the educational content out across all four days was also a hit, with each day of the meeting wellattended. “People told us repeatedly they really liked

the structural changes, which was gratifying since it was a big change, and they were also very pleased with the educational content,” said Eagleton.

Because the 2021 meeting was moved from June to August, preparations are well under way for 2022. Both Eagleton and Schanzer urged attendees to provide their feedback on VAM 2021. “The changes we made for this year were the direct result of feedback from members,” Eagleton pointed out. “We can’t create the meeting members want without them telling us what would improve VAM.” The presence of three presidents—current President Ali AbuRahma, MD, Immediate Past President Ronald L. Dalman, MD, and 2019–20 President Kim Hodgson, MD—reflected the transition of the SVS out from under the pandemic, adding extra energy to the meeting.

And then there is the all-important number 75: SVS leaders kicked off the year-long SVS 75th anniversary celebrations.

“The staff of the SVS is truly honored to serve our members and really went above and beyond to convene a successful, effective and safe VAM 2021,” noted Kenneth M. Slaw, PhD, SVS executive director. “The synergy between our member-leaders and staff was extraordinary.”

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

Left to right: Ali AbuRahma, Ronald L. Dalman and Kim Hodgson

Inset: Andres Schanzer (left) and Matthew Eagleton

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

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September 2021

PACLITAXEL

COVER STORY

Panel of vascular surgeons review latest findings on paclitaxel-coated balloons

with no major amputation events, which would have reduced the event frequency substantially and likely rendered the differences between treatment nonsignificant.

My second concern with this metaanalysis is the inclusion of technology that has been actively unapproved by the Food and Drug Administration

BY MALACHI SHEAHAN III

A recent meta-analysis by Konstantinos Katsanos, MD, of Patras University Hospital, Rion, Greece, and colleagues—“Risk of major amputation following application of paclitaxel-coated balloons [PCBs] in the lower-limb arteries: A systematic review and meta-analysis of randomized controlled trials [RCTs],” published in the European Journal of Vascular and Endovascular Surgery (EJVES)—warns of a possible heightened risk of major amputation after the use of PCBs in lower-extremity arteries.

Vascular Specialist asked some of our nation’s leaders in the care of peripheral vascular disease to comment on the clinical implications of this study.

Jessica Simons, MD, associate professor, University of Massachusetts Medical School, Worcester, Masachussetts Katsanos and colleagues conducted a systematic review and meta-analysis of existing data from RCTs on the effect of PCB use (in the femoropopliteal and infrapopliteal segments) on major amputation.

Using an incredibly rigorous methodology, they found compelling evidence for an increased hazard of major amputation associated with paclitaxel drug-coated balloons (DCBs) compared with plain balloon angioplasty. This effect was more pronounced among limbs treated for chronic limb-threatening ischemia (CLTI) as compared with intermittent claudication; among CLTI patients, they calculated a numberneeded-to-harm of 35 limbs.

Katsanos and colleagues demonstrated a dose-response effect. They posited a plausible biologic mechanism, including a contrast with drug-eluting stents.

They concluded by saying that further investigation into the benefits and risks of paclitaxel DCBs are needed. To me, the primary question that remains is: Do we really need more studies?

As I have read the evidence supporting paclitaxel DCBs, none of it has ever been strong enough to mitigate these more recent findings. Prior to this particular study, I could have imagined some CLTI patients in whom there could be some limited role, since that group is often focused on limb salvage rather than survival. But this new analysis compels me that there is neither benefit.

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“To me, the primary question that remains is: Do we really need more studies?” — Jessica Simons

Caitlin W. Hicks, MD, associate professor, Johns Hopkins Hospital, Baltimore, Maryland The newest meta-analysis of PCBs by Kastanos et al, published in EJVES last month, raises concern about the use of DCBs for the treatment of peripheral arterial disease (PAD) for the second time in three years, this time with respect to major amputation risk. While the first meta-analysis, published in the Journal of the American Heart Association (JAHA) in 2018, focused on PCBs and stents, the newest meta-analysis on the topic is specific to DCBs. Similar to the original article, my personal bias after reading the abstract was one of skepticism. That feeling didn’t change much after reading the full text.

For one, nearly half of eligible studies were excluded from the analysis. The stated inclusion criteria for the metaanalysis drew from RCTs with at least six months of follow-up, which included any type of PCBs used to treat PAD in the lower extremities, and reported counts of major amputation as an endpoint.

However, when you review the PRISMA (Preferred Reporting Items for Systematic Reviews and MetaAnalyses) flow diagram that reports study exclusions, the first point that jumps out is that 19 studies were excluded for having zero major amputation events in both study arms. Only 21 studies were included in the final analysis, meaning that nearly 50% of eligible studies were excluded.

The authors performed a variety of sensitivity analyses to demonstrate replicability of their findings, but notably did not perform one including the studies

“Similar to the original, my personal bias after reading the abstract was one of skepticism” — Caitlin W. Hicks

patients of all 21 studies evaluated. There are currently no FDA-approved DCBs for BTK applications, but the meta-analysis includes data from seven infrapopliteal studies that contributed outcomes for 1,355 out of a total of 3,760 limbs. While U.S. approvals are not the be-all and endall of technology, the FDA is notoriously one of the strictest regulatory bodies for new technology in the world, and the inclusion of devices that have been actively rejected by the FDA in the past is setting up the DCB group for failure.

My third main concern about this meta-analysis is the inclusion of patients with CLTI. The risk of major amputation is not the same for patients with claudication and CLTI. CLTI also comes in a variety of forms, and without some understanding of the extent of disease, comparing major amputation rates for a sample of patients with heterogenous forms of PAD is uninformed. It is notable that the risk of major amputation in trials limited to claudication patients was not different for DCBs compared to plain balloon angioplasty, although, strikingly, the authors do not report the crude risk in the claudication subgroup.

While I think it has been an important endeavor to raise the academic question of PCDs and their outcomes, the current available evidence does not convince me that current (FDA-approved) DCB devices increase the risk of major

amputation full stop. I will continue to use them selectively in appropriate patients until either an RCT or real-world data that adjusts for baseline differences in patient risk suggests otherwise.

“The real limitation of all meta-analyses—including this one—are the trials included” — Katharine McGinigle (FDA). For example, BD’s Lutonix DCB for below-the-knee (BTK) applications was recently rejected by the FDA for the second time in 18 months due to concerns about both clinical effectiveness and safety, yet the data from LutonixBTK was included in the meta-analysis— contributing the second largest number of

Katharine McGinigle, associate professor, University of North Carolina School of Medicine, Chapel Hill, North Carolina I congratulate the international group of authors led by Katsanos on their recent publication in EJVES. Their systematic review and meta-analysis evaluating the risk of major amputation following application of PCBs in lower-limb arteries was performed with impeccable methods

September 2021

PCDs

and raises important concerns. Based on 21 RCTs, they conclude that there appears to be a heightened risk of major limb amputation after the use of PCBs for femoropopiteal and/ or infrapopliteal revascularization.

The authors theorize that this may be due to downstream embolization and tissue deposition of paclitaxel that causes unsalvageable tissue damage, despite target vessel patency. I agree with the authors that this is concerning and that specific trials to evaluate limb salvage outcomes are needed. In the meantime, I must decide what to do in my practice, and those conclusions are harder to draw.

The real limitation of all meta-

analyses—including this one—are the trials included. In this paper, 52% of the trial participants were claudicants.

Rather than get caught up in appropriateness-of-use criteria, adherence to medical therapy and supervised exercise programs, I chose to eliminate that half of the study population from consideration. There is simply not enough information in this paper to make decisions for the treatment of claudicants.

In general, these non-invasive interventions work and we should focus more of our attention to these therapies.

If you must intervene, then avoiding drug-coated technology and the stenting of femoropopliteal lesions is easy enough if you are as equally concerned about the possible amputation and mortality risks as I am.

Taking into consideration the 11 of 21 trials including mostly patients with CLTI, the authors report a 7.2% vs. 4.7% (hazard ratio [HR] 1.56, 95% confidence interval [CI] 1.04–2.33; p=0.03) risk of limb loss with the use of PCB angioplasty versus plain balloon angioplasty over one to two years.

While there may be increased risk of limb amputation at this point using PCBs compared to deploying plain balloons, these major limb amputation rates are remarkably low.

Other registry studies report a major limb amputation rate as high as 20% within one year in patients with CLTI who are revascularized, and this is in line with the Society for Vascular Surgery

September 2021

(SVS) objective performance goals.

The authors report that the preponderance of trial participants were white males. That limits the generalizability of these results as we know that females are equally as likely to have PAD, and that Black females specifically have the highest rates of limb amputation after CLTI diagnosis.

Another major issue that limits my ability to interpret this data is the problem of imprecise language to define inclusion criteria trials of CLTI patients.

We need more precise information on wound size and location—and patient comorbid and anatomic factors—in order to really determine the expected risk of

paclitaxel an adverse outcome, as well as whether or not a slightly higher risk is merited for each individual situation. As an example, many of the trials in this meta-analysis include “Rutherford 5/6” patients.

We know that Rutherford 6 means an unsalvageable limb, so, clearly, patients with Rutherford 6 disease should not be included in a revascularization trial. This leaves the reader questioning who was actually included.

