CHAPTER III
Organ Donation and Utilization in the United States, 2004

Introduction

Organ donation is vital to the success of transplantation. Its importance has been underscored most recently by the Organ Donation Breakthrough Collaborative, which was initiated by U.S. Department of Health and Human Services Secretary, Tommy G. Thompson. The goal of the collaborative is to test and share organ donation best practices, as observed nationally by organ procurement organizations (OPOs) and large donor hospitals in the OPO service area. The collaborative has emphasized that the assessment of performance is given not only by OPO activity but also by a shared responsibility of the hospitals within the service area of the OPO to develop and implement highly effective organ donation systems. To better reflect the joint responsibility shared among these organizations, their collective performance is measured over the donation service area (DSA). DSA is the term used to define the geographical service area designated by the Federal Government and assigned to an OPO for recovery of organs from all hospitals in that region. In 2003, the most current year discussed in this report, there were 59 DSAs in the United States.

To adequately assess practices, it is necessary to develop and refine a setof standard metrics of organ donor analysis. These metrics reflect assessments of donor potential, rates of donation, timely notification of deaths to an OPO for evaluation of medical suitability, use of effective request practices, and donation rates based upon rates of conversion of potential to actual donors. This report will use all these tools to describe the activity of DSAs and the current state of organ donation in the United States. In the coming months, the collaborative will continue to focus on increasing the number of deceased donors and the donation rate as well as the number of organs transplanted per donor ( Table III-1 ). Definitions used in this report to describe the various steps in the organ donation process are provided in Table III-2. The sequence of events, from death to transplant, is illustrated in Figure III-1.

 

THE PATTERN AND PROFILE OF DECEASED ORGAN DONATION

The last decade has seen a steady increase in the number of deceased organ donors, from 5,099 donors in 1994, to 5,985 donors in 2000, and then to 6,455 in 2003 (Figure III-2) [Table 1.1]. This increase of approximately 3% per year has occurred in the face of decreasing in-hospital deaths (1).

 

In ongoing efforts to increase the number of donors, measures continue to be developed to better utilize older donors and donors with pre-existing medical comorbidities. On an organ-specific level, the only formal criteria for such donors are in kidney transplantation, where a subset of donors with a higher risk of graft failure has been designated as expanded criteria donors (ECD). In addition, a steady increase can be seen in the use of organs recovered from donors who sustained cardiac death [Table 1.1]. Donation after cardiac death (DCD) provided the initial source of organs in the early days of transplantation before brain death was clearly defined. The growth in the number of both ECD and DCD donors has been dramatic (Figure III-3) [Tables 2.1 and 2.2]. The number of older donors also grew markedly over the past decade, with donors aged 50-64 years increasing from 19% to 25% [Table 2.1]. In 2003, there was a net increase of 268 donors across all age groups compared with 2002. Over the past year, there were an additional 238 deceased donors age 50 years and older. Since 1996, more than 40% of donors each year have died of a cerebrovascular accident (CVA) or stroke. However, following a 77% increase in the number of deceased with CVA as cause of death donors between 1994 and 1999, the rate has risen by only 6% since 2000.

 

RECOVERY OF ORGANS

The changing characteristics of the donor pool appear to have resulted in an increase in the non-recovery of consented organs (Figure III-4). Non-recovery occurs because of unsuitable characteristics, such as medical history or poor organ function, or following surgical inspection of the organ in the operating room at the time of intended recovery. The number of non-recovered organs increased between 2002 and 2003, with the exception of liver [Tables 3.3, 3.6, 3.9, 3.12, 3.15, 3.18]. It is likely that the high recovery rate of livers for transplantation reflects recognition of the resilience of this organ to the effects of age and other stressors associated with transplantation. In 2003, there were 574 donors older than 65 years. From these 574 donors 5 hearts, 8 lungs, 519 livers, 2 pancreata, and 397 kidney were recovered for transplantation [Tables 2.1, 2.2, 2.3, 2.4,2.6, and 2.7]. While it is vital to make sure that every effort is directed to minimizing discarded organs and non-recovery, it is also important to understand that expanding the donor pool as it relates to a specific organ (e.g., liver), will make it appear that the discard rate of other organs is increasing, since the total number of donors will increase, while utilization of these donors may not be appropriate for other organs.

