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Ethical implications of multi organ transplants

Proposal Overview

Status: Implemented

Sponsoring Committee: Ethics Committee

Strategic Goal: Provide equity in access to transplants

View the board report and final version of the white paper (PDF - 1 M; 6/2019)

Read the proposal and white paper (PDF; 1/2019)

Contact: Abigail Fox

Executive summary

The allocation policies for multi-organ transplant (MOT) have the potential to create inequity in the organ distribution process, either in the rate of transplantation or in the time to transplantation. Such potential inconsistencies may affect the patients who are awaiting MOT as well as those who are awaiting single organ transplantation (SOT) because both groups depend upon available organs from the same limited donor pool. Prioritization of MOT candidates and the allocation rules for each combination have not been standardized across the different organs. As a result, the current allocation system has generated confusion in the transplant community about the rationale for differences in MOT allocation plans between different organ combinations.

The OPTN/UNOS Ethics Committee (hereafter “The Committee”) performed an analysis of policy and relevant literature focusing on the potential conflict in the principles of equity and utility in the allocation of multi-organ transplants. Ultimately the Committee affirmed that MOT should reflect a balance between equity and utility, with the understanding that no system can maximize both. Because the ethical issues of equity and utility that MOT raises are common with all organ combinations, the ethical principles must be carefully considered and weighed in the development and modification of MOT policy. This white paper details the ethical dilemmas that arise from conflicts between equity and utility and the recommendations of the Committee regarding the allocation of multi-organ transplants.

The 2018 OPTN/UNOS Strategic Plan called for the OPTN to “measure equity in allocation, including geographic disparities and multi-organ disparities.” This white paper lays the foundation for other committees to clarify or modify existing multi-organ allocation policy and to do so in a consistent, principled manner, which aligns with the OPTN strategic goal to provide equity in access to transplant.

Comments

Xingxing Cheng | 02/07/2019

This is a comprehensive, lucid and thoughtful summary of the pertinent ethical issues in multi-organ transplantation. As a practising transplant nephrologist, I thank the 2018 UNOS Strategic plan for making measuring equity in multi-organ allocation a priority, and the UNOS Ethics Committee for this important work. I have two comments for future editions: 1) The "Treatment options other than transplantation" section should discuss dialysis more as a viable treatment option. SOT (non-kidney) + dialysis SHOULD be openly discussed as an alternative to MOT. For most patients with kidney failure who do not have another organ failure, dialysis is most times the firstline and frequently the only treatment option for their kidney failure. It appears to violate the equity principle if a patient who with another organ failure is treated differently, such that a life-saving organ transplant + dialysis is not an option. This discussion will also lend itself well to the section on "Degree of Need" and "Standardize criteria for MOT". 2) I frequently see cases resulting from the fact that KT is always the secondary organ. When a KT candidate has a mild-moderate degree of other organ failure (most often heart or liver), which is not severe enough to place them within reach of a heart or liver transplant, the patient cannot receive a KT (and receive quantity and quality of life benefits from it) regardless their wait-time. The equity principles at conflict here are interesting to explore and opens the question of, when the kidney disease burden is greater than that of other disease burden, whether some additional priority point system (for instance, those granted to patients with primary hyperoxaluria awaiting liver-kidney) can be adopted to "level the playing field".

Anonymous | 02/08/2019

Region 7 vote-5 strongly support, 9 support, 1 abstention There was a question asked about whether or not SLK was considered when developing this paper. The committee needs to make sure that there is no conflict with current policy. There was also concern that the paper did not include K/P which is a common transplant. There was a recommendation that all multi-organ transplants be considered. Some members commented that removing DSA as a unit of allocation could disadvantage recipients of MOT. Another recommendation to the committee was to consider the effect of any policy on vulnerable populations and carefully monitor the impact post implementation.

Anonymous | 02/15/2019

The OPTN/UNOS Thoracic Organ Transplantation Committee commends the Ethics Committee for their work on analyzing the ethical principles involved when considering MOT policy and felt the white paper provided a reasonable foundation to inform future multi-organ allocation policy development. One member opined that removal of DSA from organ allocation policy may disadvantage multi-organ candidates, and that geography should be an important consideration when developing multi-organ policy, as well as something to be cognizant about in the current discussions and changes to organ distribution. Otherwise, the Committee was supportive of the white paper’s recommendations.

