Heterotopic crosscaval transcatheter tricuspid valve replacement for patients with tricuspid regurgitation : the trillium device

Abstract

Background Transcatheter tricuspid interventions are an emerging therapy for patients with severe tricuspid regurgitation (TR), but a significant proportion of patients with TR are unsuitable for orthotopic tricuspid valve (TV) approaches. Objectives The aim of this study was to investigate the performance of a dedicated heterotopic valve replacement system in patients with severe or greater TR. Methods This single-arm, multicenter study assessed the technical performance, efficacy, and safety of heterotopic cross-caval transcatheter TV replacement using the Trillium device at 30 days. Patients with severe or greater TR ineligible for surgical or other interventional orthotopic TV treatment were included. Results Between 2021 and 2023, 20 patients (median age 81 years, 40% women) were included. Device implantation was successful in all cases, and no intraprocedural deaths or conversions to surgery occurred. Postprocedurally, central venous pressure was reduced (median −3 mm Hg; Q1-Q3: −5 to −1 mm Hg; P = 0.003), and TR severity as assessed at the level of the Trillium device was reduced in all cases (P < 0.001). Within the 30-day follow-up period, 1 patient died, 2 patients experienced heart failure hospitalization, 2 required hemodialysis, and 2 experienced major bleeding. There was an improvement in NYHA functional class (P = 0.005) and a trend toward a reduction in edema severity score (median −0.5; Q1-Q3: −1 to −0; P = 0.052). Conclusions The Trillium device is a safe and effective device for the treatment of patients with severe or greater TR ineligible for other therapeutic options. The device leads to a hemodynamic and symptomatic improvement of the burden of TR, whether this translates into favorable outcomes is to be proven in randomized trials.