 

The accumulation of discarded kidneys over the past decade now exceeds 11,000 (Figure III-5). This figure suggests the possibility that further analyses into reasons for non-use might lead to practice changes resulting in improved into utilization [Table 3.2].

 

LIVING VERSUS DECEASED ORGAN DONORS

The number of living donors continues to exceed the number of deceased donors since 2001 [Table 1.1] (Figure III-6). However, it is also noteworthy that the rate of increase in living donors has not been sustained; instead, the number has almost plateaued [Table 1.1]. Among living kidney donors, women more commonly donate than do men [Table 2.9]. This imbalance of female to male living kidney donation has persisted throughout the past decade. In 2003, women constituted nearly 60% of living donors [Table 2.8]. In contrast, there have been more men who donate liver segments or lung lobes than women. However, the total number of living liver donors continued to fall in 2003 from a peak in 2001 [Tables 2.10 and 2.11] (Figure III-7). The number of living lung donors in 2003 was 29, also representing a continuing decline from a high 56 in 1999 [Table 2.11].

 

 

RELATIONSHIP OF THE LIVING KIDNEY DONOR TO THE RECIPIENT

In 2003, 32% of living kidney donors were either spousal or otherwise unrelated to the recipient [Table 2.9] (Figure III-8). This increase represents a continuing trend, and has been associated with excellent survival (Table III-3). The adjusted five-year allograft survival for an unrelated kidney transplant is not different than the survival achieved by the transplant of a kidney from a parent or child of the recipient, regardless of HLA mismatch (SRTR analysis, May 2004). These observations have influenced practice; there is little concern today about the degree of HLA match if a blood-type and cross-match compatible living donor can be identified, either known or, in some instances, unknown by the recipient.

 

ETHNICITY AND ORGAN DONATION

There are many factors associated with individual decisions to pursue or not pursue donation; one of the most frequently cited is the effect of race and ethnicity on donation. Examination of OPTN/SRTR data demonstrates that, over the last decade, the donor pool was derived from all races at a rate roughly proportionate to their distribution in National Census data [Table 2.1]. In 2003, African Americans represented 13% of the U.S. population and 14% of all organ donors. The distribution of kidney, liver, and heart donors by race was also proportionate [Tables 2.1, 2.2, 2.4, 2.6]. Organ donation by ethnicity also approximated the distribution in the general population, with the Hispanic/Latino population constituting 13% of all donors and 13% of the U.S. population. Over the last 10 years, there has been a gradual increase in the percentage of non-white, and Hispanic/Latino donors (Table III-4). While these data suggest that minority populations donate at a rate proportionate to their representation in the general population, this analysis does not reflect how many donor families were approached regarding donation, and how often consent was obtained. In this context, some studies have revealed a rate of donation significantly lower among the minority population (2,3).

A retrospective analysis performed by the Association of Organ Procurement Organizations (AOPO) from 1997 through 2000 provides useful insight regarding the impact of race on approach for donation, consent for donation, and actual donation. As shown in Figure III-9 , the percentage of potential donor families approached regarding consent ranged from 76% to 86% across all races. Families of white donors were more likely to be approached compared with non-white donors. (4)

 

For whites, consent for donation was granted only 61% of the time it was requested. For non-white donors, this consent rate was dramatically lower. Only 30% of families of Asian donors granted consent and 34% of African-American families granted consent. The combined effect of these factors is apparent when the organ donation rate is calculated by dividing the number of donors where at least one organ is recovered for the purpose of transplant by the total number of potential donors. Only 49% of white potential organ donors became actual donors. The donation rate is even lower in the minority population, with only 25% of all potential African-American organ donors and 23% of all Asian potential donors actually providing organs for transplant (4).

The effect of the lower donation rate in the minority population on the overall donor supply is illustrated in Figure III-10 . African-American and Asian individuals represented 21% and 4% of all potential organ donors, respectively, but only 12% and 2% of actual organ donors (4).

 

The reasons for lower donation rates in minority populations may include misinterpretation of religious tenets, distrust of the medical establishment, fear of premature declaration of death if a donor card had been signed, and concern among minority donors regarding the relative allocation of organs to minority recipients (5-12). Some investigators have suggested that a lack of understanding about the process generates a reluctance to donate, and that this reluctance is hidden under the guise of religious beliefs or mistrust of the medical system (13,14). Additionally, specific misconceptions about the process are perhaps more influential in the decision not to donate rather than a generalized lack of knowledge about transplantation and donation (5, 15, 16).