Limb outcomes are directly related to the severity of the wound at the time of revascularization, and until we start stratifying our analyses by the SVS WIfI (wound, ischemia, foot infection) wound classification system, we will not be able to determine the effect of other factors with a weaker signal, such as the paclitaxel dose administered.

To conclude, the authors raise an important concern that there may be downstream tissue effects of lower-extremity arterial paclitaxel administration. I agree with them that this is enough preliminary data to merit a dedicated trial to evaluate this specific safety question.

However, in the meantime, the majority of my patients with CLTI have a greater than 7.2% risk of limb loss within one or two years, and in cases of patients who are poor bypass candidates with moderate-large wounds and difficult-totreat lesions like below-the-knee popliteal occlusion, I think it is reasonable to continue to use drug-coated technology as part of a multipronged strategy to treat CLTI.

‘Proceed cautiously in use of DCBs in CLTI patients with advanced WIfI stage’

BY MICHAEL CONTE, MD, AND JOSEPH MILLS, MD THE LAST SEVERAL YEARS HAVE SEEN ongoing controversy and debate about the risks and benefits of paclitaxel-coated devices (PCDs) for patients with peripheral arterial disease (PAD). The latest contribution from Konstantinos Katsanos, MD, and colleagues raises questions about potential increased risk of amputation in patients treated with paclitaxel drugcoated balloons (DCB), particularly in the context of chronic limb-threatening ischemia (CLTI). Since the 2018 publication from the same first author highlighted a potential mortality risk, several large-scale observational studies, as well as a report from the SWEDEPAD registry, have shown no discernible mortality signal.

The issue remains somewhat unsettled, and the Food and Drug Administration (FDA) has not as yet changed its most recent guidance, urging some caution and a need for more long-term data.

From my perspective, the plausibility of potential adverse off-target effects of paclitaxel has always been greater in the treated limb rather than systemically. So, this publication should engender some appropriate caution and emphasize need for greater study given limitations in the data. It should also be put into perspective from the standpoint of both risk and benefit.

First, and most importantly, as yet there is no demonstration of clinical efficacy of drug-coated balloons (DCBs) in patients with CLTI. Clearly, patients with CLTI have ongoing major unmet needs for improved and more durable vascular interventions, but so far DCBs have not shown themselves to be the answer.

One wonders if this observation is part of that explanation. The recent failure of Lutonix-BTK to meet its efficacy endpoint further highlights the disappointing impact of DCBs where they are needed most: in patients with CLTI and severe tibial disease. The risk estimated by Katsanos is also very modest—i.e. less than three in 100 excess amputations—and is not controlled for important confounders such as limb severity (e.g. the wound, ischemia and foot infection [WIfI] stage).

But in the absence of proven efficacy in CLTI, one should be quite cautious about any increased risk profile. Drug-eluting devices and their associated pharmacology are complex, and one should be cautious about lumping multiple unique devices, and certainly

device classes, together. The potential embolization concern is legitimate but also likely to be device and formulation specific. In the interim, I would advise caution in the use of DCBs in CLTI patients with advanced WIfI stage, larger wounds, or those needing reconstructive foot surgery. We will await the results of ongoing trials such as BEST-CLI (Best endovascular versus best surgical therapy in critical limb ischemia), BASIL-3, and SWEDEPAD to get more comprehensive data on both the risks and benefits of DCBs in CLTI. Additionally, the paclitaxel controversies have spurred accelerated work to develop alternative drugs—for example limus agents—and delivery platforms that may yet prove to be the silver lining.

Furthermore, the amputation rate was only significantly different in the CLTI group, but not the claudicant group, and the overall amputation rate is much lower than would be expected in CLTI patients (about 4–7%)—which would correlate with only WIfI clinical stage 1, and perhaps stage 2, patients.

Unfortunately, we do not have any stratification of limb risk (WIfI) or runoff/ anatomy—e.g. the Global Limb Anatomic Staging System (GLASS)—so making any comparison of amputation risk without this and other information is difficult.

We also don’t have a good handle on the timing of the major amputations. If particulate embolization is the proposed mechanism, one would expect that to occur fairly early after intervention, but that is hard to ferret out.

“First, and most importantly, as yet there is no demonstration of clinical efficacy of drug-coated balloons in patients with chronic limbthreatening ischemia”

Michael Conte and (left) Joseph Mills

vascularspecialistonline.com | 5

QUALITY IN CARE

Key players behind first SVS AUC on claudication unpack details of development process

BY BRYAN KAY

Vascular surgeons have a history of going the extra mile to do the right thing for their patients. So went the theme of one of the comments sent in near the close of a recent Society for Vascular Surgery (SVS) Town Hall, during which key figures behind the Society’s first-ever set of appropriate use criteria (AUC)—set to cover the treatment of claudication—laid out some of the mechanics of bringing the upcoming document to the brink of publication.

THE SERIOUSNESS OF THE UNDERTAKING WAS laid bare at the outset of the gathering by Larry Kraiss, MD, the immediate past chair of the SVS Quality Council, who oversaw the development of the AUC. Revealing the methodology adopted to carve out the criteria as the RAND Corporation method, he duly quoted the group’s definition of appropriateness in care: “An appropriate procedure is one in which the expected health benefit exceeds the expected negative consequences by a sufficiently wide margin that the procedure is worth doing, exclusive of cost.” The RAND/UCLA (University of California, Los Angeles) method involves group decisionmaking comprised of a systematic literature review, as well as both a writing panel and a multidisciplinary rating panel. Kraiss said one of the recurring questions he faces concerns why there are two types of documents addressing quality of care—the other being clinical practice guidelines (CPGs).

Kraiss outlined how the two should interact: “When there is strong and abundant evidence to support a grade 1a clinical practice guideline either for or against a particular decision, the appropriate use criteria should generally agree with those statements because they are both using the same evidence base. However, in more nuanced clinical scenarios, CPGs may not be able to make strong recommendations given the available evidence. CPGs may therefore deliver weak or conditional recommendations, and it is in these circumstances then that AUCs explicitly recognize the lack of good evidence and mobilize expert opinion to give guidance.”

AUCs step into this void, Kraiss added. The rationale is clear: “AUCs will allow us to formally state the SVS position in the public domain and provide a means to advocate against inappropriate overuse.”

Karen Woo, MD—who co-moderated the Town Hall in early August with SVS Past President Kim Hodgson, MD, and is a member of the seven-person SVS AUC writing panel for the maiden criteria—explained the reasoning behind the selection of the RAND method.

“It’s the only standardized, validated technique for determining appropriateness, and it combines evidence with expert opinion,” Woo said. “It’s often used when we can’t perform an RCT [randomized controlled trial] in every feasible clinical scenario.”

The process behind the method is scientific, Woo continued. First comes the systematic review and metaanalysis. The writing committee creates scenarios. The rating panel then rates these across two rounds on a scale of one to nine. These range from inappropriate (1–3) to appropriate (7–9), with an indeterminate scale in between (4–6). Ultimately, the aim is to achieve a set of criteria that will result in better patient outcomes “when they are adhered to,” added Woo. Jeffrey Siracuse, MD, the immediate past chair of the SVS Appropriateness Committee and also a member of 6 | Vascular Specialist

SVS Quality Improvement Committee, walked Town Hall watchers through the arduous process of how the definitions, scenarios and assumptions were constructed.

“The final result was a mind-numbing number of hypothetical patients to consider and ratings to render— greater than 2,200, but I think ultimately it was meaningful and manageable since there was some striking agreement on a few high levels,” she said.

Woo emphasized the importance of the scenario construction portion of the process described by Simons.

“I want to highlight how important this part of the process was because everybody has to be speaking the same language so everyone can rate starting from the same place,” she said.

Kraiss provided a short overview of the fruits of the panelists’ labors: the more than 2,200 individual scenarios rated over the course of 15 hours spread across two days.

“A complete and accurate portrayal of the results will require numerous tables and accompanying narrative

Larry Kraiss

Jessica Simons

Kim Hodgson

Jeffrey Siracuse

A recent SVS Town Hall revealed the intricacies of developing the AUC on claudication

the writing panel for the intermittent claudication AUC, explained how the SVS arrived at claudication for its first set of criteria. After considering a number of conditions rather than specific interventions, the Society settled on claudication since “it is a perceived need by both the public and our Society,” he said.

Siracuse also broke down the multicameral nature of the rating panel. Eleven of the 15 members were drawn from the SVS membership, with two each brought in from the American College of Cardiology (ACC) and the Society of Interventional Radiology (SIR). The panel was also drawn from a broad geographical spread, a breadth of experience levels in terms of years in practice, and a nearly even split between academic and private or community surgeons.

In terms of the writing panel’s role, Siracuse explained that the team fleshed out relevant variables deemed important, as well as definitions, scenarios and assumptions, all reviewed by the Appropriateness Committee before being sent to the rating panel.

Jessica Simons, MD, the inaugural chair of the new

Karen Woo

describing the deliberations of the rating panel as they considered the various scenarios,” he said. “This is beyond the scope of today’s presentation; however, it is important to note again the remarkable degree of consensus achieved by the rating panel, where less than 0.5% of the scenarios met criteria for disagreement.”

