Comments

UC San Diego Center for Transplantation | 03/15/2023

The UC San Diego Center for Transplantation supports the efforts of the Committees to restructure and clarify multi-organ allocation policy. This has been a longstanding issue within the community and as the rates of multiorgan transplants has been steadily increasing and we move towards broader sharing, it is of critical importance to begin assessing, however we do believe that the continuous distribution policies should be completed before we can truly develop impactful policy. With regards to the questions the Committee specifically solicited we offer the following for consideration:

How do patients recommend improving equity in access to transplant between kidney-alone and kidney multi-organ candidates?

• Our patients report that that is their main concern is decreasing waiting time across the board.

How do transplant professionals recommend improving equity in access to transplant between kidney-alone and kidney multi-organ candidates?

• There is a perception kidney alone candidates are “ok to wait” due to high mortality for heart/lung/liver transplant candidates and the availability of dialysis. While dialysis is a life sustaining treatment, we should reconsider how we view the risk of dialysis to kidney-alone candidates. It is well known that longer dialysis time pre-transplant is associated with higher morbidity and mortality. An improvement in equity would be to assign priority points to kidney alone candidates with more than a certain amount of dialysis time (3y?) to recognize that there is a survival advantage for kidney-alone recipients who are transplanted sooner rather than later.

Should OPOs be required to offer kidneys to some kidney-alone candidates prior to offering kidneys to multi-organ candidates?

• OPOs should be required to offer kidneys to some kidney-alone candidates prior to offering kidneys to multi-organ candidates. Characteristics that should be considered for prioritization for kidney-alone candidates would include younger candidates with >3y dialysis and other candidates >5y dialysis.

Should prior living donors receive offers prior to kidney multi-organ candidates?

• Yes, absolutely. They selflessly gave a gift and should they ever find themselves in a situation of need, they deserve prioritization.

Should some or all pediatric kidney-alone candidates get additional priority for low KDPI kidneys relative to kidney multi-organ candidates?

• Yes, pediatric candidates should be sequence 1 for all low KDPI kidneys due to their need to minimize dialysis time, optimize development.

Should the OPTN develop policy on when to offer the left vs. right kidney?

• Absent evidence of a patient population that needs longer vessels for successful surgical implantation, we do not believe this is necessary.

Is it appropriate for policy to distinguish an organ offer order between liver-kidney, heart-kidney, lung-kidney, and pancreas-kidney candidates?

• Given our charge to ensure best use of this scarce resource, survival post- transplant for each organ should be considered in addition to physiology of renal dysfunction, tolerance of dialysis and survival/complications based on safety net allocation.

Are there other challenges related to multi-organ allocation not outlined in this concept paper that the Committee should address?

• Logistical concerns around late declines (post-cross clamp) and expediated re-allocation to limit cold time should be considered eventually.

Additionally, while not necessarily limited to multi-organ shares, we would recommend the Committees review the logistics of kidneys shipping, i.e. on commercial airlines, and how that impacts cold ischemic time.

Region 6 | 03/15/2023

Members in the region offered several suggestions for the committee to consider as they continue to work on multi-organ allocation.  Several attendees commented that pediatric kidney alone candidates should be prioritized above multi-organ adult candidates but below pediatric multi-organ candidates. Another attendee recommended getting data to better understand if certain types of candidates/recipients do better or worse with kidney multi-organ transplant versus a sequential transplant. One attendee recommended developing a data driven hierarchy. Another attendee recommended looking at mortality risk and post-transplant survival to determine where the priority should be between multi organ candidates and single organ candidates.  

Region 11 | 03/15/2023

A member commented that required multi-organ kidney shares disadvantage highly sensitized candidates and candidates with a CPRA 98-100 should receive priority. A member questioned including prior living donors in the priority as they tend to be healthier individuals, but others agreed on giving them priority since they have made a contribution into the system and were told they would receive priority. Another member commented that kidney pancreas candidates should not be prioritized over heart kidney, lung kidney or liver kidney nor should they be prioritized over liver/intestine/pancreas or even isolated intestine. Another member commented that if a pancreas is not offered with a kidney, it is challenging to place the pancreas alone. A member suggested that multi organ patients should be ranked on a single match run with a clear way to prioritize allocation. A member stated that improved guidance for multi-organ allocation vs single organ allocation is vital to provide consistency across all programs and to reduce conflict with transplant programs wanting one or all of the organs being offered. 

OPTN Pancreas Transplantation Committee | 03/15/2023

The Pancreas Committee thanks the OPTN Ad Hoc Multi-Organ Transplantation (MOT) Committee for the opportunity to review their Identify Priority Shares in Kidney Multi-Organ Allocation concept paper.

The Committee supports the concepts presented. The Committee voiced concern to qualifications for a safety net kidney and ask if there is any data for heart and lung at the one-year timeframe; specifically, what is the number of patients who have a glomerular filtration rate (GFR) that would qualify them for a safety net kidney? The Committee commented that those patients currently do not have timely access to transplant, but in the near future, those candidates would have prioritized access. 

The Committee suggested consideration in getting an estimate; for all of the patients who received a lung and heart transplants, there should be an estimate of their 12-month GFR and to know, as an estimate, the total number of patients that could potentially qualify for a kidney at 12 months. This data would be informative in thinking about how these kidneys may be allocated in the future.

The Committee also commented that for pediatric transplant centers, it seems unfair for a low KPDI kidney to be used by multi-organ, especially for liver-kidney and heart-kidney. In terms of weight for different MOT, it was suggested that there should be policy to govern this. 

The Committee stressed the importance to remember that first and foremost, patients who are in need of a kidney-pancreas transplant are kidney patients. This is very different from the MOTs. The Committee suggest consideration of this and how to prioritize kidney pancreas patients or it can severely impact access to kidney transplantation for insulin dependent diabetics that would otherwise be candidates.

Jonathan Fridell | 03/15/2023

The work the MOT committee is currently doing is extremely important. Over the last few allocation changes, words like “priority” and “mandatory” have been introduced into MOT kidney allocation making this very confusing. If there is a single kidney, how does one choose between directed donation, pediatric, highly sensitized, SPK, SLK, heart or lung kidney, or KTA? It is critical that this be based on a single standard policy.

