Author + information
- Received June 1, 2020
- Revision received July 17, 2020
- Accepted July 23, 2020
- Published online September 16, 2020.
- David Messika-Zeitoun, MD, PhDa,∗ (, )
- Bernard Iung, MDb,c,
- Xavier Armory, PharmD, PhDd,
- Jean-Noël Trochu, MD, PhDe,
- Erwan Donal, MD, PhDf,
- Gilbert Habib, MD, PhDg,h,
- Eric Brochet, MDc,
- Hélène Thibault, MDi,
- Nicolas Piriou, MDe,
- Bertrand Cormier, MDj,
- Christophe Tribouilloy, MD, PhDk,
- Patrice Guerin, MD, PhDl,
- Thierry Lefèvre, MDj,
- Delphine Maucort-Boulch, MD, PhDm,
- Alec Vahanian, MDb,
- Florent Boutitie, MD, PhDm and
- Jean-Francois Obadia, MD, PhDn,∗∗ ()
- aDivision of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada
- bUniversité de Paris and INSERM 1148, Paris, France
- cAPHP, Hôpital Bichat, DHU FIRE, Paris, France
- dEdouard Herriot Hospital, Pharmacy Department/Claude Bernard University- Laboratoire MATEIS, Lyon, France
- eUniversité Nantes, CHU Nantes, CNRS, INSERM, l’institut du Thorax, Nantes, France
- fCHU de Rennes, Hôpital Pontchaillou, Rennes, France and LTSI UMR1099, INSERM, Universite de Rennes-1, Rennes, France
- gAPHM, La Timone Hospital, Cardiology Department, Marseille, France
- hAix Marseille Univ, IRD, APHM, MEPHI, IHU-Méditerranée Infection, Marseille, France
- iGroupement Hospitalier Est, Hospices Civils de Lyon, Service d'Explorations Fonctionnelles Cardiovasculaires, Bron, France
- jInstitut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France
- kDepartment of Cardiology, Amiens University Hospital, EA 7517 MP3CV, Jules Verne University of Picardie, Amiens, France
- lCHU Nantes, INSERM UMR 1229, Nantes University, Interventional Cardiology unit, Institut du Thorax, Nantes, France
- mUniversité 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
- nHopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France
- ↵∗Address for correspondence:
Dr. David Messika-Zeitoun, Department of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada.
- ↵∗∗Dr. Jean-Francois Obadia, Hôpital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, 28, Avenue Doyen Lépine, 69677 Bron Cedex, France.
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 mm2, 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).
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.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Imaging author instructions page.
- Received June 1, 2020.
- Revision received July 17, 2020.
- Accepted July 23, 2020.
- 2020 American College of Cardiology Foundation
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