Simons said next steps include peer review of the AUC manuscript by the SVS Document Oversight Committee, a public comment period, SVS Executive Board review and the eventual goal of publication in the Journal of Vascular Surgery. Woo, meanwhile, picked up on the theme of vascular surgeons doing the right thing raised by the viewer comment: “Since CMS [the Centers for Medicare & Medicaid Services] is moving towards pay for performance, perhaps if we can show that we’ve developed these criteria, that they benefit patients—that we can somehow capitalize off of that. I don’t know how that’s exactly going to happen, but I think at least—I’ll just speak for myself—I would rather go to my grave knowing that I did the right thing. And I think that was reflected in our panelists.”

September 2021

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QUALITY IN CARE

SVS focuses in on launch of vascular verification program

BY CARRIE MCGRAW

The Society for Vascular Surgery (SVS), in partnership with the American College of Surgeons (ACS), has announced that it is closing in on the launch of a future program to verify quality on the part of facilities that offer vascular care.

SVS PAST PRESIDENT KIM HODGSON, MD, referenced the Vascular Center Verification and Quality Improvement Program (VCV&QIP) during his Presidential Address at the Vascular Annual Meeting (VAM) in San Diego, California, Aug. 19.

The Society’s aim in developing the verification process and program is to indicate to patients that program reviewers investigated and verified a particular institution’s quality improvement process and that it follows high standards and protocols. Verification assures patients that the centers are taking steps necessary to consistently strive for high-quality patient care.

“It is difficult for both governmental and non-governmental agencies, including third-party payors, to determine quality and appropriateness,” said Hodgson.

To address this unmet need, the SVS undertook the task of defining standards for quality, appropriateness and value for the vascular specialty. The involvement of vascular experts in defining quality and appropriateness has been pivotal in building a quality infrastructure to support members throughout the ever-changing healthcare landscape.

The SVS and ACS are working together to better define and verify high-quality and efficient care for vascular patients in both inpatient and outpatient settings,

said SVS Executive Director Kenneth M. Slaw, PhD. “The long-range goal is to have all SVS members actively engaged in quality improvement initiatives and to have this work recognized by government and private payors in efforts to reduce administrative burden through more streamlined prior authorization.”

The SVS/ACS VCV&QIP’s mission is to drive quality and value by guiding the vascular center to leverage the infrastructure necessary to perform various vascular procedures in an environment that is safe and conducive to excellent patient outcomes and to be a leader in vascular quality improvement. At its core, VCV&QIP follows six National Quality Strategies to align organizational functions to drive improvement based on the aims and priorities of the Agency for Healthcare Research and Quality (AHRQ), part of the U.S. Department of Health and Human Services. The areas are: measurement and feedback with required registry participation; certification, accreditation and regulation with required facility regulation; consumer incentives and benefit designs with thorough discussion of treatment options and consent; health information technology, working with outside software for continuation of care; innovation and diffusion with research; and workforce development with the capability of resident training.

SVS: A lesson in unity through diverse talent

BY KENNETH MADSEN, MD

Today’s emphasis on diversity is nearly inescapable, while examples of true unity seem scarcer. Is there really a way the two can co-exist or work together beneficially?

Consider some of your favorite bands, or even successful sports teams. Even a cursory assessment shows that a diversity of talents and aptitudes can and do work harmoniously to create memorable music or bring home championships. Similarly, the SVS is a very diverse society that stands to benefit tremendously if unified in purpose.

8 | Vascular Specialist

Kim Hodgson during his address

As with all ACS Quality Improvement programs, the VCV&QIP began with the development of the program’s “standards,” factors felt to be critical to the success of a program and against which a program is evaluated.

Once the standards were formulated, at the SVS level Hodgson and fellow former SVS president, Anton Sidawy, MD, identified potential pilot sites, looking for both inpatient and outpatient verification levels, to apply the standards to real-world practices and fine-tune them if needed.

Surgeons visited the first pilot site, the Albany Medical Center in Albany, New York, in April. “The verification of inpatient and outpatient vascular centers is an important step in recognition of our specialized and distinct service to our patients and to our healthcare systems,” said R. Clement Darling III, MD, of the Albany Medical Center and another former SVS president. “The verification process was valuable to help us to understand what we need to provide the best longitudinal vascular care for our patients and will provide a roadmap to help institutions and payors understand the infrastructure needed to establish and maintain a comprehensive vascular service.”

In addition, verification, “will

demonstrate to patients and providers that we are following standards and established protocols that have been peer-reviewed for their benefit by specialty-trained vascular specialists/surgeons. I thought the process was comprehensive, fair, educational, and a true benefit to our patients and our specialty of vascular surgery,” said Darling.

VCV&QIP requires institutions to examine and validate processes that should lead to the following: external credibility, improvement in quality, enhanced organizational learning, high staff effectiveness, decreased liability cost, and mitigating risk of adverse events.

The Michigan Vascular Center participated as the first office-based lab (OBL) in the pilot phase. “The Michigan Vascular Center opened its first OBL in 2005 and opened a second in 2013,” said Robert Molnar, MD, adding that the centers have been accredited by the Accreditation Association for Ambulatory Health Care (AAAHC) for more than eight years. “Our focus was always on providing care that was equivalent and even superior to that provided in the hospital setting. We felt that accreditation was important to signify our level of commitment to quality and best practice standards. When the SVS/ACS announced a vascular-specific verification program for OBLs, we wanted to participate and have our program evaluated to ensure we were providing the best possible care with the highest quality.

The process allowed us to analyze what we had established and provided a process to reaffirm our commitment to quality and our patients.”

In the coming months, SVS and ACS will finalize the standards and infrastructure to provide vascular facilities with easy access to resources in order to guide them in applying for verification.

For more information on the verification program, contact Carrie McGraw at cmcgraw@vascularsociety.org.

OUR SPECIALTY BOASTS A DIVERSE RANGE OF can package these efforts and present them to elected practices—from highly specialized vascular centers of representatives who can advocate for our needs. Some excellence to rural practices—that face a broad range current SVS PAC efforts include: lobbying support for of common but challenging vascular conditions. We enacting legislation to end cuts in Medicare payments operate efficient office-based labs (OBLs) and elegant vein scheduled for Jan. 1, 2022; H.R. 2256/S. 834, “The practices. Our interests and aptitudes Resident Physician Shortage Act”; H.R. within the Society vary widely, and we Our Society is diverse 1667/S. 610, the “Dr. Lorna Breen all seek optimal practices that provide Care Provider Protection Act”; in social and political Health reasonable work-life balance while and H.R. 3173, “Improving Seniors’ ideologies as well. Timely Access to Care Act of 2021.” also ensuring professional satisfaction.

Working in a proper setting can More information on these issues is These differences invigorate and energize us while acting available at vascular.org/VoterVoice. should not divide us as a level of protection from burnout.

While the PAC is working diligently In this manner, the diversity of our on behalf of the Society, we need practices can better ensure optimal engagement from our membership. patient care.

The impact of our messaging is directly proportional to Beyond this we must continue to look even deeper. Our the percentage of the Society that participates. Of our Society is diverse in social and political ideologies as well.

5,600 members less than 10% currently donate to the These differences should not divide us. Rather, healthy PAC. To those who donate, we thank you! To those who discourse should open our eyes to future possibilities have never donated—take a chance on us, donate to the while exposing the current challenges that are our PAC, and invest in your future as well as the future success opportunities for progress. Despite and because of our of our specialty. diversity, we must have a seat at the legislative table and do everything possible to work for one another. The KENNETH MADSEN is a member of the Society for SVS Political Action Committee (PAC) is a vehicle that Vascular Surgery PAC Steering Committee.

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‘Do we need to do a better job of making devices that fit female anatomy?’

BY BRYAN KAY

It was a burning question posed from the conference floor, and it led to some approving social media nods in its aftermath: Does the tone of conversation around the vascular anatomy of females need to morph into a discussion about the availability of devices that fit the female anatomy?

10 | Vascular Specialist

he point was provoked by another question that followed findings delivered by Scott R. Levin, MD, a general surgery resident at the Boston University School of Medicine, Boston, at the 2021 Vascular Annual Meeting (VAM) in San Diego (Aug. 18–21) suggesting female sex was associated with a higher risk of reintervention after endovascular procedures and infrainguinal bypass surgeries for intermittent claudication.

“Do we need to stop saying that women have worse anatomy than men?” came the question from Mahmoud B. Malas, MD, chief of vascular and endovascular surgery at the University of California San Diego, San Diego, in Plenary Session 6 on Aug. 21.

Malas was speaking after fellow audience member Keith D. Calligaro, MD, chief of vascular surgery and endovascular therapy at Pennsylvania Hospital in Philadelphia, rose to query Levin on two aspects of his findings.

Calligaro began by referencing a question he had posed the previous day of Thomas F. X. O’Donnell, MD, senior vascular surgery fellow at Beth Israel Deaconess Medical Center in Boston, who had delivered new findings on racial disparities in the treatment of ruptured abdominal aortic aneurysms (AAAs).

“Yesterday I rose to make a comment about a paper that was presented and why women might have higher complication rates for aortic aneurysms,” he explained. “That comment was simply because some of them have smaller iliac arteries, worse access, more complications.”