The lower donation rate in the minority population does not reflect a lack of need within these groups for transplantation. Figure III-11 illustrates the relative distribution of race within the U.S. population compared with the kidney, pancreas, and kidney-pancreas waiting lists [Tables 5.1, 6.1, and 8.1]. The representation of African Americans on the kidney transplant waiting list is nearly threefold higher than that found in the general population, undoubtedly reflecting the higher incidence of hypertension and diabetes in this population. Figure III-12 demonstrates a similar analysis for the heart and liver waiting lists [Tables 9.1 and 11.1]. Again, all races are represented on both waiting lists, though the percentage of whites on the liver waiting list is slightly higher relative to the percentage of whites in the overall population. Conversely, there exists a higher percentage of African-Americans on the heart waiting list. As with the kidney waiting list, this finding may reflect, at least in part, a difference in the incidence of end-stage liver and heart disease or a difference in access to care in these populations.

 

 

ASSESSING DONOR POTENTIAL

Although the number of organ donors and resulting transplants in the United States is easily tallied, the number of individuals who could become organ donors across the country can only be estimated (Figure III-13; SRTR analysis, June 2004). Several estimates of donor potential have relied on retrospective reviews of hospital medical records of deceased patients. The AOPO has spearheaded a multi-year chart review study with submission of data from more than 30 DSAs. The study, published in 2003, estimated that from 1997 to 1999 the annual number of brain-dead potential organ donors was between 10,500 and 13,800 (4).

 

Implicit in the AOPO chart review process or in any attempt to study organ donation is the need for the definition of a medically suitable organ donor. Consensus on the definition of what constitutes such a donor is not easily reached, because wide variation exists in the acceptance of organs among transplant centers and regions. Without a consistent definition by which to report data, comparisons across DSAs must be examined in the context of a broader array of measures and information.

In an attempt to quantify the number of medically suitable organ donors, the OPTN currently defines the term eligible death as a patient 70 years old or younger who, prior to death, is reported by a hospital to an OPO, and who is ultimately declared brain dead according to hospital policy independent of family decision regarding donation or availability of next-of-kin, independent of medical examiner or coroner involvement in case, and independent of local acceptance criteria or transplant center practice. Furthermore, this patient exhibits no absolute contraindication to organ donation, such as metastatic cancer or seropositivity for human immunodefiency virus. By restricting the pool to ages 70 years and younger who are reported by the hospital to the OPO, donors over the age of 70 years are excluded from this definition, as are patients who are declared brain dead, meet criteria, but are never reported to the OPO. This definition also excludes patients who never meet brain death criteria, but who might be considered for donation after cardiac death.

Since 2001, OPOs have been submitting monthly data to the OPTN on the number of referrals (deaths or imminent deaths) received from hospitals and the number of eligible deaths in their service area. These data are combined with OPTN data on total deceased donors recovered and reported by each DSA to the OPTN. Deceased donors comprise "actual" donors, who meet the criteria of eligible death, and "additional" donors, who are outside the definition of eligible death, e.g., the patient was over 70 years old or died after cardiac arrest. OPOs were able to see data for their own DSAs on a secure SRTR website for six months and encouraged to check and report discrepancies that appeared. In January 2004, DSA-specific data on referrals, eligible deaths, consents for donation, total deceased donor (including both actual and additional donors) and donation rates became publicly available on line at www.ustransplant.org.

REFERRALS, ELIGIBLE DEATHS, AND ACTUAL DONORS

In 2002 and 2003, U.S. hospitals referred more than one million deaths or imminent deaths to the OPOs in their DSA. Referrals increased by nearly 10% from 2002 to 2003 (1,022,280 to 1,121,392), likely because of ongoing efforts to ensure that hospitals comply with the conditions of participation developed by the Centers for Medicare & Medicaid Services (CMS). These conditions require hospitals to refer all deaths in a timely manner to their local OPO. The AOPO Death Record Review study corroborates this trend of increasing referrals, and the latest available data from the study suggest that, in 2001, 89% of all potential organ donors were referred, up from a 76% referral rate in 1997.

