Increasing the Supply of Organs for Transplantation in the U.S.

Table of Contents

Published: January 10, 2014

This is a writeup of a shallow investigation, a brief look at an area that we use to decide how to prioritize further research.

In a nutshell

What is the problem?

The need for transplants in the U.S. significantly outstrips the supply of organs, and the gap is growing. More than 120,000 people are now on the waiting list, and more than 10,000 people were removed in 2012 because they died or became too sick to receive a transplant.

What are possible interventions?

Our understanding is that most conventional interventions aim to increase the rate of consent for transplantation amongst eligible deceased donors and their families. Other avenues to increase the supply of organs might include expanding the class of potential deceased donors considered eligible to donate or providing incentives for living donors (which is currently illegal in the U.S.). We do not have a strong sense of the best opportunities available to a philanthropist in this area, but expect that they might focus on advocacy to permit incentives for donation or to expand the pool of potential deceased donors.

Who else is working on it?

The organ donation community appears to devote considerable resources towards attempting to increase rates of consent for deceased organ donation, but we do not know of any sizable organizations focused on expanding the pool of deceased donors considered eligible or advocating for incentives for living donors.

1. What is the problem?

The need for organ transplants in the U.S. does not match the current supply: 120,729 people were on the waiting list for an organ on November 1, 2013.1 Kidneys account for the vast majority of the organ shortage: 98,613 of the people on the waiting list were waiting for a kidney transplant. In 2012, 36,457 people joined the waiting list for kidneys, while only 15,939 people were removed from the wait list as a result of receiving one; 7,188 people died or became too sick to receive a kidney transplant.2 Additionally, some researchers have argued that the official waiting list significantly underestimates the true need for kidney transplants due to inequalities in access.3

Matas and Schnitzler 2003 estimated that receiving a kidney transplant from a living donor saves 3.5 quality-adjusted life years (QALYs) and about $100,000 relative to remaining on dialysis, which implies that clearing the kidney waiting list could (naively) save billions of dollars and hundreds of thousands of QALYs.4

Other organs with waiting lists include the pancreas, liver, intestine, heart, and lungs. We have not searched for estimates of the magnitude of the benefits of clearing those (shorter) lists. About 30% of all deaths on the waiting list in 2012 occurred amongst people waiting for organs other than kidneys.5

2. What are possible interventions?

There are a number of different avenues that may increase the availability of organs for transplant.

2.1 Deceased Donors

Deceased donors are the main source of organs for transplant in the U.S., and the only source available for organs other than kidneys and liver.6 We see two broad avenues for increasing the rate of deceased donor transplants:

Increasing the rate of consent of potential deceased organ donors. This could entail efforts to register more people as potential organ donors, or to improve practices by organ procurement organizations requesting consent from families of potential donors. Given that consent rates for eligible donors are already fairly high (~74%), the potential gains from this strategy may be somewhat limited.7
Expanding the criteria for potential deceased donors. Current practice in the U.S. is to only accept as potential deceased donors people who die in the hospital from devastating brain injury or after the withdrawal of life support.8 Accepting potential donors who suffer from cardiac arrest outside of a hospital setting may greatly expand the pool of potential donors, though the practice is controversial.9

2.2 Living donors

Transplants from living donors currently make up about a third of all kidney transplants, a proportion that has been declining since 2004.10 Again, we see two broad strategies for attempting to increase the number of kidneys donated by living donors:

  • Encouraging living donation by raising awareness that it is an option and reducing barriers. Efforts in this category might include training for dialysis patients about how to approach their families about the possibility of becoming living donors, promoting organ donation chains, outreach to the public about the need for living donation, or advocacy for paid time off work for donation, amongst other approaches.
  • Providing compensation or incentives to encourage living (or deceased) donation.11 U.S. law currently prohibits receipt of any “valuable consideration” in exchange for donating an organ, so there have been no trials to assess the effectiveness of different incentives; efforts to implement incentives would likely require a change to the law.12 Like expanding the pool of potential deceased donors to those who die of cardiac arrest outside the hospital, the prospect of using incentives or compensation to increase living donation is ethically controversial.

