Echocardiographic Outcomes After Transcatheter Leaflet Approximation in Patients With Secondary Mitral Regurgitation: The COAPT Trial.

Autor: Asch FM; Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC. Electronic address: federico.asch@medstar.net., Grayburn PA; Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas., Siegel RJ; Cedars-Sinai Smidt Heart Institute, Los Angeles, California., Kar S; Cedars-Sinai Smidt Heart Institute, Los Angeles, California., Lim DS; Division of Cardiology, University of Virginia, Charlottesville, Virginia., Zaroff JG; Kaiser Permanente-San Francisco Hospital, San Francisco, California., Mishell JM; Kaiser Permanente-San Francisco Hospital, San Francisco, California., Whisenant B; Intermountain Medical Center, Murray, Utah., Mack MJ; Baylor Scott & White Heart and Vascular Hospital, Plano, Texas., Lindenfeld J; Advanced Heart Failure, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee., Abraham WT; Departments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, and the Davis Heart and Lung Research Institute, The Ohio State University, Columbus, Ohio., Stone GW; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; The Cardiovascular Research Foundation, New York, New York., Weissman NJ; Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC.
Jazyk: angličtina
Zdroj: Journal of the American College of Cardiology [J Am Coll Cardiol] 2019 Dec 17; Vol. 74 (24), pp. 2969-2979. Date of Electronic Publication: 2019 Sep 28.
DOI: 10.1016/j.jacc.2019.09.017
Abstrakt: Background: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial among patients with heart failure (HF) and moderate-to-severe (3+) or severe (4+) secondary mitral regurgitation, patients treated with transcatheter mitral valve repair (TMVr) through leaflet approximation had reduced rates of HF hospitalization and mortality compared with guideline-directed medical therapy (GDMT) alone.
Objectives: The purpose of this study was to describe the echocardiographic patient qualification process for the COAPT trial, baseline echocardiographic characteristics, changes over time, and the interaction between treatment group and echocardiographic parameters on clinical outcomes.
Methods: A novel echocardiographic algorithm was implemented for grading mitral regurgitation severity during the screening process. Standardized echocardiograms were obtained at baseline and during regular follow-up intervals through 2 years, and were analyzed by a core laboratory.
Results: A total of 614 patients were randomized to TMVr plus maximally tolerated GDMT or GDMT alone. Mean baseline left ventricular (LV) ejection fraction was 31.3 ± 9.3%, LV end-diastolic volume was 192.7 ± 71 ml, and effective regurgitant orifice area was 0.41 ± 0.15 cm 2 . The beneficial effect of TMVr compared with GDMT alone was consistent in all echocardiographic subgroups, independent of the severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation, or individual mitral regurgitation characteristics. The LV ejection fraction decreased and the LV volumes progressively increased in both groups during follow-up, although less after TMVr (p < 0.05).
Conclusions: HF patients in the COAPT trial with 3+ or 4+ secondary mitral regurgitation, selected using strict echocardiographic criteria, benefitted from TMVr with reduced 2-year rates of death and HF hospitalization. Strict application of these echocardiographic criteria should enable the COAPT results to be translated to clinical practice. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).
(Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE