• Historical Example of Surgical Innovation 3: Live Liver Graft Transplantation into Adults

The groundwork for liver graft transplantation into adults developed from preliminary techniques designed for pediatric cases. In the 1980s, even the leading US liver transplantation teams working reported mortality rates of 20 to 30 percent for pediatric cases awaiting liver transplants. Progress in innovative surgical techniques such as reduced-size and split-liver cadaveric grafts began to improve the situation somewhat, but did not eliminate the risk of mortality for children on liver transplant waiting lists. In 1989, a team of surgeons in Australia accomplished the first successful transplantation of a liver from a living donor to a child, spurring a formal clinical trial in the United States that had IRB approval. Results from this study were so favorable that several liver-transplantation programs in the United States, Europe, and Asia began performing transplantations of liver grafts from living donors into selected children. The procedure has since been considerably improved through technical modifications, with over 1500 successful surgeries performed by 2001. Moreover, the fraction of graft survival at one year has increased substantially from 74 to 94 percent, and the risk of mortality prior to surgery has been significantly reduced.

In 1991, the first liver transplantation in an adult using a graft from a living donor was conducted as an emergency procedure at the University of Chicago. As with the pediatric operation, this application has crept relatively rapidly into a number of pilot studies that include adult liver graft recipients. Unfortunately, the function of this procedure carries additional concerns not present when the procedure is used in pediatric cases, namely:

1. Agreement on which technique that offers the greatest efficacy and lowest risks for donor and recipient has not been established
2. Diagnostic criteria for the procedure have not been clearly identified or standardized
3. IRB review of the protocol used in various studies has been subject to inconsistent standards for approval

The relatively rapid adaptation of liver graft procedures from living donors to adults as a focus of surgical research is troubling because it represents an innovative procedure that has not yet been standardized and accepted. Further, the procedure inherently places two people at risk, one of which is otherwise healthy. Graft donors receive no medical benefit from undergoing the transplantation, however, their health is threatened by risks that are difficult to quantify or predict. The lack of technical uniformity increases the risks that depend on the skills of their particular surgeon performing an operation that may have a morbidity rate as high as 50 percent. Any conceivable psychological benefits to be gained by donation are difficult to rationalize considering the ultimate risk for these individuals is death.

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