I am concerned that SPK may be mis-classified in some of these deliberations. It is true that SPK patients are receiving multiple organs, but they should not be classified as “MOT”. Unlike liver/heart/lung - kidney transplants, where candidates need another organ transplant and draw a kidney due to the possibility or likelihood that their kidneys will not have enough reserve, SPK candidates actually need a kidney and are listed and accrue waiting according to the same policies as KTA, and are offered a pancreas with their kidney transplant. Also unique to SPK, the majority of pancreas transplants in the USA are performed with a kidney, which is very different from the MOTs. Pancreas allografts are prone to thrombosis and ischemia reperfusion injury, meaning that only highly selected good quality donors may be suitable for pancreas transplantation. If a kidney were not to accompany the pancreas when a suitable donor is identified, it is very unlikely that the pancreas will get transplanted as a solitary organ and will be a wasted donated organ. For the other MOTs, the isolated organ would certainly still get transplanted and likely to a patient that is equally ill and with a similar mortality risk.

Previously (in the Kidney and pancreas allocation policies predating acuity circles), the SPK candidates were considered unique from other MOT and were placed ahead of the entire kidney transplant allocation as the highest priority for one of the kidneys on the actual kidney allocation policy. Waitlist mortality for patients with diabetes awaiting kidney transplantation supports this.

Association of Organ Procurement Organizations | 03/14/2023

Thank you for the opportunity to submit comments on the Organ Procurement and Transportation Network’s (OPTN’s) policy development process on behalf of the Association of Organ Procurement Organizations (AOPO). AOPO collectively represents 48 federally designated, non-profit Organ Procurement Organizations (OPOs) in the United States, which together serve millions of Americans. As an organization, AOPO is dedicated to providing education, information sharing, research, technical assistance, and collaboration with OPOs, other stakeholders, and federal agencies to continue this nation’s world-leading transplantation rates while consistently improving towards the singular goal of saving as many lives as possible. We offer the following comments for your consideration:

AOPO supports and applauds the Ad Hoc Multi-Organ Transplantation Committee’s efforts to establish an updated framework for kidney multi-organ allocation.

We look forward to having a framework that includes better guidance for how to resolve issues where required shares conflict, such as when a previously accepted organ is declined and offered to the next listed recipient requiring a multi-organ transplant that includes an organ already allocated to another recipient. Additionally, we welcome policy guidance on prioritization among candidates for organ offers for liver-kidney, heart-kidney, lung-kidney, and pancreas-kidney candidates. A blueprint that guides organ allocation should lead to increases in national consistency in how organs are allocated from multi-organ donors but should not be so prescriptive as to penalize members when flexibility is needed to achieve a transplant outcome, such as when late organ declines occur.

We understand the need to potentially prioritize some patients, such as for medical urgency, while not at the same time creating a disadvantage to recipients that are listed for a single kidney. We look to the clinical experts that provide patient care to give meaningful input to determine the priority weighing required in such a system.

Donor Network of Arizona | 03/14/2023

Donor Network of Arizona supports the concept of increased clarity in multi-organ allocation. At present, DNA grants laterality choice to the program transplanting another abdominal organ. If both kidneys are being shared with abdominal organs, DNA grants choice to the liver center. We believe that the OPO should be the ultimate arbiter of which kidney is allocated with which extra-renal organ, based on input from the transplant programs involved at the time of allocation.

Kara Knehans | 03/14/2023

A friend’s daughter has been waiting 4yrs for a multi visceral transplant, but time and hope are running out because the MELD score only shows the severity of her liver disease, not the big picture of the dire circumstances she is facing. Please consider what can be done to help, not only her, but those like her, to reach their goal of multi visceral transplant and the best opportunity for a reversal of their suffering. Thank you sincerely for your consideration.

NATCO | 03/14/2023

NATCO thanks the OPTN for the opportunity to weigh in on this concept paper. Our membership supports the idea that some candidates do warrant kidney-alone offers over multi-organ offers, such as high CPRA & pediatric. We do believe m,ore information is needed on what constitutes medical urgency for a kidney-alone proposed transplant recipient (PTR). Related to PTRs needing more than 2 organs, we feel they should retain priority over a kidney-alone PTR because they are essentially harder to match. If they receive their multi-organ transplant from the same donor, they will be less sensitized than if they have transplant from multiple donors over several ORs.

We do not support limiting one kidney for a kidney-alone PTR when the other is given to a multi-organ PTR. Again, due to the fact that multiorgan PTR’s are harder to match.

The increased safety net needs more information. Some PTR’s status should have higher priority than others (high CPRA should have increased safety net and sequential transplant over prior living donor when not medically urgent.)

We feel that post-transplant survival should be weighted into allocation—not a singular factor. We feel that there needs to be much more exploration related to this—there are many factors that impact post-transplant survival.

We do not support restricting the types of kidneys offered to multi-organ candidates. Restricting the types of Kidneys offered would make the multiorgan donor even harder to match than they currently are.

Related to candidates of equal priority we do not feel that heart-kidney, liver-kidney, lung-kidney, and pancreas-kidney should be equally weighted in policy. We feel that pancreas-kidney & heart-kidney should be weighted with higher weight than the other two required shares, but the policy should dictate an allocation order across these candidate populations.

We feel that the policy related to offer acceptances being binding is clear.

Region 7 | 03/14/2023

Many members commented that more guidance and efficiency is needed around Multi-organ allocation. Some of the impacts discussed include setting O.R. time, not being able to offer kidneys earlier, which multi-organ combinations should get priority or offered first, and late turndowns. Several members brought up the impact that this has on patients from the standpoint of knowing when to call a kidney candidate in for an offer and then when they are called in, having to tell them that the kidney is no longer available. Members recommended that a time limit (4 hours and 6 hours prior to O.R. were suggested) should be implemented for when a kidney has to be released to the kidney list. A member recommended that all organ combinations with kidney carry equal weight and we should look into waiting time or another attribute to be the tiebreaker. Several members suggested that one kidney from a donor be allocated to the kidney list and the other can be allocated with a multi-organ offer. Members commented that priority should be given to candidates that will benefit the most from the transplant; a multi-organ candidate should be healthy enough for a high probability of success or the kidney should go to a kidney alone candidate. A member commented that the safety net should be emphasized; it is important to consider acute vs chronic disease. Members shared feedback that pediatric, highly sensitized (>99%), and medically urgent kidney alone candidates should receive priority over multi-organ candidates and prior living donors should receive priority when they are medically competitive for transplantation with other candidates to help encourage more donations and to follow through on what potential living donors are told.

