OPTN/SRTR 2019 Annual Data Report: Deceased Organ Donors

SRTR uses data collected by OPTN to calculate metrics such as donation rate, organ yield, and rate of organs recovered for transplant but not transplanted. In 2019, there were 11,870 deceased donors, an increase from 10,721 in 2018; this number has been increasing since 2010. The number of deceased donor transplants increased to 32,313 in 2019, from 29,675 in 2018; this number has been increasing since 2012. The increase may be due in part to the rising number of deaths of young people due to the ongoing opioid epidemic. The number of organs transplanted included 17,425 kidneys, 1,018 pancreata, 8,275 livers, 81 intestines, 3,604 hearts, and 2,607 lungs. In 2019, 4,324 kidneys, 346 pancreata, 867 livers, 5 intestines, 31 hearts, and 148 lungs were discarded. These numbers suggest an opportunity to increase numbers of transplants by reducing discards.     

OPTN/SRTR 2017 Annual Data Report: Deceased Organ Donation

SRTR uses data collected by OPTN to calculate metrics such as donation rate, organ yield, and rate of organs recovered for transplant but not transplanted. In 2017, 1,085,646 death and imminent death referrals were made to organ procurement organizations, of which 22,265 met the definition of eligible (11,673) or imminent neurological (10,592) deaths per OPTN policy. There were 10,286 deceased donors, and this number has been increasing since 2010. The number of organs authorized for recovery has also continued to increase since 2010. The recent increase may be in part due to the rising number of deaths of young individuals due to the opioid epidemic. In 2017, 4813 organs were discarded, including 3542 kidneys, 309 pancreata, 742 livers, 4 intestines, 33 hearts, and 272 lungs. These numbers suggest a need to reduce the number of organs discarded.     

Solving the Organ Shortage Crisis: The 7th Annual American Society of Transplant Surgeons' State-of-the-Art Winter Symposium

The 2007 American Society of Transplant Surgeons' (ASTS) State-of-the-Art Winter Symposium entitled, 'Solving the Organ Shortage Crisis' explored ways to increase the supply of donor organs to meet the challenge of increasing waiting lists and deaths while awaiting transplantation. While the increasing use of organs previously considered marginal, such as those from expanded criteria donors (ECD) or donors after cardiac death (DCD) has increased the number of transplants from deceased donors, these transplants are often associated with inferior outcomes and higher costs. The need remains for innovative ways to increase both deceased and living donor transplants. In addition to increasing ECD and DCD utilization, increasing use of deceased donors with certain types of infections such as Hepatitis B and C, and increasing use of living donor liver, lung and intestinal transplants may also augment the organ supply. The extent by which donors may be offered incentives for donation, and the practical, ethical and legal implications of compensating organ donors were also debated. The expanded use of nonstandard organs raises potential ethical considerations about appropriate recipient selection, informed consent and concerns that the current regulatory environment discourages and penalizes these efforts.     

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.     

Kidney and pancreas transplantation

Data from the Scientific Registry of Transplant Recipients offer a unique and comprehensive view of US trends in kidney and pancreas waiting list characteristics and outcomes, transplant recipient and donor characteristics, and patient and allograft survival. Important findings from our review of developments during 2002 and the decade's transplantation trends appear below.
The kidney waiting list has continued to grow, increasing from 47 830 in 2001 to 50 855 in 2002. This growth has occurred despite the increasing importance of living donor transplantation, which rose from 28% of total kidney transplants in 1993 to 43% in 2002.
Policies and procedures to expedite the allocation of expanded criteria donor (ECD) kidneys were developed and implemented during 2002, when 15% of deceased donor transplants were performed with ECD kidneys. Unadjusted 1- and 5-year deceased donor kidney allograft survivals were 81% and 51% for ECD kidney recipients, and 90% and 68% for non-ECD kidney recipients, respectively.
Although more patients have been placed on the simultaneous kidney-pancreas waiting list, the number of these transplants dropped from a peak of 970 in 1998 to 905 in 2002. This decline may be due to competition for organs from increasing numbers of isolated pancreas and islet transplants.     

