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Organ Donation in the Era of the Opioid Crisis: A Clinical Strategy to Maximize Transplantation

Glazier, Alexandra K. JD, MPH1; Delmonico, Francis L. MD1,2,3; Koh, Howard K. MD, MPH4,5

doi: 10.1097/TP.0000000000001878
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1 New England Donor Services, Waltham, MA.

2 Harvard Medical School, Boston, MA.

3 The Massachusetts General Hospital, Boston, MA.

4 Harvard TH Chan School of Public Health, Boston, MA.

5 Harvard Kennedy School, Cambridge, MA.

Received 22 March 2017. Revision received 17 June 2017.

Accepted 29 June 2017.

The authors declare no funding or conflicts of interest.

All authors equally contributed to writing this article.

Correspondence: Alexandra K Glazier, JD MPH, New England Donor Services, 60 First Ave, Waltham, MA 02541. (aglazier@neds.org).

The surge in overdose deaths from opioid addiction gripping the United States has collided with another major health crisis, the pressing need for lifesaving organ transplantation. In 2015, an all-time high of over 33 000 have died from opioid overdoses.1 Concurrently, 9% of patients in the United States awaiting kidney transplants, 17% of liver transplant candidates and 20% of heart transplant candidates died on waiting list, or were removed from them, because they became too sick to benefit from transplant.2 The intersection of these 2 crises presents a grim irony—drug-related deaths could increase organ availability but also carries transmission risk of transplantation-related infections.

However, careful utilization of organs from potential donors that have died of drug overdose can leverage the benefits of transplanting organs from such increased-risk donors over the risks of no transplantation at all.3,4 Of the nation's 58 organ procurement organizations, New England Organ Bank (NEOB), now affiliated under New England Donor Services, has been in the forefront of addressing the challenge of maximizing organ procurement in this setting.5 This report describes a clinical strategy that maximizes outcomes in the era of the opioid crisis.

New England represents a current epicenter of the opioid epidemic. With the regional rise in the opioid epidemic for more than a decade, NEOB, which coordinates organ donations covering a population of 12 million and involving over 150 hospitals, has implemented with its transplant centers a clinical strategy for assessing organ suitability and maximizing availability of organs for transplantation. The strategy involves 4 parts:

  • (1) Updated guidelines for donor risk identification
  • In the context of the growing drug epidemic, NEOB implemented the 2013 US Public Health Service (PHS) Guidelines that updated formal categories for identifying donor factors of increased risk. Previously focused only on risk factors for human immunodeficiency virus (HIV) transmission, the PHS guidelines now additionally identify behavioral risk factors—such as intravenous (IV), intramuscular, or subcutaneous drug use for nonmedical reasons in the preceding 12 months—associated with recent exposure to hepatitis B virus (HBV) and hepatitis C virus (HCV).6
  • (2) Nucleic acid testing (NAT) of donors
  • After identifying potential organ donors in the increased-risk category as per the PHS Guidelines, NEOB routinely coordinates NAT testing to determine not only viral antibodies but also the presence of the virus itself. Doing so reduces the window between the time of exposure to, and detection of, HIV, HCV, and/or HBV from several weeks to less than a week.7
  • (3) Recipient informed consent
  • At the time of organ allocation, NEOB conveys all known information regarding the donor's assessed increased risk to transplant centers. In turn, as part of the informed consent process, centers must communicate that information to any intended recipient. This regulatory and policy requirement8 is a key part of the process to ensure candidates understand risks both of accepting organs from donors that meet PHS guidelines, but importantly, understand the risk of declining available organs from that donor pool.
  • (4) Treatment of donor-derived infections

Steady treatment developments have made HIV manageable and HCV curable.9 Transplant programs in the NEOB region use clinical developments that allow successful treatment of transplant recipients who contract donor-derived infections, as needed. This treatment advance changes the risk-benefit analysis significantly.

NEOB formalized this 4-part strategy to maximize the transplant benefit that can be realized from increased-risk deceased donors generally and donors that died of an overdose specifically. After the potential recipient, informed that the donor meets increased risk criteria, provides consent to proceed, transplantation can follow if donor NAT tests are negative. Even with positive NAT results, transplantation can proceed if the recipient has previously been exposed to the detected donor virus or has a risk of death without transplant that exceeds the risk of donor-transmitted infection. The first-ever U.S. transplant of an HIV+ organ into an HIV+ recipient (2016), after passage of the 2013 HIV Organ Policy Equity Act, represents a dramatic example of the risk-benefit analysis in a modern-day donor.

This approach does not completely assure against unintended infection transmission. A donor with increased risk factors can come with recent and undetectable donor infection at the time of fatal overdose injection that is within the window for viral detection.7 For HCV, for example, national studies note that when standard serology plus NAT are used to screen potential donors, the average risk of unintentional transmission is 0.001% (10.89 per 10 000)10 from donors that are identified in any category of PHS increased risk and 0.00019% (0.199 per 10 000) from donors that do not have PHS increased risk factors.10 Also, within increased risk donors, the subset with a history of IV drug use have the highest relative risk of an unexpected HCV transmission after standard serology and NAT testing at 0.003% (37.8 per 10 000).10 Understanding the risk, as part of implementing this clinical strategy, helps avoid discarding potentially lifesaving organs, allowing organ procurement organizations, transplant centers, and patients to continue to maximize every donation opportunity.4

In pursuing such a strategy, NEOB documented a 254% increase (from 26 [2012] to 92 [2016]) of organ donors who died of a drug overdose (Figure 1). The prevalence of IV drug use grew from 13% of NEOB donors (2012) to 23% (2016). That population contributed to the total number of organ donors in the region growing by more than 100 (from 217 to 338), resulting in nearly 300 additional transplants. Significantly, NEOB also reports 224 organ transplants (2012-2016) from donors with identified HCV+ at the time of organ allocation. This represents a 300% increase of HCV+ organ transplants from HCV+ donors coordinated by NEOB (Figure 2). The characteristics of the NEOB organ donors that died of a drug overdose during this period are young (average age, 33 years), male (60%), and white (86%), reflective of what has been reported in the national data.5

FIGURE 1

FIGURE 1

FIGURE 2

FIGURE 2

In the NEOB experience, out of 1132 organ transplantations from increased-risk donors (2012-2016)—which includes the pool of donors with a history of IV drug use as well as donors who met other increased risk categories in the PHS guidelines—only 2 cases of unintentional HCV transmission have occurred. In both cases, the donors died of an overdose and were categorized as increased risk by PHS criteria; 1 case had been found with an IV needle in the arm with a history of IV drug use, and the other died of an oral opioid overdose and a medical/behavioral history could not be obtained. Later determinations confirmed that the negative donor sample was drawn within the window when the virus could not be detected even by NAT. The infected recipients are currently being treated with potentially curative HCV therapy.

Dedicated efforts to address the opioid addiction crisis must continue. However, with the demand for lifesaving organs steadily outpacing supply, this new chapter in organ transplantation should also proceed, guided by constant analysis of risk versus benefit. The devastation of the opioid crisis has an unexpected silver lining in the form of deceased organ donation, proof that with a clear clinical strategy, a lifesaving legacy can emerge from what is otherwise a national tragedy.

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REFERENCES

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