Regional Differences in Communication Process and Outcomes of Requests for Solid Organ Donation

Although federal mandate prohibits the allocation of solid organs for transplantation based on “accidents of geography,” geographic variation of transplantable organs is well documented. This study explores regional differences in communication in requests for organ donation. Administrative data from nine partnering organ procurement organizations and interview data from 1339 family decision makers (FDMs) were compared across eight geographically distinct US donor service areas (DSAs). Authorization for organ donation ranged from 60.4% to 98.1% across DSAs. FDMs from the three regions with the lowest authorization rates reported the lowest levels of satisfaction with the time spent discussing donation and with the request process, discussion of the least donation‐related topics, the highest levels of pressure to donate, and the least comfort with the donation decision. Organ procurement organization region predicted authorization (odds ratios ranged from 8.14 to 0.24), as did time spent discussing donation (OR = 2.11), the number of donation‐related topics discussed (OR = 1.14), and requesters’ communication skill (OR = 1.14). Standardized training for organ donation request staff is needed to ensure the highest quality communication during requests, optimize rates of family authorization to donation in all regions, and increase the supply of organs available for transplantation.     

Noneligible Donors as a Strategy to Decrease the Organ Shortage

Organ procurement organization (OPO) performance is generally evaluated by the number of organ procurement procedures divided by the number of eligible deaths (donation after brain death [DBD] donors aged <70 years), whereas the number of noneligible deaths (including donation after cardiac death donors and DBD donors aged >70 years) is not tracked. The present study aimed to investigate the variability in the proportion of noneligible liver donors by the 58 donor service areas (DSAs). Patients undergoing liver transplant (LT) between 2011 and 2015 were obtained from the United Network for Organ Sharing Standard Transplant Analysis and Research file. LTs from noneligible and eligible donors were compared. The proportion of noneligible liver donors by DSA varied significantly, ranging from 0% to 19.6% of total liver grafts used. In transplant programs, the proportion of noneligible liver donors used ranged from 0% to 35.3%. On linear regression there was no correlation between match Model for End‐Stage Liver Disease score for programs in a given DSA and proportion of noneligible donors used from the corresponding DSA (p = 0.14). Noneligible donors remain an underutilized resource in many OPOs. Policy changes to begin tracking noneligible donors and learning from OPOs that have high noneligible donor usage are potential strategies to increase awareness and pursuit of these organs.     

Organ donation and utilization in the United States, 2004

This article discusses issues directly related to the organ donation process, including donor consent, donor medical suitability, non-recovery of organs, organs recovered but not transplanted, expanded criteria donors (ECD), and donation after cardiac death (DCD). The findings and topics covered have important implications for how to evaluate and share best practices of organ donation as implemented by organ procurement organizations (OPOs) and major donor hospitals in the same donation service areas (DSAs). In 2002 and 2003, US hospitals referred more than one million deaths or imminent deaths to the OPOs of their DSA. Referrals increased by nearly 10% from 2002 to 2003 (1,022,280 to 1,121,392). Donor consents have increased by about 5% and the number of total deceased donors has risen from 6,187 to 6,455. Since multiple organs are recovered from most donors, this increase allowed more than 500 additional wait-listed candidates to receive an organ transplant than in the prior year. Non-traditional donor sources have experienced a large rate of increase; in 2003 the number of ECD kidney donors increased by 8% and the number of DCD donors increased by 43% , from 189 donors in year 2002 to 271 donors in 2003.     

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.     

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.     

Role of Patient Factors and Practice Patterns in Determining Access to Liver Waitlist

Geographic variability in access to care is a persistent challenge in transplantation. Little is known about how patients with end‐stage liver disease are chosen for referral, evaluation and listing. Utilizing death certificate data from the Centers for Disease Control and Prevention from 2002 to 2009, estimated liver demand (ELD) was measured by aggregating annual deaths from liver disease and liver transplants performed in each donor service area (DSA). In DSAs with higher ELD, more patients per capita were listed for transplantation (p < 0.001). In addition, listing rates per ELD varied fivefold across DSAs, with more patients per ELD being transplanted in DSAs with higher listing rates (p < 0.001). After adjusting for liver donor risk index and MELD at transplant, there was no association between listing rate and posttransplant survival (HR 1.002, p = 0.77). In addition, DSAs with lower listing rates were more likely to export organs (p < 0.001) of lower liver donor risk index (p < 0.001). Listing sicker patients was associated with increased access to the waitlist and transplantation and more efficient organ utilization, but had minimal effect on posttransplant outcomes after adjusting for the resulting organ shortage.     

