New bileaflet bioprosthesis: early and mid term results.

: A new bovine pericardial bioprosthesis (AMB bioprosthesis) with a bileaflet geometry was designed and developed, with the aim of achieving uniform stress distribution within the prosthesis. The ultimate goal was to limit tissue degeneration to a minimum by attaining optimum fluid dynamics, thereby obtaining an extended clinical durability. The two-leaflet, dome-shaped geometry with a central hinge allowed a very low profile, low ventricular projection in the mitral position, large effective orifice area and low gradients. The design of the thin Delrin stent and the centrally crossing bridge was developed using finite element analysis. Pre-clinical laboratory investigations showed very low trans-valvular gradients and no mechanical or tissue failure after 400 million cycle accelerated wear test. The final model of the prosthesis was manufactured by Baxter-Edwards CVS Division and tested in sheep with good results for up to five months. A limited clinical trial was started in January 1990 and stopped one year later encompassing 12 aortic and six mitral implants. The patients were followed clinically and by echocardiography three, six and 12 months, and four years after surgery. Mean gradients were 4 mmHg in the mitral and 10 mmHg in the aortic position with only minimum regurgitation and no tissue failure. We conclude that early and mid term results with this new pericardial bioprosthesis appear to be favorable and intend to closely monitor further outcome within the limited patient population.