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
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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. / Nickenig, Georg; Estevez-Loureiro, Rodrigo; Franzen, Olaf; Tamburino, Corrado; Vanderheyden, Marc; Lüscher, Thomas F; Moat, Neil; Price, Susanna; Dall'Ara, Gianni; Winter, Reidar; Corti, Roberto; Grasso, Carmelo; Snow, Thomas M; Jeger, Raban; Blankenberg, Stefan; Settergren, Magnus; Tiroch, Klaus; Balzer, Jan; Petronio, Anna Sonia; Büttner, Heinz-Joachim; Ettori, Federica; Sievert, Horst; Fiorino, Maria Giovanna; Claeys, Marc; Ussia, Gian Paolo; Baumgartner, Helmut; Scandura, Salvatore; Alamgir, Farqad; Keshavarzi, Freidoon; Colombo, Antonio; Maisano, Francesco; Ebelt, Henning; Aruta, Patrizia; Lubos, Edith; Plicht, Björn; Schueler, Robert; Pighi, Michele; Di Mario, Carlo; Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Society of Cardiology.
in: J AM COLL CARDIOL, Jahrgang 64, Nr. 9, 02.09.2014, S. 875-884.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -