Establish Eligibility Criteria and Safety Net for Heart-Kidney and Lung-Kidney Allocation At a glance Background The Ad Hoc Multi-Organ Transplantation Committee (MOT) seeks to establish policies for heart-kidney and lung-kidney allocation. This proposal would establish criteria to make heart-kidney and lung-kidney patients eligible for a multi-organ transplant. The eligibility is based on the patient’s kidney function. This proposal also will create criteria for prioritizing patients who previously received either a heart or lung transplant, and now need a kidney transplant. The prioritization is referred to as a “safety net” for these patients. The proposed eligibility criteria and safety net prioritization are intended to improve equity in access to transplant for both multi-organ and single-organ patients. Supporting media Presentation View presentation Proposed changes Create criteria for patients who want to receive simultaneous kidney and lung transplants or simultaneous kidney and heart transplants. Create criteria to give patients some additional priority to receive a kidney after the patient has received either a heart or lung transplant. Anticipated impact What it's expected to do Create eligibility criteria for heart-kidney patients based on the patient’s current kidney function. Create eligibility criteria for lung-kidney patients based on the patient’s current kidney function. Create “safety net” criteria to prioritize patients for a kidney transplant who are experiencing kidney failure after they have received either a heart alone or lung alone transplant. What it won't do This will not change existing eligibility criteria and safety net priority for simultaneous liver-kidney (SLK) transplantation. This will not change current criteria for how a patient is prioritized for a kidney, heart, or lung transplant without an additional organ. Terms to know Multi-organ candidate: a patient who needs to receive more than one organ transplant at one time Safety-net criteria: a section of policy that allows a patient to receive priority in certain situations Click here to search the OPTN glossary Comments University of Minnesota Heart-Kidney Transplant team | 03/23/2022 We greatly appreciate the extensive work the Ad Hoc Multi-Organ Transplantation Committee has done to establish proposed policies for heart-kidney and lung-kidney allocation. We agree this is an area that is in great need of standardization and these policies regarding heart-kidney and lung-kidney allocation are overdue. However, we do have several concerns with the current proposed policies for heart-kidney allocation. 1. The most concerning aspect of this proposal relates to status 4 heart waitlist candidates. Status 4 candidates are mostly patients on durable LVAD or home inotrope support. These subjects would not be eligible for simultaneous heart-kidney (SHK) allocation, even those who are currently on dialysis, as the proposal requires the listing status to be 1, 2, or 3 on the heart transplant waitlist. The purpose of this provision is not entirely clear. While we sense that it may have been done to balance organ allocation between single organ and multi organ candidates, it extensively disadvantages the durable LVAD population currently listed as status 4 with advanced kidney disease. To our knowledge this decision is not substantiated by survival data. Given that only approximately 20% of all heart transplants are currently performed on status 4 patients, we do not feel that adding those who meet eGFR threshold within this urgency status will significantly increase the number of SHK transplants. Conversely, excluding these patients will likely result in one of two concerning outcomes: 1) It will likely spike status 3 exception requests for heart transplantation, which requires hospitalization, thus further stretching our health care resources; 2) Even more troubling is the potential removal of candidates from the heart transplant waitlist altogether, given the concern for poor outcomes with heart alone transplant in the setting of low eGFR. Thus, we strongly advocate for the following modification to the proposed policy: “an OPO is offering a heart and a PTR is also registered for a kidney, then the OPO must offer the kidney if the PTR is registered at a transplant hospital at or within 500 nautical miles (NM) of the donor hospital, and if the PTR is assigned as an adult heart status 1, 2, 3, or 4 and meets eligibility requirements, or the PTR is assigned any active pediatric heart status.” 2. For the chronic kidney disease patients, we propose meriting certain exceptions for those with an eGFR between 30 and 40 ml/min, “such as nephrotic range proteinuria, long-standing diabetes mellitus, known glomerulonephritis, imaging evidence of chronic renal disease or solitary kidney; immunologic considerations such as highly sensitized patients…etc.” While through our analysis of the Scientific Registry of Transplant Recipients (SRTR) between 1/1/2000 and 9/30/2019 comparing primary adult heart alone (HA) and simultaneous heart-kidney (SHK) transplant recipients with moderate to severe renal dysfunction, we detected a survival benefit with SHK over HA transplant in the 30-40 mL/min eGFR group using standard analysis files (SAF) analysis, the number of kidneys needed to prevent 1 death or dialysis initiation at 1 year was approximately 10. Thus further risk factor utilization would be reasonable to attempt to increase this group’s benefit of SHK transplant. 3. For the sustained acute kidney injury patients, proposing an eGFR threshold of <30 mL/min rather than <25 mL/min may be reasonable for SHK allocation. The ability to estimate eGFR is limited in those with advanced heart disease. Additionally, the currently available survival data is largely based on the eGFR value obtained immediately prior to transplant surgery and does not delineate between sustained acute and chronic kidney disease. 4. We propose transplant recipient follow-up (TRF) data collection modification to capture creatinine and eGFR at the time of heart transplant listing and monthly subsequently through the first year after transplantation. This will help address the limitation of the current SAF. UC San Diego Health Center for Transplantation | 03/23/2022 As a moderate volume program that has experienced significant growth in the last 5 years in single and multi-organ transplants, CASD strongly supports the creation of eligibility criteria and a safety net for heart-kidney and lung-kidney allocation. The experiences following the implementation of the eligibility criteria and safety net for liver-kidney candidates has been generally positive and achieved its intended purpose(s) of avoiding futile transplants, promoting best use of donated organs and promoting patient access. We believe that implementing similar policies for other multi-organ combinations including a kidney is ethically justifiable and promotes the goals of the community. As a moderate volume program that has experienced significant growth in the last 5 years in single and multi-organ transplants, CASD strongly supports the creation of eligibility criteria and a safety net for heart-kidney and lung-kidney allocation. The experiences following the implementation of the eligibility criteria and safety net for liver-kidney candidates has been generally positive and achieved its intended purpose(s) of avoiding futile transplants, promoting best use of donated organs and promoting patient access. We believe that implementing similar policies for other multi-organ combinations including a kidney is ethically justifiable and promotes the goals of the community. While experience with