经导管缘对缘修复术治疗 COAPT 不适宜的功能性二尖瓣反流患者。

Transcatheter Edge-to-Edge Repair in COAPT-Ineligible Patients With Functional Mitral Regurgitation.

机构信息

Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri, USA.

Cardiovascular Research Foundation, New York, New York, USA; St Francis Hospital and Heart Center, Roslyn, New York, USA.

出版信息

J Am Coll Cardiol. 2024 Jan 30;83(4):488-499. doi: 10.1016/j.jacc.2023.11.012.

DOI:10.1016/j.jacc.2023.11.012

PMID:38267110

Abstract

BACKGROUND

Mitral valve transcatheter edge-to-edge repair (MTEER) was approved in the United States for treatment of functional mitral regurgitation (FMR) based on results from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.

OBJECTIVES

The authors sought to analyze outcomes of MTEER in FMR patients who would have been excluded from COAPT.

METHODS

MTEER procedures performed for FMR in the TVT (Transcatheter Valve Therapy) Registry between January 1, 2013, and April 30, 2020, were categorized as "trial-ineligible" if any of the following were present: cardiogenic shock, inotropic support, left ventricular ejection fraction <20%, left ventricular end-systolic dimension >7 cm, home oxygen use, or severe tricuspid regurgitation. Trial-ineligible and trial-eligible groups were compared through 1 year using multivariable models. The primary endpoint was 1-year death or heart failure hospitalization (HFH).

RESULTS

Of 6,675 patients who underwent MTEER for FMR, 3,721 (55.7%) were trial-eligible and 2,954 (44.3%) were trial-ineligible. Trial-ineligible patients had lower rates of technical procedural success (86.9% vs 92.6%; P < 0.001) and more frequent in-hospital complications (11.8% vs 5.7%; P < 0.001) compared with trial-eligible patients. A clinically meaningful improvement in health status at 30 days was observed in 78.9% and 77.0% of patients in the trial-ineligible and trial-eligible groups, respectively. There was a higher risk of 1-year death or HFH (HR: 1.73; 95% CI: 1.57-1.91; P < 0.001) in trial-ineligible patients.

CONCLUSIONS

Among patients who underwent MTEER for FMR in the TVT Registry, nearly one-half would have been ineligible for the COAPT trial. Health status improvement at 30 days was similar in COAPT-ineligible and COAPT-eligible patients, but trial-ineligible patients had higher 1-year rates of death or HFH.

摘要

背景

基于 COAPT（经皮治疗心力衰竭伴功能性二尖瓣反流患者的二尖瓣夹合术心血管结局评估）试验结果，经导管二尖瓣边缘对边缘修复术（MTEER）在美国获批用于治疗功能性二尖瓣反流（FMR）。

目的

作者旨在分析 TVT（经导管瓣膜治疗）注册中心接受 MTEER 治疗的 FMR 患者中，那些不符合 COAPT 标准的患者的结局。

方法

2013 年 1 月 1 日至 2020 年 4 月 30 日期间，TVT 注册中心对 FMR 行 MTEER 治疗，若存在以下任何一项则归类为“不符合试验标准”：心源性休克、正性肌力支持、左心室射血分数<20%、左心室收缩末期内径>7cm、家庭吸氧或严重三尖瓣反流。通过多变量模型对 1 年的试验入选和非入选组进行比较。主要终点为 1 年时死亡或心力衰竭住院（HFH）。

结果

在因 FMR 接受 MTEER 治疗的 6675 例患者中，3721 例（55.7%）符合试验标准，2954 例（44.3%）不符合试验标准。与符合试验标准的患者相比，不符合试验标准的患者技术操作成功率较低（86.9% vs 92.6%；P<0.001），住院期间并发症发生率较高（11.8% vs 5.7%；P<0.001）。不符合试验标准和符合试验标准的患者在 30 天时健康状况均有明显改善，分别为 78.9%和 77.0%。不符合试验标准的患者 1 年时死亡或 HFH 的风险更高（HR：1.73；95%CI：1.57-1.91；P<0.001）。