Report From a Multidisciplinary Symposium on the Future of Living Kidney Donor Transplantation.

Virtually all clinicians agree that living donor renal transplantation is the optimal treatment for permanent loss of kidney function. Yet, living donor kidney transplantation has not grown in the United States for more than 2 decades. A virtual symposium gathered experts to examine this shortcoming and to stimulate and clarify issues salient to improving living donation. The ethical principles of rewarding kidney donors and the limits of altruism as the exclusive compelling stimulus for donation were emphasized. Concepts that donor incentives could save up to 40 000 lives annually and considerable taxpayer dollars were examined, and survey data confirmed voter support for donor compensation. Objections to rewarding donors were also presented. Living donor kidney exchanges and limited numbers of deceased donor kidneys were reviewed. Discussants found consensus that attempts to increase living donation should include removing artificial barriers in donor evaluation, expansion of living donor chains, affirming the safety of live kidney donation, and assurance that donors incur no expense. If the current legal and practice standards persist, living kidney donation will fail to achieve its true potential to save lives.

Projecting the Economic Impact of Compensating Living Kidney Donors in the United States: Cost-Benefit Analysis Demonstrates Substantial Patient and Societal Gains.

OBJECTIVES: The aim of this study was to show how the US government could save approximately 47 000 patients with chronic kidney failure each year from suffering on dialysis and premature death by compensating living kidney donors enough to completely end the kidney shortage. METHODS: Supply and demand analysis was used to estimate the number of donated kidneys needed to end the kidney shortage and the level of compensation required to encourage this number of donations. These results were then input into a detailed cost-benefit analysis to estimate the economic value of kidney transplantation to (1) the average kidney recipient and their caregiver, (2) taxpayers, and (3) society in general. RESULTS: We estimate half of patients diagnosed with kidney failure each year-approximately 62 000 patients-could be saved from suffering on dialysis and premature death if they could receive an average of 1½ kidney transplants. However, currently there are only enough donated kidneys to save approximately 15 000 patients. To encourage sufficient donations to save the other 47 000 patients, the government would have to compensate living kidney donors approximately $77 000 (±50%) per donor. The value of transplantation to an average kidney recipient (and caregiver) would be approximately $1.5 million, and the savings from the recipient not needing expensive dialysis treatments would be approximately $1.2 million. CONCLUSIONS: This analysis reveals the huge benefit that compensating living kidney donors would provide to patients with kidney failure and their caregivers and, conversely, the huge cost that is being imposed on these patients and their families by the current legal prohibition against such compensation.

Cost Structures of US Organ Procurement Organizations.

BACKGROUND: The goal is to provide a national analysis of organ procurement organization (OPO) costs. METHODS: Five years of data, for 51 of the 58 OPOs (2013-2017, a near census) were obtained under a FOIA. OPOs are not-for-profit federal contractors with a geographic monopoly. A generalized 15-factor cost regression model was estimated with adjustments to precision of estimates (P) for repeated observations. Selected measures were validated by comparison to IRS forms. RESULTS: Decease donor organ procurement is a $1B/y operation with over 26 000 transplants/y. Over 60% of the cost of an organ is overhead. Profits are $2.3M/OPO/y. Total assets are $45M/OPO and growing at 9%/y. "Tissue" (skin, bones) generates $2-3M profit/OPO/y. A comparison of the highest with the lower costing OPOs showed our model explained 75% of the cost difference. Comparing costs across OPOs showed that highest-cost OPOs are smaller, import 44% more kidneys, face 6% higher labor costs, report 98% higher compensation for support personnel, spend 46% more on professional education, have 44% fewer assets, compensate their Executive Director 36% less, and have a lower procurement performance (SDRR) score. CONCLUSIONS: Profits and assets suggest that OPOs are fiscally secure and OPO finances are not a source of the organ shortage. Asset accumulation ($45M/OPO) of incumbents suggests establishing a competitive market with new entrants is unlikely. Kidney-cost allocations support tissue procurements. Professional education spending does not reduce procurement costs. OPO importing of organs from other OPOs is a complex issue possibly increasing cost ($6K/kidney).

Estimated impact of novel coronavirus-19 and transplant center inactivity on end-stage renal disease-related patient mortality in the United States.