2.3 Opportunities for philanthropy

A philanthropist could plausibly pursue any of the strategies discussed above. We do not have a strong sense of which activities might be most effective or cost-effective, but our initial inclination is to focus on less conventional areas (i.e. incentives for donors, donation after uncontrolled cardiac death) because they appear to receive less attention and to have greater potential than the other approaches discussed.

In practice, we expect that a philanthropist supporting work on either of those issues would likely focus on advocacy and research. In the case of incentives for living donors, the primary approach would likely be to support advocacy efforts aimed at reversing the U.S. ban on exchanging “valuable consideration” for organ donation. On the front of expanding the pool of potential deceased donors to include those who die of cardiac arrest outside hospitals, a philanthropist might support further research to determine the costs and benefits of the approach, or advocacy efforts aimed at encouraging other actors in the transplant system to devote more resources to such approaches.

Because both of these areas appear to be relatively controversial within the organ donation community, we do not have much sense of the likelihood that these advocacy efforts would be successful.

3. Who else is working on this?

The overall organ donation community is fairly large, but our anecdotal impression is that most of the current efforts by members of the organ donation community to increase the availability of organs for donation are focused on increasing consent amongst potential deceased donors. Organizations that appear to be focused on this include Donate Life America and its affiliates in each state, and, to a lesser extent, organ procurement organizations. Our understanding is that existing efforts to encourage more living donation have focused on reducing costs and broadly encouraging living donation, and that these efforts not been sufficient to stem the decline in living donation over the past few years, but we do not what magnitude of resources have been devoted to this approach to date.13

There appears to be comparatively little focus on expanding the pool of deceased donors to include those who die of cardiac arrest outside of a hospital, or advocating for incentives for living donation. A few centers have pilot programs on the potential of donors who die of uncontrolled cardiac arrest, but we are not aware of any systematic efforts to promote the use of such donors.14 We are not aware of any sizable organizations dedicated to advocating for incentives for living (or deceased) donors, though a variety of professional organizations and think tanks have expressed support for trials.15 Others, most notably the National Kidney Foundation, have opposed trials.16

4. Questions for further investigation

Our research in this area has been relatively limited, and many important questions remain unanswered by our investigation.

Amongst other topics, further research on this cause might address:

  • The distribution of interest group opinion on incentives for organ donors and organ donation after uncontrolled cardiac arrest.17
  • The health and economic impacts of potential policy changes to significantly increase the supply of organs for transplant.
  • The cost-effectiveness of different strategies that a philanthropist might pursue to attempt to change policies to significantly increase the availability of organs for transplant.
  • How the need for organs in other countries compares to the United States and whether investing in this issue in other countries may carry higher returns than in the United States.

5. Our Process

We started our investigation of this area focusing on advocacy efforts to permit incentives for organ donor, which we perceived to be a fairly important policy issue with very limited philanthropic involvement. After learning more, we decided to slightly expand the scope of our shallow investigation to focus on efforts to significantly expand the supply of organs for transplantation (rather than just incentives).

Our investigation to date has been relatively limited, consisting of three conversations with people with knowledge of the field and a brief review of the literature.18

6. Sources

DOCUMENT SOURCE
Matas and Schnitzler 2003 Source (archive)
Matas et al. 2012 Source (archive)
Notes from a conversation with Sally Satel, 10/10/13 Source
OPTN DSA Dashboard Report Source (archive)
OPTN Waiting List Additions Source (archive)
OPTN Waiting List Removals Source (archive)
OPTN: Data Source (archive)
Rodrigue, Schold, and Mandelbrot 2013 Source
Schold et al. 2008 Source (archive)
UNC Press Release 2013 Source (archive)
Wall et al. 2013 Source
Expand Footnotes Collapse Footnotes

1.

