Bicaval TricValve Implantation in Patients With Severe Tricuspid Regurgitation

Background: Caval valve implantation is currently the only alternative for patients with severe tricuspid regurgitation (TR) who are deemed unsuitable candidates for transcatheter orthotopic therapies. Objectives: The aim of this study was to assess the efficacy and safety of TricValve system at 1-year follow-up. Methods: TricBicaval registry is a multicenter registry that retrospectively enrolled all consecutive patients with severe TR treated with TricValve system. Results: 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). Conclusions: 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.