Transcatheter Bicaval Valve Implantation For Treatment Of Severe Tricuspid Regurgitation: A Single Centre Registry

Background: Heterotopic caval valve implantation using the TricValve(R) (OrbusNeich P&F) is a unique interventional approach for treatment of severe Tricuspid Regurgitation in patients who are deemed ineligible for surgery. Given the complexity and novelty of TricValve(R) implantation, there is a pressing need for robust clinical data to evaluate its safety, efficacy, and long-term outcomes. Our study assesses the clinical results of patients followed up for 1 year from our center. Methods: Retrospective, single center registry involving patients who have undergone TricValve(R) Transcatheter Bicaval Valves System (OrbusNeich P&F) implantation for the treatment of severe tricuspid regurgitation. Results: Fourteen patients were included. The mean age was 67.5 {+/-} 8.7 years, with high surgical risk (mean EuroSCORE II 6.1 {+/-} 3.7). Procedural success was achieved in thirteen patients, with no reported in-hospital mortality or stroke among all fourteen patients. At 1-year, significant improvements were observed in New York Heart Association (NYHA) functional class (86% Class III at baseline to 0% Class III at 1 year, P=0.002) and Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scores (mean 32.0 {+/-} 7.4 to 42.4 {+/-} 12.0, P=0.015). TR Regurgitant Volume significantly decreased (65.5 {+/-} 16.9 ml to 38.2 {+/-} 13.6 ml, P=0.005). No deaths or strokes occurred during follow-up. Rehospitalization due to heart failure occurred in 14% (2 out of 14) of patients. Conclusion: In this single-center registry of high-risk patients, TricValve(R) implantation was associated with a favorable safety profile, significant reduction in tricuspid regurgitant volume, and meaningful improvements in functional status and quality of life at 1 year follow-up.