Gala organizers seek auction donations

WITH TABLES NEARLY SOLD OUT, THE “GREAT Gatsby Gala” Committee is turning its attention to gathering auction items to entice bidders in both the Live and Silent auctions.

The sky’s the limit, organizers say—anyone up for donating rides in a hot-air balloon, for example? In the past, members have donated weekend or even week-long stays at vacation homes across the country, in the mountains, and along the water. There even have been trips offered on other continents. In 2022, multiple people donated stays of five to seven days at their vacation homes or timeshares, raising more than $30,000 in donations.

All proceeds benefit the Society for Vascular Surgery (SVS) Foundation. The Gala, with its Roaring Twenties-inspired theme, harkening the days of F. Scott Fitzgerald’s 1925 classic, The Great Gatsby, will take place Friday, June 16, during VAM 2023.

Though the Gala’s Live Auction will be available only to ticket-holders, anyone, anywhere, can bid on the Silent Auction prizes, via computer. Those items will be available in early June, ahead of the Gala itself, with bidding closing during the event. Artwork from Chris Robb and a gift card to Enrico Cuini already have been donated.

To donate items for the auctions, email CLampi@vascularsociety.org

BEST-CLI takes center stage in inaugural ‘SVS Presents’ webcast

What do the results of the much-debated BEST-CLI trial mean for the vascular surgery community?

SVS members Alik Farber, MD, and Matthew Menard, MD, co-principal investigators of the trial, presented data, discussed the trial with panelists and took questions from participants during the inaugural “SVS Presents” webcast on April 12.

The ongoing series will take place on the first or second Wednesday evening monthly.

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Contribute to PAC in April: Be honored at VAM in June

This year’s VAM will include an “enhanced” Society for Vascular Surgery Political Action Committee (SVS PAC) contributor display, which will recognize SVS PAC donors from both 2022 and 2023. Deadlines for recognition for 2023 are April 15 for groups and April 30 for individuals.

The SVS will recognize practices that achieved 100% SVS PAC contributor participation within their groups in 2022 and those that achieve 100% 2023 participation in advance of the April deadline.

Members who believe their practices qualify for either 2022 or 2023 should email SVSAdvocacy@vascularsociety.org to share the name of their practice and their colleagues’ names. Members who plan to make an SVS PAC contribution for 2023, and who do so by April 30, will have their names included on the 2023 SVS PAC contributor list at VAM.

Member WILLIAM D. JORDAN JR., MD, a former president of the Association of Program Directors in Vascular Surgery (APDVS), has been named chair of the Department of Surgery at the Medical College of Georgia at August University. He will join the institution July 1. He currently is chief of the division of vascular surgery and endovascular therapy at Emory University in Atlanta.

Member BRUCE L. GEWERTZ, MD, has been named the CedarsSinai healthcare organization of Los Angeles surgeon-in-chief, to be the vice dean of clinical system development and faculty affairs. He is the former chair of the Cedars-Sinai Department of Surgery, and also is vice president of interventional services and the H & S Nichols Distinguished Chair in Surgery.

In memoriam

ROBERT HUGH JOHNSTON JR., MD, Feb. 22, Victoria, Texas, at age 92. Johnston, who trained with surgical titans Michael DeBakey, MD, and Denton A. Cooley, MD, was a cardiovascular surgeon who started the first heart program in Victoria, located in the south of the state. He also was a colonel in the United States Army, a pilot and, finally, an Episcopal priest.

Read more at vascular.org/RobertJohnstonObit

Fda

The development of medical devices in the vascular space faces increasing challenges amid moves afoot at the Food and Drug Administration (FDA), according to a leading regulatory expert in the field.

Among the developmental vehicles currently caught in the crosshairs are physician-sponsored investigational device exemption (PS-IDE) studies, Dorothy Abel, the former FDA official responsible for leading evaluation of vascular and endovascular surgery devices, recently told the 2023 Critical Issues America (CIA) annual meeting (Feb. 10–11) in Miami.

She was giving the CIA keynote address, tackling the subject of endovascular grafts across the decades, their evolution, and what lies in store for device development down the road.

Throughout, Abel, currently vice president of regulatory strategy at medical device research organization NAMSA, emphasized the importance of collaboration during the process of shepherding new products toward commercialization.