To predict whether the COVID-19 pandemic and transplant center responses could have resulted in preventable deaths, we analyzed registry information of the US end-stage renal disease (ESRD) patient population awaiting kidney transplantation. Data were from the Organ Procurement and Transplantation Network (OPTN), the US Centers for Disease Control and Prevention, and the United States Renal Data System. Based on 2019 OPTN reports, annualized reduction in kidney transplantation of 25%-100% could result in excess deaths of wait-listed (deceased donor) transplant candidates from 84 to 337 and living donor candidate excess deaths from 35 to 141 (total 119-478 potentially preventable deaths of transplant candidates). Changes in transplant activity due to COVID-19 varied with some centers shutting down while others simply heeded known or suspected pandemic risks. Understanding potential excess mortality for ESRD transplant candidates when circumstances compel curtailment of transplant activity may inform policy and procedural aspects of organ transplant systems allowing ways to best inform patients and families as to potential risks in shuttering organ transplant activity. Considering that more than 700 000 Americans have ESRD with 100 000 awaiting a kidney transplant, our highest annual estimate of 478 excess total deaths from postponing kidney transplantation seems modest.

Would government compensation of living kidney donors exploit the poor? An empirical analysis.

Government compensation of kidney donors would likely increase the supply of kidneys and prevent the premature deaths of tens of thousands of patients with kidney failure each year. The major argument against it is that it would exploit the poor who would be more likely to accept the offers of compensation. This overlooks the fact that many poor patients desperately need a kidney transplant and would greatly benefit from an increased supply of kidneys. The objective of this study is to empirically test the hypothesis that government compensation of kidney donors would exploit the poor. Exploitation is defined by economists and several noted ethicists as paying donors less than the fair market value of their kidney. Exploitation is expressed in monetary terms and compared with the economic benefit recipients receive from a transplant. Data are from the Scientific Registry of Transplant Recipients and the United States Renal Data System annual data reports. Educational attainment is used as a proxy for income. We estimate that if the government rewards living donors with a package of non-cash benefits worth $75,000 per kidney, donors would not be exploited. Much more important, this compensation would likely end the kidney shortage, enabling many more patients with kidney failure to obtain transplants and live longer and healthier lives. The value of kidney transplantation to a U.S. recipient is about $1,330,000, which is an order of magnitude greater than any purported exploitation of a living donor (zero to $75,000). Consequently, the aggregate net benefit to the poor alone from kidney transplantation would increase to about $12 billion per year from $1 billion per year currently. Most of the benefit would accrue to poor kidney recipients. But poor donors would receive the fair market value of their kidney, and hence would not be exploited. If the government wanted to ensure that donors also received a net benefit, it could easily do so by increasing the compensation above $75,000 per donor.

Views of US Voters on Compensating Living Kidney Donors.

IMPORTANCE: Patients in the United States waiting for kidney transplantation die in increasing numbers owing to the severe kidney shortage, which might be alleviated by compensating living kidney donors. OBJECTIVE: To determine the willingness of voting US citizens to become living kidney donors and to ascertain the potential influence of compensation for donation. DESIGN, SETTING, AND PARTICIPANTS: A professionally designed quantitative survey was administered by an international polling firm in June 2014. Information was collected on willingness to donate a kidney and the potential influence of compensation ($50 000); survey data included respondent age, income, education level, sex, US region, race/ethnicity, marital status, political affiliation, likelihood to vote, and employment status. The survey was performed via a random-digit dialing process that selected respondents via both landlines and mobile telephones to improve population representation. The survey included 1011 registered US voters likely to vote. MAIN OUTCOMES AND MEASURES: The degree to which the US voting public is willing to donate a kidney and the perceptions of current voters toward paying living kidney donors. RESULTS: Of the 1011 respondents, 427 were male and 584 were female, with 43% of participants between ages 45 and 64 years. With respondents grouped by willingness to donate, we found that 689 (68%) would donate a kidney to anyone and 235 (23%) only to certain persons; 87 (9%) would not donate. Most (59%) indicated that payment of $50 000 would make them even more likely to donate a kidney, 32% were unmoved by compensation, and 9% were negatively influenced by payment. CONCLUSIONS AND RELEVANCE: Most US voters view living kidney donation positively, and most would be motivated toward donor nephrectomy if offered a payment of $50 000. Because most registered voters favor such payments, and because thousands of lives might be saved should compensation increase the number of transplantable kidneys, laws and regulations prohibiting donor compensation should be modified to allow pilot studies of financial incentives for living kidney donors. Outcomes of such trials could then result in evidence-based policies, which would incorporate fair and just compensation to those persons willing to undergo donor nephrectomy.

Impact of donor hepatitis C virus infection status on death and need for liver transplant in hepatitis C virus-positive kidney transplant recipients.

