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Abstract

Objective: The objectives of this study were to assess the hemodynamic properties of the newly developed artificial heart valve prosthesis experimentally in laboratory simulation, in an animal model, and clinically in a human model and to compare the results measured by catheterization and echocardiography.Methods: (1) Laboratory simulation. The prosthesis was tested using a pulsatile flow simulator in the aortic position. Hydrodynamics parameters were automatically analyzed through a custom-designed data processing program. (2) Results: (1) Laboratory simulation. The results showed that the value of the transvalvular gradient (DP) decreased with the increase of heart rate, and the values were not greater that 10 mm Hg at any given tissue annulus diameter. (2) Animal experiment. The mean DP value of the six sheep was 5.2 ± 1.7 mm Hg intraoperatively, while the corresponding DP value of the two sheep 2.5 years after implantation was 6.1 ± 0.3 mm Hg measured by open cardiac catheterization. (3) Clinical patient observation. The mean DP values in the aortic position measured by catheterization and echocardiography were 6.26 $ 4.10 and 9.42 $ 7.48 mm Hg, respectively. The gradients in the mitral position were 2.10 $ 1.9 and 5.28 $ 4.10 mm Hg, respectively.Conclusions: The results demonstrate that the new-type bileaflet heart valve prosthesis only generates a relatively low transvalvar gradient and thus has good hemodynamic properties. Am. J. Hematol. 81:563-567, 2006. V V C 2006 Wiley-Liss, Inc.