David Messika-Zeitoun1, Bernard Iung2, Xavier Armoiry3, Jean-Noël Trochu4, Erwan Donal5, Gilbert Habib6, Eric Brochet7, Hélène Thibault8, Nicolas Piriou4, Bertrand Cormier9, Christophe Tribouilloy10, Patrice Guerin11, Thierry Lefèvre9, Delphine Maucort-Boulch12, Alec Vahanian13, Florent Boutitie12, Jean-Francois Obadia14. 1. Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada. Electronic address: DMessika-zeitoun@ottawaheart.ca. 2. Université de Paris and INSERM 1148, Paris, France; APHP, Hôpital Bichat, DHU FIRE, Paris, France. 3. Edouard Herriot Hospital, Pharmacy Department/Claude Bernard University-Laboratoire MATEIS, Lyon, France. 4. Université Nantes, CHU Nantes, CNRS, INSERM, l'institut du Thorax, Nantes, France. 5. CHU de Rennes, Hôpital Pontchaillou, Rennes, France and LTSI UMR1099, INSERM, Universite de Rennes-1, Rennes, France. 6. APHM, La Timone Hospital, Cardiology Department, Marseille France; Aix Marseille Univ, IRD, APHM, MEPHI, IHU-Méditerranée Infection, Marseille, France. 7. APHP, Hôpital Bichat, DHU FIRE, Paris, France. 8. Groupement Hospitalier Est, Hospices Civils de Lyon, Service d'Explorations Fonctionnelles Cardiovasculaires, Bron, France. 9. Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France. 10. Department of Cardiology, Amiens University Hospital, EA 7517 MP3CV, Jules Verne University of Picardie, Amiens, France. 11. CHU Nantes, INSERM UMR 1229, Nantes University, Interventional Cardiology unit, Institut du Thorax, Nantes, France. 12. 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. 13. Université de Paris and INSERM 1148, Paris, France. 14. Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France. Electronic address: jean-francois.obadia@chu-lyon.fr.
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 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).
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).
Authors: Andrew J S Coats; Stefan D Anker; Andreas Baumbach; Ottavio Alfieri; Ralph Stephan von Bardeleben; Johann Bauersachs; Jeroen J Bax; Serge Boveda; Jelena Čelutkienė; John G Cleland; Nikolaos Dagres; Thomas Deneke; Dimitrios Farmakis; Gerasimos Filippatos; Jörg Hausleiter; Gerhard Hindricks; Ewa A Jankowska; Mitja Lainscak; Christoph Leclercq; Lars H Lund; Theresa McDonagh; Mandeep R Mehra; Marco Metra; Nathan Mewton; Christian Mueller; Wilfried Mullens; Claudio Muneretto; Jean-Francois Obadia; Piotr Ponikowski; Fabien Praz; Volker Rudolph; Frank Ruschitzka; Alec Vahanian; Stephan Windecker; Jose Luis Zamorano; Thor Edvardsen; Hein Heidbuchel; Petar M Seferovic; Bernard Prendergast Journal: Eur Heart J Date: 2021-03-18 Impact factor: 29.983
Authors: Max Berrill; Ian Beeton; David Fluck; Isaac John; Otar Lazariashvili; Jack Stewart; Eshan Ashcroft; Jonathan Belsey; Pankaj Sharma; Aigul Baltabaeva Journal: Front Cardiovasc Med Date: 2021-12-02