Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
Universitäts Medizin, Mainz, Germany.
J Am Coll Cardiol. 2021 Jan 26;77(3):229-239. doi: 10.1016/j.jacc.2020.11.038.
Tricuspid regurgitation (TR) is a frequent disease with a progressive increase in mortality as disease severity increases. Transcatheter therapies for treatment of TR may offer a safe and effective alternative to surgery in this high-risk population.
The purpose of this report was to study the 1-year outcomes with the TriClip transcatheter tricuspid valve repair system, including repair durability, clinical benefit and safety.
The TRILUMINATE trial (n = 85) is an international, prospective, single arm, multicenter study investigating safety and performance of the TriClip Tricuspid Valve Repair System in patients with moderate or greater TR. Echocardiographic assessment was performed by a core laboratory.
At 1 year, TR was reduced to moderate or less in 71% of subjects compared with 8% at baseline (p < 0.0001). Patients experienced significant clinical improvements in New York Heart Association (NYHA) functional class I/II (31% to 83%, p < 0.0001), 6-minute walk test (272.3 ± 15.6 to 303.2 ± 15.6 meters, p = 0.0023) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (improvement of 20 ± 2.61 points, p < 0.0001). Significant reverse right ventricular remodeling was observed in terms of size and function. The overall major adverse event rate and all-cause mortality were both 7.1% at 1 year.
Transcatheter tricuspid valve repair using the TriClip device was found to be safe and effective in patients with moderate or greater TR. The repair itself was durable at reducing TR at 1 year and was associated with a sustained and marked clinical benefit with low mortality after 1 year in a fragile population that was at high surgical risk. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR; NCT03227757).
三尖瓣反流（TR）是一种常见疾病，随着疾病严重程度的增加，死亡率呈递增趋势。对于高危人群，经导管治疗 TR 可能提供一种安全有效的替代手术的方法。
本报告旨在研究 TriClip 经导管三尖瓣修复系统的 1 年结果，包括修复耐久性、临床获益和安全性。
TRILUMINATE 试验（n=85）是一项国际性、前瞻性、单臂、多中心研究，旨在评估 TriClip 三尖瓣修复系统治疗中重度或以上 TR 患者的安全性和性能。由核心实验室进行超声心动图评估。
与基线时的 8%相比，在 1 年时，71%的患者 TR 减轻至中度或以下（p<0.0001）。患者的纽约心脏协会（NYHA）心功能分级 I/II（31%至 83%，p<0.0001）、6 分钟步行试验（272.3±15.6 至 303.2±15.6 米，p=0.0023）和堪萨斯城心肌病问卷（KCCQ）评分（改善 20±2.61 分，p<0.0001）均有显著改善。在大小和功能方面，右心室逆重构显著。1 年时，总主要不良事件发生率和全因死亡率均为 7.1%。
在中重度或以上 TR 患者中，使用 TriClip 装置经导管三尖瓣修复是安全有效的。在 1 年时，修复本身可持久降低 TR，并且在高手术风险的脆弱人群中，1 年后死亡率低，可带来持续显著的临床获益。（TRILUMINATE 研究：使用 Abbott 经导管夹修复系统治疗中重度或以上 TR；NCT03227757）。