Region 1 | 03/14/2023

During the discussion, an attendee stated that this is an issue that has been acknowledged and ignored since 2008, so this is the community’s opportunity to address it. Several attendees stated they were glad to see this topic being discussed. A member commented that often multi-organ allocation tends to include higher quality kidneys, which often times are treated poorly in an effort to protect the survival of the heart or the lung, for example, and if the transplanted kidney ends up failing due to that, it should not be allowed. The member continued on to say that most multi-organ patients do not need a kidney more than a patient listed for kidney alone, including those patients who have been waiting longer. Finally, the member pointed out that multi-organ transplant outcomes are not followed as closely as single organ transplants. Another member stated that it makes sense to give priority to certain kidney-alone candidates, such as pediatric candidates, highly sensitized candidates, and medically urgent candidates. An attendee agreed that 99-100% sensitized patients should get priority for kidney-alone transplants. Some attendees remarked that not all multi-organ candidates are alike, and some should come ahead of kidney-alone, but not all of them. One attendee suggested considering who is sicker versus who can wait longer, as well as which organ is driving the transplant because with kidney-pancreas transplants, usually the kidney is needed. The attendee added that for some multi-organ candidates, the safety net should be considered. A member remarked that whatever is decided, it needs to be clearly stated in policy and incorporated in the OPTN Computer System, so that members can easily understand it. 

Gift of Life Michigan | 03/14/2023

We look forward to having a framework that includes better guidance for how to resolve issues where required shares conflict, such as when a previously accepted organ is declined and offered to the next listed recipient requiring a multi-organ transplant that includes an organ already allocated to another recipient. Additionally, we welcome policy guidance to distinguish an organ offer order between liver-kidney, heart-kidney, lung-kidney, and pancreas-kidney candidates. A blueprint that guides organ allocation should lead to increases in national consistency in how organs are allocated from multi-organ donors but should not be so prescriptive as to penalize members when flexibility is needed to achieve a transplant outcome, such as when late organ declines occur.

The system developed should be data-driven. We understand the need to potentially prioritize some patients, such as for medical urgency, while not at the same time creating a disadvantage to recipients that are listed for a single kidney. We look to the clinical experts that provide patient care to give meaningful input to determine the priority weighing required in such a system.

Transplant Families | 03/14/2023

Transplant Families supports the comments of the OPTN Pediatric Transplantation Committee.

American Society of Transplant Surgeons | 03/14/2023

How do transplant professionals recommend improving equity in access to transplant between kidney-alone and kidney multi-organ transplant (MOT) candidates? Kidney transplant alone (KTA) candidates make up much of the volume of patients on the solid organ transplant waitlist, the longest wait time, and their “medical necessity” is often underestimated since we have HD as an option, as waitlist mortality is still a significant occurrence and an increasingly important outcome measure. We should consider the impact to this group of patients as it relates to kidneys being allocated for MOT. Should OPOs be required to offer kidneys to some kidney-alone candidates prior to offering kidneys to multi-organ candidates? If yes – what characteristics should prioritize kidney-alone candidates for offers prior to multi-organ candidates? Yes, during allocation, many OPOs “hold” kidneys for possible MOT scenarios and do not prioritize timely allocation. Many kidneys can wait, but ischemic time especially matters for: • Pediatric recipients (and its potential effect on DGF) • Higher KDPI kidneys Allocating kidneys after cross clamp is not an ideal time to be dealing with an unplaced organ. Also, there are scenarios where access to kidney should be prioritized over MOT as it relates to access to future organ offers. • Highly sensitized KTA • Highly sensitized simultaneous pancreas and kidney (SPK) Should prior living donors receive offers prior to kidney multi-organ candidates? Yes, the numbers of these patients are very low and given the nature of kidney donation to save lives, they should receive priority over most MOT. Should some or all pediatric kidney-alone candidates get additional priority for low KDPI kidneys relative to kidney multi-organ candidates? Yes, children needing a kidney transplant should be a top priority and should get priority over most MOT. In the absence of policy relating to kidney laterality, how do OPOs currently decide when to offer the left vs. right kidney? Currently choice is usually given to the MOT candidate center. Should the OPTN develop policy on when to offer the left vs. right kidney? Yes, choice should be given to the kidney alone candidate or SPK candidate in most circumstances. Is it appropriate for policy to distinguish an organ offer order between liver-kidney, heart-kidney, lung-kidney, and pancreas-kidney candidates? Liver-kidney (SLK), heart-kidney (SHK), lung-kidney should be viewed similarly as the kidney is not the primary live saving organ for the transplant; rather it’s the liver, heart, or lung. For an SPK it can be viewed differently, as the lifesaving organ is more often the kidney. If so, what data should be used to inform such an allocation order? Kidney outcomes in SPK recipients generally surpass kidney alone outcomes in many instances, however kidney outcomes in liver-kidney, heart-kidney, lung-kidney typically do not surpass kidney alone outcomes in these MOT situations. We should consider utility and long-term outcomes in more of the decision making. As one example, it is not uncommon that a kidney is allocated to a low status SLK or SHK over a pediatric recipient who will likely have more life years served from receiving that kidney. How can the OPTN provide the necessary level of direction for multi-organ allocation without impinging upon the ability of OPOs to place organs efficiently? Prioritizing pediatric, prior living donors and highly sensitized kidney alone and SPK recipients will go a long way to achieve more equity for kidney candidates and increase the efficiency and utilization of kidney placement. Potential Specific Proposed Solutions: 1) If a match run has patients with 100% PRA. One kidney should be mandatory to the KTA list. 2) If a match run has a patient with 98-100% PRA on the SPK list. One kidney should be reserved for this population. 3) High priority (status 1) SHK, and MELD>35 SLK should likely remain a priority. 4) If no medically urgent SLK and SHK, before its moved move to lower priority MELD or status, then one kidney should be preserved for: pediatrics, previous living donor. 5) Medically urgent KTA should always be offered a kidney. 6) 2 hours before scheduled OR, any kidneys not offered to MOT should be primary offer to KTA list. (No more “holding”, for a MOT backup)