Developers should work together across the spectrum of interested parties—manufacturers, testing facilities, regulatory agencies—to establish the best bench-testing and animal study protocols, and what needs to be gleaned from the clinical setting, to get to requirements centered on a risk-based rationale for testing, she said. This might entail looking at “what does the device need to be able to do; what can go wrong if it does not do that, what type of testing do we need to help us believe that it is going to do what it is supposed to do,” explained Abel, who co-founded the FDA’s early feasibility studies program.

She contrasted the difference in standards between what is required in the European Union (EU) and the U.S. “In the U.S., it is kind of a guidance—it helps FDA understand what should be done,” Abel said. “But in the EU, they take it very seriously,” she added. “If it is written in a standard as something that needs to be done, you are going to have to do it in order to get the device to market.”

Abel posed the overarching question—“Is the future now?”—of the medical device development landscape, answering herself: “I am kind of hoping that it is not.” Her reasoning? Those challenges that potentially limit PS-IDEs.

“The FDA has recently shut down the opportunity for doing some sponsor-investigator IDEs,” Abel said. “We do not know yet what their thinking is; whether that is going to apply to all IDEs in this space; or if it is going to be focused on particular manufacturers, or types of devices. But, it is a little bit concerning, because we want to

Short neck AAAs: ‘Choosing what is best for the patient’

NAVIGATING CASES OF ABDOMINAL aortic aneurysm (AAA) with short neck anatomy poses a serious challenge to vascular surgeons, but the list of potential options available to carry out repairs are numerous— and decision-making can be optimized by using a bespoke algorithm.

That was the message delivered by Ross Milner, MD, chief of vascular surgery and co-director of the Center for Aortic Diseases at the University of Chicago Medicine, in a session on endovascular aneurysm repair (EVAR) controversies at the 2023 Critical Issues America (CIA) annual meeting in Miami (Feb. 10–11).

Milner outlined the four core pathways open to surgeons when they are confronted with short necks—defined as greater than 4mm and less than 10mm: open repair, fenestrated EVAR (FEVAR) or physicianmodified endografts (PMEGs), off-label chimney EVAR (ChEVAR), and endosuture aneurysm repair (ESAR).

In short, he said, the treatment ultimately elected should be dictated by the individual patient.

Milner

“I think in the past you’ve seen a lot of talks that are designed as debates between one of these techniques, and we commonly joke about different techniques not working well,” he told CIA 2023. “The reality is, when you’re looking at each one of your patients, and you’re sitting in the office, and trying to make a decision, I think we incorporate all of these options.”

Milner uses his algorithm, or decision tree, in order to help establish which approach is going to best serve the patient in front of

Compiled by Bryan Kay and Jocelyn Hudson

make sure people continue to study these devices responsibly.”

Right now, the FDA is focused on devices from a protection standpoint, with the agency often taking a skeptical view of new technology, Abel observed. “What is even more concerning, to go along with that skepticism, is there is a little less communication. They have almost doubled the size of postmarket studies as compared to the premarket studies in the most recent approvals, and it is not clear exactly what their fear is.”

The focus needs to be on patients, she said. “I am afraid that has gone away a little bit. Because there is so much focus on safety, they are not thinking about, ‘We need better things to take care of our patients in general.’”

From another angle, Abel highlighted how blame is apportioned when things go wrong. “Sometimes we are asking the wrong questions,” she said, referring to the example of ruptures occurring in patients fitted with endovascular devices. “Why did they have the ruptures? Were they not being followed? Is it really the endograft’s fault? Is it your fault? Is it the patient’s fault? But the FDA automatically goes, ‘It is the manufacturers who need to collect more data to figure out what is going on because we have these ruptures.’” him. This includes figuring out the patient’s physiologic risk, the level of urgency of a procedure, durability based on risk profile/ age, the direction of the renal arteries, and the state of the aortic arch anatomy.

“When I look at the anatomy, the things I look at from an anatomic standpoint are: how do the renal arteries come off the aorta?” he said. “At least in my hands, I find that for chimney approaches, downwardgoing renal arteries are easier. For upwardgoing, fenestrated is easier. But again, in different people’s hands, it’s probably different. I also look at the anatomy of the neck and the tortuosity. ”

Open repair can be valuable in the right set of patients, Milner continued, but is “highly invasive,” and “the risk of renal failure with open surgery is greater than with complex EVAR, and likely leads to worse outcomes.”

