Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated. We sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting. The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment. Enrolled subjects (n = 511) were elderly (79 ± 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III/IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21% to 75% I/II, < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 26-point improvement, <0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline right ventricular tricuspid annular plane systolic excursion (RV TAPSE) were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; < 0.0001; OR: 0.636; 95% CI: 0.415-0.974; = 0.0375). Mortality was not associated with baseline TR grade or with center volume. Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population. (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device [bRIGHT]; )

中文翻译：

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bRIGHT 研究中三尖瓣边对边修复的真实一年结果


众所周知，严重的三尖瓣反流 (TR) 如果不及时治疗，会导致生活质量下降并增加死亡风险。我们试图报告在当代现实环境中使用 TriClip 系统（雅培心血管）进行三尖瓣经导管边对边修复 (TEER) 治疗的受试者的 1 年临床结果。 bRIGHT（一项评估使用 Abbott TriClip 装置治疗的严重三尖瓣反流患者的观察性真实世界研究）批准后研究是一项前瞻性、单臂、开放标签、多中心上市后登记，在欧洲 26 个地点进行，具有中央事件裁决和超声心动图核心实验室评估。纳入的受试者（n = 511）是患有明显合并症的老年人（79±7岁）。总共 88% 的受试者有基线大量或急流 TR，80% 的受试者属于 NYHA 功能等级 III/IV。 1 年时，81% 的 TR 降低至中等或更低。第 1 年观察到 NYHA 功能分级（21% 至 75% I/II，< 0.0001）和堪萨斯城心肌病问卷 (KCCQ) 评分（19 ± 26 分改善，<0.0001）显着改善。 30 天时达到中等或较低 TR 的受试者的一年死亡率显着降低；然而，在 30 天时达到中度、轻度或微量 TR 的受试者之间的死亡率没有差异。除了 30 天 TR 降低外，基线血清肌酐和基线右心室三尖瓣环平面收缩期偏移 (RV TAPSE) 与 1 年死亡率独立相关（OR：2.169；95% CI：1.494-3.147；< 0.0001；或：0.636；95% CI：0.415-0.974；=0.0375）。死亡率与基线 TR 等级或中心体积无关。 对于现实世界不同人群中患有严重 TR 和晚期疾病的受试者，使用 TriClip 系统进行三尖瓣 TEER 在 1 年内是安全有效的。（一项评估使用 Abbott TriClip 装置治疗的严重三尖瓣反流患者的观察性现实世界研究 [bRIGHT]；）