Department of Internal Medicine and Cardiology/Pneumology, University of Bonn, Bonn, Germany.
Department of Cardiology, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom.
J Am Coll Cardiol. 2014 Sep 2;64(9):875-84. doi: 10.1016/j.jacc.2014.06.1166.
The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited.
The aim of this multinational registry is to present a real-world overview of TMVR use in Europe.
The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data.
A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation).
This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms.
经导管二尖瓣修复术（TMVR）在欧洲已被广泛接受，但在真实患者中关于即刻成功率、安全性和长期超声心动图随访的数据仍有限。
本多中心注册研究旨在展示欧洲 TMVR 应用的真实世界概况。
经导管瓣膜治疗 Sentinel 先导注册研究是一项前瞻性、独立、连续收集个体患者数据的研究。
共有 628 例患者（平均年龄 74.2±9.7 岁，63.1%为男性）于 2011 年 1 月至 2012 年 12 月在欧洲 8 个国家的 25 个中心接受 TMVR 治疗。最常见的发病机制是功能性二尖瓣反流（FMR）（n=452[72.0%]）。大多数患者（85.5%）存在高度症状（纽约心脏协会心功能分级 III 级或以上），高逻辑欧洲心脏手术风险评估系统评分（EuroSCORE）（20.4±16.7%）。即刻手术成功率高（95.4%），在 FMR 和退行性二尖瓣反流中相似（p=0.662）。61.4%的患者植入 1 个夹子。住院死亡率低（2.9%），各组间无显著差异。估计 1 年死亡率为 15.3%，FMR 和退行性二尖瓣反流的死亡率相似。估计 1 年因心力衰竭再次住院的比例为 22.8%，FMR 组显著更高（25.8%比 12.0%，p[log-rank] =0.009）。15 个中心的 368 例连续患者提供了 1 年随访的配对超声心动图数据，显示 1 年内二尖瓣反流程度持续降低（6.0%的患者存在严重二尖瓣反流）。
本独立、当代注册研究表明，TMVR 即刻成功率高，并发症发生率低，1 年时可持续降低二尖瓣反流严重程度，改善临床症状。
