Background. Ventricular assist devices have been shown to be effective as b
ridges to transplantation and recovery for patients with end-stage heart fa
ilure. Current technology has been limited because of the need for percutan
eous connections with controllers. The HeartSaver ventricular assist device
(VAD) (World Heart Corporation, Ottawa, Ontario, Canada) was developed wit
h the intention of having a completely implantable, portable VAD system. Th
e system consists of an electrohydraulic blood pump, internal and external
battery power, and a transcutaneous energy transfer and telemetry unit that
allows for power transmission through the skin. Control of the device may
be achieved locally or remotely through a variety of communication systems.
Methods. The device has been modified with the Series II preclinical versio
n being available for in vitro (mock loop) and in vivo (bovine model) testi
ng.
Results. Seventeen Series II devices have been functional on mock loops or
other testing trials for an accumulated 900 days of operation. There have b
een eight acute experiments using a bovine model to test various components
as they have become available from manufacturing. Mean pump output was 10.
4 +/- 1.1 L/min in full-fill/full-eject mode. Changes in the last 24 months
include (1) cannula redesign for better port alignment and integration of
tissue valves; (2) battery redesign to convert to new lithium-ion cells; (3
) optimized infrared information and electromagnetic inductance energy tran
smission through various skin thicknesses and pigmentation; and (4) improve
d reliability of internal and external controller hardware and software.
Conclusions. Modifications have been required to optimize the HeartSaver VA
D's performance. The final HeartSaver VAD design will be produced in the ne
ar future to allow for formal in vitro and in vivo testing before clinical
implantation. (C) 2001 by The Society of Thoracic Surgeons.