The CardioWest total artificial heart bridge to transplantation: 1993 to 1996 national trial.
BACKGROUND
We performed a controlled study of a total artificial heart in bridge to transplantation. We hypothesized that the CardioWest total artificial heart used in a selected population of decompensating cardiac transplantation candidates would result in improved survival compared with matched controls.


METHODS
The CardioWest trial started in 1993 in six United States institutions under an investigational device exemption from the Food and Drug Administration. Four centers contributed 27 implant and 18 matched retrospective control patients.


RESULTS
Of the implant patients, 25 (93%) received a transplant, 24 (89% of the total, 96% of those transplanted) were discharged and are currently surviving. In the control group, 10 patients died awaiting transplantation, 8 received a transplant, and 7 were discharged with 6 surviving (p = 0.00001). All adverse events were documented with respect to time. Thirteen serious adverse events occurred, 11 of which occurred in the 2 patients that died during implant.


CONCLUSIONS
In a selected group of patients with endstage heart disease, use of the CardioWest total artificial heart is lifesaving. When compared with the series of matched retrospective controls, a significant improvement in survival was found in the CardioWest implant group.
Copeland
J G
JG
Cardiothoracic Surgery and Artificial Heart Program, University of Arizona Health Sciences Center, Tucson 85724, USA. jgc@u.arizona.edu
Arabía
F A
FA
Banchy
M E
ME
Sethi
G K
GK
Foy
B
B
Long
J
J
Kormos
R L
RL
Smith
R G
RG
D000293:Adolescent; D000328:Adult; D005260:Female; D016027:Heart Transplantation / Q000009:adverse effects / Q000401:mortality; D006354:Heart, Artificial; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D012086:Reoperation; D015996:Survival Rate; D016896:Treatment Outcome