Transcatheter Aortic Valve Replacement
Clinical Trial2020 Dec 16;S1936-8798(20)32011-2.
JOURNAL：JACC Cardiovasc Interv. Article Link
MP van Wiechen, D Tchétché, N Dumonteil et al. Keywords: TAVR; vascular closure device; dedicated plug-based VCD vs suture-based VCD
OBJECTIVES - The authors 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.
BACKGROUND - Vascular complications after TAVR are relevant and often associated with VCD failure.
METHODS - The MASH trial (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) 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.
RESULTS - 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.
CONCLUSIONS - 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.