IN VIVO AND CLINICAL STUDY OF PHOENIX-7 TOTAL ARTIFICIAL HEART

Abstract

This paper concerned with results of implantation of the Phoenix-7 total artificial heart (TAH) in the growing calves. Experimental study had been conducted 41 times in 41 calves. All the calves could breathe, stand, eat and void by themselves in two hours after operation. The causes of death essentially included respiratory failure, sepsis, hemorrhage shock, thrombo-embolism, and multiple organ failure. Autopsy was performed in all deaths. The phoenix hearts were opened and examined. Blood morphology and blood chemistry were welt analyzed. Deformation of the red blood cells was found in most of the cases. Cell destruction, however, was not obvious. Besides, there was no evidence of red blood cell aggregation. Initial clinical experience was undertaken for a 46-year-old male who was in cardiogenic shock. The patient was indwelled with intra-aortic balloon counter-pulsation (IABP) and supported by extra-corporeal membrane oxygenator (ECMO) before the implantation. With IABP and ECMO, the patient's blood pressure was maintained at 90/60mmHg, but oliguria persisted with the complication of hemolysis. The patient was then implanted with the Phoenix-7 TAH and the condition was improved tremendously. With the TAH, the patient's blood pressure was maintained at 90∼100mHg / 40∼50mmHg. Cardiac output was adequately maintained at 4.2~5.8 Llmin by an operating model on modifying the parameters of driving air pressure for both the right and left hearts, heart rate and systolic ratio. The patient had been on the device for 15 days until a successful simultaneous orthotopic heart and heterotopic kidney transplantation from a suitable donor was undertaken.