Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients’ quality of life. This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR. The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessments were performed at a core laboratory. At 3 years, TR was reduced to moderate or less in 79% of subjects, and a reduction of at least 1 grade was achieved in 92% of subjects. TR reduction achieved at 1 year was sustained through 3 years. Subjects also experienced an improvement in heart failure symptoms assessed by NYHA functional class and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire at 3 years compared to baseline. The site-reported heart failure hospitalization rate decreased from 0.56 events/patient-year 1 year before device implantation to 0.14 events/patient-year 3 years after device implantation, representing a reduction of 75% ( 0.0001). In the longest follow-up to date of any T-TEER therapy, the TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR [TRILUMINATE]; )

中文翻译：

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经皮边对边修复三尖瓣反流：TRILUMINATE 研究的 3 年结果


三尖瓣反流（TR）是一种常见的瓣膜疾病，对患者的生活质量有重大影响。本研究旨在报告使用来自 TRILUMINATE 的 TriClip (Abbott) 植入物进行三尖瓣经导管边缘到边缘修复 (T-TEER) 的最终 3 年结果（使用 Abbott 经导管夹修复系统对中度或以上患者进行的 TRILUMINATE 研究） TR）治疗严重症状 TR 的研究。 TRILUMINATE 研究（N = 98 名受试者）是一项国际性、前瞻性、单臂、多中心研究，旨在调查具有 TriClip 植入物的 T-TEER 在有症状的中度或重度 TR 患者中的安全性和性能。超声心动图评估在核心实验室进行。 3 年时，79% 的受试者 TR 降低至中度或更低，92% 的受试者至少降低 1 级。 1 年实现的 TR 减少持续了 3 年。与基线相比，受试者 3 年时根据 NYHA 功能分级评估的心力衰竭症状和根据堪萨斯城心肌病问卷评估的生活质量也有所改善。现场报告的心力衰竭住院率从装置植入前 1 年的 0.56 事件/患者年下降到装置植入后 3 年的 0.14 事件/患者年，减少了 75% (0.0001)。在迄今为止任何 T-TEER 疗法中最长的随访中，TRILUMINATE 研究证明 TriClip 手术既安全又有效，对有症状的中度或重度 TR 受试者可在 3 年内持续获益。 （使用 Abbott 经导管夹修复系统对中度或以上 TR 患者进行的 TRILUMINATE 研究 [TRILUMINATE]；）