CBS 2019
CBSMD教育中心
English

科学研究

科研文章

荐读文献

Red Cell Distribution Width in Patients with Diabetes and Myocardial Infarction: an analysis from the EXAMINE trial How Low to Go With Glucose, Cholesterol, and Blood Pressure in Primary Prevention of CVD Frequency of nonsystem delays in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention and implications for door-to-balloon time reporting (from the American Heart Association Mission: Lifeline program) Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes: The Task Force for the diagnosis and management of chronic coronary syndromes of the European Society of Cardiology (ESC) Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials The Future of Cardiovascular Computed Tomography Advanced Analytics and Clinical Insights Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative The HACD4 haplotype as a risk factor for atherosclerosis in males Combining IVUS and Optical Coherence Tomography for More Accurate Coronary Cap Thickness Quantification and Stress/Strain Calculations: A Patient-Specific Three-Dimensional Fluid-Structure Interaction Modeling Approach

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.