An Assessment of Ineligible Donor Use in Solid Organ Transplant.

BACKGROUND: In the United States, the demand for organ transplants far outpaces available organs. The use of Organ Procurement and Transplantation Network-defined ineligible donors is an immediate method for increasing donations. However, the use of ineligible donors varies across organ procurement organizations (OPOs), and its association with recipient survival remains unclear. METHODS: We evaluated ineligible donor use from 2008 to 2020 by OPO and its association with graft and recipient survival across demographics. RESULTS: In this study of 297 223 organ donations, 42 184 (14%) did not meet eligibility criteria as defined by the Organ Procurement and Transplantation Network. Log-rank tests on Kaplan-Meier curves suggested differences in graft and patient survival between eligible and ineligible recipients for kidney and liver transplants ( P ≤ 0.01 for all). Recipients of ineligible kidney and liver donations saw a 2.20% and 9.38% decrease in 10-y graft survival probability, respectively. There were no statistically significant graft and patient survival differences for recipients of ineligible heart, lung, and pancreas donations. Multivariate proportional hazard models showed eligibility was associated with kidney, liver, and lung graft survival ( P ≤ 0.02 for all). However, if OPOs increased ineligible donor use to meet the current 75th percentile use rate, there could be as many as 1000 transplants and 6291 life-years gained annually. CONCLUSIONS: Ineligible donor use can provide significant survival benefit for patients who would otherwise never receive a transplant. Methods to reduce regional heterogeneity in ineligible donor use could increase the number of transplants and improve outcomes for waiting patients.

Assessment of National Organ Donation Rates and Organ Procurement Organization Metrics.

Importance: Organ transplant is a life-saving procedure for patients with end-stage organ failure. In the US, organ procurement organizations (OPOs) are responsible for the evaluation and procurement of organs from donors who have died; however, there is controversy regarding what measures should be used to evaluate their performance. Objective: To evaluate OPO performance metrics using combined mortality and donation data and quantify the associations of population demographics with donation metrics. Design, Setting, and Participants: This national cohort study includes data from the US organ transplantation system from January 2008 through December 2017. All individuals who died within the US, as reported by the National Death index, were included. Exposures: Death, organ donation, and donation eligibility. Main Outcomes and Measures: Evaluation of the variation in donation metrics and the use of ineligible donors by OPO and demographic subgroup. Results: This study included 17 501 742 deaths and 75 769 deceased organ donors (45 040 men [59.4%]; 51 908 White individuals [68.5%]). Of these donors, 15 857 (20.9%) were not eligible, as defined by the OPOs. The median donation metrics by OPO were 0.004 (range, 0.002-0.012) donors per death, 0.89 (range, 0.68-1.30) donors per eligible death, and 0.72 (range, 0.57-0.86) eligible donors per eligible death. The OPOs in the upper quartile of the overall eligible donors per eligible death metric were in the upper quartile of annual rankings on 90 of 140 occasions (64.3%). There was little overlap in top-performing OPOs between metrics; an OPO in the upper quartile for 1 metric was also in the upper quartile for the other metrics on 37 of 570 occasions (6.5% of the time). The median donor eligibility rate, defined as the number of eligible donors per donor, was 0.79 (range, 0.61-0.95) across OPOs. Age (eg, 65 to 84 years, coefficient, -0.55 [SE, 0.03]; P < .001; vs those aged 18 to 34 years), sex (male individuals, -0.09 [SE, 0.02]; P < .001; vs female individuals), race (eg, Black individuals, 0.35 [SE, 0.02]; P < .001; vs White individuals), cause of death (eg, central nervous system tumor, 0.48 [SE, 0.08]; P < .001; vs anoxia), year (eg, 2016-2017: -0.10 [SE, 0.03]; P < .001; vs 2008-2009), and OPO were associated with the use of ineligible donors; OPO was a significant factor associated with performance in all metrics (χ256, 500.5; P < .001; coefficient range across individual OPOs, -0.15 [SE, 0.09] to 0.75 [SE, 0.09]), even after accounting for population differences. Female and non-White individuals were significantly less likely to be used as ineligible donors. Conclusions and Relevance: We demonstrate significant variability in OPO performance rankings, depending on which donation metric is used. There were significant differences in OPO performance, even after accounting for differences in potential donor populations. Our data suggest significant variation in use of ineligible donors among OPOs, a source for increased donors. The performance of OPOs should be evaluated using a range of donation metrics.

Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant.

Importance: Presumed consent, or an opt-out organ transplant policy, has been adopted by many countries worldwide to increase organ donation. The implication of such a policy for transplants in the United States is uncertain, however. Objective: To simulate the potential implications of a presumed consent policy in the United States. Design, Setting, and Participants: In a decision analytical model, a simulation model was developed using cohort data from January 1, 2004, to December 31, 2014, in the Organ Procurement and Transplantation Network Standard Transplant Analysis and Research files. All US patients (n = 524 359) who were on the waiting list for at least 1 solid organ and all deceased organ donors during the study period were included in the analyses. All data and statistical analyses were performed from January 30, 2019, to July 31, 2019. Main Outcomes and Measures: Increase in the organs available for donation and life-years gained associated with a 5%, 15%, or 25% increase in deceased donors, based on the published changes from a presumed consent policy. Results: This study considered 524 359 unique candidates (aged ≥18 years; 320 908 [61.2%] male) for a solid organ transplant from January 1, 2004, to December 31, 2014. With a base case scenario of a 5% presumed consent-associated increase in donors, the removals (owing to death or illness) from the waiting list for all organs would have an associated 3.2% to 10.4% mean reduction, depending on the random or ideal allocation of new organs to patients on the waiting list. Sensitivity analyses showed that waiting list removals could be decreased up to 52%; however, this reduction was not enough to completely eliminate waiting list removals during the study period. The biggest estimated increases in annual life-years gained associated with a presumed consent policy were in kidney transplant candidates (95% CIs by deceased donor increase: 5% increase, 3440-3466 years; 15% increase, 10 321-10 399 years; 25% increase, 17 201-17 332 years) and liver transplant candidates (95% CIs by deceased donor increase: 5% increase, 898-905 years; 15% increase, 2693-2714 years; 25% increase, 4448-4523 years). Adoption of a presumed consent policy could result in a 4295-year (95% CI, 4277-4313 years) to 11 387-year (95% CI, 11 339-11 435 years) increase in life-years, accounting for the survival advantages associated with a transplant. Conclusions and Relevance: In this study, presumed consent was estimated to be associated with modest but important improvement in the number of organ transplants and increases in life-years gained for patients awaiting an organ transplant. Further consideration and even debate about the ethical and public policy implications of a presumed consent policy are warranted.