Changing Metrics of Organ Procurement Organization Performance in Order to Increase Organ Donation Rates in the United States

The shortage of deceased‐donor organs is compounded by donation metrics that fail to account for the total pool of possible donors, leading to ambiguous donor statistics. We sought to assess potential metrics of organ procurement organizations (OPOs) utilizing data from the Nationwide Inpatient Sample (NIS) from 2009–2012 and State Inpatient Databases (SIDs) from 2008–2014. A possible donor was defined as a ventilated inpatient death ≤75 years of age, without multi‐organ system failure, sepsis, or cancer, whose cause of death was consistent with organ donation. These estimates were compared to patient‐level data from chart review from two large OPOs. Among 2,907,658 inpatient deaths from 2009–2012, 96,028 (3.3%) were a “possible deceased‐organ donor.” The two proposed metrics of OPO performance were: (1) donation percentage (percentage of possible deceased‐donors who become actual donors; range: 20.0–57.0%); and (2) organs transplanted per possible donor (range: 0.52–1.74). These metrics allow for comparisons of OPO performance and geographic‐level donation rates, and identify areas in greatest need of interventions to improve donation rates. We demonstrate that administrative data can be used to identify possible deceased donors in the US and could be a data source for CMS to implement new OPO performance metrics in a standardized fashion.     

Unintended Consequences of the New National Kidney Allocation Policy in the United States

The new national Kidney Allocation System of the Organ Procurement and Transplantation Network (OPTN), effective as of December 4, 2014, was designed to improve the chances of transplanting the most highly sensitized patients on the waitlist, those with calculated panel reactive antibody values of 98%, 99% and 100%. Recently, it was suggested that these highly sensitized patients will experience inequitable access, given the reported high prevalence of antibodies to HLA‐DP, and the fact that only about 1/3 of deceased donors are typed for HLA‐DP antigens. Here we report that 320/2948 flow cytometric crossmatches performed for the Northwestern transplant program over the past 28 months were positive solely due to HLA‐DP donor‐specific antibodies (11%; 16.5% of patients with HLA antibodies—sensitized patients). We further show that 58/207 (12%) HLA‐DR serologically matched donor‐recipient pairs had a positive B cell flow crossmatch due to donor‐specific HLA class II antibodies, and 2/34 (6%) serologic zero‐HLA‐A‐B‐DR mismatch had a positive flow crossmatch due to HLA‐DSA. We therefore provide information regarding the necessity and importance of complete donor HLA typing including both chains of the HLA‐DP antigen (encoded by HLA‐DPA1 and HLA‐DPB1) at the time of organ offer.     

Now is the time for the Organ Procurement and Transplantation Network to change regulatory policy to effectively increase transplantation in the United States; Carpe Diem

With the Centers for Medicare and Medicaid Services proposing to remove outcome measures from the transplant centers’ renewal for Conditions of Participation an exciting opportunity surfaces for the Organ Procurement and Transplantation Network to make an equally bold change and allow for increased transplantation options for patients in the United States.     

Liver transplantation from active COVID-19 donors: A lifesaving opportunity worth grasping?

COVID-19 pandemic dramatically impacted transplantation landscape. Scientific societies recommend against the use of donors with active SARS-CoV-2 infection. Italian Transplant Authority recommended to test recipients/donors for SARS-CoV-2-RNA immediately before liver transplant (LT) and, starting from November 2020, grafts from deceased donors with active SARS-CoV-2 infection were allowed to be considered for urgent-need transplant candidates with active/resolved COVID-19. We present the results of the first 10 LTs with active COVID-19 donors within an Italian multicenter series. Only two recipients had a positive molecular test at LT and one of them remained positive up to 21 days post-LT. None of the other eight recipients was found to be SARS-CoV-2 positive during follow-up. IgG against SARS-CoV-2 at LT were positive in 80% (8/10) of recipients, and 71% (5/7) showed neutralizing antibodies, expression of protective immunity related to recent COVID-19. In addition, testing for SARS-CoV-2 RNA on donors’ liver biopsy at transplantation was negative in 100% (9/9), suggesting a very low risk of transmission with LT. Immunosuppression regimen remained unchanged, according to standard protocol. Despite the small number of cases, these data suggest that transplanting livers from donors with active COVID-19 in informed candidates with SARS-CoV-2 immunity, might contribute to safely increase the donor pool.

