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Protocol for Relative Hydrodynamic Assessment of Tri-leaflet Polymer Valves
Published on: October 17, 2013
Assessment of hemodynamics properties of a new-type artificial heart valve prosthesis using catheterization and
1Shantou Medical College, Shantou University, Shantou 515031, China. yjzeng@bjut.edu.cn
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) Animal experiment. Six sheep subjected to mitral replacement with 21-mm-valve prosthesis were measured by open cardiac catheterization intraoperatively. Doppler echocardiography and open cardiac catheterization under dobutamine stress were performed in two sheep subjected to implantation 2.5 years ago. (3) Clinical patient observation. Observations were carried out on 14 patients with aortas replacement and 10 patients with bicuspid replacement using both doppler echocardiography and open cardiac catheterization.
Results:
(1) Laboratory simulation. The results showed that the value of the transvalvular gradient (DeltaP) 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 DeltaP value of the six sheep was 5.2 +/- 1.7 mm Hg intraoperatively, while the corresponding DeltaP 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 DeltaP values in the aortic position measured by catheterization and echocardiography were 6.26 approximately 4.10 and 9.42 approximately 7.48 mm Hg, respectively. The gradients in the mitral position were 2.10 approximately 1.9 and 5.28 approximately 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.
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