Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial.
mitral regurgitation
outcomes
transcatheter mitral valve therapy
Journal
JACC. Cardiovascular imaging
ISSN: 1876-7591
Titre abrégé: JACC Cardiovasc Imaging
Pays: United States
ID NLM: 101467978
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
received:
01
06
2020
revised:
17
07
2020
accepted:
23
07
2020
pubmed:
21
9
2020
medline:
28
8
2021
entrez:
20
9
2020
Statut:
ppublish
Résumé
This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the MitraClip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial. It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials. In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months. We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mm In the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the MitraClip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698).
Sections du résumé
OBJECTIVES
This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the MitraClip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial.
BACKGROUND
It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials.
METHODS
In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months.
RESULTS
We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mm
CONCLUSIONS
In the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the MitraClip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698).
Identifiants
pubmed: 32950444
pii: S1936-878X(20)30645-8
doi: 10.1016/j.jcmg.2020.07.021
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT01920698']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
742-752Commentaires et corrections
Type : CommentIn
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 Funded by the French Ministry of Health and Research National Program and Abbott Vascular. Dr. Messika-Zeitoun has received consultant fees from Edwards Lifesciences. Dr. Iung, has received consultant fees from Edwards Lifesciences; and travel fees from Boehringer Ingelheim. Dr. Trochu has received speaker honoraria, travel, and grant support from Abbott and Novartis; honoraria for lectures or advisory boards from Amgen, Bayer, and Resmed; and grants from the EU programme Horizon 2020; and is an unpaid member of the Corvia Medical Scientific Advisory Group outside the submitted work. Dr. Donal has received research facilities from General Electric Healthcare; and consultant fees from Abbott. Dr. Brochet has served as proctor for Abbott. Dr. Piriou has received consultant fees from Abbott. Dr. Guerin has been a consultant for Abbott, Edwards Lifesciences, and Boston Scientific. Dr. Lefèvre has served as proctor for Abbott. Dr. Vahanian has been a consultant for Cardiovalve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.