Circulatory death determination in uncontrolled organ donors: a panel viewpoint.

One barrier for implementing programs of uncontrolled organ donation after the circulatory determination of death is the lack of consensus on the precise moment of death. Our panel was convened to study this question after we performed a similar analysis on the moment of death in controlled organ donation after the circulatory determination of death. We concluded that death could be determined by showing the permanent or irreversible cessation of circulation and respiration. Circulatory irreversibility may be presumed when optimal cardiopulmonary resuscitation efforts have failed to restore circulation and at least a 7-minute period has elapsed thereafter during which autoresuscitation to restored circulation could occur. We advise against the use of postmortem organ support technologies that reestablish circulation of warm oxygenated blood because of their risk of retroactively invalidating the required conditions on which death was declared.

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.

Family initiated discussions about organ donation at the time of death.

Some family members initiate organ donation discussions before being approached by donor coordinators or healthcare providers. We examined differences between families that did vs. did not initiate organ donation discussions and factors predicting donation consent among those families that self-initiated the discussion. Next-of-kin of donor-eligible individuals (147 donors, 138 non-donors) from one organ procurement organization completed a telephone interview. Seventy-three families (25.6%) first mentioned organ donation, and 54 (74%) of them consented to donation. Several characteristics of the deceased and next-of-kin were associated with whether family members initiated the donation discussion with donation coordinators or healthcare providers. Moreover, family mention of donation was more likely to yield consent when the deceased was younger (OR=0.95, CI=0.92-0.99), next-of-kin was a registered donor (OR=3.86, CI=2.84-6.76), and when family was more satisfied with the healthcare team (OR=1.20, CI=1.04-1.39). Knowing the deceased's donation intentions and being exposed to positive organ donation messages are more likely to trigger families to raise donation with providers. Organ procurement organizations (OPOs) and healthcare providers should work collaboratively to develop strategies for how best to respond to families who initiate this conversation.

Liver transplantation using controlled donation after cardiac death donors: an analysis of a large single-center experience.

The use of donation after cardiac death (DCD) donors may provide a valuable source of organs for liver transplantation. Concerns regarding primary nonfunction (PNF) and intrahepatic biliary stricture (IHBSs) have limited the enthusiasm for their use. A retrospective analysis of 1436 consecutive deceased donor liver transplants performed between December 1998 and October 2006 was conducted. These included 108 DCD liver transplants, which were compared to 1328 transplants performed with organs from donors meeting the criteria for donation after brain death (DBD). The median follow-up was 48 months. The 1-, 3-, and 5-year patient survival and graft survival for DCD donors were 91.5%, 88.1%, and 88.1% and 79.3%, 74.5%, and 71.0%, respectively. The 1-, 3-, and 5-year patient survival and graft survival for DBD donors were 87.3%, 81.1%, and 77.2% and 81.6%, 74.7%, and 69.1%, respectively. Patient survival and graft survival were not significantly different between DCD donors less than 60 years old, DCD donors greater than 60 years old, and DBD donors. Causes of graft loss included IHBSs (n = 9), PNF (n = 4), recurrent hepatitis C virus (n = 4), hepatic artery thrombosis (n = 1), rejection (n = 2), and patient death (n = 13). Contrary to previously published data, excellent long-term patient survival and graft survival can be obtained with DCD allografts, and in our experience, they are equivalent to those obtained from DBD allografts.

Relationship of exposure to organ donation information to attitudes, beliefs, and donation decisions of next of kin.

CONTEXT: Public education campaigns about organ donation are common, but their association to actual attitudes, beliefs, and decisions about organ donation among family members of donation-eligible individuals is unknown. OBJECTIVE: To examine the sources of organ donation information identified by donor and nondonor families who participated in a large-scale study to examine factors that influence organ donation decisions. DESIGN: Semistructured telephone survey conducted after a passive recruitment strategy. SETTING AND PARTICIPANTS: Participants were 285 next of kin of donor-eligible individuals (147 donors, 138 nondonors) from one organ procurement organization. RESULTS: Most (85.6%) of next of kin were exposed to at least 1 source of donation information that was important to them, although the types of donation information they were exposed to varied widely. White and educated adults were more likely to have been exposed to more donation information than had minorities and persons with less education. Favorable attitudes and beliefs about organ donation, donor designation, and sharing donation intentions with others were all associated with more exposure to different types of donation information. Donation consent was more likely when next of kin had been exposed to more donation information in the months preceding the family member's death. CONCLUSIONS: When examined in the context of other recent research, these findings argue for continued development and implementation of public education campaigns for organ donation, with an emphasis on repeated exposure over time.

CMS oversight, OPOs and transplant centers and the law of unintended consequences.

The Health Resources and Services Administration launched collaboratives with the goals of increasing donation rates, increasing the number of organs transplanted, eliminating deaths on the waiting list and improving outcomes. The Center for Medicare and Medicaid Services (CMS) recently published requirements for organ procurement organizations (OPOs) and transplant centers. Failure to meet CMS performance measures could result in OPOs losing their service area or transplant centers losing their CMS certification. CMS uses analyses by the Scientific Registry of Transplant Recipients (SRTR) to evaluate a transplant center's performance based on risk-adjusted outcomes. However, CMS also uses a more liberal (one-sided) statistical test rendering more centers likely to qualify as low performing. Furthermore, the SRTR model does not incorporate some important patient variables in its statistical model which may result in biased determinations of quality of care. Cumulatively, there is much unexplained variation for transplant outcomes as suggested by the low predictive ability of survival models compared to other disease contexts. OPOs and transplant centers are unlikely to quietly accept their elimination. They may take certain steps that can result in exclusion of candidates who might otherwise benefit from transplantation and/or result in fewer transplants through restricted use of organs thought to carry higher risk of failure. CMS should join with transplant organizations to ensure that the goals of the collaborative are not inhibited by their performance measures.

Does family disagreement affect donation decisions by next of kin?

CONTEXT: Information about the relationship between family disagreement and donation decisions may facilitate development of strategies to help families resolve conflict and possibly increase donation consent rates. OBJECTIVE: To assess how family interactions influence next-of-kin decisions about organ donation. DESIGN: Semistructured survey. SETTING AND PARTICIPANTS: Next of kin of potential donors (147 donors, 138 non-donors) from 1 organ procurement organization participated in a semistructured telephone interview, answering questions about the presence and influence of others during decision making related to organ donation. RESULTS: When others were actively involved in the donation decision (68%), disagreement about the donation decision occurred in 32% of cases. Compared with families initially in agreement, families not in agreement were less likely to donate (P < .001), took longer to make a decision (P < .001), and were less likely to make the same decision now (P < .001). Family disagreement was significantly associated with having more family members involved in the discussion, characteristics of the deceased (younger age, not married, nonwhite race, fewer days in the hospital, trauma-related death), next-of-kin characteristics (less education, less favorable organ donation beliefs), not knowing the deceased's donation intentions, less satisfaction with the health care team, and perceptions of a less compassionate donation requester. CONCLUSIONS: Family disagreement occurred in one-third of donation approaches when other family members were present. Such disagreement is most likely to contribute to donation refusal when the deceased's donation intentions are unknown. Recognizing and assessing the nature of family disagreement may increase donation consent.

Pediatric organ donation: what factors most influence parents' donation decisions?

