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根据二尖瓣反流病因进行的经导管二尖瓣修复:来自西班牙MitraClip注册研究的真实世界数据。

Transcatheter mitral repair according to the cause of mitral regurgitation: real-life data from the Spanish MitraClip registry.

作者信息

Pascual Isaac, Arzamendi Dabit, Carrasco-Chinchilla Fernando, Fernández-Vázquez Felipe, Freixa Xavier, Nombela-Franco Luis, Avanzas Pablo, Serrador Frutos Ana María, Pan Manuel, Cid Álvarez Ana Belén, Hernández-Antolín Rosa Ana, Andraka Ikazuriaga Leire, Cruz-González Ignacio, Díez Gil José Luis, Alcasena Juango María Soledad, Berenguer Jofresa Alberto, Alonso-Briales Juan H, Li Chi Hion, Benito González Tomás, Regueiro Ander, Armijo Germán, León Víctor, Amat-Santos Ignacio J, Romero Miguel, Trillo Nouche Ramiro, Fernández-Golfín Covadonga, Ruiz Gómez Lara, Campos-Arjona Rafael, Millán Xavier, Garrote Coloma Carmen, Sanchis Laura, Jiménez-Quevedo Pilar, Morís César, Hernández-García José María, Serra Antonio, Pérez de Prado Armando, Estévez-Loureiro Rodrigo

机构信息

Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Asturias, Spain; Departamento de Biología Funcional, Universidad de Oviedo, Oviedo, Asturias, Spain.

Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

出版信息

Rev Esp Cardiol (Engl Ed). 2020 Aug;73(8):643-651. doi: 10.1016/j.rec.2019.07.018. Epub 2019 Nov 13.

DOI:10.1016/j.rec.2019.07.018
PMID:31732437
Abstract

INTRODUCTION AND OBJECTIVES

Transcatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR.

METHODS

Observational, multicenter, and prospective study with consecutive patient inclusion. The primary endpoint was the combination of all-cause mortality and new readmissions due to heart failure after 1 year. We compared clinical and procedural characteristics and the event rate for each MR group. We performed a multivariate analysis to identify predictive variables for the primary endpoint.

RESULTS

A total of 558 patients were included: 364 (65.2%) with functional etiology, 111 (19.9%) degenerative and 83 (14.9%) mixed. The mean age was 72.8±11.1 years and 70.3% of the sample were men. There were 95 (17%) events in the overall sample. No significant differences were found in the 3 groups in the number of primary outcome events: 11 (11.3%) in degenerative MR, 71 (21.3%) in functional MR, and 13 (18.1%) in mixed MR (P=.101). Independent predictors were functional class (P=.029), previous surgical revascularization (P=.031), EuroSCORE II (P=.003), diabetes mellitus (P=.037), and left ventricular ejection fraction (P=.015).

CONCLUSIONS

This study confirms the safety and efficacy of TMVR with MitraClip irrespective of MR etiology in real-life data and shows the main factors related to prognosis during the first year of follow up.

摘要

引言与目的

使用MitraClip进行经导管二尖瓣修复术(TMVR)是严重二尖瓣反流(MR)的高手术风险患者的一种治疗选择。本研究的主要目的是分析根据MR病因划分的严重MR患者的结局差异。

方法

采用观察性、多中心、前瞻性研究,连续纳入患者。主要终点是1年后全因死亡率和因心力衰竭再次入院的综合情况。我们比较了各MR组的临床和手术特征以及事件发生率。我们进行了多变量分析以确定主要终点的预测变量。

结果

共纳入558例患者:364例(65.2%)为功能性病因,111例(19.9%)为退行性病因,83例(14.9%)为混合性病因。平均年龄为(72.8\pm11.1)岁,样本中70.3%为男性。总体样本中有95例(17%)发生事件。三组主要结局事件数量无显著差异:退行性MR组11例(11.3%),功能性MR组71例(21.3%),混合性MR组13例(18.1%)(P = 0.101)。独立预测因素为心功能分级(P = 0.029)、既往外科血管重建术(P = 0.031)、欧洲心脏手术风险评估系统II(EuroSCORE II)(P = 0.003)、糖尿病(P = 0.037)和左心室射血分数(P = 0.015)。

结论

本研究证实了在实际数据中,无论MR病因如何,使用MitraClip进行TMVR的安全性和有效性,并显示了随访第一年期间与预后相关的主要因素。

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