Outcomes Stratified by Adapted Inclusion Criteria After Mitral Edge-to-Edge Repair.

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.

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Dr Orban has received speaker honoraria from Abbott Medical. Dr Kalbacher has received speaker honoraria from Abbott Medical and Edwards Lifesciences; has received travel expenses from Abbott Medical and Edwards Lifesciences; and has received proctor fees from Edwards Lifesciences. Dr Hausleiter has received speaker honoraria from Abbott Medical. Dr Pfister has received speaker honoraria and travel expenses from Abbott Medical. Dr Baldus has received speaker honoraria from Abbott Medical and Edwards Lifesciences; and has received research grants from Abbott Medical. Dr Lubos has received speaker honoraria, travel expenses, and research grants from Abbott Medical. Dr Lurz has received speaker honoraria from Abbott Medical; and has received consultant fees from Abbott Medical and Edwards Lifesciences. Dr Karam has received consultant fees from Abbott Medical. Dr Iliadis has received consultant fees from Abbott Medical and Edwards Lifesciences; and has received travel expenses from Abbott Medical. Dr Petrescu has received consultant fees and research grants from Abbott Medical. Dr Metra has received consultant fees from Abbott Medical; and has received speaker honoraria from Edwards Lifesciences. Dr Windecker has received research grants from Abbott Medical and Edwards Lifesciences. Dr Ludwig has received travel expenses from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.