Could the reason for the higher level of complications among women demonstrated in the claudication study be put down to the fact women “tend to have smaller infrainguinal arteries and therefore less durable long-term results?”

Calligaro said, further querying: “You commented women are less likely to be given statins. I’m aware of several papers that have shown women are less likely to take statins when they’re prescribed. I don’t know why. I’ve read several papers on this subject, and I don’t know that anyone really knows the reason, but that’s what a lot of the data shows.”

The data gathered by Levin and

colleagues demonstrated that female sex was associated with lower use of aspirin and statins prior to both infrainguinal bypasses and endovascular interventions.

“But we don’t know based on using the database why this is the case,” said Levin. “We do know that aspirin-statin use is associated with lower rates of reintervention, and so the lower rates of aspirin-statin may have contributed to higher reintervention. We did actually control for preoperative medication in our multivariable analysis. Further prospective studies would be needed to tease out the causes of why there are these differences by sex.”

For Malas’ part, he asked Levin Mahmoud B. whether the profession Malas needed “to do a better job of making devices that fit women,” saying it was not that women have “worse anatomy than men” but rather smaller vessels. “Is the problem, with an aneurysm or peripheral intervention, that we don’t make stuff that fits women’s anatomy better?”

Levin said that the present study— which queried the Vascular Quality Initiative (VQI) for all suprainguinal and infrainguinal bypasses as well as endovascular interventions for intermittent claudication from 2010– 2020—was not able to demonstrate causes, nor did it probe specific devices.

“But I think that would be useful for future studies to look at and control for specific devices,” he said.

After performing bivariable and

“Is the problem, with an aneurysm or peripheral intervention, that we don’t make stuff that fits women’s anatomy better?” — Mahmoud B. Malas multivariable analyses to evaluate the association of sex with perioperative and long-term outcomes, what the chief findings of the investigation did show was that among endovascular procedures for intermittent claudication, female patients more often had iliac interventions, less often had infrainguinal interventions, and less often underwent stenting or atherectomy (all p<0.05), according to Levin et al.

This was based on 64,752 endovascular interventions (62% male, 38% female sex) prized out of the VQI on claudicants. Furthermore, female patients more often had access site hematomas (3.6% vs. 2.3%; p<0.001) and stenosis or occlusion (0.3% vs. 0.2%; p=0.001). Female patients had lower oneSeptember 2021

year reintervention-free survival (84.3% vs. 86.3%; p<0.001), with no differences in amputation or death. Female sex was independently associated with one-year reintervention (hazard ratio [HR] 1.16, 95% confidence interval [CI] 1.09–1.24; p<0.001), but not amputation or death.

Among those who underwent infrainguinal bypasses (9,314 surgeries; 70% male, 30% female), female patients had fewer infrapopliteal targets and more often received prosthetic conduits (p<0.05 for all), Levin explained. There were no differences in perioperative outcomes. Female patients had lower one-year reintervention-free survival (79% vs.

81.2%; p=0.04) with no differences in amputation or death. Female sex Scott R. Levin was independently associated with oneyear reintervention (HR 1.16, 95% CI 1.03–1.31; p=0.016), but not amputation or death.

As for suprainguinal bypasses (3,227 surgeries; 63% male, Keith D. 37% female), “female Calligaro patients more often underwent bypass from the axillary artery (p<0.05). Female patients had fewer perioperative surgical site infections (0.9% vs. 1.8%; p=0.048). There was no significant difference by sex for one-year reintervention, amputation, or death, even adjusted for comorbidities,” Levin added.

Levin also reported that female patients were less likely to present with independent ambulatory status preoperatively, which persisted postoperatively after endovascular interventions.

Meanwhile, for endovascular interventions and infrainguinal bypasses, female patients were less often on aspirin (73.4% vs. 77.3% and 71.5% vs. 74.8%, respectively) and statins (71.8% vs. 76.7% and 73.1% vs. 76%, respectively)—all with a p value of <0.001.

Levin concluded: “Female patients undergoing interventions for claudication were less often on aspirin and statins.

Interventionists treating female claudication patients should increase their efforts to maximize medical therapy, even patients exhibiting with worse baseline ambulatory function and worse function after peripheral vascular interventions.

After peripheral vascular interventions and infrainguinal bypasses, female patients had increased risk of reintervention. Future research should clarify reasons for poorer intervention durability in female patients.”

Ruptured AAA disparities The data demonstrating racial disparities among patients treated for rAAAs, delivered by O’Donnell during a special September 2021

scientific session on diversity, equity unstable to undergo repair, patients and inclusion Aug. 20, included refusing repair, comorbidities one statistic showing that Black such that repair would be patients were significantly futile?” less likely to undergo transfer O’Donnell said: “That’s prior to repair compared always the interesting to white patients (49% vs. question with something 62%; p=0.002)—with rates like NIS, and why we wanted of transfer high. “This was to use the two databases, and consistent in crude and adjusted that’s something you can tease analyses, in sub-analyses limited to Thomas F. X. out in the VQI, and we know only stable patients, and was not from the VQI that the rate of O'Donnell modified by insurance status, type of presentation in terms of instability operation, or hospital volume,” O’Donnell is the same, so, all things being equal, the revealed. race comorbidities were slightly higher but O’Donnell and colleagues examined presentation as an unstable patient was all repairs of rAAA in both the VQI from about the same, so some of that increase 2003–2020 to evaluate transfer rates and in turndown may be due to the comorbid outcomes in Black vs. white patients in burden. But since the instability is about the National Inpatient Sample (NIS) from the same, you can’t attribute all of that.”

2004–2015 to examine turndown rates.

Calligaro, raising the same point he later They found nearly 5,000 (6.2% Black) in asked of Levin the following day, urged the former and 50,000 (6% Black) in the caution in how the data is interpreted. latter. Mixed effects logistic regression, Cox “There are several publications also regression and marginal effects modeling showing that women are less likely to were used to study the interaction between race, insurance status, type of operation— open repair vs. endovascular aneurysm Females were 30% less repair (EVAR)—and hospital volume. likely to undergo surgery There was no significant difference in for PAD, national database perioperative mortality (Blacks 22% vs. whites 26%; p=0.098) or complications study finds (52% vs. 52%; p=0.64), the researchers found. But O’Donnell said the data show A review of more than 1 million patients that Black patients were significantly more receiving vascular surgery over a 16-year likely to be turned down for repair when period identified significant sex-related disparities in the treatment of abdominal presenting with rAAA (37% vs. 28%; odds aortic aneurysms (AAAs) and peripheral ratio [OR] 1.5 [1.2–1.9]; p<0.001). “There arterial disease (PAD)—with females 30% was a significant interaction between less likely to undergo surgery in the case race and insurance status with respect to of PAD. turndown,” he explained.

“The first annual Women’s Vascular “Patients with private insurance Summit highlighted sex- and genderunderwent operations at similar rates related knowledge gaps in vascular disease regardless of race, but among patients and treatment,” first author Katharine with Medicare or Medicaid/self-pay, Black McGinigle, MD, assistant professor in the patients were less likely than whites to division of vascular surgery at the University of North Carolina in Chapel Hill, writes in undergo repair (Medicare: 64% vs. 72%; the June edition of the Journal of Vascular p=0.001; Medicaid/self-pay: 43% vs. 61%, Surgery (JVS). “This finding suggests an p=0.031).” opportunity for further research to improve Furthermore, patients with Medicaid/ care and outcomes in people who identify self-pay were less likely to undergo as women, specifically”. repair compared to patients of the same Speaking to Vascular Specialist, race with either Medicare or private McGinigle went into more detail about insurance (p<0.05), O’Donnell added. He the meeting and its importance: “The concluded: “Black patients with rAAA Women’s Vascular Summit, directed by are poorly served by the current systems co-author Linda Harris, [MD], is an annual meeting for medical professionals who of interhospital transfer in the United treat vascular disease in females. For all States, as they less often undergo transfer vascular conditions, the research presented prior to repair. Although postoperative at this meeting has illustrated that there outcomes appear similar, this may be false are significant sex-related knowledge gaps. optimism, as Black patients, especially the Females tend to have different presenting underinsured, are more often turned down symptoms than males, present later in for repair even after adjustment. Significant the disease course, and are more often work is needed to better understand the misdiagnosed.” reasons underlying these disparities and The research team hypothesized that identify targets to improve the care of once the diagnosis is made, there also would be differences in the intervention Black patients with rAAA.” rate and type of intervention performed.

Session moderator Bernadette Aulivola, The purpose of this study, therefore, was to MD, professor of surgery and director identify all operations performed for AAA, of the division of vascular surgery and carotid artery stenosis (CAS) and PAD in the endovascular therapy at Loyola University U.S., and to provide data on sex-related Medical Center in Maywood, Illinois, asked disparities in treatment.

O’Donnell to explain how he and his fellow Using the Healthcare Cost and Utilization researchers defined turndown, or failure to Project National Inpatient Sample, the offer an operation, elaborating, “How do research team identified all hospitalizations you catch out whether that’s patients too

undergo repair at the same size, and that they have a higher mortality for elective and ruptured, open versus endo,” he said.

“Frankly, I don’t think it’s because women are turned down for surgery per se. One reason that comes to mind is for instance with EVARs—they may have smaller iliac arteries, worse access and higher complication rates … I’m not aware of any anatomic differences between African Americans in terms of aortoiliac anatomy but there may be other things we’re not aware of.”

