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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

Georg Nickenig, Rodrigo Estevez-Loureiro, Olaf Franzen, Corrado Tamburino, Marc Vanderheyden, Thomas F Lüscher, Neil Moat, Susanna Price, Gianni Dall'Ara, Reidar Winter, Roberto Corti, Carmelo Grasso, Thomas M Snow, Raban Jeger, Stefan Blankenberg, Magnus Settergren, Klaus Tiroch, Jan Balzer, Anna Sonia Petronio, Heinz-Joachim Büttner, Federica Ettori, Horst Sievert, Maria Giovanna Fiorino, Marc Claeys, Gian Paolo Ussia, Helmut Baumgartner, Salvatore Scandura, Farqad Alamgir, Freidoon Keshavarzi, Antonio Colombo, Francesco Maisano, Henning Ebelt, Patrizia Aruta, Edith Lubos, Björn Plicht, Robert Schueler, Michele Pighi, Carlo Di Mario
Journal of the American College of Cardiology 2014 September 2, 64 (9): 875-84

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.

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