Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry

TY - JOUR

T1 - Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry

AU - Nickenig, Georg

AU - Estevez-Loureiro, Rodrigo

AU - Franzen, Olaf

AU - Tamburino, Corrado

AU - Vanderheyden, Marc

AU - Lüscher, Thomas F

AU - Moat, Neil

AU - Price, Susanna

AU - Dall'Ara, Gianni

AU - Winter, Reidar

AU - Corti, Roberto

AU - Grasso, Carmelo

AU - Snow, Thomas M

AU - Jeger, Raban

AU - Blankenberg, Stefan

AU - Settergren, Magnus

AU - Tiroch, Klaus

AU - Balzer, Jan

AU - Petronio, Anna Sonia

AU - Büttner, Heinz-Joachim

AU - Ettori, Federica

AU - Sievert, Horst

AU - Fiorino, Maria Giovanna

AU - Claeys, Marc

AU - Ussia, Gian Paolo

AU - Baumgartner, Helmut

AU - Scandura, Salvatore

AU - Alamgir, Farqad

AU - Keshavarzi, Freidoon

AU - Colombo, Antonio

AU - Maisano, Francesco

AU - Ebelt, Henning

AU - Aruta, Patrizia

AU - Lubos, Edith

AU - Plicht, Björn

AU - Schueler, Robert

AU - Pighi, Michele

AU - Di Mario, Carlo

AU - Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Society of Cardiology

N1 - Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PY - 2014/9/2

Y1 - 2014/9/2

N2 - BACKGROUND: The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited.OBJECTIVES: The aim of this multinational registry is to present a real-world overview of TMVR use in Europe.METHODS: The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data.RESULTS: A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation).CONCLUSIONS: This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms.

AB - BACKGROUND: The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited.OBJECTIVES: The aim of this multinational registry is to present a real-world overview of TMVR use in Europe.METHODS: The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data.RESULTS: A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation).CONCLUSIONS: This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms.

KW - Aged

KW - Catheterization

KW - Echocardiography

KW - Europe

KW - Female

KW - Heart Valve Prosthesis/adverse effects

KW - Heart Valve Prosthesis Implantation/methods

KW - Humans

KW - Male

KW - Middle Aged

KW - Mitral Valve/surgery

KW - Mitral Valve Insufficiency/surgery

KW - Pilot Projects

KW - Prospective Studies

KW - Registries

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1016/j.jacc.2014.06.1166

DO - 10.1016/j.jacc.2014.06.1166

M3 - SCORING: Journal article

C2 - 25169171

VL - 64

SP - 875

EP - 884

JO - J AM COLL CARDIOL

JF - J AM COLL CARDIOL

SN - 0735-1097

IS - 9

ER -