Sánchez-Recalde Angel, Domínguez-Rodríguez Luis M, Rosseel Liesbeth, Nombela-Franco Luis, Pfister Roman, Amat-Santos Ignacio, Butter Christian, Di Mauro Michele, Cruz-González Ignacio, Freixa Xavier, Swaans Martin, Wilde Christoph, Cacela Duarte, Sarnago Fernando, Del Trigo María, Estévez-Loureiro Rodrigo, López-Mínguez José Ramón, De Torres-Alba Fernando, Montenegro Marcio, Pérez-Fernández Ruth, Guzman Gabriela, Pajín Fernando, Mylotte Darren, Pan Manuel, Kristoff Cornelis, Carrillo-Suarez Xavier, de la Torre José María, Ruiz Quevedo Valeriano, Salido Luisa, Parraga Rocio, Altlhoff Jan, Fernández-Cordón Clara, Guarracini Stefano, Lopez-Tejero Sergio, Abdul-Jawad Altisent Omar, Lautenschläger Lion, Ramos Ruben, Puri Rishi, Zamorano José L
Hospital Universitario Ramon y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain.
Hospital Universitario Ramon y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain.
JACC Cardiovasc Interv. 2025 Aug 11;18(15):1913-1924. doi: 10.1016/j.jcin.2025.06.023.
Caval valve implantation is currently the only alternative for patients with severe tricuspid regurgitation (TR) who are deemed unsuitable candidates for transcatheter orthotopic therapies.
The aim of this study was to assess the efficacy and safety of TricValve system at 1-year follow-up.
TricBicaval registry is a multicenter registry that retrospectively enrolled all consecutive patients with severe TR treated with TricValve system.
Of 204 patients included, 71.1% had renal insufficiency, 87.3% had massive or torrential TR, and 82.4% had TRI-SCOREs of ≥4 points. Intraprocedural success was 96.1%, and clinical success at 30 days was 83%. Functional class significantly improved with 19.8% of patients in NYHA functional class I or II at baseline vs 81.5% (P < 0.001) after a median follow-up period of 8.8 months (Q1-Q3: 1.5-12.3 months). A significant pressure reduction in the inferior vena cava was observed, alongside a marked decrease in signs of right heart failure. Heart failure hospitalizations significantly decreased during follow-up compared with the year preimplantation (60.8 [95% CI: 50.5-73.1] vs 26.9 [95% CI: 19.1-37.8] events per 100 patient-years; P < 0.001). At 1 year, the major adverse event rate was 19.1%, and mortality increased with increasing TRI-SCORE (0-3 points, 6.7% [95% CI: 1.7%-24.6%]; 4 or 5 points, 23.4% [95% CI: 14.4%-36.7%]; ≥6 points, 28.8% [95% CI: 19.8%-40.8%], log-rank P = 0.020).
In this highly comorbid population with severe TR, caval valve implantation using the TricValve system led to significant 1-year clinical improvement, with mortality rates aligned with baseline TRI-SCORE.
腔静脉瓣植入术目前是被认为不适合经导管原位治疗的严重三尖瓣反流（TR）患者的唯一替代方案。
本研究的目的是评估TricValve系统在1年随访期的疗效和安全性。
TricBicaval注册研究是一项多中心注册研究，回顾性纳入了所有连续接受TricValve系统治疗的严重TR患者。
在纳入的204例患者中，71.1%有肾功能不全，87.3%有大量或重度TR，82.4%的TRI-SCORE≥4分。手术成功率为96.1%，30天时的临床成功率为83%。功能分级显著改善，基线时19.8%的患者为纽约心脏协会（NYHA）功能I或II级，而在中位随访8.8个月（四分位间距：1.5 - 12.3个月）后这一比例为81.5%（P < 0.001）。观察到下腔静脉压力显著降低，同时右心衰竭体征明显减少。与植入前一年相比，随访期间心力衰竭住院率显著降低（每100患者年60.8 [95%置信区间：50.5 - 73.1]次事件 vs 26.9 [95%置信区间：19.1 - 37.8]次事件；P < 0.001）。1年时，主要不良事件发生率为19.1%，死亡率随TRI-SCORE升高而增加（0 - 3分，6.7% [95%置信区间：1.7% - 24.6%]；4或5分，23.4% [95%置信区间：14.4% - 36.7%]；≥6分，28.8% [95%置信区间：19.8% - 40.8%]，对数秩检验P = 0.020）。
在这一合并症严重的重度TR患者群体中，使用TricValve系统进行腔静脉瓣植入术在1年时带来了显著的临床改善，死亡率与基线TRI-SCORE相符。
