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.     

Organ Donation and Utilization, 1995–2004: Entering the Collaborative Era

Continued progress in organ donation will help enable transplantation to alleviate the increasing incidence of end-stage organ disease. This article discusses the implementation and effect of the federally initiated Organ Donation Breakthrough Collaborative; it then reviews organ donation data, living and deceased, from 1995 to 2004. It is the first annual report of the Scientific Registry of Transplant Recipients to include national data following initiation of the collaborative in 2003. Prior to that, annual growth in deceased donation was 2%–4%; in 2004, after initiation of the collaborative, deceased donation increased 11%. Identification and dissemination of best practices for organ donation have emphasized new strategies for improved consent, including revised approaches to minority participation, timing of requests and team design. The number of organs recovered from donation after cardiac death (DCD) grew from 64 in 1995 to 391 in 2004. While efforts are ongoing to develop methodologies for identifying expanded criteria donors (ECD) for organs other than kidney, it is clear DCD and ECD raise questions regarding cost and recovery. The number of living donor organs increased from 3493 in 1995 to 7002 in 2004; data show trends toward more living unrelated donors and those providing non-directed donations.     

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.     

Increasing organ donation and transplantation: the U.S. experience over the past decade

The growing gap between the need for and supply of transplantable organs in the U.S. led to several initiatives over the past decade. UNOS implemented policies intended to facilitate the use of expanded criteria donor kidneys with mixed success. The U.S. government sponsored several organ donation and transplantation collaboratives, leading to significant increases in organ donation over several years. The use of organs from donors dying from cardiac death has increased steadily over the past decade, with such donors now exceeding 10% of the total. Revisions of state anatomic death acts allowed persons to declare their intention to donate by enrolling in state donor registries, facilitating the identification of willing donors by organ procurement organization. Despite these initiatives, the disparity between organ demand and supply has continued to grow, primarily as a result of marked increase in the number of candidates awaiting kidney transplantation.     

Call to Develop a Standard Acquisition Charge Model for Kidney Paired Donation

We propose a Medicare Demonstration Project to develop a standard acquisition charge for kidney paired donation. A new payment strategy is required because Medicare and commercial insurance companies may not directly pay living donor costs intended to lead to transplantation of a beneficiary of a different insurance provider. Until the 1970s, when organ procurement organizations were empowered to serve as financial intermediaries to pay the upfront recovery expenses for deceased donor kidneys before knowing the identity of the recipient, there existed similar limitations in the recovery and placement of deceased donor organs. Analogous to the recovery of deceased donor kidneys, kidney paired donation requires the evaluation of living donors before identifying their recipient. Tissue typing, crossmatching and transportation of living donors or their kidneys represent additional financial barriers. Finally, the administrative expenses of the organizations that identify and coordinate kidney paired donation transplantation require reimbursement akin to that necessary for organ procurement organizations. To expand access to kidney paired donation for more patients, we propose a model to reimburse paired donation expenses analogous to the proven strategy used for over 30 years to pay for deceased donor solid organ transplantation in America.     

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.     

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 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.     

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.     

Changing patterns in organ donation in Eurotransplant, 1990–1994

Abstract Organ transplantation has become the treatment of choice for patients with end-stage organ failure and has led to progressive increases in the size of waiting lists over the past decade. Unfortunately, from 1990 to 1994, the number of organ donors remained stable while the number of organs transplanted from these donors increased by only 10 %. In view of the severity of the current organ shortage, elderly individuals are increasingly being accepted as organ donors. The graft survival rate with kidneys from donors older than 55 years is 5 % lower than that with kidneys from younger donors at 1 year and 9 % lower at 3 years post-transplantation. Graft survival is also significantly lower with organs from donors who die from cerebrovascular accidents than it is with organs from donors whose cause of death is cerebral trauma. The number of patients waiting for a nonrenal donor organ has increased rapidly in the past 5 years, and an increasing number of donor kidneys are now being provided by multior-gan donors. The favorable graft survival rate with multiorgan donor kidneys, which is significantly better than that obtained with single organ donor kidneys, confirms their suitability for renal transplantation.     

