Bicaval TricValve Implantation in Patients With Severe Tricuspid Regurgitation: 1-Year Outcomes From the TricBicaval Registry.

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.