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The Allocation of Cadaver Kidneys for Transplantation in the United States: Consensus and Controversy

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The Allocation of Cadaver Kidneys for Transplantation in the United States: Consensus and Controversy SPECIAL ARTICLE J Am Soc Nephrol 10: 2237–2243, 1999 The Allocation of Cadaver Kidneys for Transplantation in the United States: Consensus and Controversy JOHN F. NEYLAN, MOHAMED H. SAYEGH, THOMAS M. COFFMAN, GABRIEL M. DANOVITCH, ALAN M. KRENSKY, TERRY B. STROM, LAURENCE A. TURKA, and WILLIAM E. HARMON, FOR THE ASN TRANSPLANT ADVISORY GROUP The development of organ transplantation as a widely available 7,061 cadaver and 1,812 living donor transplants were per- and clinically effective therapy has provided an enormous formed (3). Currently, there are 41,744 patients enrolled on the benefit for the care of patients with end-stage renal disease cadaver waiting list (a 200% increase), while only 8,938 ca- (ESRD). One-year cadaver donor graft survival rates have daver donor renal transplants (a 24% increase) were performed improved from 52% to nearly 90% between 1977 and 1998 in the United States last year (4) (Figure 3). The average (1,2). Such outcomes have encouraged more patients to request waiting time for cadaver donor renal transplants has increased transplantation as their preferred mode of therapy. Unfortu- to more than 1000 days, with some groups, such as African- nately, the number of cadaver donors has not increased at an Americans, waiting substantially longer. If the waiting list equivalent rate to meet the expanded demand. The problem is increases by 20% per year and the number of cadaveric kidney compounded further by the increasing prevalence of patients transplants remains below 10,000 per year, it is anticipated that treated for ESRD (2) (Figure 1). The widening gap between the by 2010 the mean waiting time for a transplant will approach number of renal transplant candidates and available donors is 10 years, unless there are dramatic advances in xenotransplan- shown in Figure 2. As the imbalance between supply and tation or tissue engineering. demand worsens, the allocation of donor organs to recipients Partly as the result of this lengthening waiting period, the becomes an increasingly important issue and the subject of use of living donors, especially living unrelated donors, has increasing controversy. The factors that have influenced the increased dramatically. Living-donor kidney transplants ac- development of organ donation, recovery and allocation, and counted for 31% of all transplants in 1998 (4), and the number consequent access to renal transplantation in the United States of “emotionally related” donations has increased sevenfold in are complex. The present system is dependent on volunteerism, the past decade (3). In addition, expanded criteria of medical public trust, and a continued assessment of outcomes to acceptability of cadaveric donors have been utilized with achieve a difficult balance of equity and justice. greater frequency; and newer experiments, such as proposals This report summarizes the history and development of for donor exchanges between blood type mismatched but oth- cadaver kidney allocation in the United States and is meant to erwise suitable living donor-recipient pairs (5), age matching serve as a background overview. The American Society of for elderly recipients (6–8), and paired kidney transplants Nephrology (ASN), as a professional organization whose (9,10) have all occurred because of the increasing discrepancy members are responsible for patients who are dependent on the between the number of donors and candidates for kidney fair allocation of cadaver kidneys for transplantation, must transplantation. develop a position on this difficult issue. The ASN Transplant Advisory Group has initiated the process with this overview and proposes that the ASN develop an official position on Structure and History of Kidney Allocation kidney organ allocation by the year 2000. Organ Procurement Organizations Organ Procurement Organizations (OPOs) developed in the Donor Shortage 1960s as a result of the increasing success in the transplantation At the end of 1988, there were 13,943 people waiting for of cadaveric kidneys. In the early days, these organizations cadaver kidney transplants in the United States. In that year, resulted from the voluntary collaborative efforts of multiple transplant programs in a localized geographic area. After the passage of federal law creating the Medicare entitlement pro- gram for patients with ESRD in 1972, the proliferation of Received June 23, 1999. Accepted July 16, 1999. kidney transplantation as a federally funded therapy for ESRD Correspondence to Dr. William E. Harmon, Nephrology Division, Childrens and the consequent demand for more donor organs stimulated Hospital, 300 Longwood Avenue, HU 217, Boston, MA 02115. Phone: 617- 355-0129; Fax: 617-232-2949; E-mail: [email protected] a dramatic increase in the number of OPOs nationwide. In the 1046-6673/1010-2237 latter half of the 1970s, Medicare funding became available for Journal of the American Society of Nephrology independent as