In this issue: 2G uest Editorial Expiation, Karl Wallenda, Oppenheimer and us 7C areer SVS calls on members to participate in financial compensation survey— and help bolster results
SEPTEMBER 2023 Volume 19 Number 09
THE OFFICIAL NEWSPAPER OF THE
13 E lections The SVS Executive Board breaks down the demographics 15 Venous Disease Venous valve technologies set to address “large unmet need worldwide”
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SVS MEMBERS RALLY TO RESPOND TO CMS STENTING COVERAGE EXPANSION
CLINICAL TRIALS
When women are PIs: A story foretold on the vascular frontlines “Multifactorial” issues persist in gender representation in vascular leadership and trial enrollment, reports Éva Malpass
e would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and, ultimately, better outcomes in women,” states Melina R. Kibbe, MD, dean at the University of Virginia School of Medicine, Charlottesville, Virgina, as she reflects on two decades of missed opportunities, the underrepresentation of women as clinical principal investigators (PIs), and women’s under-enrollment as participants in vascular trials. Her statement is far from isolated—underpinned by a growing body of research which addresses key gender inequities in study leadership and participation. Vascular Specialist spoke to prominent names across the global vascular space on their experiences as a PI, meditations on the barriers to access, and the vital work needed to improve diversity across the board. Mounting data from recent research has spurred widespread review of women’s progression in the vascular field to date. In particular, focus has been placed on how the gender of PIs has affected the balance of male and female participants enrolled in trials. Conducted in April this year, Kibbe et al evaluated 1,427 clinical trials published in the Journal of the American Medical Association (JAMA), The Lancet, and the New England Journal of Med-
Nearly one-third of the public comments submitted to the Centers for Medicare & Medicaid Services (CMS) on a controversial proposed coverage decision affecting carotid stenting were submitted by SVS members. “We could not have been more pleased with our members’ response to a proposal that we, as a Society, believe will negatively impact patient care, result in unnecessary procedures, and increase the number of strokes across the vascular patient spectrum,” said SVS President Joseph Mills, MD. Of approximately 760 responses, at least 237 were initially identified as being from SVS members, he said. “There may well be even more.” In July, CMS released a proposed decision that would significantly broaden coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. The proposal would expand Medicare coverage of the procedure to individuals previously only eligible for coverage in clinical trials, remove the limitation of coverage to only high surgical risk individuals, and remove facility standards and approval requirements. The proposal adds shared decision-making with the patient prior to the procedure and allows Medicare Administrative Contractors (MAC) discretion for all other coverage of carotid artery PTA concurrent with stenting not otherwise addressed in the national coverage determination. Comments were due by Aug. 10. In the weeks prior to that, SVS leaders wrote the Society’s formal comment and embarked on a careful campaign to solicit
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