January 2025 | Issue 105
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6 C X 2025
SWEDEPAD set to premiere
11 WAVE trial
New data shared at VEITHsymposium
14 Profile
Vincent Rowe
20 P AD legacy impact award Roger Greenhalgh honoured
US ARC STUDY
98.4%
clinically meaningful benefit
80% rate of ulcer size reduction at 12 months
VenoValve device patency
One-year SAVVE trial results are ‘most encouraging data ever produced for a bioprosthetic vein valve’ The one-year data from the SAVVE trial represent the “most encouraging clinical data that have ever been produced for a bioprosthetic deep vein valve” in more than half a century of attempts at developing such a device, according to leading venous disease specialist Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK).
T
he prospective, non-blinded, single-arm, multicentre Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) pivotal trial enrolled 75 patients with chronic venous insufficiency (CVI) at 21 sites in the USA. The headline findings include 98.4% VenoValve (Envveno Medical) device patency, 85% clinically meaningful benefit and an 80% rate of ulcer size reduction at 12 months. Fresh from delivering these positive one-year data at the 2024 VEITHsymposium (19–23 November, New York, USA), site principal investigators Matthew Smeds (Saint Louis University, Saint Louis, USA) and Raghu Motaganahalli (Indiana University, Indianapolis, USA) are both ebullient about what the results might mean for the future of the treatment of CVI and venous ulcerations. The data show that 85% of patients surgically implanted with a bioprosthetic VenoValve reached the one-year milestone having achieved a clinically meaningful benefit of a three or more-point improvement in revised Venous Clinical Severity Score (rVCSS); a 7.91 point average improvement in rVCSS; clinically meaningful benefit across all CEAP (Clinical, Etiological, Anatomical and Pathophysiological) classes of patients enrolled (C4b–C6); 97% target vein patency at one year; and significant resolution in venous ulcerations.
“It is the first device we have had to treat deep venous insufficiency in years,” Smeds tells Vascular News in an interview in the days after presenting at VEITH 2024. “These patients are typically relegated to compression therapy alone. There are no really great surgical options for this issue.” Similarly, Motaganahalli describes the novel device as representing a “game-changer” given how previous attempts at developing a surgical option for the CVI patient population failed to take hold. “The procedure does not have a steep learning curve; technically, this is a procedure that can be accomplished by any trained vascular surgeon. It is not technically demanding,” he says. “Before, these were technically demanding operations: if you really look at the
The procedure does not have a steep learning curve.” Raghu Motaganahalli
New data support role of F/BEVAR for treatment of thoracoabdominal aortic aneurysms A RECENT PROSPECTIVE, multicentre cohort study provides insights into early and late aorticrelated mortality and rupture after fenestrated and branched endovascular aneurysm repair (F/ BEVAR) of thoracoabdominal aortic aneurysms (TAAAs). Researchers claim these are likely to represent the most comprehensive data on the topic for the foreseeable future, citing the unworkable nature of a randomised study. Gustavo Oderich (University of Texas Health Science Center at Houston–McGovern Medical School, Houston, USA) and colleagues, on behalf of the US Aortic Research Consortium (ARC), write in Circulation that F/BEVAR has been used as a minimally invasive alternative to open surgical repair to treat patients with TAAAs. The authors explain that, despite the widespread use of fenestrated and branched aortic devices worldwide, they are not currently commercially approved by the US Food and Drug Administration (FDA). Access to these devices, they continue, is limited to those centres with ongoing physician-sponsored investigational device exemption (PS-IDE) studies. The researchers detail that the US ARC has been collecting prospective data from these studies since 2018. The aim of the present study, the authors note, was to evaluate aorticrelated mortality and aortic aneurysm rupture after F/BEVAR of TAAAs. In order to do so, the research team analysed patients enrolled in eight prospective, non-randomised, PSIDE studies between 2005 and 2020 who underwent elective F/BEVAR of asymptomatic intact TAAAs. The primary endpoints of the study, Oderich et al detail, were Continued on page 4
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