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Region 8 | 03/14/2023

An attendee commented it would be unethical, from a utilitarian perspective, to transplant a kidney with another organ, other than a pancreas. He supports the idea to adjust with EPTS depending on which organ the kidney is allocated with. He suggested that kidney extra renal could be transplanted based on the kidney match run, and that the kidney should allocated by the list, regardless of the multi-organ transplant (MOT). Attendees pointed out the local programs tend to get preference on the choice of kidney, which doesn’t seem equitable. And both kidneys should not be allocated to the MOT unless the kidneys were not allocated on the kidney list. An attendee commented that if a kidney-alone and heart-alone have already been allocated, OPOs won’t offer the primary to the kidney program because an MOT candidate is behind the heart-alone candidate. Attendees requested a policy to determine when the kidney-alone can be placed primary on the kidney list.

In support of the project, an attendee commented that the proposal incorporating kidney allocation in MOT with kidney-alone is an optimal path forward (utilizing composite allocation score). An attendee suggested that eligibility for a kidney should be based on need for a kidney, regardless of whether there is another organ. The member further suggested that the committee develop a composite score that gives some priority for MOT candidates, but also weighs other factors of MOT and kidney-alone candidates (dialysis time, kidney disease severity, CPRA, etc.). An attendee commented the focus should be on getting organs transplanted and pointed out the non-used organ numbers. An attendee pointed out that candidates with high CPRAs or who are very sick should be preferentially given a kidney along with the other needed organ. There was a suggestion that candidates should be evaluated on a need basis. An attendee said this project addresses a challenge of bias in favor of MOT recipients and against kidney-alone candidates. Attendees suggested that consistency is important and there needs to be clear guidance to support transplant professionals. A member pointed out there is a perception that the best kidneys are "lost" to MOT candidates.

From a pediatric candidate perspective, an attendee commented that it is still difficult when a MOT takes a kidney over a candidate who is first on the kidney-alone wait list. The member suggested that the choice of kidney also need to be identified. If a program can only use one kidney, where both are available and the program has to share the other kidney with a MOT candidate, then the program should have the ability to identify which kidney it wants to use. 

OPTN Histocompatibility Committee | 03/14/2023

Candidates with a CPRA of >98% need to be prioritized within multi-organ allocation, and CPRA >98% single organ kidney candidates need to be prioritized over less sensitized MOT candidates.

One consideration for multi-organ transplantation versus safety net transplantation is the risk of sensitizing the recipient and that impact on outcomes.

Kidney-pancreas candidates may have a different priority than other MOT candidates due to the availability of insulin therapies, but waiting list mortality and post-transplant outcomes should be evaluated in order to prioritize within multi-organ transplant types as well as prioritize multi-organ candidates versus single organ kidney candidates. 

American Society of Transplantation | 03/14/2023

The American Society of Transplantation (AST) generally supports what is outlined in the concept paper, “Identify Priority Shares in Kidney Multi-Organ Allocation,” and offers the following comments for consideration:

• This policy should be specific regarding the groups at highest-risk for waitlist mortality due to current policy inequity and there should be standard criteria for prioritization of kidney-alone candidates before multi-organ transplant (MOT) candidates. Considerations for kidney-alone prioritization should include highly sensitized patients, pediatric patients, medically urgent patients with exhausted access options, and previous living donors.
• Until all organs are allocated using continuous distribution systems and there are single, integrated match runs for each donor, OPOs will continue to struggle with simultaneous lists to guide allocation.
• The allocation of low KPDI organs in the context of MOT should be governed by policies that ensure access to these organs for pediatric patients. Kidney allocation should not preclude access for appropriate MOT candidates; however, access to these low KDPI organs should be restricted based upon MOT listing criteria as are currently used for SLK.
• Further evaluation of the actual impact experienced by kidney alone candidates resulting from the inequity of multiorgan allocation policies is recommended. If the actual disadvantage is significant, then dual listing criteria and safety net policies might need to be revisited. The concept of one kidney per donor going to an MOT mandates the other kidney goes to a kidney only candidate also deserves additional analysis and consideration.
• It is strongly recommended that the OPTN develop similar, medically appropriate chronic kidney disease (CKD) criteria (e.g., end stage renal disease (ESRD), estimated glomerular filtration rate (eGFR) ≤ 30) for all remaining MOT policies where a kidney is involved, including SPK, and “safety net” policies for single organ transplant recipients who develop progressive CKD/ESRD within a year of getting a transplant.
• The proposal does not include any discussion of how MOT recipient outcomes are not currently included in center performance data. We believe that this topic needs to be addressed and MOT outcomes should be better tracked. Centers should have some accountability for these outcomes and more robust data will help determine if MOT remains in a recipient's best interest and the best interest of the organ.
• Laterality choice should be specified by the center with highest allocation priority.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/14/2023

This proposal is not pertinent to ASHI or its members.

OPTN Liver & Intestinal Organ Transplant Committee | 03/14/2023

The OPTN Liver and Intestinal Organ Transplantation Committee thanks the OPTN Ad Hoc Multi Organ Transplantation Committee for their efforts on producing this concept paper. 

The Committee is supportive of any effort to create more clear prioritization between multi-organ candidates. In general, the Committee supports the use of acuity or risk of waitlist mortality to prioritize candidates on the waitlist but understands a common acuity metric likely is not available for all multi-organ combinations.

OPTN Lung Transplantation Committee | 03/14/2023

The OPTN Lung Transplantation Committee thanks the OPTN Ad Hoc Multi-Organ Transplantation Committee for their concept paper and the opportunity to provide feedback. Members said that kidney multi-organ candidates should still have access to high quality kidneys, as they should not be penalized for needing more than one organ. However, members acknowledged that it may be justifiable to offer some kidneys to kidney-alone candidates first, particularly for populations facing increased waitlist mortality. Members also noted that a longer graft survival as indicated by a low Kidney Donor Profile Index is not essential for multi-organ candidates since graft survival is already more limited in multi-organ recipients. Members supported the list of exceptions for groups that may warrant offers over multi-organ candidates, except a member expressed opposition to kidney-pancreas candidates being prioritized over other kidney multi-organ candidates (e.g. lung-kidney candidates). A member said that type 1 diabetic kidney-pancreas candidates should also receive priority over other multi-organ candidates due to high waitlist mortality.