Paul Grimm | 02/15/2019

Situation. 11-year-old child on dialysis, highly sensitized, without a living donor and with 2 years of wait time and undergoing desensitization. PRA 92%. Excellent KDPI donor kidney is allocated to a high PRA 70-year-old individual. The other kidney is allocated to an older adult with pancreas. Our pediatric patient was the backup for both kidneys. If it was solitary kidney donor, the child would have been allocated the kidney that went to the K/P. Because it was a pancreas/kidney, the kidney was taken from the child. Is this fair? The child is ultimately going to live a lot longer than the 70-year-old and the K/P recipient. The child was highly sensitized and had been waiting a long time with no suitable offers, it would likely be a very long time before another kidney of the same quality would be available. This is not an outlying nor rare event. This is commonly seen time and again in our region. As the pancreas transplant is not lifesaving but is life-affirming, as is the kidney transplant, why should the pancreas demand priority? What is the rationale for the kidney being dragged by the pancreas and not vice versa? Suggestion: This issue could be fixed by making kidney criteria be primary. If a person needs a pancreas as well, that would be dragged if they got allocated the kidney. Then the competition for everybody needing a kidney would be leveled for at least this organ combination. Another option would be to alternate allocations in this situation so the kids have some shot at high quality donors. i.e. kidney goes to K/P this time, then the next time it goes to a child.... Either of these options would go very far to reduce the inequities of allocation for which children inordinately suffer, especially in regions with active K/P programs.

Region 1 | 02/18/2019

Region 1 vote-7 strongly support, 4 support, 0 abstention, 0 oppose, 0 strongly oppose

Anonymous | 02/21/2019

Region 5 Vote: 4 strongly support, 16 support, 2 abstention, 1 oppose The comment was made that for future policy development, the mortality of liver alone vs heart/liver and lung/liver requires analysis to develop appropriate priority. MOT data should be publically available as the results are currently unavailable. In addition, it was mentioned that regarding futility in multi-organ transplant, it is very important to carefully define futility and identify where it is to be able to make decisions about MOT based on real medical urgency.

Anonymous | 02/25/2019

Region 8 vote: 6 strongly support, 12 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose Members expressed that this paper is very informative and they appreciate the work of the committee. A member asked if the committee is proposing any strategies to address disadvantaged groups, possibly by having a waiting time threshold. For example, after a certain amount of waiting time has passed a candidate receives additional priority. Members would also like the committee to include specific suggestions for policy changes in the paper.

Anonymous | 02/27/2019

The Minority Affairs Committee (MAC) thanks the Ethics Committee for its white paper and applauds the effort to address multi-organ transplant (MOT) and its ethical implications. A MAC member encouraged the Ethics Committee to include more data on longevity issues of renal allografts associated with MOT in the white paper. The MAC also discussed whether more data from the results of SLK and "safety net" policies in liver and its potential applicability to thoracic MOT could be included in the MOT discussion as helpful to identify strategies to create a fair MOT system that correctly accounts for medical urgency.

Anonymous | 02/28/2019

The Transplant Coordinators Committee reviewed the proposal during a conference call on January 16, 2019. Overall, the Committee favored the concepts presented in the white paper in order to guide future policy on multi-organ transplantation (MOT). Committee members commented that the logistical and ethical topics presented within the paper are bona fide issues when considering broader sharing of all organs. Suggestions shared by the Committee included 1) adding advice regarding intraoperative decline by a guest recovery team and the challenges associated with re-allocation of organs that are traditional recovered by an accepting transplant program’s own recovery team (e.g.: heart or lung recovery), 2) further discussion by the Ethics Committee on the potential inequity associated with a MOT candidate receiving multiple offers and rapid transplantation and impact on candidates in need of a solitary organ transplant, and 3) expansion of content in the guidance pertaining to pediatric donor organs used in MOT (both in adult and pediatric candidates).

Region 10 | 02/28/2019

Region 10 Vote: 0 strongly support, 11 support, 7 neutral/abstain, 1 oppose, 0 strongly oppose; There is concern for pediatric patients in DSAs that perform many multi-organ transplants. It will negatively impact the pediatric population. More kidneys with a KPDI less than 35 went to MOT candidates than pediatric patients. There should be some sort of consideration for pediatrics in the white paper. One member stated that they would like to see firm recommendations for multi-organ versus single-organ transplants, which the white paper lacks.

