The HeartSaver left ventricular assist device: an update.
BACKGROUND
Ventricular assist devices have been shown to be effective as bridges to transplantation and recovery for patients with end-stage heart failure. Current technology has been limited because of the need for percutaneous connections with controllers. The HeartSaver ventricular assist device (VAD) (World Heart Corporation, Ottawa, Ontario, Canada) was developed with the intention of having a completely implantable, portable VAD system. The 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 version being available for in vitro (mock loop) and in vivo (bovine model) testing.


RESULTS
Seventeen Series II devices have been functional on mock loops or other testing trials for an accumulated 900 days of operation. There have been 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 transmission through various skin thicknesses and pigmentation; and (4) improved reliability of internal and external controller hardware and software.


CONCLUSIONS
Modifications have been required to optimize the HeartSaver VAD's performance. The final HeartSaver VAD design will be produced in the near future to allow for formal in vitro and in vivo testing before clinical implantation.
Hendry
P J
PJ
Division of Cardiac Surgery, University of Ottawa Heart Institute, Ontario, Canada.
Mussivand
T V
TV
Masters
R G
RG
Bourke
M E
ME
Guiraudon
G M
GM
Holmes
K S
KS
Day
K D
KD
Keon
W J
WJ
D000818:Animals; D004867:Equipment Design; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D019919:Prosthesis Implantation / Q000379:methods