Interventional Treatment of Severe Tricuspid Regurgitation Early Clinical Experience in a Multicenter, Observational, First-in-Man Study

Background-Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept. Methods and Results-Twenty-five patients (mean age, 73.9 +/- 7.6 years; women, 52.0%) with severe symptomatic TR despite optimal medical treatment deemed unsuitable for surgery were treated with caval valve implantation under a compassionate clinical use program. Technical feasibility defined as procedural success, hemodynamic effect defined as venous pressure reduction, and safety defined as periprocedural adverse events were evaluated, with clinical follow-up at discharge and up to 12 months. The functional impact was evaluated by assessment of New York Heart Association class at the time of hospital discharge. The total number of valves implanted in the caval position was 31. Patients were treated with single (inferior vena cava-only; n= 19; 76.0%) or bicaval valve implantation (inferior vena cava+superior vena cava; n= 6; 24.0%). Either balloon-expandable valves (Sapien XT/3: n= 18; 72.0%) or self-expandable valves (TricValve: n= 6; 24.0%; Directflow: n= 1; 4.0%) were used. Procedural success was achieved in 96% (n= 24). Early and late valve migration requiring surgical intervention occurred in 1 patient each. Thirty-day and in-hospital mortality were 8% (2 of 25) and 16% (4 of 25). Causes of in-hospital mortality included respiratory (n= 1) or multiple organ failure (n= 3) and were not linked to the procedure. Mean overall survival in the study cohort was 316 +/- 453 days (14-1540 days). Conclusions-Caval valve implantation for the treatment of severe TR and advanced right ventricular failure is associated with a high procedural success rate and seems safe and feasible in an excessive-risk cohort. The study demonstrates hemodynamic efficacy with consistent elimination of TR-associated venous backflow and initial clinical improvement. These results encourage further trials to determine which patients benefit most from this interventional approach.