Objective: To study a bioprosthesis with discontinuation of the annular support, named the "Less Stented " bioprosthesis. The Phase 1 objective was an "in vitro" study, during which the hemodynamic characteristics of the prosthesis were analyzed. Phase 2 of this study consisted of an initial clinical implant protocol. Methods: The "Less Stented" bioprosthesis consists of a glutaraldehyde treated bovine pericardium prosthesis manufactured by Braile Biomedica Ltda, São José do Rio Preto, São Paulo, Brazil, using the same manufacturing protocols as the stented bioprostheses but with discontinuation of the annular support. Bioprostheses were tested in a pulse simulator system and analyzed in a cardiac simulator with respect to the transvalvular gradient, regurgitant fraction and leakage volume, discharge coefficient, performance and efficiency index. The two patients of the clinical protocol were analyzed according to the functional class (NYHA), an echocardiographic study and magnetic resonance, in both the pre-and postoperative periods. Results: The transvalvular gradients ranged from 6.37 to 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 increase in flow, 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 with good clinical evolutions. Conclusions: "Less-Stented " bioprostheses may represent a new alternative to aortic valve replacement. Descriptors: Bioprostheses. Heat valve prosthesis. Aortic valve, surgery. Resumo Objetivo: Estudar bioprótese com descontinuidade do anel de sustentação, a bioprótese "Less Stented ". O objetivo da fase 1 do trabalho foi o seu estudo "in vitro", onde foram avaliadas as características hemodinâmicas. O objetivo da fase 2 é relatar a experiência clínica inicial. Método: As biopróteses foram confeccionadas e avaliadas laboratorialmente na Braile Biomédica, em São José do Rio Preto, São Paulo. São próteses de pericárdio bovino, tratadas
Novo conceito de Bioprótese: bioprótese com descontinuidade do anel de sustentação(Less Stented) ®New concept of Bioprostheses: a biosprothesis with discontinuation of the annular suport, the "Less Stented" POMERANTZEFF, PMA ET AL -New concept of Bioprostheses: a biosprothesis with discontinuation of the annular suport, the "Less Stented"