BACKGROUND Untreated severe tricuspid regurgitation (TR) carries a poor prognosis. OBJECTIVES The authors report the 1-year outcomes of transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Structural Heart) in patients with complex tricuspid valve anatomies. METHODS The multicenter, international TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal) trial included a single-arm cohort, with complex tricuspid valve anatomies excluded from the randomized arm (ie, anticipated TR reduction but not to moderate or less after TEER). The primary outcome endpoint of the single arm was 1-year survival with a Kansas City Cardiomyopathy Questionnaire score improvement ≥10 points. RESULTS In the primary analysis population (N = 100), the mean age was 80 ± 6 years, and 35% had a cardiac implantable electronic device lead. Nearly 90% of patients had massive or torrential TR, 44% had prior left-sided valve interventions, 63% had ≥4-segmental tricuspid leaflet morphology, and the coaptation gap averaged 7.4 ± 2.7 mm. The primary endpoint was met (outcome: 46.2%, performance goal: 30%; P = 0.0008). A total of 81% of subjects had moderate or less TR at 1 year. No major adverse events or deaths occurred within 30 days postprocedure. One-year all-cause mortality and heart failure hospitalization were 15% and 24%, respectively. Significant improvements in NYHA functional class and Kansas City Cardiomyopathy Questionnaire overall scores occurred and were maintained at 1 year. CONCLUSIONS In patients with complex tricuspid anatomies, TEER with the TriClip system demonstrated excellent procedural safety with significant TR reduction and associated improvements in quality of life at 1 year.

中文翻译：

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复杂三尖瓣解剖结构患者的经导管边对边修复术。


背景 未经治疗的严重三尖瓣反流 （TR） 预后不良。目的 作者报告了使用 TriClip 系统 （Abbott Structural Heart） 在复杂三尖瓣解剖结构患者中经导管边对边修复 （TEER） 的 1 年结果。方法 多中心、国际 TRILUMINATE Pivotal （评估接受三尖瓣修复系统 Pivotal 治疗的患者心血管结局的试验） 试验包括一个单臂队列，复杂的三尖瓣解剖结构被排除在随机组之外 （即，预期的 TR 减少，但在 TEER 后没有达到中度或更低）。单组的主要结局终点是 1 年生存率，堪萨斯城心肌病问卷评分提高 ≥10 分。结果 在主要分析人群 （N = 100） 中，平均年龄为 80 ± 6 岁，35% 的患者有心脏植入式电子设备导线。近 90% 的患者有大块或暴发性 TR，44% 既往有左侧瓣膜介入治疗，63% 有 ≥4 节三尖瓣叶形态，接合间隙平均为 7.4 ± 2.7 毫米。达到主要终点（结果：46.2%，性能目标：30%;P = 0.0008）。共有 81% 的受试者在 1 年时出现中度或轻度 TR。术后 30 天内未发生重大不良事件或死亡。一年全因死亡率和心力衰竭住院率分别为 15% 和 24%。NYHA 功能分级和堪萨斯城心肌病问卷总分显著改善，并维持在 1 年。结论 在具有复杂三尖瓣解剖结构的患者中，使用 TriClip 系统的 TEER 表现出优异的手术安全性，1 年时 TR 显着减少，生活质量得到相关改善。