Despite the increase in the number of referrals, the number of eligible deaths reported remained virtually flat from 2002 to 2003: 12,015 in 2002 and 12,031 in 2003 (SRTR analysis, June 2004). The number of eligible deaths reported for 2002 and 2003 is consistent with the estimated number of potential organ donors from published chart review studies (4). It is important to recall that the approximately 10% of AOPO potential donors patients were never referred to the OPO and would be absent from these data, as would be patients over the age of 70 years, those who sustain cardiac death, and patients excluded because of their medical history or other clinical parameters.

Consents increased 4% and actual donors rose 3% from 2002 to 2003. The donation rate (defined as number of actual donors divided by the number of eligible deaths) increased from 48% in 2002 to 49% in 2003. In sharp contrast to this overall modest growth, the number of "additional" donors (those over the age of 70 years or donors after cardiac death) rose 23%, from 444 in 2002 to 547 in 2003 (SRTR data analysis, May 2004; Table III-1).

DIFFERENCES IN POTENTIAL AND DONATION BY DSA

A comparison for 2003 across the 59 DSAs is complicated by the fact that DSA population, number of transplant centers and patients, and geographic coverage vary dramatically. In prior years, performance was measured and compared across DSAs using the standard metric "organ donors per million population." Although it was easily calculated, the per million living population was inherently flawed and potential organ donors per million varies dramatically across DSAs (17). The AOPO Death Record Review study reported a more than two-fold difference in potential donors (using AOPO criteria) per million at the DSA-level. Based on data from 16 DSAs over a three-year period, the number of potential donors per year ranged from 28 to 63 per million population (mean, 41). The number of deceased donors per year ranged from 16 to 28 per million population (mean, 20) and the donation rate for the 1997-1999 period ranged from 32% to 58% (mean, 49%.) The study found no significant relationship between the number of donors per million population and the donation rate (R2=0.124) (4).

Despite SRTR/OPTN data showing an essentially flat number of eligible deaths from 2002 to 2003 at the national level, comparing the reported number of eligible deaths across DSAs for 2002 and 2003 illustrates enormous variability year-to-year in the underlying donor potential at the DSA-level. Seventeen DSAs experienced at least a 10% increase from 2002 to 2003 in eligible deaths, while 15 DSAs experienced at least a 10% decrease in eligible deaths. The remaining 27 DSAs had eligible deaths in 2003 within 10% of their 2002 number. The 2002 to 2003 changes ranged from a 43% decrease in eligible deaths to a 47% increase in eligible deaths. Across all DSAs, the total increase in eligible deaths from 2002 to 2003 was 16, representing a 0.1% increase overall (SRTR analysis, August 2004).

Donation rates at the DSA level also vary dramatically. The 2003 national donation rate (calculated as actual donors divided by reported eligible deaths) was 49%, but donation rates within the 59 DSAs ranged from a low of 31% to a high of 85%. Twenty-six DSAs fell below the national average, three were at the national average, and 30 were above the national average donation rate for 2003. It bears repeating that these comparisons must be undertaken within the context of acknowledging the lack of consistent baseline definitions for data reporting; it must be considered, too, that these rates do not account for donors over the age of 70 years, donors after cardiac death, or potential organ donors who are not referred to the OPO (SRTR analysis, August 2004).

DIFFERENCES IN PROCUREMENT AND UTILIZATION

Although there have been several proposals [Joint Commission on Accreditation of Healthcare Organizations white paper (1), Crystal City conference (18), and Health and Human Services Collaborative] to encourage best practices in organ donation, wide variations exist in the number of organs recovered and transplanted across UNOS regions (1).

Donation After Cardiac Death

These differences are particularly evident among donors after cardiac death (all organs). Twelve DSAs accounted for 77% of DCD; 23 DSAs accounted for the remaining 23% of DCD; and 24 DSAs had no DCD in 2003 (SRTR analysis, May 2004). In the DSA with the largest fraction of DCD, such donors comprised over 23% of the DSAs deceased organ donors in 2003, an increase of 93% in deceased organ donors over the prior year. Nationally, the increase in DCD recoveries has been dramatic (all organs) (Figure III-14). This subset of donors has increased by 43%, from 189 donors in year 2002 to 271 donors in 2003  [Table 2.1 and 2.2].

 

During the last decade, there were 1,180 occurrences of DCD. The number of donors after cardiac death increased steadily through this period, with 57 in 1994 and 271 in 2003 [Table 2.1]. This decade of experience progressed in two distinct eras (Figure III-14). During Era 1 (1994 through 1998) there were 345 total DCD (average=69/year) of which 340 (average=68/year) donated kidneys [Table 2.2]. In Era 2 (1999 through 2003), the number of DCD increased to 835 (average=167/year), of which 800 (average=160/year) donated kidneys. The absolute number of DCD increased dramatically in the last two years, from 189 cases in 2002 to 271 cases in 2003 (Figure III-14; SRTR analysis, May 2004).