OPTN Transplant Administrators Committee | 03/14/2023

The Transplant Administrators Committee thanks the Ad Hoc Multi-Organ Transplantation Committee for their efforts in developing this concept paper.

TAC members offer the following comments and questions:

Recommendation that pediatrics get kidney priority before multi-organ candidates so they are not disadvantaged by MOT allocation. 

Support for the idea of balancing single kidney candidates with MOT candidates by including certain criteria or restrictions. Consistency across all OPOs is necessary when it comes to allocating the kidneys to kidney alone versus MOT.

Support for the upcoming implementation of the safety net for heart-kidney and lung-kidney allocation. 

Support the idea of offering one kidney to the MOT candidate and the second kidney to a kidney-alone candidate. The “binding offer” issue needs to be addressed since all match runs are not done simultaneously. 

Suggestion that the order in which match runs are executed needs to be evaluated since it impacts MOT allocation.

OPTN Transplant Coordinators Committee | 03/14/2023

The Transplant Coordinators Committee thanks the Ad Hoc Multi-Organ Transplantation Committee for their efforts in developing this concept paper.

A member commented that it was good to see the overall number of SLK transplants decreasing, which might be related to the previous SLK policy changes which included the safety net. She further added that the best utilization of organs is important and post-transplant outcomes need to be monitored. For example, if a heart alone patient passes away when a heart-kidney transplant would have provided the best chance of survival. Lastly, she added that late turndowns are an issue and commented that if someone receives a kidney offer then it should not be reallocated to another candidate. 

A member noted that pediatric patients make up 1% of transplants so they should be prioritized along with high CPRA and medically urgent candidates. She added that when a kidney-pancreas is involved it becomes more complicated if the second kidney is being allocated as part of an SLK. She noted that there have been circumstances where her center is not offered the kidney but is identified as a backup. The member noted that her center still must be prepared if they are the backup offer to mitigate cold ischemic time if they eventually become primary.

A member noted that from a pediatric standpoint, seeing 1-20% KDPI kidneys going to MOT candidates is difficult because pediatric candidates face the potential for additional kidney transplants if they don’t receive the best possible kidney. She added that laterality is also an issue for pediatrics because anatomy, whether it is a vessel or size issue, can impact organ offer acceptance. 

A member asked if the MOT Committee had discussed prior living donors. Another member commented that prior living donors already receive additional priority for deceased donor kidney alone, but they are currently not one of the groups identified for priority in the proposal. The MOT Committee member responded that she would bring this comment back to the MOT Committee.

A member commented that with the safety net going into place for heart and lung, should the MOT Committee review the impact of those changes before moving forward with these policies. 

A member noted that it is always a struggle to balance waitlist times with long-term outcomes. Each organ system prioritizes candidates differently, with only lung considering long-term outcomes. Another member added that a separate scoring system might be beneficial or include an attribute for MOT in the development of the continuous distribution models. A member added that it would be nice if transplant centers could indicate willingness to accept a single organ or dual organ or if the medical complexity of a candidate requires them to receive both organs from the same donor.

Several members stated that the safety net offers priority for individuals on dialysis or with severe kidney disease. A member noted that it is a positive thing at her center based on the experience with liver and that it is a seamless process from the coordinator’s perspective.

A member commented that if a candidate receives a kidney through the safety net within the first year, they should be excluded from the outcomes like simultaneous transplants. Currently there are reservations about moving forward with a kidney transplant early because programs are worried about the outcomes in that first year.

OPTN Organ Procurement Organization Committee | 03/14/2023

The OPO Committee thanks the Ad Hoc Multi-Organ Transplantation Committee for their efforts in developing this concept paper and offers the following comments.

Several members supported the priority for certain kidney alone candidates, particularly the high CPRA candidates who might be disadvantaged because they get fewer compatible organ offers. 

Comment about marginal kidneys being allocated to a multi-organ candidates and the increased risk for delayed graft failure or poorer outcomes. 

Agreement that once an isolated kidney is offered, it should not be withdrawn in favor of a multi-organ candidate.

Comment about how complex the various multi-organ allocation policies are and how there is potential for conflicting policy language that does not provide adequate guidance for OPOs. A member added that his OPO tries to identify the MOT candidates first but acknowledged that better guidance for OPOs is needed to identify which organ combinations have higher priority. Another member acknowledged that identifying the priority is challenging because it depends on the individual patients.

Several members noted that organ turndowns also impact both kidney alone and multi-organ candidates when the OPO is trying to reallocate one or multiple organs.

Comment about needing strong policies to hold both OPOs and transplant centers accountable when trying to allocate organs.

Members expressed support for future efforts to consolidate the multi-organ policies.

OPTN Operations & Safety Committee | 03/13/2023

The Operations and Safety Committee thanks the OPTN Ad Hoc Multi-Organ Allocation Committee for their efforts on the Identify Priority Shares in Kidney Multi-Organ Allocation white paper. 

The Committee voiced support of the requirements listed for the required kidney shares being a good start. The Committee voiced concern for pediatric kidneys and these being a small group of patients who fall through the cracks with multi-organ offers. There is concern that as more kidneys are combined with other organs, this will affect pediatric patients.

The Committee commented that there should be clear education and support once this project gets to a point of being made into policy and that guidance should be in place if there are multiple multi-visceral cases in determining how these offers are ranked in comparison to the kidney list. Allocation is becoming more complex and when adding in these different rules, the lists that OPO members receive do not necessarily align with the rules so OPOs are constantly trying to figure out how to move forward. It was commented that this is a complication of the system and there are many variables attributed to this so there should be consideration in terms of how this comes across for the training for the OPO staff members who are involved. The Committee cautioned that the more complex these cases become, the likelihood of an error occurring increases.

