Percutaneous Mitral Valve Edge-to-Edge Repair

• Published in: Journal of the American College of Cardiology Vol. 64; no. 9; pp. 875 - 884
• Main Authors: Nickenig, Georg, MD, PhD, Estevez-Loureiro, Rodrigo, MD, PhD, Franzen, Olaf, MD, Tamburino, Corrado, MD, PhD, Vanderheyden, Marc, MD, Lüscher, Thomas F., MD, Moat, Neil, MS, Price, Susanna, MD, PhD, Dall’Ara, Gianni, MD, Winter, Reidar, MD, PhD, Corti, Roberto, MD, Grasso, Carmelo, MD, Snow, Thomas M., MD, Jeger, Raban, MD, Blankenberg, Stefan, MD, Settergren, Magnus, MD, PhD, Tiroch, Klaus, MD, Balzer, Jan, MD, Petronio, Anna Sonia, MD, Büttner, Heinz-Joachim, MD, Ettori, Federica, MD, Sievert, Horst, MD, Fiorino, Maria Giovanna, MD, Claeys, Marc, MD, PhD, Ussia, Gian Paolo, MD, Baumgartner, Helmut, MD, Scandura, Salvatore, MD, Alamgir, Farqad, MD, Keshavarzi, Freidoon, MD, Colombo, Antonio, MD, Maisano, Francesco, MD, PhD, Ebelt, Henning, MD, Aruta, Patrizia, MD, Lubos, Edith, MD, Plicht, Björn, MD, Schueler, Robert, MD, Pighi, Michele, MD, Di Mario, Carlo, MD, PhD
• Format: Journal Article
• Language: English
• Published: New York Elsevier Inc 02-09-2014; Elsevier Limited
• Subjects: Cardiology; Cardiovascular; Internal Medicine; MitraClip; mitral regurgitation; percutaneous mitral valve repair; Pulmonary arteries; registry; Regulatory approval; Studies; Surgery; Values; European System for Cardiac Operative Risk Evaluation; systolic pulmonary artery pressure; LVEF; odds ratio; left ventricular ejection fraction; New York Heart Association; TMVR; MitraClip; percutaneous mitral valve repair; mitral valve; NYHA; registry; OR; mitral regurgitation; MR; CI; degenerative mitral regurgitation; DMR; MV; FMR; SPAP; transcatheter mitral valve repair; functional mitral regurgitation; EuroSCORE; confidence interval; mitral valve regurgitation
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2014.06.1166

Abstract 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.