BRIDGE TO TRANSPLANTATION WITH THE CARDIOWEST TOTAL ARTIFICIAL-HEART - THE INTERNATIONAL EXPERIENCE 1993 TO 1995

Background: After reapproval by the Food and Drug Administration of th e CardioWest total artificial heart for clinical investigation, an int ernational study was started in January 1993 to ascertain the safety a nd efficacy of this device for bridging to heart transplantation. To d ate, 40 devices have been implanted in five centers. Methods: Retrospe ctive data collection from participating centers provided enough mater ial for analysis of patient selection, patient survival, adverse event s, and comparison with contemporary devices used for bridge to transpl antation. Results and Conclusions: Twelve patients (30%) died after im plantation 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 be fore transplantation. There were two deaths after transplantation (1 r ejection, 1 multiorgan failure) leaving 26 patients (65% of the total patients and 93% of those who were transplanted) who survived to disch arge from the hospital. There was one fate death from rejection at one month post discharge. The mean survival time of the 25 surviving pati ents is 12 months. These results compare favorably with those of other contemporary devices used for bridge to transplantation.