     

Improving safety in organ recovery transportation: Report from the ASTS/UNOS/AST/AOPO transportation safety summit

Despite the passage of a decade since the tragic loss of an organ recovery team from the University of Michigan, there are currently no national standards governing air and ground transportation of organ recovery personnel. Consequently, the American Society of Transplant Surgeons, the Association of Organ Procurement Organizations, and the United Network for Organ Sharing jointly convened a transportation summit to review and update recommendations for national transportation standards. Expanded air transport quality assurance protocols, including a requirement for two engine turbine‐powered aircraft piloted by two qualified pilots certified through onsite inspections was recommended. Ground transportation providers must ensure adequate safety restraints are available, ambulance avoided if possible, and the use of lights and sirens minimized. Finally, adequate insurance coverage for all team members, including trainees should be provided and should not rely on carrier liability insurance policies. The summit participants have committed the support of their organizations to promote and enact these regulations nationally.     

The clinical relevance of Organ Procurement and Transplantation Network screening criteria for program performance review in the United States

The Organ Procurement and Transplantation Network is charged with overseeing the quality of transplant programs in the United States. However, there has been controversy over whether too many programs are being identified as underperforming. It has also been suggested that dramatic improvements in outcomes throughout the United States have made the thresholds for determining which deceased donor transplant programs are underperforming no longer clinically relevant. The Scientific Registry of Transplant Recipients compared actual and expected 1‐y graft survival for transplant programs identified as underperforming in the most recent cohort (transplants from July 1, 2012 to December 31, 2014). For most organs, actual 1‐y graft survival was substantially lower for programs identified as underperforming than for programs identified as performing as expected. Differences were smallest for kidney programs: median 1‐y graft survival 89.2% vs 95.4% in large‐volume programs identified and not identified for Membership and Professional Standards Committee review, respectively. Median expected graft survival was only slightly lower (94.8% vs 95.1%, respectively), suggesting that identified and not identified programs tend to have similar risk tolerances. An excess of 143 grafts were lost from kidney programs identified as underperforming. Transplant programs identified as underperforming generally have reduced 1‐y graft survival that stakeholders may consider clinically relevant.     

Deceased Donor Intervention Research: A Survey of Transplant Surgeons,Organ Procurement Professionals,and Institutional Review Board Members

Innovative deceased donor intervention strategies have the potential to increase the number and quality of transplantable organs. Yet there is confusion over regulatory and legal requirements, as well as ethical considerations. We surveyed transplant surgeons (n = 294), organ procurement organization (OPO) professionals (n = 83), and institutional review board (IRB) members (n = 317) and found wide variations in their perceptions about research classification, risk assessment for donors and organ transplant recipients, regulatory oversight requirements, and informed consent in the context of deceased donor intervention research. For instance, when presented with different research scenarios, IRB members were more likely than transplant surgeons and OPO professionals to feel that study review and oversight were necessary by the IRBs at the investigator, donor, and transplant center hospitals. Survey findings underscore the need to clarify ethical, legal, and regulatory requirements and their application to deceased donor intervention research to accelerate the pace of scientific discovery and facilitate more transplants.     

Hand transplantation in the United States: A review of the Organ Procurement and Transplantation Network/United Network for Organ Sharing Database

Hand transplantation is the most common application of vascularized composite allotransplantation (VCA). Since July 3, 2014, VCAs were added to the definition of organs covered by federal regulation (the Organ Procurement and Transplantation Network (OPTN) Final Rule) and legislation (the National Organ Transplant Act). As such, VCA is subject to requirements including data submission. We performed an analysis of recipients reported to the OPTN to have received hand transplantation between 1999 and 2018. Forty‐three patients were identified as having been listed for upper extremity transplantation in the United States. Of these, 22 received transplantation prior to July 3, 2014 and 10 from then to December 31, 2018. Of patients transplanted after 2014, posttransplant functional scores included a decrease in Disabilities of the Arm, Shoulder and Hand questionnaire in 3 of 10 patients, Carroll test scores ranging from 9 to 60 of 99, and monofilament testing with protective sensation achieved in 4 of 6 patients. Complications included rejection in nine recipients with Banff scores from II‐IV. One patient experienced graft failure 5 days after transplantation. Of the remaining patients, two were reported as receiving monotherapy and seven receiving dual or triple immunosuppression therapy. The inclusion of VCA in the OPTN Final Rule standardized parameters for safe implementation and data collection.     

