Transcatheter Edge-to-Edge Repair in COAPT-Ineligible Patients With Functional Mitral Regurgitation.

BACKGROUND

Mitral valve transcatheter edge-to-edge repair (MTEER) was approved in the United States for treatment of functional mitral regurgitation (FMR) based on results from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.

OBJECTIVES

The authors sought to analyze outcomes of MTEER in FMR patients who would have been excluded from COAPT.

METHODS

MTEER procedures performed for FMR in the TVT (Transcatheter Valve Therapy) Registry between January 1, 2013, and April 30, 2020, were categorized as "trial-ineligible" if any of the following were present: cardiogenic shock, inotropic support, left ventricular ejection fraction <20%, left ventricular end-systolic dimension >7 cm, home oxygen use, or severe tricuspid regurgitation. Trial-ineligible and trial-eligible groups were compared through 1 year using multivariable models. The primary endpoint was 1-year death or heart failure hospitalization (HFH).

RESULTS

Of 6,675 patients who underwent MTEER for FMR, 3,721 (55.7%) were trial-eligible and 2,954 (44.3%) were trial-ineligible. Trial-ineligible patients had lower rates of technical procedural success (86.9% vs 92.6%; P < 0.001) and more frequent in-hospital complications (11.8% vs 5.7%; P < 0.001) compared with trial-eligible patients. A clinically meaningful improvement in health status at 30 days was observed in 78.9% and 77.0% of patients in the trial-ineligible and trial-eligible groups, respectively. There was a higher risk of 1-year death or HFH (HR: 1.73; 95% CI: 1.57-1.91; P < 0.001) in trial-ineligible patients.

CONCLUSIONS

Among patients who underwent MTEER for FMR in the TVT Registry, nearly one-half would have been ineligible for the COAPT trial. Health status improvement at 30 days was similar in COAPT-ineligible and COAPT-eligible patients, but trial-ineligible patients had higher 1-year rates of death or HFH.

Informations de copyright

Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures This research was supported by the ACC/STS TVT Registry. The views expressed in this paper represent those of the author(s), and do not necessarily represent the official views of the registry or its associated professional societies identified at CVQuality.ACC.org/NCDR. Dr Chhatriwalla is a proctor for Edwards Lifesciences, and Medtronic Inc; and is on the Speakers Bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr Cohen receives research grant support and consulting income from Abbott, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Vemulapalli has grants from Abbott Vascular, Boston Scientific, HeartFlow, American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health, and Patient Centered Outcomes Research Institute; and serves as a consultant to Boston Scientific, Premiere, Janssen, and Zafgen. Dr Huded has received consulting fees from Boston Scientific; and has received a research grant from Abbott Vascular. Dr Lindenfeld has been a consultant for Abbott, Alleviant, AstraZeneca, Biotronik, Boston Scientific, CVRx, Edwards Lifesciences, Merck, Medtronic, V-wave, Vascular Dynamics, Whiteswell, and Vectorious; and receives research funding from AstraZeneca. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Abbott, Daiichi-Sankyo, CorFlow, Apollo Therapeutics, Cardiomech, Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Miracor, Vectorious, Neovasc, Ancora, Elucid Bio, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, and HighLife; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; his daughter is an employee at IQVIA; and his employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Sorajja is a consultant for Abbott Structural, Anteris, Edwards Lifesciences, Evolution Medical, Shifamed, WL Gore, xDot, ValCare, 4C Medical, Medtronic, Boston Scientific, and vDyne.