SLK does provide a reasonable starting point for other organ combinations, we do have some concerns regarding the application of the safety net rules specific to AKI for the lung-kidney patients. Due in part to the small number of patients, there is a lack of data to support the 6-week timeframe in this population. Lung patients are at a higher risk for acute exacerbations and there are reports that post-lung transplant abdominal surgery increases mortality rates. While it would be reasonable for the Committee to start with the 6-week timeframe with a commitment to modify as more experience becomes available the creation of an emergency exception pathway may also be advisable until more experience is gained. We would also urge the Committee to consider revising allocation rules for other multi-organ combinations (ex: heart + liver + kidney). Currently heart “pulls” other organs but there are instances in which, for example, a patient’s liver disease may actually be driving their illness (Status 1b and MELD of 40+) which are not accounted for in the current system. Patient Affairs Committee | 03/23/2022 The Patient Affairs Committee thanks the OPTN Ad Hoc Multi-Organ Transplantation Committee for their efforts on the Establish Eligibility Criteria and Safety Net for Heart-Kidney and Lung-Kidney Allocation proposal. The Committee emphasizes that single organ transplant candidates need to feel confident that multi-organ transplant candidates are not unfairly prioritized. The Committee cites this may be accomplished through multi-organ transplant candidates demonstrating clinical need for the organs, clear criteria, and equal treatment of both single organ and multi-organ transplant candidates. The Committee supports the eligibility criteria and safety net framework. The Committee recommends to ensure that the proposal and policy are appropriately communicated to the general public. The Committee requests a review of post-transplant outcomes for multi-organ transplant recipients to demonstrate the need for the change. This analysis needs to be available to the public annually as this will allow the community to be confident those most in need receive a life-saving organ. Children's Hospital Los Angeles | 03/23/2022 Our center’s main concerns about this proposal surround the rather restrictive criteria needed to obtain a heart and kidney from the same donor. We recognize that the proposed “Safety Net” is intended to be a resource for patients who do not meet criteria for single-donor simultaneous multi-organ transplant, but I would propose that any case that requires use of the proposed safety net system should be viewed as a failure of the allocation system to provide the right procedure for the recipient. And with the restrictions on SLuK and SHK transplant proposed, we will indeed need that safety net to rescue these single organ transplant failures. SLuK and SHK are more common in 2022 than previously because these procedures have a high success rate and lower risk for certain patients compared with KAH and KAL transplants. “Safety net” kidney candidates may have to spend months in critical care environments after their heart or lung transplants, struggling to attain basic functionality that could have been achieved in days with a SLuK or SHK, and with avoidable secondary morbidity and potentially mortality. These transplants constitute only a tiny portion of the kidney transplants, and only 15% of the total MOT kidney transplants. The proposal may therefore harm the outcomes of what could have been successful SLuK and SHK transplants, and may not significantly benefit the overall kidney transplant community by making available potentially 25-100 kidney transplants per year to the kidney transplant waiting list, compared with the 25,000 transplants done for that population per year, for a less than 0.4% potential impact on that population. Specifically, the proposal seeks to restrict SLuK and SHK transplants to those recipients meeting the criteria for sustained acute, or chronic kidney injury. In the critical care environments that these high urgency patients are supported in, patients in multiorgan heart failure are often not candidates for single organ transplant. The idea of delaying heart transplant until they qualify for kidney transplant as well, a minimum of 6 weeks into their kidney failure, may unfortunately have a negative survival impact, and erode some of the progress seen in recent years with the use of these MOT strategies for our sickest patients in thoracic organ transplant. While we understand that there must be some criteria for SluK and SHK urgency, we have strong concerns that the proposed criteria may be too strict. Please consider a substantial reduction in the duration of sustained acute kidney injury category. We find the goal of limiting the distance for SluK and SHK donors to either 250 or 500 nm to be counterintuitive. If these patients are able to obtain a quality heart donor at a longer distance than 500nm, the viability of the kidney portion of the transplant is not limiting for the survival of the patient, and constraining to closer donors only shrinks the donor pools for these very ill patients. We do not see the benefit to creating an artificial barrier at 500nm to limit these organs’ availability. Finally, we suggest harmonizing the sustained acute injury threshold for GFR (currently set at set at 25 ml/min), with the CKD criteria at listing which is set at 30 ml/min, to avoid confusion. We sincerely agree that we need to maximize the beneficence and fairness of kidney allocation, and the idea that high quality donors are being used for these patients only "briefly" on the list for kidney transplant can be difficult for primary kidney patients to accept. However, we would argue that these few combined transplants are truly life saving, and generally extremely necessary and beneficial. We would support the development of some reasonable guardrails on the listing of patients for combined transplant, but we feel that this proposal goes a bit too far. Kidney Transplantation Committee | 03/23/2022 The Kidney Committee thanks the Ad Hoc Multi Organ Transplantation Committee for their work on this proposal. The Committee supports this proposal to establish eligibility criteria and safety net for Hr-Ki and Lu-Ki patients. Several members agreed that Heart Status 4 and 5 candidates should be considered within the eligibility criteria, particularly for dialyzed patients, such that a status 5 heart candidates meeting the criteria could receive required kidney offers within 500 nautical miles. One member felt that heart-kidney candidates at Heart Status 4 or 5 should be eligible for permissible extra-renal shares, but not mandatory heart-kidney offers. The member pointed out that a heart-kidney candidate could have relatively low priority on the kidney match run, while other kidney candidates higher on the match run are medically urgent, highly sensitized, etc. Several members expressed concerns regarding transplanting extra-renal organs into high eGFR candidates, and potential impacts to kidney-alone candidate access, particularly for pediatric kidney candidates. One member remarked that the criteria should be restrictive of high eGFR heart-kidney candidates. Some members recommended that extra-renal transplant should be broken up into prioritized tiers, to balance the relative medical urgencies of multi-organ and single-organ kidney candidates and incorporate utility considerations. Members acknowledged that there will be more opportunity to weigh multi-organ and single-organ kidney candidate priority as each organ moves to a continuous distribution allocation