Current Status and Future Directions for a Total Artificial Heart with A Past

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The total artificial heart (TAH) now known as the CardioWest was the product of work in Dr. Willem Kolff's laboratory at the University of Utah. It made a clinical debut in the early 1980s as a permanent device, the Jarvik-7 TAH. In the mid 1980s, it was used successfully as a bridge to transplantation as the Symbion TAH. Sufficient data from that experience documented its safety and efficacy; however, regulatory issues led to the loss of its investigational device exemption (IDE) in January 1991 and the subsequent halt of all implants in the U.S.A. and significant diminution of them in Europe. Our hypothesis, based upon work accumulated up to that time, was that this device had sufficient merit in terms of functional characteristics and previous documentation to be useful as a short-term bridge to transplant and as a longer term circulatory support device, especially because of its proven portability. We thus set out to reinstate the IDE and re-study the same device, now named the CardioWest TAH. As of January 1993, a new IDE study was begun with accompanying collaboration with U.S., Canadian, and French teams. Since then, we have completed our IDE study and generated 114 implants. In the national study, 25 of the 27 implanted patients (93%) were transplanted, and 24 were discharged (89% of the total; 96% of those transplanted). Compared with a series of 18 matched control patients with a discharge rate of 39%, the discharge rate of patients treated with the CardioWest was significantly better (p < 0.00001). In our own institutional experience, 24 patients were implanted, 1 remains on the TAH, 19 of 23 (83%) were transplanted, and 19 were discharged (83% of the total and 100% of those transplanted). Finally, worldwide, there have been 114 implants of the CardioWest TAH with 72 transplanted (63%) and 66 discharged (58% of total and 92% of those transplanted). Implant times have been as long as 186 days. Work is underway to readapt the Heimes driver, a camera case sized portable pneumatic driver, to the TAH. Given the efficacy and durability of the device and the potential of portability, the future for out of hospital living with this device appears more realistic than ever.

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