BACKGROUND: Only 29% of deceased donor kidney recipients with hepatitis C virus (HCV) receive HCV-positive (HCV+) kidneys. These kidneys are discarded 2.5 times more often than their HCV-negative (HCV-) counterparts, possibly due to the sense that an HCV+ kidney may adversely affect recipient liver function. The goals of this study were to characterize liver disease in HCV+ kidney recipients and compare rates of liver-related outcomes by kidney donor HCV status. STUDY DESIGN: Observational cohort study. SETTING & PARTICIPANTS: 6,250 patients with HCV who had a kidney transplant in 1995-2008 as captured in the United Network for Organ Sharing (UNOS) database. Liver-related outcomes were assessed by cross-linking with the liver waitlist and transplant data sets. PREDICTOR: HCV status of transplanted kidney. OUTCOMES: Joining the liver waitlist, receiving a liver transplant, death. MEASUREMENTS: Time to event. RESULTS: Only 63 (1%) of HCV+ kidney recipients eventually joined the liver waitlist during the 13-year study period. Those who received HCV+ kidneys had a 2.6-fold higher hazard of joining the liver list (P < 0.001); however, the absolute difference in rate of listing between recipients of HCV- and HCV+ kidneys was <2%. This is consistent with findings of only 2% lower patient survival at 3 years in HCV+ patients receiving HCV+ versus HCV- kidneys. LIMITATIONS: We lacked data for HCV viral load and genotype of both HCV+ recipients and transplanted HCV+ kidneys. CONCLUSIONS: Because transplant with an HCV+ kidney may reduce waiting-time by more than a year for an HCV+ patient and there is a high risk of kidney waitlist mortality, a 2% increased rate of adverse liver outcomes and 2% increased rate of death at 3 years should not universally preclude the use of HCV+ kidneys when the intended recipient is also HCV+.

Incentives for organ donation: proposed standards for an internationally acceptable system.

Incentives for organ donation, currently prohibited in most countries, may increase donation and save lives. Discussion of incentives has focused on two areas: (1) whether or not there are ethical principles that justify the current prohibition and (2) whether incentives would do more good than harm. We herein address the second concern and propose for discussion standards and guidelines for an acceptable system of incentives for donation. We believe that if systems based on these guidelines were developed, harms would be no greater than those to today's conventional donors. Ultimately, until there are trials of incentives, the question of benefits and harms cannot be satisfactorily answered.

Satisfaction with renal replacement therapy and education: the American Association of Kidney Patients survey.

BACKGROUND AND OBJECTIVES: This study was undertaken by the American Association of Kidney Patients (AAKP) to better understand ESRD patients' satisfaction with their current renal replacement therapy (RRT) and the education they received before initiating therapy. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In addition to an open invitation on the AAKP website, nearly 9000 ESRD patients received invitations to complete the survey, which consisted of 46 questions. Satisfaction was measured on a 1 (extremely dissatisfied) to 7 (extremely satisfied) scale. RESULTS: Survey respondents were younger, more highly educated, and more likely to be white as well as employed as compared with the U.S. dialysis population. A total of 977 patients responded. Overall patient satisfaction with current RRT treatment varied from a low of 4.5 for in-center hemodialysis (ICHD) to a high of 6.1 in transplant (TX) patients. Peritoneal dialysis (PD) and home hemodialysis (HHD) mean scores were 5.2 and 5.5, respectively. PD, HHD, and TX patients' satisfaction scores were significantly higher than those of ICHD patients (P < 0.05). Approximately 31% of respondents felt that the therapies were not equally and fairly presented as treatment options, and 32% responded that they were not educated regarding HHD. CONCLUSIONS: ESRD patients are not uniformly advised about all possible treatment methods and hence were only moderately satisfied with their pretreatment education. Once on RRT, those on a home therapy or with a kidney TX are more satisfied than those with ICHD.

The high-risk recipient: the Eighth Annual American Society of Transplant Surgeons' State-of-the-Art Winter Symposium.

The evolution of organ transplantation has produced results so successful that many transplant programs commonly see recipients with medical risks, which in the past, would have prohibited transplantation. The Eighth Annual American Society of Transplant Surgeons State-of-the-Art Winter Symposium focused on the high-risk recipient. The assessment of risk has evolved over time, as transplantation has matured. The acceptance of risk associated with a given candidate today is often made in consideration of the relative value of the organ to other candidates, the regulatory environment, and philosophical notions of utility, equity, and fairness. In addition, transplant programs must balance outcomes, transplant volume, and the costs of organ transplantation, which are impacted by high-risk recipients. Discussion focused on various types of high-risk recipients, such as those with coronary artery disease, morbid obesity, and hepatitis C; strategies to reduce risk, such as down-staging of hepatocellular carcinoma and treatment of pulmonary hypertension; the development of alternatives to transplantation; and the degree to which risk can or should be used to define candidate selection. These approaches can modify the impact of recipient risk on transplant outcomes and permit transplantation to be applied successfully to a greater variety of patients.

Fatal and nonfatal hemorrhagic complications of living kidney donation.