OPTN: Data

2.Statistics based on numbers reported at the time of writing:

OPTN Waiting List Additions

OPTN Waiting List Removals

3.“Based on our results depicted in Figure 4, there is evidence to suggest that many patients on the kidney transplant waiting list (categorized into the lowest quartile of survival expectancy) perhaps should be excluded from the waiting list as their survival would likely be limited even after kidney transplantation. Over the study period, this group included almost 11 000 patients. Alternatively, it is also apparent from this figure that among dialysis patients not listed for transplantation, the top quartile of patients has reasonable survival expectancy and many of these nearly 80 000 patients should be listed utilizing life expectancy as the main driving factor for allocation. Therefore, the cumulative impact of listing all patients with
adequate’ life expectancy for transplantation would substantially increase, rather than decrease, the kidney transplant waiting list from the current level of approximately 70 000 to almost 140 000 patients accompanied by successful efforts to increase access to viable patients. In other words, our study suggests that in relative terms, the problem of not listing patients rapidly for transplantation is paramount and significantly outweighs concerns of more selectively screening candidates who are listed with diminished potential benefit from the procedure.
Of course, there are important caveats to the findings of this analysis and the estimated impact of different listing strategies. First of all, among patients with good life expectancy who are currently not listed for a transplant, there exists a certain subset of patients who simply do not prefer transplantation as a therapeutic option independent of medical need (12,31). However, it is also likely that the majority of patients with a good prognosis who are not listed are encountering well-described access problems rather than a lack of interest. In fact, the patient groups identified in this study who are not listed despite having a good prognosis are disproportionately represented groups that have been described to have access barriers to kidney transplantation such as African–Americans, females and patients with less generous insurance coverage (10,16,19). Additional sources of disparities in delayed time or failure to list for transplantation have been attributed to a lack of education, financial issues, late referrals and workups from providers, differences in belief systems and also a perception among physicians as to the viability of certain patients’ potential prognosis after the procedure (16,20,31,32). These phenomena may also have significant regional components and in many cases, ‘appropriate’ transplant candidates may be relative to the applicable dialysis population for a given center. A portion of the disparities may also reflect that while certain groups (e.g. African–Americans) have relatively equivalent patient survival rates following transplantation, graft survival rates may be significantly diminished, as such listing practices may incorporate these assessments of ‘viability’ that were not examined in our analysis. However, the magnitude of the overlapping risk profile of these populations suggests that enhanced procedures and policies governing access to transplantation are still required and improved understanding of the etiology of these disparities is needed.” Schold et al. 2008 pgs 62-64.

4.

“We found that a LURD transplant saved $94 579 (US dollars, 2002), and 3.5 quality-adjusted life years (QALYs) were gained. Adding the value of QALYs, a LURD transplant saved $269 319, assuming society values additional QALYs from transplantation at the rate paid per QALY while on dialysis.
At a minimum, a vendor program would save society >$90000 per transplant and provides QALYs for the ESRD population. Thus, society could break even while paying $90 000/kidney vendor.” Matas and Schnitzler 2003, abstract. Adjusting for inflation since 2002 would raise the $94,579 number above $100,000.

With a waiting list of nearly 100,000 people and savings of roughly $100,000 and 3.5 QALYs per transplant, clearing the waiting list for kidneys through transplants might conceptually save $10 billion and 350,000 QALYs. We think it appropriate to regard this calculation with skepticism, and believe it could easily be off by an order of magnitude or more.

5.OPTN Waiting List Removals: 6,367 people died while waiting for any organ in 2012; 4,519 died while waiting for a kidney.

6.OPTN Waiting List Removals

7.The total US consent rate amongst eligible deaths from January to June 2013 was 73.7%. OPTN DSA Dashboard Report, ‘National Metrics’ sheet.

8.“More than 115,000 patients are wait-listed for organs despite that there are 12,000 who die or become too ill to receive transplants annually.5 Donation after neurologic determination of death (DNDD) and live donation provide nearly all organs for transplantation, with supply falling far short of demand (Table).5 In DNDD, a patient incurs devastating brain injury; brain death is determined with rigorous diagnostic procedures establishing “irreversible cessation of all functions of the entire brain, including the brain stem.”14,16
More recently, DCDD has been promoted worldwide and classified according to Maastricht Criteria (Figure 1).17 In the United States, controlled donation after circulatory determination of death (cDCDD) is preferred, evidenced by the Centers for Medicare & Medicaid Services and The Joint Commission requiring hospitals to have a policy among its accreditation criteria.18,19 In cDCDD, an authorized party of a terminally ill patient lacking decisional capacity, or rarely the patient, requests that life-sustaining treatments be discontinued. The authorized party is approached to consider organ donation, and after informed consent is obtained, life-sustaining measures are withdrawn in a controlled setting (eg, operating room).
If respiration and circulation cease within 60 minutes and do not return spontaneously within 5 minutes (accounting for autoresuscitation), the patient is pronounced dead from “irreversible cessation of circulatory and respiratory functions,” and organ preservation and recovery efforts commence promptly.13,20 Often, the time from cessation of life support to circulatory-respiratory arrest exceeds 60 minutes, thus limiting cDCDD’s effect on organ supply: prolonged hypotension leads to irreparable organ damage.21” Wall et al. 2013 pg 2.