system. Heart Failure Society of America | 03/23/2022 HFSA generally supports the proposal but is concerned it would be high risk for heart transplant patients with important renal dysfunction. Please see the attached letter for more detailed comments regarding the following areas of concern: (1) In patients with AKI, the six-week time frame is not reasonable for UNOS Status 1 and 2 patients; (2) Dialysis after heart transplant is associated with increased mortality; (3) The new heart allocation system adopted in 2018, as presently written, could potentially drive dual organ requests due to the critical shock presentation of many patients (UNOS 1 and 2 transplants); and (4) The proposal should be monitored post-implementation to understand any impact on access to multi-organ transplants for African Americans, Hispanics, women, and other potentially underserved populations in order to promote health equity. Attachment Ethics Committee | 03/23/2022 The OPTN Ethics Committee thanks the OPTN Ad Hoc Multi-Organ Transplantation Committee for the opportunity to comment on their policy proposal. The Ethics Committee felt that this proposal aligns with their white paper, Ethical Implications of Multi-Organ Transplants, and supports this proposal. It is suggested that the Committee develops a thorough monitoring plan and shares the results with the community post-implementation. Organ Procurement Organization Committee | 03/23/2022 The OPO Committee thanks the Ad Hoc Multi-Organ Transplantation Committee for their efforts in developing this proposal. The Committee supports this proposal and improved clarity and consistency in multi-organ allocation across organ combinations. The Committee agrees that these criteria are reasonable, and important to appropriate allocation of abdominal organs in multi-organ combinations. Some members recommended re-evaluating the SLK required-share circle size, to align with the proposed circle size for heart-kidney and lung-kidney. Several members noted that efficiency and clarity in multi-organ allocation is critical to improving utilization of high KDPI kidneys. Anonymous | 03/23/2022 I strongly support this proposal. There needs to be a better way to prioritize single kidneys vs multiple organ combinations. There are specific circumstances where kidneys should be prioritized over multiple organ transplants including pediatric patients, highly sensitized candidates who may be less likely to receive another organ offer and previous living donors. American Society of Transplantation | 03/23/2022 In general, the American Society of Transplantation supports the safety net concept and the distance threshold of 500NM from the donor hospital; however, there are numerous concerns that the proposed eligibility criteria will not meet the needs of all candidates. Overall, the AST the following comments are offered for consideration: • Based on a recent Heart-Kidney Consensus Conference publication (Am J Transplant. 2021; 00:1–9), SHK patients are more severely ill as the etiologies of renal disease are much less recoverable both from the insulting pathology and the adverse cardiac hemodynamics around the heart transplant. Acknowledging the need for consistent policy across organ transplant lines, we must also appreciate that the pathophysiology of kidney injury and damage may vary in different organ failure settings, which is important to consider in developing criteria and prioritization • There is evidence that some candidates with a GFR of 30-40ml/min, including some who have chronic kidney disease (CKD), may benefit from SHK transplants (Shaw et al PMID: 33350052, Gallo et al PMID: 32165347). • The proposed policy is too rigid to allow all appropriate patients access to SHK. These concerns could be addressed by an exception pathway with a review board to allow consideration of other markers of CKD such as proteinuria. The AST would support proposed changes if there were an adjudication pathway such as a review board to consider nuanced scenarios. If not, it is imperative that the OPTN study the impact of these changes on heart and lung transplant recipients shortly after implementation and promptly proposed additional modifications to address unintentional consequences that are identified. • Status 4 heart candidates on dialysis should be included in the SHK eligibility criteria and there should also be consideration for outpatient status 5 and 6 candidates on dialysis. Active heart candidates with an eGFR less than 30 ml/min should be eligible for SHK regardless of their assigned heart status. • Multi-organ transplants disadvantage kidney alone candidates, including pediatric kidney disease patients. We recommend that modeling be performed to ensure that the proposed policy does not further exacerbate this. Attachment Histocompatibility Committee | 03/23/2022 The OPTN Histocompatibility Committee appreciates the opportunity to review this proposal. The Committee members are supportive of the Ad Hoc MOT Committee’s proposal. Committee members requested the MOT Committee consider two additional ideas in their proposal or for a future iteration. The first is to consider an approach for prioritizing the optimal organs in circumstances where there are multiple organ combinations competing for kidneys, including situations with highly sensitized candidates who may be less likely to receive or be able to accept another organ offer. Second, another member suggested that the MOT Committee perform a post-implementation evaluation of heart, lung, or liver recipients who later receive a kidney through the safety net prioritization process in order to determine whether the recipients would have qualified for the kidney at the time of their heart, lung, or liver transplant. The member suggested this data may help the committee evaluate the utility and fairness of the safety net prioritization. Heart Transplantation Committee | 03/23/2022 The OPTN Heart Transplantation Committee (Committee) greatly appreciates the opportunity to comment on the Ad Hoc MOT Committee’s proposal. Committee members expressed deep concern regarding three specific aspects of the proposal. First, the Committee members’ consensus is that restricting access to Simultaneous Heart-Kidney (SHK) transplantation to adult heart statuses 1, 2, and 3 is extremely detrimental to the health of the adult heart status 4 candidates who have ventricular assist devices (VAD) and chronic inotropes. According to the Committee members, transplant programs will essentially have to let the health of their status 4 candidates worsen, in hopes that the candidate qualifies for heart statuses 1, 2, or 3. Second, the Committee was also concerned with the SHK eligibility requirement that a candidate with acute kidney injury must receive dialysis at least once a week for the prior six consecutive weeks or have an estimated CrCL or GFR less than or equal to 25 mL/min for the same period of time. The members agreed that requiring six weeks of dialysis to qualify for SHK for a candidate who has an acute kidney injury and who is supported by a temporary mechanical device is a long time (most temporary devices last days to a couple weeks and renal failure patients are poor candidates for durable devices) and puts the patient at risk. This puts the patient and the transplant program in a precarious situation around making those difficult decisions. The Committee’s third point is related to access to listing on the waitlist. Committee members discussed the findings from several peer-reviewed journals suggesting that heart recipients who require dialysis following transplant have significantly higher 30-day and one-year mortality than recipients who did not require dialysis. Several Committee members stated that a heart transplant program is unlikely to list a patient when it is likely that the patient will end up on dialysis following the heart transplant because of the mortality associated with post-transplant dialysis. Finally, the consensus of the Committee was that the proposal would be greatly improved by expanding SHK eligibility to adult heart status 4 candidates who are receiving dialysis. The members also agreed that the proposed safety net language could improve access to kidneys for heart transplant recipients, in part because the safety net policy does not impose any restrictions on an individual’s adult heart status. Transplant Administrators Committee | 03/23/2022 The Committee thanks the OPTN Ad Hoc Multi Organ Transplantation Committee for the opportunity to provide feedback on their proposal Establish Eligibility Criteria and Safety Net for Heart-Kidney and Lung-Kidney Allocation. The Committee supports this proposal with the following comments: 1) The Committee supports the use of 500 NM as the distance threshold for required heart-kidney shares. 