Anonymous | 03/15/2019

The OPTN/UNOS Patient Affairs Committee (PAC) thanks the Ethics Committee for the opportunity to comment on the proposal to ethical implications of multi organ transplants. The PAC noted the following: • Inclusion of an appendix, glossary or footnotes which explain the ethical constructs and terminologies used throughout the document is necessary. As it is now, there are ethical terms used in the document that may be harder for an average patient to understand. • The definition of utility should be clarified to state that each non-directed donated organ goes to the person whom is a match and most in need of an organ. • The recommendation for more robust data reporting and closer monitoring of outcomes was supported • A similar document focused on pediatric SOT vs. MOT should be composed The PAC asked the following questions, which were answered by the sponsoring committee’s presenter to the satisfaction of the Committee: Q: How are the new changes to geographic distribution (e.g. concentric circles) going to affect MOT allocation? A: The Ethics Committee acknowledges that the impact of geography on MOT allocation should be better understood. The organ-specific committees are will eventually consider this issue. Q: There was a general lack of understanding around when multi-organ transplant would be appropriate or necessary, versus single organ transplant. Are there any specific examples that could be cited to explain the differences in MOT and SOT allocation? A: The purpose of the document was to focus on clarifying how the current MOT system is determining the prioritization of candidates. However, the Ethics Committee did agree that more data collection on MOT allocation was warranted. Q: What are the next steps for this guidance document post-Board consideration? A: The Ethics Committee does not generally write policy proposals. The Committees mainly use ethical white papers to help inform future policy proposals. It should be noted that this white paper is merely the beginning of solving issues stemming from MOT policies. A larger, joint-committee workgroup should form to tackle the issues surrounding MOT policies. The PAC supported the Ethic Committee’s white paper on MOT. Although specific concerns were raised that were beyond the scope of the white paper, and the speaker suggested were more appropriate for the organ-specific committees.

Anonymous | 03/15/2019

Region 4 vote-5 strongly support, 9 support, 1 abstention, 1 oppose, 0 strongly oppose

Children's Hospital Medical Center | 03/19/2019

Our various teams and in particular the Kidney transplant program read the white paper on Multi-Organ transplant (MOT) vs Single Organ transplant (SOT). We wish to commend the committee on the work put into the development of the paper. It is nice that the paper reflects that any MOT policies should not have negative effects on children. I think the paper did an excellent job of describing all of the possible implications but needs to make more firm recommendations on the impact of MOT on SOT. In all the measured tone, it is easy to miss the massive impact that MOT has on children in DSA’s where MOT is common, in particular higher volume Kidney-Pancreas programs. There were 1800 MOTs last year and only somewhere around 750 pediatric transplants. The transplant community already determined that it is ethically appropriate to allocate KDPI < 35% organs preferentially to children. When you consider that the AVERAGE KDPI of MOTS are 18% to 36%, the majority of KDPI < 35% organs went to MOTs instead of children. There were more < 35% KDPI kidneys allocated to MOT last year than there were total kidney transplants combined. Perhaps a more thorough analysis of the data might yield for further understanding. MOT is taking the best organs from the patients who stand to benefit from them the most, and making them wait longer for them. Our organization is interested in next steps with the white paper is board-approved. Perhaps, a larger, joint committee of all organs and those identified as being potentially negatively impacted could be constructed to better tackle the challenges of MOT.