9.Wall et al. 2013:

“In 2006, the Institute of Medicine emphasized uDCDD [uncontrolled donation after circulatory determination of death]’s potential to increase substantially organ availability.22 Recommendations were based on published data from Spain and the United States demonstrating that prolonged warm ischemic times inherent with uDCDD are not insurmountable barriers to successful transplantation.10,11,22-24 uDCDD cases present when an unexpected cardiac arrest occurs, and after all lifesaving measures are exhausted, medical providers order termination of resuscitation in accordance with evidence proving any additional lifesaving measures are futile (<1% survival).1,2,25 As in cDCDD, death is determined by “irreversible cessation of circulatory and respiratory functions.”13-16,20,21” pg 2.

“uDCDD program success is noteworthy. In 2011, uDCDD programs in Spain provided 158 more kidneys (3.4 per million population), to compose 6.7% of all kidney donations, results doubled from 2000. Since initiating similar programs in 2006, France has provided nearly 80 uDCDD kidneys annually
(1.2 per million population).44 In contrast, US cDCDD has increased progressively during the past decade, supplying from 87 to 848 donors, but currently accounts for only 10.6% of all deceased donors.5 This increase is marginalized by uDCDD’s potential, considering that 61% of US organs could be supplied by uDCDD if all opportunities were realized (Table).22 Although graft survival outcomes are somewhat less for uDCDD kidneys compared with outcomes from DNDD, they are in the acceptable range for nonstandard-criteria organs.7,10,23,24,45-49 In Spain, uDCDD liver transplantation has yielded encouraging results,8,50 and outcomes for uDCDD lung transplants are comparable to those from DNDD.51,52” pg 3.

“Despite great potential, US uDCDD programs are being blocked by Health Resources and Services Administration (HRSA) commissioned expert panels that suggest preservation strategies that reestablish oxygenated circulation to the brain retroactively negate previous death determination based on circulatory-respiratory criteria and hence violate the dead donor rule.12,13 In this article, we assert that in uDCDD, all efforts at saving lives are exhausted before organ donation is considered, and death is determined according to “irreversible cessation of circulatory and respiratory functions” evidenced by “persistent cessation of functions during an appropriate period of observation and/or trial of therapy” as specified in the US Uniform Determination of Death Act and its supporting documents.14-16 Therefore, postmortem in vivo organ preservation with chest compressions, mechanical ventilation, and normothermic extracorporeal membrane oxygenation (nECMO) is legally and ethically appropriate.” pg 2.

10.“Live-donor kidney transplantation (LDKT) accounts for one third of kidney transplants performed in the United States and continues to offer superior outcomes compared with maintenance dialysis and deceased-donor kidney transplantation for individuals with end-stage kidney disease (1). Figure 1 shows a remarkable 265% increase in the annual number of living donors from 1988 to 2004. In each year during this time period, there was an increase in living donation relative to the previous year. This increase in living donation may be attributed to several factors, including advances in histocompatibility testing, new laparoscopic surgical techniques, findings of comparable graft survival outcomes with genetically related and unrelated living donors, and greater public awareness about the need for organ donors. However, since the peak of 6647 donors in 2004, the annual number of living donors has declined from the previous year in all but 1 year (2009) despite the emergence of novel programs to expand kidney donation (2-8).” Rodrigue, Schold, and Mandelbrot 2013 pg 767.

11.See, e.g., Matas et al. 2012 and Notes from a conversation with Sally Satel, 10/10/13.

12.“In order for incentives for organ donation to be tested in the U.S., the National Organ Transplant Act, which outlaws such incentives, would have to be amended either through a stand-alone piece of legislation or as part of some other bill.” Notes from a conversation with Sally Satel, 10/10/13.

