Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial |
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Authors: | Maarten P. van Wiechen Didier Tchétché Joris F. Ooms Thijmen W. Hokken Herbert Kroon Francesca Ziviello Angie Ghattas Saifullah Siddiqui Clémence Laperche Ernest Spitzer Joost Daemen Peter P. de Jaegere Nicolas Dumonteil Nicolas M. Van Mieghem |
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Affiliation: | 1. Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands;2. Department of Cardiology, Clinique Pasteur, Toulouse, France |
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Abstract: | ObjectivesThis 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.BackgroundVascular complications after TAVR are relevant and often associated with VCD failure.MethodsThe 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.ResultsA 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.ConclusionsPlug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers. |
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Keywords: | MANTA ProGlide transcatheter aortic valve replacement vascular closure devices vascular complications ACT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0040" }," $$" :[{" #name" :" text" ," _" :" activated clotting time BMI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0050" }," $$" :[{" #name" :" text" ," _" :" body mass index STS" },{" #name" :" keyword" ," $" :{" id" :" kwrd0060" }," $$" :[{" #name" :" text" ," _" :" Society of Thoracic Surgeons TAVR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0070" }," $$" :[{" #name" :" text" ," _" :" transcatheter aortic valve replacement VCD" },{" #name" :" keyword" ," $" :{" id" :" kwrd0080" }," $$" :[{" #name" :" text" ," _" :" vascular closure device |
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