In vitro evaluation of a stentless porcine aortic bioprosthesis. A preliminary study

Currently available aortic bioprosthetic heart valves are all relatively suboptimal due to the constraints placed on leaflets by stenting. The constraints on the stenting mechanism may directly or indirectly cause turbulence in the orifice neighborhood, be nidi of tissue calcification, and impart transleaflet stress differentials. To address all these deficiencies, we undertook the development of a stentless porcine aortic bioprosthesis (SPAB). This study evaluates the hemodynamic performance and durability of this design in special chambers with near physiologic compliance. The results are compared to those shown by a stented porcine aortic bioprosthesis. The pressure measurements under steady flow conditions showed that the hemodynamic performance (including pressure gradient and effective orifice area) of SPAB is superior to that of its stented counterpart, especially in the smaller sizes. In addition, it is expected that this stentless design should minimize the mechanical stress to which the leaflets are subjected throughout the cardiac cycle, thus enhancing the durability of the bioprosthesis. In our accelerated durability study for up to 2 equivalent years, no valve failure has been observed. More in vitro studies under pulsatile flow conditions, including color Doppler flow visualization, are currently being conducted.