Kidney and Pancreas Transplantation in the United States, 1997–2006: The HRSA Breakthrough Collaboratives and the 58 DSA Challenge

Growth in the number of active patients on the kidney transplant waiting list has slowed. Projections based on the most recent 5-year data suggest the total waiting list will grow at a rate of 4138 registrations per year, whereas the active waiting list will increase at less than one-sixth that rate, or 663 registrations per year. The last 5 years have seen a small trend toward improved unadjusted allograft survival for living and deceased donor kidneys. Since 2004 the overall number of pancreas transplants has declined. Among pancreas recipients, those with simultaneous kidney-pancreas transplants experienced the highest pancreas graft survival rates.
In response to the ongoing shortage of deceased donor organs, the US Health Resources and Services Administration launched the Organ Donation Breakthrough Collaborative in September 2003 and the Organ Transplantation Breakthrough Collaborative (OTBC) in October 2005. The 58 DSA Challenge is prominent among the goals adopted by the OTBC. Its premise: were each of the 58 existing donation service areas to increase the number of kidney transplants performed within their boundaries by 10 per month, an additional 7000 transplants over current annual levels would result. Such an increase could potentially eliminate the national kidney transplantation waiting list by 2030.     

OPTN/SRTR 2017 Annual Data Report: Lung

Each year since 2012, the number of lung transplants has increased, reflecting an increase in the number of donors, improved use of recovered organs, and more candidates being listed for transplant. However, the need for organs continues to outpace available donors. Despite an increase of 126 donors in 2017, 1360 candidates remained on the waiting list at the end of the year, and 326 patients died or became too sick to undergo transplant. Approximately 14,000 individuals were living with a lung transplant in 2017; 9492 were aged 50 years or older, 4075 were aged 18‐49 years, and 408 were aged younger than 18 years.     

The First 5 Years of the Newest Eurotransplant Member State: Hungarian Results of International Organ Exchange From 2014 to 2018

IntroductionHungary joined Eurotransplant International (ET) to improve the chance of transplantation for Hungarian patients and patient outcomes, including access and graft and patient survival. After 5 years of full membership, the evaluation of numbers and quality indicators is possible.MethodA comparison was made between 5 years prior to a preliminary cooperation agreement (2007-2011) and 5 years after full ET membership (2014-2018). During the 2 study periods, we analyzed numbers and circumstances of deceased organ donors, multiorgan donors, donated organs, and transplantations in Hungary and development of waiting lists along with international organ exchanges.ResultThe number of actual organ donors increased by 22.09% (729 vs 890), an additional 823 organ removals represents an increase of 42.71% (1927 vs 2750). There were 46.51% more transplants managed in the selected periods (1561 vs 2287). The number of new patients on the waiting list increased (2305 vs 3247; 40.87%). The mean kidney mismatch number decreased from 3.21 to 2.96.ConclusionJoining ET has been an effective and efficient in terms of increasing access to organs and the lives of patients on the Hungarian waiting list posttransplant. It is also a benefit for patients with special needs because the number of organ transplants is greater than the increased number of donors.     

OPTN/SRTR 2018 Annual Data Report: Kidney

Despite the ongoing severe mismatch between organ need and supply, data from 2018 revealed some promising trends. For the fourth year in a row, the number of patients waiting for a kidney transplant in the US declined and numbers of both deceased and living donor kidney transplants increased. These encouraging trends are tempered by ongoing challenges, such as a large proportion of listed patients with dialysis time longer than 5 years. The proportion of candidates aged 65 years or older continued to rise, and the proportion undergoing transplant within 5 years of listing continued to vary dramatically nationwide, from 10% to nearly 80% across donation service areas. Increasing trends in the recovery of organs from hepatitis C positive donors and donors with anoxic brain injury warrant ongoing monitoring, as does the ongoing discard of nearly 20% of recovered organs. While the number of living donor transplants increased, racial disparities persisted in the proportion of living versus deceased donors. Strikingly, the total number of kidney transplant recipients alive with a functioning graft is on track to pass 250,000 in the next 1‐2 years. The total number of pediatric kidney transplants remained steady at 756 in 2018. Deeply concerning to the pediatric community is the persistently low level of living donor kidney transplants, representing only 36.2% in 2018.     