2) The Committee appreciates that the proposal mirrors Liver-Kidney allocation and therefore provides standardization between Heart, Lung, and Liver-Kidney allocation. 3) The Committee supports the use of 30 mL/min as an eGFR cutoff for the same reason. Region 6 | 03/23/2022 Sentiment: 1 strongly support, 9 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: An attendee noted the nautical miles for heart/kidney is larger than for lung/kidney, and recommended the Committee consider changing the liver/kidney to 500 nautical miles to avoid confusion for the OPOs. Another attendee added there should be a maximum GFR for chronic kidney disease criteria because of the large swings in GFR with cardiac failure. Several attendees suggested the committee consider leaving albumin out of the equation given its variability. Minority Affairs Committee | 03/22/2022 The OPTN Minority Affairs Committee thanks the OPTN ad Hoc Multi Organ Transplantation Committee for the opportunity to comment on Establish Eligibility Criteria and Safety Net for Heart-Kidney and Lung-Kidney Allocation. The Minority Affairs Committee supports the development of a safety net for multi organ transplant candidates, citing the success of the simultaneous liver- kidney transplant safety net. The Committee also noted that the Multi Organ Transplantation Committee should monitor the number of transplants to pediatric and other vulnerable populations to ensure this policy is not impacting access to transplant for these populations. Region 2 | 03/22/2022 4 strongly support, 13 support, 4 neutral/abstain, 1 oppose, 1 strongly oppose - Overall, members of the region support the proposal, but offered some suggestions. One member noted that this proposal will help kidney patients who often lose out on transplants due to the high volume of multi-organ transplants. It was also noted that a review board would be beneficial to understand the variability in multi-organ listing practices across the country. The comments were split on whether the review board should be retrospective or prospective. Another member expressed support of the safety net provision in the proposal due to the success of the liver/kidney safety net that has been a part of policy for several years. Another member noted that there should be a plan to readdress metrics within a short period of time because there is concern that multi-organ transplants disadvantage kidney only recipients and may not help survival in multi-organ recipients. Lastly, a member stressed the importance of continuing to monitor the data from the simultaneous liver-kidney allocation policies to make sure that mortality rates have improved since implementation. The data from that policy will help with developing similar polices for heart-kidney and lung-kidney allocation. American Society of Transplant Surgeons | 03/21/2022 Please see the attached document. Attachment Region 11 | 03/21/2022 Sentiment: 5 strongly support, 4 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose. Comments: Overall the region supported the proposal. Several members shared their support of this proposal and the importance of consistency across organs. One attendee added that since this policy includes a 500 NM radius for heart-kidney and lung-kidney, this should also be the case for liver-kidney. A member disagreed with the proposal, saying that heart-kidney candidates are not the same as liver-kidney or lung-kidney candidates. The member also stated that status 4 heart candidates should be included, not just status 1-3. NATCO | 03/21/2022 NATCO supports the 500NM range from the donor hospital for SHK transplant consistent with the broader sharing established with the heart allocation change in 2018. However, we note some discrepancies with the MOT proposal to mirror the SLK transplant criteria (status 1, 2, 3) to the revised heart allocation scheme that provided a higher priority for patients with combined advanced heart and kidney disease (Status 5) due to higher mortality. In addition, patients on mechanical circulatory support (MCS) with renal failure on hemodialysis listed Status 4 will no longer have access to a SHK transplant under the current proposal. Our membership also raised concerns on the GFR cut off of CrCl<30 being too rigid. In addition, the cut off period of 365 days for “safety net” policies may also be too rigid as research has shown that a small cohort of patients develop ESRD in the first year after heart alone transplant. NATCO also recommends developing a more comprehensive plan for monitoring of these policy changes, prior to implementation. In addition, NATCO recommends OPTN to define “sufficient sample size” to be accumulated prior to reporting metrics. American Society of Pediatric Nephrology | 03/21/2022 The American Society of Pediatric Nephrology appreciates the work of the Ad Hoc Multi Organ Committee in developing this request for feedback and the opportunity to support it. Multiorgan transplant candidates are currently one of the groups that are prioritized above pediatric kidney candidates for transplantation. Previously, most multiorgan combinations did not have listing criteria. This was both a violation of the National Organ Transplant Act, which stated that allocation policy “shall be specific for each organ type or combination of organ types” and created opportunities for disparities in listing practices. These disparities ultimately affect pediatric access to kidney transplantation, as children located near centers with generous multiorgan listing criteria will have fewer opportunities to receive an organ than those near centers with more stringent criteria. The American Society of Pediatric Nephrology supports clarification of kidney allocation for such multiorgan combinations while preserving pediatric access. We support the creation defined listing criteria for all organ combinations. This policy’s recommended eGFR criteria of less than 30ml/min, while more generous than criteria for adult kidney-alone candidates, preserves multiorgan transplantation for those adults with the highest medical need while maintaining access to transplantation for kidney-alone candidates. The currently proposed safety net listing would help to minimize the negative impact on adult candidates while preserving pediatric access to low-KDPI kidneys. We request the OTPN engage in robust pre-implementation modeling of the proposed listing criteria that specifically includes pediatric transplant rates (stratified by age at listing), wait time, mortality on the