Treatment of Severe Tricuspid Regurgitation with the TricValve System Implantation-Preliminary Results of a Prospective Registry.

Background: Tricuspid regurgitation (TR) is a common valvular heart disease that often causes disabling symptoms. Caval valve implantation with the TricValve system is one of the transcatheter treatment options proposed for TR symptom reduction. With this prospective registry, we aim to summarize our early experience with TricValve system implantation. Methods: Registry participants, selected out of patients who were referred for TR treatment but who were not eligible for the transcatheter tricuspid edge-to-edge valve repair (T-TEER), were qualified for the caval valve implantation following a HeartTeam discussion. Results: Four patients (four women; median age 71 years; 67.5-77 years) in whom a one-year follow-up was completed were included in the study. The patients were highly symptomatic in the NYHA class III despite intensive diuretic treatment; all of them were considered a high-mortality risk during conventional cardiac surgery. The TricValve system was successfully implanted in all patients. At 6-month follow-up, we observed a reduction in symptoms in three out of four patients. Up to 12 months, only one patient survived, with a reduction in symptoms of NYHA class II; two patients died because of heart failure; one died due to a progression in neoplastic disease. Conclusions: In highly symptomatic TR patients who were not eligible for the T-TEER and who had a prohibitive risk of cardiac surgery, TricValve implantation led to a reduction in symptoms in a 6-month perspective. Long-term survival was limited mainly by heart failure progression and severe concomitant disorders. Further studies are needed to fully elucidate the role of caval valve implantation in the treatment of TR patients.