Assessment of a new silicone tri-leaflet valve seamlessly assembled with blood chamber for a low-cost ventricular assist device.

We have developed a practical, low-cost ventricular assist device (VAD) comprising a newly designed blood chamber with a silicone lenticular sac and two silicone tri-leaflet valves (STV), made en bloc. This new VAD is seamless, can be made cost-effectively and assembled with the blood chamber and valve as one body. This novel design should reduce the incident of thrombus formation because of the absence of a junction at the connecting ring and because of the use of flexible silicone materials which have both antithrombogenecity and biocompatibility. In in vitro hemodynamics testing, a batch of 3 consecutively manufactured VADs with STVs underwent hydrodynamic functional testing. These showed less regurgitation, a lower value of water hammer phenomenon, and a slightly greater pressure gradient across the valves than a mechanical valve (MV) [Björk-Shiley monostrut valve]. The flow and pulsatile efficiency were adequate and similar to that of a VAD with MVs. In in vitro durability and hemolysis tests, a VAD with STV functioned well for 54 days and showed similar hemolytic profiles to a VAD with MVs. In an in vivo acute experiment using an adult sheep, our device was problem-free providing sufficient output as a left ventricular assist device (LVAD). Although it will be necessary to decrease the pressure gradient across this STV in the future, our device showed efficient performance as a practical land cost-effective VAD for short term use.