Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial

• Published in: JACC. Cardiovascular interventions Vol. 14; no. 2; p. 149
• Main Authors: van Wiechen, Maarten P, Tchétché, Didier, Ooms, Joris F, Hokken, Thijmen W, Kroon, Herbert, Ziviello, Francesca, Ghattas, Angie, Siddiqui, Saifullah, Laperche, Clémence, Spitzer, Ernest, Daemen, Joost, de Jaegere, Peter P, Dumonteil, Nicolas, Van Mieghem, Nicolas M
• Format: Journal Article
• Language: English
• Published: United States 25.01.2021
• Subjects: transcatheter aortic valve replacement; ProGlide; vascular complications; MANTA; vascular closure devices
• ISSN: 1876-7605; 1876-7605
• DOI: 10.1016/j.jcin.2020.09.052

This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD. Vascular complications after TAVR are relevant and often associated with VCD failure. The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site-related major or minor vascular complications at 30-days' follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions. A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site-related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts. Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers.