Development of a totally implantable pulsatile centrifugal pump as a ventricular assist device

The Taita No. 1 ventricular assist device (T-VAD) is a totally implantable pulsatile impeller centrifugal pump driven by a magnetically suspended motor. The flow can achieve 2.01 +/- 0.17 L/min against a pressure of 100 mm Hg under 0.266 +/- 0.017 amp and 13.55 +/- 0.41 voltage. The speed was around 3,500 rpm. It consumed less than 6 W of power, resulting in less heat production and mechanical bearing complications. The impeller vane was designed to have both radial and axial curves according to the stream surface and stream lines to reduce thrombosis and hemolysis. Eight calves weighing 80 to 100 kg (mean 87 +/- 12 kg) were used for experiments. With the calves under general anesthesia, left posterolateral thoracotomy was performed to connect the inflow tube with the atrial appendage and to anastomose the outflow tube with the descending aorta. The calves usually awoke and stood up within hours after discontinuation of anesthetics. The mean survival of the calves was 75 +/- 42 days (range 33-148 days). The terminations of experiments were mainly due to infection. During the course of pumping, no significant deterioration of liver or renal function was noted. The evaluation of serum samples from the implanted calves indicated that hemolysis was not associated with use of the T-VAD. The average daily free hemoglobin level was 8.08 +/- 3.05 mg/dl, which was less than the set limit of 20 mg/dl. The red blood cell and platelet count and hemoglobin of implanted animals were within the normal range. In our results, the T-VAD provided competent pulsatile function without severe blood damage or organ dysfunction.