wait list, access to high-quality kidneys, and the effect on disadvantaged groups such as blood group B, the highly sensitized and minorities. Region 7 | 03/21/2022 Sentiment: 4 strongly support, 10 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Members of the region support the proposal and one member noted that some standardization in multi-organ transplantation is needed in order to maximize usage of kidneys for single organ patients. There is a mortality benefit for kidney transplant for heart/lung recipients, but obviously there is also a significant mortality benefit for kidney recipients and balancing the two is important. Several members expressed concerns with the required GFR in order to qualify for heart/kidney and lung/kidney transplantation. For both organ combinations, members suggested a GFR less than or equal to 40 mL/min. Concerns were also raised about the proposed requirement for dialysis at least once every 7 days for patients qualifying based on sustained acute kidney injury. Some members thought that requirement is too stringent for heart and lung patients and the committee should review data that would support such a requirement. Another member suggested that in order to qualify for multi-organ transplantation the proposal should require a measured GFR instead of an eGFR. Heart and lung patients often have decreased muscle mass and eGFR calculations can be unreliable. Members expressed support for the proposed “safety net” for those patients who don’t qualify for the simultaneous multi-organ transplant, but who later need a kidney. Without the “safety net” those patients could end up waiting years for a kidney transplant. Lastly, a member would like to see the committee work on a project to address allocation for patients who need more than two organs. OPTN Pediatric Transplantation Committee | 03/20/2022 The Pediatric Committee thanks the OPTN Multi-Organ Transplantation Committee for the opportunity to review their public comment proposal. The Committee provides the following feedback: The Committee agreed with the proposal and were happy to see that pediatric candidates would be placed ahead of safety net patients in that classification. The Committee emphasized that this should establish a precedent for future safety net policies. They also noted that it is critical to continue monitoring access to transplant and outcomes for pediatric single-organ candidates after these changes to multi-organ allocation are implemented. The Committee expressed the importance of focusing on the downstream effects of MOT versus single-organ prioritization on pediatric candidates. For example, pediatric kidney candidates on the match run with other MOT candidates are allocated the organ much later and with minimal to no time to allow for the organ to be transplanted. Region 1 | 03/18/2022 Sentiment: 5 Strongly Support; 7 Support; 0 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. Comments: Overall the region supported the proposal. A member commented that this proposal would hopefully decrease the number of simultaneous heart-kidneys being allocated to patients with an eGFR greater than 30. An attendee remarked that both heart both heart and lung transplant create a hostile environment for a kidney transplant to recover and that the safety net makes a lot of sense. Another member expressed that this proposal is long overdue and hoped that it will be implemented soon. Adam Frank | 03/18/2022 I generally support this policy. I do have concerns that the data presented regarding the Safety Net policy impact on Liver Kidney allocation is incomplete for what the OPTN needs to evaluate. Just showing that the SLK numbers have stabilized is insufficient. I would have liked to see how many Kidneys after Livers were being done annually in the US. In addition, how is the graft survival of those transplant? Is the graft survival as good as an ESRD recipient receiving those organs? We are approaching five years of data so this can be accomplished. It should be recognized that a deceased donor kidney going into a prior liver recipient benefitted by the Safety Net policy is a kidney allocated away from the candidates with just ESRD. Thus the total yearly number of simultaneous liver kidneys and kidneys after liver should be seen as the whole siphon away from the ESRD population based on Safety Net policy. What is this number and how do these kidney transplant do? I hope this data will be shown to the UNOS board before this new policy for Heart and Lung is finally approved. Ashrith Guha | 03/18/2022 I strongly support kidney transplant consideration for heart transplant recipients with compromised kidney function with some caveats. The caveats: 1. Patient has to be optimized prior to GFR calculation as far as heart function is concerned with use of inotropes and or temporary MCS and hemodynamically optimized defined as Cardiac index >2.2 and wedge pressure <20 2. Consideration of combined heart -kidney transplant higher GFR -upto 35 with presence of other stigmata for kidney dysfunction such as increased echogenicity on ultrasound and proteinuria Lung Transplantation Committee | 03/17/2022 The OPTN Lung Transplantation Committee appreciates the opportunity to provide feedback on the OPTN Ad Hoc Multi-Organ Transplantation Committee’s Establish Eligibility Criteria and Safety Net for Heart-Kidney and Lung-Kidney Allocation proposal. Committee members discussed the poor overall outcomes for isolated lung transplant recipients should they go into end-stage renal failure and supported the need for a safety net for these patients. Committee members noted that there has been some feedback on understanding how sick the candidates with a CAS of 28 are and explained that there is an educational opportunity to explain the difference between CAS and the lung allocation score (LAS). The Committee supported this proposal as they felt it would improve access to lung transplant for patients experiencing kidney disease and provide a fairer assessment of a patient’s candidacy for transplant. Region 9 | 03/17/2022 Sentiment: 3 strongly support, 4 support, 1 neutral/abstain, 2 oppose, 0 strongly oppose. Comments: One member had a concern about the kidney alone candidates and recommended removing safety net priority from the KDPI 21-34% sequence. Another member had concerns about LVAD status 4 heart candidates and recommended the committee address these patients in the policy. One member strongly supported the proposal and added that there are a lot of HR-Kidney recipients with 3 functioning kidneys. Another member commented that the policy should not disadvantage pediatric candidates. Membership and Professional Standards Committee | 03/16/2022 The MPSC thanks the Multi-Organ Transplantation Committee for presenting its proposal and shares the following feedback from its discussion: MPSC members provided a variety of comments on the proposed GFR threshold of 30 mL/min. One member commented that it was too low for heart candidates, and another commented that it was too high for lung candidates. A third member supported aligning the policies with the existing liver-kidney policy for simplicity. Another member explained that heart failure patients often receive continuous renal replacement therapy before transplant, which could raise a patient’s eGFR over the eligibility threshold. Several MPSC members expressed concerns that the safety net proposed for heart-kidney candidates would not benefit seriously ill heart recipients who may not have enough kidney function to support their heart transplant while waiting for a kidney. Several MPSC members raised broader multi-organ allocation issues that need to