OBJECTIVE: To identify factors that influence parents' decisions when asked to donate a deceased child's organs. DESIGN: Cross-sectional design with data collection via structured telephone interviews. SETTING: One organ procurement organization in the Southeastern United States. PARTICIPANTS: Seventy-four parents (49 donors, 25 nondonors) of donor-eligible deceased children who were previously approached by coordinators from one organ procurement organization in the southeastern United States. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Multivariate analyses showed that organ donation was more likely when the parent was a registered organ donor (odds ratio [OR] = 1.4, confidence interval [CI] = 1.1, 2.7), the parent had favorable organ donation beliefs (OR = 5.5, CI = 2.7, 12.3), the parent was exposed to organ donation information before the child's death (OR = 2.6, CI = 1.7, 10.3), a member of the child's healthcare team first mentioned organ donation (OR = 1.4, CI = 1.2, 3.7), the requestor was perceived as sensitive to the family's needs (OR = 0.4, CI = 0.2, 0.7), the family had sufficient time to discuss donation (OR = 5.2, CI = 1.4, 11.6), and family members were in agreement about donation (OR = 2.8, CI = 1.3, 5.2). CONCLUSIONS: This study identifies several modifiable variables that influence the donation decision-making process for parents. Strategies to facilitate targeted organ donation education and higher consent rates are discussed.

When the donor says yes and the family says no.

Signed donor cards clearly demonstrate the donor's intention to donate organs after death. In many states, this donation cannot be rescinded by the next of kin, and organs can be recovered from the donor even if the family objects. The family usually does not object if the donor has signed an organ donor card, especially if the donor had discussed the issue with the family. In some situations, however, the family objects to donation despite the signed organ donor card. If the organ procurement organization pursues donation, adverse publicity and even legal action are possible. It can be a challenge for organ procurement personnel to deal with families who object to donation in the face of a signed organ donor card in a manner that will lead to successful organ recovery without adverse consequences. This article describes 4 cases where the donor had a signed organ donor card but the family initially objected to donation. Ultimately organs were recovered from 3 of these donors.

Patients' willingness to talk to others about living kidney donation.

BACKGROUND: Living donor kidney transplantation has several advantages for patients with end-stage renal disease. However, many patients are reluctant to pursue this treatment option, preferring instead to wait for a deceased donor organ. OBJECTIVE: To examine predictors of patients' willingness to talk to others about living kidney donation. METHODS: One hundred thirty-two adult patients awaiting kidney transplantation who were enrolled in a randomized trial examining the effectiveness of education on rates of live donor kidney transplantation completed a baseline rating of their willingness to talk to others about living kidney donation. Also, patients completed measures of knowledge and concerns about living donation and a rating of perceived health. RESULTS: Slightly more than half the patients (56.1%) had low willingness to talk to others about living donation. The following variables were associated with higher willingness to talk to others: white race (odds ratio, 3.31; confidence interval, 1.7-7.4), college education (odds ratio, 3.43, confidence interval, 2.0-5.6), fewer concerns about living donor kidney transplantation (odds ratio, 0.31; confidence interval, 0.2-0.6), and less favorable perceptions of their current health status (odds ratio, 4.31; confidence interval, 2.6-7.6). CONCLUSION: White race, more education, less concern about living donor kidney transplantation, and poorer perceived health are associated with greater willingness to talk to others about living kidney donation. These findings have important implications for educating patients about living donor kidney transplantation.

A randomized trial of a home-based educational approach to increase live donor kidney transplantation: effects in blacks and whites.

