Effect of Mitral Valve Gradient After MitraClip on Outcomes in Secondary Mitral Regurgitation: Results From the COAPT Trial.

OBJECTIVES

The authors sought to evaluate the association between mean mitral valve gradient (MVG) and clinical outcomes among patients who underwent MitraClip treatment for secondary mitral regurgitation (SMR) in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.

BACKGROUND

In the COAPT trial, patients with heart failure (HF) and severe SMR who remained symptomatic despite guideline-directed medical therapy had marked 2-year reductions in mortality and HF hospitalizations after treatment with MitraClip.

METHODS

MitraClip-treated patients were divided into quartiles (Q) based on discharge echocardiographic MVG (n = 250). Endpoints including all-cause mortality, HF hospitalization, and health status measures at 2 years were compared between quartiles.

RESULTS

Mean MVG after MitraClip was 2.1 ± 0.4 mm Hg, 3.0 ± 0.2 mm Hg, 4.2 ± 0.5 mm Hg, and 7.2 ± 2.0 mm Hg in Q1 (n = 63), Q2 (n = 61), Q3 (n = 62), and Q4 (n = 64), respectively. There was no difference across quartiles in the 2-year composite endpoint of all-cause mortality or HF hospitalization (43.2%, 49.2%, 40.6%, and 40.9%, respectively; p = 0.80), nor in improvements in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire score, or 6-min walk time. Results were similar after adjustment for baseline clinical and echocardiographic characteristics, post-procedure MR grade, and number of clips (all-cause mortality or HF hospitalization Q4 [44.6%] vs. Q1 to Q3 [40.3%]; adjusted hazard ratio: 1.23, 95% confidence interval: 0.60 to 2.51; p = 0.57).

CONCLUSIONS

Among HF patients with severe SMR, higher MVGs on discharge did not adversely affect clinical outcomes following MitraClip. These findings suggest that in select patients with HF and SMR otherwise meeting the COAPT inclusion criteria, the benefits of MR reduction may outweigh the effects of mild-to-moderate mitral stenosis after MitraClip.

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The COAPT Trial was sponsored by Abbott, which also provided funding to the Cardiovascular Research Foundation to support statistical analysis and administrative/editorial assistance for this paper. Dr. Herrmann has received institutional grant support from Abbott Vascular, Ancora, Boston Scientific, Edwards Lifesciences, and Medtronic; and consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr. Lim has received research grant support and consulting fees from Abbott Vascular. Dr. Kar has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, and Mitralign; and has received consulting income from Abbott and Boston Scientific. Dr. Lindenfeld has received consulting fees from Abbott, Edwards Lifesciences, Boston Scientific, Relypsa, Boehringer Ingelheim, V-Wave, CVRx, and Impulse Dynamics; and research grant support from AstraZeneca. Dr. Abraham has received research grant support from Abbott; and consulting fees from Abbott and Edwards Lifesciences. Dr. Grayburn has received research grant support from Abbott, Edwards Lifesciences, Medtronic, W.L. Gore, and Boston Scientific; has consulted for Abbott, Edwards, Medtronic, and Neochord; and has imaging core laboratory contracts with Edwards Lifesciences, Neochord, W.L. Gore, and Cardiovalve. Drs. Asch and Weissman are director and associate director, respectively, of an academic echocardiography core laboratory with institutional contracts with Abbott, Neovasc, Ancora, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and Livanova. Dr. Mack has served as coprincipal investigator for the Edwards Lifesciences–sponsored PARTNER 3 trial and the Abbott-sponsored COAPT trial; and has served as study chairman for the Medtronic-sponsored APOLLO trial. Dr. Stone has received speaker or other honoraria from Cook, Terumo, Qool Therapeutics, and Orchestra Biomed; has served as a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, and Cardiomech; and has equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.