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

被引:361
作者
Nickenig, Georg [1 ]
Estevez-Loureiro, Rodrigo [2 ]
Franzen, Olaf [3 ]
Tamburino, Corrado [4 ]
Vanderheyden, Marc [5 ]
Luescher, Thomas F. [6 ]
Moat, Neil [7 ]
Price, Susanna [8 ]
Dall'Ara, Gianni [2 ]
Winter, Reidar [9 ]
Corti, Roberto [6 ]
Grasso, Carmelo [4 ]
Snow, Thomas M. [2 ]
Jeger, Raban [10 ]
Blankenberg, Stefan [11 ]
Settergren, Magnus [9 ]
Tiroch, Klaus [12 ]
Balzer, Jan [13 ]
Petronio, Anna Sonia [14 ]
Buettner, Heinz-Joachim [15 ]
Ettori, Federica [16 ]
Sievert, Horst [17 ]
Fiorino, Maria Giovanna [18 ]
Claeys, Marc [19 ]
Ussia, Gian Paolo [20 ]
Baumgartner, Helmut [21 ]
Scandura, Salvatore [4 ]
Alamgir, Farqad [22 ]
Keshavarzi, Freidoon [22 ]
Colombo, Antonio [23 ]
Maisano, Francesco [24 ]
Ebelt, Henning [25 ]
Aruta, Patrizia [4 ]
Lubos, Edith [11 ]
Plicht, Bjoern [26 ]
Schueler, Robert [1 ]
Pighi, Michele [2 ]
Di Mario, Carlo [2 ]
机构
[1] Univ Bonn, Dept Internal Med & Cardiol Pneumol, Bonn, Germany
[2] Royal Brompton Hosp, NIHR Biomed Res Unit, Dept Cardiol, London SW3 6NP, England
[3] Rigshosp, Dept Cardiol, DK-2100 Copenhagen, Denmark
[4] Ferrarotto Hosp, Dept Cardiol, Catania, Italy
[5] Onze Lieve Vrouw Hosp, Dept Cardiol, Aalst, Belgium
[6] Univ Zurich Hosp, Dept Cardiol, CH-8091 Zurich, Switzerland
[7] Royal Brompton Hosp, NIHR Biomed Res Unit, Dept Cardiac Surg, London SW3 6NP, England
[8] Royal Brompton Hosp, NIHR Biomed Res Unit, Intens Care Unit, London SW3 6NP, England
[9] Karolinska Univ Hosp, Dept Cardiol, Stockholm, Sweden
[10] Univ Basel Hosp, Dept Cardiol, CH-4031 Basel, Switzerland
[11] Univ Herzzentrum Hamburg, Dept Gen & Intervent Cardiol, Hamburg, Germany
[12] Helios Klinikum Wuppertal, Dept Cardiol, Wuppertal, Germany
[13] Univ Klinikum Dusseldorf, Dept Cardiol, Dusseldorf, Germany
[14] Azienda Osped Univ Pisana, Cardiothorac & Vasc Dept, Cardiac Catheterizat Lab, Pisa, Italy
[15] Univ Herzzentrum Freiburg, Dept Cardiol & Angiol 2, Bad Krozingen, Germany
[16] Spedali Civili Brescia, Cardiothorac Dept, Brescia, Italy
[17] CardioVasc Centrum Frankfurt, Dept Cardiol & Vasc Med, Frankfurt, Germany
[18] Osped Civ ARNAS, Dept Cardiol, Palermo, Italy
[19] Univ Hosp Antwerpen, Dept Cardiol, Edegem, Belgium
[20] Policlin Tor Vergata, Dept Cardiol, Rome, Italy
[21] Univ Klinikum Munster, Dept Cardiol & Angiol, Munster, Germany
[22] Castle Hill Hosp, Dept Cardiol, Cottingham, England
[23] Univ San Raffaele, Dept Cardiol, Milan, Italy
[24] Univ San Raffaele, Dept Cardiovasc Surg, Milan, Italy
[25] Univ Klinikum Halle Saale, Dept Cardiol, Halle, Germany
[26] Univ Clin Essen, Dept Cardiol, Essen, Germany
关键词
MitraClip; mitral regurgitation; percutaneous mitral valve repair; registry; SURGICAL-RISK PATIENTS; REGURGITATION; THERAPY; MITRACLIP(R); OUTCOMES; REDUCTION; SURGERY; SYSTEM; ANNULOPLASTY; REPLACEMENT;
D O I
10.1016/j.jacc.2014.06.1166
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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. (C) 2014 by the American College of Cardiology Foundation.
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收藏
页码:875 / 884
页数:10
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