O’Donnell accepted the point, explaining that his group had looked at aortoiliac anatomy previously. “What we found in the VQI at least was that Black patients—and similarly in this population as well—had more iliac aneurysms, but more often were actually treated with EVAR. That’s borne out in this dataset: Black patients were about 10% more likely to undergo EVAR. So some of it may be anatomic differences, but I don’t think that can explain a significant portion either.” of adult patients (≥18 years old) diagnosed with AAA, CAS or PAD who underwent vascular surgery from 2000–2016. The authors specify that they used census data and sex-specific population disease prevalence estimates from the National Institute of Health and Agency for Healthcare Research and Quality to calculate the number of U.S. adults with AAA, CAS and PAD. McGinigle and colleagues detail that there were 1,021,684 hospitalizations for vascular surgery over the 16-year study period: 13% AAA (21% female, 79% male), 40% CAS (42% female, 58% male), and 47% PAD (42% female, 58% male).

Females were older than males at the time of surgery (median age, 71.3 years vs.

69.7 years) and less likely to have private insurance (18% vs. 23%). In addition, minimal differences were seen across race/ethnicity, comorbidities and hospital characteristics.

After accounting for disease prevalence, the authors report in JVS that females were 25% less likely to undergo surgery for AAA and 30% less likely to undergo surgery for PAD compared with males, were less likely to receive an endovascular procedure compared with open for AAA or CAS, and more likely to receive one for PAD. McGinigle remarked on these findings: “We know we need to improve AAA screening rates, and now we know that even when the diagnosis is made, we need to be operating more in women. […] It appears as if females are getting more endovascular revascularizations in this study, but we caution that all of the patients in this database are admitted to a hospital, so it is likely that women are just more often getting admitted for complications for a common outpatient procedure. The gender-stratified rates of outpatient treatment are known.

“Shared decision-making around the indication for treatment is important, and in the future it will be interesting to study how females versus males make these decisions, particularly in conditions like claudication where there are not objective parameters for intervention.”—Jocelyn Hudson and Bryan Kay

vascularspecialistonline.com | 11

HONORED AT VAM

SVS bestows Lifetime Achievement Award on Robert B. Smith III

BY BETH BALES Among his many professional achievements in a career of a “golden age of vascular surgery” that overlapped with the growth and maturation of the specialty and the endovascular revolution, Robert B. Smith III, MD, most remembers the “many young men and women who trained with us over those years and today excellently service patients’ needs.”

SMITH, WHO RETIRED 11 YEARS AGO, ON THE morning of Aug. 19 at the Vascular Annual Meeting (VAM) in San Diego officially received the Society for Vascular Surgery (SVS) Lifetime Achievement Award, one of the highest honors the SVS can bestow upon a member. In performing the introduction, Past President Kim Hodgson, MD, called Smith “a venerated master who has left a lasting impact on the vascular world.” He actually was named award recipient in 2020 but cancellation of the 2020 VAM moved his ceremony to 2021. Due to health issues “of my lovely wife of 68 years,” Smith accepted the award via video from his home in Georgia.

He began his career as a resident at Columbia Presbyterian Medical Center in New York, working with the famed Arthur Vorhees, MD, who invented a plastic prosthesis for correction of diseased arterial segments.

“He was a great teacher who became a friend and collaborator until his death in 1992,” said Smith.

His residency, said Hodgson, “jump-started his immersion in vascular surgery where his career overlapped with the growth and maturation of vascular surgery and the endovascular revolution.”

After residency he returned to Emory University—

Robert B. Smith III accepts award

where he’d attended college and medical school—as a faculty member. There, Garland Perdue, MD, “congenial colleague, active role model and gifted administrator,” was also his benefactor. He and Perdue performed Georgia’s first successful renal transplant, and he helped refine the distal splenorenal shunt, a major innovation in the care of patients with portal hypertension, said Hodgson. Surgeons from across the country have visited Emory to observe the liver team performing shunt procedures.

In 1969, they started a vascular surgery fellowship, comprised of one additional year of training after general surgery training. It was “one of the earliest such programs in the country and the first to receive approval by a national accrediting agency,” said Smith. “We trained more than 60 vascular surgery residents” over more than four decades, he added, who are now working across the country and even the world. Four, in fact, followed Smith

as Emory’s head of vascular surgery: Alan Lumsden, MD, Elliot Chaikof, MD, Thomas Dodson, MD, and the current chair, William Jordan, MD. In turn, those trainees praise Smith, calling him “both a master surgeon and the go-to vascular surgeon at Emory,” said Hodgson.

“I am an admiring enthusiast for what you and your teams do on a daily basis,” Smith told the VAM audience.

“I am aware it is a great privilege to be a physician and even more a surgeon and especially a surgeon in a subspecialty that frequently is a life-, brain- or limb-saving discipline.” Receiving the award is the “highest honor of my professional career and I am profoundly grateful,” he said. “It’s a humbling experience as I join those prestigious leaders who have received this award previously.”

The award also “is an affirmation of the entire division of vascular surgery at Emory,” he added, thanking Hodgson and others “for this very special recognition.”

SAVE THE DATE! 2022

June 15–18, 2022 • Boston, MA TH ANNIVERSARY!

VASCULAR ANNUAL MEETING AN

BOSTON MASSACHUSETTS

Help celebrate the Society for Vascular Surgery’s 75th birthday at the 2022 Vascular Annual Meeting.

12 | Vascular Specialist

September 2021

YOUR SVS

What is taxonomy and how does it affect vascular surgeons?

BY KEVIN MARTIN, MD

Have you ever had a bill denied for services of your assistants and not known why? Have you received cryptic messages on an explanation of payments that indicates your assistant is not allowed to bill for services? As the use of professional extenders increase, this is becoming a more frequent issue.

SEVERAL SURGEONS HAVE AIRED questions over the past year about denials on billing for their mid-level or advanced practice providers (APPs), physician assistants (PA) or nurse practitioners (NP).

Some of these denials are related to taxonomy code issues. Taxonomy is the classification of providers ticking away on computers in the background, about which many physicians know little. When a provider signs up to practice after getting the appropriate license, one gets an National Provider Identifier (NPI) number but also a taxonomy code number, which goes into the Medicare Provider Enrollment, Chain and Ownership System (PECOS) and insurers’ computers. The taxonomy code tells the computer what type of provider you are. For physicians, this usually never changes, i.e., once a vascular surgeon, always a vascular

surgeon. Many physicians never even know they have a taxonomy number as this is usually handled by credentialing employees when the physician first starts work. So, the problems are not with the vascular surgeon, but with the APPs. For PAs, there are only three taxonomy codes, but issues occur when a PA starts work with a medical practice, changes jobs, and is hired by surgeons and does not change his or her taxonomy code. Then there can be conflicts with surgical groups being told that they cannot be with other groups in risk-sharing models (accountable care organizations) as the computer sees a primary care billing from the surgical group PA (the computer thinks this is still a medical PA), which cannot be allowed.

When an APP changes jobs, it is important to review and update the taxonomy code.

For nurse practitioners, there are 18

SVS branding campaign wins communications award

BY BETH BALES AND KRISTIN CROWE

taxonomy codes, and for certified This is a separate issue from the clinical nurse specialists (CCNS) desire of some APPs to have there are 34. None of those 52 independent practices without a codes specifies a surgical NP or collaborative agreement with a CCNS. There can be problems physician. with computers thinking that For those in multispecialty billings from these are medical groups with the same tax providers rather than surgical identification number, the providers. taxonomy code for the physician To decrease problems, there are can identify the separate specialty workarounds. None is perfect but while the APP taxonomy code is they do allow some flexibility. not specific enough. Depending on First, one should be aware of the site of service, the physician these taxonomy codes and make can also edit/amend the note after sure that everyone is signed seeing the patient and take up with the correct code.

No. of taxonomy over the billing under split/ codes: PAs 3, NPs 18 The following section of the shared service. Physicians then and CCNS 34 Centers for Medicare and get the credit for the billing.

Medicaid Services (CMS) This may play havoc with website, vascular.org/TaxonomyDataset, APPs’ pay if their remuneration is heavily is a good place to start to check the based on work relative value unit (wRVU)/ taxonomy codes. The PECOS (vascular. billing production. But some electronic org/PECOS) can be checked to make sure medical records have a way to track the the taxonomy code is correctly listed.

APP productivity as well as the physician APPs traditionally are considered to be billing. These are some of the ways to working in the same field/specialty as the avoid billing problems, but making sure physicians with whom they work. The the taxonomy codes are correct is the first supervising physician can be listed on a step. If there are recurrent denials on APP claim with the APP so the computer can billing, coordination between credentialing recognize the specialty within which the and billing staff can alleviate/resolve many APP is working, based on the physician’s of these problems. taxonomy code. There must be a collaborative agreement between the APP KEVIN MARTIN was writing on behalf and the physician to use the latter’s name/ of the SVS Coding Committee, of which he is code that pulls the service to a specialty. a member.