Solid organ donation after death in the United States: Data‐driven messaging to encourage potential donors

US deceased donor solid organ transplantation (dd‐SOT) depends upon an individual's/family's altruistic willingness to donate organs after death; however, there is a shortage of deceased organ donors in the United States. Informing individuals of their own lifetime risk of needing dd‐SOT could reframe the decision‐making around organ donation after death. Using United Network for Organ Sharing (UNOS) data (2007‐2016), this cross‐sectional study identified (1) deceased organ donors, (2) individuals waitlisted for dd‐SOT (liver, kidney, pancreas, heart, lung, intestine), and (3) dd‐SOT recipients. Using US population projections, life tables, and mortality estimates, we quantified probabilities (Pr) of (1) becoming deceased organ donors, (2) needing dd‐SOT, and (3) receiving dd‐SOT. Lifetime Pr (per 100 000 US population) for males and females of becoming deceased organ donors were 212 and 146, respectively, and of needing dd‐SOT were 1323 and 803, respectively. Lifetime Pr of receiving dd‐SOT was 50% for males, 48% for females. Over a lifetime, males were 6.2 and females 5.5 times more likely to need dd‐SOT than to become deceased organ donors. Organ donation is traditionally contextualized in terms of charity toward others. Our analyses yield a new tool, in the form of quantifying an individual's own likelihood of needing dd‐SOT, which may assist with reframing motivations toward deceased donor organ donation.     

COVID‐19 in Spain: Transplantation in the midst of the pandemic

Spain has been one of the most affected countries by the COVID‐19 outbreak. As of April 28, 2020, the number of confirmed cases is 210 773, including 102 548 patients recovered, more than 10 300 admitted to the ICU, and 23 822 deaths, with a global case fatality rate of 11.3%. From the perspective of donation and transplantation, the Spanish system first focused on safety issues, providing recommendations for donor evaluation and testing, and to rule out SARS‐CoV‐2 infection in potential recipients prior to transplantation. Since the country entered into an epidemiological scenario of sustained community transmission and saturation of intensive care, developing donation and transplantation procedures has become highly complex. Since the national state of alarm was declared in Spain on March 13, 2020, the mean number of donors has declined from 7.2 to 1.2 per day, and the mean number of transplants from 16.1 to 2.1 per day. Increased mortality on the waiting list may become a collateral damage of this terrible pandemic.     

Organ Procurement Organizations and the Electronic Health Record

The adoption of electronic health records (EHRs) has adversely affected the ability of organ procurement organizations (OPOs) to perform their federally mandated function of honoring the donation decisions of families and donors who have signed the registry. The difficulties gaining access to potential donor medical record has meant that assessment, evaluation, and management of brain dead organ donors has become much more difficult. Delays can occur that can lead to potential recipients not receiving life‐saving organs. For over 40 years, OPO personnel have had ready access to paper medical records. But the widespread adoption of EHRs has greatly limited the ability of OPO coordinators to readily gain access to patient medical records and to manage brain dead donors. Proposed solutions include the following: (1) hospitals could provide limited access to OPO personnel so that they could see only the potential donor's medical record; (2) OPOs could join with other transplant organizations to inform regulators of the problem; and (3) hospital organizations could be approached to work with Center for Medicare and Medicaid Services (CMS) to revise the Hospital Conditions of Participation to require OPOs be given access to donor medical records.     

Incentivizing Authorization for Deceased Organ Donation With Organ Allocation Priority: The First 5 Years

The allocation system of donor organs for transplantation may affect their scarcity. In 2008, Israel's Parliament passed the Organ Transplantation Law, which grants priority on waiting lists for transplants to candidates who are first‐degree relatives of deceased organ donors or who previously registered as organ donors themselves. Several public campaigns have advertised the existence of the law since November 2010. We evaluated the effect of the law using all deceased donation requests made in Israel during the period 1998–2015. We use logistic regression to compare the authorization rates of the donors’ next of kin in the periods before (1998–2010) and after (2011–2015) the public was made aware of the law. The authorization rate for donation in the period after awareness was substantially higher (55.1% vs. 45.0%, odds ratio [OR] 1.43, p = 0.0003) and reached an all‐time high rate of 60.2% in 2015. This increase was mainly due to an increase in the authorization rate of next of kin of unregistered donors (51.1% vs. 42.2%). We also found that the likelihood of next‐of‐kin authorization for donation was approximately twice as high when the deceased relative was a registered donor rather than unregistered (89.4% vs. 44.6%, OR 14.27, p < 0.0001). We concluded that the priority law is associated with an increased authorization rate for organ donation.     

