Abstract
The authors have been developing a centrifugal pump with a magnetically suspended impeller (MSCP) designed for total artificial heart and long-term ventricular support. The MSCP consists of a magnetic bearing, an impeller and housing, and a driving motor. The impeller is suspended by a magnetic bearing, therefore providing contact free rotation of the impeller inside the pump. This study was designed to evaluate long-term durability and nonthrombogenicity of the MSCP in a chronic sheep model. The blood contacting surfaces of the pump and conduits were completely modified by a heparin immobilization technique (Hepaface). The MSCP was placed paracorporeally as a left heart bypass between left ventricle and descending aorta in three adult sheep. Coumadin was given orally to maintain prothrombin time at 15-20 sec. The coagulation and hematologic parameters, including plasma free hemoglobin, were periodically monitored throughout the experiment. Under daily movement in the cage, the pump could produce average flow rates of 3-6 L/min (50-100 ml/kg) at 1,700-2,000 rpm. Although the arterial pulse contour decreased, there was no physiologic deterioration. The axial impeller excursion monitored by a position sensor was < 25 microns. Plasma free hemoglobin level remained at < 5 mg/dl throughout the experiment. There was no increase in the motor current, which indicates no massive thrombus formation around the impeller. One experiment was terminated at 70 days due to Hall sensor dysfunction of the motor. The retrieved pump was entirely free from thrombus formation. There was no detectable thrombus formation inside the pump or the inflow and outflow conduits. Hematologic, renal, and hepatic parameters remained within the normal range throughout the experiment. The other two sheep have survived for more than 395 and 41 days without major complication. These studies demonstrated that the MSCP has significant potential for long-term use.
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