Anonymous | 03/13/2023

Multiorgan candidates are prioritized above all kidney-alone transplant candidates, which negatively affect pediatric kidney transplant wait times. Poorer outcomes are seen when pediatric patients are passed over for multi-organ candidates or other population groups. Growth and developmental problems can be permanently impaired when passed over for transplantation. I am in favor of requiring offering the second kidney to a kidney-alone candidate when one kidney is offered to a multi-organ candidate as well as prioritizing certain groups above multiorgan listings. For example, Kidney-Panc transplants receive some of the lowest KDPI organs which should go to a medical urgent, pediatric patient or previous living donor first.

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The American Society of Pediatric Nephrology | 03/13/2023

The American Society of Pediatric Nephrology (ASPN) appreciates the opportunity to submit comments to the Organ Procurement & Transplantation Network (OPTN) on the multi-organ allocation concept paper. In current kidney allocation, children are prioritized- but only for kidneys with a KDPI <35 percent. This helps direct high-quality kidneys to patients with a long-expected lifespan, but also effectively limits the pool of kidneys to which children have access. Multi-organ candidates are prioritized above pediatric kidney-alone candidates in the current system and are, on average, receiving kidneys with KDPI <35%, despite having significantly lower patient and graft survival. Based on published data, a pediatric kidney candidate was bypassed for a multi-organ candidate approximately 1.6 times per week between 2015 and 2019.  

ASPN strongly supports addressing this issue by prioritizing pediatric candidates above multi-organ candidates, including kidney-pancreas candidates, in allocation. An allocation policy that prioritizes one kidney from each donor for kidney-alone candidates could be a highly effective means to do this. It is simple, would allow immediate and rapid allocation of one kidney, and preserve access to transplant for both pediatric and critically ill multi-organ candidates. Additionally, it would function similarly under both the current KAS and any future Continuous Distribution system.

The Society also strongly supports clarifying existing policy to state that a kidney, once accepted by a kidney-alone candidate, cannot be reallocated to a multi-organ ‘required share’. This type of reallocation is a violation of long-standing OPTN policy, places undue burden on patients and families who travel to the transplant hospital only to have their hopes dashed, and creates confusion and mistrust in the system.  

Kidneys are typically the last organ to be allocated, as OPOs must wait to see if they are needed for a multi-organ transplant. Kidney-alone patients often wait as ‘back up’ until the last moment, when patients need to be rushed in to their transplant centers or risk the kidney accumulating longer cold ischemia time. Establishing policies that allow for definitive allocation of the kidney prior to the operating room would make the process more timely and efficient.

The Society applauds the OPTN for addressing critical concerns with multi-organ allocation and looks forward to policy changes that correct these long-standing problems.

Anonymous | 03/13/2023

Changing priorities for allocating organs that currently go to dual organ transplant adults. The priorities increase the priority of children, so that some of these organs are mandated to be offered to a child.

Anonymous | 03/11/2023

Prior living donor (for kidney and liver) needs to be a trump card factor, placing those individuals above all other recipients. These heroes voluntarily donated, and were intensively screened for initial and prospective good health. Their need represents unusual misfortune or screening failure. EXISTING LIVING DONORS HAVE BEEN PROMISED THIS PRIORITIZATION. Future living donors will be disincentivized if this is one among many factors. These donors graciously provide a higher quality organ than any deceased donor. As a potential recipient, I feel living donors ethically and practically deserve our highest gratitude and priority. Living donors are the area of greatest potential donor growth, PLEASE DON’T SCREW IT UP!

Ron Wolfson | 03/11/2023

I strongly advise UNOS to maintain priority status for living kidney donors who themselves need a kidney at some point. I and my family was assured that should the need arise, I would be “first in line” for a cadaver kidney. To “de-prioritize” living donors will devastate the number of people willing to donate! Please do not change your policy!

Region 9 | 03/09/2023

During the discussion, an attendee expressed support for the allocation of kidneys to some kidney alone candidates, and that an inordinate number of low KDPI kidneys are going to multi organ transplants when some should be prioritized in other ways. The attendee added they were supportive of the safety net, but cautioned there is a downside, for example, when a multi-organ patient in need of kidney may not do well if an older liver is given, and then the safety net provides them a much better kidney that they don’t need. The attendee continued that programs should be encouraging living donation for multi-organ kidney candidates. Another attendee was concerned to hear that a good kidney that could go to a pediatric candidate is going to a multi-organ candidate instead, and that while kidney transplant is increasing, the additional organs being recovered are harder to place DCD and older kidneys. The attendee continued to say that the committee needs to seriously consider the risk of dying without a transplant. Another member remarked that the safety net is too generous, allowing high quality kidneys to be taken away from more appropriate candidates, and that EPTS should be taken into consideration for multi-organ and safety net candidates to help provide balance. The member added that there should be consideration for adjusting the priority of safety net candidates in the allocation sequence. Another member said that we have so many predictive analytics, so these should be built into the allocation system. There was an additional comment encouraging review of programs who repeatedly accept multi-organ allocations and end up not using one of the organs, as well as a review and assessment of multi-organ patient outcomes. Another member expressed support reserving one kidney for kidney-alone candidate allocation. A member stated that there are multiple important issues that disadvantage low EPTS, kidney-only candidates from getting access to the best low KDPI kidneys that need to be addressed.

OPTN Ethics Committee | 03/08/2023

The OPTN Ethics Committee thanks the Ad-Hoc Multi-Organ Transplantation Committee for the opportunity to provide feedback on this proposal. The Committee agrees with the goal of updating the framework for kidney multi-organ allocation but encourages the MOT Committee to keep the following considerations in mind.

It is reasonable to have required kidney shares to some kidney-alone candidates prior to multi-organ candidates based on a candidate’s status as pediatric, highly sensitized, and medically urgent to improve post-transplant outcomes. A more nuanced definition of when someone may require a kidney may help add clarity to the proposal. Prioritizing survival and long-term outcomes should be a goal of organ allocation, and it makes sense that heart and lung multi-organ candidates are the most urgent, followed by liver, and then SPK. The Committee supports reserving one kidney for pediatric patients from a donor who may have two potential multiorgan recipients, as well for as 0-ABDR mismatch or identical blood group patients. The Committee suggests further elaboration of the possibility of requiring offering a kidney to go to a kidney-alone candidate, as this may impact equity negatively.

