ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. Heart Valve Disease
VITTA TRIAL – Safety and performance at 3-year follow-up after implantation of the VIVERE® aortic bioprosthesis
Luiz Carlos Bettiati Junior 1
Davi Jean Buoro Cassano 1
Caio Eduardo Gullo 2
João Carlos Ferreira Leal 3
1. Hospital De Caridade São Vicente De Paulo, Jundiaí, Brazil
2. Hospital Nossa Senhora (Fundação Pio XII), Barretos, Brazil
3. Hospital Beneficência Portuguesa, São José do Rio Preto, São José do Rio Preto, Brazil
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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.
Summary
Keywords
anticalcificant treatment, Aortic Valve, Bioprosthesis, Bovine pericardium, cardiac surgery, Cardiac valve prosthesis
Received
10 December 2025
Accepted
27 January 2026
Copyright
© 2026 Bettiati Junior, Buoro Cassano, Gullo and Ferreira Leal. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: João Carlos Ferreira Leal
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