VITTA TRIAL – safety and performance at 3-year follow-up after implantation of the VIVERE® aortic bioprosthesis

Introduction: The durability of aortic bioprostheses remains limited by progressive tissue calcification, the main mechanism underlying structural valve deterioration. Aiming to mitigate this process, the VIVERE® Biological Heart Valve Prosthesis, treated with the REALOG® anticalcification technology, was developed to reduce degenerative effects associated with glutaraldehyde fixation. Objective: To evaluate the safety, clinical performance, and hemodynamic outcomes of the VIVERE® Biological Heart Valve Prosthesis over 36 months following aortic valve replacement. Methods: Retrospective, multicenter, single-arm study included patients with aortic valve disease who underwent valve replacement using VIVERE® bioprosthesis. Clinical success (valve implantation without complications and no major adverse event until hospital discharge), linearized rates of major adverse events-composite and valve-related (death and/or stroke and/or reintervention), survival, clinical efficacy (NYHA class I-II), and hemodynamic performance (valve area, mean gradient, and presence of regurgitation or paravalvular leak) were assessed. Follow-up was conducted for up to 36 months after implantation. Continuous variables were expressed as mean ± standard deviation, and categorical variables as frequencies and percentages. Survival was assessed by Kaplan-Meier analysis, and linearized event rates expressed per 100 patient-years. Results: 106 patients were included, with a mean age of 67 ± 11.6 years. Clinical success was observed in 88.7% of patients, with a linearized rate of valve-related major adverse composite events of 1.0% per patient-year and a 36-month survival of 87.7%. At 36 months, there was an 80% reduction in mean gradient and a 71% increase in effective orifice area, with 87.5% of patients in NYHA functional class I-II. No structural valve deterioration or paravalvular leak was observed at 36 months. Conclusion: At 36 months, VIVERE® demonstrated favorable valve-related safety and efficacy, with low valve-related mortality, stable hemodynamics, and sustained functional improvement.