ANAHITA DUA NAMED 2023 PRESIDENTIAL LEADERSHIP SCHOLAR

SOCIETY FOR VASCULAR SURGERY (SVS) MEMBER

Anahita Dua, MD, has been named a Presidential Leadership Scholar for 2023.

She is one of 60 scholars in this eighth annual class. Dua is an associate professor of surgery at Massachusetts General Hospital and Harvard Medical School in Boston.

‘Voices of Vascular’ series celebrates Women’s History Month

THE CONTRIBUTIONS OF THE Society for Vascular Surgery’s women members take center stage this month as part of the SVS Foundation’s “Voices of Vascular” series.

THE SOCIETY FOR VASCULAR SURGERY will debut “SVS Presents” April 12, a monthly webinar series that provides an evening of educational programming for members.

“Presents” is in response to a key finding from the 2021 Educational Needs Assessment and the 2022 SVS Member Survey, which indicated online education opportunities as a top member priority.

During the COVID-19 pandemic, the SVS produced more than 40 webinars in 2020 alone. Through the educational needs assessment, members stated their interest for the SVS to continue to offer online education, but to condense the offerings to once a month.

“‘SVS Presents’ aims to consolidate the offerings to an identifiable time, hopefully decreasing ‘Zoom meeting fatigue,’” said Education Council Chair Linda Harris, MD. “We are also trying to better engage various committees, councils and membership sections to decrease the work and increase the audience for all presentations.”

The first presentation, on April 12, from 7–8 p.m. (CDT), will focus on the trial results released in late 2022 on the BEST-CLI trial. The second, May 3, will introduce the 2023–24 candidates for Society president and treasurer to SVS members prior to the start of voting. Future topics include advocacy, leadership development, quality practice and guidelines.

“SVS Presents” will take place either the first or second Wednesday evening of every month, excluding January and June due to holidays and preparation for the Vascular Annual Meeting (VAM). Some months will have several hours of programming while others will offer just one hour. This year will be a pilot year to measure interest and increase engagement from all SVS member segments. Planners hope to expand programming and encourage committees to utilize this specific day each month for educational content.

In the effort to standardize SVS educational programming, leaders hope to increase opportunities to participate in the activities. Webinars will be the focus at first, with hopes to offer other educational opportunities, such as releasing video content or micro-learning opportunities, or even hosting the Society’s popular TweetChats.

Presidential Leadership Scholars are “making a difference in the world by applying lessons in leadership learned from the presidential experiences of Presidents George W. Bush, Bill Clinton, George H.W. Bush and Lyndon B. Johnson,” according to program leaders.

“I am honored to be a part of this program that teaches leadership skills utilized by our past presidents of Bush, Clinton and Johnson and their administrations to make the world a better place,” said Dua of her honor.

Her project focuses on decreasing amputations rates among Americans through targeted legislative changes “that would optimize the multidisciplinary team approach to limb salvage, making it both standardized and accessible.”

Her intent is to address limb amputation—one of the most detrimental and costly outcomes of diabetes—and its prevalence amongst minority groups.

The scholars will travel to each participating presidential center to learn from former presidents, key officials of their administrations, business and civic leaders, and leading academics. Dua and the other scholars will study and put into practice varying approaches to leadership and exchange ideas to help strengthen their impact.

SVS, VQI sent letters to CMS

The Society for Vascular Surgery (SVS) and the Vascular Quality Initiative (VQI) have sent letters to the Centers for Medicare & Medicaid Services (CMS) regarding changing the National Coverage Determination for percutaneous transluminal angioplasty of the carotid artery concurrent with stenting.

Read the SVS and VQI letters at vascular.org/ StentingResponseCMS

Spot Light

In memoriam

See vascular.org/Mackeyobit

Pay SVS dues to receive SVS benefits, including VAM discount

With registration for the 2023 Vascular Annual Meeting (VAM) right around the corner, those people who have not paid their SVS 2023 dues have a good incentive to do so quickly. Members receive a discount on not only VAM but also other SVS educational courses. Other benefits include standing to vote in SVS elections (Active and Senior categories only), access to the Journal of Vascular Surgery, the SVSConnect online community, branding tools and more. Pay dues at vascular.org/Invoices

If non-members apply for membership by May 1, they could receive the membership discount for VAM, which is subject to application approval. Dues must be paid prior to the meeting to receive the member rate; the rate difference will be refunded after the meeting.