Kidney damage during organ recovery in donation after circulatory death donors: data from UK National Transplant Database

During the last 10 years, kidneys recovered/transplanted from donors after circulatory death (DCD) have significantly increased. To optimize their use, there has been an urgent need to minimize both warm and cold ischemia, which often necessitates more rapid removal. To compare the rates of kidney injury during procurement from DCD and donors after brain death (DBD) organ donors. A total of 13 260 kidney procurements were performed in the United Kingdom over a 10-year period (2000-2010). Injuries occurred in 903 procedures (7.1%). Twelve thousand three hundred seventy-two (93.3%) kidneys were recovered from DBD donors and 888 (6.7%) from DCD donors. The rates of kidney injury were significantly higher when recovered from DCD donors (11.4% vs. 6.8%, p < 0.001). Capsular, ureteric and vascular injuries were all significantly more frequent (p = 0.002, p < 0.001 and p = 0.017, respectively). Discard because of injury was more common after DCD donation (p = 0.002). Multivariate analysis demonstrated procurement injuries were significantly associated with DCD donors (p = 0.035) and increased donor age (<0.001) and donor body mass index (BMI; 0.001), donor male gender (p = 0.001) and no liver donation (0.009). We conclude that procurement from DCD donors leads to higher rates of injury to the kidney and are more likely to be discarded.     

How large is the organ donor potential in Germany? Results of an analysis of data collected on deceased with primary and secondary brain damage in intensive care unit from 2002 to 2005

The number of potential organ donors depends on various factors, among which the number of deceased with primary or secondary brain damage is the most decisive. In the north-east donor region of Germany with 7.69 million inhabitants, 2019 cases of deceased with primary or secondary brain damage were reported by 136 intensive care units during 2002-2005. In a study, 64% of these deceased were identified as potential donors. This represents 40.7 potential donors per million inhabitants. It can be concluded that in the other donor regions of Germany a comparable number of potential donors exists, yet not all possible donors are being detected and referred. The conversion rate (percentage of potential donors who become effective donors) in the years 2002-2005 was 47%. The main reason for the conversion rate being so low was the large number of relatives who declined an organ donation (73%). More than 90% of the relatives in the north-east region did not know the deceased's will in the acute situation. From our point of view the high refusal rate can be decreased mainly by two measures: improvement of the family approach and integrating the topic of organ donation into schools' curricula.     

Changing patterns in organ donation in Eurotransplant, 1990–1994

Organ transplantation has become the treatment of choice for patients with end-stage organ failure and has led to progressive increases in the size of waiting lists over the past decade. Unfortunately, from 1990 to 1994, the number of organ donors remained stable while the number of organs transplanted from these donors increased by only 10%. In view of the severity of the current organ shortage, elderly individuals are increasingly being accepted as organ donors. The graft survival rate with kidneys from donors older than 55 years is 5% lower than that with kidneys from younger donors at 1 year and 9% lower at 3 years post-transplantation. Graft survival is also significantly lower with organs from donors who die from cerebrovascular accidents than it is with organs from donors whose cause of death is cerebral trauma. The number of patients waiting for a nonrenal donor organ has increased rapidly in the past 5 years, and an increasing number of donor kidneys are now being provided by multiorgan donors. The favorable graft survival rate with multiorgan donor kidneys, which is significantly better than that obtained with single organ donor kidneys, confirms their suitability for renal transplantation.     

History of deceased organ donation, transplantation, and organ procurement organizations

The historical development of deceased organ donation, transplantation, and organ procurement organizations is reviewed. The concept of transplantation, taking parts from one animal or person and putting them into another animal or person, is ancient. The development of organ transplantation brought on the need for a source of organs. Although many early kidney transplants used kidneys from living donors, these donors could not satisfy the ever-growing need for organs, and extrarenal organs were recovered only from deceased donors. This need for organs to satisfy the great demand led to specialized organizations to identify deceased donors, manage them until recovery occurred, and to notify transplant centers that organs were available for their patients. The functions of these organ procurement organizations expanded to include other required functions such as education, accounting, and compliance with state and federal requirements. Because of the shortage of organs relative to the demand, lack of a unified organ allocation system, the perception that organs are a national resource and should be governed by national regulations, and to improve results of organ procurement organizations and transplant centers, the federal government has regulated virtually all phases of organ procurement and transplantation.     