The Committee notes that medical necessity should dictate listing for kidney multi-organ candidates and that in the absence of medical necessity, prior living donors should be given priority over multi-organ candidates. The Committee supports offer acceptance being binding for efficiency- and equity-related reasons.

American Nephrology Nurses Association (ANNA) | 03/08/2023

See Attachment

Attachment

Bhavna Chopra | 03/06/2023

I agree that some kidney alone recipients such as highly sensitized kidney recipients, pediatric recipients, above the multi organ transplant recipients, especially where kidney is not the primary organ driving the mortality risk on these transplant recipients. Kidney after liver safety net can be utilized. Similarly kidney after heart and other organs should also be facilitated.

Region 5 | 03/03/2023

A member commented that there should be uniformity and that OPOs could disadvantage candidates if they are inconsistent. The member suggested to look at the data. Another member pointed out that when there is an increase in the size of a particular resource there is a corresponding increase in behavior. The member suggested to look at the modeling to determine the impact on the increase of the availability of these organs. The member also reminds the committee that it is taking the kidney from a single kidney candidate. A member commented that providing more guidance to OPOs will decrease variability in practice is an important goal. Pediatric kidney candidates should be prioritized to receive offers of appropriate kidneys prior to multi-organ candidates with lower medical urgency. The member explained that this is particularly applicable to adult kidney-pancreas candidates, who should not be prioritized above pediatric candidates for kidneys, where the kidney would be appropriate for the child. The number of pancreas-kidney adult candidates is small relative to the adult waitlist, but is a significant number relative to the pediatric waitlist. There needs to be consideration for prioritizing multiple organ candidates differently based on the candidates’ risk of waitlist mortality. As a pediatric center, it would be great to see guidelines in place for multi-organ allocation. It would be nice to limit multi organ so both kidneys do not go to multivisceral. The member asked to see multivisceral in the match run so that it could help with planning and save time communicating with the OPO. A member pointed out that there are times when the kidneys are released from mandatory share, and then the center is on standby until the organ is placed. A member noted her strong support of the creation of allocation priorities in kidney multi organ transplants. A member suggested the committee to consider living donor kidney transplantation in the group of candidates. In high risk candidates, delayed renal transplantation should be considered so that the low KDPI kidneys are not automatically allocated to patients with a high risk death or graft failure.

Region 10 | 02/28/2023

Several attendees noted that kidney/pancreas transplants should not be considered a multi-organ combination. Kidney/pancreas candidates should be considered kidney candidates who also need a pancreas. Including kidney/pancreas in the multi-organ shares will result in fewer pancreas transplants. Another attendee noted that more data is needed to evaluate the number of times both kidneys from one donor went to multi-organ candidates versus when at least one kidney went to a kidney alone candidate. An attendee noted that, to the degree possible, criteria for multi-organ transplant needs to be standardized and uniform across all multi-organ combinations. The attendee would favor a small subset of kidney-alone candidates that would be allocated first choice of one kidney above multi-organ candidates. Reasonable kidney-alone candidates for such a policy could include prior living donors and kidney candidates without vascular access. There needs to be a policy providing appropriate allocation order among multiorgan candidates, but it needs to be based on acuity or need, not just category of organ. For example, a heart/kidney shouldn’t always have priority over a lung/kidney. Another attendee added that highly sensitized, medically urgent, and pediatric kidney-only candidates should receive priority over multi-organ candidates in some situations. Lastly, an attendee implored the committee to ensure representation from all involved stakeholder organizations, including OPOs.

Region 3 | 02/24/2023

During the discussion, one attendee commented that offering isolated kidneys ahead of multi-organ transplant is difficult for OPOs and there needs to be flexibility in the policy. Another attendee commented that previous living donors who need an isolated kidney should have priority over multi-organ transplant candidates. One attendee commented that there should be similar eligibility criteria for kidney pancreas candidates as with simultaneous liver and kidney candidates. Another attendee commented that while they were generally supportive, they did not agree with requiring one kidney to go to a kidney-alone candidate when offering multi-organs due to the potential to adversely affect patients awaiting multi-organ transplants. One attendee supported some controls and prioritization for highly sensitized kidney patient, but added that multi-organ recipients are very sick, making it harder to get them organs. They went on to recommend that this should focus on using more of the kidneys we recover before denying this very small number of patients kidneys they need. Another attendee commented that patients truly needing multi organ transplants do better with both organs. They went on to comment that the issue becomes when high quality kidneys bypass pediatric patients, prior living donors, high PRA patients and other vulnerable populations. One attendee recommended monitoring multi-organ listing criteria for trends and lessons learned. 

OPTN Pediatric Transplantation Committee | 02/23/2023

The OPTN Pediatric Transplantation Committee thanks the Ad-Hoc Multi-Organ Transplantation Committee for the presentation and opportunity to provide feedback. The Committee is in favor of the proposal, especially as it relates to prioritizing pediatric candidates over some multi-organ candidates – specifically kidney-pancreas adult candidates. Issues raised for the MOT Committee to consider include: 

• First, some concern was noted with prioritizing highly sensitized kidney candidates over pediatric candidates as the highly sensitized candidates already receive significant priority. 

• Additionally, there may be a consideration to reduce the priority that kidney-pancreas candidates get with respect to other multi-organ candidates because the mortality risk for KP patients on the waitlist has been reduced with advances in treatment for diabetes

The Committee is in favor of prioritizing kidney offers for medically urgent candidates, candidates needing more than two organs, and pediatric candidates. 

 The Committee recommends against prioritizing subsets of pediatric candidates instead of prioritizing children as an overall group. Patient and graft survival for pediatric candidates is longer than that anticipated by adult candidates. Poorer outcomes are seen when pediatric patients are passed over for multi-organ candidates or other population groups. Although waitlist mortality is low for children awaiting kidneys, the growth and developmental problems children face are severe and can permanently impair their potential for both. The Committee is in favor of requiring offering the second kidney to a kidney-alone candidate when one kidney is offered to a multi-organ candidate; we anticipate that this will avoid disadvantaging pediatric patients while maintaining some level of priority for multi-organ candidates. The Committee is also in favor of policy dictating an allocation order across heart-kidney, liver-kidney, lung-kidney, and pancreas-kidney based on medical urgency, mortality, and safety net eligibility and suggested that these could be handled by review boards. 

