Design, manufacturing, and testing of a paracorporeal pulsatile ventricular assist device: São Paulo Heart Institute VAD.

This paper describes the design of a ventricular assist device (VAD), its manufacturing, and testing. The VAD presented is pulsatile, with a free-floating membrane, smooth internal surfaces, and pericardial valves. It comprehends also a pneumatic driving unit capable of operating in the "full to empty," EKG synchronized or asynchronous modes. In vitro tests were performed to assess its mechanical durability, hydrodynamic performance, and hemolysis. To optimize cannulas and implant techniques, we performed in vivo tests in 22 sheep and 8 calves. In these tests, we also evaluated hemolysis and the device's capacity to normalize hemodynamic parameters during induced cardiac failure. The VAD worked for 4,000 h without failure in a mock circulatory loop. In full to empty mode, it displayed a rate-mediated "Starling-like" performance. Optimum output was achieved with a systole duration of 40% of the cycle. The in vitro hemolysis index (IH) was 6.7 +/- 2.1. Hemolysis in animal experiments was clinically nonsignificant. In calves with induced cardiac failure, the VAD was able to normalize hemodynamic parameters within 120 min.