Impact of the OPTN transmissible diseases policy and US PHS increased risk donor guidelines on living donor candidates

Donor‐derived human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) transmissions in transplantation have led to policies mandating assessment of donor behavioral history, and disclosure of donor increased risk (IR) status to recipients. Organ Procurement Transplantation Network (OPTN) policy safeguards were promulgated in the context of deceased donation, with its narrow time window for organ utilization and uncertainty about donor history. These policies have been applied to living donation without substantive data on risk of disease transmission in living donor transplantation. Unlike for deceased donors, the OPTN does not collect data on living donor IR status. Given the feasibility of thorough living donor evaluation via already‐mandated lab tests and clinical assessments, living donor IR assessment and associated disclosures may have limited benefit in improving recipient informed consent. Applying the current IR policy to living donors may also introduce unintended consequences to donors and recipients, causing donors psychological harm, delays in donation to avoid IR status disclosure, and potential withdrawal from donation. We suggest strategies that reduce risk of harm to donor candidates while maintaining policy compliance, and review additional approaches for evaluating risk of disease transmission in living donor candidates. Data on the risk of disease transmission by living donors are needed to inform policy modification.     

Organ Donation and Utilization in the United States, 1996–2005

The success of clinical transplantation as a therapy for end-stage organ failure is limited by the availability of suitable organs for transplant. This article discusses continued efforts by the transplant community to collaboratively improve the organ supply. There were 7593 deceased organ donors in 2005. This represents an all-time high and a 6% increase over 2004. Increases were noted in deceased organ donation of all types of organs; notable is the increase in lung donation, which occurred in 17% of all deceased donors. The percentage of deceased donations that occurred following cardiac death has also reached a new high at 7%. The number of living donors decreased by 2%, from 7003 in 2004 to 6895 in 2005. This article discusses the continued efforts of the Organ Donation Breakthrough Collaborative and the Organ Transplantation Breakthrough Collaborative to support organ recovery and use and to encourage the expectation that for every deceased donor, all organs will be placed and transplanted.     

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.     

The organ procurement costs of expanding deceased donor organ acceptance criteria: Evidence from a cost function model

A potential solution to the deceased donor organ shortage is to expand donor acceptability criteria. The procurement cost implications of using nonstandard donors is unknown. Using 5 years of US organ procurement organization (OPO) data, we built a cost function model to make cost projections: the total cost was the dependent variable; production outputs, including the number of donors and organs procured, were the independent variables. In the model, procuring one kidney or procuring both kidneys from double/en bloc transplantation from a single-organ donor resulted in a marginal cost of $55 k (95% confidence interval [CI] $28 k, $99 k) per kidney, and procuring only the liver from a single-organ donor results in a marginal cost of $41 k (95% CI $12 k, $69 k) per liver. Procuring two kidneys for two candidates from a donor lowered the marginal cost to $36 k (95% CI $22 k, $66 k) per kidney, and procuring two kidneys and a liver lowers the marginal cost to $24 k (95% CI $17 k, $45 k) per organ. Economies of scale were observed, where high OPO volume was correlated with lower costs. Despite higher cost per organ than for standard donors, kidney transplantation from nonstandard donors remained cost-effective based on contemporary US data.     

Preliminary Marked Increase in the National Organ Donation Rate in Israel Following Implementation of a New Organ Transplantation Law

Israel's organ donation rate has always been among the lowest in Western countries. In 2008 two new laws relevant to organ transplantation were introduced. The Brain‐Respiratory Death Law defines the precise circumstances and mechanisms to determine brain death. The Organ Transplantation Law bans reimbursing transplant tourism involving organ trade, grants prioritization in organ allocation to candidates who are registered donors and removes disincentives for living donation by providing modest insurance reimbursement and social supportive services. The preliminary impact of the gradual introduction and implementation of these laws has been witnessed in 2011. Compared to previous years, in 2011 there was a significant increase in the number of deceased organ donors directly related to an increase in organ donation rate (from 7.8 to 11.4 donors per million population), in parallel to a significant increase in the number of new registered donors. In addition the number of kidney transplantations from living donors significantly increased in parallel to a significant decrease in the number of kidney transplantations performed abroad (from 155 in 2006 to 35 in 2011). The new laws have significantly increased both deceased and living organ donation while sharply decreasing transplant tourism.     

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.