Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany.
Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.
JACC Cardiovasc Interv. 2024 Feb 26;17(4):535-548. doi: 10.1016/j.jcin.2023.11.014. Epub 2023 Nov 20.
According to the TRILUMINATE (Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) trial, transcatheter tricuspid edge-to-edge repair (T-TEER) improves quality of life beyond medical treatment, while no effects on heart failure hospitalization (HFH) and survival were observed at 1 year. However, the generalizability of the TRILUMINATE trial to real-world conditions remains a subject of discussion.
The aim of this study was to apply the clinical TRILUMINATE inclusion and exclusion criteria to a real-world T-TEER patient group and evaluate symptomatic and survival outcome in TRILUMINATE-eligible and TRILUMINATE-ineligible patients.
Clinical TRILUMINATE inclusion and exclusion criteria were applied to a cohort of patients who underwent T-TEER at 5 European centers from 2016 to 2022. Study patients were compared regarding baseline characteristics, survival, HFH, and symptomatic outcomes as measured by NYHA functional class, a quality-of-life questionnaire and 6-minute walk distance.
Of 962 patients, 54.8% were classified as TRILUMINATE eligible, presenting with superior left ventricular function and fewer comorbidities compared with the ineligible population. Tricuspid regurgitation reduction, improvement in NYHA functional class, quality of life, and exercise capacity were comparable in both groups. However, the 1-year survival and HFH rates significantly differed (tricuspid regurgitation ≤2+ at discharge, 82% vs 85%; survival, 85% vs 75%; HFH, 14% vs 22% for eligible vs ineligible patients).
The observed differences in survival and HFH outcomes suggest a limited generalizability of TRILUMINATE to real-world conditions and indicate the need for additional studies evaluating the outcomes after T-TEER in less selected patient populations.
根据 TRILUMINATE（经导管三尖瓣瓣环成形术治疗患者的心血管结局临床试验）试验，经导管三尖瓣缘对缘修复（T-TEER）改善了生活质量，优于药物治疗，而在 1 年内并未观察到心力衰竭住院（HFH）和生存率的改善。然而，TRILUMINATE 试验在真实世界条件下的普遍性仍然存在争议。
本研究旨在将临床 TRILUMINATE 的纳入和排除标准应用于真实世界的 T-TEER 患者群体，并评估 TRILUMINATE 合格和不合格患者的症状和生存结果。
将临床 TRILUMINATE 的纳入和排除标准应用于 2016 年至 2022 年在欧洲 5 个中心接受 T-TEER 的患者队列。比较两组患者的基线特征、生存率、HFH 和症状结局，如纽约心功能分级（NYHA）、生活质量问卷和 6 分钟步行距离。
在 962 名患者中，54.8%被归类为 TRILUMINATE 合格患者，与不合格患者相比，左心室功能更好，合并症更少。两组患者的三尖瓣反流减少、NYHA 心功能分级改善、生活质量和运动能力相当。然而，1 年生存率和 HFH 率存在显著差异（出院时三尖瓣反流≤2+，合格组为 82%，不合格组为 85%；生存率，合格组为 85%，不合格组为 75%；HFH，合格组为 14%，不合格组为 22%）。
观察到的生存率和 HFH 结局差异表明，TRILUMINATE 在真实世界条件下的普遍性有限，并表明需要进一步研究评估在选择较少的患者群体中 T-TEER 后的结局。
