Evolution of an electrohydraulic ventricular assist device through in vivo testing. The EVAD Team.

Abstract

A totally implantable intrathoracic electrohydraulic ventricular assist device has been developed at the University of Ottawa Heart Institute. In vivo testing has been instrumental in its progressive development. A total of 15 experiments (4 acute, 11 performance) have been performed using male calves (62-117 kg). Data from the acute experiments, human fit trials, fluid dynamic studies, and hydraulic/energy efficiency analyses formed the basis for the development of a compact, single piece ventricular assist device called the Unified System in which the volume displacement chamber, motor, and blood chamber are housed within a compact 600 cc, 740 g unit. The performance experiments indicated that the unified system could support calves for periods up to 96 hr. The mean postoperative cardiac output was 7.1 +/- 0.7 L/ min (range = 4.9-11), mean blood pressure was 99.7 +/- 5.8 mmHg, and mean pulmonary artery pressure was 32.1 +/- 1.2 mmHg. The operative technique for intrathoracic implantation has been developed. The major problems encountered were of respiratory failure, improved by device repositioning in the calf; decreased blood inflow to the device that was improved by cannula redesign; circuit board fracture corrected by design modification; and a power supply problem that was limited to a single unit. The preliminary experiments have helped in the design modifications of the Unified System. The improved version of the system will undergo formal performance, reliability, and chronic in vivo testing before human implantation.