3 18 34

The Branding Toolkit, introduced a year ago, includes as a huge opportunity to promote a vascular practice. fliers, posters and brochures that can be customized with Hundreds of SVS members have accessed the toolkit member logos, addresses and photos. Additional tools by downloading and/or customizing fliers, postcards, to help SVS members engage with additional referral videos, social media ads and more. Now, the SVS wants audiences, hospital leadership, patients and consumers to hear Branding Toolkit success stories. will be added over time.

The contest includes two categories: both the most “I’m proud of this award, as I am proud of the creative and most effective uses of the toolkit. Each immense effort that has gone into making the campaign winner will be able to choose between admission to the a reality,” said SVS Executive Director Kenneth M. Slaw, 2022 Vascular Annual Meeting (VAM) or a $250 social PhD. media ad campaign.

“Members identified branding as a SVS also will conduct a drawing, No. 1 initiative in 2018, and now the with the winner, selected at random, SVS and Springboard have given our receiving one free year of SVS members the tools they need to have membership dues for 2022. To enter, effective conversations in their own members can submit any number of local markets with referral sources,” customized pieces from the toolkit, noted Joseph Mills, MD, SVS vice with each piece serving as one entry T president and former chair of the into the drawing.

Public and Professional Outreach Winners will be announced at the Committee, which worked to develop VEITHSymposium in Orlando later in the campaign and toolkit.

November.

“Use them,” he added. “Make a “The SVS has really demonstrated difference for yourselves and our a commitment to every member with profession by getting this message out the branding effort,” said Benjamin in different ways and as often as you J. Pearce, MD, chair of the SVS can.”

Our November issue Public and Professional Outreach highlighted the SVS branding Committee. “The Branding Toolkit Brand your practice and win allows each member to create a Meanwhile, members have the chance to tell their bespoke set of patient-centered and practice-oriented stories, promote their practices and spread the word materials to help get the word out about vascular about the vascular surgery specialty—and win prizes. surgery. I encourage all members to participate in the They simply need to use the SVS Branding Toolkit toolkit contest and drawing, not just for the prizes, but and then share how they put it to use by entering the to get firsthand experience with this resource.”

SVS Branding Contest by Nov. 1 The Branding Toolkit represents a commitment to the For more information on the branding campaign and toolkit branding of the vascular surgery profession and serves visit vsweb.org/Branding.

19 CONGRESS

SVS PAC What the Society is doing for vascular surgery in D.C. as election arrives

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COVID-19 ALI amid the pandemic

AMPUTATIONS Value of podiatry in limb salvage

THE BIG PICTURE

Members asked; SVS listened.

The Society for Vascular Surgery (SVS) has launched a Branding Toolkit to help its members brand the specialty in order to elevate and differentiate their practices.

ANATOMY OF A BRANDING CAMPAIGN: MAKING VASCULAR SURGERY MORE VISIBLE

BY BETH BALES

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

September 2021

JVS ASSOCIATE EDITOR Ulka Sachdev-Ost recalls her mother's career

CHANGE SERVICE REQUESTED

SVS WON ITS AWARD IN THE COMMUNICATIONS category, for “initiatives that disseminate an important message or promote a medical society’s mission through effective content and delivery methods.” The other categories are advocacy, education, leadership and membership.

The entry, “Translational branding: Applying a national brand strategy to improve your member’s local brand,” highlighted the Society’s ongoing branding campaign and Branding Toolkit to help vascular surgeons communicate their role in comprehensive vascular care to referral sources and patients, and to emphasize that “Surgery is only part of our story.” SVS works with Springboard Brand & Creative Strategy to develop the campaign and the toolkit.

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Featured in this issue:

his first set of branding tools tells referring physicians what vascular surgeons do and why they are critical partners when it comes to treating their patients with circulatory disease.

With the toolkit, vascular surgeons also can emphasize to other healthcare professionals that surgery is only part of the repertoire of treatment they offer.

The tools, to help members communicate about the comprehensive care they provide, have been in development for more than two years, said Joseph Mills, MD. He led the branding effort as chair of the Public and Professional Outreach Committee.

SVS members identified branding as their No. 1 initiative in 2018, he said.

Subsequent research identified confusion among patients as well as other physicians with respect to which medical specialty best treats vascular issues and highlighted the misconception that surgery is the only treatment modality vascular surgeons offer.

To address these issues, the branding effort emphasizes two main concepts, said Mills: “We provide comprehensive care, and surgery is only part of our story. No one else providing components

“We provide comprehensive care, and surgery is only part of our story”— Joseph Mills

of vascular care is trained and capable of offering all of the available options and long-term follow-up care that we can do.

“No one wants to get rid of the essential fact that we’re surgeons—but we’re not only that. We don’t just solve patients’ acute problems. We provide care for their vascular disease for the rest of their lives.”

In many instances, he noted, “we are viewed as highly technical surgeons who are relied upon for episodic interventions.

“So to brand ourselves properly, the key message going forward is that we must do what we say we do, which is to provide comprehensive and longitudinal care.”

See page 4

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

The Society for Vascular Surgery (SVS) branding campaign has received a “Profiles of Excellence Award” from the American Association of Medical Society Executives for outstanding achievement by medical societies.

Vol.16 No.11 NOVEMBER 2020

vascularspecialistonline.com | 13

LOWER EXTREMITY

Amputation rates higher for people with PAD who are poor or Black

BY JOCELYN HUDSON

POVERTY AND BLACK RACE WERE associated with higher rates of lowerleg amputation among people with peripheral arterial disease (PAD) who live in metropolitan areas, according to new research published in a special issue of the Journal of the American Heart Association (JAHA), an open access journal of the American Heart Association (AHA).

The analysis on PAD-related amputations is one of 16 new research studies highlighting health disparities among people from diverse population groups published in the special spotlight issue of JAHA. JAHA senior associate editor Pamela Peterson, MD, of the University of Colorado Denver, and associate editor Sula Mazimba, MD, from the University of Virginia Health System, Charlottesville, Virginia, note that while management of cardiovascular disease has reduced death rates over time, there are still “striking disparities” in the U.S. that have widened along racial, ethnic,

socioeconomic and geographical lines.

“We hope that this issue of JAHA will reinforce the recent American Heart Association’s presidential advisory statement urging all stakeholders to a committed path towards transforming the conditions of historically marginalized communities, improving the quality of housing and neighborhood environments of these populations, advocating for policies that eliminate inequities in access to economic opportunities, quality education and healthcare, and enhancing allyship among racial and ethnic groups,” they wrote.

The study, “Geographic and

FDA approves expanded PAD indication for rivaroxaban plus aspirin

BY JAMIE BELL

The Janssen Pharmaceutical Companies of Johnson & Johnson announced in late August that the Food and Drug Administration (FDA) had approved an expanded peripheral arterial disease (PAD) indication covering the rivaroxaban vascular dose—2.5mg twice daily plus 100mg of aspirin once daily—to include patients who have recently undergone a lowerextremity revascularization (LER) owing to symptomatic PAD.

T

he approval is based on data from the phase III VOYAGER PAD study. According to a press release, rivaroxaban is now the first and only therapy indicated to help reduce the risks of

September 2021

socioeconomic disparities Fanaroff and colleagues found that ZIP in major lower-extremity codes with a higher proportion of Black amputation rates in residents had higher amputation rates metropolitan areas,” by than ZIP codes with lower proportions Alexander Fanaroff, MD, of of Black residents. In addition, ZIP codes the University of Pennsylvania, with lower median household income, Philadelphia, et al, is an analysis more residents eligible for Medicaid of national Medicare claims and worse scores on the Distressed data to determine ZIP codeCommunities Index scale (a composite level variation in rates of marker of socioeconomic status), had amputation higher amputation “We found that closer rates compared among Medicare proximity to specialized to ZIP codes beneficiaries. with higher PAD care within “Limb socioeconomic metropolitan areas amputation status, even can be does not ensure access after adjusting delayed and for clinical and to high quality care” — demographic or prevented by timely and characteristics.

Alexander Fanaroff aggressive “Though treatment. amputation However, lack of access to rates are generally higher in rural areas, specialized care may delay this finding shows that the association PAD diagnosis and limit between lower socioeconomic status, efforts to save the limbs if it race and amputation rate extends to has progressed to the advanced major metropolitan areas as well as rural disease stage,” explained regions,” Fanaroff said. “We found that Fanaroff. closer proximity to specialized PAD care within metropolitan areas does not ensure access to high quality care. Strategies targeted to communities with high amputation rates are also needed in urban areas to reduce these disparities.”

A recent AHA scientific statement noted sex and ethnic disparities exist in the diagnosis and treatment of chronic limb-threatening ischemia (CLTI).

major cardiovascular events (MACE) in patients with coronary artery disease (CAD) and major thrombotic vascular events, such as myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, in patients with PAD, including patients who have recently undergone LER due to symptomatic PAD. “For more than 20 years, many physicians have used dual antiplatelet therapy after lower-extremity revascularization due to symptomatic PAD with limited data to support efficacy and safety in this setting. Now, the VOYAGER PAD and COMPASS clinical studies have demonstrated the utility of dual pathway inhibition in targeting both platelets and thrombin in patients with PAD. These data provide a new mechanism of treatment using an evidence-based strategy for this vulnerable population,” said Marc P. Bonaca, MD, of the University of Colorado Anschutz Medical Campus, Aurora, Colorado. “This FDA approval of rivaroxaban plus aspirin is a major advancement for PAD management and sets the stage to evolve the current standard of care for patients with PAD,” he added.