Patterns of geographic variability in mortality and eligible deaths between organ procurement organizations

Eligible deaths are currently used as the denominator of the donor conversion ratio to mitigate the effect of varying mortality patterns in the populations served by different organ procurement organizations (OPOs). Eligible death is an OPO‐reported metric rather than a product of formal epidemiological analysis, however, and may be confounded with OPO performance. Using Scientific Registry of Transplant Recipients and Centers for Disease Control and Prevention data, patterns of mortality and eligible deaths within each OPO were analyzed with the use of formal geostatistical analysis to determine whether eligible deaths truly reflect the geographic patterns they are intended to mitigate. There was a 2.1‐fold difference in mortality between the OPOs with the highest and lowest rates, with significant positive spatial autocorrelation evident in mortality rates (Moran I = .110; P < .001), meaning geographically proximate OPOs tended to have similar mortality rates. The eligible death ratio demonstrated greater variability, with a 4.5‐fold difference between the OPOs with the highest and lowest rates. Contrary to the pattern of mortality rates, the geographic distribution of eligible deaths among OPOs was random (Moran I = ?.002; P = .410). This finding suggests geographic patterns do not play a significant role in eligible deaths, thus questioning its continuing use in OPO performance comparisons.     

Importance of incorporating standardized,verifiable, objective metrics of organ procurement organization performance into discussions about organ allocation

Identifying and supporting specific organ procurement organizations (OPOs) with the greatest opportunity to increase donation rates could significantly increase the number of organs available for transplant. Accomplishing this is complicated by current Scientific Registry of Transplant Recipients/Centers for Medicare & Medicaid Services metrics of donation rates and OPO performance that rely on eligible deaths. These data are self‐reported and unverifiable and have been shown to underestimate potential organ donors. We examine the limitations of current OPO performance/donation metrics to inform discussions related to strategies to increase donation. We propose changing to a simple, verifiable, and uniformly applied donation metric. This would allow the transplant community to (1) better understand inherent differences in donor availability based on geography and (2) identify underperforming areas that would benefit from systems improvement agreements to increase donation rates.     

Geographic disparities in lung transplant rates

In November 2017, in response to a lawsuit from a New York City lung transplant candidate, an emergency change to the lung allocation policy eliminated the donation service area (DSA) as the first geographic tier of allocation. The lawsuit claimed that DSA borders are arbitrary and that allocation should be based on medical priority. We investigated whether deceased‐donor lung transplant (LT) rates differed substantially between DSAs in the United States before the policy change. We estimated LT rates per active person‐year using multilevel Poisson regression and empirical Bayes methods. We found that the median incidence rate ratio (MIRR) of transplant rates between DSAs was 2.05, meaning a candidate could be expected to double their LT rate by changing their DSA. This can be compared directly to a 1.54‐fold increase in LT rate that we found associated with an increase in lung allocation score (LAS) category from 38‐42 to 42‐50. Changing a candidate's DSA would have had a greater impact on the candidate's LT rate than changing LAS categories from 38‐42 to 42‐50. In summary, we found that the DSA of listing was a major determinant of LT rate for candidates across the country before the emergency lung allocation change.     

Quantifying organ donation rates by donation service area

Previous measures of OPO performance based on population counts have been deemed inadequate, and the need for new methods has been widely accepted. This article explains recent developments in OPO performance evaluation methodology, including those developed by the SRTR. As a replacement for the previously established measure of OPO performance – donors per million population – using eligible deaths as a national metric has yielded promising results for understanding variations in donation rates among the donation service areas assigned to each OPO. A major improvement uses "notifiable deaths" as a denominator describing a standardized maximal pool of potential donors. Notifiable deaths are defined as in-hospital deaths among ages 70 years and under, excluding certain diagnosis codes related to infections, cancers, etc. A most proximal denominator for determining donation rates is "eligible deaths," which includes only those deaths meeting the criteria for organ donation upon initial assessment. Neither measure is based on the population of a geographic unit, but on restricted upper limits of deaths that could be potential donors in any one locale (e.g., hospital or OPO). The inherent strengths and weaknesses of metrics such as donors per eligible deaths, donors per notifiable deaths, and number of organs per donor are discussed in detail.     

Investigating Geographic Variation in Mortality in the Context of Organ Donation

Organ procurement organizations (OPOs) report a nearly fourfold difference in donor availability as measured by eligible deaths per million population (PMP) based on hospital referrals. We analyzed whether mortality data help explain geographic variation in organ supply as measured by the number of eligible deaths for organ donation. Using the 2007 National Center for Health Statistics’ mortality data, we analyzed deaths occurring in acute care hospitals, aged ≤ 70 years from cerebrovascular accidents and trauma. These deaths were mapped at the county level and compared to eligible deaths reported by OPOs. In 2007, there were 2 428 343 deaths reported in the United States with 42 339 in‐hospital deaths ≤ 70 years from cerebrovascular accidents (CVA) or trauma that were correlated with eligible deaths PMP (r²= 0.79.) Analysis revealed a broad range in the death rate across OPOs: trauma deaths: 44–118 PMP; deaths from CVA: 34–118 PMP; and combined CVA and trauma: 91–229 PMP. Mortality data demonstrate that deaths by neurologic criteria of people who are likely to be suitable deceased donors are not evenly distributed across the nation. These deaths are correlated with eligible deaths for organ donation. Regional availability of organs is affected by deaths which should be accounted for in the organ allocation system.     

