Impact of US Public Health Service Increased Risk Deceased Donor Designation on Organ Utilization

Mathew R. P. Sapiano; Jefferson M. Jones; James Bowman; Marilyn E. Levi; Sridhar V. Basavaraju


American Journal of Transplantation. 2019;19(9):2560-2569. 

In This Article

Abstract and Introduction


Under US Public Health Service guidelines, organ donors with risk factors for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) are categorized as increased risk donors (IRD). Previous studies have suggested that IRD organs are utilized at lower rates than organs from standard risk donors (SRD), but these studies were conducted prior to universal donor nucleic acid test screening. We conducted risk-adjusted analyses to determine the effect of IRD designation on organ utilization using 2010-2017 data (21 626 heart, 101 160 kidney, 52 714 liver, and 16 219 lung recipients in the United States) from the Organ Procurement and Transplantation Network. There was no significant difference (P < .05) between risk-adjusted utilization rates for IRD vs SRD organs for adult hearts and livers and pediatric kidneys, livers, and lungs. Significantly lower utilization was found among IRD adult kidneys, lungs, and pediatric hearts. Analysis of the proportion of transplanted organs recovered from IRD by facility suggests that a subset of facilities contribute to the underutilization of adult IRD kidneys. Along with revised criteria and nomenclature to identify donors with HIV, HBV, or HCV risk factors, educational efforts to standardize informed consent discussions might improve organ utilization.


Since the emergence of the human immunodeficiency virus (HIV) epidemic, the US Public Health Service (PHS) has made recommendations to reduce the risk of HIV transmission associated with organ transplantation.[1–3] Historically, these recommendations included strategies to identify HIV-related risk factors among donors based in part on characteristics that have been recognized to be associated with transmission to recipients.[3] Recommendations also included laboratory testing of donors initially to detect anti-HIV antibodies, with additional testing added as technologies such as nucleic acid testing (NAT) have been developed.[1] In 2013, based on transplant-related transmission events and reports of poor recipient outcome from hepatitis B (HBV) and C (HCV) transmission, the PHS released a revised guideline to reduce the risk of unintended HIV, HBV, and HCV transmission through transplantation.[1] These recommendations were enhanced by recommending specific recipient informed consent, expanded donor HCV (anti-HCV antibody and NAT) and HBV (surface antigen and core antibody) laboratory screening, and recipient monitoring for evidence of disease transmission. The recommendations were not intended to restrict transplantation but to facilitate appropriate donor laboratory screening, enhance informed decision making by recipients, and ensure prompt recognition of donor-derived disease transmission so treatment could be initiated.

Per the 1994 guideline, organ donors were screened for HIV using serologic testing. Donors with risk factors for HIV infection and transmission to recipients were designated "Centers for Disease Control and Prevention (CDC) High Risk" donors.[3] The 2013 guideline modified terminology to "Increased Risk Donor (IRD)" and recommended HCV NAT for all donors and HIV NAT or p24 antigen testing for IRD.[1] "Increased" was adopted over "high" to convey the continued, though small, possibility of donor-derived disease transmission despite NAT. As a result of the opioid epidemic, the proportion of the donor population that is categorized as IRD has increased.[4] IRD has a higher prevalence of HBV and HCV infection in comparison with standard risk donors (SRD).[4] Several studies have reported underutilization of organs from IRD, but have methodological limitations that reduce the relevance of previous estimates of underutilization for current decision making. The most substantial limitations of previous studies were inadequate control for donor HCV serostatus and the use of limited risk adjustment models[5,6] as well as other limitations such as the exclusion of extended criteria donors (ECD) or organs recovered after cardiac death,[5] and older study time-frames.[5,7] Understanding the impact of IRD designation on organ utilization is important. Studies have shown that patients awaiting transplantation who decline IRD organs have increased mortality compared to patients who accept IRD organs.[6,8] Additionally, effective therapies are available for HIV, HBV, and HCV.

To determine whether IRD categorization is associated with decreased utilization of organs, we analyzed data obtained from the Organ Procurement and Transplantation Network (OPTN).* We developed separate risk adjustment models for adult and pediatric heart, kidney, liver, and lungs and tested for a relationship between IRD categorization and underutilization after accounting for these risk adjustment factors, first with all donors, then with HBV and HCV NAT and/or serology-positive donors removed. These donors were removed because, while a large numbers of HBV and HCV NAT or antibody-positive donors are designated IRD, per the 2013 guideline, use of these organs is characterized as potentially resulting in expected donor-derived infection.[1] Decisions to accept or decline these organs are more likely to be due to the test results rather than donor IRD status. In addition to quantifying utilization, we further examined utilization by region and organ type. CDC, Health Resources and Service Administration (HRSA), and other federal partners are currently considering revisions to the 2013 guideline recommendations. Utilization effects described are further discussed in context of future guideline recommendation revisions.