be resolved. OPOs need guidance on how to allocate organs when multiple multi-organ candidates appear across match runs (e.g., a heart-liver candidate and a liver-kidney candidate). The amount of discretion OPOs currently have leads to wide variability in allocation that could be causing inequity. A member suggested prioritizing multi-organ candidates on the primary organ’s match run to avoid situations where an organ needed by a multi-organ candidate on one match run is no longer available because a candidate on another match run has already accepted it. An MPSC member expressed concern that the proposal will negatively affect pediatric kidney waitlist mortality and suggested studying the effects of the proposed policy on children. The MOT committee should also consider how to prioritize pediatric kidney candidates who are starting to experience dialysis complications. Transplant Coordinators Committee | 03/16/2022 The Transplant Coordinators Committee applauds the work of the OPTN Multi Organ Transplantation Committee and appreciates the opportunity to provide feedback on Establish Eligibility Criteria and Safety Net for Heart-Kidney and Lung-Kidney Allocation. This proposal is strongly supported by the Committee, with a member noting that the mirroring of current Liver-Kidney allocation makes it much easier to understand than existing Heart-Kidney or Lung-Kidney policy. It was noted that the proposed eGFR of 30 ml/min for Heart-Kidneys could be low, as some candidates with slightly higher eGFR could still require a transplant. Additionally, the Committee expresses concern that the change in policy could reduce the rate of needed safety net heart-kidney transplants, as there is an increased likelihood of antibody formation with heart transplant, but the policy is based off of liver safety net kidney criteria. American Nephrology Nurses Association (ANNA) | 03/11/2022 ANNA supports this proposal and agree with establishing eligibility criteria and prioritization for safety net. Attachment George Bayliss | 03/09/2022 A different standard than eGFR should be used in the criteria for acute kidney injury. The eGFR equations used to calculate clearance are only useful in the steady state, not in a state flux in renal function like AKI. As a general rule we estimate clearance at less than 10 ml/min for anyone with acute injury. It would seem to make more sense to use one of the accepted criteria scales for AKI like the AKIN definition, which includes both change in serum creatinine and change in urine output. The policy should specify throughout that eGFR is calculated with a race free equation like the CKD Epi refit since calculating it with an equation that includes race would give Black patients a higher eGFR and possibly delay receipt of a simultaneous MOT or safety net kidney when they would have met criteria if a race-free equation were used. Anonymous | 03/08/2022 This is, in my opinion, long overdue. I am hopeful there is strong support and that this is implemented. This would help greatly as we face the challenge of trying to determine which of our very sickest heart or lung transplant candidates needs a kidney also while not potentially allocating a precious kidney to someone who may recover function a few months out. Region 3 | 03/02/2022 • Sentiment: 2 strongly support, 10 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose Patrick Henry | 02/26/2022 I question the use of 265 days post-transplant as the cutoff for providing transplant recipients who need a kidney. The need for kidney transplants among lung and heart transplant recipients is (my guess) quite common, given the impact of anti-rejection medications on the patient. Why is the timeframe so limited? What is the median time before a lung/heart tx recipient comes to need a kidney transplant? I suggest that would be the appropriate time limit for providing safety net priority listing to the patient in need. Region 8 | 02/23/2022 4 strongly support, 9 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose - Region 8 supported this proposal. A member commented that the "Safety Net" for heart and lung, candidates create a significant inequity for kidney-alone transplant candidates. The member suggested that rather than giving a priority with a new category ("inside the safety net" & KDPI) the extra-renal candidates should wait at an equivalent "Expected Post-Transplant Survival" level. A member strongly supported this proposal and explained that OPOs should not be caught in the middle between kidney/extra-renal situations, and the focus should be on the best interest of the patient and donor gift outcome. A member suggested that the committee should explore the possibility of adding a waiting component to the multi organ allocation of kidney after a primary organ transplant in order to reduce inequities in wait time for patients on the kidney-alone list. It was commented that the proposal is a reasonable balance but there is too much risk to kidney-alone recipients. ISHLT | 02/23/2022 In the setting of certain metabolic diseases (eg methylmalonic aciduria, hereditary complement C3 deficiency, glycogen storage diseases, homozygous protein C deficiency, primary hyperoxaluria, atypical hemolytic uremic syndrome) liver transplantation serves as a form of gene therapy to correct the underlying defect causing disease. While important for SLK transplants, we do not believe that this is applicable to SHK or SLuK transplants. ISHLT | 02/23/2022 The ISHLT is in agreement with the use of a 500NM range from the donor hospital and is consistent with the broader sharing established with the heart allocation change in 2018. ISHLT | 02/23/2022 The revised heart allocation scheme provided a higher priority for patients with combined advanced heart and kidney disease (Status 5) due to higher mortality associated with the condition. The MOT proposal that SLK transplant should only be restricted to Status 1,2 and 3 is therefore counterintuitive and essentially invalidates Status 5 in the new allocation scheme for SHK transplant candidates. Furthermore, patients on durable mechanical support with renal failure on hemodialysis listed Status 4 will no longer have access to a simultaneous kidney transplant under the current proposal. This places the proposed transplant candidate at a significant disadvantage due to higher mortality established in heart transplant patients requiring hemodialysis after transplant. ISHLT | 02/23/2022 While we are in agreement that patients with CKD and eGFR≤30 ml/min is an appropriate threshold for SHK transplant eligibility, select patients may need consideration for SHK transplant at eGFR between 30 and 45 ml/min (Kobashigawa et al AJT 2021) and believe the cutoff of 30ml/min is too stringent and somewhat arbitrary particularly as determination of creatinine based eGFR in the setting of heart failure may be difficult (Jonsson et al. ESC Heart Fail. 2020). We are however strongly supportive of the safety net to allow centers to proceed with heart alone in patients with borderline renal function. ISHLT | 02/23/2022 The ISHLT feels that clinical criteria for dual organ transplantation are not equivalent for patients with end stage heart disease, lung disease or liver disease. Chronic kidney disease is often compounded by hemodynamic pertubations in end-stage heart disease and renal recovery may therefore be compromised after heart transplantation. Numerous studies outline poor prognosis in the setting of renal failure after heart transplantation. This was a major subject of discussion at the AST Consensus conference on SHK transplantation (Kobashigawa et al AJT 2021) where data on patient outcomes following