Improvements in organ donation: Riding the coattails of a national tragedy

The US organ donation system has received attention from the highest levels of government. It has been debated whether increased donation is attributable solely to the opioid epidemic, or to broader performance improvements of the 58 OPOs. We evaluated Organ Procurement and Transplantation Network (OPTN) data of all deceased donors from 1/1/2009 to 12/31/2018. We hierarchically created four categories: (a) donor's mechanism of death coded as “drug intoxication” by the OPO; or donor coded as another mechanism of death but his/her history noted (b) intravenous drug use, (c) non-intravenous drug use (eg, snorting), or (d) no drug use. The first three categories were grouped as “drug-related.” In 2018, there were 2700 more deceased donors than 2009. While the number of donors dying from a non–drug-related death decreased by 52, the number of drug-related deaths increased by 2752 (102% of increase from 2018 vs 2009). While there have been improvements in performance at some OPOs, based on these data it is indisputable that nationally the increased number of donors is almost wholly attributable to the drug epidemic, and reflects the byproduct of a national tragedy, rather than an improved system to be celebrated.     

The Emerging Role of Brazil in Clinical Trial Conduct for Transplantation

Brazil is a country with over 190 000 000 inhabitants and a health system composed of a large public, government managed system. Between 1999 and 2010 the number of deceased donors increased by 161%, from 3.8 to 9.9 pmp, and the number of solid organ transplants increased by 121%, from 2891 to 6402. This growth was a consequence of the creation of a well‐organized national transplant program. Government funding, decentralization and educational investment in transplant coordinators and related professional were decisive. In 2009 Brazil was the second largest country in the absolute number of kidney transplants (n = 4259). There are significant region disparities in performance which are mainly due to the development status. Improvements in transplant and research regulations resulted in an increasing participation of Brazilian transplant centers in multicenter trials, reaching over 44 studies during the last 11 years. Brazilian centers have been involved in clinical trials using everolimus, sirolimus, fingolimod, mycophenolate mofetyl, mycophenolate sodium, tacrolimus modified‐release, sotrastaurin, belatacept, JAK3 inhibitor CP690,550 and valganciclovir. The still increasing number of transplants performed every year along with more efficient regulatory and sanitary analysis, organized clinical research programs and reduction in region performance disparities will eventually increase even more the participation of Brazil in trials worldwide.     

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.     

Organ Donation and Utilization in the United States, 1997–2006

Deceased organ donation has increased rapidly since 2002, coinciding with implementation of the Organ Donation Breakthrough Collaborative. The increase in donors has resulted in a corresponding increase in the numbers of kidney, liver, lung and intestinal transplants. While transplants for most organs have increased, discard and nonrecovery rates have not improved or have increased, resulting in a decrease in organs recovered per donor (ORPD) and organs transplanted per donor (OTPD). Thus, the expansion of the consent and recovery of incremental donors has frequently outpaced utilization. Meaningful increases in multicultural donation have been achieved, but donations continue to be lower than actual rates of transplantation and waiting list registrations for these groups. To counteract the decline in living donation, mechanisms such as paired donation and enhanced incentives to organ donation are being developed. Current efforts of the collaborative have focused on differentiating ORPD and OTPD targets by donor type (standard and expanded criteria donors and donors after cardiac death), utilization of the OPTN regional structure and enlisting centers to increase transplants to match increasing organ availability.     