The “Voices” series is designed to help celebrate the diversity in the vascular surgery specialty. It debuted in February, Black History Month, and will continue throughout the year. In March, “Voices” will highlight profiles of women, their lives, their road to becoming vascular surgeons and their views of the vascular surgery specialty. The March celebration is in collaboration with the SVS’ Women’s Section.

Audra Duncan, MD, section cochair of the SVS Women’s Steering Committee, explained why such efforts matter.

“More than half of our incoming medical students are women. SVS recognizes this trend and is committed to recruiting and promoting young surgeons to represent the future of surgery, by embracing diversity and equity, including gender equity,” said Duncan. “Several studies support that patients may have better outcomes when they can be taken care of by physicians of similar gender, race or ethnicity, so it is critical that the face of the SVS reflects the diversity of the populations we care for in order to achieve the best outcomes for our patients.”

In addition, Boston Scientific, the campaign’s presenting sponsor, will match all gifts to the SVS Foundation up to $10,000 through March 31.

That means a gift goes two times as far to support Women in Vascular— past, present and future. Donors can double their impact today by visiting give.classy.org/WHM2023

Patient education is an important part of the campaign, and includes information on how vascular disease impacts women differently and how to inform women about the common signs of vascular disease to promote health and change outcomes.

CAGENT VASCULAR HAS ANNOUNCED the results of a comparative subanalysis of the PRELUDE-below-the-knee (BTK) study versus plain balloon angioplasty.

The study was led by Marianne Brodmann, MD, from the Medical University of Graz in Graz, Austria. This subanalysis compared their PRELUDE-BTK subset to a consecutive plain balloon angioplasty group.

The Serranator-treated lesions had an average final residual stenosis of 17.2±8.2% vs. 33.7±15.7% in the plain balloon angioplasty group. This represents a 49% average improvement in final residual stenosis. In chronic total occlusions (CTO), there was a 62% improvement in final residual stenosis compared to the plain balloon angioplasty group.

The average balloon inflation pressure was 5atm in the Serranator group vs. 9atm in the conventional balloon angioplasty group. Additionally, Serranator-treated arteries demonstrated 2.4 times greater calculated flow improvement versus plain balloon angioplasty. These data, analyzed by the same independent core lab, were recently published in the Journal of Endovascular

Therapy. Brodmann stated: “As an early user of serration angioplasty, it was meaningful to quantify through this subanalysis what we have experienced using the Serranator device.

“William Tang [UC Irvine, Irvine, California] developed a novel model, anchored by Poiseuille’s law, from which we were able to derive the volumetric blood flow from lumen gain achieved with the Serranator compared to conventional balloon angioplasty.

“These results suggest an advantage for serration technology that should allow for superior wound healing and patient outcomes, while minimizing the need for stent placement.”

Raman Sharma, MD, from Mount Sinai Medical Center in New York, who was was an early adopter of serration technology, said: “When it comes to BTK interventions, there simply have not been great options for physicians to treat patients, who are often in jeopardy of limb loss.”

Sharma added: “The results from this subanalysis study support what we have seen in our experience; the Serranator provides greater lumen gain and blood flow versus conventional technology.”

RESCUE trial shows reduction in segmental and main pulmonary artery occlusions

ROBERT A. LOOKSTEIN, MD, FROM THE Icahn School of Medicine at Mount Sinai Hospital in New York City, presented the results of a subanalysis of Thrombolex’s National Heart, Lung and Blood Institute (NHLBI)-sponsored RESCUE trial during the late-breaking trial session at the Society for Interventional Radiology (SIR) annual scientific meeting (March 4–9) in Phoenix.

The core laboratory analysis of this investigational device exemption (IDE) trial demonstrated that pharmacomechanical catheter-directed thrombolysis (PMCDT) therapy using the Bashir endovascular catheter from Thrombolex led to a significant reduction in segmental arterial occlusions (71%; p<0.0001), which correlated with the reduction in right ventricular to left ventricular (RV/LV) ratio (p= 0.0026). There was also a significant reduction in main pulmonary artery (PA) occlusions (61%; p<0.0001) but this did not correlate significantly with the reduction in RV/LV ratio. This reduction in occlusions of not only the main PAs but also the segmental arteries explains why the overall reduction in PA obstruction, as assessed by the refined Modified Miller Index, is greater with the Bashir endovascular catheter than that which has been reported in contemporary thrombectomy or thrombolysis trials for the treatment of acute pulmonary embolism (PE). RESCUE is a prospective, multicenter trial evaluating the Bashir catheter in 109 patients with intermediate-risk acute PE at 18 sites in the U.S. The Bashir catheter was used to deliver 7mg of recombinant tissue plasminogen activator (r-tPA) into each PA over a five-hour infusion period.

