Longer-Term Outcomes After Kidney Transplantation From Seronegative Deceased Donors at Increased Risk for Blood-Borne Viral Infection

Abstract

Background Transmission of human immunodeficiency virus (HIV) and hepatitis C to transplant recipients has drawn attention to the use of allografts from seronegative donors at increased risk for viral infection (DIRVI). Methods We performed a cohort study of 7,803 kidney transplant recipients whose kidneys were recovered through one of two organ procurement organizations (OPO) from 1996 to 2007. Detailed OPO data on donor risk factors were linked to recipient data from the Organ Procurement and Transplantation Network. Results Median recipient follow-up was 3.9 years. 368 (5%) patients received DIRVI kidneys, a third of which were procured from donors with a history of injection drug use or commercial sex work. Compared to standard criteria kidney recipients, DIRVI kidney recipients were more likely to be HIV-positive or Black. In multivariable Cox regression, using DIRVI recipients as the reference, recipients of standard criteria donor kidneys had lower mortality (HR 0.71, p<0.01) and no difference in death-censored allograft failure (HR 1.09, p=0.62), whereas recipients of expanded criteria donor kidneys had no significant difference in mortality (HR 0.98, p=0.83), but a higher allograft failure rate (HR 1.93, p<0.01). High-quality data on post-transplant recipient viral testing were not available. Conclusions DIRVI kidney recipients experienced higher mortality than standard criteria kidney recipients. This finding could be explained if sicker patients received DIRVI kidneys (i.e., residual confounding) or the less likely possibility of undetected transmission of viral infections. Given the limitations of registry data used in this analysis, prospective studies are needed to further elucidate these findings.

Turn down for what? Patient outcomes associated with declining increased infectious risk kidneys

“…Our study suggests that IRD kidneys provide a significant and substantial survival benefit to candidates who accepted them for transplant compared to those who declined them and waited for a non-IRD kidney. While we were unable to determine viral transmission in candidates who accepted IRD kidneys, the risks of disease transmission, while non-zero (17), are low, with separate studies of 368 (14), 89 (11), and 50 IRD recipients (12) each having reported zero viral transmissions after 3.9 years, 4.3 years, and 11.3 months of follow-up time, respectively.…”

“…5,6 The estimated risk of infection also varies by the criterion for which the donor was labeled IRD, with injection drug users posing the highest HCV risk at 32.4 per 10 000, men who have sex with men at 3.5 per 10 000, and hemophiliac donors at 0.027 per 10 000. 5 One study of IRD recipients has shown higher mortality in IRD as compared to SCD recipients 14 ; however, this analysis was based on data from 1996 to 2007 and the clinical characteristics of donors labeled IRD has changed significantly over time, even more so since the PHS guidelines change in 2014. 1 More recent studies of outcomes following IRD transplants have shown similar patient mortality and graft loss between IRD and non-IRD recipients.…”

“…Studies have shown similar (11–13) and higher (14) risk of mortality and reduced (11) and similar (12, 14) risk of graft failure associated with IRD versus standard criteria donor (SCD) kidney transplants. However, candidates on the waitlist do not have the opportunity to choose between simultaneous offers of an IRD kidney and a similar non-IRD kidney.…”

“…Unfortunately, the risks associated with IRD kidney transplantation remain controversial. Studies have shown similar [11][12][13] and higher 14 risk of mortality and reduced 11 and similar 12,14 risk of graft failure associated with IRD versus standard criteria donor (SCD) kidney transplants.…”

Development of organ-specific donor risk indices

“…A careful evaluation is needed before a characteristic is defined as high‐risk to forestall a slippery slope on which organs with certain characteristics (eg, African American donor) are considered inferior, are transplanted into high‐risk recipients, and are eventually associated with poor outcomes; this would culminate in a vicious cycle that would be hard to disprove in future analyses. Neither the KDRI nor the LDRI accounts for the donor risk of transmitting viral infections, such as human immunodeficiency virus, hepatitis B virus, and HCV, as determined by the Centers for Disease Control and Prevention criteria for high‐risk donors 48, 49. The allograft survival of organs from donors with a higher risk for transmitting infections has been found to be better than the survival of high‐risk organs as determined by the KDRI 50.…”