Transplantation using organs from living donors has resulted in a significant increase in the overall number of solid organ transplant procedures worldwide. In this context, it is notable that living donation accounts for more than 50% of the kidney transplants undertaken in the US in the last decade and that living kidney donation is rapidly increasing to similar levels in other countries. In contrast, living donation has only marginally impacted on the overall number of transplants undertaken for other solid organs such as liver, pancreas, lung and intestine. Still, even if the number of the latter procedures represents less than 1% of the overall number of transplants made possible with the use of living donors, they are an invaluable source of organs for patients in terminal organ failure.
However, for living donation to progress successfully and possibly further expand, all the steps must be in place to ensure that these procedures take place in the context of the existing regulatory frameworks and that all the fundamental ethical principles are applied. Furthermore, efforts must be made to minimize the risk of undesirable events in the donor and to maximize the benefit to recipients.
Indeed, undesirable events have been reported following live organ donation. These vary widely among organs in terms of type, time of onset, severity and incidence that is estimated to be up to 28% in the case of liver transplantation. The risk of major complications is reasonably low. Still, living donation has been associated with fatal peri-operative events in the donor but also with later complications that may be mis- or under diagnosed and, ultimately, be inadequately treated with health consequences to the donors.
Several studies have now reported that living donor nephrectomy is associated with the risk of increased blood pressure, proteinuria and possibly end stage renal disease. Furthermore, although survival of living kidney donors is similar to that of the general population, it has been hypothesized that this may be due to the optimal [or even superior] donor conditions at the time of their donation.
Taken together, these observations unquestionably demonstrate that living organ donation is inextricably associated with some degree of risk to the donor health. In this light, the development of a set of recommendations to identify and correct any health issue in living organ donors is encouraged. This is essential in order to enable the safe expansion of living donation programs worldwide. Furthermore, recent studies suggest that living donors feel pressure to donate but don’t always fully understand the risks involved, thus efforts should be made to develop standardized informed consents .
- Living organs donor Registries should be developed in each country with ongoing transplantation programs, which entail the use of living donors. Registries should be
organ-specific and should report details on the donor characteristics, type of procedures and outcomes. Registries should be kept updated.
- A centralized supra-national organ-specific database should be considered.
- A task force of international experts in live organ donation should be constituted [one for each organ]. These experts should convene annually to review the data collected
in the registries. This task force should preferably be operating under the guidance/”umbrella” of the WHO.
- Long-term clinical follow up of any live organ donor should be mandatory and implemented according to standards/principles internationally agreed upon that clearly
indicate timing and type of investigations to be conducted after live organ donation
- Consideration should be given to developing a standardized informed consent for each organ type in order to provide donors the best information on risks.
- The donor follow up should be conducted throughout the donor lifespan and should continue with the same meticulousness irrespective of the outcome of the transplant
itself. A strategy should be identified to ensure that no patient is lost during follow up.
- Donor follow up should be provided free of charge and without “logistic burden” (i.e.: if the donor moves to another area or country, access to free healthcare in the new
location should be provided)
- Identification of adverse events should be thoroughly documented. If severe, they should be timely reported to national health authorities, the [organ-] specific task force
of international experts, and to those responsible for updating registries. If deemed necessary, the task force of international experts may decide to convene to specifically
analyze the problem arisen.
- In conjunction with the WHO, the task force of international experts may release reports or documents to be distributed to National Health Authorities to possibly recommend
measures that may have to be put in place as a consequence of the reported adverse event.