CLINICAL RESEARCH
Impact of Mitral Regurgitation Severity
and Left Ventricular Remodeling on
Outcome After Mitraclip Implantation
Results From the Mitra-FR Trial
David Messika-Zeitoun, MD, PHD,
a
Bernard Iung, MD,
b,c
Xavier Armoiry, PHARMD, PHD,
d
Jean-Noël Trochu, MD, PHD,
e
Erwan Donal, MD, PHD,
f
Gilbert Habib, MD, PHD,
g,h
Eric Brochet, MD,
c
Hélène Thibault, MD,
i
Nicolas Piriou, MD,
e
Bertrand Cormier, MD,
j
Christophe Tribouilloy, MD, PHD,
k
Patrice Guerin, MD, PHD,
l
Thierry Lefèvre, MD,
j
Delphine Maucort-Boulch, MD, PHD,
m
Alec Vahanian, MD,
b
Florent Boutitie, MD, PHD,
m
Jean-Francois Obadia, MD, PHD
n
ABSTRACT
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
2
,
RVOL $45 ml or RF $50%) as in patients with milder MR degree. The same was seen in subsets with the milder LV
remodeling using either diastolic or systolic diameters or volumes. When parameters of MR severity and LV remodeling
were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-
diastolic volume ratio $ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients.
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).
(J Am Coll Cardiol Img 2020;-:-–-) © 2020 by the American College of Cardiology Foundation.
ISSN 1936-878X/$36.00 https://doi.org/10.1016/j.jcmg.2020.07.021
From the
a
Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada;
b
Université de Paris and INSERM 1148,
Paris, France;
c
APHP, Hôpital Bichat, DHU FIRE, Paris, France;
d
Edouard Herriot Hospital, Pharmacy Department/Claude
Bernard University- Laboratoire MATEIS, Lyon, France;
e
Université Nantes, CHU Nantes, CNRS, INSERM, l’institut du Thorax,
Nantes, France;
f
CHU de Rennes, Hôpital Pontchaillou, Rennes, France and LTSI UMR1099, INSERM, Universite de Rennes-1,
Rennes, France;
g
APHM, La Timone Hospital, Cardiology Department, Marseille France;
h
Aix Marseille Univ, IRD, APHM,
MEPHI, IHU-Méditerranée Infection, Marseille, France;
i
Groupement Hospitalier Est, Hospices Civils de Lyon, Service
d’Explorations Fonctionnelles Cardiovasculaires, Bron, France;
j
Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques
Cartier, Massy, France;
k
Department of Cardiology, Amiens University Hospital, EA 7517 MP3CV, Jules Verne University of
Picardie, Amiens, France;
l
CHU Nantes, INSERM UMR 1229, Nantes University, Interventional Cardiology unit, Institut du
Thorax, Nantes, France;
m
Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie
Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique-Bioinformatique, Pôle Santé Publique, Hospices Civils de
Lyon, Villeurbanne, France; and the
n
Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation
Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France. Funded by the French Ministry of Health and
JACC: CARDIOVASCULAR IMAGING VOL. -, NO. -, 2020
ª 2020 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
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