While DCD organs make up a small fraction of organs recovered for transplant, they appear to be good quality organs. The number of organs transplanted per donor versus the number of organs recovered per donor for DCD is 2.04 versus 2.57. This translates to approximately 79% of organs recovered from DCD donors being transplanted, which compares favorably with non-DCD (89%). Among kidney donors, 82% of DCD organs recovered are transplanted, which is significantly greater than the 62% of recovered kidneys transplanted from ECD (Table III-5). The difference in the number of recovered kidneys transplanted between DCD and ECD donors likely represents the better medical condition of DCD donors compared with ECD donors. Nonetheless, despite these observations, as well as increasing experience with DCD kidneys and several reports that support the use of intra-abdominal organs from DCD, relatively few OPOs currently perform DCD recoveries (SRTR analysis, May 2004).

Between 1999 and 2003, 44 of 59 OPOs reported at least one DCD recovery. Of these 44 OPOs, 26 accounted for 95% of DCD activity, and 18 of these OPOs handled five or fewer DCD cases in either era (SRTR analysis, May 2004). In 2003 only eight OPOs performed 10 or more DCD recoveries.

Some instances of DCD also have characteristics that fulfill expanded kidney donor criteria. Among the 256 DCD kidney donors in 2003, 46 (18%) also fulfilled ECD criteria [Table2.2].

Heart

The number of hearts recovered declined from a peak of 2,525 in 1994 to 2,121 in 2003 [Table 3.13] (Figure III-15). The heart is one of the most highly utilized organs after recovery, with a discard rate of only 1% after procurement. The regional variation of use for this organ is minimal, with only seven DSAs having less than 95% of recovered hearts transplanted. The number of shared hearts across DSAs since 1997 has remained constant, between 30% and 35% [Table 3.13]. However, after consent the number of hearts not procured doubled from 1,292 in 1994 to 2,601 in 2003 [Table 3.15]. This increase in the turndown rate probably reflects a change in number of donors with a CVA as cause of death. Recent reports of hormonal resuscitation to stabilize donors may allow for a further increase in utilization of cardiac donors in the future (19).

 

Lung

In 1994 compared with 1,772 procured in year 2003 [Table 3.16] (Figure III-15). The number of lungs shared across DSAs has remained constant at about 40% for the last three years. Similar to the cardiac experience, the decline in the number of lung offers is notable, as non-recovery of consented organs has increased from 6,321 in 1994 to 8,521 in 2003 [Table 3.18]. Two thirds of donors were turned down because of poor lung function. Although the mean number of organs transplanted was 1.76 lungs per donor nationwide, four DSAs transplanted fewer than 1.5 lungs per donor, and three DSAs had zero lung donors. (SRTR Analysis, May 2004)

Liver

Liver procurement has continued to increase each year, from 4,093 donors in 1994 to 5,680 donors in 2003 (Figure III-16). In 2003, there was an increase of 7% compared with year 2002 [Table 2.4]. A continual increase has been seen in donors 50-64 years of age. The number of livers recovered from donors ages 50-64 years doubled since 1994, from 680 to 1,348 liver donors in 2003, with a 30% increase in just the last five years, from 1,036 in 1999 to 1,348 donors in 2003. Similar trends are seen in the procurement of livers from donors over 65 years of age, with the number of liver donors increasing from 164 in 1994 to 519 this past year. The most dramatic increase has been in the number of livers obtained from DCD donors in the last five years, 38 (0.8%) in 1999 were DCD donors compared with 158 (3%) in 2003 [Table 2.4].

 

Overall, compared with other abdominal transplants, there is high utility for liver, with only 4% of recovered organs discarded [Table 3.7 and 3.8]. The majority of organs discarded were because of biopsy results. In addition, 548 consented donors did not undergo procurement, predominantly because of issues pertaining to graft quality [Table 3.9]. Not surprisingly, the non-procurement rates were higher among older donors and DCD donors compared with donors less than 60 years old.