American Society of Transplantation | 03/19/2019

The American Society of Transplantation is supportive of this white paper and offers the following comments for consideration: The committee has done an excellent job framing the contemporary and salient features of “equity” and “utility” as these two concepts relate to the final rule interpretation of national organ distribution. Development and refinement of policies for MOT allocation will require national consensus, oversight, and monitoring to assure balance between equity and utility and to assure fairness to potentially disadvantaged groups based on geography, socioeconomic status, and age. A focus on national standardization would assure consistency and fairness. Assessment of equity poses greater challenges in comparison to utility as outcomes such as survival are inherently more measurable. Approaches that reduce the need for MOT would likely maximize equity. Policies should attempt to establish standardized criteria for MOT combinations based on categories of need. Given the paucity of evidence, it is anticipated that such criteria would be consensus rather than evidence-based. However, data collection and analysis resources need to be deployed to model and review outcomes related to the development and implementation of these criteria. Central oversight and review will be critical from the standpoints of patient eligibility; center qualifications; and outcomes monitoring. This white paper also acknowledges that MOT may further reduce access to already disadvantaged groups. Medically, this includes sensitized candidates and pediatric candidates. Significant ethnic disparities in MOT are illustrated. Access to health care as well as geographic and economic disparities may be further exaggerated due to potential limited geographic availability of MOT as well as the potential need for greater economic resources and access to healthcare required for MOT. In addition to “minimizing additional harm to disadvantaged subgroups,” efforts should be made to achieve greater balance in correcting disparities that presently exist. Despite the successes of the paper, a significant limitation is the omission of a dedicated discussion on the needs and potential impact on pediatric transplant candidates. The Society’s pediatric constituency strongly advocates for a future effort to address the substantial effects of MOT and kidney-pancreas transplants on children. The Society is advocating for more specific MOT data outcome collection and utilization monitoring. We suggest that the data groups be collected retrospectively to help determine inequities and possibilities based on current utilization patterns. 1. Group 1. MOT where one organ transplanted would not survive without the other (heart/lung). We do believe that futility should be considered. If the transplant is a “last ditch effort,” then survival of the recipient should be considered. This addresses the concept of utility versus futility. 2. Group 2. MOT where one organ is lifesaving and the other is life enhancing (liver/ kidney or heart/kidney). It is our opinion that, in this instance, priority should be reconsidered and not instinctively given to the MOT for both organs- as one organ is life enhancing and one is lifesaving. We believe there is data collection and analysis needed to determine what kidney function criteria justly allocates a kidney to a patient on the heart or liver list. As an example, there is no standard way of assessing the ability of the kidney to recover function once the heart is transplanted (while undergoing hemodynamic stress on heart-lung bypass and inotropic/pressor stress perioperatively). If native renal function does return, this can lead to the possibility of the recipient of the MOT to have 3 working kidneys post-surgery and the SOT candidate still on dialysis. 3. Group 3. MOT where both are life enhancing (pancreas/kidney). Additional focus on KP and pediatric prioritization are necessary as this is an instance when low KDPI kidneys, which would normally be prioritized for children, are being given to older recipients preferentially. In the proposed policy document there is stated that a member of the OPTN/UNOS pancreas community felt that “additional focus on KP and pediatric prioritization was unnecessary”. Additional analysis of the data related to KP and pediatric DD kidney candidates is necessary. Additionally, discussion and consideration as to whether pediatric DD kidney candidates should remain behind KP candidates in the allocation sequence is needed. 4. The Society also suggests that all MOT listing criteria developed in the future be objective and not subjective. For example, ICU status should not change the priority. Some more advanced centers are more comfortable keeping critical patients on the floor and less experienced centers are quicker to transfer to an ICU. These opportunities for disparities should be eliminated. The Society is grateful for the development of this white paper and supports the concept of standardization criteria for exemptions and a transparent central review committee process of these requests. We recommend that the criteria be stringent and standardized across all organs to limit the opportunity for inequity.

Anonymous | 03/19/2019

To Whom it May Concern, On behalf of the American Nephrology Nurses Association (ANNA), thank you for allowing us the opportunity to comment on the Organ Procurement and Transplantation Network (OPTN) Public Comment Proposals 01/22/19- 03/22/19. Our comments for several of the current policy proposals are as follows: OPTN Standards for Public Comment 01/22/19 – 03/22/19 Ethical implications of multi organ transplants: ANNA supports. We agree with a balance between equity and utility.

Anonymous | 03/19/2019

The Pediatric Transplantation Committee (Pediatric Committee) commends the Ethics Committee for their effort in creating the white paper and thanks them for their presentation on the document. A Pediatric Committee member asked what data the Ethics Committee considered in creating their recommendations, specifically if the waitlist outcomes of the pediatric population were considered independently. The Pediatric Committee was concerned that the white paper does not do enough to address the pediatric population, especially regarding their prioritization within kidney allocation. The Pediatric Committee noted that many high-quality kidneys are allocated to adult kidney-pancreas candidates instead of pediatric candidates. The Pediatric Committee suggested that the Ethics Committee discuss this issue in this paper or a separate paper, instead of leaving it for the individual committees to decide. A Pediatric Committee member suggested that the Ethics Committee provide recommendations on how to address disparities in multi-organ transplantation for vulnerable populations.

American Society of Transplant Surgeons | 03/21/2019

The American Society of Transplant Surgeons (ASTS) strongly supports the OPTN/UNOS white paper, “Ethical Implications of Multi-Organ Transplants” and overall found this to be a thoughtful consideration of the ethical principles related to MOT. While ASTS supports this as a white paper, that support would not necessarily extend to policy derived from its contents. We strongly believe that all policy development should undergo public comment regardless of its origins as white papers or guidance documents.