In his practice, Milner and colleagues do not perform procedures with PMEGs but rather on-label FEVARs. “It’s FDA approved, it’s all transfemoral, it’s indicated for 4mm neck, but it can be limited by anatomy, and sometimes the device just can’t be made,” he explained.

Investors and developers too are not beyond criticism, Abel continued. “Bad things can happen to potentially ruin good devices, and some of those bad things come from assumptions,” she said.

In order to ensure a successful future in the device development field, Abel returned to the concept of collaboration. And that also includes patients, she said. In the past, Abel recalled, “we kind of fell short. We did not have the patients involved early on. I think we need the patients involved.”

Shooting for the stars is laudable, she said, but “be happy to take some baby steps—they keep you moving forward.” Also be realistic, Abel advised. “Often we see timelines driven by investors.” And, whenever possible, be conservative, she added. “If you have a way to test something in a less risky population, why not do that first so you can de-risk the future? The goals are to solve problems, improve lives, reduce harm.” Learning not only from mistakes, but also successes is important, Abel concluded. “I think one of the big successes in endografts has been the sponsor-investigator studies. We have learned so much—I know it is over 30 years—but it is a relatively short amount of time when you think about medicine and the complexity of what is being done. And, cooperation is key.”

ChEVAR, meanwhile, has performed “relatively well” for his team in the treatment of complex anatomy. “Its limitations are gutter leaks and stroke risk,” Milner said.

Then there is short neck ESAR, he added, which incorporates EndoAnchors with an Endurant stent-graft. Overall, said Milner, his decision tree breaks down to, first, physiologic risk. “If it’s low, consider open surgery,” he said. “If high, go with an endovascular approach. For FEVAR, I look at iliac access, the direction of the renals, the neck tortuosity, the urgency of the procedure; for ChEVAR, again, iliac access, the direction of the renals, neck tortuosity and the aortic arch anatomy; for ESAR, calcification and thrombus, and reverse taper of the neck.”

Responding to skepticism over the ESAR procedure, Milner acknowledged controversy centers on a central question: ”What is the true neck? And all of us know that a 4mm neck is exceptionally challenging to use EndoAnchors on. I know that this is written as an indication, but that is hard to do,” he said, concluding: “Many options exist; choose what is best for your patient.”

Getinge receives FDA premarket approval for the iCast covered stent system

GETINGE‘S iCAST covered stent system has received premarket approval from the Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.

The iCast covered stent system, sold outside the U.S. under the brand name Advanta V12, has been used by clinicians for 20 years and is the most clinically evaluated balloon-expandable polytetrafluoroethylene (ePTFE)-covered stent in the world, with data published in over 550 articles, Getinge says.

VIZ.AI RECEIVES FDA 510(K) CLEARANCE FOR ABDOMINAL AORTIC ANEURYSM AI ALGORITHM

Viz.ai recently announced it has received Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm (AAA). Viz AAA is the first FDA-cleared AI-powered solution for the detection and triage of suspected AAA, the company claims.

“There is an estimated 1.1 million Americans living with an AAA. The majority of these patients are asymptomatic and many are unaware of their disease until a rupture occurs. This is a catastrophic medical emergency, resulting in over 10,000 deaths each year,” said Philip Batista, MD, from Cooper University Health Care in Camden, New Jersey. “This algorithm is a powerful new tool for healthcare professionals to more readily identify and capture individuals with AAA and, importantly, automatically refer those at imminent risk for rupture.”

Viz AAA uses artificial intelligence (AI) to automatically search for the presence of a AAA from computed tomography angiography (CTA) from any scanner in a hospital network, a press release details. The new AI algorithm and clinical workflow solution will be a part of the Viz Aortic Module, an AI solution designed to accelerate treatment decisions for all aortic pathology.

GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*

INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts. CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available.

used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS Heparin Surface. Products listed may life, VIABAHN and designs are trademarks of W. L. Gore & Associates.

2021 W. L. Gore & Associates, Inc. 21373436-EN DECEMBER