“The RESCUE trial demonstrated rapid resolution of obstruction in the main, and especially segmental, arteries, with less than a 1% major bleeding rate. It is imperative that future PE trials assess the reduction in obstruction in more distal PAs since it has been shown that both the degree of residual PA obstruction and reduction in pulmonary vascular volumes, presumably due to reduced PA inflow, are significant predictors of late PE-related mortality.

This novel approach with the Bashir catheter and low-dose tPA represents a major advance in the treatment of acute PE,” added Lookstein.

DATA FROM A NEW PRESPECIFIED analysis of the phase III VOYAGER

PAD clinical trial show that low-dose rivaroxaban plus aspirin resulted in a 33% reduction in acute limb ischemia (ALI) and a 15% reduction in major adverse limb and cardiovascular events, with or without dual antiplatelet therapy (DAPT).

The data were presented at the American College of Cardiology’s 72nd annual scientific session (ACC.23), hosted in New Orleans, Louisiana (March 4–6).

The new findings reinforce the benefits of the Xarelto (rivaroxaban; Janssen Pharmaceutical Companies of Johnson & Johnson) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following lower-extremity revascularization in patients with peripheral arterial disease (PAD).

“These data demonstrate an evolution in the medical therapy of patients undergoing lower extremity revascularization for symptomatic [PAD],” said lead study author of the VOYAGER PAD analysis, Marc P. Bonaca , MD, of the University of Colorado Anschutz Medical Campus in Aurora, Colorado. “We hope these data assist clinicians in understanding how to implement antithrombotic therapy in practice and overall support initiation of rivaroxaban in the first days after revascularization, regardless of whether or not DAPT is utilized.”

Those treated with Xarelto plus aspirin after lower-extremity revascularization saw a 33% reduction in acute limb ischemia, with a trend toward greater benefit observed early (≤30 days hazard ratio [HR]=0.45; 95% confidence interval [CI] 0.24–0.85) vs. late (>90 days HR=0.75; 95% CI 0.60–0.95).

Xarelto plus aspirin was more effective than antiplatelet therapy alone in preventing ALI after lower-extremity revascularization (Kaplan-Meier estimate from 0 to 90 days 1.02% vs. 2.10%, respectively, and 4.3% and 5.7% from 91 days to three years). The hazard ratio for the rate of thrombolysis in myocardial infarction (TIMI) major bleeding at 0 to 90 days was HR 2.01 (range 0.9–4.47) and from days 91 up to three years was HR 1.28 (range 0.82–1.99), neither of which were statistically significant.

Janssen Pharmaceutical Companies of Johnson & Johnson noted in a press release announcing the new results that the Xarelto vascular dose is the first and only approved anticoagulant for PAD.

EU ministers approve changes to MDR transition

Stenting

DISTAL EMBOLIC PROTECTION USING a filter has been associated with improved transfemoral carotid artery stenting (tfCAS) outcomes in terms of in-hospital stroke and death risks—underpinning current Society for Vascular Surgery (SVS) guidelines, and supporting the notion that, “if a filter cannot be placed safely, an alternative approach to carotid revascularization should be considered”.

Sophie Wang, MD, Patric Liang, MD, both Harvard Medical School in Boston, and colleagues deliver this message in a recent Journal of Vascular Surgery (JVS) publication in which they detailed a retrospective, propensity score-matched cohort analysis of tfCAS patients in the Vascular Quality Initiative (VQI) across a 16-year period.

“Distal embolic protection confers a benefit in stroke/death rates following tfCAS compared to unprotected stenting,” the authors concluded in their “take-home message” in JVS

THE EUROPEAN UNION’S COUNCIL OF Ministers has adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR).

Producers of medical devices will have until Dec. 31, 2027, for higher-risk devices and until Dec. 31, 2028, for medium- and lowerrisk devices in order to meet the legal requirements.

The extension of the transition period will be granted under certain conditions, ensuring that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.

The regulation—which changes the way that medical devices are certified for use in the European market—first came into effect in 2021 with an initial three-year transition period, having been delayed by one year in 2020 due to the onset of the COVID-19 pandemic.

However, challenges in the implementation of the legislation led to concerns about a potential shortfall in the availability of certain medical devices, which prompted a rethink in the timetable for the regulation as proposed by the European Commission in December.