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经 MitraClip 二尖瓣修复术治疗心脏再同步化治疗无反应者的二尖瓣关闭不全可改善症状并促进逆重构。

Correction of mitral regurgitation in nonresponders to cardiac resynchronization therapy by MitraClip improves symptoms and promotes reverse remodeling.

机构信息

Division of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, Lugano, Switzerland.

出版信息

J Am Coll Cardiol. 2011 Nov 15;58(21):2183-9. doi: 10.1016/j.jacc.2011.06.061.

Abstract

OBJECTIVES

This study evaluated the safety, efficacy, and effect of MitraClip treatment on symptoms and left ventricular (LV) remodeling in nonresponders to cardiac resynchronization therapy (CRT).

BACKGROUND

Moderate to severe functional mitral regurgitation (FMR) frequently persists after CRT, contributing to reduced or no response to CRT. Percutaneous repair with the MitraClip has been proposed as an additional therapeutic option in select patients with significant FMR.

METHODS

Fifty-one severely symptomatic CRT nonresponders with significant FMR (grade ≥2, 100%) underwent MitraClip treatment. Changes in New York Heart Association functional class, degree of FMR, LV ejection fraction (EF), and LV end-diastolic/end-systolic volumes (EDV/ESV) before and after (3, 6, and 12 months) MitraClip implantation were recorded. Mortality data, including cause of death, were collected.

RESULTS

MC treatment was feasible in all patients (49% 1 clip, 46% 2 clips). There were 2 periprocedural deaths. Median follow-up was 14 months (25th to 75th percentile: 8 to 17 months). New York Heart Association functional class improved acutely at discharge (73%) and continued to improve progressively during follow-up (regression model, p < 0.001). The proportion of patients with significant residual FMR (grade ≥2) progressively decreased during follow-up (regression model, p < 0.001). Reverse LV remodeling and improved LVEF were detected at 6 months, with further improvement at 12 months (regression model, p = 0.001, p = 0.008, and p = 0.031 for ESV, EDV, and LVEF, respectively). Overall 30-day mortality was 4.2%. Overall mortality during follow-up was 19.9 per 100 person-years (95% confidence interval: 10.3 to 38.3). Nonsurvivors had more compromised clinical baseline conditions, longer QRS duration, and a more dilated heart.

CONCLUSIONS

FMR treatment with the MitraClip in CRT nonresponders was feasible, safe, and demonstrated improved functional class, increased LVEF, and reduced ventricular volumes in about 70% of these study patients.

摘要

目的

本研究评估了经导管二尖瓣夹合术(MitraClip)治疗心脏再同步化治疗(CRT)无反应者的安全性、疗效和对症状及左心室(LV)重构的影响。

背景

CRT 后常持续存在中重度功能性二尖瓣反流(FMR),导致 CRT 反应降低或无反应。经皮二尖瓣修复术采用 MitraClip 已被提议作为有大量 FMR 的选择患者的另一种治疗选择。

方法

51 例严重 CRT 无反应且有大量 FMR(≥2 级,占 100%)的患者接受了 MitraClip 治疗。记录二尖瓣夹合术前后(3、6、12 个月)纽约心功能协会(NYHA)心功能分级、FMR 程度、LV 射血分数(EF)和 LV 舒张末期/收缩末期容积(EDV/ESV)的变化。收集死亡率数据,包括死亡原因。

结果

所有患者(49%夹 1 个瓣叶,46%夹 2 个瓣叶)均可行 MitraClip 治疗。围手术期有 2 例死亡。中位随访时间为 14 个月(25%至 75%分位值:8 至 17 个月)。NYHA 心功能分级在出院时即得到改善(73%),且在随访期间持续逐渐改善(回归模型,p<0.001)。在随访期间,有大量残余 FMR(≥2 级)的患者比例逐渐减少(回归模型,p<0.001)。LV 逆重构和 LVEF 改善在 6 个月时即可检测到,12 个月时进一步改善(回归模型,p=0.001、p=0.008 和 p=0.031,用于 ESV、EDV 和 LVEF)。总体 30 天死亡率为 4.2%。随访期间的总死亡率为每 100 人年 19.9 例(95%置信区间:10.3 至 38.3)。死亡患者的临床基线情况更差,QRS 持续时间更长,心脏更大。

结论

在 CRT 无反应者中,采用 MitraClip 治疗 FMR 是可行的、安全的,并在大约 70%的研究患者中改善了心功能分级,增加了 LVEF,并减少了心室容积。

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