In Situ Normothermic Regional Perfusion for Controlled Donation After Circulatory Death—The United Kingdom Experience

Organs recovered from donors after circulatory death (DCD) suffer warm ischemia before cold storage which may prejudice graft survival and result in a greater risk of complications after transplant. A period of normothermic regional perfusion (NRP) in the donor may reverse these effects and improve organ function. Twenty‐one NRP retrievals from Maastricht category III DCD donors were performed at three UK centers. NRP was established postasystole via aortic and caval cannulation and maintained for 2 h. Blood gases and biochemistry were monitored to assess organ function. Sixty‐three organs were recovered. Forty‐nine patients were transplanted. The median time from asystole to NRP was 16 min (range 10–23 min). Thirty‐two patients received a kidney transplant. The median cold ischemia time was 12 h 30 min (range 5 h 25 min–18 h 22 min). The median creatinine at 3 and 12 months was 107 µmol/L (range 72–222) and 121 µmol/L (range 63–157), respectively. Thirteen (40%) recipients had delayed graft function and four lost the grafts. Eleven patients received a liver transplant. The first week median peak ALT was 389 IU/L (range 58–3043). One patient had primary nonfunction. Two combined pancreas–kidney transplants, one islet transplant and three double lung transplants were performed with primary function. NRP in DCD donation facilitates organ recovery and may improve short‐term outcomes.     

Navigating the COVID-19 pandemic: Initial impacts and responses of the Organ Procurement and Transplantation Network in the United States

COVID-19 has been sweeping the globe, hitting the United States particularly hard with a state of emergency declared on March 13, 2020. Transplant hospitals have taken various precautions to protect patients from potential exposure. OPTN donor, candidate, and transplant data were analyzed from January 5, 2020 to September 5, 2020. The number of new waiting list registrations decreased, with the Northeast seeing over a 50% decrease from the week of 3/8 versus the week of 4/5. The national transplant system saw near cessation of living donor transplantation (−90%) from the week of 3/8 to the week of 4/5. Similarly, deceased donor kidney transplant volume dropped from 367 to 202 (−45%), and other organs saw similar decreases: lung (−70%), heart (−43%), and liver (−37%). Deceased donors recovered dropped from 260 to 163 (−45%) from 3/8 compared to 4/5, including a 67% decrease for lungs recovered. The magnitude of this decrease varied by geographic area, with the largest percent change (−67%) in the Northeast. Despite the pandemic, discard rates across organ has remained stable. Although the COVID-19 pandemic continues to evolve, OPTN data show recent evidence of stabilization, an indication that an early recovery of the number of living and deceased donors and transplants has ensued.     

Organ donation and utilization in the USA

The processes leading to donor identification, consent, organ procurement, and allocation continue to dominate debates and efforts in the field of transplantation. A considerable shortage of donors remains while the number of patients needing organ transplantation increases.
This article reviews the main trends in organ donation practices and procurement patterns from both deceased and living sources in the USA. Although there have been increases in living donation in recent years, 2002 witnessed a much more modest growth of 1%. Absolute declines in living liver and lung donation were also noted in 2002.
In 2002, the number of deceased donors increased by only 1.6% (101 donors). Increased donation from deceased donors provides more organs for transplantation than a comparable increase in living donation, because on average 3.6 organs are recovered from each deceased donor. The total number of organs recovered from deceased donors increased by 2.1% (462 organs). Poor organ quality continued to be the major reason given for nonrecovery of consented organs from deceased donors.
The kidney is the organ most likely to be discarded after recovery. Over the past decade the discard rate of recovered kidneys has increased from 6% to 11%. Many of these are expanded criteria donor kidneys.     

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.     