BACKGROUND: Blacks are disproportionately affected by chronic kidney disease, but are far less likely to undergo live donor kidney transplantation (LDKT) than whites. We assessed the differential effectiveness in blacks and whites of a home-based (HB) LDKT educational approach. STUDY DESIGN: A planned secondary analysis of a previously published randomized trial. SETTING & PARTICIPANTS: 132 patients (60 black, 72 white) approved for kidney transplantation at 1 kidney transplant center in the southeastern United States. INTERVENTION: Assignment to receive either standard clinic-based (CB) transplant education (n = 69) or CB plus an HB (CB + HB) LDKT education program (n = 63). The HB education program was culturally sensitive for blacks, including using a minority health educator, brochures that highlight minority transplant recipients and donors, and discussion of race-specific outcome data. OUTCOMES: Primary outcomes were proportions of patients with live donor inquiries, evaluations, and transplants 1 year after study participation. MEASUREMENTS: Medical record and questionnaire data. RESULTS: 69 patients were assigned to the CB group, and 63 to the CB + HB group. After 1 year, there were 96 living donor inquiries (72.7%), 62 living donor evaluations (47.0%), and 54 LDKTs (40.9%). Patients assigned to the CB + HB group were more likely to have had living donor inquiries (odds ratio [OR], 1.7; confidence interval [CI], 1.2 to 3.0), a living donor evaluated (OR, 2.7; CI, 1.4 to 5.4), and LDKT (OR, 3.0; CI, 1.5 to 5.9). The effect was greater in blacks than whites for living donor evaluations and LDKT, but not for living donor inquiries (treatment-by-race interaction, P < 0.001, P < 0.001, and P = 0.8, respectively). Blacks in the CB + HB group were more likely to have had at least 1 living donor inquiry (51.7% versus 77.4%), at least 1 living donor evaluated (17.2% versus 48.4%), and LDKT (13.8% versus 45.2%) than those in the CB group. By comparison, whites in the CB + HB group were more likely to have had at least 1 living donor inquiry (72.5% versus 87.5%), at least 1 living donor evaluated (47.5% versus 71.9%), and LDKT (42.5% versus 59.4%) than those in the CB group. LIMITATIONS: Single-center study with greater dropout rate in the CB + HB group. CONCLUSIONS: These results suggest that a culturally sensitive LDKT education program that reaches out to blacks and their social support network can overcome some barriers to LDKT in this population.

Intention to register as organ donors: a survey of adolescents.

BACKGROUND: Little is known about factors that influence the intention of adolescents to register as organ donors. The identification of such factors has important implications for the development and implementation of educational programs and subsequent donor registration rates. OBJECTIVE: To determine whether adolescents with an expressed commitment to becoming organ donor registrants differ significantly from nondonors on sociodemographic characteristics and factors influencing their decision. PARTICIPANTS: Four hundred forty-five adolescents visiting a Department of Motor Vehicles office for a permit or license (n=153) or attending a driver's education course (n=292) completed a semistructured interview and questionnaire. RESULTS: Female (52.6%) and white (55.8%) adolescents were more likely to have favorable donation intentions relative to male (45.6%) and nonwhite (39.0%) adolescents (chi2 = 7.5, P = .02, and chi2 = 19.7, P = .003, respectively). Those with favorable donation intentions also endorsed significantly more positive factors (benevolence, need awareness, existentialism) as being more important in their decision. Adolescents who did not want to donate (58.7%) and those who were undecided (23.1%) were less likely to have discussed their decision with parents than were those who wanted to donate (67.7%, chi2 = 63.6, P = .0001). Finally, providing adolescents with a free driver's license in exchange for organ donor registration would have the greatest impact on registering undecided adolescents (29.8%, chi2 = 33.2, P = .0001). CONCLUSIONS: There is a pressing need for more systematic and culturally sensitive organ donation education directed toward adolescents, and the Department of Motor Vehicles and driver's education courses may be appropriate venues. An educational program from the U.S. Department of Health and Human Services, Decision: Donation, could be used in this context.

Attitudes toward financial incentives, donor authorization, and presumed consent among next-of-kin who consented vs. refused organ donation.

BACKGROUND: Financial incentives, donor authorization, and presumed consent are strategies designed to increase organ donation rates. Surveys designed to assess attitudes toward these initiatives have been conducted with the general public, transplant patients, and transplant professionals. METHODS: To assess attitudes toward financial incentives, donor authorization, and presumed consent and to identify multivariate predictors of such attitudes, we conducted telephone interviews with 561 family members who had recently been asked for consent to donate the organs of a deceased family member (348 donors, 213 nondonors). RESULTS: Financial incentives would have made a difference in the donation decision for 54% of nondonors (vs. 46% of donors, P=0.02), and a higher percentage of nondonors would themselves become donors if financial incentives were available (P=0.03). Donors had significantly more favorable attitudes toward donor authorization (P<0.0001) and presumed consent (P<0.0001) policies. Overall, 54% of participants thought that family permission for donation was unnecessary when the deceased documented their donation intention, and 24% favored a presumed consent law with an opting out provision. CONCLUSIONS: Of the three initiatives, donor authorization is likely supported by more donor and nondonor families than either financial incentives or presumed consent. Public education efforts should aim to better inform the public regarding existing and proposed donor authorization legislation and its benefits for registered organ donors and their families.