Anonymous | 03/21/2019

The Liver and Intestinal Organ Transplantation Committee (the Liver Committee) commends the Ethics Committee for their work in creating this white paper. After hearing a presentation on the white paper, the Liver Committee had no further comments.

Anonymous | 03/21/2019

Region 2 Vote: 12 strongly support, 9 support, 0 neutral/abstain, 2 oppose, 0 strongly oppose One member noted that their center has several younger patients that are too sick to withstand single organ transplants. The white paper asks the question on whether it is ethical to give more than one organ to one patient when two patients could have benefited from those organs. The member urged that the committee not discount those patients that cannot survive without a multi-organ transplant. Two members voiced praise for the white paper, stating that this is a good first step in trying to tackle a very complicated aspect of organ donation and transplant.

Ira Copperman | 03/22/2019

The purpose of my comment is to make sure multi-organ transplants, such as SKP, are given their full weight during all of the discussion of eliminating DSA and Region. In the case of SKP, there is ample evidence that the kidney should follow the pancreas in this case to get better surgical and long-term medical outcomes. The shorter ischemic time of the pancreas should make it necessary that the kidney is given to the candidate and goes along to surgical completion. There are ample situations where multi-organ transplants that include the kidney should be considered as one transplantable unit and the sickest patient should be the primary concern given the complications that occur from staying on a waitlist until a simultaneous multi-organ transplant can be done.

ASHI | 03/22/2019

The American Society for Histocompatibility and Immunogenetics (ASHI) strongly supports this white paper and believes that it can serve as a guide for alleviating disparities in multi-organ transplants.

Anonymous | 03/22/2019

19 strongly support, 11 support, 3 abstention Comments: One member pointed out that it is important to think about the quality of kidneys being used in MOT because quality kidneys are being redirected from pediatric patients for MOT.

Anonymous | 03/22/2019

8 strongly support, 10 support, 3 abstain, 1 oppose, 3 strongly oppose Comments: In general, the region supported the proposal with minimal commentary. Members questioned how MOT candidates would be prioritized, because there are times when MOT allocation is “blocking” SOT allocation (e.g. when kidneys are pulled for allocation to heart/kidney candidates). In tangent with these concerns was how certain MOT combinations prevent the use of the pancreas. Due to this concern, members supported prioritizing kidney/pancreas candidates, especially since diabetic patients are shown to have better outcomes when allocated both a kidney and a pancreas. Another suggestion was for the OPTN to consider creating safety nets (like SLK) for other multi-organ combinations, such as heart/kidney.

