Montreal Heart Institute, Montreal, Quebec, Canada.
University Heart and Vascular Center Hamburg, Hamburg, Germany.
Eur J Heart Fail. 2022 May;24(5):887-898. doi: 10.1002/ejhf.2492. Epub 2022 Apr 17.
Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI.
From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalization after 1 year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0-83.0, EuroSCORE II 4.7% [IQR 2.7-9.7]), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (n = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT.
This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes.
经导管二尖瓣置换术(TMVI)为不适合传统治疗的二尖瓣反流(MR)患者提供了一种新的治疗选择。CHOICE-MI 注册研究旨在调查接受 TMVI 筛查的患者的结局。
2014 年 5 月至 2021 年 3 月,在 26 个中心,对经评估不适合经导管缘对缘修复(TEER)且二尖瓣手术风险高的 MR 患者进行 TMVI 筛查。对接受 TMVI 治疗的患者和因 TMVI 而不合格的患者(转至 bailout-TEER、高危手术或药物治疗(MT))的特征和结局进行了调查。主要复合终点为 1 年后全因死亡率或心力衰竭住院。共纳入 746 例患者(78.5 岁,四分位距 [IQR] 72.0-83.0,EuroSCORE II 4.7%[IQR 2.7-9.7]),229 例(30.7%)患者使用 10 种不同的专用设备接受 TMVI 治疗。1 年后,95.2%的患者残余 MR≤1+,TMVI 治疗患者的主要终点发生率为 39.2%。在 TMVI 不合格的患者(n=517,69.3%)中,bailout-TEER、高危手术和 MT 后的残余 MR≤1+发生率分别为 37.2%、100.0%和 2.4%。1 年后,bailout-TEER 组、高危手术组和 MT 组的主要终点发生率分别为 28.8%、42.9%和 47.9%。
该注册研究纳入了迄今为止接受 TMVI 治疗的最大数量的患者。使用 10 种专用设备进行 TMVI 可实现可预测的 MR 消除,并在 1 年内持续改善功能。在 TMVI 不合格的患者中,bailout-TEER 和高危手术是合理的替代方法,而 MT 与较差的临床和功能结局相关。