13.“We propose a multilayered approach to attenuate the decline in living kidney donation, one that engages key stakeholders–the transplant centers, the broader transplant community, and the state and national governments. Transplant centers could examine trends in their LDKT rate since 2004 and use existing quality improvement processes to identify, implement, and evaluate strategies to address any downward pressures on LDKT. For instance, some centers have successfully employed patient navigators (6), home-based education (5), dialysis center-based interventions (8), and enhanced educational processes in the transplant center (7, 52, 53) to increase LDKT willingness and rates. These quality improvement initiatives and findings could then be disseminated to the broader transplant community for further evaluation and replication. The broader transplant community, using existing organizational structures (e.g., United Network for Organ Sharing Living Donor Committee and American Society of Transplantation’s Living Donor Community of Practice) could identify and disseminate ‘‘best practices’’ for removing barriers to living donation and LDKT as well as develop policies to reduce financial disincentives to living donation. At the level of state and national governments, legislation could be developed to expand tax reduction incentives for living donors and prohibit discrimination against living donors by insurers. Together, the transplant community and government agencies could modify existing legislation and increase funding to allow existing financial assistance programs to reimburse living donors for lost wages. Additionally, transplant regulations and performance report cards must be carefully evaluated for their potential adverse impact on LDKT and living donation accessibility.
The decline in living donation over the last several years is indisputable. It is tempting to attribute this decline to random variation and to assume the number of living donors will return to levels observed in 2004. However, despite novel programs to help patients find suitable living donors, national financial programs and state tax incentives for living donors, and heightened general public awareness of living kidney donation, there is considerable downward pressure on living donation rates. Furthermore, the recent decline in living donation appears most prominent among men, blacks, and younger and lower income adults, which may further exacerbate existing LDKT disparities (54-59). We believe that this persistent downturn in living donation should be cause for action within the transplant community, as it potentially leads to longer waiting times for transplantation, greater dialysis exposure, higher death rates on the waiting list, lower graft and patient survival for recipients, and higher overall healthcare costs for the care of patients with end-stage renal disease. Programmatic, scientific, policy, and legislative efforts to identify and remove barriers to living donation are needed to ensure that LDKT remains a viable option for patients with CKD.” Rodrigue, Schold, and Mandelbrot 2013 Pgs 771-772.

14.

“In 6 months, our team approached 9 authorized parties for cardiac arrests meeting initial screening criteria. None were eligible because all deceased lacked previous consent. The NYS Department of Health imposed this restriction to legally justify preservation team entry into private residences. During uDCDD program implementation, only 18% of New Yorkers were registered donors.55 Despite not realizing any donation opportunities, detailed analysis of our operations notes revealed that those approached for organ donation decisions were not offended by being asked so soon after witnessing their loved one’s unexpected death.
The University of Pittsburgh Medical Center derived its uDCDD protocol for ED settings by using a dedicated, independent, hospital rapid transplant response team (Condition T).56 For registered donors who were pronounced dead in the ED, Condition T was activated for immediate donor preservation with acellular cold perfusion. In 3 years, only 2 kidneys were recovered from 1 uDCDD donor. Both failed ex vivo performance testing.40 The main reason for lack of candidates was requiring previous consent for organ donation. Despite Pennsylvania’s having 43% of its residents in the registry, few potential uDCDD candidates had joined.55
The University of Michigan, funded by HRSA to evaluate nECMO in cDCDD, received a NIH grant to expand its protocol for individuals failing ED resuscitation.57,58 Michigan’s program may be successful because individuals without previous first-person consent for organ donation will be eligible. Other anecdotal uDCDD cases have been reported at transplant conferences. Most are Maastricht IV cases in which neurologic death preceded circulatory-respiratory death.” Wall et al. 2013 pgs 3-4.