Houston Methodist Hospital | 03/22/2019

This comment is the opinion of the Houston Methodist Hospital. As MOT becomes more prevalent it will become increasingly important to consider whether existing allocation policies for MOT are ethically justifiable. The OPTN/UNOS White Paper focuses on how two ethical considerations, utility and equity, should inform thinking about allocation of organs for MOT. The dual aims of bringing about the most benefit and distributing benefit fairly, when understood correctly, provide a helpful framework for determining whether allocation policies are ethically justifiable. The apparent motivation for reevaluating allocation policies for MOT was the observation of “MOT-driven differences” is distribution of organs. Differences in organ allocation rates among various populations may, but do not necessarily, indicate inequitable distribution of these scarce resources. Whether these differences are ethically problematic turns on whether there are morally salient differences among the populations themselves. If there are not, unequal distribution of organs may be unethical. Our group believes that there are explanations for the observed MOT-driven differences that suggest the practice of MOT is not exacerbating inequitable distribution of organs. First, the demographics of people waiting for MOT differ significantly from those waiting for Isolated Kidney (IK) transplantation. 32% of candidates on the waiting list of IK transplantation are black, slightly lower than the 35% of IK recipients (OPTN National Data website). In contrast, 20.9% of candidates on the waiting list for MOT in 2017 are black, on par with the 18% of MOT recipients who are black. Data for transplanted recipient’s ethnicity varies very differently when reviewed by organ type. The suggestion that there is an ethnicity inequality is not accurate. Data indicates black recipients receiving MOT are equal or actually higher when compared to those receiving a specific organ. See Table 2 below. The SOT performed for liver, black percentage is 9.6% vs, the liver-kidney black percentage of 14.4%. These data suggest that racial differences in organ transplants come not from allocation policies but from variations in disease and waiting list demographics that are likely explained by the prevalence of different conditions is different populations. Similarly, differences socioeconomic status among MOT and IK transplant recipients might simply reflect the fact that MOT is typically performed at high-volume medical institutions that draw geographically from a more urban population than centers performing IK transplantation. Therefore, the differences identified are likely to be the result of variations in the populations these types of interventions target rather than by inequities in organ allocation policies. Table 1 Data All MOT Listed in 2017 per UNOS STAR Data Race/Ethnicity Freq. Percent White 1,491 55.3 Black 564 20.92 Hispanic/Latino 512 18.99 Asian 81 3.0 Other 48 1.78 Total 2,696 100 Table 2 Data 1/1/88-2/28/19 as reported by https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/ Transplanted To Date by Ethnicity Volume White Black Hispanic Asian American Pacific Multi- Indian/ Alaska Islander racial Native ALL DD 604,205 61.8% 20.3% 12.1% 4.1% 0.7% 0.3% 0.6% Kidney (DD) 297,313 49.1% 29.5% 14.1% 5.3% 1.0% 0.4% 0.6% Liver (DD) 158,707 71.9% 9.6% 13% 4.1% 0.6% 0.2% 0.6% Heart 72,893 72.1% 16.4% 7.7% 2.5% 0.3% 0.3% 0.6% Lung 38,739 84.5% 7.9% 5.6% 1.4% 0.3% 0.1% 0.3% ALL MOT 13,152 64.3% 16.4% 14.4% 3.3% 0.7% 0.3% 0.6% Kidney-Liver 8,966 64.3% 14.4% 16.% 3.6% 0.8% 0.2% 0.6% Kidney-Heart 1,733 56.8% 28.9% 8.6% 4.1% 0.4% 0.8% 0.3% Kidney-Lung 58 69.0% 17.2% 12.1% 1.7% Liver-Heart 285 63.9% 20.4% 12.3% 2.1% 0.7% 0.7% Liver-Lung 109 92.7% 2.8% 4.6% The fact that higher quality organs go to MOT compared to IK transplants can also be justified by the inherent risk in MOT patients. While it is true that Multi-Organ Donors tend to be younger than those who donate kidneys alone (Reece, Veatch, Abt, & Amaral, 2013) the practice has evolved from clinical experience with outcome of the higher risk of poor outcomes in MOT compared to single organ recipients. In fact it is the treating physician prerogative to “match” organ quality to patient illness as is widely practiced in liver and heart transplants. Even in IK transplants the system finds it ethical to distribute the best kidney to highly sensitized patients and Zero mismatched recipients in an attempt to improve outcome. The differences identified in the OPTN/UNOS white paper are therefore the result of clinically justified judgment rather than inequities in organ distribution policies. As a result, we believe that the MOT-driven differences described in the OPTN/UNOS White Paper do not represent ethically problematic inequities in organ allocation but rather variations that are justifiable based on underlying characteristics of the interventions and the populations who undergo them. One additional concern is that withholding MOT from these potential candidates, mortality will significantly increase. In a large retrospective analysis, it was demonstrated that mortality among patients with pre-transplant renal dysfunction (defined as MDRD-GFR <25 or dialysis requirement) who undergo liver transplant alone as opposed to SLKT increases by 13.2% within the first year following transplant. In contrast, mortality among SLKT recipients is equivalent to that see in patients without pre-transplant renal dysfunction who receive LTA (Brennan TV Clinical transplantation, 2014). While specific data is not as readily available in other organ systems, ongoing renal dysfunction following transplant is a well-known risk factor for patient mortality. Thus, policy changes which prevent MOT have the potential to significantly increase the number of futile transplants, which violates the Final Rule. Furthermore, analysis of data from patients at our center demonstrates that despite a significantly higher medical acuity among recipients of SLKT compared to KTA, KTA and SLKT recipients matched 1:3 based on recipient age, gender, race, and KDRI exhibit equivalent mortality and death-censored kidney allograft survival at 5 years following transplantation (Lunsford et al., 2017). Thus, when comparing equivalent patient populations, long-term outcomes for SOT compared with MOT do not differ significantly. Our analysis suggests that the Ethics Committee should reconsider several of the White Paper’s 13 recommendations. We reject the assessment that there is an “adverse impact” associated with “cherry-picking” high-quality organs for MOT (Recommendation 2) given that this difference is a result of outcome concerns and object to the cherry picking analogy. We also suggest that creating a national review board (Recommendation 3) for MOT would create an additional and unnecessary step in the already extensive process for patients being listed for transplant. We reject the assessment there is an ethnicity inequality (Recommendation 7). There is actually a higher percentage of blacks in the MOT candidates and recipients for SLK vs LTA and the differences identified are likely to be the result of variations in the populations these types of interventions target rather than by inequities in organ allocation policies. Finally, we believe that establishing additional standards for centers performing MOT (Recommendation 10) is likely to exacerbate inequities in access, likely making it more difficult for those who live in medically underserved areas to take advantage of this innovation. We appreciate the opportunity to submit our concerns on behalf of Houston and South Texas patients to the committee and look forward to solutions that to maintain an equitable and fair system for transplantation. References Lunsford, K. E., Saharia, A., Balogh, J., Nguyen, D. T. M., Graviss, E. A., Manner, C. J., ... & Knight, R. J. (2017). Equivalent Renal Allograft Survival Following Simultaneous Liver Kidney Transplantation Compared to Matched Kidney Transplant Alone Recipients: A Match Cohort Analysis. Transplantation, 101(5). 146-147. Reece, P.P., Veatch, R.M., Abt, P.L., & Amaral, S. (2013). Revisiting Multi-organ Transplantation In the Setting of Scarcity. American Journal of Transplantation, 14(1). 21-26. https://doi.org/10.111.ajt.12557

