Four-year clinical and echocardiographic outcomes after tricuspid valve replacement using a novel bovine pericardial valve bioprosthesis.

Objective: To describe our experience and evaluate the clinical outcomes and hemodynamic performance of a new bovine pericardial valve bioprosthesis when used off-label for tricuspid valve replacement (TVR). Methods: We retrospectively reviewed 82 consecutive patients who underwent 83 TVR procedures (1 patient required early reoperation for paravalvular leak) with the new bioprosthesis between July 2021 and April 2025 at our institution. The mean clinical follow-up was 2.3 ± 1.1 years (94% completed), and the mean echocardiographic follow-up was 2.0 ± 1.1 years (75% completed). The primary end point was bioprosthetic valve dysfunction; secondary end points were survival, perioperative outcomes, major complications, and hemodynamic performance. Results: Mean age was 66.6 ± 14.0 years; 51.2% (42/82) were female. New York Heart Association class III-IV symptoms were present in 65.2% (45/69). Principal indications were annular dilatation (65.7%, 46/70) and TriClip failure (11.4%, 8/70). Mean Society of Thoracic Surgeons and TRI-SCORE were 6.9 ± 11.4 and 11.8 ± 7.1, respectively. Sternotomy was performed in 41.0% (34/83) and minimally invasive access in 59.0% (49/83). Concomitant procedures included left-sided valvular surgery (47.0%, 39/83) and left atrial appendage closure (26.5%, 22/83). The most common prosthesis size was 33 mm (67.5%, 56/83). As the primary end point, no valve thrombosis was observed and 2.6% (2/77) developed severe central tricuspid regurgitation (TR) requiring percutaneous reintervention. New moderate intraprosthetic TR occurred in 13.3% (6/45) of patients. Thirty-day mortality was 15.9% (13/82). Major complications included new pacemaker implantation (19.3%, 16/83), reoperation for bleeding (7.2%, 6/83), and cerebrovascular events (7.2%, 6/83). Echocardiography showed stable mean gradients (3.2 ± 1.3 mm Hg at discharge; 3.0 ± 1.2 mm Hg at latest follow-up). Otherwise, 1.3% (1/77) underwent redo TVR for early paravalvular leak. Bioprosthetic endocarditis occurred in 5.2% (4/77), all treated conservatively. Actuarial 4-year survival was 63% and freedom from valvular reintervention was 92%. Conclusions: The new bioprosthesis implanted in the tricuspid position in this high-risk cohort demonstrated stable hemodynamics; however, 2 cases of valvular dysfunction needing reintervention occurred at 2 years, with 6 cases of stable moderate central TR observed at follow-up. These complications highlight the need for longer follow-up to establish durability and guide patient selection and postoperative care.