Rivaroxaban now has nine indications in the U.S. The phase III VOYAGER PAD trial, which demonstrated the rivaroxaban vascular dose reduced the risk of MACE and

Symptomatic PAD post-LER: 2.5mg of rivaroxaban twice daily plus 100mg of aspirin once reduces MALE/MACE by 15%

major adverse limb events (MALE) by 15% in patients with symptomatic PAD post-LER compared to aspirin alone.

The VOYAGER PAD trial saw no significant difference in thrombolysis in myocardial infarction (TIMI) major bleeding between rivaroxaban with aspirin compared to aspirin alone.

The results from the VOYAGER PAD study complement findings from the landmark phase III COMPASS trial, which also examined the dual-pathway approach of rivaroxaban with aspirin in CAD and/or PAD patients and further supports this FDA label extension in PAD patients.

Data from the phase III COMPASS trial resulted in FDA approval in 2018 to reduce the risk of MACE, such as heart attack, stroke and cardiovascular death in people with chronic PAD and CAD. While there were more major bleeds with the rivaroxaban vascular dose in COMPASS, there was no significant difference in rates of fatal bleeding, intracranial bleeding or symptomatic bleeding into a critical organ.

Meanwhile, new data from VOYAGER PAD presented at the 2021 Vascular Annual Meeting (VAM) suggested rivaroxaban plus aspirin should be considered after lowerextremity bypass regardless of conduit type, as reported in Vascular Connections, a sister publication of Vascular Specialist.

2.5mg 100mg

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NEWS BRIEFS

PAD

Save the date for new PAD skills workshop

BY BETH BALES

September is National PAD Awareness Month, and the Society for Vascular Surgery (SVS) will spend the month not only calling attention to causes and treatment for the disease, but also planning a peripheral arterial disease (PAD) skills workshop.

THE HANDS-ON WORKSHOP, aimed at practicing surgeons, includes more than 10 hours of didactics, smallgroup sessions and four hours of skills training. It will be held Feb. 11 and 12, 2022, at the Orthopedic Learning Center (OLC) in the SVS headquarters office building in Rosemont, Illinois.

To be able to provide individual and personalized attention, attendance is

limited to 75 attendees. Members have long requested such a workshop because they treat PAD patients frequently but don’t necessarily have the latest skills and knowledge, said Vikram Kashyap, MD, program chair alongside Patrick Geraghty, MD, with additional planning coming from Daniel McDevitt, MD. Fifteen “top-notch” surgeon-instructors will teach, the doctors said.

SVS draws attention to Medicare cuts as PAD Awareness Month kicks off THE SOCIETY FOR VASCULAR SURGERY (SVS) has mobilized a special task force to take action on proposed cuts by the Centers for Medicare and Medicaid Services (CMS) that would severely hammer vascular care, potentially harming access to specialty care. The SVS Task Force on CMS Payment Cuts, cochaired by Matthew Sideman, MD, and William Shutze, MD, is working with a number of other specialty societies and coalitions to submit both technical letters and letters of personal stories from physicians as to how these proposed cuts will impact patient care.

UCLA-SVS review course less than month away There’s less than a month left to register for the Sixth Annual UCLA-SVS Symposium set to take place Oct. 1 to 3 at the Beverly Hilton in Beverly Hills, California.

“A COMPREHENSIVE REVIEW AND UPDATE OF What’s New in Vascular and Endovascular Surgery” offers a valuable, in-depth review of the specialty for those preparing to take the vascular board examinations as well as providing the basic didactic education for vascular residents and fellows in training.

The Division of Vascular and Endovascular Surgery at UCLA and the Society for Vascular Surgery offer the course jointly. More information, including the course description, faculty, agenda, objectives, accreditation and more, is available at vascular.org/ Symposium21.—Beth Bales

September 2021

“Surgeons like being trained by surgeons who they know, who can speak clearly about the advantages of different therapies and different clinical settings,” said Kashyap.

Community practitioners do not typically have a great many opportunities for hands-on instruction, added McDevitt, chair of the new SVS Community Practice Section.

“Our surgeons read about techniques but need a comfort level when they start executing them,” he said. “Educational opportunities are limited, as is the ability to try equipment unimpeded.”

In addition, new devices are introduced frequently. “Surgeons need to know ‘where does this new device fit into my practice,’” said Geraghty. “They want clear feedback and advice.”

The workshop will feature only approved devices grouped by areas of different facets of participants’ clinical practices.

CMS’ proposed physician fee schedule, if implemented as proposed, will result in a devastating 11.4% cut to vascular surgery.

That cut incorporates changes to the conversion factor, the fourth and final year of the market update to supplies and equipment, and a new proposal to update clinical labor pricing. This year’s drop is reinstating the cut that Congress prevented last year, which further emphasizes the need for continued congressional intervention to protect patient care, advocates have said. By some estimates, vascular surgical procedures are set to incur some of the steepest cuts under the proposed rule.

CMS cuts are particularly harsh for revascularization services, especially in the office setting or OBLs, with some cuts estimated up to 22%. SVS is mobilizing members and all resources possible in an attempt to educate CMS on the impact of these cuts on patient lives and the business of running an effective private

First patient enrolled in AAA-SHAPE Netherlands study Shape Memory Medical has announced the initiation of AAASHAPE Netherlands, the company’s prospective, multicenter early feasibility study of the Impede-FX RapidFill device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). The Dutch study’s first procedure was performed by Michel Reijnen, MD, a vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands. Ted Ruppel, president and chief executive officer of Shape Memory Medical said, “The addition of Dutch sites to the AAA-SHAPE program accelerates our ability to evaluate Impede-FX RapidFill and its potential to improve sac regression in AAA patients following EVAR.” The study will enroll up to 15 patients across three centers in The Netherlands.— Jocelyn Hudson

Workshop topics will cover the entire gamut of PAD, including the latest tools and treatments such as deep vein arterialization, tibial interventions, intravascular ultrasound (IVUS) and intravascular lithotripsy. Of note, cadaver specimens, table-top models and hands-on deployment will be utilized to optimize the sessions.

Additional didactics on national trends in open and endovascular therapies, treatment settings, complications, plus billing and coding will be highlighted.

Adding this training is an important step for the Society and its members, said Kashyap. “Every day, every month, we have tremendous changes in treating occlusive disease. Feedback from the Vascular Annual Meeting (VAM) showed that members want really hands-on, detailed information on advanced endovascular techniques.”

Registration will open the first week in November. Look for information in the Pulse biweekly electronic newsletter, on social media and other SVS channels.

practice. “If these cuts go into effect, we may lose a large percentage of private practices as they simply will no longer be able to sustain sufficient margin to pay for employees, supplies and office space,” noted Shutze.

The proposed cuts are also being driven by a provision that purports to update clinical labor data, with an anticipated severe impact on cardiology, vascular surgery, venous, radiation oncology and radiology practices. Earlier this summer, the Surgical Care Coalition—of which the SVS is a member—said the fee schedule failed to address pending cuts to surgical care and continued to threaten patient care by reaffirming “previously imposed misguided cuts.”

“We believe we understand what CMS is trying to do, but the methodology and focus is sufficiently flawed and harmful to the mainstream of Medicare recipients who are in need of vascular care, that implementation must be halted,” said Sideman.—Bryan Kay

Spotlight: Daniel Clair, MD, has been named the inaugural chair of the newly formed Department of Vascular Surgery in the Section of Surgical Sciences at Vanderbilt University Medical Center and professor of vascular surgery in the Vanderbilt University School of Medicine, Nashville, Tennessee.

His appointment is effective Oct. 1.

Member Rajesh Malik, MD, has been appointed chief of vascular surgery at New York-Presbyterian Brooklyn

Methodist Hospital. He is an assistant professor of surgery (interim) at Weill Cornell Medicine. In his new role, Malik will lead the expansion of vascular surgery services at the hospital. He is a founding member of the South Asian American Vascular Society.

Caitlin W. Hicks, MD, and Linda Harris, MD, are editors of the new book Vascular Disease in Women: An Overview of the Literature and Treatment Recommendations, which highlights the epidemiology, natural history and treatment of vascular disease in women.

Scott Kujath, MD, has been named the new medical staff president of North Kansas City Hospital in Kansas City.

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COMMENTARY

Corner Stitch

In this month’s trainee column: Mindfulness and wellbeing

The art of surgery in the present moment

BY ANNA KINIO, MD

As a young surgeon-in-training, and a millennial, the concept of mindfulness and wellbeing perfuses my day-to-day life.

Reminders of the importance of “being present” and “taking care of yourself” come from all directions: in newsletters, inspirational quotes on social media and advertisements offering everything from yoga classes to aromatic diffusers. I am as guilty as the next person of falling for this materialistic version of wellbeing, buying the agenda with inspirational quotes that will surely change my life, or signing up for a meditation app that I use religiously for a week before letting it fall by the wayside.

