Development of a ventricular assist device for out-of-hospital use

Background: Success with temporary ventricular assist devices, has prompted interest in devices developed for long term use outside of the hospital se tting. Methods: A totally implantable intrathoracic electro-hydraulic ventricular assist device has been developed. Design focused on providing the recipient with a near normal quality of life. To meet this goal the system utilizes transcutaneous energy transfer and biotelemetry to eliminate percutaneous d rive-lines/cables as well as a displacement chamber capable of pressure equ alization to atmospheric pressures, so as to eliminate the need for percuta neous venting. An implanted battery provides backup power to allow the reci pient the ability to bathe, shower, or swim without connection to an extern al power source. An integrated telemedicine capability allows the device to be monitored/controlled remotely, using telephone lines. Results: The system has been tested in vitro with early prototypes running for up to 5 1/2 years. The system was studied in calves (n = 25) with durat ions of support of up to 30 days, demonstrating the ability of the device t o function as a totally implantable device without percutaneous connections . Conclusions: The various in vitro and in vivo studies have demonstrated the feasibility of the totally implantable device. Chronic in vivo experiments will follow in preparation for regulatory submissions for human use.