Bridge to transplantation with the CardioWest total artificial heart: the international experience 1993 to 1995.

ABSTRACT

BACKGROUND: After reapproval by the Food and Drug Administration of the CardioWest total artificial heart for clinical investigation, an international study was started in January 1993 to ascertain the safety and efficacy of this device for bridging to heart transplantation. To date, 40 devices have been implanted in five centers. METHODS: Retrospective data collection from participating centers provided enough material for analysis of patient selection, patient survival, adverse events, and comparison with contemporary devices used for bridge to transplantation. RESULTS AND CONCLUSIONS: Twelve patients (30%) died after implantation and before transplantation after an average of 10.6 +/- 10 days of support. The major cause of death in this group was multiorgan failure. Twenty-eight patients (70%) were supported 36 +/- 36 days before transplantation. There were two deaths after transplantation (1 rejection, 1 multiorgan failure) leaving 26 patients (65% of the total patients and 93% of those who were transplanted) who survived to discharge from the hospital. There was one late death from rejection at one month post discharge. The mean survival time of the 25 surviving patients is 12 months. These results compare favorably with those of other contemporary devices used for bridge to transplantation.