BUT BEYOND THIS SUPERFICIAL and easily marketable concept of mindfulness, I do believe that the art of being present has an important place in our lives, and especially in the operating room (OR). As someone with a constant stream of self-talk, much of it negative, I was forced to address this head-on in my second year of residency. As Henry Ford famously put it—“Whether you think you can or you think you can’t, either way you are right”—and I decidedly thought

that I could not. In the OR, I would live in fear of performing in front of my staff. The nerves would start the night before and increase until I was in the OR, shaking and berating myself harshly for performing so poorly, sometimes also playing a script of what I was sure the staff were thinking in my head. Clearly this did nothing to help my surgical prowess, and led to even simple acts becoming tense and poorly executed.

Understanding the concept of

Insights from the VAM 2021 floor: The future of vascular surgery

BY KRISTIN CROWE AND ANNA VECCHIO

T

he Vascular Annual Meeting (VAM) presents great opportunities for medical students and residents who aspire to be vascular surgeons to network with, engage with and learn from vascular surgeons from all over the world. After a long day of vascular education, many of these VAM 2021 attendees gathered at the General Surgery Resident and Medical Student Reception Aug. 18, the first day of the meeting. The reception presented a chance for future vascular surgeons to build connections and network with their peers.

They shared what brought them to this year’s VAM,

18 | Vascular Specialist

mindfulness has traditionally been will start making mistakes. While the difficult for the surgical community, studies on mindfulness in surgery remain which is ironic given the great amount small, research confirms the positive of mindfulness that occurs in a surgical effects of mindfulness-based training theater. As Carter C. Lebares, MD, that seems intuitive. Studies show that director of the UCSF Center using mindfulness training can for Mindfulness in Surgery improve executive function in San Francisco puts it: scores, increase the “mindfulness consists speed of motor skills, of specific cognitive improve working skills including memory, and lower interoception stress and surgeon (an awareness of burnout. passing thoughts, As for my emotions and journey, it sensations), continues to be a emotional work in progress, regulation but I am happy to (development be evolving away of nonreactivity in from the anxiety-ridden response to stimuli) and and overly self-conscious metacognition version of myself. (conscious awareness “The nerves would start Lots of practice on of one’s cognitive surgical skills has the night before and my control processes).” helped, but so has increase until I was in working on being It is clear that these skills are already the operating room, fully present when being put to use in the a task in shaking and berating performing OR by many of the the OR. myself harshly for attendings with whom For me this is we work. They may the true value of performing so poorly” be recognized as those mindfulness, far from who are able to obtain the commercialized the “flow state” where total focus on the idea that we put on a pedestal. I think present activity leads to complete union that, as a specialty, we will only gain value with the task at hand. in recognizing mindfulness as a skillset Beyond achieving this desirable that needs to be actively developed and state, the implications of the surgeon’s worked on for a fully balanced surgical mindfulness-based skills extend beyond training. him or herself. The surgeon who can I know for my part it is a muscle which take a breath and calmly deal with I will continue flexing every day. After all, intraoperative bleeding will create a better the present moment is all we truly have. working environment than the surgeon who starts cursing, worrying that his or ANNA KINIO is a vascular surgery resident her patient will die, and barking at the in the department of surgery at McGill assistant and anesthesiologist, who in turn University in Montreal.

and some advice they would give to their younger selves, as well as to anyone just starting out in the medical field—student or otherwise.

“I worked on a project with Thomas Forbes, division chair and professor at the University of Toronto. The project was accepted for presentation at VAM, which intersected my involvement with the project and my interest in vascular surgery. It was perfect,” said Allen Li, a medical student at the University of Ottawa, Canada.

“Don’t be afraid to be involved and to do things that you want to do,” advised Jessica Nguyen, a medical student at Queens University, Kingston, Ontario, Canada. Nguyen encouraged students not to “mute themselves,” and encouraged them to speak up and truly get involved.

A group of rising fourth-year medical students had the occasion to meet and connect with each other for the first time at VAM, touching on what they were most looking forward to at the in-person meeting.

SVS Diversity Medical Student VAM Travel Scholarship recipients Falen Demsas, Ariel Francois and Aderike Anjorin talked of their excitement at the

prospect of meeting other like-minded people who share a similar interest and passion for the future of the vascular surgical specialty.

“VAM has given me the invaluable opportunity to meet fellow students and see the latest research in the field,” said Anjorin, who is currently taking a research year at Duke University School of Medicine in Durham, North Carolina.

“VAM gives a great feel for the culture of different programs. Most interviews will be virtual for this year, so having the opportunity to meet anyone I can and find my place in the field is very valuable,” said Deena El-Gabri, a fourth-year medical student at the University of Wisconsin.

“Most interviews will be virtual for this year, so having the opportunity to meet anyone I can and find my place in the field is very valuable” — Deena El-Gabri

XXXXXXXXX 2021

VASCULAR PRACTICE

Surgeons relate patientreported outcomes experiences Ashley K. Vavra, MD, and Christopher J. Smolock, MD, talk to Vascular Specialist about why they decided to collect patientreported outcomes (PROs), how they got started with them and the challenges they have faced. Vavra is a member and Smolock a recent member of the Society for Vascular Surgery (SVS) Performance Measures Committee.

Why did you decide to collect patient-reported outcomes?

AV: My feeling is that PROs are a way to help us as vascular surgeons better set expectations among the patients who we treat for how a vascular disease or treatment will affect their day-to-day life.

As we learn more, I am hopeful that PROs will also help us learn how to better define the success of particular treatments or interventions.

CS: Seeing patients in long-term followup, it became apparent that a technically successful and complication-free intervention or operation did not always correlate positively with a patient’s quality of life (QOL) throughout recovery. A striking example of this paradox is in acute aortic dissection patients who are treated by means of percutaneous endografts.

How did you get started?

AV: I first looked at the literature on PROs in vascular surgery patients.

However, the more I read, the more questions I had about which measures to collect and how to collect them. I found it helpful that the SVS released reporting guidelines for thoracic outlet syndrome that included two recommended PRO measures for collection; Ashley K. Vavra I used that as a starting point.

CS: We began using general QOL/ PRO surveys in retrospective research studies, one of which involved patients with total aortic replacement in multiple modalities over multiple stages. We began

approaching extensive aortic repairs in this manner, presuming an advantage for the multi-stage, multi-modal approach in survival and QOL. Instead, we observed that patient QOL was not necessarily better than single-stage, open surgery.

aortic dissection, as it educates them on this expected outcome. The minimally invasive nature of such a procedure does not necessarily prepare the patient for a prolonged period of convalescence.

How do you collect the PROs?

AV: The first challenge is response rates, and I have found that having an option to collect measures while patients are in the office is helpful. Another challenge is how to use the data. Since I have yet to analyze the data from our own experience and there aren’t benchmarks to help guide interpretation, I find it challenging to know exactly how to counsel patients on their results. Hopefully, this will improve as we learn more about how specific measures correlate with vascular disease and treatments.

CS: We are working on incorporating disease-specific PROs for each of the entities we treat. We also need to broaden the reach of this to the majority of our outpatient visits in a way that is not onerous to the patient or the provider.

AV: I started collecting PROs prospectively using a paper form that is then entered in the electronic medical record (EMR).

However, our institution has now set up a method of electronic collection for patients through the patient portal of our EMR. CS: We started collecting prospectively and electronically for some patients during outpatient check-in but are still working through this process.

How do you use them with patients?

AV: So far, I have only used them on an individual patient basis and discussed trends if they are available.

CS: I use retrospective Christopher J. QOL data following aortic Smolock interventions to inform patients of potential challenges post-procedure that might seem counterintuitive. This has been especially helpful for our patients who experience weeks to months of malaise after a percutaneous intervention for

What challenges have you faced?

“I find it challenging to know exactly how to counsel patients on their results.”— Ashley K. Vavra

USPSTF expands prediabetes, type 2 diabetes screening recommendation The United States Preventive Services Task Force (USPSTF) has issued an updated recommendation statement suggesting that clinicians screen for prediabetes and type 2 diabetes in overweight or obese adults aged 35–70 years—capturing adults at an age bracket five years younger than that contained in the previous advisory from 2015.

THE B-CLASSED RECOMMENDATION MEANS THE USPSTF BELIEVES there is high certainty the net benefit from the offer or referral for effective preventive interventions is moderate “or there is moderate certainty that the net benefit is moderate to substantial.”

The update is based on a systematic review aimed at evaluating screening for prediabetes and type 2 diabetes in asymptomatic, non-pregnant adults as well as preventive interventions for those with prediabetes.

“Based on data suggesting that the incidence of diabetes increases at age 35 years compared with younger ages, and on the evidence for the benefits of interventions for newly diagnosed diabetes, the USPSTF has decreased the age at which to begin screening to 35 years,” the statement reads.

Furthermore, evidence on the optimal screening interval for adults with an initial normal glucose test result is limited, with cohort and modeling studies suggesting that “screening every three years may be a reasonable approach for adults with normal blood glucose levels.”

USPSTF members led by Karina W. Davidson, PhD, of Feinstein Institutes for Medical Research at Northwell Health, Manhasset, New York, authored the recommendation, which was recently published in the Journal of the American Medical Association (JAMA). “Screening asymptomatic adults for prediabetes and type 2 diabetes may allow earlier detection, diagnosis, and treatment, with the ultimate goal of improving health outcomes,” the authors wrote. The update replaces the 2015 USPSTF recommendation statement.—Bryan Kay

September 2021

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