Chronic in vivo evaluation of an electrohydraulic total artificial heart.

Abstract

Development of the Abiomed total artificial heart (TAH) designed for human use is progressing. Implant durations of longer than 60 days have been achieved in calves. The device consists of blood pumps, valves, and a hydraulic atrial flow balancing chamber fabricated from polyetherurethane. The energy converter, a centrifugal hydraulic pump with a rotary fluid switching valve, is positioned between the blood pumps. In two consecutive chronic in vivo studies (47 days and longer than 60 days), cardiac output was maintained in excess of 8 l/min. The atrial flow balancing chamber maintained a mean right-to-left pressure gradient of 7.5 and -1.4 mmHg in each respective study. There were no pulmonary complications. Platelet counts, fibrinogen concentrations, and hematocrit values returned to baseline levels within 20 days, whereas bilirubin, serum glutamic-oxaloacetic transaminase, blood urea nitrogen, and creatinine levels returned to normal within 1 week of implant. After the first post-operative day, plasma free hemoglobin levels of less than 10 mg/dl indicated no device-related hemolysis throughout the duration of the studies. At explant (47 day study), pathologic analysis showed no renal infarcts, no tissue necrosis, and no thermal damage. The device was fully encapsulated by 2-4 mm thick fibrous connective tissue. A newly designed textured-to-smooth surface inflow showed no signs of pannus ingrowth or thrombotic complications. These studies demonstrate that this TAH is suitable for long-term implantation.