heart transplant and renal failure was discussed in detail. The monitoring for acute sustained kidney injury for 6 weeks and even establishment of criteria to assess renal function every 7 days is unrealistic for patients presenting in cardiogenic shock requiring temporary mechanical support. For example, for patients on ECMO (Status 1) maintenance of support for >1 week is associated with poor outcomes – if patients on ECMO requiring renal replacement therapy were to be transplanted with heart alone, outcomes are poor (Jasseron et al Transplantation 2016). In this situation, high cardiac failure rates translate to poor organ utilization. Region 4 | 02/18/2022 2 strongly support, 12 support, 5 neutral/abstain, 3 oppose, 1 strongly oppose - Region 4 generally supported the proposal. One attendee commented that the biggest concern with multi organ allocation is increased late turn downs in OR or preoperatively. Another attendee expressed concern with the GFR cut off in this proposal adding that from a cardiac perspective, heart is more susceptible to other disease issues than liver and the difference should be fully considered. They had additional concerns that if the proposed GFR cut off in policy is implemented, getting sufficient statistics with the small number of sHK transplants done would make it difficult to change the cutoff post implementation. One attendee recommended that the committee determine where MOTs should fall in the allocation sequence in relation to single organ candidates. Another attendee requested more input into the criteria and reassessment of qualification criteria in light of the physiology of the disease presented from the heart/lung transplant community. Abhishek Kumar | 02/17/2022 For simultaneous heart-kidney transplant: Regarding qualifying eGFR: Studies have shown that the risk of mortality in heart transplant recipients increases inversely as their eGFR at the time of listing as well as transplant reduces with highest risk in recipients with eGFR <30ml/min. Recent paper by Shaw et.al showed that there was a survival advantage in simultaneous heart kidney (SHK) vs isolated heart (HA) if the eGFR at transplant was >40. They also showed that 25% of all SHK (n = 148) were performed at eGFR >40 ml/min/1.73 m2 where there was no survival advantage. I feel that having a eGFR cut off of <30ml/min for SHK is reasonable, however I have concerns about the duration of safety-net. We had shown that 1 year incidence of end stage kidney disease (ESKD) in recipients of heart alone transplant is low. Even in <30ml/min eGFR group where the overall risk of ESKD is high, only < 5% develop ESKD in the first year after isolated heart transplant. Even among patients who eventually develop ESKD, only minority end up on dialysis within the first year. This may be secondary to patient selection and isolated heart transplant was most likely offered to patients in this group as they might have other predictors which likely improved their renal survival (like Aki, acute cardio-renal syndrome, not diabetic). A safety net of one year may be inadequate to maximize the anticipated benefit which safety-net intends to provide. Habib PJ, Patel PC, Hodge D, et al. Pre-orthotopic heart transplant estimated glomerular filtration rate predicts post-transplant mortality and renal outcomes: An analysis of the UNOS database. J Heart Lung Transplant. 2016;35(12):1471-1479. doi:10.1016/j.healun.2016.05.028 Kumar A, Howard A, Thomas CP. Estimated Glomerular Filtration Rate at Transplant Listing and Other Predictors of Post-Heart Transplant Mortality and the Development of ESRD. Transplantation. 2020;104(11):2444-2452. doi:10.1097/TP.0000000000003159 Shaw BI, Samoylova ML, Sanoff S, et al. Need for improvements in simultaneous heart-kidney allocation: The limitation of pretransplant glomerular filtration rate. Am J Transplant. 2021;21(7):2468-2478. doi:10.1111/ajt.16466 For simultaneous Lung-Kidney transplant: Qualifying eGFR: Historically a minimum estimated glomerular filtration rate (eGFR) of 50ml/min is required for eligibility for lung transplantation, although a recent study has advocated for a lower threshold. Having a threshold of 50ml/min has been used as mortality among lung transplant recipients with lower eGFR is associated with high mortality. A critical question, the answer to which we don't know yet is whether offering kidney pre-emptive or in other words giving a simultaneous Lung Kidney transplant to candidates with low eGFR (say < 50ml/min) will improve mortality. Having a cutoff of <30ml/min may have unintended consequence of increased lung-kidney transplant with not much benefit and making such recommendation may be premature. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-fifth adult lung and heart-lung transplant report—2018, showed that 1-year incidence of severe renal dysfunction (dialysis + creatinine of >2.5mg/dl) after lung transplant was just 5.7% (1.3%+4.4% respectively) and five-year incidence of chronic dialysis was 2.8%. A safety-net duration of 1 year appears to be adequate duration as it has the potential to help about 50% of patients who will eventually develop ESKD in the first five years. Chambers DC, Perch M, Zuckermann A, et al. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-eighth adult lung transplantation report - 2021; Focus on recipient characteristics. J Heart Lung Transplant. 2021;40(10):1060-1072. doi:10.1016/j.healun.2021.07.021 Osho AA, Castleberry AW, Snyder LD, et al. Assessment of different threshold preoperative glomerular filtration rates as markers of outcomes in lung transplantation. Ann Thorac Surg. 2014;98(1):283-290. doi:10.1016/j.athoracsur.2014.03.010 I understand OPTN's efforts to streamline their multi-organ allocation and have the same qualifying eGFR as well as duration of safety-net criteria for heart-kidney and lung-kidney allocation, however these are very different organs with different mortality and perhaps different set of criteria should be formulated. Kind regards, Abhishek Anonymous | 02/16/2022 My center performs heart-kidney transplants, and I feel the proposed criteria for the simultaneous heart-kidney transplants are too restrictive. Hearts are not livers – SRTR data shows that the hazard ratio for mortality post-heart transplant is 1.22 when the GFR is 30-44, and 1.55 when < 30, and wasn’t even separately defined for a GFR < 20. Livers, being immunologically “privileged”, do not suffer the same risk or rate of rejection with low GFR’s, and may be able to afford lower thresholds for simultaneous dual-organ transplants than hearts. In addition, hearts have to deal with cardiorenal syndromes, both type I and type II. The biggest reason for early graft failure in hearts is right-heart failure, which is triggered by volume overload, and an underfunctioning kidney, worsened by just having come off cardiopulmonary bypass, is a big contributor to early cardiac graft dysfunction. The biggest reason for late graft failure in hearts is aggressive coronary disease, which will only be accelerated by placing these fresh hearts on dialysis. Finally, one must not underestimate the difficulty of identifying a negative crossmatch safety net kidney, as often, heart recipients will have had multiple sensitization events (stents, coronary artery bypass grafting, ventricular assist devices) prior to their first transplant, and if awaiting a negative crossmatch prior to a second, staged transplant, cannot afford the prolonged waits of years that highly sensitized kidney recipients frequently face, as this prolonged time on dialysis would significantly increase the already substantial risk of accelerated coronary disease in the