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MitraClip亚太注册研究:功能性与退行性二尖瓣反流的结局差异

The MitraClip Asia-Pacific registry: Differences in outcomes between functional and degenerative mitral regurgitation.

作者信息

Tay Edgar, Muda Nasir, Yap Jonathan, Muller David W M, Santoso Teguh, Walters Darren L, Liu Xianbao, Yamen Eric, Jansz Paul, Yip James, Zambahari Robaayah, Passage Jurgen, Ding Zee Pin, Wang Jian'an, Scalia Gregory, Soesanto Amiliana M, Yeo Khung Keong

机构信息

Department of Cardiology, National University Heart Centre, Singapore.

Department of Cardiology, Institut Jantung Negara, Kuala Lumpur, Malaysia.

出版信息

Catheter Cardiovasc Interv. 2016 Jun;87(7):E275-81. doi: 10.1002/ccd.26289. Epub 2015 Oct 28.

Abstract

OBJECTIVES

The objective of this study is to describe and compare the use of the MitraClip therapy in mitral regurgitation (MR) patients with degenerative MR (DMR) and functional MR (FMR).

INTRODUCTION

Percutaneous edge-to-edge repair of severe MR using the MitraClip device is approved for use in the USA for high risk DMR while European guidelines include its use in FMR patients as well.

METHODS

The MitraClip in the Asia-Pacific Registry (MARS) is a multicenter retrospective registry, involving eight sites in five Asia-Pacific countries. Clinical and echocardiographic characteristics, procedural outcomes and 1-month outcomes [death and major adverse events (MAE)] were compared between FMR and DMR patients treated with the MitraClip.

RESULTS

A total of 163 patients were included from 2011 to 2014. The acute procedural success rates for FMR (95.5%, n = 84) and DMR (92%, n = 69) were similar (P = 0.515). 45% of FMR had ≥2 clips inserted compared to 60% of those with DMR (P = 0.064).The 30-day mortality rate for FMR and DMR was similar at 4.5% and 6.7% respectively (P = 0.555). The 30-day MAE rate was 9.2% for FMR and 14.7% for DMR (P = 0.281). Both FMR and DMR patients had significant improvements in the severity of MR and NYHA class after 30 days. There was a significantly greater reduction in left ventricular end-diastolic diameter (P = 0.002) and end systolic diameter (P = 0.017) in DMR than in FMR.

CONCLUSIONS

The MitraClip therapy is a safe and efficacious treatment option for both FMR and DMR. Although, there is a significantly greater reduction in LV volumes in DMR, patients in both groups report clinical benefit with improvement in functional class. © 2015 Wiley Periodicals, Inc.

摘要

目的

本研究的目的是描述和比较二尖瓣反流(MR)患者中,缘对缘修复术(MitraClip)治疗退行性二尖瓣反流(DMR)和功能性二尖瓣反流(FMR)的应用情况。

介绍

在美国,使用MitraClip装置对重度MR进行经皮缘对缘修复已被批准用于高风险DMR患者,而欧洲指南也将其应用于FMR患者。

方法

亚太地区缘对缘修复术注册研究(MARS)是一项多中心回顾性注册研究,涉及亚太地区五个国家的八个地点。比较接受MitraClip治疗的FMR和DMR患者的临床和超声心动图特征、手术结果及1个月的结果[死亡和主要不良事件(MAE)]。

结果

2011年至2014年共纳入163例患者。FMR(95.5%,n = 84)和DMR(92%,n = 69)的急性手术成功率相似(P = 0.515)。45%的FMR患者植入≥2个夹子,而DMR患者为60%(P = 0.064)。FMR和DMR的30天死亡率相似,分别为4.5%和6.7%(P = 0.555)。FMR的30天MAE发生率为9.2%,DMR为14.7%(P = 0.281)。FMR和DMR患者在30天后MR严重程度和纽约心脏协会(NYHA)心功能分级均有显著改善。DMR患者左心室舒张末期内径(P = 0.002)和收缩末期内径(P = 0.017)的减少幅度明显大于FMR。

结论

MitraClip治疗对FMR和DMR均是一种安全有效的治疗选择。虽然DMR患者左心室容积减少幅度明显更大,但两组患者均报告临床获益,心功能分级得到改善。©2015威利期刊公司。

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