Anonymous | 03/22/2019

The Pancreas Committee thanks the Ethics Committee for its work developing the MOT white paper. The Pancreas Committee agrees with the MOT white paper’s treatment of kidney-pancreas (KP) transplants as differing from other multiple organ procedures in certain significant ways. Specifically, about 80-85% of transplanted pancreata are used in KP transplants, indicating that the pancreas is less likely than other MOT organs to be utilized as a solitary transplant, and could otherwise be discarded if not utilized in a KP. Allocation is already established to prioritize KP transplants to reflect that these transplants maximize life years from transplant (LYFT) more than most kidney-alone transplants. The Committee also felt that it would be misrepresentative to include KP alongside the more rare types of MOT that do not uniquely address one disease. A leading cause of kidney failure is diabetes, which is often treated with combined KP transplant. In many cases, the kidney is the primary organ and the pancreas is supplementary, which counters the assumption that KP is unnecessarily pulling kidneys. An additional difference is that while KP candidates must meet kidney waiting time criteria, many MOT candidates may not have criteria to meet and are listed pre-emptive of medical need. In general, the white paper’s recommendations regarding establishing minimum requirements for MOT allocation; holding centers accountable by collecting data and reviewing outcomes; identifying the impact of organ failure on quality of life and on long term survival; and establishing the priority of the organ combination in relation to single organ transplant alternatives; do not directly apply to KP transplantation, which already accounts for these measures in its allocation system. The Pancreas Committee indicated overall support for the efforts of the Ethics Committee and the MOT white paper in an online poll.

Anonymous | 03/22/2019

The OPO Committee supports this white paper and only question how the Ethics Committee reviews approved white papers or guidance documents to ensure they are current. The OPO Committee recommends that this review process be specified more clearly with consideration to the following questions: • What would the application be? • Should these reviews/updates be approved by the Board? Vote: 1 Strongly Support, 10 Support, 0 Abstain/Neutral, 0 Oppose, 0 Strongly Oppose

S Little | 03/22/2019

I consider this white paper to be going in the right direction for ethical considerations of MO transplants. While I believe it’s common to consider the aspect of helping three patients, as opposed to providing three organs to one individual, ethically I believe consideration of equity and utility need to be weighed. I support prioritizing MOT candidates, and opening the discussion for what else can be done to equitize organ allocation.

Joseph Hillenburg | 03/22/2019

I echo the concerns previously stated by the Pediatric Committee with respect to ensuring fairness for pediatric candidates.

Region 9 | 03/26/2019

Vote: 5 strongly support, 18 support, 1 abstain, 2 oppose, 1 strongly oppose Comments: The region generally supported the proposal but there was some concern that kidney/pancreas transplants were not included. In addition, some members commented that high quality kidneys are going to SPK transplants taking kidneys from pediatric candidates. There was also concern raised about SLK and a comment that too much priority is being given to candidates who are listed under the safety net. Some members recommended that the committee look at outcomes as they relate to MOT’s. There needs to be balance between equity and utility.