ArticleFrontiers in cardiovascular medicine2026
VITTA TRIAL - safety and performance at 3-year follow-up after implantation of the VIVERE® aortic bioprosthesis.
Article in Frontiers in cardiovascular medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
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.
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