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Incidence, predictors, and outcomes associated with acute kidney injury in patients undergoing transcatheter aortic valve replacement: from the BRAVO-3 randomized trial Cardiovascular Magnetic Resonance as a complementary method to Transthoracic Echocardiography for Aortic Valve Area Estimation in patients with Aortic Stenosis: A systematic review and meta-analysis 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC) Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM) Transcatheter Aortic Valve Implantation Represents an Anti-Inflammatory Therapy Via Reduction of Shear Stress-Induced, Piezo-1-Mediated Monocyte Activation Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement Why and How to Measure Aortic Valve Calcification in Patients With Aortic Stenosis Delirium After TAVR: Crosspassing the Limit of Resilience Considerations for Optimal Device Selection in Transcatheter Aortic Valve Replacement: A Review Impact of myocardial fibrosis on left ventricular remodelling, recovery, and outcome after transcatheter aortic valve implantation in different haemodynamic subtypes of severe aortic stenosis Health Status After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

Clinical Trial2020 Dec 16;S1936-8798(20)32011-2.

JOURNAL:JACC Cardiovasc Interv. Article Link

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

MP van Wiechen, D Tchétché, N Dumonteil et al. Keywords: TAVR; vascular closure device; dedicated plug-based VCD vs suture-based VCD

ABSTRACT


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 siterelated major or minor vascular complications at 30-daysfollow-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 siterelated 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.