Increasing the Number of Organ Transplants in the United States by Optimizing Donor Authorization Rates

While recent policies have focused on allocating organs to patients most in need and lessening geographic disparities, the only mechanism to increase the actual number of transplants is to maximize the potential organ supply. We conducted a retrospective cohort study using OPTN data on all “eligible deaths” from 1/1/08 to 11/1/13 to evaluate variability in donor service area (DSA)‐level donor authorization rates, and to quantify the potential gains associated with increasing authorization rates. Despite adjustments for donor demographics (age, race/ethnicity, cause of death) and geographic factors (rural/urban status of donor hospital, statewide participation in deceased‐donor registries) among 52 571 eligible deaths, there was significant variability (p < 0.001) in donor authorization rates across the 58 DSAs. Overall DSA‐level adjusted authorization rates ranged from 63.5% to 89.5% (median: 72.7%). An additional 773–1623 eligible deaths could have been authorized, yielding 2679–5710 total organs, if the DSAs with authorization rates below the median and 75th percentile, respectively, implemented interventions to perform at the level of the corresponding reference DSA. Opportunities exist within the current organ acquisition framework to markedly improve DSA‐level donor authorization rates. Such initiatives would mitigate waitlist mortality while increasing the number of transplants.     

On Patients Who Purchase Organ Transplants Abroad

The international transplant community portrays organ trade as a growing and serious crime involving large numbers of traveling patients who purchase organs. We present a systematic review about the published number of patients who purchased organs. With this information, we discuss whether the scientific literature reflects a substantial practice of organ purchase. Between 2000 and 2015, 86 studies were published. Seventy‐six of these presented patients who traveled and 42 stated that the transplants were commercial. Only 11 studies reported that patients paid, and eight described to what or whom patients paid. In total, during a period of 42 years, 6002 patients have been reported to travel for transplantation. Of these, only 1238 were reported to have paid for their transplants. An additional unknown number of patients paid for their transplants in their native countries. We conclude that the scientific literature does not reflect a large number of patients buying organs. Organ purchases were more often assumed than determined. A reporting code for transplant professionals to report organ trafficking networks is a potential strategy to collect and quantify cases.     

Effects of broader geographic distribution of donor lungs on travel mode and estimated costs of organ procurement

On November 24, 2017, US lung transplant policy replaced donor service area with 250-nautical-mile radius as the first unit of allocation. Understanding this policy's economic impact is important, because the United States is poised to adopt the broadest feasible geographic organ distribution. All lung transplant recipients from January 1, 2015, to December 31, 2018, in the Scientific Registry of Transplant Recipients, were included. Recipients before and after November 24, 2017 were in the donor service area-first and 250-nautical-mile donor service area-free periods, respectively. Travel time was estimated using a Google application; mode was assigned as flying when driving time was longer than 60 min. Travel costs were estimated by mode and distance. Travel distance and time for organ procurement increased under the policy change. The estimated proportion of organs traveling by air increased from 61% to 76%. Estimated average costs increased by $14 051 if travel mode changed to flying, resulting in an average increase of $1264 for all transplants. Travel costs were highest for candidates <18 years and adults with high lung allocation scores. Broader geographic distribution increased estimated organ procurement costs for a small percentage of lung transplants. Further analysis should elucidate the broad economic impact of such policies.     

