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Bridge to transplantation with the CardioWest total artificial heart: the international experience 1993 to 1995
J G Copeland1, A Pavie, D Duveau
1Cardiothoracic Surgery, University Heart Center, Tucson, AZ 85724, USA.
Insights
The CardioWest total artificial heart effectively bridges patients to heart transplantation, with 65% surviving hospital discharge. This device shows favorable outcomes compared to other bridge-to-transplant options.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Transplantation Medicine
Background:
- The CardioWest total artificial heart received Food and Drug Administration reapproval for clinical investigation.
- An international study commenced in January 1993 to evaluate its safety and efficacy.
- Forty devices were implanted across five centers for bridge-to-transplant purposes.
Purpose of the Study:
- To ascertain the safety and efficacy of the CardioWest total artificial heart.
- To evaluate its role as a bridge to heart transplantation.
- To compare its performance with contemporary bridging devices.
Main Methods:
- Retrospective data collection from participating international centers.
- Analysis of patient selection criteria.
- Evaluation of patient survival, adverse events, and outcomes.
Main Results:
- 30% of patients (12/40) died before transplantation, primarily from multiorgan failure.
- 70% of patients (28/40) received transplantation after an average support of 36 days.
- 65% of all patients (26/40) survived hospital discharge, with 93% of transplanted patients surviving.
Conclusions:
- The CardioWest total artificial heart demonstrates favorable survival rates for bridging patients to heart transplantation.
- Multiorgan failure was a significant cause of mortality in patients not reaching transplantation.
- Long-term survival in this cohort reached a mean of 12 months for survivors, comparing well with other devices.
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.