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 artifi cial heart used in a selected population of decompensating cardiac transpla ntation candidates would result in improved survival compared with matched controls. Methods. The CardioWest trial started in 1993 in six United States institut ions under an investigational device exemption from the Food and Drug Admin istration. Four centers contributed 27 implant and 18 matched retrospective control patients. Results. Of the implant patients, 25 (93%) received a transplant, 24 (89% o f the total, 96% of those transplanted) were discharged and are currently s urviving. In the control group, 10 patients died awaiting transplantation, 8 received a transplant, and 7 were discharged with 6 surviving (p = 0.0000 1). All adverse events were documented with respect to time. Thirteen serio us adverse events occurred, 11 of which occurred in the 2 patients that die d during implant. Conclusions. In a selected group of patients with endstage heart disease, u se of the CardioWest total artificial heart is lifesaving. When compared wi th the series of matched retrospective controls, a significant improvement in survival was found in the CardioWest implant group. (C) 1998 by The Soci ety of Thoracic Surgeons.