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Ann Thorac Surg 1998;66:1662-1669
© 1998 The Society of Thoracic Surgeons

The CardioWest total artificial heart bridge to transplantation: 1993 to 1996 National Trial

^a Cardiothoracic Surgery and Artificial Heart Program, University of Arizona Health Sciences Center, Tucson, Arizona, USA
^b Loyola University Medical Center, Maywood, Illinois, USA
^c LDS Hospital, Salt Lake City, Utah, USA
^d University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA

Accepted for publication May 20, 1998.

Address reprint requests to Dr Copeland, Cardiovascular and Thoracic Surgery, The University of Arizona Health Sciences Center, 1501 N. Campbell Avenue, Room 4402, Tucson, AZ 85724
e-mail: (jgc{at}u.arizona.edu)

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 end-stage 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.

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