Living Donor Liver Transplantation: How Can We Better Protect the Donors?

The article by Yamamoto and co-workers in this issue of Transplantation (1) again highlights the need for continuing reassessment of living-donor liver transplantation (LDLT): how can we improve the outcome for both donor and recipient and how can we avoid disastrous complications as reported here? We would like to recommend (again) that a registry of living donor complications be established in order to prospectively and retrospectively monitor donor outcomes. Would a registry prove to be helpful or would it be yet another costly nuisance in the already highly regulated field of organ transplantation? It is now 12 years since the first LDLT utilizing the right lobe was performed. Over this period, there has been tremendous development regarding its technique, the indications for the procedure, and the selection of the donors. So what would a registry improve? Before the widely publicized death in New York City, there were only anecdotal reports about deaths or the need for liver transplantation following the donor procedure. The Vancouver meeting then reported 14 deaths worldwide in approximately 7,000 LDLT procedures (2). A total of 19 donor deaths and one donor in a chronic vegetative state from a total of 2,087 LDLTs were reported at the 2006 World Transplant Congress in Boston (3). Although four of these were judged to be unrelated to the partial hepatectomy, the mortality is still about 0.5% for right lobe and <0.1% for left lateral and left lobe donation by a previously healthy individual. In the United States, 3,066 liver transplants with organs from living donors have been performed. Three donors died shortly after the procedure and three more in the two years following donation, but possibly still related to the procedure. Recognizing the importance of a more systematic evaluation of this issue, the United Network for Organ Sharing has implemented a policy that the death of a liver donor or the need for transplantation following living donation is a reportable event to the Organ Procurement and Transplantation Network (4). However, in addition to these short-term complications, we need information about long-term outcome in the live liver donor, medical problems that could arise years after donation, physically and psychologically. What is the rate of bile duct strictures five years out, or the incidence of bowel obstruction due to adhesions? The rate of incisional hernias is also unknown, but it appears to be unusually high possibly due to the initially impaired protein-synthesis by the regenerating liver. Is there a significant rate of posttraumatic stress disorder in the live liver donor? There have been rare reports in the literature (5). Should a pre- or intraoperative liver biopsy be done, and what is its usefulness? A registry would record techniques and outcomes from different institutions, and could help facilitate multicenter studies and research efforts. How much more useful data would be generated and be available to the public! Hazardous techniques would be more quickly identified and working guidelines established (e.g., best method for bile duct reconstruction). Another advantage would be the value of this registry as a marketing tool for the participating centers. Those forming this new living-donor network of reporting results would presumably represent a large percentage of all LDLT procedures in the United States. More patients would be attracted to a center that is participating and following general guidelines than to an isolated, low-volume center drawing on the experience of a few transplants per year. One important caution might be: could a registry possibly have a negative effect, limiting the availability of living donor transplantation? The publicity that stimulated the state-imposed governance in New York in 2002 led to a drastic decrease in LDLT procedures, from 155 performed in Region 9 in 2001 to 76 in 2002 (51%). In the same timeframe, LDLTs performed in the rest of the United States fell less dramatically from 364 to 287 (21%), also influenced by the negative publicity and uncertainty that followed this donor's death. Interestingly, Region 2, neighboring Region 9, experienced an even lower decrease in numbers in 2002, only 17% (donation 38 in 2002, down from 46), apparently absorbing patients due to the difficult political situation in Region 9. Therefore, it appears that the imposition of overly stringent, politically defined regulations following a major complication is more likely to restrict full exploration of the potential of LDLT. The transplant community would be better served by preemptively establishing its own oversight process before another donor death (which statistically is inevitable) further disillusions public opinion and trust and encourages less helpful federal- and state-imposed regulations. Who then should lead and oversee the registry? Ideally, all transplant centers submitting data should have a voice in determining the quality and quantity of data collected. A committee would be elected to oversee the development of a data collection program (existing concepts and software could be adjusted to the specific situation). Transplant centers would give permission for a central agency to contact their donors in follow-up or report outcome measures via their own data managers. Unfortunately, perhaps the most crucial question is: how would the registry be funded? Previously recommended registries have been judged by government agencies to be not cost-effective. Perhaps a cost-sharing process could be established. Similar to the United Network for Organ Sharing, where every transplant center registration of a transplant candidate requires a fee to be paid, hospitals and government might co-pay the costs required to enter donors into the database. It is also likely that a registry could attract industry sponsors, who would probably welcome the opportunity to support a process designed to save lives by helping to uncover dangerous practices early. A crude estimate would be that two data managers would have to be employed, at an annual cost of US $50,000 each. About 320 LDLTs are performed annually in the United States. A fee of US $500 per donor would be enough to initiate the program. It is clear to us that dedication rather than goodwill are needed to initiate this registry, the unfortunate alternative being the next donor death producing severe damaging effects on public trust, if there is the perception that inadequate surveillance was instituted following the previous deaths.

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