Phase 1 Ex Vivo Studies of the Baylor/NASA Axial Flow Ventricular Assist Device

The Baylor/NASA ventricular assist device (VAD) is a small, electrically driven, valveless axial flow pump that is implantable inside the chest cavity. It is intended to assist a diseased heart. In the phase 1 study of this pump development program, the 2-day pump is intended to produce an assist device for cardiopulmonary bypass (CPB) application. The main focus of this phase of the program was to develop a pump which produced minimum blood trauma. Antithrombogenic features are planned to be incorporated into the phase 2 pump. In this phase 1 study, eight pumps were implanted paracorporeally in two calves as LVADs to assess hemolysis, pump performance, efficiency, and stability, the goal for this study being a 2-day implantation. The pump running times ranged from 18 to 203 (78.1 ± 23.7; mean ± SE) h. Plasma free hemoglobin levels were below 13.7 mg/di, except for one case complicated by inflow cannula obstruction due to pannus formation. Pump speed was maintained between 10100 and 11400rpm. Pump output ranged from 3.6 to 5.11/min. The electrical power required by the system ranged from 10.5 to 12.8W. No detectable organ dysfunction was noted and postmortem evaluations demonstrated no pump-related adverse effects in any of the calves. Thrombus deposition was observed mainly at the hub area and flow straightener. For the next series of experiments (phase 2), the thrombogenic regions in these subacute experiments should be eliminated.