“A researcher at The University of North Carolina at Chapel Hill has received a $4 million, three-year grant from the National Institutes of Health for a clinical trial to study assessment and transplantation of lungs from victims of sudden death.
The National Heart, Lung, and Blood Institute awarded a $4,185,275 grant (1 UM1 HL113115-01A1) to UNC for the study, which will begin Sept. 1 and will be led by Thomas M. Egan, MD, principal investigator. Dr. Egan, a thoracic surgeon, is professor of surgery in the Division of Cardiothoracic Surgery, Department of Surgery at UNC.
Dr. Egan, who started the lung transplant program at UNC in 1989, is internationally known for his research on lung transplantation. His research has focused on use of lungs for transplant from patients who have died suddenly, outside the hospital, and have not been on mechanical ventilation. These are known as non-heart-beating donors. Dr. Egan has shown that lungs are still viable after circulation stops because they self-oxygenate (other organs require blood circulation to obtain oxygen). His lab has perfused and ventilated human lungs outside the body (ex vivo) to determine if they are suitable for transplant; the lab also has worked to show the safety of transplanting these lungs. If successful, Dr. Egan’s project could greatly increase the number of lungs available for transplant.
Currently, solid organs for transplant come primarily from patients who have suffered brain death and have been on mechanical ventilation before controlled circulatory arrest. However, many lungs from these donors cannot be used for transplant because of inflammation or infection during a prolonged interval of brain death. Lungs retrieved from NHBDs may not only be much more plentiful; they may be superior to lungs currently being transplanted from brain-dead donors.
Duke University (R. Duane Davis, MD, principal investigator for the subaward), Carolina Donor Services, the regional organ procurement organization, and Lung Banks of America, a non-profit oganization, will have subawards on the grant. Wake County Emergency Medical Services, law enforcement, the medical examiner’s office and other government entities have cooperated to ensure the project is successful.
Lungs from the non-heart-beating donors that are found acceptable after ex-vivo assessment will be transplanted at UNC and Duke to patients who have consented to use of the lungs under FDA- and IRB-approved protocols. Outcomes will be compared to patients contemporaneously transplanted with lungs from conventional organ donors.” UNC Press Release 2013

15.“Although no organization has a major campaign to promote incentives for kidney donations, various people and organizations are in favor of a pilot study:

  • The Cato Institute and the American Enterprise Institute would be in favor of a pilot.
  • Save Lives Now New York is a newer organization in favor of a pilot.
  • The American Society for Transplant Surgeons did a poll a few years ago and found that the majority of surgeons it surveyed were in favor of pilot trials, but it does not lobby on the issue.
  • The American Association of Kidney Patients and the Polycystic Kidney Disease Foundation would probably look favorably on a trial, but they are not advocating for one.
  • The United Network for Organ Sharing was in favor of a pilot in the 1990s but has been largely silent on the matter since then.
  • The American Medical Association expressed the need for pilot programs for deceased donation but does not lobby for them.”

Notes from a conversation with Sally Satel, 10/10/13.

16.“The National Kidney Foundation (NKF) is resolutely against incentives for kidney donation. In the Congressional hearings on kidney donation of the 1990s, the NKF supported pilots of incentives for deceased donors, but in a 2000 hearing, it expressed the concern that incentives for kidney donation would crowd out altruistic giving.” Notes from a conversation with Sally Satel, 10/10/13.

17.Sally Satel, an advocate for incentives, characterized the distribution of interest groups as follows:“ForAlthough no organization has a major campaign to promote incentives for kidney donations, various people and organizations are in favor of a pilot study:

  • The Cato Institute and the American Enterprise Institute would be in favor of a pilot.
  • Save Lives Now New York is a newer organization in favor of a pilot.
  • The American Society for Transplant Surgeons did a poll a few years ago and found that the majority of surgeons it surveyed were in favor of pilot trials, but it does not lobby on the issue.
  • The American Association of Kidney Patients and the Polycystic Kidney Disease Foundation would probably look favorably on a trial, but they are not advocating for one.
  • The United Network for Organ Sharing was in favor of a pilot in the 1990s but has been largely silent on the matter since then.
  • The American Medical Association expressed the need for pilot programs for deceased donation but does not lobby for them.

Against

The National Kidney Foundation (NKF) is resolutely against incentives for kidney donation. In the Congressional hearings on kidney donation of the 1990s, the NKF supported pilots of incentives for deceased donors, but in a 2000 hearing, it expressed the concern that incentives for kidney donation would crowd out altruistic giving.” Notes from a conversation with Sally Satel, 10/10/13.

We believe that further research may reveal a somewhat different picture.

18.The only conversation for which we were able to produce public notes was with Sally Satel: Notes from a conversation with Sally Satel, 10/10/13.