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

doi:10.1016/j.jacc.2014.06.1166

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 BüttnerFederica 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, Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Society of Cardiology

380 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	Journal of the American College of Cardiology
Vol/bind	64
Udgave nummer	9
Sider (fra-til)	875-84
Antal sider	10
ISSN	0735-1097
DOI	https://doi.org/10.1016/j.jacc.2014.06.1166
Status	Udgivet - 2 sep. 2014

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10.1016/j.jacc.2014.06.1166

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Nickenig, G., Estevez-Loureiro, R., Franzen, O., Tamburino, C., Vanderheyden, M., Lüscher, T. F., Moat, N., Price, S., Dall'Ara, G., Winter, R., Corti, R., Grasso, C., Snow, T. M., Jeger, R., Blankenberg, S., Settergren, M., Tiroch, K., Balzer, J., Petronio, A. S., ... Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Society of Cardiology (2014). 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. Journal of the American College of Cardiology, 64(9), 875-84. https://doi.org/10.1016/j.jacc.2014.06.1166

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 et al.
I: Journal of the American College of Cardiology, Bind 64, Nr. 9, 02.09.2014, s. 875-84.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Nickenig, G, Estevez-Loureiro, R, Franzen, O, Tamburino, C, Vanderheyden, M, Lüscher, TF, Moat, N, Price, S, Dall'Ara, G, Winter, R, Corti, R, Grasso, C, Snow, TM, Jeger, R, Blankenberg, S, Settergren, M, Tiroch, K, Balzer, J, Petronio, AS, Büttner, H-J, Ettori, F, Sievert, H, Fiorino, MG, Claeys, M, Ussia, GP, Baumgartner, H, Scandura, S, Alamgir, F, Keshavarzi, F, Colombo, A, Maisano, F, Ebelt, H, Aruta, P, Lubos, E, Plicht, B, Schueler, R, Pighi, M, Di Mario, C & Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Society of Cardiology 2014, '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', Journal of the American College of Cardiology, bind 64, nr. 9, s. 875-84. https://doi.org/10.1016/j.jacc.2014.06.1166

@article{07eda7abe4694c24844dc49b6e697310,

title = "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",

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.",

keywords = "Aged, Catheterization, Echocardiography, Europe, Female, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Humans, Male, Middle Aged, Mitral Valve, Mitral Valve Insufficiency, Pilot Projects, Prospective Studies, Registries, Time Factors, Treatment Outcome",

author = "Georg Nickenig and Rodrigo Estevez-Loureiro and Olaf Franzen and Corrado Tamburino and Marc Vanderheyden and L{\"u}scher, {Thomas F} and Neil Moat and Susanna Price and Gianni Dall'Ara and Reidar Winter and Roberto Corti and Carmelo Grasso and Snow, {Thomas M} and Raban Jeger and Stefan Blankenberg and Magnus Settergren and Klaus Tiroch and Jan Balzer and Petronio, {Anna Sonia} and Heinz-Joachim B{\"u}ttner and Federica Ettori and Horst Sievert and Fiorino, {Maria Giovanna} and Marc Claeys and Ussia, {Gian Paolo} and Helmut Baumgartner and Salvatore Scandura and Farqad Alamgir and Freidoon Keshavarzi and Antonio Colombo and Francesco Maisano and Henning Ebelt and Patrizia Aruta and Edith Lubos and Bj{\"o}rn Plicht and Robert Schueler and Michele Pighi and {Di Mario}, Carlo and {Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Society of Cardiology}",

year = "2014",

month = sep,

day = "2",

doi = "10.1016/j.jacc.2014.06.1166",

language = "English",

volume = "64",

pages = "875--84",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc",

number = "9",

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TY - JOUR

T1 - Percutaneous mitral valve edge-to-edge repair

T2 - 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

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

KW - Heart Valve Prosthesis Implantation

KW - Humans

KW - Male

KW - Middle Aged

KW - Mitral Valve

KW - Mitral Valve Insufficiency

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 - Journal article

C2 - 25169171

SN - 0735-1097

VL - 64

SP - 875

EP - 884

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 9

ER -

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

Abstract

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