Managing a Scarce Resource in Pediatric Liver Transplantation

Maximize Donation

At a basic level, transplantation systems operate like any other market with supply and demand. Globally, all systems must address the fact that demand outstrips supply. Efforts toward increasing supply are constantly underway, maximizing donations of organs and thus limiting waitlist mortality. Early in this process is the acceptance of the public to contribute to the transplant system by becoming an organ donor, either as a living donor or after death. The United States operates on an opt-in system with the assumption that one cannot presume consent without direct expression. Members of the public register to become donors when applying for a driver’s license at the Department of Motor Vehicles or directly to their state’s donor registry via public awareness drives or their own initiative. Despite these geographical and sometimes inconsistently applied efforts, demand continues to outpace supply in the United States. Countries such as Spain, Austria, and Chile have transitioned to a system of presumed consent for organ donation. In Chile, for example, this was initially a simple opt-out at the time of renewing a driver’s license, but in 2013, Chile amended the Organ Donor Act, which both required a notarized statement to become a nondonor and made donors prioritized for transplantation. Although there are many differences between countries that choose opt-in versus opt-out systems, based on a 2014 study by Shepherd et al. that analyzed 48 different countries’ transplantation rates, there is a general increase in the number of liver and kidney transplants in countries that choose an opt-out system.

Whether a system chooses opt-in or opt-out, the public still needs to consent without coercion to participate in organ donation. This requires addressing the incentives for a population to choose to participate while avoiding the excessive monetization that can place vulnerable populations at risk. In 2008, Israel passed two laws, the Brain-Respiratory Death Law and the Organ Transplantation Law, in an attempt to improve organ donation rates in the country. Those who give consent to donate organs after their death, living donors, and first-degree relatives (at variable levels) are given priority allocation. This has resulted in an increase in donation in Israel from 7.8 in 2008 to 11.4 donors per million population in 2011 as well as registered donors and those who consent for donation. Although the increase in donations should be celebrated for the benefit to waitlist recipients, there are still ethical considerations under debate. For example, does the law give an advantage to the highly educated, who would be more aware of the new law? To combat this dilemma, Israel engaged in a public education campaign to make sure its population was fully aware of the changing laws.

Additionally, a system must remove disincentives so that potential donors do not opt out because of the excessive burden from altruistic living donation. The 2008 Israeli laws included clauses that addressed earning loss reimbursement, fixed-sum transportation refund, reimbursement for 7 days of recovery, 5 years' reimbursement of medical/work capability loss/life insurance, and reimbursement of psychological consultations and treatments following donation. This led to an increase in living kidney donation from 71 total cases in 2010 to 117 in 2011. The removal of disincentives is important but must be balanced to avoid undue compensation, which we will discuss later.

Simply having incentives and removing disincentives is not enough if the public is not aware of a system’s efforts to improve. Education and public awareness programs are key to gain the trust of a population to donate. At the same time Israel was changing its incentives, Australia established the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 and created the Organ and Tissue Authority government agency in 2009. This agency developed the DonateLife program to educate the public alongside several grassroots efforts to work together and make reforms to the Australian transplant system. Although this has improved donation rates from 11.9 donors per million people in 1990 to 14.9 donors per million people in 2011, a single change is not enough to transform a national transplant system, and local opinion holds that there is still more work to be done. Additionally, effective education needs to evolve over time as the methods used to spread information and misinformation change. Social media and web-based applications have dramatically changed how the public obtains information and communicates, but they have varying levels of engagement in the medical community despite their ubiquity among potential donors and recipients.

Several efforts are also underway to expand the available donor pool beyond the ideal healthy young donor. Extended criteria donors (ECD) include donations after circulatory death (DCD), steatotic allografts, high-risk behavior, advanced age, and multiple comorbidities. In the United States, The Joint Commission (the primary US healthcare-accrediting organization) requires that transplant programs develop DCD policies to increase their use. In India, the majority of deceased donor grafts are ECD with very acceptable outcomes. Scoring algorithms such as the United Kingdom DCD Risk Score can help identify ECD that carry a relatively lower risk of ischemic cholangiopathy or primary graft nonfunction. Grafts with stage 1 or 2 fibrosis have been shown to have acceptable long-term patient survival. Additionally, domino donation for specific conditions, such as maple syrup urine disease, allows for increased organ donation without the risk of recurrence in the domino recipient. Various treatment modalities are being developed to limit the risk of complications. With the availability of effective direct-acting antiviral agents with excellent safety profiles, hepatitis C is no longer an absolute contraindication to organ donation, although the high financial burden of these medications may limit their widespread use.

Deceased donors are one side of the equation. Living directed and undirected liver donations are also used at variable rates between countries. These donations can be further classified into living related, emotionally related, and altruistic donors. In the United States, living donation is increasing every year but remains a fraction of the total performed liver transplants. In Japan, however, the reverse is true, with living donation representing the vast majority of liver transplantation in adults and children. These differences are the result of complex intersections of culture, public knowledge, legislation, and health system infrastructure resulting in different approaches to fit the needs of the particular population. The vast majority of these organs come from related donors such as parents to children. Altruistic donation from unrelated donors is performed, but the degree of risk assumed by the donor makes this practice controversial and, if not carefully monitored, open to abuse. Should living donation fail, families may be reassured that deceased donation is still available as a backup, often as a status 1A priority, depending on the transplant system. Careful planning must take place to limit this, as live donation transplant failure will further stress the already scarce deceased donor pool.

Potential living donors inherently assume a higher degree of risk in transplantation because they do not receive any benefit from the removed organ. Strategies to maximize donation need to be made with efforts to protect vulnerable populations who are at potential risk by unfair systems. This is especially true in pediatrics where the population cannot always speak with its own voice or have access to advocacy. Additional high-risk groups include those with limited education, limited capital, and prisoners. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism helps provide guidance on minimizing some of these risks.

Unethical practices of organ donation monetization and the use of capital prisoners highlight these high-risk groups, with opposition stemming from the long-felt aftermath of historic abuses. There remains, however, a continued call for reasoned ethical debate about donation monetization and the use of capital prisoners. These arguments support the use of the context of a country’s own culture with appropriate checks and balances. Marketplace models have been developed to show how monetary incentives could help bridge the gap between the number of donations and those on the waiting list. Arguments have been advanced that an ethically run and legal commercial marketplace could reduce the incentive to use a violent and coercive illegal market.