well as hospital-based OPOs, leading to further Copyright © 1999 by the American Society of Nephrology refinements of these operations. Today, there are 65 active 2238 Journal of the American Society of Nephrology J Am Soc Nephrol 10: 2237–2243, 1999 many states. Beginning January 1, 1996, the Health Care Financing Administration required that an OPO include an entire state or territory, or that it recover organs from at least 50 potential or 24 actual donors per calendar year (11). There appears to be variable performance of OPOs across the country when assessed according to the traditional, al- though increasingly contested, productivity measure of organs procured per million base population. Based on the 5,788 cadaveric donors from whom organs were recovered in 1998 and an estimate of the U.S. census at 272.6 million population, the national average is 21.2 donors per million population per Figure 1. Living end-stage renal disease (ESRD) patients on Decem- year. The wide range for individual OPOs varies from approx- f ber 31 by year and treatment modality. , number of dialysis patients; imately 10 to 40 donors per million. Some of the difference u, number of patients with functioning transplants. Adapted from may be related to substantial regional differences in medically reference (2). suitable organ donor candidates, differences in automobile fatality rates, and the incidence of homicide and other trau- matic causes of death. Also, there appear to be cultural differ- ences in attitudes toward donation as well as differences in permission rates between rural and urban areas. Thus, newer performance measures based instead on numbers of medically suitable candidates are being proposed to more accurately define OPO productivity. Nonetheless, it is clear that some OPOs have taken a leadership role in developing more inno- vative educational programs and in the implementation of new protocols, such as recovery of organs from non-heart-beating donors (12–14). Comprehensive death audits of hospital records have yielded Figure 2. Number of candidates for cadaver kidney transplants (u) considerably higher estimates of medically suitable donors and the number of cadaver kidney donors (f) in the United States than the current national average, perhaps as high as 55 donors from 1988 to 1998. Each donor may contribute two kidneys, so the per million (15). Thus, actual conversion rates of suitable number of transplants is greater than the number of donors. Adapted donors may be less than 50% of the maximal potential. In from references (3) and (4). 1998, in an effort to enhance potential donor identification and conversion to actual organ recovery, the Department of Health and Human Services (DHHS) issued a rule for conditions of hospital participation in Medicare that required hospitals to notify OPOs of all potential deaths. This rule was based on an experiment in Pennsylvania that demonstrated enhanced donor identification and conversion when experienced OPO staff were able to contact donor families and direct the request for donation (16,17). Some have suggested that the 5.6% increase in cadaver donors for 1998 may be in part attributable to the implementation of this new rule nationwide. However, even with such measures in place, family refusals remain the most significant barrier to donation, turning down, on average, more than one out of every two requests for organ donation (18,19). f u Figure 3. Number of cadaver donor ( ) and living donor ( ) renal Public attitudes and behavior thus remain a significant hurdle. transplants performed in the United States from 1988 to 1998. Adapted from references (3) and (4). National Organ Transplant Act In 1984, Congress passed PL 98-507, known as the National Organ Transplant Act (NOTA), which prohibited the sale of OPOs servicing defined regions throughout the United States. human organs, established grants for OPOs, and called for the There is, however, no universally accepted structure for an establishment of a national system of organ sharing. In addi- OPO. For example, some OPOs service a small geographic tion, NOTA created a multidisciplinary task force to conduct area and a single transplant center, whereas other OPOs serve an examination of organ donation and transplantation. The task as many as six states or more than 15 transplant centers. In force’s extensive list of recommendations included the setting some areas of the country, there are multiple OPOs within one of performance standards for OPOs and transplant centers, as state or even one city, whereas in others a single OPO serves well as the establishment of protocols within hospitals dealing J Am Soc Nephrol 10: 2237–2243, 1999 Cadaver Kidney Allocation 2239 with brain death and organ donation (20). One important outgrowth has been the Uniform Anatomical Gift Act, now established in every state, which maintains the right of every individual aged 18 years or older to donate organs or tissues for purposes including transplantation. The legislation further es- tablishes the right of the individual to designate such direction before death and validates the legality of such methods of declaration as the organ donor card.
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