Intestine

Of the many types of transplant procedures, intestinal transplantation is performed least often and only by a small number of centers. Two thirds of the recovered organs are transplanted outside the DSA in which they were recovered. In 2003, 122 intestines were recovered [Table 3.10].

Kidney

The number of kidneys procured has continued to show a slight increase, approximately 2% each year [Table 3.1], mirroring the increase in the number of donors each year. Although in recent years the increase in kidney donation appears, in large part, because of increased numbers of older or expanded criteria donors, the percentage of procured kidneys that are discarded and the frequency of the reasons given for discard have remained essentially unchanged since 1995. Each year, 10%-14% of recovered kidneys are discarded [Table 3.2]. Adverse biopsy result is the reason given for discard for approximately 40% of discarded recovered kidneys. However, the characteristics of a donor kidney biopsy that predict the quality of organ function are not universally accepted (20-24). An additional 25% of recovered kidneys are declined based on clinical judgment, with reasons for declining classified as "organ unsatisfactory" or "poor organ function/infection."

Similar to the thoracic experience, the number of kidneys not recovered after consent was obtained has increased each year. Only 469 donor organs were not recovered after consent in 1994 compared with 1,053 in year 2003. In 1994, only 44% of the non-recovered kidneys were deemed unsatisfactory or had poor organ function; however, in the more recent era, 1999-2003, almost 60% met these criteria. [Table 3.3].

Pancreas

Pancreas procurement seems to have plateaued in the last few years at approximately 1,800 per year from 2000 to 2003 [Table 3.4] (Figure III-16). The discard rate is almost twice that of renal organs, approximately 17% of recovered pancreata. As with kidneys, the majority of the discards are because of concerns about poor quality. Among recovered pancreata that were discarded in 2003 unavailability of the recipients was the reason for discard in 14% of cases [Tables 3.2 and 3.5]. An additional 10% of pancreata were not recovered after consent, because recipients were unavailable (SRTR analysis, May 2004) [Table 3.6].

Expanded Criteria Kidney Donors

OPTN policy 3.5.1 defines ECD as a kidney donor older than age 60 years, or between ages 50 and 59 years and including one of the following medical criteria: died from a stroke, had a history of hypertension, or had a serum creatinine greater than 1.5 mg/dl at the time of death. Overall in 2003, the number of ECDs increased by 8% to 1,169 kidney donors compared with a 1% decrease among standard criteria donors (SCD) for kidney (SRTR analysis, May 2004).

The national mean of kidneys recovered per donor was constant at 1.99 for SCD, DCD, and ECD; however, the transplant rate was only 1.83, 1.63, and 1.24 kidneys per donor, respectively. Utilization of recovered organs varied widely. In the past, the criteria for ECD had been left to the interpretation of individual centers. Several reports suggested that outcomes of renal allografts from donors who are older and/or have hypertension, died from a CVA, or have elevated creatinine had a lower graft survival rate. While the intent has been to increase the use of these organs and to ensure candidates are informed about ECD transplant outcomes, the mean number of kidneys transplanted from ECD donors was only 1.24 compared with 1.78 organs from all donors less than 60 years of age. The number of kidneys transplanted from ECD donors may represent an underestimate. Some centers transplant both kidneys from a single ECD donor into a single recipient and count this procedure as a single transplant. However, for accounting purposes, OPOs count both kidneys separately as recovered organs. The regional variation was greatest in ECD organs, with many programs having a more conservative clinical practice. Of 59 OPOs, 23 (39%) reported transplant rates for ECD kidneys in their DSAs of less than 1.20 kidneys per donor, with 12 (20%) reporting a rate of 1.0 or less.

POTENTIAL FOR DEFINING EXPANDED CRITERIA LIVER DONORS

There are several deterrents that prevent procurement and transplant of livers from expanded donors. The most limiting factor is the lack of objective criteria, e.g., cardiac anatomy and function for hearts or oxygen challenge in lungs, that can be uniformly applied. The decision to use a particular donor liver continues to be subjective and is best described by Heaton and colleagues, who note the decision is not proven right until after transplant (25). These decisions are made given the reality that no reliable support exists for a failed liver and that even the best clinical judgment may result in the need for retransplant of the recipient.

Expanded criteria for kidney donors were developed based on lower graft survival in certain categories. Similarly, criteria could be developed for liver donors to allow for improved use of liver grafts and better information for recipients. In most instances, the decision to procure and transplant a graft is based on a constellation of clinical data. Each one of these factors by itself may not jeopardize outcome. None of the functional tests (such as the MEGx test, which utilized lidocaine metabolism) have withstood the test of time (26).

