Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair
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Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair. / Koell, Benedikt; Orban, Mathias; Weimann, Jessica; Kassar, Mohammad; Karam, Nicole; Neuss, Michael; Petrescu, Aniela; Iliadis, Christos; Unterhuber, Matthias; Adamo, Marianna; Giannini, Cristina; Melica, Bruno; Ludwig, Sebastian; Massberg, Steffen; Praz, Fabien; Pfister, Roman; Thiele, Holger; Stephan von Bardeleben, Ralph; Baldus, Stephan; Butter, Christian; Lurz, Philipp; Windecker, Stephan; Metra, Marco; Petronio, Anna Sonia; Hausleiter, Jörg; Lubos, Edith; Kalbacher, Daniel; EuroSMR Investigators.
in: J AM COLL CARDIOL, Jahrgang 78, Nr. 24, 14.12.2021, S. 2408-2421.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair
AU - Koell, Benedikt
AU - Orban, Mathias
AU - Weimann, Jessica
AU - Kassar, Mohammad
AU - Karam, Nicole
AU - Neuss, Michael
AU - Petrescu, Aniela
AU - Iliadis, Christos
AU - Unterhuber, Matthias
AU - Adamo, Marianna
AU - Giannini, Cristina
AU - Melica, Bruno
AU - Ludwig, Sebastian
AU - Massberg, Steffen
AU - Praz, Fabien
AU - Pfister, Roman
AU - Thiele, Holger
AU - Stephan von Bardeleben, Ralph
AU - Baldus, Stephan
AU - Butter, Christian
AU - Lurz, Philipp
AU - Windecker, Stephan
AU - Metra, Marco
AU - Petronio, Anna Sonia
AU - Hausleiter, Jörg
AU - Lubos, Edith
AU - Kalbacher, Daniel
AU - EuroSMR Investigators
N1 - Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2021/12/14
Y1 - 2021/12/14
N2 - BACKGROUND: Although mitral valve transcatheter edge-to-edge repair (M-TEER) achieves symptomatic benefit for a broad spectrum of patients with relevant secondary mitral regurgitation, conflicting data exist on its prognostic impact.OBJECTIVES: Adapted enrollment criteria approaching those used in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and MITRA-FR (Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation) trials were retrospectively applied to a European real-world registry to evaluate the influence of the respective criteria on outcomes.METHODS: A total of 1,022 patients included in the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry and treated with M-TEER (November 2008 to September 2019) were stratified into COAPT-eligible (n = 353 [34.5%]) and COAPT-ineligible (n = 669 [65.5%]) as well as MITRA-FR-eligible (n = 408 [48.3%]) and MITRA-FR-ineligible (n = 437 [51.7%]) groups.RESULTS: Although the stratification of patients according to adapted MITRA-FR criteria led to comparable outcomes regarding all-cause mortality (P = 0.19), the application of adapted COAPT enrollment criteria demonstrated lower mortality rates in COAPT-eligible compared with COAPT-ineligible patients (P < 0.001). Multivariable Cox regression analysis identified New York Heart Association functional class IV (hazard ratio [HR]: 2.29; 95% confidence interval [CI]: 1.53-3.42; P < 0.001), logarithmic N-terminal pro-brain natriuretic peptide (HR: 1.47; 95% CI: 1.24-1.75; P < 0.001), and right ventricular-to-pulmonary arterial coupling (HR: 0.10; 95% CI: 0.02-0.57; P = 0.009) as independent predictors of outcome. Yet improvement of functional outcome was demonstrated in a subset of patients irrespective of COAPT eligibility status.CONCLUSIONS: In this real-world cohort of patients with secondary mitral regurgitation undergoing M-TEER, the retrospective application of adapted COAPT enrollment criteria successfully identified a specific phenotype demonstrating lower mortality rates. On the contrary, stratification according to adapted MITRA-FR criteria resulted in comparable outcomes.
AB - BACKGROUND: Although mitral valve transcatheter edge-to-edge repair (M-TEER) achieves symptomatic benefit for a broad spectrum of patients with relevant secondary mitral regurgitation, conflicting data exist on its prognostic impact.OBJECTIVES: Adapted enrollment criteria approaching those used in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and MITRA-FR (Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation) trials were retrospectively applied to a European real-world registry to evaluate the influence of the respective criteria on outcomes.METHODS: A total of 1,022 patients included in the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry and treated with M-TEER (November 2008 to September 2019) were stratified into COAPT-eligible (n = 353 [34.5%]) and COAPT-ineligible (n = 669 [65.5%]) as well as MITRA-FR-eligible (n = 408 [48.3%]) and MITRA-FR-ineligible (n = 437 [51.7%]) groups.RESULTS: Although the stratification of patients according to adapted MITRA-FR criteria led to comparable outcomes regarding all-cause mortality (P = 0.19), the application of adapted COAPT enrollment criteria demonstrated lower mortality rates in COAPT-eligible compared with COAPT-ineligible patients (P < 0.001). Multivariable Cox regression analysis identified New York Heart Association functional class IV (hazard ratio [HR]: 2.29; 95% confidence interval [CI]: 1.53-3.42; P < 0.001), logarithmic N-terminal pro-brain natriuretic peptide (HR: 1.47; 95% CI: 1.24-1.75; P < 0.001), and right ventricular-to-pulmonary arterial coupling (HR: 0.10; 95% CI: 0.02-0.57; P = 0.009) as independent predictors of outcome. Yet improvement of functional outcome was demonstrated in a subset of patients irrespective of COAPT eligibility status.CONCLUSIONS: In this real-world cohort of patients with secondary mitral regurgitation undergoing M-TEER, the retrospective application of adapted COAPT enrollment criteria successfully identified a specific phenotype demonstrating lower mortality rates. On the contrary, stratification according to adapted MITRA-FR criteria resulted in comparable outcomes.
KW - Adaptation, Physiological
KW - Aged
KW - Cardiac Catheterization/methods
KW - Europe/epidemiology
KW - Female
KW - Follow-Up Studies
KW - Heart Valve Prosthesis Implantation/methods
KW - Humans
KW - Male
KW - Mitral Valve/surgery
KW - Mitral Valve Insufficiency/mortality
KW - Outcome Assessment, Health Care/methods
KW - Prognosis
KW - Registries
KW - Retrospective Studies
KW - Survival Rate/trends
U2 - 10.1016/j.jacc.2021.10.011
DO - 10.1016/j.jacc.2021.10.011
M3 - SCORING: Journal article
C2 - 34886961
VL - 78
SP - 2408
EP - 2421
JO - J AM COLL CARDIOL
JF - J AM COLL CARDIOL
SN - 0735-1097
IS - 24
ER -