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, Vol. 78, No. 24, 14.12.2021, p. 2408-2421.

Research output: SCORING: Contribution to journalSCORING: Journal articleResearchpeer-review

Harvard

Koell, B, Orban, M, Weimann, J, Kassar, M, Karam, N, Neuss, M, Petrescu, A, Iliadis, C, Unterhuber, M, Adamo, M, Giannini, C, Melica, B, Ludwig, S, Massberg, S, Praz, F, Pfister, R, Thiele, H, Stephan von Bardeleben, R, Baldus, S, Butter, C, Lurz, P, Windecker, S, Metra, M, Petronio, AS, Hausleiter, J, Lubos, E, Kalbacher, D & EuroSMR Investigators 2021, 'Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair', J AM COLL CARDIOL, vol. 78, no. 24, pp. 2408-2421. https://doi.org/10.1016/j.jacc.2021.10.011

APA

Koell, B., Orban, M., Weimann, J., Kassar, M., Karam, N., Neuss, M., Petrescu, A., Iliadis, C., Unterhuber, M., Adamo, M., Giannini, C., Melica, B., Ludwig, S., Massberg, S., Praz, F., Pfister, R., Thiele, H., Stephan von Bardeleben, R., Baldus, S., ... EuroSMR Investigators (2021). Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair. J AM COLL CARDIOL, 78(24), 2408-2421. https://doi.org/10.1016/j.jacc.2021.10.011

Vancouver

Bibtex

@article{73078cc9bf5a4723b39ad3c85640484f,
title = "Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair",
abstract = "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.",
keywords = "Adaptation, Physiological, Aged, Cardiac Catheterization/methods, Europe/epidemiology, Female, Follow-Up Studies, Heart Valve Prosthesis Implantation/methods, Humans, Male, Mitral Valve/surgery, Mitral Valve Insufficiency/mortality, Outcome Assessment, Health Care/methods, Prognosis, Registries, Retrospective Studies, Survival Rate/trends",
author = "Benedikt Koell and Mathias Orban and Jessica Weimann and Mohammad Kassar and Nicole Karam and Michael Neuss and Aniela Petrescu and Christos Iliadis and Matthias Unterhuber and Marianna Adamo and Cristina Giannini and Bruno Melica and Sebastian Ludwig and Steffen Massberg and Fabien Praz and Roman Pfister and Holger Thiele and {Stephan von Bardeleben}, Ralph and Stephan Baldus and Christian Butter and Philipp Lurz and Stephan Windecker and Marco Metra and Petronio, {Anna Sonia} and J{\"o}rg Hausleiter and Edith Lubos and Daniel Kalbacher and {EuroSMR Investigators}",
note = "Copyright {\textcopyright} 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.",
year = "2021",
month = dec,
day = "14",
doi = "10.1016/j.jacc.2021.10.011",
language = "English",
volume = "78",
pages = "2408--2421",
journal = "J AM COLL CARDIOL",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "24",

}

RIS

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 -