One potential criterion is donor age. Liver donor age has increased steadily over time. Although initial studies suggested that organs from donors older than 50 years have poor outcomes, more recent studies indicate that only donors older than 65 or 70 years have lower patient and graft survival at two years. Rull et al reported a higher rate of graft loss in recipients who received grafts from donors older than 65 years, in particular, if there are other factors such as steatosis on the liver biopsy. If the recipient had a difficult surgery with a blood replacement requirement greater than 10 units, one-half of the grafts failed early in the post-transplant course (27). In a more recent report (2001), Busquets et al observed that liver allografts from donors older than 70 years had a six-month survival of 56%; survival at 54 months was 25% (28). DebRoy et al have demonstrated an important interaction between older donor age and prolonged cold ischemia time, such that the combination is associated with particularly poor outcome (29).

Another likely criterion would be the degree of steatosis. The escalating incidence of obesity among the general population suggests that steatosis could be an increasing concern in evaluating donor livers. The reported incidence is estimated to be between 9% and 26%. Steatotic livers have been associated with an increased incidence of poor graft function and primary non-function. There is consensus that grafts with greater than 60% fat should not be used for transplant (30). In a time-matched control study Marsman et al have shown that grafts with moderate steatosis up to 30% have decreased graft survival at four months and also decreased patient survival at two years (31). Recent studies report no increased risk from using grafts with microvesicular steatosis (32). However, the interpretation of fat on biopsy is subject to the judgment of the local pathologist and transplant surgeon.

Other widely accepted clinical criteria that increase risk of non-function include ICU stay greater than five days, particularly without nutritional support; hypernatremia with serum sodium greater than 160 mEq/dL; hypoxia; vasopressor use with an increase in liver chemistries; and prolonged cold ischemia time. Cause of death does not appear to be a predictor of non-function among liver donors.

In addition to these donor-specific criteria, the decision whether to use a liver from a extended donor must take into account the severity of illness of the intended recipient. Such grafts placed into severely ill recipients provide a recipe for a dismal outcome, suggesting that these grafts should be directed away from recipients with high MELD scores, perhaps greater than 30 (33). On the other end of the illness scale, recent data presented by Merion et al suggest that those candidates with a MELD score less than 15 had a higher risk of mortality with transplant than did medically managed patients on the waiting list (34). Clearly, the use of an extended donor liver in these healthier candidates is not in the best interest of that individual candidate. It may be reasonable to offer such livers first to recipients with a MELD score between 15 and 30, after obtaining informed consent. As more data are collected these criteria may need to be modified.

SUMMARY

This chapter provides an overview of organ donation trends in the United States. Recently, the number of deceased donor organ recovered per year has been increasing gradually. Non-traditional donor sources have experienced a much larger rate of increase; the number of ECD kidney donors has increased 8% and the number of DCD donors has increased 43% during the past year (Figure III-3). The relative percentage of Hispanic and African American donors has trended upward as well. Although the number of living donors continues to exceed the number of deceased donors, the rate of growth from this source was smaller in 2003 (Figure III-6). Unrelated living kidney donation has been shown to achieve excellent graft survival. Currently, unrelated donors comprise over 30% of all living kidney donors.

The number of potential donors in the United States is estimated to be between 10,500 and 13,800 (4), which is consistent with the number of eligible deaths reported by DSAs nationwide. Despite the fact that the total number of eligible deaths remained flat in 2003, there exists a large amount of variability in donor potential at the DSA-level. Donation rates among DSAs also vary considerably — although these rates currently do not account for DCD or donors above 70 years of age.

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CONTRIBUTORS

The following individuals prepared this chapter: Francis L. Delmonico¹, MD; Ellen Sheehy², MPPM, MAR; William H. Marks³, MD, PhD; Prabhakar Baliga⁴, MD; Joshua J. McGowan⁵, MS; John C. Magee⁶, MD. ¹Massachusetts General Hospital; ²Association of Organ Procurement Organizations; ³Swedish Medical Center; ⁴Medical University of South Carolina (MUSC) Medical Center; ⁵Scientific Registry of Transplant Recipients / University Renal Research and Education Association; ⁶Scientific Registry of Transplant Recipients / University of Michigan.