Novo conceito de Bioprótese: bioprótese com descontinuidade do anel de sustentação (Less Stented)®

Abstract

OBJECTIVE: To study a bioprosthesis with discontinuation of the annular support, named the Less Stented® bioprosthesis. The Phase 1 objective was the vitro study, during which the hemodynamic characteristics were analyzed. Phase 2 of this study consisted of an initial clinical implant protocol. METHOD: The Less Stented bioprosthesis consists in a glutaraldehyde treated bovine pericardium prosthesis manufactured by Braile Biomedica Ltda, Sao Jose do Rio Preto, Sao Paulo, Brazil, using the same manufacturing protocols as the stented bioprosthesis but with discontinuation of the annular suport. Bioprostheses were tested in a pulse simulator system and analyzed in cardiac simulator. with respect to the transvalvular gradient, regurgitant fraction and leakage volume, discharge coefficient, performance and efficiency index. The two patients of clinical protocol were analyzed according to the functional class (NYHA), an echocardiographic study and magnetic resonance, in both pre and postoperative periods. RESULTS: The transvalvular gradients ranged between 6.37 and 11.62 mmHg with a mean flow between 4.39 and 7.96 L/min, giving a good correlation (0.8291) on the regression curve with the increase in flow. The regurgitant fraction ranged between 10.95% and 17.94% and leakage volume between 4.49% and 7.87%. The discharge coefficient, performance and efficiency index showed favorable behavior with the flow increase, with good coefficient correlations for all three variables (0.9385, 0.9332 and 0.9024, respectively). The two patients submitted to Less Stented® bioprostheses implant presented good clinical evolutions. CONCLUSION: Less Stented® bioprostheses may represent a new alternative to aortic valve replacement.