Consequences of Eliminating HLA-B in Deceased Donor Kidney Allocation to Increase Minority Transplantation

HLA matching contributes to the disparity in Caucasian compared to minority kidney transplantation. HLA-B locus matching was eliminated from kidney allocation to shift a projected 166 organs from Caucasians to minorities annually. This study estimated the economic and quality-of-life impact of this policy. Cost-effectiveness analysis was performed using a Markov model. Data from the United States Renal Data System (USRDS) were used to estimate race-specific outcomes, patient and graft survival, quality-adjusted life years (QALYs) and medical costs in U.S. dollars. The greatest benefit is expected in African Americans, with expected savings of US 7.5 million dollars and 243 QALYs. Smaller cost and QALY benefits are seen in other minority groups. In Caucasians, a loss of 7.0 million dollars and a decrease of 967 QALYs are expected with the shift of organs. Overall, this policy is expected to save US 5400 dollars for each QALY that is lost. The same increase in minority transplantation would be expected from increasing Caucasian donation rates by 5.5%, or African-American donation by 29.0%, each producing large cost savings and QALY gains. Policies to increase minority transplants by increasing donation rates may prove more cost effective than the elimination of HLA-B matching from deceased donor kidney allocation.     

The First 2 Years of Activity of a Specialized Organ Procurement Center: Report of an Innovative Approach to Improve Organ Donation

The number of patients requiring organ transplants continues to outgrow the number of organs donated each year. In an attempt to improve the organ donation process and increase the number of organs available, we created a specialized multidisciplinary team within a specialized organ procurement center (OPC) with dedicated intensive care unit (ICU) beds and operating rooms. The OPC was staffed with ICU nurses, operating room nurses, organ donor management ICU physicians, and multidisciplinary staff. All organ donors within a designated geographic area were transferred to and managed within the OPC. During the first 2 years of operation, 126 patients were referred to the OPC. The OPC was in use for a total of 3527 h and involved 253 health workers. We retrieved 173 kidneys, 95 lungs, 68 livers, 37 hearts, and 13 pancreases for a total of 386 organs offered for transplantation. This translates to a total of 124.6 persons transplanted per million population, which compares most favorably to recently published numbers in developed countries. The OPC clearly demonstrates potential to increase the number of deceased donor organs available for transplant. Further studies are warranted to better understand the exact influence of the different components of the OPC on organ procurement.     

OPTN/SRTR 2018 Annual Data Report: Lung

The primary goal of US lung allocation policy is to ensure that candidates with the highest risk for mortality receive appropriate access to lung transplant. In 2018, 2562 lung transplants were performed in the US, reflecting a 31% increase over the past 5 years. More candidates are being listed for lung transplant, and the number of donors has increased substantially. Despite an increase of 84 lung transplants in 2018, 365 adult candidates died or became too sick to undergo transplant. In 2018, 24 new child (ages 0‐11 years) candidates were added to the lung transplant waiting list. Fifteen lung transplants were performed in recipients aged 0‐11 years, three in recipients aged younger than 1 year, two in recipients aged 1‐5 years, and ten in recipients aged 6‐11 years. Of 27 child candidates removed from the waiting list in 2018, 16 (59.3%) were removed due to undergoing transplant, six (22.2%) due to death, one (3.7%) due to improved condition, and one (3.7%) due to becoming too sick to undergo transplant.     

Organ Donation and Utilization in the United States: 1998–2007

Organ transplantation remains the only life-saving therapy for many patients with organ failure. Despite the work of the Organ Donation and Transplant Collaboratives, and the marked increases in deceased donors early in the effort, deceased donors only rose by 67 from 2006 and the number of living donors declined during the same time period. There continues to be increases in the use of organs from donors after cardiac death (DCD) and expanded criteria donors (ECD). This year has seen a major change in the way organs are offered with increased patient safety measures in those organ offers made by OPOs using DonorNet^©. Unfortunately, the goals of 75% conversion rates, 3.75 organs transplanted per donor, 10% of all donors from DCD sources and 20% growth of transplant center volume have yet to be reached across all donation service areas (DSAs) and transplant centers; however, there are DSAs that have not only met, but exceeded, these goals. Changes in organ preservation techniques took place this year, partly due to expanding organ acceptance criteria and increasing numbers of ECDs and DCDs. Finally, the national transplant environment has changed in response to increased regulatory oversight and new requirements for donation and transplant provider organizations.