Regarding clarifying binding organ offer acceptance, the Committee suggests using the primary offer mechanism. Regarding how the OPTN can provide more direction in policy without impinging on an organ procurement organization’s (OPO’s) ability to place organs efficiently, the Committee suggests clarifying what OPOs can and cannot do once an offer is sent to a program. In general, the Committee is in favor of the proposal and suggests that the MOT Committee carefully consider pediatric impact moving forward.

Region 2 | 02/21/2023

One attendee suggested educating programs that list a candidate for multi-organ, when the second organ is not medically necessary. It is not just a problem for kidney alone candidates, but also for liver alone candidates. Such education efforts may help to reduce the number of unnecessary multi-organ transplants. Additionally, it is important to ensure balance of access based on need of transplant. Another attendee noted that any future limitations on multi-organ transplants need to be organ combination specific. Rule outs for heart/kidney transplants may not be the same for heart/liver transplants. The Regional Councillor added that the community needs to see more data around the kidney after liver safety net as well as how much access to quality kidney transplantation the EPTS candidate population is obtaining. This data is needed so that the community can best identify kidney priority shares. In terms of allocation, an OPO attendee noted that the OPO community would welcome more direction and less flexibility with multi-organ sharing. It is difficult for OPOs to make decisions regarding priority of allocation. Another attendee suggested that when allocating kidneys, one should be allocated to multi-organ candidates and the other kidney should be offered to kidney alone candidates. There is data that shows outcomes are better for single organ recipients compared to multi-organ recipients. Another attendee noted that more needs to be done to show that multi-organ recipients who receive a kidney do satisfy demonstrable medical need for the kidney, and that they receive a kidney commensurate with their age and EPTS score. Lastly, an attendee noted concern with focusing solely on KDPI as criteria to allocate kidneys. KDPI is not really accurate for pediatric donors, so you could be diverting very good kidneys with a >20 KDPI from a child/adolescent because we are applying an adult measure to pediatric donors.  

Region 4 | 02/21/2023

Several attendees were supportive of the work of the Multi-Organ Transplant committee and commented that one kidney should go to a kidney-alone candidate and the other kidney to a multi-organ recipient. They went on to comment that we need to prioritize offers to multi-organ candidates based on medical urgency. One recommendation was to establish a scoring system that put all multi-organ transplants on a single list, adding that this may help OPOs and allow more low KDPI kidneys to be allocated to the kidney-alone list. Two attendees supported giving priority to kidney/pancreas candidates to improve the utilization of pancreata. Several attendees supported giving priority to pediatric candidates ahead of multi-organ transplants. One attendee added that data shows that pediatric transplant rates vary based on how close pediatric kidney candidates are to multi-organ transplant centers. They went on to comment that the increase in multi-organ transplant allocation disadvantages children and kidney alone candidates.  One attendee was concerned about limiting options for Heart/Kidney candidates as these candidates don’t have great options without a kidney. They went on recommend getting more data about outcomes for these recipients before proceeding. There was also a request for data showing: The relationship between KDPI and multi-organ transplant patients and graft survival, the volume and timing of offers for multi-organ transplants stratified by KDPI, waiting times for SLKs vs. pediatric and other renal recipient groups, patient and graft survival for multi-organ transplant vs. kidney alone (peds, prior living donors, etc.) recipients, multi-organ transplant patient survival on the list vs. post-transplant. They went on to comment that we may have reduced death on the waiting list but increased post-transplant mortality.

OPTN Kidney Transplantation Committee | 02/14/2023

The Kidney Committee thanks the MOT Committee for the presentation and the opportunity to provide a public comment on the concept paper. The Committee supports the concept of prioritizing kidney-alone candidates or limiting the number of kidneys going to MOT combinations in general. Committee members commented medical need should be a consideration, and kidneys should be prioritized for those candidates who are medically urgent and would not survive without a kidney transplant, even if they are multi-organ candidate. Committee members also commented kidney-alone pediatric candidates should receive priority compared to some MOT candidates. The Committee generally agreed with the Multi-Organ Transplantation Committee's list of kidney candidate populations who should be considered for priority relative to multi-organ candidates. Additionally, the Committee commented simultaneous kidney-pancreas should be considered separately from other organ combinations (ex. simultaneous liver-kidney or heart-kidney). There was also support for cases where one kidney is used for an MOT transplant, reserving the second kidney for a kidney-alone candidate. A member commented an increase in MOT transplant candidates dramatically affects the kidney-alone candidates, even with safety net rules. Members also commented the decision on how the organ combinations are allocated should not be left to OPO’s. Committee members suggested reviewing data on how many donor kidneys are allocated as pairs for MOT transplant versus a single kidney.

JONDAVID MENTEER | 02/09/2023

I appreciate the goals of this proposal, and in general I am not opposed to the idea of having some kidney recipients considered before MOT candidates. I also appreciate that pediatric kidney recipients deserve additional consideration as they are disadvantaged by a current system that allows potential donors to go to adult MOT recipients. However, pediatric heart-kidney candidates are a tiny and very ill population, and would be ill-served by a policy that favors prioritization of a pediatric kidney-only recipient over a pediatric heart-kidney candidates. These patients often get few offers before death after waiting months on the waitlist in critical condition, and may die on the waitlist if pediatric kidney single organ recipients are favored by a policy such as this one. The same proposal with exception that pediatric heart kidney transplant recipients (especially those under 1.3 m2) could be top priority would be acceptable.

UCSF Immunogenetics and Transplantation Laboratory, Director: Rajalingam Raja | 02/07/2023

We welcome placing the highly sensitized candidates with a CPRA 98-100% for kidney offers over multi-organ candidates. The MOT committee should consider adding the previous kidney donors to this group.

Anonymous | 02/02/2023

Is there a way to "pay back" or add priority to a kidney only recipient that has been passed over multiple times due to multi-organ allocation?

Anonymous | 02/01/2023

I support the proposal, specifically including prioritization of high cPRA kidneys and SLK, Heart Kidney and Lung Kidney.

Steven Weitzen | 01/29/2023

It only makes sense to identify priority shares for purposes of equity.