Complejo Hospitalario Universitario Alvaro Cunqueiro, Vigo, Spain.
Hospital Universitario Ramon y Cajal, CIBERCV, Madrid, Spain.
JACC Cardiovasc Interv. 2022 Jul 11;15(13):1366-1377. doi: 10.1016/j.jcin.2022.05.022. Epub 2022 May 17.
Severe tricuspid regurgitation (TR) is frequently associated with significant morbidity and mortality; such patients are often deemed to be at high surgical risk. Heterotopic bicaval stenting is an emerging, attractive transcatheter solution for these patients.
The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and inferior vena cava.
TRICUS EURO (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) is a nonblinded, nonrandomized, single-arm, multicenter, prospective trial that enrolled patients from 12 European centers between December 2019 and February 2021. High-risk individuals with severe symptomatic TR despite optimal medical therapy were included. The primary endpoint was quality-of-life (QOL) improvement measured by Kansas City Cardiomyopathy Questionnaire score and New York Heart Association (NYHA) functional class improvement at 6-month follow-up.
Thirty-five patients (mean age 76 ± 6.8 years, 83% women) were treated using the TricValve system. All patients at baseline were in NYHA functional class III or IV. At 30 days, procedural success was 94%, with no procedural deaths or conversions to surgery. A significant increase in QOL at 6 months follow-up was observed (baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores 42.01 ± 22.3 and 59.7 ± 23.6, respectively; P = 0.004), correlating with a significant improvement in NYHA functional class, with 79.4% of patients noted to be in functional class I or II at 6 months (P = 0.0006). The rates of 6-month all-cause mortality and heart failure hospitalization were 8.5% and 20%, respectively.
The dedicated bicaval system for treating severe symptomatic TR was associated with a high procedural success rate and significant improvements in both QOL and functional classification at 6 months follow-up.
严重三尖瓣反流（TR）常与较高的发病率和死亡率相关；此类患者通常被认为具有较高的手术风险。异位双腔静脉支架置入术是一种新兴的、有吸引力的经导管治疗方法。
本研究旨在评估专为上、下腔静脉设计的生物瓣的 30 天安全性和 6 个月疗效。
TRICUS EURO（TricValve®经导管双腔静脉瓣膜系统治疗严重三尖瓣反流患者上、下腔静脉的安全性和疗效）是一项非盲、非随机、单臂、多中心、前瞻性试验，于 2019 年 12 月至 2021 年 2 月在 12 个欧洲中心入组患者。该试验纳入了即使接受最佳药物治疗仍有严重症状性 TR 的高危患者。主要终点是通过堪萨斯城心肌病问卷评分和纽约心脏协会（NYHA）功能分级改善评估的 6 个月随访时生活质量（QOL）的改善。
35 例患者（平均年龄 76 ± 6.8 岁，83%为女性）接受了 TricValve 系统治疗。所有患者在基线时均为 NYHA 功能分级 III 或 IV 级。30 天内，手术成功率为 94%，无手术死亡或转为手术。在 6 个月的随访中观察到 QOL 显著改善（基线和 6 个月时堪萨斯城心肌病问卷评分分别为 42.01 ± 22.3 和 59.7 ± 23.6，P=0.004），并与 NYHA 功能分级的显著改善相关，6 个月时 79.4%的患者被认为处于功能分级 I 或 II 级（P=0.0006）。6 个月的全因死亡率和心力衰竭住院率分别为 8.5%和 20%。
专门用于治疗严重症状性 TR 的双腔静脉系统与较高的手术成功率以及 6 个月随访时 QOL 和功能分级的显著改善相关。