A 10-year analysis of organ donation after cardiac death in the United States.

BACKGROUND: The greatest challenge facing transplantation today is how to increase the number of organ donors. Patients with severe brain injury who are not brain-dead can donate organs after they are removed from a ventilator and allowed to die, termed donation after cardiac death (DCD). METHODS: We analyzed the database of all organs recovered from deceased donors in the United States from 1994 through 2003 to determine DCD trends in the United States. The database was obtained from the United Network for Organ Sharing (UNOS). RESULTS: There were 57,681 deceased donors reported from 1994 through 2003. Of these, 1,177 were donors without a heartbeat (DWHB), 55,206 were brain dead donors, and 1,298 were unspecified donors. At least one organ was transplanted from 1010 of the 1177 DWHB. Organ procurement organizations (OPOs) reported 0-212 DWHB accounting for up to 12.3 percent of deceased donors. There was a steady annual increase in the number of DWHB, but in 2003 there were still 19 of 59 OPOs that recovered no DWHB. A total of 2,231 organs were transplanted from the 1,177 DWHB donors, and another 665 organs were recovered for transplantation but not transplanted. The transplanted organs included 1,779 kidneys, 395 livers, 54 pancreata, 2 lungs, and 1 heart. Organs from DWHB can be successfully transplanted. CONCLUSIONS: Wider use of DWHB has the potential to greatly increase the number of organ transplants performed each year in the United States.

Are organ donation attitudes and beliefs, empathy, and life orientation related to donor registration status?

CONTEXT: The severe organ donor shortage necessitates additional research on variables that may distinguish those who register to be organ donors and those who do not. Such research has important implications for the development of educational interventions. OBJECTIVE: To examine whether registered organ donors differ significantly from nondonors on measures of organ donation beliefs and attitudes, empathy, and life orientation. DESIGN AND SETTING: Prospective participants were approached about the study while visiting a local branch of the Department of Motor Vehicles. Once consent was obtained, participants completed several questionnaires. PARTICIPANTS: Two hundred fifty community dwellers who visited the Department of Motor Vehicles office in Alachua County, Fla. MAIN OUTCOME MEASURES: Organ donor registration status, beliefs about organ donation, attitudes toward organ donation, empathy, and life orientation (ie, optimism). RESULTS: Registered organ donors reported more positive beliefs toward organ donation than did nonregistered participants or participants who were undecided about their registration status. Registered organ donors also reported more positive organ donation attitudes and more optimism than did nonregistered participants.

Development of a successful non-heart-beating organ donation program.

To help alleviate the organ shortage, transplant centers are using organs from expanded-criteria donors, who were considered unsuitable just a few years ago, such as non-heart-beating donors. In 1998, we made a concerted effort to increase the number of non-heart-beating donors recovered by our organ procurement organization. In this paper, we discuss the steps in establishing this program, including transplant center support, estimating the number of potential non-heart-beating donors, organ procurement support, protocol development, hospital development, education, putting the protocol into practice, follow-up, and effect of the program on organ procurement. With the establishment of this program, the number of non-heart-beating donors increased from 2% to 5% per year to over 10% for the past 2 years. From these donors, 61 of 82 recovered kidneys were transplanted into 58 patients, and 18 of 20 recovered livers were transplanted. A non-heart-beating donor program can significantly add to the number of organ transplants and successful transplantations.