Keith Myers

In vitro pulsatile flow evaluation of a stentless porcine aortic bioprosthesis.

Suboptimal hemodynamic performance, tissue calcification, and limitation in long-term durability have been encountered clinically after aortic valve replacement with currently available bioprostheses. It is believed that some of these problems may be caused, directly or indirectly, by the stents of the bioprostheses. To address these deficiencies, the authors undertook the development of the Edwards Prima Stentless Bioprosthesis. This study was designed to evaluate the hemodynamic performance of the Edwards Prima Stentless Bioprosthesis in a pulse duplicator system. The stented Carpentier-Edwards Porcine Bioprosthesis (Baxter Healthcare Corp., Irvine, CA), which has been used in United States clinics for more than 10 years, was used as a control device. The flow fields in the vicinity of the test bioprostheses were inspected with color Doppler flow mapping. The transvalvular pressure gradients were measured invasively with a catheter and calculated with the Doppler determined velocity using a simplified Bernoulli equation. Additionally, the leakage volumes were determined with an electromagnetic flowmeter. In the Doppler flow mapping study, during systole, a central flow was observed distal to the stentless and stented bioprostheses. The central flow distal to the stentless bioprosthesis was broader than that observed distal to its stented counterpart. During diastole, no regurgitation was detected by color Doppler flow mapping in either the stentless or stented groups. The Doppler determined transvalvular pressure gradients correlated well with those measured by catheter (r = 0.990). Moreover, it was learned that the transvalvular pressure gradients of the stentless bioprosthesis were less than those of its stented counterpart, especially for the smaller sizes. The leakage volumes determined by the electromagnetic flowmeter were minimal for both the stentless and stented bioprostheses. In conclusion, the results of this study indicated that the hemodynamic performance of the Edwards Prima Stentless Bioprosthesis was superior to that of its stented counterpart, particularly in the smaller sizes.