Transplantation of Declined Liver Allografts Following Normothermic Ex‐Situ Evaluation

The demand for liver transplantation (LT) exceeds supply, with rising waiting list mortality. Utilization of high‐risk organs is low and a substantial number of procured livers are discarded. We report the first series of five transplants with rejected livers following viability assessment by normothermic machine perfusion of the liver (NMP‐L). The evaluation protocol consisted of perfusate lactate, bile production, vascular flows, and liver appearance. All livers were exposed to a variable period of static cold storage prior to commencing NMP‐L. Four organs were recovered from donors after circulatory death and rejected due to prolonged donor warm ischemic times; one liver from a brain‐death donor was declined for high liver function tests (LFTs). The median (range) total graft preservation time was 798 (range 724–951) min. The transplant procedure was uneventful in every recipient, with immediate function in all grafts. The median in‐hospital stay was 10 (range 6–14) days. At present, all recipients are well, with normalized LFTs at median follow‐up of 7 (range 6–19) months. Viability assessment of high‐risk grafts using NMP‐L provides specific information on liver function and can permit their transplantation while minimizing the recipient risk of primary graft nonfunction. This novel approach may increase organ availability for LT.     

Unintended consequences of changes to lung allocation policy

Organ allocation for transplantation aims to balance the principles of justice and medical utility to optimally utilize a scarce resource. To address practical considerations, the United States is divided into 58 donor service areas (DSA), each constituting the first unit of allocation. In November 2017, in response to a lawsuit in New York, an emergency action change to lung allocation policy replaced the DSA level of allocation for donor lungs with a 250 nautical mile circle around the donor hospital. Similar policy changes are being implemented for other organs including heart and liver. Findings from a recent US Department of Health and Human Services report, supplemented with data from our institution, suggest that the emergency policy has not resulted in a change in the type of patients undergoing lung transplantation (LT) or early postoperative outcomes. However, there has been a significant decline in local LT, where donor and recipient are in the same DSA. With procurement teams having to travel greater distances, organ ischemic time has increased and median organ cost has more than doubled. We propose potential solutions for consideration at this critical juncture in the field of transplantation. Policymakers should choose equitable and sustainable access for this lifesaving discipline.     

Geographic disparity in kidney transplantation under KAS

The Kidney Allocation System fundamentally altered kidney allocation, causing a substantial increase in regional and national sharing that we hypothesized might impact geographic disparities. We measured geographic disparity in deceased donor kidney transplant (DDKT) rate under KAS (6/1/2015‐12/1/2016), and compared that with pre‐KAS (6/1/2013‐12/3/2014). We modeled DSA‐level DDKT rates with multilevel Poisson regression, adjusting for allocation factors under KAS. Using the model we calculated a novel, improved metric of geographic disparity: the median incidence rate ratio (MIRR) of transplant rate, a measure of DSA‐level variation that accounts for patient casemix and is robust to outlier values. Under KAS, MIRR was _1.751.81_1.86 for adults, meaning that similar candidates across different DSAs have a median 1.81‐fold difference in DDKT rate. The impact of geography was greater than the impact of factors emphasized by KAS: having an EPTS score ≤20% was associated with a 1.40‐fold increase (IRR = _1.351.40_1.45, P < .01) and a three‐year dialysis vintage was associated with a 1.57‐fold increase (IRR = _1.561.57_1.59, P < .001) in transplant rate. For pediatric candidates, MIRR was even more pronounced, at _1.661.92_2.27. There was no change in geographic disparities with KAS (P = .3). Despite extensive changes to kidney allocation under KAS, geography remains a primary determinant of access to DDKT.

     

Geographic disparities in liver supply/demand ratio within fixed‐distance and fixed‐population circles

Recent OPTN proposals to address geographic disparity in liver allocation have involved circular boundaries: the policy selected 12/17 allocated to 150‐mile circles in addition to DSAs/regions, and the policy selected 12/18 allocated to 150‐mile circles eliminating DSA/region boundaries. However, methods to reduce geographic disparity remain controversial, within the OPTN and the transplant community. To inform ongoing discussions, we studied center‐level supply/demand ratios using SRTR data (07/2013‐06/2017) for 27 334 transplanted deceased donor livers and 44 652 incident waitlist candidates. Supply was the number of donors from an allocation unit (DSA or circle), allocated proportionally (by waitlist size) to the centers drawing on these donors. We measured geographic disparity as variance in log‐transformed supply/demand ratio, comparing allocation based on DSAs, fixed‐distance circles (150‐ or 400‐mile radius), and fixed‐population (12‐ or 50‐million) circles. The recently proposed 150‐mile radius circles (variance = 0.11, P = .9) or 12‐million‐population circles (variance = 0.08, P = .1) did not reduce the geographic disparity compared to DSA‐based allocation (variance = 0.11). However, geographic disparity decreased substantially to 0.02 in both larger fixed‐distance (400‐mile, P < .001) and larger fixed‐population (50‐million, P < .001) circles (P = .9 comparing fixed distance and fixed population). For allocation circles to reduce geographic disparities, they must be larger than a 150‐mile radius; additionally, fixed‐population circles are not superior to fixed‐distance circles.     

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.