BACKGROUND Conservative treatments for tricuspid regurgitation (TR) frequently yield suboptimal outcomes. Transcatheter interventions provide a new therapeutic avenue, with ongoing assessments of safety and effectiveness. OBJECTIVES The TriStar (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System) study investigated 1-year outcomes of the K-Clip transcatheter tricuspid annuloplasty system in treating patients with severe functional TR. METHODS Patients with TR grade ≥4, resistant to medical management, were enrolled and selected by core laboratory evaluation. Oversight by a data and safety monitoring board and event adjudication by a clinical events committee occurred. Assessments at 30 days, 6 months, and 1 year included echocardiographic data, clinical symptoms, quality of life, study endpoints, and major adverse events. RESULTS A total of 96 patients (mean age 72.6 years, 59.4% women) were included, with a 97.9% implantation success rate. One-year outcomes showed 5.2% all-cause mortality, a 19.8% composite major adverse event rate, and no device-related reinterventions. TR decreased by ≥1 grade in 94.2%, and by ≥2 grades in 87.2% of patients. Kaplan-Meier estimates demonstrated 94.7% ± 2.3% survival and 90.4% ± 3.0% freedom from heart failure rehospitalization. NYHA functional class significantly improved (P < 0.001), with 97.7% reaching functional class I or II. The 6-minute walk distance improved by 42.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score increased by 7.0 points (P < 0.001). CONCLUSIONS The K-Clip transcatheter tricuspid annuloplasty system showed high procedural success, a favorable safety profile, sustained TR reduction, and marked improvements in clinical outcomes and quality of life at 1 year. (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System [TriStar]; NCT05173233).

中文翻译：

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K-Clip 经导管三尖瓣环成形术系统在严重功能性三尖瓣反流患者中的中期结果。


背景 三尖瓣反流 （TR） 的保守治疗经常产生次优结局。经导管介入治疗提供了一种新的治疗途径，并持续评估安全性和有效性。目的 TriStar （用 K-Clip™ 经导管瓣环成形术系统治疗三尖瓣反流的验证性临床研究）研究调查了 K-Clip 经导管三尖瓣环成形术系统治疗严重功能性 TR 患者的 1 年结果。方法 TR ≥4 级患者，对药物治疗有抵抗力，通过核心实验室评估入组和选择。发生了数据和安全监测委员会的监督以及临床事件委员会的事件裁决。30 天、 6 个月和 1 年的评估包括超声心动图数据、临床症状、生活质量、研究终点和主要不良事件。结果 共纳入 96 例患者 （平均年龄 72.6 岁，59.4% 为女性），植入成功率为 97.9%。一年结局显示全因死亡率为 5.2%，复合主要不良事件发生率为 19.8%，并且没有与设备相关的再干预。94.2% 的患者 TR 下降了 ≥1 级，87.2% 的患者下降了 ≥2 级。Kaplan-Meier 估计显示，94.7% ± 2.3% 的生存率和 90.4% ± 3.0% 的心力衰竭再住院率。NYHA 功能分级显著改善 （P < 0.001），97.7% 达到 I 级或 II 级功能分级。6 分钟步行距离增加 42.8 m （P < 0.001），堪萨斯城心肌病问卷评分增加 7.0 分 （P < 0.001）。 结论 K-Clip 经导管三尖瓣环成形术系统显示出较高的手术成功率、良好的安全性、持续的 TR 减少，以及 1 年时临床结局和生活质量的显着改善。（用 K-Clip™ 经导管瓣环成形术系统治疗三尖瓣反流的验证性临床研究 [TriStar];NCT05173233）。