OBJECTIVE: After anecdotal reports of severe hemorrhage from failure of surgical clips to sustain closure of renal artery stumps in live donor nephrectomies were received, this study was designed to identify specific surgical techniques that are associated with an increased risk of failure to control bleeding and might represent opportunities to improve patient safety. BACKGROUND: Preventing complications for living kidney donors must be paramount in addressing end-stage renal failure through living kidney donation. Major hemorrhage from technical failure, albeit an infrequent occurrence, can cause significant, yet preventable, morbidity or death. Open and laparoscopic approaches to living kidney donation use several vascular control methods, some of which may be more prone to failure and life-endangering hemorrhage than others. METHODS: To define hemorrhagic complications of living kidney donation, a survey was sent to all 893 surgeon-members of the American Society of Transplant Surgeons. Descriptive and bivariate analyses were used to ascertain study participant characteristics, most frequently used vascular control techniques, and incidence of events (death, transfusion, reexploration or conversion to open nephrectomy, or contralateral [remaining kidney] renal failure). Outcomes of hemorrhage and comments by respondents were sought as were data from other sources. RESULTS: In 213 surveys returned (24%), 66 and 39 episodes of arterial and venous hemorrhage were reported, respectively. Among arterial control problems, 2 resulted in donor death and 2 resulted in renal failure; 19 episodes required transfusion. Open conversions in laparoscopic nephrectomy or late reoperations for hemorrhage were reported for 29 cases. Locking and standard clips applied to the renal artery were associated with the greatest risks. CONCLUSIONS: Significant hemorrhagic complications occur with living kidney donation in both open and laparoscopic approaches. Loss of arterial control jeopardizes donor life and health, especially when it occurs in the postoperative period. Vascular transfixion provides the best vascular control of major vessels.

The impact of transplantation with deceased donor hepatitis c-positive kidneys on survival in wait-listed long-term dialysis patients.

Whether transplantation of deceased donor kidney allografts from donors with antibodies against hepatitis C virus (HCV) confers a survival advantage compared with remaining on the kidney transplant waiting list is not yet known. We studied 38,270 USRDS Medicare beneficiaries awaiting kidney transplantation who presented with end-stage renal disease from April 1, 1995 to July 31, 2000. Cox regression was used to compare the adjusted hazard ratios for death among recipients of kidneys from deceased donors, and donors with antibodies against hepatitis C (DHCV+), controlling for demographics and comorbidities. In comparison to staying on the waiting list, transplantation from DHCV+ was associated with improved survival among all patients (adjusted hazard ratio for death 0.76, 95% CI 0.60, 0.96). Of patients receiving DHCV+ kidneys, 52% were themselves hepatitis C antibody positive (HCV+), so outcomes associated with use of these grafts may have particular implications for HCV+ transplant candidates. Recommendations for use of DHCV+ kidneys may require analysis of data not currently collected from either dialysis or transplant patients. However, transplantation of DHCV+ kidneys is associated with improved patient survival compared to remaining wait-listed and dialysis dependent.

Differences in patient and transplant professional perceptions of immunosuppression-induced cosmetic side effects.

BACKGROUND: A two-part study was initiated to compare kidney transplant patient and transplant professional perceptions regarding immunosuppression-related physical changes and their impact on transplant recipients. METHODS: Parallel surveys were developed and administered to transplant patients and active transplant clinicians. RESULTS: Eighty percent of surveyed patients reported immunosuppression-induced hirsutism, gingival hyperplasia, acne, alopecia, or cushingoid facies. Hirsutism (94%) and gingival hyperplasia (51%) occurred more frequently in cyclosporine patients (p < 0.01); alopecia (30%) occurred more frequently in tacrolimus patients (p < 0.01). Patient reported incidence of physical changes significantly exceeded observations by professionals for every condition (p < 0.01), however 84.4% of affected patients reported feeling "happy to endure" changes "for the sake of having a transplant." Patients also reported emotional and social effects due to physical changes, an outcome underestimated by transplant professionals (p < 0.01). Patients and professionals communicated about physical changes; however, more than half of affected patients believed communication occurred "rarely/never" while over half of the professionals believed communication occurred "every visit/most of the time." Although most physicians believed changes could be addressed, doctors recommended treatment for less than half of the affected patients. When recommended therapy changes were pursued, treatments were effective in the majority of cases. CONCLUSIONS: Incidence of immunosuppression-related physical changes is high and somewhat dependent on drug regimen. Although patients seem willing to accept cosmetic changes for the sake of having a transplant, physical changes have a psychosocial impact that is underestimated by clinicians. Immunosuppression-related physical changes remain underaddressed; effective interventions offer opportunities for improved care.