transplanted heart from ongoing dialysis. Would we then offer a safety net for the failed heart transplant after the delayed kidney transplant? The heart is NOT a liver, and should not be treated as such, and the OPTN needs to be cognizant of the resistance this proposal would generate in the thoracic community Region 5 | 02/16/2022 9 Strongly Support, 19 Support, 4 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose - There was a recommendation for the committee to look at liver/kidney combination (in order to identify if any of those kidneys would be declined) and to provide an EPTS KDPI guidance document. There was a request for clarification on how multi-organ combos should be prioritized for allocation. A member suggested to thoroughly model this in order to determine how children will be effected since pediatric patients do not get priority for KDPI >35%. The member expressed concern that the safety net would disadvantage pediatric kidney transplant patients. A member asked why didn’t the committee set the GFR at 20, as listing criteria, (since that is done for kidney alone when listing)? Region 10 | 02/16/2022 1 Strongly Support, 13 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose - The region supports the proposal, but had some comments for the committee to consider. Two members highlighted that the qualifying GFR of 30 mL/min for patients diagnosed with chronic kidney disease is too low of a qualifying GFR score. They noted that thoracic professionals and certain data point to a qualifying GFR score of 50 mL/min. In addition, a member stated that a simultaneous heart-kidney or lung-kidney recipient may not need a higher quality kidney and should not be offered Sequence A or B kidneys. For the kidney safety net component, a member asked that as data becomes available that the committee review mortality rate data for patients who qualify for the kidney safety net but do not get transplanted. It was also noted that the proposal does not offer any guidance as to which multi-organ combination should get priority if there is only one kidney available for multi-organ allocation. Lastly, another member stated that it would be beneficial to have a review process for those cases that do not specifically meet the proposed criteria. Carol Conrad | 02/11/2022 This seems very fair as to allocation and criteria to establish kidney function that qualifies for MOT. I agree that directed living donor of kidneys should be assessed first, given the stewardship of MOT. Operations and Safety Committee | 02/11/2022 The Operations & Safety Committee thanks the OPTN Ad Hoc Multi-Organ Transplantation Committee for their efforts on this proposal. The Operations & Safety Committee supports this proposal and acknowledges it is a good initial start to addressing multi-organ transplantation. The Committee supports all three criteria. The Committee affirms that 500 NM away from the donor hospital is an appropriate threshold. The Committee agrees that this proposal should benefit the pediatric transplant community as well. The Committee suggests that education include an emphasis on the impact of candidates needing single organs. LifeGift | 02/10/2022 Note agreement with suggestions from Stanford posted in this public comment. Luke Preczewski | 02/08/2022 I think this proposal makes sense. I agree with other commenters that safety net should reserved for those transplanted without a simultaneous kidney to incentivize avoiding the simultaneous transplant where possible, with a safety net available should it be needed. I also think this committee should urgently take up multivisceral transplants (by which I mean any transplant including both an intestine and a liver). The new liver allocation policy has been hugely detrimental to candidates for MVT, and US policy lags other countries with intestinal transplant who prioritize patients akin to Status 1 / high MELD patients. Lehigh Valley Hospital | 02/07/2022 Agree wholeheartedly with Dr Cheng and colleagues at Stanford’s K/KP Program. Regarding their comments to enhance the proposal, I agree completely with suggestions 2) and 3). Regarding suggestion 1), I would add that whenever we discuss kidney + other transplantation, insufficient attention is directed to the mortality on the kidney transplant wait list. Consequently, I would suggest that Safety Net patients post heart or lung transplants in need of a kidney transplant NOT be included in KDPI:>20% to <35% allocation, specifically deleting bucket #27 from Table 8-9: Allocation of kidneys from deceased donors with KDPI scores greater than 20% but less than 35%. Thanks for the opportunity to comment on this generally welcome proposal. Hans Gritsch | 02/03/2022 The number of patients that are likely to benefit from a simultaneous kidney with other solid organ transplant continues to increase. We need to look carefully at the criteria for dual listing. However, we also need to encourage living kidney donation. It is now possible for living donors to donate in advance of recipient need. We also need to be good stewards of the existing supply of kidneys which are needed for the kidney only recipients. There should be some matching of EPTS and kidney quality in the design of the "rescue" option. Stanford University Kidney & Pancreas Transplantation | 02/03/2022 We discussed the proposal amongst the physicians and surgeons of the Stanford Kidney and Pancreas Transplant Program. Overall we strongly support the proposal which 1) standardizes eligibility criteria for SHK and SLuK, 2) provides uniformity across all combinations of kidney-related MOTs with the limitations of data and 3) provides a Safety Net mechanism to provide patient Safety Net and encourage innovation in staged MOT. Specific suggestions for UNOS in enhancing the proposal: 1) In the implementation of this proposal in the Kidney Allocation System, we recommend developing a more nuanced allocation sequence, accounting for the fact that the allocation priority for the thoracic organ (e.g. how bad their heart/lung failure is) does not equal the allocation priority for the kidney (e.g. how bad their kidney failure is), and using heart/lung priority to skip the entire kidney list is not justified (https://pubmed.ncbi.nlm.nih.gov/33594713/). 2) Prior to implementation of the current policy, we recommend developing a more comprehensive plan for monitoring of policy post-hoc: metrics, and thresholds for tweaks to the policy. We need specific MOT metrics that go beyond the usual patient and graft survival. -For example, kidney graft failure after MOT is underreported, because patients can have recovery of residual kidney function (https://pubmed.ncbi.nlm.nih.gov/22759344/). That's why we're putting forward nuclear med scans at ~6 months post-MOT for all SLK/SHK/SLuK to quantify this. -The rate of living kidney donation should also be a metric. 3) As a modification to the current proposal: Make MOT recipients who have received a kidney INELIGIBLE for the kidney Safety Net so that transplant programs have an incentive to defer the kidney transplant in patients not anticipated to do well: Current Safety Net criteria extends to people who received MOT in the first place. This means a patient can receive a SHK, have a failed kidney graft, and then be kidney Safety Net eligible. This really removes incentives for transplant programs to be judicious in considering which patients do better with staged approaches and which do with SHK (PMID: 32279361). Xingxing Cheng Stanford University Adult Kidney and Pancreas Transplant Program Marc Melcher | 01/27/2022 I think this would improve the care of heart patients and maximize the use of high quality kidneys.