Freixa Xavier, Estévez-Loureiro Rodrigo, Carrasco-Chinchilla Fernando, Millán Xavier, Amat-Santos Ignacio, Regueiro Ander, Nombela-Franco Luis, Pascual Isaac, Cid Belen, López-Mínguez José Ramón, Hernández-Antolín Rosa Ana, Cruz-González Ignacio, Andraka Leire, Goicolea Javier, Ruíz-Quevedo Valeriano, Díez Jose Luís, Berenguer Alberto, Baz José Antonio, Pan Manuel, Benito-González Tomas, Briales Juan H Alonso, Li Chi Hion, Sanchis Laura, Serrador Ana, Jiménez-Quevedo Pilar, Avanzas Pablo, Salido Luisa, Fernández-Vázquez Felipe, Hernández-García José Maria, Arzamendi Dabit
Hospital Clinic de Barcelona, Institut Clínic Cardiovascular, 08036 Barcelona, Spain.
Hospital Universitario de León, 24071 León, Spain.
J Clin Med. 2021 Feb 12;10(4):734. doi: 10.3390/jcm10040734.
Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system.
This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system.
A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively; = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group; = 0.032).
The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.
近期关于功能性二尖瓣反流(FMR)患者经皮二尖瓣修复术(PMVR)与最佳药物治疗对比的随机数据似乎凸显了学习曲线的重要性,这不仅关乎手术结果,还涉及患者选择。本研究旨在比较当代使用第二代Mitraclip装置(Mitraclip NT)进行PMVR的患者系列与既往使用第一代系统治疗的队列。
本多中心研究收集了2012年至2017年间18个中心的个体数据。根据第一代Mitraclip在上半年(对照组1)或下半年(对照组2)的使用情况或Mitraclip NT系统的使用情况,将队列分为三组。
本研究共纳入545例连续患者。其中,分别有182例(33.3%)、183例(33.3%)和180例(33.3%)患者在对照组1、对照组2和NT队列中接受了二尖瓣修复术。93.3%的患者手术成功,组间无差异。主要不良事件在组间无统计学差异,但对照组1的心包积液发生率较高(分别为4.3%、0.6%和2.6%;P = 0.025)。NT组12个月时死亡、手术及因充血性心力衰竭(CHF)入院的复合终点较低(对照组1为23.5%,对照组2为22.5%,NT组为8.3%;P = 0.032)。
本文表明,随着时间推移,使用Mitraclip系统进行PMVR的当代患者临床结局有所改善。