PROGRESS IN THE DEVELOPMENT OF A TRANSCUTANEOUSLY POWERED AXIAL-FLOW BLOOD PUMP VENTRICULAR ASSIST SYSTEM

Development of the Jarvik 2000 intraventricular assist system for long -term support is ongoing. The system integrates the Jarvik 2000 axial flow blood pump with a microprocessor based automatic motor controller to provide response to physiologic demands. Nine devices have been ev aluated in vivo (six completed, three ongoing) with durations in exces s of 26 weeks. Instrumented experiments include implanted transit-time ultrasonic flow probes and dual micromanometer LV/AoP catheters. Trea dmill exercise and heart pacing studies are performed to evaluate cont rol system response to increased heart rates. Pharmacologically induce d cardiac dysfunction studies are performed in awake and anesthetized calves to demonstrate control response to simulated heart failure cond itions. No deleterious effects or events were encountered during any p hysiologic studies. No hematologic, renal, hepatic, or pulmonary compl ications have been encountered in any study. Plasma free hemoglobin le vels of 7.0 +/- 5.1 mg/dl demonstrate no device related hemolysis thro ughout the duration of all studies. Pathologic analysis at explant sho wed no evidence of thromboembolic events. All pump surfaces were free of thrombus except for a minimal ring of fibrin, (similar to 1 mm) on the inflow bearing. Future developments for permanent implantation wil l include implanted physiologic control systems, implanted batteries, and transcutaneous energy and data transmission systems.