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Cardiac surgery following transcatheter aortic valve replacement Prognostic Value of Computed Tomography-Derived Extracellular Volume in TAVR Patients With Low-Flow Low-Gradient Aortic Stenosis Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Rheumatic Aortic Stenosis Empagliflozin, Health Status, and Quality of Life in Patients with Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR 5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation of Vitamin K Antagonists or Direct Oral Anticoagulants Evaluation and Management of Aortic Stenosis in Chronic Kidney Disease: A Scientific Statement From the American Heart Association Stroke Complicating Infective Endocarditis After Transcatheter Aortic Valve Replacement Acute Aortic Syndrome Revisited: JACC State-of-the-Art Review

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.