The cost of procuring deceased donor kidneys: Evidence from OPO cost reports 2013‐2017

Using 5 years of US organ procurement organization (OPO) data, we determined the cost of recovering a viable (ie, transplanted) kidney for each of 51 OPOs. We also examined the effects on OPO costs of the recovery of nonviable (ie, discarded) kidneys and other OPO metrics. Annual cost reports from 51 independent OPOs were used to determine the cost per recovered kidney for each OPO. A quadratic regression model was employed to estimate the relationship between the cost of kidneys and the number of viable kidneys recovered, as well as other OPO performance indicators. The cost of transplanted kidneys at individual OPOs ranged widely from $24 000 to $56 000, and the average was $36 000. The cost of a viable kidney tended to decline with the number of kidneys procured up to 549 kidneys per year and then increase. Of the total 81 401 kidneys recovered, 66 454 were viable and 14 947 (18.4%) were nonviable. The costs of kidneys varied widely over the OPOs studied, and costs were a function of the recovered number of viable and nonviable organs, local cost levels, donation after cardiac death, year, and Standardized Donor Rate Ratio. Cost increases were 3% per year.     

Split liver transplantation is utilized infrequently and concentrated at few transplant centers in the United States

Split liver transplantation (SLT) is 1 strategy for maximizing the number of deceased donor liver transplants. Recent reports suggest that utilization of SLT in the United States remains low. We examined deceased donor offers that were ultimately split between 2010 and 2014. SLTs were categorized as “primary” and “secondary” transplants. We analyzed allocation patterns and used logistic regression to evaluate factors associated with secondary split discard. Four hundred eighteen livers were split: 54% from adult, 46% from pediatric donors. Of the 227 adult donor livers split, 61% met United Network for Organ Sharing “optimal” split criteria. A total of 770 recipients (418 primary and 352 secondary) were transplanted, indicating 16% discard. Ninety‐two percent of the 418 primary recipients were children, and 47% were accepted on the first offer. Eighty‐seven percent of the 352 secondary recipients were adults, and 7% were accepted on the first offer. Of the 352 pairs, 99% were transplanted in the same region, 36% at the same center. In logistic regression, shorter donor height was associated with secondary discard (odds ratio 0.97 per cm, 95% CI 0.94‐1.00, P = .02). SLT volume by center was not predictive of secondary discard. Current policy proposals that incentivize SLT in the United States could increase the number of transplants to children and adults.     

MELD is MELD is MELD? Transplant center–level variation in waitlist mortality for candidates with the same biological MELD

Recently, model for end-stage liver disease (MELD)-based liver allocation in the United States has been questioned based on concerns that waitlist mortality for a given biologic MELD (bMELD), calculated using laboratory values alone, might be higher at certain centers in certain locations across the country. Therefore, we aimed to quantify the center-level variation in bMELD-predicted mortality risk. Using Scientific Registry of Transplant Recipients (SRTR) data from January 2015 to December 2019, we modeled mortality risk in 33 260 adult, first-time waitlisted candidates from 120 centers using multilevel Poisson regression, adjusting for sex, and time-varying age and bMELD. We calculated a "MELD correction factor" using each center's random intercept and bMELD coefficient. A MELD correction factor of +1 means that center's candidates have a higher-than-average bMELD-predicted mortality risk equivalent to 1 bMELD point. We found that the “MELD correction factor” median (IQR) was 0.03 (−0.47, 0.52), indicating almost no center-level variation. The number of centers with “MELD correction factors” within ±0.5 points, and between ±0.5–± 1, ±1.0–±1.5, and ±1.5–±2.0 points was 62, 41, 13, and 4, respectively. No centers had waitlisted candidates with a higher-than-average bMELD-predicted mortality risk beyond ±2 bMELD points. Given that bMELD similarly predicts waitlist mortality at centers across the country, our results support continued MELD-based prioritization of waitlisted candidates irrespective of center.